chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain on left arm, reaching 10/10; cannot sleep more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jun2021 (Lot number: EW0180) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Dilated cardiomyopathy" (unspecified if ongoing); "Known allergies Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish. Concomitant medication(s) included: CARVEDILOL; ENTRESTO. Vaccination history included: Bnt162b2 (Dose Number: 1, vaccine location=Left arm, prev dose lot number: EW0177), administration date: 15May2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (medically significant) with onset 04Jun2021, outcome "not recovered", described as "Severe pain on left arm, reaching 10/10"; INSOMNIA (medically significant) with onset 04Jun2021, outcome "not recovered", described as "cannot sleep more". The events "severe pain on left arm, reaching 10/10" and "cannot sleep more" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: pain assessment: (04Jun2021) 10/10; sars-cov-2 test: (11Dec2021) negative, notes: Nasal swab. Therapeutic measures were taken as a result of pain in extremity, insomnia. Clinical course: The patient had severe pain on left arm, reaching 10/10, she cannot sleep more than 4-5 hours without being awakened by intense pain. AE resulted in Doctor or other healthcare professional office/clinic visit. AE treatment: Steroid shot into left sub acromial bursa. The patient had no covid prior vaccination.   No follow-up attempts are possible. No further information is expected.
Headache, UrticariaPruritus, Diarrhea, NauseaVomiting, Dose 2: empl states that on Feb 22 lip did not feel normal, when they awoke on Tues, Feb 23 RIGHT facial droop, called EMS, taken to ED, dx w Bells Palsy. cannot blink R eye, R eye tears; cannot open RIGHT side of mouth, difficu Narrative:  2/23 called EMS, taken to ED, dx bells palsy, fu neurologist appt 2/26
Skin break out exacerbated; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin break out exacerbated) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Skin break out exacerbated). At the time of the report, RASH (Skin break out exacerbated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information for the event was not provided.
1. Throat closed up, could not breathe 2. Coughing 3. Nausea  Treated with: EpiPen x2 Oxygen Nebulizer Treatment
Stiff neck and back pain, slight difficulty swallowing. Saw Primary Care provider who diagnosed meningismus. No neurological signs, afebrile. At the suggestion of Infectious Disease/Travel Medicine specialist, a lumbar puncture was done; all cerebral spinal fluid studies were within normal limits, final culture report is still pending.
put the patient down; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: twice before Jan2021. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 immunization, reaction(s): "mild reaction". The following information was reported: FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "put the patient down". Additional information: The event lasted for about 36 hours (as reported).  The lot number for BNT162B2 was not provided and will be requested during follow up.
Case number PHEH2013US026605 is an initial spontaneous report received from a nurse on 26 Dec 2013. This report refers to a nurse of an unknown age and gender. On 26 Dec 2013, when the doctor pulled out MENVEO (batch number. M13051, expiry date: 31 May 2015) the vial containing the powder broke off and the powder spilled out all over the box and on to the fingers of the nurse. No adverse event was reported.
painful burning mouth rash; painful buring rash on legs and arms; pain ful burning rash on groin; did not prevent shingles; Information was received on 05-APR-2019 from a lawyer regarding a case in litigation involving a male patient, age and history unknown.  On an unspecified date the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles.  The vaccine did not prevent shingles but rather cause the patient to suffer a painful burning rash all over hands, arms, mouth, groin and legs.  As a result the patient suffered significant medical expenses, pain and suffering.  Outcome of the rashes was not provided.    Additional information has been requested.
A female consumer reported that she received influenza virus vaccine, trivalent, types a&b (2000-2001 formula)(manufacturer unknown) vaccine. The patients concurrent illnesses include hypersensitivity and eczema with past history of bronchitis and asthma. Following the immunization she developed a "worse than normal skin reaction" all over her body. The reporter noted that at the time of the event, she attributed these symptoms to the winter weather and dry skin. The consumer reported to similar occurrences following previous immunizations with a flu vaccine. See Case ID HQ9120205DEC2001 and HQ9120305DEC2001. No additional information is available as of the date of this report. A 15-day follow up report received 5/15/2002 adds: Follow up info received 02/19/2002 from pt, contained name and address of treating physicians. The reporter states she has received the flu shot for over 8 years. Over the last 8 years, she has developed increasingly "worsened" rashes, each winter, spreading to more areas of her body, mostly her hands, arms and legs. She has also developed "uncontrollable" itching on the back, face and gums. The pt stated that her legs and arms would bleed from the "itching rashes". In the last few years she has developed "borderline" asthma. The pt also noted that she chose not to receive the flu shot this year and so far has not experienced any of these symptoms. Her dermatologist determined a positive skin test to thimerosol.
Information has been received from a physician concerning a 15 year old female who in August 1996, was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (no lot# provided). On 14-MAR-2008 twelve years after vaccination, the patient experienced chickenpox. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested.
Chills- body aches- diarrhea- night sweats- fatigue  lasted 8 days
fever; restlessness; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, restlessness and chills. On an unknown date, the outcome of the fever, restlessness and chills were recovered/resolved.   It was unknown if the reporter considered the fever, restlessness and chills to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The reporter stated that her husband had the Shingrix vaccine about two years ago.  He experienced fever, chills, and restlessness for about a day and a half afterwards.   The reporter was referred to health care professional.  The reporter did not consent to followup.
Pt developed a large area of induration and erythema 21.5 X 9.5 cm.
Headache; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 48-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06Jul2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included brain hemorrhage that has resolved.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jul2021, on the day of vaccination, the patient experienced headache which did not go away. Therapeutic measures were taken as a result of headache and included treatment with unspecified medication started on an unknown date. The clinical outcome of the event headache was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Pain at the injection site; This is a spontaneous report from a contactable Nurse or Other Health Care Professional. This nurse reported for a 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot Number: EW0185; Expiration Date: Aug2021) via an unspecified route of administration on 15May2021 (at the age of 16 years) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No illness at time of vaccination. No family medical history relevant to ae. It was unknown if any AEs following prior vaccinations. Patient was not taken any medications within 4 weeks, prior vaccination. No additional vaccines administered on same date of the Pfizer suspect. No history of all previous immunization with the Pfizer vaccine considered as suspect. The caller stated that on 15may2021, the same day of vaccine in the afternoon after the first dose, patient experienced goosebumps, tingling, numbness to the left side of her face and left arm, and pain at the injection site in her arm. All the adverse events resulted in physician office. Relevant tests were none. The outcome of events was not recovered.  Further follow up excepted. Batch/lot number can be obtained.
5-10 min after vaccination patient came back  complain of COB, lightheadness , blurred vision monitor with team. pulls was ok patient did not need EpiPen inject. patient was send to ER after EMT arrival, also before EMT arrival she vomited
I got my first dose of the Pfizer vaccine on September 7th. When I went in for my yearly physical exam I had blood work done. My blood work came back showing I had low red blood cell counts. My doctor then recommended I go to a hematologist, also because of some other health issues. I went on October 6th to my hematologist. They wound up having to redo my blood work on the 13th and I waited almost 4 weeks for the results. I was informed my red blood cell count was back to normal and there's a possibility it was low due to the vaccine. I had never heard of that before but that's what my doctor told me. I feel fine now, although I was also told I have folic acid anemia and some other health related conditions but I'm fairly certain those are unrelated to the red blood cell count being low. At least that's what I was told.
Patient received shot Monday and was fine throughout the 15 minute waiting period.  I received a 3-way call today (wednesday) from the pt and his wife who was very concerned.  The pt described feeling like he had been drinking and taking drugs without consuming any such product and just feels like hes in a fog or a dream.  He does not remember receiving the shot 2 days ago and has no memory of the 2 days after the shot.  He thinks that it is Tuesday and it is Wednesday.  He also reports having very weird, lucid dreams/nightmares and hallucinations where he is seeing his surroundings as his work office and thinks he's at work but is actually at home. I referred pt to urgent care and wife is on her way home to take him in.
9 days after receiving MMR vaccine had an atypical febrile seizure - febrile, eyes rolled back and right arm had clonic movements.
Pain in arm, at injection site. confirmed she did not have pain in joint, ruling out intraarticular injection. Pain has remained consistent since receiving shot in November.
I95.9 HYPOTENSION 4/14/2023 ACUTE CHOLECYSTITIS
Covid19 Adverse Event.  1st vaccine received on 01/12/2022.  86 y/o with PMHx DM, HTN, HLD, MI, Cardiac Stents, Chronic Kidney dz stage 3 presents to ED with c/o cough, fevers, SOB and inability to lay flat so has had to sleep sitting up for the past 2 weeks.  CXR- no acute process, Room air sats 98% and pt febrile.  Treated with IV ABx and IV steroids.
Extremely red, itchy, burning skin at creases of elbows on both arms, shot arm & non-shot arm. It is not at the shot site.
Pt's mom states that the pt was vaccinated at another office. No records available. On 03/21/2002, the pt broke out with 10 chicken pox post chicken pox vaccine administration.
Pt was a non responder after recv series of 3 hepta B;  given on 24May, 26Jun, 26Nov, 1990.
COVID 19 Treatment; Sars Cov2 infection; mild fever; aches; severe soar throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset Jun2022, outcome "unknown", described as "Sars Cov2 infection"; PAIN (non-serious) with onset Jun2022, outcome "unknown", described as "aches"; PYREXIA (non-serious) with onset Jun2022, outcome "unknown", described as "mild fever"; OROPHARYNGEAL PAIN (non-serious) with onset Jun2022, outcome "unknown", described as "severe soar throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received other medication in past 2 weeks.  No follow-up attempts are possible. No further information is expected.
No additional AE reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from an other health professional and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions were and concomitant therapies were not reported.  On 31-AUG-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U020240, expiration date: 28-JUN-2023 (both confirmed to be valid) administered for prophylaxis (strength, and route of administration were not provided) (product storage error). The vaccine underwent a temperature excursion of 5.7 degree Fahrenheit for 0 hours 30 minutes and 0 seconds. There was previous temperature excursion of 6 degree Fahrenheit up to 14 degree Fahrenheit (9.1 degree Fahrenheit) for 1 hour 6 minutes and 0 seconds . No additional adverse event reported (no adverse event), no further information provided.
This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in April 2018 experienced sore arm ( please refer case US2018154156)). On 22nd August 2018, the patient received the 2nd dose of SHINGRIX. On 22nd August 2018, several hours after receiving SHINGRIX, the patient experienced upset stomach, frequent bowel movements and diarrhea. On 23rd August 2018, the patient experienced fever, shivering, headache and dizziness. On an unknown date, the outcome of the upset stomach, shivering, headache, dizziness, frequent bowel movements and diarrhea were recovered/resolved and the outcome of the fever was recovering/resolving. It was unknown if the reporter considered the upset stomach, fever, shivering, headache, dizziness, frequent bowel movements and diarrhea to be related to SHINGRIX. Additional details were reported as follows: At 17:00, the patient received SHINGRIX in left arm. The couple of hours after receiving SHINGRIX vaccine, the patient experienced stomach upset in the form of increased number of bowel movements, which the patient called a running stomach. On the next morning after receiving SHINGRIX, the patient felt a light headache and dizziness by the afternoon the patient experienced fever recorded as 39.7 degree C and shivering.  At the time of reporting, all symptoms resolved except fever, which was 38.2 degree C. The patient did not experience any of these symptoms after the 1st dose, but only sore arm. The contact details of the physician was provided.
had vaccination still got it/suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 80-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In FEB-2023, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had vaccination still got it/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-Mar-2023 The case was received from the patient via interactive digital media. The patient had his/her vaccination 2 years ago but still got them. The patient had that shingles just a month ago (from the reporting date). The patient stated that thank god he/she was ok now. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
PATIENT GOT HIS VACCINE AND THEN WATCHED HIS GIRLFRIEND GET HER SHOT, PATIENT STATED HE SAW ME WITH THE NEEDLE AND GIVE IT TO HER AND THEN HE GOT SICK FEELING.  PATIENT SAT ON FLOOR AND GOT HOT AND TURNED A GREENISH COLOR BEFORE PASSING OUT, PATIENT WAS IN AND OUT FOR ABOUT 2 MINUTES. PATIENT CAME TO AND JOKED ABOUT IT AND SAID THIS HAS HAPPENED BEFORE.  PATIENT WANTED TO WALK OFF AND LEAVE, WE HAD HIM SET DOWN AND HIS GIRLFRIEND WENT TO GET WATER AND A SNACK FOR HIM.  BEFORE SHE RETURNED HE FAINTED AGAIN AND I HELD HIM UP IN THE CHAIR. HE CAME TO AND STARTED FEELING BETTER.   EMS ARRIVED AND CHECKED HIM OUT, PATIENT WAS TAKEN TO AMBULANCE TO BE CHECKED OUT MORE.  GIRLFRIEND SAID THEY WOULD RELEASE HIM AFTER WATCHING HIM FOR 30 MINUTES.
Patient C/O severe pain during administration with nausea and near syncope within minutes after the injection. Pt had complaint of pain ongoing after the injection with decreased ROM in right arm along with tingling sensation in fingers of right arm and continued nausea and mild headache for several days. Now, 7 days after vaccine administration, patient still C/O mild headache.
about 1 hr p/immun pt very fussy, crying, difficult to console, occasional screaming; APAP given; no fever noted; fussiness & crying stopped by 9PM that noc; duration 10-12 hrs;
The next day 10/05/2021 at 7:00am I woke up with intense body aches and a 100.7 degree Fahrenheit fever. I felt dizzy and sick and had a headache for the whole day. I did not feel better or experience a reduced fever  until the next morning. On the same day, my sister woke up feeling sick. It turns out, she had Covid-19. Then I participated in a virtual visit with a healthcare provider. They told me that my symptoms were likely from the vaccine, but the still scheduled me for a Covid test 5 days after my last exposure to my sister. The next day, 10/06/2021, I felt better. My Covid test was negative.  On 10/11/2021 I woke up feeling sick again. I had a sore throat and some shortness of breath. I had another telehealth visit and received a Covid test on this day. My Covid test was negative. My sickness progressed, and I had Congestion, head-pressure, sneezing, around a 100.4 Fahrenheit fever, and a really bad cough. I continued to feel very sick until Thursday morning (10/14/2021), when I started to feel a bit better.  After I received my second Pfizer vaccine on 02/11/2021,  I felt terrible for about a day, and then I kept getting sicknesses/commons colds for the next couple months, a lot more often than usual. I think my delayed sickness may relate to the vaccine last winter, and this fall.
3:00 PM Rash and blotchiness on chest with itchiness. Patient tongue feeling hot. 3:15 PM Patient tongue started swelling - 25 mg diphenhydramine given IM and sent to ER. Received 0.3 mg epinephrine IM in ER.
Possible blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Possible blood clot) 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) .5 milliliter. On an unknown date, the patient experienced THROMBOSIS (Possible blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Possible blood clot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details were not provided.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.