chrisvoncsefalvay/vaers-outcomes huggingface dataset:
leg (muscles); muscle pain in legs; leg (muscles); muscle pain in legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Anal Cancer", start date: 1999, stop date: 1999, notes: Pertinent details: Laser surgery; "TIA", start date: 2001, stop date: 2001, notes: Pertinent details: Rest d recuperate; "Hysterectomy uterus removed Pre cancer" (unspecified if ongoing), notes: Pertinent details: Surgery removed uterus; "SUT", start date: 2007, stop date: 2007, notes: Pertinent details: ablation for irregular heartbeats; "dryness of vagina" (ongoing); "Pain" (ongoing); "Gerd" (ongoing); "Inflammation" (ongoing); "supplements" (ongoing). Concomitant medication(s) included: ESTRADIOL taken for vulvovaginal dryness, pain (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing); HYDROCHLOROTHIAZIDE taken for inflammation (ongoing); VITAMIN D [COLECALCIFEROL] taken for supplementation therapy (ongoing); VITAMIN B 12 [CYANOCOBALAMIN] sublingual taken for supplementation therapy (ongoing); METAMUCIL [PLANTAGO OVATA] taken for supplementation therapy (ongoing); MAGNESIUM taken for supplementation therapy (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious), outcome "not recovered" and all described as "leg (muscles); muscle pain in legs". The event "leg (muscles); muscle pain in legs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, myalgia. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Beginning 4/2/2021 I noticed that my sense of taste and smell changed. It was not lost, and I did not have these symptoms after recovering from being ill from Covid-19 or after the 1st vaccine, just weeks after the 2nd dose.  Specifically soap smells differently, all soaps and I can no longer distinguish between different fragrances in soaps. Cucumbers smell rotten although I used to like the smell of cucumbers.  Various foods taste differently.  Things that smell differently consistently smell different in the same way.  In other words, soap now has different smell to me than it used to, but it always smells the same to me.  I thought it would go away but nothing has changed since it started back in April.
This spontaneous report as received from a Registered Nurse regarding a 5 year old child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 15-AUG-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Patients arm where shot was given got red, warm and had a little  hardness to area.
Overall itching and slight Asthma for about an hour.  Followed shortly after by swelling and redness around injection point at the inside base of bicep.  As of this report redness and swelling continue to expand and very painful to touch.
I have had body aches and severe joint pain since the day after I got the vaccine.  Some days I can't get out of  bed.  Sleeping is becoming more difficult due to the intense pain in my joints.  Knees, hips, shoulders and hands are the worst.
Menstrual bleeding(period) has been delayed for 15 days. No bleeding as of this day. Pregnancy blood test is negative.
Developed severe body aches, headache, fatigue. Fever reached 103.9.
TOOK A WEEK GAP BETWEEN THE SECOND AND THE THIRD DOSE; This spontaneous case report (PVX2019-1603) was received from a caregiver on 20-Jun-2019. It describes a female consumer who "took a week gap between the second and the third dose". She was receiving Vivotif capsule for an unknown indication.  Case report: The consumer did not take Vivotif doses according to the schedule. The doses were taken on 10-Jun-2019, 12-Jun-2019, and 19-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took a week gap between the second and the third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took a week gap between the second and the third dose" was considered as not applicable.
numbness on the left side of her body; vertigo; This is a spontaneous report from a contactable consumer (reporting for herself).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced numbness on the left side of her body and vertigo in Dec2020.  The clinical outcome of numbness on the left side of her body was unknown and of vertigo was recovering.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
missed dose; This spontaneous report was received from a healthcare professional concerning a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.   In 2020 (reported as a year ago), the patient received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency and route were not reported) as prophylaxis. It was unable to confirm with the patient that the product was quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient wanted to know if she needed to restart the series. The missed dose (product dose omission issue) was reported.
Information has been received from a physician concerning a 21 year old female who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Subsequently on 24-JUL-2008 the patient experienced pain at the injection site, numbness, tingling and difficulty swallowing. Outcome of the adverse event were not reported. The patient sought unspecified medical attention. Additional information has been requested.
H1N1 vaccine administered at school clinic. Students received vaccine 9AM - 10:20AM and kept for 10 min observation. Patient mentioned to health care professional that she had received many shots but did not remember them as she was in a coma. Upon further questioning, it was mentioned that she had been bitten by a dog on her face. The scar was on her (R) side of her face et I was to her left. She received the vaccine and waited the 10 minutes for observation. She returned to class at the end of that 10 minutes. The group of 4 nurses were in the music room from 10:20 AM (time of last student) until 11:00 AM when we went for lunch. Upon returning from lunch I checked with the secretary that we were resuming clinic et if she would announce to staff. She mentioned that pt had gone to library et had an episode where her "eyes rolled back in her head" et passed out hitting her head. School staff called her mom to come pick her up et she then went to MD office. I later learned she then was sent to ER for MRI, CT scan. The ER had released her but on way home, she suffered a seizure @ 7PM per mom her mother took her back to ER. Secretary then states she was life flighted to Children's. School nurse had called Thurs. Jan 28 to report situation et had spoke to nurse. An incident (VAERS) was initiated. I spoke to nurse to ask more questions, et she had not heard any further details but would keep us in the loop. 2/1/2010 T/C to secretary at school, pt is back home et was released from over the weekend. T/C to mom to ask questions to complete VAERS report. She confirmed picking pt up from school et took her to doctors office. Was then sent to ER for tests. The seizures occurred at around 7pm et they returned to ER. They were not able to control the seizures, so pt was given a paralytic agent et ventilator in order to be transported per life flight to children's. Mom was not sure which day she was extubated, but she was discharged over the weekend. She can now walk but does continue to have pseudo seizures. MD's could not find any other etiology for the seizures et believe the vaccine to be the culprit. She did not confirm the story about the coma previously experienced by pt only that she mysteriously suffered 2 puncture wound to (R) cheek. She never lost consciousness.
Information has been received from a female pharmacist who is also the patient with Sjogren's syndrome and "other health issues" who on 04-JUN-2007 was vaccinated with a first dose of Gardasil. On 04-JUN-2007 immediately post vaccination the patient did not feel good and developed pain in her left arm, nausea, and headache. On an unspecified date the symptoms resolved. On 09-JUN-2007 and 10-JUN-2007 the patient felt sick, had pains in her legs and whole body, resembling "flu like symptoms." On 18-JUL-2007 the patient developed vasculitis in her right leg. On 04-AUG-2007 the patient was hospitalized with a diagnosis of, bilateral pulmonary embolism. She was treated with 5 mg of COUMADIN daily and 81 mg of Aspirin daily. On 10-AUG-2007 the patient was discharged from the hospital. At the time of the report the patient's outcome was unknown. The reporting pharmacist considered the events to be other important medical events. Additional information has been requested.
When I got the 1st shot, my arm was hurting.; The back of my head is hurting ever since; It hurts right where my neck meets the back of my head on both sides.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (When I got the 1st shot, my arm was hurting.), HEADACHE (The back of my head is hurting ever since) and NECK PAIN (It hurts right where my neck meets the back of my head on both sides.) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-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) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced HEADACHE (The back of my head is hurting ever since) and NECK PAIN (It hurts right where my neck meets the back of my head on both sides.). On 15-Jun-2021, the patient experienced PAIN IN EXTREMITY (When I got the 1st shot, my arm was hurting.). At the time of the report, PAIN IN EXTREMITY (When I got the 1st shot, my arm was hurting.), HEADACHE (The back of my head is hurting ever since) and NECK PAIN (It hurts right where my neck meets the back of my head on both sides.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. No relevant concomitant medications were reported. Consent given for Safety follow up/contact. Reporter stated  ,"If I don't answer, tell them to just leave a message".   This case was linked to MOD-2021-223105 (Patient Link).
Headache; Fever of 103.2/fever went up again to 101.0; Tired; Sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 08Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 12 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 09Jun2022, outcome "unknown", described as "Sleepy"; FATIGUE (non-serious) with onset 09Jun2022, outcome "unknown", described as "Tired"; PYREXIA (non-serious) with onset 09Jun2022 at 19:00, outcome "recovered" (Jun2022), described as "Fever of 103.2/fever went up again to 101.0"; HEADACHE (non-serious) with onset 10Jun2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional Information: "My Son # is 12-year-old. He received his first booster shot on Wednesday 08Jun2022. On Thursday 09Jun2022 at 7 pm he had a fever of 103.2. He was fine all day but by evening he got tired and sleepy and took a nap. When I got home from work, I noticed his high fever. I gave him 2 Advil and he was fine for the rest of the night and Friday morning. Later today, Friday the 10Jun2022 his fever went up again to 101.0. Again, he was tired and had a headache. So, I gave him Advil and the fever has subsided. Event took place after use of product".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On the 11th day following my first dose, I have a knot come up at the injection site.  The site is swollen, you can feel the knot under the skin.  It is hard.  The skin is read and has heat in it.
Patient's father stated patient was over the age of 12. When we tried submitting to insurance DOB written on consent for, was denied due to incorrect DOB. Father spoke and wrote incorrect DOB. According to insurance DOB is exact date.
Pt recv vax on 1/20/99; 3 hr post vax pt exp sore, red, swollen, warm vax site x 3 day; tx=ice
patient had a STEMI 5 days after second dose of vaccine.  Treated successfulyly with drug eluting stent.
people are getting breakthrough cases; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (people are getting breakthrough cases) 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (people are getting breakthrough cases). At the time of the report, VACCINATION COMPLICATION (people are getting breakthrough cases) outcome was unknown.            Relevant concomitant product usage were not reported by the reporter. No treatment details were added.  Patient mentioned that people were getting breakthrough cases despite administration of 2 doses and booster dose of Moderna COVID-19 Vaccine.
This spontaneous report was received from a registered nurse referring to a patient of currently 1 year of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) with lot # L009205, expiry date 17-MAR-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were not previous temperature excursion. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Pt states he felt some numbness and a lump in his throat following the vaccination.  He arrives to the observation area with his mom, patient did not attend school today because he was having a migraine. arrives 1400 to observation BP 128/69 HR 83 oxygen sat 97% room air 1405 pt feels that he can breathe easier 1415 he still feels like he has a small lump in his throat bp 126/62 hr 90 oxygen sat 97% room air 1420 patient stateshe feels like he is back to normal mom feels comfortable taking him home 1425 patient left observation via wheelchair and his mom with symptoms relieved
Upon receiving the vaccination the onset of nausea, migraine, and arm aches were experienced. Several hours later the aches moved to upper body aches causing pain breathing. Upon night, dizziness had set in. I fell unconscious hitting my head and received treatment for a concussion. I am currently pending a CT Scan to check for brain bleeding.
Case number PHEH2012US022488 is an initial spontaneous report received from a consumer on 12 Nov 2012. This report refers to a 66-years-old female patient. Her medical history included rheumatoid arthritis and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 28 Oct 2012. It was reported that she began having symptoms of pain in joints (knees, shoulders and feet) on 29 Oct 2012. She went to physician and it was reported that she still had pain on 12 Nov 2012. No further information was provided.
This spontaneous report as received from a nurse refers to a 38 year old female patient with thyroid disease, Gastroesophageal reflux disease (GERD) and allergy to MACRODANTIN. Medical history was not reported. On 12-NOV-2014 varicella titers were performed and the result was 0.46 (units not provided). On 26-NOV-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) injection, 0.5 ml, subcutaneous, lot # K005178, expiration date 10-APR-2016, as a school requirement. Concomitant therapies included SYNTHROID and omeprazole. The nurse informed that 17-DEC-2014 the patient developed an itching and burning rash on an unspecified location on her body, also informed that on an unknown date in December 2014 (also reported as a couple days later) the patient developed pustules from head to toe on her body, the nurse stated that the patient was seen by a dermatologist on an unspecified date and also stated that on 17-JAN-2015 the patient had a titer level drawn for the varicella and the result on the titer was 1.05 (units not provided). The outcome of the events was recovered on an unspecified date. Additional information has been requested.
I experienced vertigo and "off-center" dizziness which continues after two weeks.  It has gotten better but I still experience it at times.
shortness of breath; Fever 100 +; left arm pain; malaise/feel sick; headache; feel sick and tired; This is a spontaneous report from a contactable other Health Professional (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 14:45 (Batch/Lot Number: Unknown) at the age of 62-year-old, as 1st dose, single for covid-19 immunisation. Medical history included covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. There were no concomitant medications. The patient previously received other Pfizer vaccine (unspecified name) on 27Apr2021 administered in left arm for immunisation. The patient experienced shortness of breath, fever 100 +, left arm pain, malaise, headache, feel sick and tired on 19May2021. No treatment was taken for adverse event (AE). Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  Information about lot/batch number has been requested.; 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 shortness of breath 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.
Vaccine administered at approx 9 AM. By 1:30 PM she reported feeling ill, hands cold and fingers numb bilaterally, general shakiness, some deep breathing. Was sent to her physician and developed a rash by the time she got there on arm and neck. Treated and released.
3RD DOSE COVID VACCINE GIVEN 1/4/2022, MODERNA #066H21A; Pt brought to hospital 9/8/22 with c/o weakness and worsening confusion; found to be positive for COVID; saturating well on RA; given ABX; dc'd to home with hospice (name of hospice not in medical records) where pt passed away
Moderate pain in the left arm and surrounding muscle, eventually radiating into the left side of the neck, behind the ear. Pain appeared the following day after the shot and lasted about 2 days before going away fully.
This spontaneous report was received from a physician referring to a 17 year old female patient who is also her niece. Pertinent medical history and drug allergies were reported as none. On approximately 10-SEP-2014 (reported as about 2 weeks ago) the patient was vaccinated with GARDASIL dose 1 (dose/ route not reported). Concomitant medication was reported as none. On 10-SEP-2014, 15 minutes after vaccination, the patient experienced nausea, muscle weakness and muscle pain. The physician stated that the patient was only able to do 15 minutes of moderate activity (disability), whereas before vaccination she was healthy and energetic. The physician stated that the patient saw an unspecified physician who treated her with unspecified antibiotics for "strept throat" and there was no improvement in symptoms. The physician stated that the patient had a blood test for mono, Lyme disease and a CBC (complete blood count) which she stated was normal. The reporter indicated that the patient had missed 7 or 8 days of school because of fatigue and pain (disability). The patient sought medical attention. There was no intervention required to prevent seriousness criteria. The event was not life-threatening. There was no hospitalization reported. The outcome of the events was reported as not recovered/not resolved. The causality of the events was unspecified. No PQC reported. Additional information is not expected.
Sudden Hearing Loss in my left ear.  Crackling in my right ear with muscle aches.
Pt recv vax on 11/17/98; 12 hr post vax pt exp shoulder pain/ itching/ swelling to elbow x 2 wk, fever ; tx=Tylenol, ice pack & Allegra
DESCRIPTION BY PHYSICIAN:  "SEVERE ILLNESS WHEN GIVEN FLU SHOT": HIGH FEVER, MALAISE
30 Jul 2021:  1st dose of Pfizer vaccine  I had a minor reaction 15 minute after the administration of the vaccine which included hives, itching, and white tiny bubbly spots (on arms, legs, tummy, and others).  Took Benadryl for 3 days, hives and itching were resolved, but the white spots remain.   Next 3-4 days included itching, headache, fatigue, sore throat, and body ache  All symptoms have subsided except for headache.  I?ve had headaches daily since 30 July 2021.  Some headaches are mild and some are severe.    Some medicines help for 2-6 hours such as Tylenol, Excedrin, Fioricet, and others but the headaches come right back.  As of today, I?ve had headaches for 31 days (29 Aug 2021).