chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 54 years old male patient who received two doses of vaccine FLUBLOK QIV in a year. The patient's past medical history and concomitant medication were not provided. On 26-Oct-2018, patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine, lot QFAA1821 (expiry date:30-Jun-2019) via unknown route in the left deltoid. On 14-Nov-2018, the patient again received a 0.5 ml dose of suspect Influenza Quadrivalent Recombinant Vaccine, lot QFAA1821 (expiry date:30-Jun-2019) via unknown route in the left deltoid. It was a case of actual medication error due to extra dose administered. As per recommended dosage schedule, FLUBLOK QIV should be given once in a year. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I woke up with like ringing in my ears or hissing and it never stops; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization.  On an unspecified date, in Feb2021, the patient reported "I received my second dose of Pfizer vaccine on the Feb 22nd which was almost two weeks ago and the day next morning after the second dose I woke up with like ringing in my ears or hissing and it never stops. I just wanted to know if this been reported by anybody, was it a possible effect of the vaccine." Outcome of the event was unknown.  No follow-up attempts are possible. No further information is obtained.
After I received the second shot my right hip started hurting to the point I can still barely walk. Chills, mild headaches, stomach pains, indigestion issues, fatigue, sleeping more than 12 hours a day began after the 1 shot  1 & 1/2 weeks. Chills remaining after 2nd shot, weakness in right hip/groin area, sleeping more than 12 hours a day on weekends, fatigue, headache, loss of appetite, dizziness and overall feeling not like myself.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of PROQUAD (lot # M003434 with expiration date 19-JUL-2017, lot # L044056 with expiration date 02-MAY-2017; dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
itching around the site of injection; Sore arm around the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching around the site of injection) and VACCINATION SITE PAIN (Sore arm around the site of injection) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No relevant medical history reported.  Concomitant products included TRAMADOL, PREDNISONE and TORSEMIDE for an unknown indication.   On 16-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching around the site of injection) and VACCINATION SITE PAIN (Sore arm around the site of injection). At the time of the report, VACCINATION SITE PRURITUS (itching around the site of injection) and VACCINATION SITE PAIN (Sore arm around the site of injection) outcome was unknown.            No treatment drug reported.  Patient asked if she should put and ice pack on it or use cortisone cream. Patient mentioned she has only one lot and she was not sure whether its from the first vaccine or the second vaccine
I ended up having really bad itching in my head and scalp, palms, and on my head. It went to my feet and hands. They burned really bad. There was pain and then my skin was sensitive all over. Like pinching needles. That has worsen tremendously. I have Blood Pressure now. I have never had Blood Pressure before. Its mainly just the pain in my hands and legs and burning and high blood pressure. I do not have itching anymore it just comes and goes now. I went to the doctor the second week of May with my PCP and she sent me to an immunologist and allergy doctor. The allergy doctor sent me to the neurologist. They sent me to the ER. Then I went to the cardiologist. The cardiologist sent me to the dermatologist. I had a biopsy to see what is going on with my hands. They have done ENG test, electrocardiogram, blood work, pretty much everything. Everything came back normal.
Nausea, headache, fever, chills, body aches, severe arm tenderness, swelling, warmth and redness and fatigue; Tylenol, Pepcid, fluids and rest; approximately 24hrs
Reports that it has been 11 days since he received his 2nd COVID-19 vaccine and he is running a temp of 102. He has a continuous cough, headache, chills, diarrhea, fatigue and sore throat. There is SOB at times when he coughs. So much, he can't catch his breath. Patient said Tylenol will bring down the temp for about an hour then it shoots right back up.
Information has been received from a medical assistant concerning a male patient of unknown age. On an unknown date the patient was vaccinated with MMR II, subcutaneous. The medical assistant reported that the MMR II was administered to the patient post supported excursion. No adverse effects were reported. Additional information is expected.
Tinnitus in both ears began within 30 days of vaccine series without other cause.  Ear ringing non-stop in both ears and has continued to present.  Extremely high blood pressure spikes were discovered in Septemberof 2022 and I was placed on medication after feeling ill off and on with no known explanation for 1-2 months.  No pre-existing condition or history of high blood pressure prior to the vaccine.
Case number PHEH2013US021248 is an initial spontaneous report received from a consumer (patient's wife) on 10 Oct 2013: This report refers to a 65-year-old male patient. His medical history was not reported. This poly-medicated patient was vaccinated with H1N1 pandemic influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. Since an unknown date he found it hard to walk and his muscles ached. Three to four weeks after taking the shot he could not get off the couch and was sweating and these symptoms led to the diagnosis of diabetes. Reporter stated that her husband got disabled from taking the vaccine. He had to quit work because of it. The wife reported it took them a while to find the cause. No further information about outcome, seriousness and causality was reported.
flu; ingredient in the shot I'm allergic to; Initial information was received on 26-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional via social media. (under reference number: US-SA-SAC20210302000763).  This case involves an adult patient who experienced flu (influenza) and ingredient in the shot I am allergic to (drug hypersensitivity), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and ingredient in the shot I am allergic to (drug hypersensitivity) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.
Pain in the arm for 2 days; Tightness of chest on 2nd day after 2nd shot; black spot about the size of a pencil eraser appear under his nail; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL 3249), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Unknown if had allergies. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown if the patient received any other medications within 2 weeks of vaccination. On 11Feb2021 patient experienced Pain in the arm for 2 days.  Tightness of chest on 2nd day after 2nd shot. One week after 2nd dose, patient had black spot about the size of a pencil eraser appear under his nail.  It lasted 3 weeks until an antibiotic was taken. The problem resolves, but nail is weak and fragile. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment with doxycycline 100mg. Prior to vaccination, unknown if the patient diagnosed with COVID-19. Since the vaccination, unknown if the patient has been tested for COVID-19. The outcome of the events was recovered with sequelae.  Follow-up attempts completed. No further information expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2013, the patient was treated for a vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
6 days following flu shot had onset of pain beginning at top of shoulders & extending to both arms & up back of neck - great difficulty lifting arms & head, as well as difficulty coughing.  Interfered with sleeping.  Denied wheezing, SOB, hives or reddness. Self medicated with Tylenol Q2-3 hours.  Started resolving in 2 days, completely resolved after 4 days. Did not contact MD or seek other medical treatment.
Patient developed erythematous patches on her arms, back and stomach during the evening on 9/11/08.  She was evaluated at the clinic on 9/12/08.  No vesicles.  I spoke with her father on 9/15/08 and he reports that child has recovered.
swollen arm; really uncomfortable; Rash; bullseye like red blood area around the site of injection; lethargy; stiffness of the neck; itchiness on their body; muscle aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (lethargy), MUSCULOSKELETAL STIFFNESS (stiffness of the neck), PRURITUS (itchiness on their body), PERIPHERAL SWELLING (swollen arm) and FEELING ABNORMAL (really uncomfortable) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LETHARGY (lethargy), MUSCULOSKELETAL STIFFNESS (stiffness of the neck), PRURITUS (itchiness on their body) and MYALGIA (muscle aches). On 23-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), FEELING ABNORMAL (really uncomfortable), RASH (Rash) and VACCINATION SITE ERYTHEMA (bullseye like red blood area around the site of injection). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. On 16-Jan-2021, LETHARGY (lethargy), MUSCULOSKELETAL STIFFNESS (stiffness of the neck) and MYALGIA (muscle aches) had resolved. At the time of the report, PRURITUS (itchiness on their body), PERIPHERAL SWELLING (swollen arm), FEELING ABNORMAL (really uncomfortable), RASH (Rash) and VACCINATION SITE ERYTHEMA (bullseye like red blood area around the site of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 23-Jun-2021, the patient experienced a delayed reaction with a swollen arm, intense itching and a bullseye like red blood area around the site of injection. Other concomitant medications included statins. Other treatment medications included lotion, steroid and ice. The patient felt an improvement of 90 percent after receiving hydrocortisone.
Fever to 101.2 x 12 hrs.  Continued fever at 100 through 24 hrs.  Total body aches.  Chills.  Nausea. Severe headache.   All mostly resolved in a total of 36 hrs.
Extreme fatigue; nausea; low grade fever; redness, warmth and swelling of arm from directly below injection site to just above the elbow.
Upper arm swollen, red tender from shoulder to elbow. Skin tight, shiny, red, very painful. Began at VARIVAX site.
Pt recvd 1st dose of HepB on 8MAR91 & a few hrs p/vas exp severe weakness, h/a, malaise, flushing, t102; w/in 2 days the sx subsided spontanteously;
About 3 1/2 hours after receiving the FLUZONE, the patient called & said that she had diarrhea, & felt hot & itchy, & said her asthma was acting up...she didn't think the nebulizer was helping, so advised to go to E.R. if nebulizer not helping.
Anaphylaxis shock, was given a shot of benadryl, put on an ambulance and taken to the nearest hospital. I was on oxygen therapy at the hospital for several hours then sent home.
MD reported pt rec'd 1st dose of vax w/out adverse event; 2nd dose of vax in MAR90, 8wks post vax exp polyarthritis in small & large joints; @ time of report, sx had remitted;
swollen arm, hand, bump/bulge on pointer finger swollen lymph nodes with flu like symptoms  sore, body aches, fever first day  (99.7, 100, 99.5, and saturday night 99.7) nausea, vomiting, sore arm sore sunday: arm swollen, lymph nodes swollen (hard balls)
Chronic arthralgias and fatigue began 6 mons. post anthrax immunization. Impression - unrelated to immunizations.
Body aches, post nasal drip, sore throat, fatigue, tactile sensitivity, joint aches -- last 4 weeks so far.
Severe dizziness, onset early a.m. Monday September 6th, 2021 and continued through Wednesday September 8th, 2021. Lack of appetite during same time frame.
Redness and swelling from elbow to shoulder in vaccinated arm. Started approx 36 hrs after injection. No fever tried cool compress which made symptoms worse.
he's got a diagnosis and it's SARS; he's got a diagnosis and it's SARS; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he's got a diagnosis and it's SARS". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative; positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.  Clinical course: Reporter reported as one of his coworkers has been out sick and in isolation for like 2 weeks. He says he kept testing negative for Covid over and over again but was continually getting worse and had no idea what it was. He said that he's got a diagnosis and it's SARS.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a consumer for VARIVAX (merck), a Pregnancy Registry product, concerning a 19 year old daughter with drug allergy to sulfa, ABILIFY and prednisone who on 05-MAR-2012 was vaccinated with a dose of VARIVAX (merck), (dose and route not reported), (Lot# 671083/0826AA, exp date 02-JUN-2013). There was no concomitant medication. On an unknown date (shortly after vaccination) the patient learned that she was pregnant. The patient did not seek medical attention. No treatment was given for adverse event. At the time of the report the patient's status was not recovered. Additional information was received from patient. Patient delivered a healthy baby boy without any anomalies on 10-NOV-2012 at 39 weeks gestation. The infant was delivered C-section and weighed 9lbs., 6oz at birth. Patient said it was a difficult pregnancy with some preterm labor experienced but was able to carry her baby to full term. Patient also confirmed the VARIVAX (merck), vaccine given while pregnant was the first dose. No further information is available. Upon internal review the infant was delivered C-section was considered medically significant. Additional information is not expected.
2+ months post-vaccination (second dose) patient noted that her card read "Pfizer" for second dose (as opposed to "Moderna" which is what she was told she received). She contacted the SLE Vaccine site--reported the incident. On review, her electronic/EMR documentation states "moderna" was administered as indicated above, however---scanned consent/paper documentation instead says "Pfizer lot EL9266 exp date 5/3/21" was administered on 2/17/21" which reflects what she states her card has written on it. Nurse involved interviewed-unable to definitively confirm which vaccine was actually administered. At the time the vaccine pods had both Moderna and Pfizer in them (no longer procedure).  Findings reviewed honestly with patient--apologies for confusion and resulting concern given.  Shared CDC guidance/summary regarding administration of two different vaccines (specifically that there is no repeated dose and also no immediate danger).
Flu like symptoms Fatigue Headache Swollen eyes Swollen face Shortness of breath Muscle aches  Joint pain
received a late second dose of Shingrix, first dose on 5Jul2018 and second on 21Apr2021; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th July 2018).   On 21st April 2021, the patient received the 2nd dose of Shingrix. On 21st April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
9NOV93 c/o soreness, swelling & heat to lt arm; markedly swollen lt detloid region; tender & painful to touch & painful on abduct/adduct fullness & swelling supra clavicular area-node 1x2 cm; ?cellulitis react to Td vax;
How long should general side effects of the 2nd dose of the COVID-19 vaccine last?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long should general side effects of the 2nd dose of the COVID-19 vaccine last?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long should general side effects of the 2nd dose of the COVID-19 vaccine last?). At the time of the report, VACCINATION COMPLICATION (How long should general side effects of the 2nd dose of the COVID-19 vaccine last?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. List of concomitant medication were not given.
10-hours after vaccination, I experienced an inability  to swallow, tingling sensation in face; lips began to feel swollen, chills. Took a Zyrtec and symptoms went away within an hour.
Congestion, diaphoresis, flushing, tongue tingling, joint discomfort, dyspnea.