chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 02 February 2009 from a health care professional. A 14 year old male patient received MENACTRA (lot number U2824AA) administered in the left deltoid intramuscularly on 31 January 2009 in the morning. On that same day, approximately 12 hours later, the patient experienced a generalized seizure. Details regarding the seizure were not provided. The patient was taken to the emergency room. On 31 January 2009 a CT scan, CBC (complete blood count), and metabolic panel were completed. The results were normal. BC (blood culture) was pending at the time of the report. The patient was awaiting a neurology consult, however the consult had not been scheduled at the time of the report. The patient's recovery status was not reported. No further information was provided. List of Documents held by Sender: none.
I received the COVID vaccine last week on 12/22 at 5:30pm. I felt achy for a day and then had a sore arm for about 2-3 days. I felt fine until last night (12/29) at about 7pm I noticed my arm was itching around the injection site. The L deltoid appeared swollen, red, a little painful, and itchy, with slight hiving around the injection site.  As of 5pm on 12/30, it is still the same status as last night, if not a little worse. The itchiness comes and goes, but it remains red and swollen.
This spontaneous report was received from a register nurse, refers to an unknown number of patients, of unknown and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 single vial dose, Lot#: L012215, expiration date: 21-JAN-2017; lot# K009874, expiration date: 19-MAR-2016; Lot#: L012215, expiration date: 13-JAN-2017; Lot#: L199261, expiration date: 28-FEB-2017; Lot#: L99271, expiration date: 30-MAR-2017; Lot# M03211, expiration date: 01-MAR-2017; (strength, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. No product quality complain was involved. Lot numbers L199261, L199271, M03211 are an invalid lot number for PNEUMOVAX 23. This is one of several reports received from the same reporter. Additional information has been requested.
Osteomyelitis; Bacteremia; Endocarditis; Mitral valve vegetation; Myositis; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the right arm on 18Dec2020 22:00 (at the age of 47 years) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included thyroid cancer from 1996 to an unspecified date; anxiety; and asthma. Concomitant medications included thyroid (ARMOUR THYROID), escitalopram oxalate (LEXAPRO), drospirenone, ethinylestradiol betadex clathrate (YAZ), cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE). On 20Dec2020, the patient had osteomyelitis, bacteremia, endocarditis, mitral valve vegetation and myositis. The reported events resulted into an emergency room visit. The patient was hospitalized for ten days due to the reported events. The events were also reported to have caused disability, and were life-threatening. The patient was treated with intravenous antibiotics, steroids and pain regimen for all the events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination; and had been tested for COVID-19 (Nasal swab) on 11Jan2021, with a negative result.  Information about lot/batch number has been requested.  Follow-up (31Mar2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported events cannot be completely excluded. Concomitant medical conditions represent confounding factors. This case will be reassessed when 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.
Pt recvd vax 7AUG92 & approx 1 hr later exp an allergic type reaction of sneezing & coughing; @ the time of report pt had recovered;
Post vax, pt complained of pain at injection site, later he experienced nausea, vomiting, fever, body aches and abdominal cramps. Pt presented to clinic with symptoms on 10/23/00. Treated for viral gastroenteritis; pneumonia.
Urticaria, 2-3 hours after vaccination, with flu shot broke out in hives.
I HAVE A POCKET OF FLUID IN MY ARM PIT OF THE ARM WITH INJECTION.  DID NOT GET 2ND SHOT.  HAVE VISITED MY HEALTHCARE PROVIDER AND HAVE HAD SEVERAL SCANS AND MAMMOGRAMS TO INDICATE ITS FLUID ONLY AND WAS NOT DRAINED.  WAS TOLD WOULD ONLY FILL UP AGAIN.  CONCERNED REGARDING COVID VACCINE INGREDIENTS.  ASSUME SOME INGREDIENTS MAY BE SIMILAR SO IM CHECKING INTO IT TO BE SURE.
Report symptoms of fever (101.5) c hills, body aches, HA, and nausea day 1 post vaccination . Treatment: Tylenol. Outcome: Fever resolved (99.8) nausea, body aches, chills and HA remains unchanged. Does not interfere with ADLs.
This is a spontaneous report from a contactable consumer (patient). A 51-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207, Expiry date was not reported) via an unspecified route of administration, administered in arm left on 15Apr2021 07:00 as dose 2, single and first dose via an unspecified route of administration, administered in arm left on 22Feb2021 07:00 (Lot Number: Ew0169, Expiry date was not reported) (age at the vaccination 51-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included PROBIOTICS taken for an unspecified indication, start and stop date were not reported. The patient had experienced covid test result as positive on 19Aug2021, 1st dose 22feb2021/2nd dose 15apr2021, cold like symptoms, cough, runny nose on 18Aug2021 05:00. The patient did not receive treatment for the adverse event. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on 19Aug2021 Nasal Swab. The patient received probiotics medications in two weeks. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested positive since the vaccination. The outcome of the event Covid test result: Positive was unknown and rest of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Onset about 10 hours after injection - pain at injection site, significant fatigue, severe headache, sensitivity to light, fever, chills
Temp to 102, c/o stomach cramps, leg pains @ 22FEB91 client taken to ER; Test results pending client to f/u w/MD today;
Vaccinated 17 year old; A spontaneous report was received from a healthcare professional concerning a 17-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Mar 2021, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: 013A21A) for prophylaxis of COVID-19 infection.    The patient was vaccinated at 17 years old. No Treatment information was provided.    Action taken with mRNA-1273 in response to the events was not provided.  The event vaccinated at 17 years old was considered resolved on 04 mar 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 01321A) with no associated AEs reported.
feeling bad; could not sleep; Nausea; feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling sick), FEELING ABNORMAL (feeling bad), INSOMNIA (could not sleep) and NAUSEA (Nausea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION COMPLICATION (feeling sick), INSOMNIA (could not sleep) and NAUSEA (Nausea). On an unknown date, the patient experienced FEELING ABNORMAL (feeling bad). On 05-Feb-2021, INSOMNIA (could not sleep) had resolved. On 08-Feb-2021, VACCINATION COMPLICATION (feeling sick) had resolved. At the time of the report, FEELING ABNORMAL (feeling bad) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.; Sender'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.
Arm hurts/my arm is still sore; I had fever/ low grade temperature 96 or a 97 and I ran 99.2; Diarrhea; was so sick I could hardly get out of my chair/I was sick for 3 days; This is a spontaneous report from a non-contactable consumer (patient). A female patient(unspecified age) received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. Medical history included that patient had the Covid was hospitalized, it was scary and was like she will die and also had pneumonia with it. Concomitant medication was not reported. On an unspecified date, patient's arm hurts/ arm was still sore, diarrhea, was so sick that could hardly get out of chair, had a low grade temperature 96 or a 97 and she had 99.2, fever and was sick for 3 days. Lab test included COVID-19 antibody test on an unspecified date and result was positive had body temperature measurement and result was low grade temperature 96 or a 97 and she had 99.2. Reporter seriousness for arm hurts/ arm was still sore, diarrhea, was so sick that could hardly get out of chair, had a low grade temperature 96 or a 97 and she had 99.2, fever and was sick for 3 days was unspecified. Outcome for all events was unknown.  Follow-up attempts are needed. Information on the lot/batch number is expected.
38 yo healthy pt had sure LMP of 1/30/21, and 1st Moderna COVID vaccine given 2/13/21 and 2nd one given 3/13/21.  she had non viable pregnancy found on 4/14/21 (1st ultrasound)  - she thought she was 10 wks and she was found to be 5 wks and no fetal pole nor yolk sac then.   she did have a non viable pregnancy as well 10/30/20, so not sure if COVID vaccine was related or not.  she has no health issues besides being an older female.  she works as a high school teacher for hybrid in person school, so really wanted the COVID vaccine.
I had an adverse effect after my 2nd shot: extreme aching, headache. The onset of symptoms started 2 hours after injection and ended 12 hours later. I was confined to the bed during the duration.   Yesterday, 8 weeks after injection of 2nd dose, the symptoms returned starting at 1:30 and becoming full force one hour later. Symptoms were the same as before except much more severe.  The extreme body aches and headaches were almost intolerable and lasted 12 hours after onset. I was confined to bed for the duration. Self treatment included Advil and muscle relaxer (tizanidine).
Information has been received from the nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of PEDVAXHIB (lot # L038502, expiry date 06-AUG-2018; dose and route not provided) that was improperly stored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
0.5 ml Fluviron given to pt Rec for >4 yrs. Box marked but not actual vial. Pt had no reaction
I got the 2nd dose (the 'booster shot') of the SHINGRIX shingles vaccine and had what I believe was a negative reaction over and above the reaction that can be normally anticipated. About 4 hours after I received the vaccine I developed extreme muscle pains in my neck, shoulders, arms, legs - all over my body. For a while it was so bad that I could barely lift my arms or walk. I also developed a headache that was far worse than any headache I had ever had. I also had the chills and shivering that is listed as one of the side effects and a slight temperature (99 degrees). But the thing that really alarmed me was that my blood pressure went up to the high 140s from its normal range of the 120s, and my heart rate went up from where it usually is in the middle 60s to around 80. This all lasted around 12 hours. I'm fine now but the doctor described this as a 'worrying reaction' and advised me not to get the hepatitis B shot or the pneumonia shot that I was planning to get. (BTW, I had absolutely no reaction to the 1st of the two SHINGRIX shots, and I have never had a reaction to a flu shot).
h/a, urticaria & joint pains on 3rd day p/1st dose of vax;
itchy, red and swollen, fever.  Alcohol and Cold compress/ice pack.  I took Tylenol, Zyrtec and Benadryl from Saturday the 13-today16th. Itchy is gone but swelling, redness and fever remains. Went to my Dr. office for review advised that it was an infection at the site of vaccine (Cellulitis) and she placed me on antibiotics.
After 1 week, patient reported that she had shingles (confirmed by lab results) and was started on empiric antiviral and antibiotic therapy. She had previously received shingrix and fluad on the same visit.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 20-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration 07-MAY-2021. No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2021-363733 (Patient Link).
Itchy and painful rash on lower back for five days.  Erythematous papular rash on lower back-some look like excoriated vessicles. Seen in office on 8/25/08
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. Approximately on an unknown date in February 2010 (reported as approximately 2 or 3 years ago), the patient was vaccinated with dose 1 GARDASIL (lot #, expiration date and route not reported). The nurse reported that the patient was in office on 21-FEB-2013 (reported as 'now') to receive dose 2 GARDASIL (lot #, expiration date and route not reported) which would be late. Dose 1 was administered by a different unspecified provider. No symptoms reported. No other details. Additional information has been requested.
Husband showed me a picture of her arm bruised in a circle and he claimed she has been in pain up to now since she was given the vaccination .
Information has been received from a physician concerning a 4 year old female who at 1 year of age was vaccinated with a dose of varicella vaccine live. Concomitant vaccination most likely included a dose of MMR. Subsequently, the patient developed Zoster in the genital area, buttocks, and down one leg. The pain was one sided. A culture was taken to differentiate with Herpes Simplex virus, and differentiated that it was Varicella Zoster virus. The patient was afebrile. Unspecified medical attention was sought. The patient was treated with acetaminophen (+) codeine phosphate, which did not relieve the pain, and acyclovir. The patient received no other medicines and was not hospitalized. It took one week before resolution. Additional information has been requested.
I noticed it felt itchy the next morning, she does get eczema at times, and thought that's what it was.  She tried cortisone cream yesterday for the itching, but it did not help.  This morning when she woke up the rash had spread and was all the way up her arm.  She was putting cold compresses on it as well.  She went to the UC at 1:00 this afternoon, who ordered an antibiotic and told her that there seemed to be an infection at the site of the needle.   Told her not to use the cortisone cream, to use the cold packs.
lt arm inj site swollen (size of a racket ball) warm/painful to touch;low grade fever (100.6);2 days later swelling went down w/redness;small nodule gone p/about 2wks;malaise, fatigue, chronic cough, chest discomfort;
One week after immunizations patient had a brief (3 minutes) generalized tonic-clonic seizure.  Had low grade fever for several days prior to that.  History of one previous seizure last year.
Systemic: tooth sensitivity, could not eat or chew-Severe, Systemic: Joint Pain-Medium, Additional Details: 3/19/21: after work, patient came home and noticed itchy rashes on both ankles\r\n3/20/21: Overnight, patient experienced tooth sensitivity, uncomfortable and painful to chew/eat. 1 top and 1 bottom teeth affected more than the others. Experienced joint pain in hips, hands, and ankles. Patient had history of arthritis\r\n3/21/21: Joint pain continued. Rash on R ankle had a few tiny blisters\r\n3/22/21: Dentist appt where one tooth was extracted. amox & pain med started, rash and pain went away
Redness and swelling. Instructed to apply ice, mom also gave patient Infants Acetaminophen.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # L040459, expiration date reported as 06-APR-2017 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit for 187 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt Rec'd Covid vaccine and injection in Lt eye for macular degeneration. Monday 1/11 slurring speech/jumbled words since dinner, went to bed, wife states improved from last night but still difficult clearly communicating. Also reports difficulty writing. Came to ED and admitted for stroke evaluation. Stable for discharge home 1/13 with neurology follow up visits.
Rash, itching, raised red bumps starting on ankles and spreading up legs. Then started on wrists, and spreading up arms. Topical Betamethasone did not help. Benadryl only helped itching a little, but did not help rash. Rash started 5 days after first Moderna vaccine, and is still progressing.
Patient presented to outside hospital with tactile fever and generalized tonic clonic seizure; was in status epilepticus, intubated for airway protection, resolved.
Heat in neck that resulted in swelling, itching and difficulty breathing for 4 hours, occured within a minute post vaccination. I had no confidence in the Medical Staff as I was told "I haven't encountered this before so I don't know what to do unless you will need an Epipen."
Patient received FLUAD and PNEUMOVAX 23 vaccine on 10/10/18 with no signs and symptoms of allergic reaction upon administration. However, on Wednesday 10/17 a adverse event was reported to pharmacist during her shift at 4830. Both husband and wife state that right arm in which they received FluAD vaccine caused substantial swelling that took a week to subside. Patient informed RPH that arm was sore, throbbing and red like a sunburn and took a week to subside.
Asthmas/having asthma attacks; bronchitis; This is a spontaneous report from a contactable consumer (patient) via Medical Information team and Pfizer sponsored program, Pfizer First Connect. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history  included asthma. Concomitant medication includes a bunch of medications for asthma. The patient had her first dose of COVID vaccine on 13Jan2021. The patient said that she does have asthma anyway and her asthma goes into bronchitis in 2021 very quickly. So she was just put on Prednisone. She is wondering if she can start Prednisone and an antibiotic for her asthma. The patient already had asthma but she is starting Prednisone and an antibiotic. And antibiotic is not something that she normally takes. The patient stated, "I took the Pfizer vaccine on Wednesday, the first dose and I am having a bad asthma attack (in Jan2021) and I don't know what my doctor put me on, wanted me to take Prednisone and an antibiotic (Unspecified Medication). The patient ask, "Can I take those after taking the vaccine?" The patient was asked about treatment for the event and stated, "Not until 2 days but right now I am having one. I just want to know if I can take Prednisone and antibiotic to get rid of this. Just my regular asthma medications that I am taking. My Albuterol inhaler, my Nebulizer and that's it." The outcome of the events was unknown.  Information about Lot/Batch has been requested.
24 HOURS AFTER THE VACCINE HE BEGAN HAVING HIGH FEVER, AND VOMITING. HIS FEVERS BECAME HIGH TO 103.7, HAD DIFFICULTY BREATHING, PRESENTED TO THE LOCAL ER, AND HOSPITALIZED. CT SCAN SHOWED NO PULMONARY EMBOLISM, BUT HAD SIGNS OF PNEUMONIA. COVID-19 TEST WAS NEGATIVE.  He was hypoxic, requiring oxygen.
This pt was IZ with her 4th dose of varicella vax in 12/99. She tested negative for varicella antibodies on 2 occasions, the second in 01/00.
the newly FDA (Food and Drug Administration) authorized Moderna bivalent formulation has a slightly higher dosage than what their child recently received.  According to the guidelines from the CDC (Centers for Disease Control and Prevention), it is recommended that we repeat their child?s most recent dose of COVID-19 vaccine to ensure proper protection.
Fever of 102F Chills Nausea  Headache All for about 36 hours
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored (1.7 Centigrade for 19 minutes) GARDASIL 9 (lot # L020015 with expiration date: 16-AUG-2017, lot# L026602 with expiration date: 19-OCT-2017 and lot# L043214 with expiration date: 30-AUG-2017, dose and route were unknown). No adverse effects were reported. Additional information has been requested.