chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were not reported) to prevent shingles. Concomitant therapy was not reported. On an unknown date, the patient developed redness at the injection site after receiving ZOSTAVAX and the redness did not go away after a week. The patient sought medical attention by contacting pharmacist. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Mild to moderate neck pain on Monday after injection on Sunday.  Neck pain and stiffness increased Tuesday afternoon and on Wed he was unable to rotate head or hold head up against gravity due to severe neck pain. On Thursday the pain  was moderate but able to sit up  and move around slowly. Still unable to rotate head without pain as stiffness.
Information has been received from a consumer, concerning her female friend (age unspecified), who was vaccinated on unspecified dates, with a first and second dose of Gardasil and subsequently developed ovarian cysts. No further information is available.
Symptoms began on 05/01/21 with fever, rapid heart rate, headache, chest pains, disorientation, nauseous and dizzy spells. I have kept a log of symptoms of when they occur, the time they occur and what the symptom is.
softball lymph node underneath their arm, this was brand new.; really really bad headache.; felt like someone was crushing their bones; a terrible terrible back ache; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (felt like someone was crushing their bones), BACK PAIN (a terrible terrible back ache), ILLNESS (felt sick), LYMPHADENOPATHY (softball lymph node underneath their arm, this was brand new.) and HEADACHE (really really bad headache.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031h21a) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced BONE PAIN (felt like someone was crushing their bones), BACK PAIN (a terrible terrible back ache), ILLNESS (felt sick) and HEADACHE (really really bad headache.). On 20-Nov-2021, the patient experienced LYMPHADENOPATHY (softball lymph node underneath their arm, this was brand new.). At the time of the report, BONE PAIN (felt like someone was crushing their bones), BACK PAIN (a terrible terrible back ache), ILLNESS (felt sick), LYMPHADENOPATHY (softball lymph node underneath their arm, this was brand new.) and HEADACHE (really really bad headache.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-395931 (Patient Link).
Maculopapular dermatoses overlying poster elbows, anterior knees. Occurred 24 hours after yellow fever and typhoid vacc.
wife states had swollen gland & rash 2wk p/vax;not seen by this MD;c/o sore throat & also devel a overall body rash;sx devel approx 2 days ago w/ sore throat; BP 126/94, resp 14, T96.8;scattered papules, erythematous vesicle;
Patient had been sitting in observation around 5 minutes , vomited large amount emesis.  Denies feeling nauseated prior, stated  it just came up , taken to EMS room cleaned up , tolerated 1/2 cup water , no further issues.  Left clinic no issues feeling fine.
Tested NAAT positive for COVID 11/11/21 after being fully vaccinated.
I have received all 3 Lymerix vaccine shots. The last being on 11/17/00, within a few months of the 1st vaccinations on 12/99 and 11/99. I began experiencing soreness and stiffness in both wrists and my right elbow. It has continued and seems chronic.
we're still sick from that shot; she has terrible muscle pain; nausea; headache; joint pain; we had a real adverse reaction to it; spasms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (we had a real adverse reaction to it), ILLNESS (we're still sick from that shot), MYALGIA (she has terrible muscle pain), MUSCLE SPASMS (spasms) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051E21A and 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter .  Concomitant products included PAROXETINE for an unknown indication.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced VACCINATION COMPLICATION (we had a real adverse reaction to it), MYALGIA (she has terrible muscle pain), MUSCLE SPASMS (spasms), NAUSEA (nausea), HEADACHE (headache) and ARTHRALGIA (joint pain). On 20-Sep-2021, the patient experienced ILLNESS (we're still sick from that shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (we had a real adverse reaction to it), ILLNESS (we're still sick from that shot), MYALGIA (she has terrible muscle pain), MUSCLE SPASMS (spasms), NAUSEA (nausea), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2021, Body temperature: 102 (High) Patient  had highest temperature she recorded was 102 degrees Fahrenheit..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 18:00 as dose 4 (booster), single (Lot number: G55342) at the age of 42 years, in left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient received PAXLOVID as COVID 19 Treatment from 18Sep2023 to 23Sep2023.
Pt developed progressive facial drooping and ptosis on R side over the course of the day on 9/3/14. Seen at urgent care and treated for Bell's Palsy with oral acyclovir and prednisone.  Symptoms were approximately 50% improved within 24 hours.
4/3 extreme fatigue, chills, body aches and multiple fevers, sore arm 4/4 fatigue, minor body aches, headache, sore and slightly swollen arm at injection site, arm was red and warm, right side of jaw was sore 4/5 swollen sore upper arm including shoulder, redness from elbow to shoulder, neck pain with knots and headache mostly on right side of head 4/6 swollen arm and hard, warm with redness. Headache in am.  Getting relief with Ibprofen and benadryll.
Trigger thumb; This is a spontaneous report from a contactable Other HCP (Patient). A 51-year-old female patient (Not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), second vaccination dose via an unspecified route of administration at the age of 51-years, administered in the right arm on 12Feb2021 15:00 (Batch/Lot Number: EL9269) as single dose for covid-19 immunization. Medical history included narcolepsy. First dose of bnt162b2 was administered on 18Jan2021 for COVID 19 immunization, lot EL3246, in the right arm. Concomitant medications included escitalopram escitalopram oxalate (LEXAPRO 10mg), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL 30mg) and valaciclovir hydrochloride (VALTREX 500mg). It was reported that patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Also, patient was not diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 after the vaccination. Since the vaccination, patient had not tested for COVID-19. Patient had no allergies to medications, food, or other products. On 13Feb2021 at 11:00, the patient experienced trigger thumb. Patient was not received any treatment for the event. The patient was not recovered from the event. The reporter considered there was a reasonable possibility that the event was caused by bnt162b2.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
SHAKING; HEADACHE; This spontaneous report received from a patient concerned a 26 year old female. 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-APR-2021, the subject experienced shaking. On 26-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shaking, and had not recovered from headache. This report was non-serious.
Pt vaccinated with MMR/HIB TITER developed fever, listless x 2 days (102); 30NOV brokeout w/rash became cranky, arching her back. Dx virus.
In 4 days patient reported lightheadedness. About one week after more leg weakness. 2-2 1/2 weeks after episode with stomach cramping and diarrhea.
Cold, blurred vision, headache (feels like swelling pressure of brain), cough, labored breathing (heavy chest), nausea. Was feeling better on Wednesday 09/25/13.
Info has been received from a surgical supply company concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #64116/1160L). Subsequently the pt developed a 3" red spot on the right bicep which lasted "for a long time". Unspecified medical attention was sought. "Dr. requests a lot check".  The reporter also mentioned 2 other pts (WAES #0303USA00409 and 0303USA00571).  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
states she is on traveling tour and was notified of exposure to covid on Friday 10/8. Pt completed at home pharmacy nasal swab/rapid test Sunday with Negative results and this morning Tuesday 10/21 (positive) Pt is not having any symtpoms
Severe Muscle Pain; Injection Site Pain; Fever; Malaise; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, 2 days after receiving Shingrix, the patient experienced muscle pain, injection site pain, fever and malaise. On an unknown date, the outcome of the muscle pain, injection site pain, fever and malaise were unknown.   It was unknown if the reporter considered the muscle pain, injection site pain, fever and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient vaccinated with Shingrix and was experiencing severe muscle pain, injection site pain, fever and malaise. The reporter did not consent to follow-up.
Rashes at the right and left arm, back, chest and everywhere; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes at the right and left arm, back, chest and everywhere) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced RASH (Rashes at the right and left arm, back, chest and everywhere). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Rashes at the right and left arm, back, chest and everywhere) outcome was unknown.            Co-suspect drug includes Unspecified Flu-Shot. No concomitant medications was provided by the reporter.
Died; A spontaneous report was received from a Consumer concerning a patient where age and gender unspecified who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event Death.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the Anatomical location unspecified  for prophylaxis of COVID-19 infection.  On unknown date, The patient experienced the event Death.  Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was Fatal.  The reporter assessed the event Death related to the study drug was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Fever, chills, uncontrollable laughing/crying, out of body experience- 2 hours post vaccination x 8 hours. Extreme nausea, dizziness, fever - 3 days post vaccination. Uncontrollable laughing/crying, chills, fever - 6-8 days post vaccination. PCP visit for symptoms. Given ZOFRAN for nausea - 5 days post vaccination. Out of work and school x 2 days.
Headache, nausea, confusion, photophobia, seizure requiring a call to 911 and a visit the emergency room.
Patient returned to the pharmacy morning of 3/19/18 stating that her arm was still red and swollen and itching beyond just the vaccine site. Upon examination, confirmed redness, swelling and a bit warm to the touch extending almost to the elbow. Patient states that it is still spreading. Slight bruising at injection site noted. Recommended patient see primary care physician to assess reaction.
App. 2 weeks after vaccine, seen in our office with headache, vomiting, and stiff neck.  09/25/2007 Reviewed hospital medical records which reveal patient experienced headache, vomiting & stiff neck along w/fever.  Had cold s/s for approx 1 wk prior.  Admitted 9/6-9/9/07.  Improved & d/c to home on no meds. FINAL DX: Viral meningitis.
pt recvd pedvaxHIB on 27DEC91 & over the ensuing wks a sterile abscess slowly devel; pt presented to MD on 20FEB92 & the abscess was approx 1 cm in size;
This spontaneous report as received from a healthcare worker refers to a female friend of unknown age. Concomitant medication, medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot number were not reported). On an unknown date, after received GARDASIL the patient experienced adverse reaction related to unspecified "hormonal imbalances". The patient received unspecified treatment. The outcome of hormonal imbalances was unknown. Additional information has been requested.
Pt recv vax on 11/5/98; 3 hr post vax pt exp cough, tight/squeaky chest, stiff neck, sore vax site until noon 11/6/98
PATIENT CALLED IN TO SAY AFTER HER 2ND PFIZER VACCINE SHE BAGAN TO HAVE ISSES WITH WEAKNESS & PAIN IN HER RIGHT ARM, THEN RANGE OF MOTION ISSUES. SHE HAS A HARD TIME REACHING BEHIND HER TO PUT HER CLOTHES ON ETC. SHE CAN MOVE THE ARM UP & DOWN NOW AND CAN HOLD A TEA CUP BETTER THAN WHEN IT FIRST STARTED GIVING HER ISSUES. SHE STATED SHE IS NOT A PERSON TO COMPLAIN BUT SHE HAD TO CALL HER DOCTOR BECAUSE OF THE PAIN. SHE HAS A THROBBING ACHY PAIN AT NIGHT WHEN SHE SLEEPS. WAKES HER UP. SHE WILL CONTINUE TO F/U WITH HER PCP.
Muscle and joint pain, broke out in hives, hives turned into blisters in buttocks area.
Difficulty breathing, wheezing, paleness, weakness ad fast heart beat. Took him to the ER. They administered 3 breathing treatments. He has been at the doctors' numerous times since shot date as he continues to have trouble breathing. No problems prior to shots.
A report has been received from a Health Professional concerning a child, female subject, who had been receiving Nasal FLUMIST. FLUMIST started during 2012. The patient experienced Influenza A which started on 14-Jan-2013. The patient recovered from the event. The report was considered to be non-serious by the reporter.
second influenza vaccine was given after patient received one 3 or 4 weeks prior to 31-Oct-2020, with no adverse event; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case from an other healthcare professional.  This case involves an adult patient of unknown age for whom it was reported second influenza vaccine was given after patient received one 3 or 4 weeks prior to 31-oct-2020 (vaccination error), while the patient started therapy with vaccine influenza quadrival a-b multidose vaccine preserved [Fluzone Quadrivalent Multidose] at an unknown dose, once via unknown route (Batch number and expiration date were unknown) for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), concurrent conditions and family history were not provided. Concomitant medication was not reported.   Final diagnosis was a second influenza vaccine was given after patient received one 3 or 4 weeks prior to 31-oct-2020.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as not applicable.  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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding the batch number.
Passed out; Zero appetite; Arm was very painful; Fatigued; Major chills; Fever; A Spontaneous report was received on 16 Mar 2021 concerning a female patient of unspecified age.  On unspecified date she had her first Moderna COVID-19 vaccine and developed events include Fever, Major chills, Zero Appetite, Severe Fatigue which resulted in passing out, Painful Arm.  On the next day morning or after 24 hours she was said to be completely all right.  Patient age, pregnancy information, concomitant medications, other relevant history, current condition or lab data is not specified as this report was taken up from the social media source.  The outcome of the above listed events were said to be resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Extreme shoulder pain in and around injection site, nausea, vomiting, body aches, fever, chills, headache.  Felt as though nurse either struck the bone or I could go into anaphylaxis at time of injection. Began flu like symptoms approximately 2 hours after injection.  Heavy (almost drove myself to the hospital) began 18 hours after injection. Ended approximately 35 hours later.
Started to feel numbness in R side of upper gums in mouth and tingling and numbness at R temple. Soon I was feeling more scattered numbness and tingling on R side of face. After about 15 min, was sort of slurping while talking, like after getting numbing at dentist. No noticeable drooping of R side of face. This more or less resolved after 20-30 min however in the past many days, I feel occasional numbness or tingling - very minor. Worried about 2nd dose but do plan to get it.
Patient began complaining of (R) foot and leg numbness around 6 PM the day the vaccine was given. Patient developed headache and sensation of heat on back of head around the same time 2 days later, the patient complained of numbness in (R) hand that spread to (L) hand. The next day, the heat on her head and a feeling of lightheadedness prompted an ER visit. The following day, she returned to ER due to no improvement.
headache; fatigue; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (hcp) via Regulatory authority (under reference number 00793253).  This case involves a 21-year-old female patient who experienced headache and fatigue, after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines were given to the patient.  On 30-Sep-2021, the patient received a dose of 0.5mL suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2106, expiry date 28-May-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 30-Sep-2021, the patient developed a non-serious headache and fatigue (on the same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "caller states she received a flu shot at a flu vaccine clinic and she believes she received FLUZONE HIGH DOSE; states she is 21 years old; asks if there are any dangers to a 21 year old receiving FLUZONE HIGH DOSE. Caller states she is experiencing headache and fatigue, asks if this is normal. While completing AE/safety report, caller states according to information she was provided at flu vaccine clinic, she actually received FLUBLOK; caller states she did not receive FLUZONE HIGH DOSE QUADRIVALENT. Caller asks if FLUBLOK is okay for a 21 year old."  Details of laboratory were not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the both the reported events.
I experienced a sore and stiff neck on shoulder on my left side.  This did not go away and after 10 days it moved to my right side.  Then after several days moved back to my left side again while slowly fading away from my right side.  It lasted over 6 weeks until the end of November 2012.  I had difficulty working and sleeping due to the discomfort.
I mistakenly used the Pfizer age 12 plus monovalent vial  instead of using the Pfizer age 12 plus bivalent as the booster. I contacted the mom about 20 to 30 minutes later after realizing it was the wrong vial, explained the patient had already received a monovalent dose last year as a booster. I had also told mom I talked with provider in the building and felt patient will most likely be fine as reassurance.
Moderna Covid-19 Vaccine EUA:  fatigue: shortness of breath; heart pain; high blood pressure; runny nose; chills; stomach pain; nausea; body ache
Second dose of bivalent booster given to patient. Patient notified. First bivalent booster dose given on 9/22/22.