chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse via medical assistant and refers to a 13-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M039317; expiry date: 20-SEP-2018) for prophylaxis. The dose of VARIVAX was reconstituted with properly stored sterile diluent (MERCK). The doses of VARIVAX were exposed to temperature ranges between 6° Fahrenheit (F) to 14°F during a time frame of 1 hour 20 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported. Product Quality Complaint (PQC) was not involved. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1710USA014649: Original Case: 1709USA008666: US-009507513-1710USA014650: US-009507513-1710USA014651: US-009507513-1709USA008666: Original Case: 1709USA008666.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 62-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 5th March 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site lump, injection site rash, injection site erythema, injection site warmth, pain in arm and swelling arm. On an unknown date, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the injection site lump, injection site rash, injection site erythema, injection site warmth, pain in arm and swelling arm were recovered/resolved and the outcome of the activities of daily living impaired was unknown. The reporter considered the injection site lump, injection site rash, injection site erythema, injection site warmth, pain in arm and swelling arm to be probably related to SHINGRIX. It was unknown if the reporter considered the activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The patient developed a knot the size of an orange at the injection site after a dose of SHINGRIX on left deltoid. The injection site was warm and hot. The patient developed a 3 inch wide rash underneath the injection site, swelling down the arm where the injection was given, and soreness in the arm in which the vaccine was given. The arm soreness interfered with the patient's activities of daily living for 3 weeks. The adverse effects lasted about one month.
17 year 7 month old female was given the 1st Moderna vaccine; A spontaneous report was received from a pharmacist concerning a 17 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No concomitant medications were reported.  On 23 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), for prophylaxis of COVID-19 infection.  The pharmacist reported and called in for guidelines that a 17 year 7 months old female patient was given the first COVID-19 vaccine on 23 JAN 2021 and wanted to know if they should give the second dose. The patient was not pregnant. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, inappropriate age at vaccine administration, was considered recovered.; Reporter's Comments: This case concerns a 17 year old female who received her first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
38 year old G3 P2 22 week *pregnant no complications. At approximately 11:33 the patient reported hives to upper arms and axilla, Denies SOB, swelling to lips, eyes, tongue and  throat,  diaphoresis, N/V chest pain or abdominal pain. Medicated with 25 mg of Benadryl. by mouth
MUSCLE AND JOINTS SWELLING, STIFFNESS AND ACHING, ELEVATED BLOOD PRESSURE, SLEEP DEPREVATION, IRRITABILITY, ARTHRITIC TYPE JOINT PAINS TO SPINAL REGION-SHOULDER-KNEES AND ANKLES, NUMBNESS TO RIGHT FRONTAL FOOT AND GREAT TOE, ATTENTION DEFICIT DISORDER, LOSS OF MEMORY, AND NIGHT SWEATS, STRESS ISSUES, INCREASE IN HIGH PITCHED TINNITUS.
Bell's Palsy; This is a spontaneous report from a non-contactable nurse (patient's wife). A 4-decade-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. Medical history included Herpes Zoster (chicken pox and shingles), and hypogammaglobulinemia from an unknown date. The patient's concomitant medications were not reported. The reporter asked if her husband should receive his 2nd dose of vaccine after experiencing Bell's Palsy 12 hours after 1st dose. The patient had history of herpes zoster (chicken pox, shingles) on the same side of his face as the paralysis now (Bells Palsy). The patient was in a lot of pain and asked how serious Bell's Palsy is. Outcome of the event was unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.; 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 Bell's palsy cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
This spontaneous report as received from a pharmacist via field representative refers to a patient of unknown age. On 17-NOV-2014, the patient was vaccinated with ZOSTAVAX vaccine (strength, dose, route of administration, anatomical location, lot # and expiration date not reported). No concomitant medication was reported. On an unknown date in November 2041, the patient developed full blown shingles. The outcome of the event was reported as not recovered/not resolved. The causality of the event was unknown. The patient sought medical attention. The pharmacist saw the patient on 21-NOV-2014. The patient was also seen by an unspecified physician. A product quality complaint (PQC) was not involved. Additional information has been requested.
Heavy bleeding starting 10 days after my last period ended (I usually have a 30 day cycle).
08/13/99 pt received vax. 09/01 pt developed severe rash with over 100 lesions with fever of 102.6. Lesions were vesicular, itchy rash located mainly in the pharynx and head, not to lungs or brain. Sought medical treatment and was placed on 800 mg QID acyclovir. Also noted that he lost 4 pounds during course of illness. He recovered.
got tired after the first vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "got tired after the first vaccine". Additional information: I got tired after the first vaccine and mentioned that it could be because her age was 78, just in general. She don't have any symptoms. She was scheduled on 08Jun2021 for the second one.  No follow-up attempts are possible. No further information is expected.
She had a reaction; This spontaneous report was received from a consumer, via Pfizer, and refers to her daughter, a 1-year-old female patient. No inforamation was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (dose, route, lot number and expiration date were not reported) and had a reaction to the vaccine. The outcome of the event was unknown.  The event was related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).
Had fever and muscle pain and stiffness, could barely walk the night of the 17th.  Profound fatigue on the 18th. Felt better on the 19th, but that night my heart was racing( pulse was 120) sweating, dizzy, lightheaded. From the 17th until today, having these same issues.  Havent seen a doctor yet because I don't have health insurance.
Provider ordered "DTaP4" and "Hepatitis B4", medical assistant gave Pediarix and Hepatitis B vaccine.
Pt came in 9/22/04 gave IPV (IM), MMR SQ on right arm, DTaP given LA IM, pt back next day due to reaction, swollen, red, hard right arm, checked by doctor.
Patient developed cellulitis at injection site.  70% of the arm with inflamed. Patient experienced fever, sweating, and aching arm.
nausea; vomiting; Dose of VARIVAX was accidently given to a pregnant woman at 11 weeks gestation. She was taking unspecified prenatal vitamins prior to administration and was prescribed the following the day of her appointment: ASPIRIN 81 MG, GINGER 500 MG, ONDANSETRO; VARIVAX was accidently given to a pregnant woman; This spontaneous prospective pregnancy report was received from a nurse practitioner, regarding a 20-years-old female patient. The patient's pertinent medical history included tachycardia as current condition. The patient's previous drug reactions or allergies were not reported. Concomitant medication included prenatal vitamins (not specified).  On 17-OCT-2022, at 11 weeks of gestation(last menstrual period was not reported, approximately on 01-AUG-2022), the patient was accidentally vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 0.5 milliliters subcutaneously as prophylaxis (lot number: U025205, which was determined to be valid, with an expiration date on 13-AUG-2023) (scheme and anatomical location of administration was not reported) (exposure during pregnancy) (Contraindicated product administered).  On an unspecified date, the patient was also vaccinated with a flue vaccine (not specified, manufacturer unknown) and a Covid-19 vaccine (not specified, manufacturer unknown) (strengths, doses, schemes, routes and anatomical locations of administration, lot numbers and expiration dates were not reported).  On 17-OCT-2022 (reported as after vaccination), the patient experienced nausea and vomiting. The outcome of the events was not reported.  The pregnancy outcome was not reported at the time of the report therefore, the fetal outcome was unknown. No additional adverse event was reported.  The patient was prescribed on the day of her appointment acetylsalicylic acid (ASPIRIN), ginger, ondansetron, pyridoxine and doxylamine, but by the time of the report it was unclear if she started these medications.  The causal relationship between nausea and vomiting and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
This spontaneous report was received from a Licensed Practical Nurse, referring to herself a non pregnant female patient, via a company representative, with unknown age. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose, frequency, route of administration, lot/batch number and expiration date were not provided). No concomitant medication was reported. On an unknown date, after receiving ZOSTAVAX, the patient experienced a large red swollen area around the injection site that lasted about a week. The patient sought for medical attention (unspecified) and was treated with prednisone (manufacturer unknown). The outcome of the events, was reported as recovered on an unspecified date which "lasted about a week". Additional information is not expected since no permission was given for further contact.
Headache, Fever, Injection site tenderness, Mild fever,body aches, chills , fatigue, left axillary lymph node. Narrative:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Lot number: fk9895) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive, notes: Had Positive Antigen test and positive symptoms on 25Jul; (31Jul2022) Negative, notes: antigen test negative on 31Jul; (03Aug2022) Positive, notes: Super strong positive antigen test on 03Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received Anti-viral treatment of Paxlovid from 25Jul2022 to 30Jul2022 for COVID-19. Vaccine administration time: 09:00 AM.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Pt recvd vax 6AUG92 & following vax devel t103 & flu-like sx for a duration of 4 days; 16AUG92 devel rash w/areas of vesiculation & intense pruritis; 26AUG92 devel skin desquamation;
Initial misuse report received from a healthcare professional on 19 JUNE 2013. A 16-year-old patient had received a dose of ADACEL on 24 APRIL 2012 and then again on 17 JUNE 2013 not realizing had received dose in 2012. No adverse event was reported. Documents held by sender: none
Diarrhea; muscle aches; extreme fatigue; Headache; This is a spontaneous report from a contactable consumer (patient's wife). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via unspecified route on left arm single dose for keeping from getting COVID on 21Jan2021 at 68-year-old. No medical history and concomitant medication. The patient had headache and diarrhea on 22Jan2021, muscle aches and extreme fatigue on 23Jan2021. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the event diarrhea was resolved on 25Jan2021; outcome of the other events was not resolved.
it's an auto immune which I believe got triggered after the vaccine; developed Lichen Planus in the mouth; This is a spontaneous report form a contactable consumer (patient).   A 39-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 (Batch/Lot number was not reported) at the age of 38-year-old,  as single dose for covid-19 immunisation. The patient had received the first dose of the same vaccine on unknown date. The patient medical history was none. The patient's concomitant medications were not reported.  On 22Apr2021 at 12:00 AM after the second dose of Pfizer COVID Vaccine, he developed Lichen Planus in the mouth, it's an auto immune which he believes got triggered after the vaccine. The outcome of the events was not recovered. The patient received an unspecified treatment. No covid prior vaccination and no covid test post vaccination.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
This spontaneous report as received from a nurse via company representative refers to many male patients of unknown age. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route were not reported). The nurse reported that on an unknown date, many male patient have passed out while on GARDASIL. Action taken with GARDASIL was unknown. The outcome of passed out was unknown. Upon internal review, the event passed out was considered as medically significant. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2014, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Rash, chest pain, tachycardia, numb tongue, hard to swallow
back pain; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "not recovered", described as "back pain". Additional Information: The patient would like to know if it is fine to take steroids. She had her 1st dose last 23Mar2021 and she was currently experiencing back pain and would like to take steroids.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Rash developed within 48 hours. Rash spread slightly as time lapsed and was hot to the touch. Patient was advised to take Benadryl and have it checked by medical doctor as soon as possible.
4/3- 10:45 am Shot given.   Immediate warm feeling in arm 11:00 am  by the end of the waiting period arm hurt, felt heavy and stiff 12:00 pm dull headache, loss of appetite 3:00 pm low grade temp: 99.1 body aches 6:00 pm temp: 100.2, husband noticed left arm was severely swollen, tight, and hot.  No rash or change in color. 10:00 pm  and Throughtout the night:  Chills, sweats, severe body aches, severe headache (could barely lift my head off the pillow), elevating fever, left arm felt heavy, hot and swollen,  4/4-5:00 am temp: 102.9, took 600 mg ibuprofen  Slept well  8:00 am:  temp 100 No body aches, chills, sweats.  All other symptoms continued About 1:30 pm temperature increased again.  It topped out at 101.5 in the evening.  Took 600 mg ibuprofen.  Slept all night.   4/5- wake up temp: 99.1  continued headache, nausea, heavy feeling throughout body  Temp throughout the day ranged from 99.1-99.7.   Headache dissipated about mid-day.   4/6- temp 98.5 upon wake up.  By mid-morning all symptoms had dissipated, but still linger in the background.  More energy.   4/7- normal temperature.  Increased energy, returned to work.  Mid-day, mild tummy issues and lightheadedness returned.
Patient has red circle on left thigh the size of a quarter. The area is warm to the tough and painful to patient. Patient will start Cephalexin 250mg/5ml he will take 3 ml by mouth 3 times a day for 10 days. Also he will take Benadryl 2.5 ml by mouth every 6 hours as needed for 3 days.
PT COMPLAINED THAT INJECTION SITE WAS BOTHERING HER ON 20 AUG 09. REDDENED AREA MEASUROING 30MM X 65MM ON MEDIAL ASPECT OF RIGHT UPPER ARM. 20MM OF INDURATION NOTED WERE INJECTION WAS GIVEN.
Pt experienced hypotension, headache, dizziness, difficulty breathing, pallor, diaphoresis shorthly after vaccination.
Woke up with what seemed to be a mild outbreak of Chicken Pox, red, blistery pustules on hands and feet and trunk area. Developed, severe, chronic hives in June 2013 and continues to worsen over time, with no help from any doctors.  She has now developed Angioedema, whole face swells, develops severe respiratory distress, gastrointestinal problems, including vomiting and diarrhea, severe headaches, depression, shaking, allergies.  She basically is a different child with numerous health problems with no explanation and no cure.  My daughter has 2 epi pens kept near her at all times, one with her and one is kept at school.  Have spent so much money and numerous specialists to try to find answers to no avail.