chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information had been received on 19-OCT-2016 from a pharmacist regarding a 60 year old female patient with penicillin allergy and pertinent medical history of hypertension and hypothyroidism. On 16-OCT-2016, the patient received ZOSTAVAX (lot # M028798, expiration date 18-AUG-2017) 0.65ml 19400 PFU subcutaneously in the left arm. Concomitant medications included unspecified blood pressure medications and unspecified thyroid medications. On 18-OCT-2016, the patient began to experience redness at the injection site. On 19-OCT-2016, the redness was six inches in length at the injection site. Patient's present status was not recovered. Patient sought medical attention and called the pharmacist. The pharmacist advised the patient to contact her physician regarding her symptoms. Patient received unspecified treatment for her adverse event. No further information was provided. Additional information has been requested.
Has received flu shots in past 7 years with no problem. Could not raise arm above shoulder height. By 8:30 pm got headache, chills, temp was normal, took Tylenol and slept for 1 hour. Woke up at 1:30 am with severe chills, shaking 100.9 temp, nausea, vomiting for 1 hour, called doctor who recommended ER if could not keep liquids. Went to ER by 3am. At 4am seen by ER doctor and got IV fluids and anti nausea medication. At 5:30am temperature of 100.8 given Tylenol left at about 6am on 10/30/2005 slept until 1 pm woke up feeling better, a bit tired, but overall fine.
Around 9pm on 03/18/2021 I noticed stiffness in my arm and checked injection site. Injection site is swollen, red and generating heat.
Patient was mistakenly given pediatric formulation and dose of the Pfizer COVID-19 vaccine. Patient did not experience any adverse symptoms or side effects. The patient had left the facility before, PA-C realized the error. Once the error was recognized, the patient was contacted and advised that she had been given the pediatric dose, which is only about 1/3 of the adult dose and that she may not mount and adequate response to the vaccine, which means she may not have protection against COVID-19. Patient was called by PA and was advised to return to the clinic as soon as possible so that we can administer the adult dose of the Pfizer COVID-19 vaccine. Patient stated understanding.
pt recv vax 1OCT96 & 17JUN97 pt devel chickenpox consisting of 12 lesions;f/u info reported that no adverse exp occurred;
Muscle weakness and spasms to the point of not being able to walk for the evening of inoculation and the following 2 days. Ongoing extreme stiffness and significantly reduced range of motion. Inability to stand or walk for long periods of time. In addition had considerable muscle pain that seemed to move throughout the body the evening of the vaccination and the subsequent 2 days. Note: After first vaccination had muscle weakness and stiffness beginning the evening of the vaccine though significantly less.
COVID Breakthrough. Symptoms since 12/7/21, Tested positive as outpatient on 12/15/21, came to ED on 12/21/21 with SOB, body aches.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 16-JUL-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose, route and dose number were not provided). Excursion temperature and time: -0.6 degrees Celsius for 1 hour and 53 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
+Spiked fever during routine enzyme infusion therapy to 102, (72 hrs after vaccine given) then had seizure.
The day after getting Gardasil, patient reported nausea, vomiting, sore throat, generalized myalgia, generalized itching and itching and bruise at injection site. Symptoms resolved 5/16/07. This is in follow up information has been received from a registered nurse, concerning a 26 year old female patient, with imgraine headaches and an allergy to "drops for pink eye," who on 14-May-2007 at approximatel 10:00 am was vaccinated with the first dose, 0.5 ml. IM in the lef deltoid, of GARDASIL (invalid lot # provided). Concomitant therapy included ethinyl estradiol (+) NUVARING. There was no illness at the time of vaccination. On 15-May-2007 the patient experienced "nausea, vomiting, myalgia, a sore throat, itching and bruising at the injection site. "The following day, 16-May-2007, the patient recovered all of the events. No further information is expected.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-OCT-2012 18:23, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
slightly sore arm; This is a spontaneous report from a contactable pharmacist in response to a healthcare professional letter. A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EM9809) intramuscularly in the upper left arm on 10Feb2021 at 15:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number EL1289) on 19Jan2021 at 10:30 (at the age of 76-years-old) for COVID-19 immunisation and experienced sore arm, headache, and slight sinus headache. On an unspecified date, the patient experienced slightly sore arm which lasted one day post-vaccination. The outcome of slightly sore arm was recovered on an unspecified date.
AFTER VACCINIA OF HUSBAND PRE-DEPLOYMENT, PATIENT DEVELOPED IDENTICAL RASH ON THE DELTOID ARE CORRESPONDING TO THAT WHICH WOULD BE IN CONTACT WITH HUSBAND (VACCINEE) IN BED. VERY LIKELY SECONDARY VACCINATION BY CONTAGION. PATIENT WAS VACCINATED IN CHILDHOOD ROUTINELY.
No additional AE; The patient stated he went to his doctor today to get the second shot and they have told him that they don't accept his insurance and they did not administer the second dose.; The patient stated he went to his doctor today to get the second shot and they have told him that they don't accept his insurance and they did not administer the second dose.; This spontaneous was received from a consumer referring to himself as a male patient of unknown age. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided by reporter.  On 18-NOV-2020, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, route of administration and anatomical injection site were not provided; dose, frequency, lot number, and expiration date were reported as unknown) as prophylaxis.  On 18-DEC-2020 (also reported as today), the patient went to his doctor to get the second shot and they told him that they do not accept his insurance and they did not administer the second dose (inappropriate schedule of product administration and circumstance or information capable of leading to medication error). The consumer has been unable to find another provider that has the Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) vaccine in his area. No additional adverse event reported. At the reporting time the outcome of inappropriate schedule of product administration, and circumstance or information capable of leading to medication error was unknown.
First dose was completed on 1/7/2021 and the second was completed on 2/4/2021. In March 2021, experienced change in menstrual cycle. Have a hx of PMS, but nothing as severe as was experienced in March, April, May, and June of 2021.  Had a marked increase in PMS well above normal, including cystic like acne, hair loss (coming out almost in clumps), edema, irritability, mood swings.  PMS would start a week after the end of the last period.  Had a significant increase in dysmenorrhea and menorrhagia.  Periods would last for seven to nine days, with four to five days of heavy bleeding (specifically, would use 10 or more maximum sized pads in a 24 hour period, and still had problems with cleanliness despite signficant pad use). Also had bleeding in between periods for first time. Did not in any way connect this to the vaccine until I heard on the media that a number of other women had reported this effect after they completed their shots.
The patient was found deceased at home about 24 hours after immunization. Date of Death:: 12/29/2020; estimated time of death 6:00pm
When I had the second shot my iron was already low. When they pulled out the needle my blood ran down my arm, I didn't know low iron affects your clotting ability. It was an unusual situation that never happened before. March 6th I went to the ER too because I was so exhausted and it was because of my low iron, I thought I wasn't sleeping well. The ER doctor said my iron was low and I needed to get it up or I'll have to get a blood transfusion, it was at an 8 and isn't supposed to be lower than a 12. Since I got the covid shot I've had 12-14 day periods, every 20-21 days and has been severe and has been happening since Feb, and is leading to my anemia. And I've never ever had this. It's a new symptom so the Ob-Gyn doctors don't know what to do. I've had 2 massive blood blowouts and clots that have soaked my pants, I've never had this in my entire life. And this makes me very exhausted.
REALLY COLD, COULDN'T GET WARM; STIFF FOR SEVERAL HOURS; FELT ODD; MUSCLES ACHED; A BIT OF A HEADACHE; SORE WHERE THE INJECTION WAS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers . No concomitant medications were reported. On MAR-2021, the subject experienced really cold, couldn't get warm. On MAR-2021, the subject experienced stiff for several hours. On MAR-2021, the subject experienced felt odd. On MAR-2021, the subject experienced muscles ached. On MAR-2021, the subject experienced a bit of a headache. On MAR-2021, the subject experienced sore where the injection was. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from really cold, couldn't get warm, stiff for several hours, muscles ached, a bit of a headache, sore where the injection was, and felt odd. This report was non-serious.
A76yo male with PMH of Smoker, HTN, Malignant neoplasm of  the Prostate, Mixed hyperlipidemia, Bladder Carcinoma, Heme +ve stool,  Hyperlipidemia, Carcinoma of the Prostate, CHF He received JSN Covid-19  vaccine on March 20, 2021 per policy and protocol without complication No  ADE reported
swelling in his legs; his legs turned hard and red; his legs turned hard and red; concussion; involved in a car crash; vaccine had been expired; did not have any pneumoccal pneumonia titers; the patient was instead given pneumococcal pneumonia in July 2009; This spontaneous report was received from the patient's mother referring to an approximately 1 month old male patient. Concomitant vaccins included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid, polio vaccine and hib vaccine. In 2009, the patient received diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL). After being vaccinated with diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), the patient experienced abdominal pain, diarrhea, an asthma attack, coughing, reflux, fever, waking up in bouts of sweat, projectile vomiting, rashes and was screaming for no reason as a baby. Historical drugs included montelukast sodium (SINGULAIR), ranitidine, fluticasone propionate (FLONASE), loratadine (CLARLTIN), and salbutamol sulfate and other over-the-counter drug medicines. the patient's historical condition also included shortness of breath. The patient was allergy to diphenhydramine hydrochloride (BENADRYL).  In July 2009, the patient was instead given individual shots rotavirus vaccine, live, oral, pentavalent (ROTATEQ), varicella virus vaccine live (oka/merck) (VARIVAX), pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, lot #, and expiration date of all therapies were not reported, route of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was oral, route of other vaccines was not reported) for prophylaxis.   In 2012 the patient did not have any pneumococcal pneumonia titers so a second pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) shot was given. After the vaccination, the patient experienced swelling in his legs and his legs turned hard and red. On 05-AUG-2016, the patient received his first shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin (RHA)) (one shot; strength, dose detail, route, were not reported; lot # K000997 and expiration date 22-JAN-2016) for prophylaxis (expired vaccine used). In 2019, the patient was involved in a car crash, magnetic resonance imaging (MRI) and x-ray in stomach was performed without result provided. In 2020 he received a concussion.   The outcome of all events was not provided.  Causality assessment was not provided.
CLINICAL IMPRESSION 1. Fever and chills  2. SIRS (systemic inflammatory response syndrome)  3. Acute midline thoracic back pain  4. Lumbar back pain
HIVES ON UPPER TORSO, BACK, ARMS. PATIENT USED TRIAMCINOLONE CREAM WITH IMPROVEMENT AND NOTIFIED PHARMACY ON 7/12/15 AT 5:55 PM AND I RECOMMENDED PATIENT ALSO TAKE ORAL BENADRYL. UPON FOLLOW-UP ON 7/13/15, PATIENT REPORTED MORE IMPROVEMENT AND I SUGGESTED SHE CONTINUE WITH THE STEROID CREAM AND BENADRYL AND TO SEE DOCTOR IF CONDITION WORSENS OR NO MORE IMPROVEMENT.
Patient had pain after shot was given. Patient use ice and TYLENOL to ease the pain but they didn't help as much. On 01/11/16, the pain was bad as the first day.
Pharmacy held an immunization clinic for employees of a large local business at their office location. The patient, a 15-year-old, attended with her parents. We were offering COVID-19 boosters to employees and had both Pfizer and Moderna options for them. We were not expecting any pediatric patients to attend this event. The patient's DOB was overlooked, and she was given 0.25ml of the Moderna COVID-19 vaccine. She had previously been vaccinated with Pfizer COVID-19 vaccine; her last dose had been June 5, 2021.
On 1/27/00, the pt developed a moderate to severe case of chicken pox. The pt sought unspecified medical treatment. Additionally it was noted that "two weeks later the pt's sibling also developed a moderate case of chicken pox." Additional information has been requested. Follow up states on an unspecified date the patient recovered. No further information is available.
Information has been received from a consumer concerning her 12 year old daughter with no drug allergies and no medical history, who on 06-JUN-2007 was vaccinated with a first dose of Gardasil. Concomitant suspect therapy on 06-JUN-2007 included "a hepatitis shot" (manufacturer unknown). Concomitant therapy on 06-JUN-2007 included "a tetanus shot" (manufacturer unknown). Subsequently, the patient began to have convulsions. Her body became rigid and her eyes "rolled backward." The entire episode lasted approximately thirty seconds. No laboratory diagnostics were performed. The patient recovered on an unspecified date "and is fine." No product quality complaint was involved. Additional information is not available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose number unknown (booster), single (Lot number: GJ6738) at the age of 38 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Dec2021 as dose number unknown, single (Lot number: FJ8760) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2023) Positive, notes: on day 1 of testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes: Paxlovid from 14Feb2023 to 18Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
none The local Health Department asked us to file a report as this injection was given 12 days after the 30 day refrigerator time was up. This office was not aware that a refrigerated Moderna vial has to be used within thirty days,. The expiration date on the form was 7-11-22.
Matalic taste immediate after shot given 30 min later started having headache. Started having body aches 1600- started feeling (R) facial symptoms tingle, itchy, eye blurry, 1800 (R) facial droop, slured speech, 1900, was in so much pain (R) facial droop, severe pain in body (R) arm where shot was given was in so pain. Next day still had facial drooping, headache body sore. Went to the ER 10/16/21 - for stroke like symptoms
patient has shingles after receiving the first dose of Shingirx; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced shingles. The reporter consent to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (6 days later I contracted COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced COVID-19 (6 days later I contracted COVID). At the time of the report, COVID-19 (6 days later I contracted COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.
Information has been received from an office manager via a company representative referring to a 78 year old male patient. The patient's pertinent medical history and drug allergies were not provided. There was no concomitant medication reported. On 16-FEB-2017, the patient was vaccinated with ZOSTAVAX (lot number and expiration date unknown) 0.65 ml, subcutaneously for prevention of herpes zoster. On 17-FEB-2017, the patient experienced difficulty breathing and "could not fill his lungs". On 20-FEB-2017, the patient came in for office visit due to difficulty breathing and was given DECADRON 8/4 mg. On 22-FEB-2017, the patient went to unspecified emergency room for difficulty breathing. Unspecified Blood work and a computerized axial tomography (CAT) scan was done at the emergency room and everything was fine. The outcome of the event was reported as not recovered. The causal relationship between ZOSTAVAX and the event was not provided. Additional information has been requested.
Rash began around 11/14/2021 following moderna booster vaccination on 11/02/2021. Rash appears then resolves and reappears in different areas around the body, Pt reports no change in soaps, lotions, laundry detergent, diet or other medications. Pt using hydrcortisone cream to treat
Fever 103.5 on 5/5/11, rash, unresponsive x 1-2 minutes, ? febrile seizure
little jiffy on my nose; funny rash and a little on the upper chest; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (little jiffy on my nose) and RASH (funny rash and a little on the upper chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL DISCOMFORT (little jiffy on my nose) and RASH (funny rash and a little on the upper chest). At the time of the report, NASAL DISCOMFORT (little jiffy on my nose) and RASH (funny rash and a little on the upper chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No allergies was reported.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
I did not have respiratory problems, I started feeling very fatigued, then started having issues in my gut. I took a home COIVD-19 test that came back positive. I called my doctor to discuss my symptoms with her and to let her know my home COVID-19 test was positive. She prescribed the antiviral Paxlovid, I started the medication the next day. The medication made my stomach hurt more, once the five-day regimen was over, I felt better. This is the third time I have had COVID-19, I feel as if long haul COVID-19 along with my hiatal hernia are wreaking havoc with my abdominal area.