chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took flu shot Friday and Sunday morning went to mail box and had weakness in legs.  Could not walk so she crawled to her house and up stairs to call her daughter on the phone.  Blood pressure and pulse were normal.  Admitted to hospital for tests.  Doctor stated all tests negative.  She had same symptoms the past two years after flu vaccine but didn't relate these symptoms with the flu shot.  The symptoms have progressively worsened since the first ones 3 years ago.  Medical doctor recommended no further flu shots and reported it to our health department.  Stated after two days her symptoms ceased and she had no further problems.  Still has a little soreness in the thighs, but she can walk without difficulty.  Instructed client I would fill out form and she might be contacted.  Instructed her not to take any further vaccines in future.
Headaches started the next day from shot, April 29th,)  numbness/ tingling of face, legs, arms, pinching feeling, numbness in left and right size.  Slight nausea,( April 30th 2021_ presently.
1400 pm 8/3/07 Mother called today reporting swollen, hard hot area around lower injection site on rt upper arm. Her so c/o knee pain decreased slightly lethargic. Taken to Dr @ 1400 pm today for observation. Records of Immunization faxed to Dr.
Neck stiffness, muscle tenderness of neck, upper back, shoulders, upper arms.  Intense for 10 days, persists at the time of this report (11/25/2015) but with less intensity.
shingles after Shingrix / Suspected vaccination Failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cystitis interstitial.   In FEB-2023, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: shingles after Shingrix / Suspected vaccination Failure) (serious criteria medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: Receipt date: 14-AUG-2023 A physician reported that he/she was inquiring regarding a patient who was vaccinated 6 months ago with Shingrix, did receive 2 dose series. The patient came in today (on reporting day) with Shingles active.  The reporter wanted to know when or if he should revaccinate with Shingrix. The vaccine administration facility was the same as primary reporter. This case was considered as suspected vaccination failure since the detail regarding laboratory confirmation of shingles was unknown at the time of reporting.
brought to the emergency department on 2/6/2022 with chief complaints of difficulty breathing required BiPAP in the ER. Cough/shortness of breath for past week.  Patient on prednisone and doxycycline from January 29th. 8 Days ago. Patient apparently tested negative for COVID-19 at that time.  Repeat COVID-19 screen in the ER 2/6  positive.    In the ER patient hypertensive tachycardic tachypneic hypoxic blood pressure 152/110 heart rate 137 respiratory rate 28 87% saturation on room air.  Drinks alcohol 4-6 beers twice per week.  CTA negative for PE, no pulmonary infiltrate No acute chest abnormalities  Patient required BiPAP, received respiratory treatment IV Solu-Medrol magnesium sulfate received morphine ketamine in the emergency department.  Labs radiology studies reviewed Admitted to moderate care floor.  Pulmonary consulted.  Patient placed on IV steroids, Levaquin, respiratory treatment.See H&P for all the details regarding admission.. 2/7- Respiratory status improved. Patient taken off BiPAP,Switched to nasal cannula. Reported having cough with brown sputum.  Sputum cultures no growth to date.   2/8- Patient weaned off oxygen on room air this morning.  Did not require BiPAP. Afebrile.  Respiratory status stable. 2/9- Patient feels well and wants to go home. Patient denies any shortness of breath this morning.  No chest pain no abdominal pain nausea or vomiting.  Minimal cough.  Patient seen by Pulmonary this morning.  Patient received 3 days of antibiotics, discontinued today.  Advised to continue Decadron for 7 more days. Cleared patient for discharge home.
Covid Infection - chills, fever, fatigue, congestion, sinus pain, cough SOB, myalgias, Headaches Started 3 days prior to visit on 10/12/21 Monoclonal antibodies dexamethasone 6 mg QD Cyclobenzaprine HCL 10 mg HS PRN
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Patient fainted about 3-4 minutes after injection. He was in waiting area to be monitored so already seated and did not experience a fall. He lost consciousness for probably about 20 total seconds. His pulse was fine when I went to assist him and he was breathing. Regained consciousness on his own and was given water and directed to sit with his head down. Continued to check on him and he reported feeling better each time over the course of 30 minutes. Overall minor syncope.
Right ankle swollen for 2 days; Body aches; Fever of 101; Extreme headache; Sore throat; Ear ache; Hives; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the left arm on 17Sep2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Concomitant medications included acyclovir (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PC3183) via an unspecified route of administration in the left arm on 27Aug2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 18Sep2021 at 06:00, the patient had right ankle swollen for 2 days, body aches, fever of 101, extreme headache, sore throat, ear ache, hives and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event right ankle swollen for 2 days was resolved on an unknown date in Sep2021 while that of the events body aches, fever of 101, extreme headache, sore throat, ear ache, hives and dizziness was not resolved at the time of the report.
Patient felt achy all over and had a headache; Patient felt achy all over and had a headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included RA (rheumatoid arthritis) from an unknown date and unknown if ongoing. Concomitant medications included methotrexate taken for an unspecified indication, start and stop date were not reported. The patient felt achy all over and had a headache on an unspecified date. Event took place after use of product. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
pt recv vax 7/31/97 & pt became preg LMP 8/2/97 & estimated date of delivery is 5/10/98;pt devel a UTI & tx w/ATB;pt vaginal cult was positive for group B strep;
I had the virus in August of 2020 for 30 days until symptom free.  ON 2/6/2021 received first vaccine injection.  within 3 minutes a light headache started.  That evening, rash and itching on right fore-arm and under chin. took benedryl. Woke at 3:30 am on 2/7 not feeling well and left arm very sore and could not touch.  6:30 am - chills with severe body shaking and 101 temp.  7:30 am 102.2  took tylenot 8 hr 650 mg. Oxygen at 96, heart rate at 76 and BP 117/68. 8:00 am 101.9 temp. 10 am 100.6 temp. 1:30 pm 102.9 temp. 2:00 pm 103.3  Took Tylenol, extra strength 2 tabs. 8:30 pm used inhaler due to chest pains  101.3 temp. took benedryl.  Oxygennn @98  HR-82 BP 145/77.  11.00 pm 103.3 temp. took 2 tylenol.  Mon 8:00 Monday am continued/ 100.2 temp  oxygen 97  HR-70; 99.2 temp  BP 110/71.  7 pm. took Benedryl for congestion.   Quit taking stats.  Fatigue and rest took play at this point.  Since then have had intermittent low grade fever in 99.2 to 99.9.  Same with headache and extreme fatigue.  Have high risk husband that I take care of .  He had his first vaccine at same time.  No side effect at all.  I am scheduled for 2nd vaccine on March 6th.  I am very apprehensive about taking it with this reaction.  Please advise/recommend if I should proceed.  My PCP stated that these reactions were evidence the vaccine is working.  Is this because I had the virus???  Both the virus and vaccine have been really hard on me.  I am usually a very active person and since August, I have been struggling with fatigue.  First time in life.   Thank you.
Patient stated that her arm started to hurt about a hour after she received the vaccine.  She said it hurts when she exercises with her weights (hurts even when she tried to do 2lbs of weight and she normally does 10lbs for her chest press) Stated she even hurts when she unloads the dishwasher. Stated that taking an aleve (which she doesn't like to take medication) can let her sleep at night. Pt stated that it isn't her shoulder that hurts it is more her tricept. (Stated that if you go down about 1in under your armpit on the outside of her arm is where it hurts.  Said her arm feels weak. Says it feels better if she puts coconut oil and lavender on it and it gets better after she takes a hot shower.  Ask pt if she would like me to call the doctor or wait another week before contacting them.  She stated to wait another week and see if it gets better. Told Patient I would call her back on Monday (12/5/16) and if not better I will contact her doctor.  Pain has lasted her 3 weeks.
Felt aches and pains day after vaccination.  Vaccination site was extremely tender and painful.  Had a serious chill in afternoon about 21 hours after vaccination.  Significant headache.  Felt like the flu.  Was very tired.  Took a nap. temperature was 100.9 when I went to bed.  I woke up the next morning Dec 8th feeling better, but still had the headache
a lot of congestion since and is coughing and coughing up a lot of phlegm; a lot of congestion since and is coughing and coughing up a lot of phlegm; a lot of congestion since and is coughing and coughing up a lot of phlegm; This is a spontaneous report received from a contactable consumer. This 80-year-old male consumer (patient) reported for himself.  An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Batch/Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration on 22Apr2021 as DOSE 1, SINGLE (at the age of 80-years-old) for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications were not reported. The patient had his first dose on the 22Apr2021. Ever since then the patient has had a lot of congestion since and was coughing and coughing up a lot of phlegm. The patient was due for second shot on 13May2021 at 10:30 hours but was not in the condition to get it so the patient did not receive it. The Patient has a COPD problem but was not coughing up phlegm before the vaccine. The patient was thinking about getting the second dose at a later date and queried whether the need to restart the series to get the second dose. The patient knew that the timing of the two doses was 3 weeks and queries whether he have to restart the series since the patient did not get the second dose. The patient could not say whether the vaccine was the reason for the congestion but reported that it did start after the first dose. The patient mentioned that he will reach out to his primary care provider to see about getting the second dose there. The clinical outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
a 60 year old female was given GARDASIL 9 vaccine by her physician; This spontaneous report was received from a registered pharmacist and refers to a 60-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-MAR-2021, the patient was vaccinated by a physician with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, administered intramuscularly (IM) (lot # 1602281, expiration date: 21-JUL-2021) for prophylaxis (product administered to patient of inappropriate age). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1602281; expirationdate: 21-JUL-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Fever 103 degs 4 days after shot. Severe bright red maculo papular , ABS, face, neck, trunk, arms and legs, conjunctivitis 7 days after shot.
This spontaneous report as received from a medical assistant via a company representative refers to a 11-12 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (lot # not reported) (dose 1, intramuscular, dose as indicated, strength and total daily dose not reported). Concomitant therapies included MENACTRA and TDAP (unspecified). The patient experienced syncope after receiving the first dose of GARDASIL. The patient fainted in office during the visit and sought for unspecified medical attention by being attended to office. No treatment was given. The patient was recovered in office. This is one of several reports received from the same source. Additional information is not expected.
pt recv vax; pt was limp, lethargic & unresponsive the eve p/ vax;
This spontaneous report was received from a registered nurse referring to a patient of currently 4 years 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 PROQUAD (Merck) with lot # L006393, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. 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.
sudden loss of memory/memory problems; Head fullness; Tinnitus; Irregular heart rate/palpitations; Difficulty breathing; Hoarseness; Numbness; Inner ear pain; Acid reflux; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations) and DYSPNOEA (Difficulty breathing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Ciproflocxin drug allergy neuropathy temporary 5 most) since 23-Jun-2021 and Drug hypersensitivity (Botox drug allergy throat tightness for one week.) since 01-Apr-2009. Concomitant products included VITAMIN D NOS for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations), DYSPNOEA (Difficulty breathing), DYSPHONIA (Hoarseness), HYPOAESTHESIA (Numbness), EAR PAIN (Inner ear pain) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). At the time of the report, AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations), DYSPNOEA (Difficulty breathing), DYSPHONIA (Hoarseness), HYPOAESTHESIA (Numbness), EAR PAIN (Inner ear pain) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.7 °F (normal) 98.7 degree F. On an unknown date, Heart rate: 120 (High) Beats per minute and >100 (High) >100 beats per min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided by the reporter.  Patient taken X-RAY on July 2021 by ENT.
Pt came in for Covid-Bivalant Booster was Given Regular Covid vaccine in  Error.
Right thigh injection site became red, swollen and hot to touch, one day after receiving vaccines.
Red rash to cheeks, body, low grade fever x1 day. Treated with oral steroid.
Per patient, she had received the COVID vaccine at her workplace and developed 30-40 minutes later symptoms of throat tightness, chest tightness and difficulty swallowing and was given at her workplace in the ED oral Benadryl, oral Decadron and IM epi. About an hour and a half later she developed symptoms of recurrent throat tightness and was given another dose of IM Epi and was then transferred to this hospital for further evaluation as per the patient "all of her symptoms are pretty much "unchanged"". She was observed for many hours in the ED without evidence of recurrent symptoms and was later discharged with a 3 day prescription of prednisone and prn diphenhydramine for itching.
Very sore , and progressively worse as night went on. Could not sleep, could barely lift arm up without intense pain
Within several hours of 2nd vaccination, left arm started to swell with redness, between 3:30 and 10:00 that arm had redness/swelling that expanded up to armpit.  Pt. took Claritin during this time and also next morning.  Antihistamine only helped with itching.  Redness/swelling resolved in 4 days.
Impaired balance specific to right side only. 4 occurrences of swaying to the right with complete loss of control of lower extremities.
Patient was given the Moderna Bivalent vaccine approved for 6 years and older. Patient is only 5 years old.
Vaccine leaked out of my arm; Vaccine ran down about 4 inches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DISCHARGE (Vaccine leaked out of my arm) and EXPOSURE VIA SKIN CONTACT (Vaccine ran down about 4 inches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (Vaccine leaked out of my arm) and EXPOSURE VIA SKIN CONTACT (Vaccine ran down about 4 inches). At the time of the report, VACCINATION SITE DISCHARGE (Vaccine leaked out of my arm) and EXPOSURE VIA SKIN CONTACT (Vaccine ran down about 4 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up information received on 29-APR-2021 contains non-significant information.
This spontaneous pregnancy report received from a consumer via a company representative concerned a neonate of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's parent received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose and start therapy date were not reported, 1 in total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was exposed to vaccine in utero via transplacental (fetal exposure during pregnancy). It was reported that the pregnancy was discovered one month after vaccination. On an unspecified date, the patient was born with a heart defect (heart disease congenital) and passed away from unknown cause of death at 4 weeks of birth. It was unknown if an autopsy was performed. The reporter suspected it to be an adverse event related to the vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause of death, and the outcome of congenital heart defect and fetal exposure during pregnancy was not reported. This report was serious (Death, Congenital Anomaly/Birth Defect, and Other Medically Important Condition). This parent/child case is linked to 20220617426. Sender's Comments: V0: 20220617386 -COVID-19 VACCINE AD26.COV2.S- Death, Congenital heart defect. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220617386 -COVID-19 VACCINE AD26.COV2.S-Fetal exposure during pregnancy. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered not related. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
Approx. 15 minutes after getting vaccines, child experienced seizure like symptoms with emesis x1.  After 5 minutes, in which vital signs were taken (stable), child was coherent x3.  Copy of vitals sent with ER persons that answered 911 call.  Child transported via ambulance to ER, released shortly.  Mom to sign ROI for ER report.  MD states "not time seizure".
NO Adverse Reactions were noted in patient, Reporting because patient was given PEDIARIX and Hep B vaccines on the same day.
Within 5-10 minutes I started feeling light-headed and slightly nauseous. I had taken an antihistamine 45 minutes before the injection due to a similar reaction after my first J&J vaccine. The symptoms worsened slightly so I took a second antihistamine about 45 minutes after the vaccine injection . This resolved the symptoms by about 1.5 hours after the vaccine injection.