chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the authors of a published literature article, regarding  a 21 year old female patient, who was referred for possible hepatitis B virus (HBV) infection following routine testing for sexually transmitted infections (STIs). The patient had a past medical history of iron deficiency anemia and irregular menses. She had unprotected intercourse with a single partner 5 months prior to evaluation, and denied medications, prior surgery, transfusion of blood products, or intravenous drug use. Her paternal grandfather had an unknown type of liver cancer, but neither of her parents had any known liver disease. Review of the patient's medical record revealed she underwent her second hepatitis b vaccine (recombinant) (manufacturer unknown) vaccination (strength, dose, administration route, lot number and expiration date were not reported) for prophylaxis, on an unspecified date the day before her primary physician ordered STI testing. On an unspecified  date, a viral hepatitis panel was drawn 30 hours following her vaccination, and was qualitatively positive for hepatitis B surface antigen (HBsAg), which prompted extensive follow-up lab testing and gastroenterology consultation. The patient's physical exam was without stigmata of chronic liver disease, and was otherwise unremarkable. Repeat testing drawn 6 days after vaccination demonstrated normal liver-associated enzymes, and negative hepatitis B surface antibody (HBsAb), HBsAg, anti-hepatitis B core IgG and IgM, hepatitis B e-antigen and antibody, and undetectable HBV DNA by polymerase chain reaction (PCR). The outcome of hepatitis b surface antigen positive was resolved on an unspecified date. Authors stated that the patient's HBsAg positivity reverted within 6 days of vaccine exposure, but if testing was indicated or clinical uncertainty exists, they recommend deferring at least 2 weeks following vaccination. Hepatitis b surface antigen positive was considered to be related to hepatitis b vaccine (recombinant) (manufacturer unknown). Authors also stated that HBsAg positivity was common following vaccination, and usually did not extend beyond 14 days. Deferring HBV testing for an appropriate period might prevent not only patient anxiety, but also expensive and unnecessary follow-up testing and specialist consultation.
pt recv vax 20JAN97 & mom states 21JAN97 pt has been crying on & off since yesterday;cried for about 2hr @ a time, unusual high pitch cry, otherwise no other c/o;mom states on 23JAN pt calmer, still irritable @ times;
Initial report received from a healthcare professional on 31 MAY 2013. A 17-year-old female patient, who had no illness at the time of vaccination and whose concomitant medications were not reported, had received an intradermal dose of ADACEL (lot number: U3956AA with expiry date 16 NOVEMBER 2013, anatomical site of vaccination was not reported) on 31 MAY 2013. The patient was allergic to Augmentin. It was reported that ADACEL prefilled syringe was inadvertently administered intradermal "as in administering a TB test" on 31 MAY 2013 and immediately following the vaccination, the patient developed "local site reaction" of redness and swelling. Laboratory investigations and corrective medications were not reported. Till the time of this report, the patient had not recovered from the events. Follow-up information received from healthcare professional on 11 JULY 2013. Date of vaccination was updated from 31 MAY 2013 to 28 MAY 2013.  The patient address was reported and was updated in patient address screen. Documents held by sender: none
hard and painful to raise her arm; range of motion is painful; warmth and swelling; warmth and swelling; Skin reaction; This is a spontaneous report from a contactable nurse  A 58-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot CH3594, exp.date 28Feb2022) at 0.5 ml single dose via intramuscular route in the left deltoid on 09Dec2019 10:33.  On the same date the patient also received the second dose of varicella zoster vaccine rge (CHO) (SHINGRIX, lot YM74C, exp,date 08Mar2020) via intramuscular route in the right deltoid. The patient had received the first dose of shingrix on 05Jul2019. The patient had not medical history. On 09Dec2019 the patient experienced Skin reaction, warmth and swelling, hard and painful to raise her arm and range of motion is painful. The outcome of the events Skin reaction, Feeling hot and swelling was reported as recovered. The outcome of the other adverse events was reported as not recovered.  The events Skin reaction, hard and painful to raise her arm and range of motion is painful were assessed as serious.; Sender's Comments: The association between the events "skin reaction, hard and painful to raise her arm, and range of motion is painful" with pneumococcal 13-valent conjugate vaccine can not be fully excluded based on the close temporal relationship.  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.
Appoximately 3-5 minutes after immunization, the patient said he felt like he was going to pass out. He was seated and his eyes wide open. The muscles in his hand seemed to contract. Although his eyes were wide  open, the patient could not respond to voice commands. It appeared to us to be a seizure. The patient was back to normal in about 15-20 minutes and only felt tired. EMS worker asked if patient wanted to be taken to hospital of go home. The patient chose to go home. I spoke with the mother of patient 6 hours later and she said he was doing fine and was going to see a doctor in 2 days for follow up.
RN administered 12+ dose Pfizer vaccine to patient. NP immediately recognized that vaccine count did not match up and inquired further with RN who at that time realized she had given the wrong strength of vaccine ot the patient.
4PM screaming, high pitched cry x 40 min on the way to MD office, pt went to sleep when arrived @ MD office pt began crying again;
The problem started around May 14  with facial nerve pain around my right eye and temple. Just super sensitive to touch. It then became very painful down low behind my right ear. It didn't burn, but it did feel like nerve pain and it was throbbing.  It was r3eally quite painful. Then I noticed that my right eye didn't feel right and neither did my mouth.  I went to look in the mirror and my face wasn't right . It was all sagging on the right side. My eye brow had fallen, my eye wouldn't blink on it's own and I couldn't smile on the right side of my mouth. I checked for all the signs of stroke and fortunately my speech was okay and my tongue worked okay.  I did a video call with my Dr. the next day and she said I have Belle"s Palsy.  The pain behind my ear lasted about 3 days. It is now a week past the diagnosis of Belle's and my face is still paralyzed. I read that there were cases of Belle's Palsy in the trials and felt I should report this.
Information has been received from a nurse referring to a male patient of unknown age (over 65 years old). Information about patient's current condition or medical history was not reported. The nurse reported that the patient received his first dose of ZOSTAVAX (lot# not reported, 0.65ml, subcutaneously) on 25-MAR-2014 and then inadvertently was administered a second dose of ZOSTAVAX (lot# not reported, 0.65ml, subcutaneously) on 27-MAR-2015. No adverse effects were reported. Additional information has been requested.
woke up from nap @ 330PM & was inconsolable until 8PM (p/3rd dose of APAP); red, swollen leg; low-grade fever;
severe reaction to the pneumonia vaccine; This spontaneous report was received from a 66 year old female patient, via other company. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced a severe reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  (vaccination complication).       The outcome of the event vaccination complication and the causal relationship between the event and vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  was not reported.; Sender's Comments:  AE-2020-24035
Pain on feet; difficulty for walking; muscular pain, loss and weakness; fatigue; weight loss
pt stated after she got the vax later that day she started getting violent shaking with chills, 100.7 temp, headache, vomiting, diarrhea, and fatigue. When she woke up the next day she is still very weak and nauseated with a 99.6 temp.  She has only taken Tylenol for her symptoms.  Pt will reach out to her PCP regarding her symptoms.
No adverse event reported.  The patient's mother filled out the immunization consent form and screening form.  On both forms mother wrote the date of birth of the patient as 11/16/2008.  Before the pharmacist gave the vaccination, she confirmed the patient's age. Account flagged the account because the patient's actual date of birth through vital records is 11/16/2009.  I tried to call mother several times.  Her voice message is full and I am unable to leave a message.
I had my vaccination on 09/09/2022. On 09/22/2022 I had a spot on my back that looked like a burn. I saw my dermatologist on 09/27/2022 and stated that it was Shingles. I chose not to take the prescription. Two weeks after vaccination I also had gastrointestinal bleeding. I did see my primary doctor on 09/23/2022 and they are going to do a colonoscopy in 01/2023.
patient stated that within 3 minutes he started to feel faint and his heart started racing. he started to sweat and passed out in floor. Gash on eyebrow
Information has been received from a medical assistant(also reported as office manager) referring to a 14 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 28-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Narrative: COVID infection following COVID vaccine series 01/29, Pfizer, dose #1 02/18 , Pfizer, dose #2 0823 COVID swab, result: detected 08/20 pt cc: exposure: unknown 08/23 SARS-COV-2 Variant Sequencing result: pending
pt came today for 4mos boosters;upon questioning mom reports exactly 48hrs p/vax pt became extremely fussy;exp inconsolable crying x 4hrs;called MD today & ordered ped DT in place of DTP
Skin is tender all over; Itchy; Skin was flushed; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING, PAIN OF SKIN, and PRURITUS in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced FLUSHING and PRURITUS. On 15-Jan-2021, the patient experienced PAIN OF SKIN. The patient was treated with BENADRYL on 14-Jan-2021 at a dose of 25 milligram. At the time of the report, FLUSHING, PAIN OF SKIN, and PRURITUS had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications included Diphenhydramine.   Reporter did not allow further contact; 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.
EE received flu shot on the L arm this morning at 9:21 am. Approx. 11:30 am EE experienced itchiness on the back of the neck on the L, then L fingers, then L arm. Sensation resolved approximately 10 minutes later at 11:40 am. EE reports similar Sx with some foods without other complication.
acute left leg pain and swelling 15 hour after vaccination with subsequent same day ER visit and ultrasound diagnosis of acute left leg DVT (blood clot) diagnosed.
PATIENT GIVEN HALF DOSE OF  MODERNA BOOSTER  AND SHOULD HAVE BEEN GIVEN FULL DOSE DUE TO BEING IMMUNO COMPRIMISED
Narrative: 69yo male had open heart cardiac surgery at contracted outside  hospital and was in community care skilled home health for post op. care. Primary Medical Diagnosis: Atherosclerotic Heart Disease of Native Coronary Artery without Angina Pectoris(ICD-10-CM I21.10) Problem list: hyperparathyroidism due to renal insufficiency, HTN, ESRD on HD, anemia of CKD, HFpEF (EF 45% 2019), HLD, chronic ischemic heart disease, arthritis, hx of PE (2015) Patient was DCd from Rehab on 12/14/21 s/p CABG- at hospital 11/19-12/18/21. Then home health care. Pt then died at home on 12/28/2021 while still in home health care. Pt had received covid vaccine on 1/6/21, 2/3/21, and 8/24/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Immediately after receiving the vaccine, I experienced chills and fatigue. The symptoms lasted about 24-48 hours. Five months later, I started feeling like I had water in my ears and they were popping. I went to see my doctor and she said that there was not an infection. She had me take Flonase nasal spray twice a day. My doctor said the sound had to do with eustachian tubes. I am still hearing the popping in my ears, but it seems to have reduced.
Upper chest + neck + facial flushing & lower arms. About 10 minutes after vaccine (Influenza) pt presented to primary MD + pt reports MD treated for adverse reaction to influenza vaccine. Pt started on methyl prednisolone as Rxed taper by Dr.
Information has been received from a physician concerning a 14 year old female who on 07-MAY-2011 was vaccinated IM with 0.5 ml first dose of GARDASIL (lot number:666987/1016Z). The patient received a dose of VARIVAX (Merck) at the same time on 07-MAY-2011. The physician reported that the patient "fainted about 5 minutes after receiving the shot". It could not be determined which vaccine caused the fainting. The patient did not seek medical attention. No treatment was given for the event. At the time of the report, the patient had recovered from fainted on 26-MAY-2011. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 54-year-old male patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine, Hepatitis B vaccine and ENGERIX B. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On 28th April 2017, the patient received the 4th dose of ENGERIX B. On 28th April 2017, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and less than a day after receiving ENGERIX B, the patient experienced therapy non-responder and needle injury. On an unknown date, the outcome of the therapy non-responder and needle injury were unknown. It was unknown if the reporter considered the therapy non-responder and needle injury to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and ENGERIX B. Additional details were provided as follows: In 2009, the patient received 3 doses of Hepatitis B vaccine. On 28th April 2017, immediately after receiving 4th dose of ENGERIX B vaccine, the patient had a needle prick. The Medical Doctor wanted to know what the guidance was with regards to vaccination of this patient or health care professional due to a dirty needle prick. On 28th April 2017, the patient's antibody concentrations against hepatitis B was 9 mIU per mL. On 26th May 2017, the patient received 5th dose of ENGERIX B.
While administering HPV to patient, patient fainted about 2 seconds after and was out for about 5 seconds. Came to and was feeling fine after. Checked on her three more times and was doing fine.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Myalgia, Fatigue, Pharyngitis, Strain (Strain of the Right Inguinal / Femoral area), Abdominal pain, Lumbar strain, Upper respiratory tract infection, Chest discomfort, Leg pain (leg pain, chronic, left), Knee pain (Knee pain Left,Acute), Synovitis, Eczema, Molluscum contagiosum and Cerumen impaction. Previously administered products included for Drug use for unknown indication: MMR Vaccine on 22-Jan-2010, Inactivated poliovirus vaccine on 22-Jan-2010 and DTAP Vaccine on 22-Jan-2010; for Product used for unknown indication: Influenza Vaccine. Past adverse reactions to the above products included No adverse event with DTAP Vaccine, Inactivated poliovirus vaccine, Influenza Vaccine and MMR Vaccine. Family history included Asthma (Asthma NOS W/ACUTE EXACERBATION) since an unknown date. Concurrent medical conditions included Lumbar strain, GERD, Epigastric pain, Dermatitis (Dermatitis,Peri Oral), Bronchitis (Bronchitis, Acute), UTI, Urticaria, Rhinitis allergic, Hearing disability and Penicillin allergy. Concomitant products included EPINEPHRINE (EPIPEN) for Allergic reaction, LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) for Asthma, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR UNSPEC) for Breathing difficult, TRIAMCINOLONE ACETONIDE for Eczema, SALBUTAMOL SULFATE (PROAIR HFA) for Wheezing and Cough, MONTELUKAST SODIUM (SINGULAIR), MONTELUKAST SODIUM from 30-Jul-2020 to an unknown date and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) from 04-Jun-2020 to an unknown date for an unknown indication.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Physical examination: results not reported Results not reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Problems included  H1N1 Vaccine  Other Medications included NEBULIZER DEVICE(Respiratory Therapy Supplies) Use as directed upto four times daily, Last Refill : 30/ Inhalation 3, 18 Dec 2018.
A couple of days after my first shot on April 9th, I was sitting at my kitchen counter at home.  My ears started ringing so loud that I yelled at my husband to turn the TV down.  He came to where I was sitting and told me the TV was not on.  I got my second shot on May 7th.  Since that time the ringing has been continuous in both ears.  It has not stopped.  I have seen my ENT 3 times.  I have been to an Audiologist specializing in tinnitus 2 tiems.   I go to an acupuncture doctor.  I go see a chiropractor.  I take supplements now.  I quit eating anything with gluten.  I have almost completely stopped eating meat.  I bought $400.00 ear buds that did not help.  Not one doctor has helped. It is horrible.
I am having very tight chest feelings and feel like I can't take a deep breath. This has gone on since about a half hour after the vaccine was forced on me. My employer forced me to get this vaccine against my will or I would face termination immediately even though I requested exemption and was told I had to be compliant. My questions were not answered and were avoided and ignored. I was not given any information about the batch number or ingredients of the vaccine.
This is a spontaneous report from a contactable female consumer who reported for her father. A 78-year-old male patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml single in Oct2015. The patient medical history was not reported. Concomitant medication included aspirin at 1 DF daily. The patient experienced blood marrow stops making blood in Nov2015 with outcome of not recovered, her father's weight was down to 166, he was 185 before he got sick after taking the shot on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included on unknown date blood count: 7.7; platelet count: 19; weight: 185 lbs; weight: 166 lbs; white blood cell count: 1.9. Therapeutic measures were taken as a result of blood marrow stops making blood included chemotherapy, blood transfusion, platelets, he also need to had this surgery to have a port put in to administer it. She mentioned that he had to have transfusion every week.
Fever, 100.4 F; chills, body aches, headache, fatigue.  Pain, erythema, itching and swelling surrounding injection site.  Local reaction began at 4:30 PM, systemic reaction began at 6:00 PM.  Treated with APAP 1000 mg at 6:30 PM and Naproxyn 440 mg at 10:30 PM on 7/09/20.  Repeated Naproxen 440 mg at 10:00 AM 7/10/20.  Second dose of APAP 1000 mg at 10:00 PM 7/10/20.  Missed work on 7/10/20 .  Had Covid-19 test done 7/11/20, nasopharyngeal swab; result negative.  Symptoms resolved by 7/12/20 with slight lingering fatigue.  Returned to work 7/13/20.  Local reaction lasted until 7/15/20, getting milder every day
5days p/vax pt exp limping w/rt leg pain. 4/1/99 pt woke w/crying & leg pain. MD ofc 4/2 nodule was felt at rt leg. seen again 4/7 c/o bilateral leg pain, bilateral knee fusion. temp 99f.
Excessive swelling, Paint redness, heat rise at injection site, spread from shoulder to elbow of right arm. On-set 3+ hours after admin. -Patient returned next day given antihistamine (cetirizine) cold pack therapy recommended, counseled on more severe symptoms to go to ER.
Erythema, swelling, warmth and pain around injection site-left upper extremity. Exacerbated by pressure and movement of left arm. Symptoms constant. Treatment-ice, elevate, and NSAIDs. Will avoid #2 dose.
Palpitations, dry eyes, vertigo, rash on chest several hours after receiving vaccine.  Resolved within a few hours.
fingers swelled in the upper joints and red -all fingers rheumatoid arthritis got worse-joint pain
3-4 weeks after bladder inflammation lasted 6mth implant in my body for the rest of my life. I will have inflammation for at least a year. Saw Primary care and though I had bladder infection. They referred me to Dr.