chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a healthcare worker concerning a 14 year old female with penicillin allergy and drug hypersensitivity of DARVOCET-N who on 16-JAN-2009 was vaccinated intramuscularly with a first dose of GARDASIL (lot # 661766/0652X) 0.5 mL. There was no concomitant medication. Within a few hours of receiving GARDASIL the patient experienced a rash on her neck and chest. The patient called the practice. On unspecified date, the patient recovered. Follow up information was received from a medical assistant. It was reported the patient was vaccinated with GARDASIL at 10:00 am on 16-JAN-2009 in the left deltoid. The patient went home after receiving GARDASIL and took a bath. At 12:00 pm on 16-JAN-2009 she developed a rash on her neck and chest. She took over the counter Benadryl per package instruction. No further information was available.
Information has been received from a 67 year old male consumer with high blood pressure and enlarged prostate who on 08-JUL-2006 was vaccinated SC in the left arm with a 0.5 ml dose of varicella-zoster virus vaccine live (Merck).  Concomitant therapy included Terazosin hydrochloride (HYTRIN) and testosterone gel.  On 13-JUL-2006 the patient experienced soreness in the left arm where the shot was administered.  By 14-JUL-2006 the patient had severe muscle pain in the left arm.  Aspirin was taken and alleviated the pain.  On 15-JUL-2006 the patient developed a fever of 101 degrees.  The fever dissipated by the morning of 16-JUL-2006.  Unspecified medical attention was sought.  The patient recovered on 17-JUL-2006.  There was no product quality complaint involved.  Additional information has been requested. Follow up - information received from the physician indicated that he did not have any information from the patient about any adverse reactions. Additional information in not expected.
given a dose of Kinrix that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 394C2, expiry date 18th January 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th March 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, 4 years old patient received already expired Kinrix vaccine,which led to expired vaccine used. The reporter consented to follow up.
Information has been received from a licensed practical nurse concerning a 20 year old female who on 14-AUG-2007 was vaccinated with a dose of Gardasil (lot# 658100/0525U). On 14-AUG-2007 the patient experienced syncope, dizziness and fatigue. Unspecified medical attention was sought. The patient's syncope and dizziness and fatigue persisted. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Pt was admitted to tertiary care hospital for 10 days for aspiration pneumonia and NSTEMI before transfer to critical access hospital. He was transferred on 9/26 and on 10/1 patient was more somnolent and confused and tested for COVID-19 and found to be positive.
Chronic cough onset first-day post-vaccination. Confirmed serious bronchitis. Potentially unseen atypical pneumonia.
Worn out; achy all over; This is a spontaneous report received from a contactable nurse. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but unknown Manufacturer), for Covid-19 immunization, on unspecified dates.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Worn out"; PAIN (non-serious), outcome "unknown", described as "achy all over".  Additional information: Additional Context: patient  got her adult Pfizer BioNtech COVID booster shot. The next day, she was worn out and achy all over. She knew that could happen, and it did.   The lot number for BNT162B2 was not provided and will be requested during follow up.
This case was reported by a physician via call center representative and described the occurrence of vaccination failure in an unspecified number of child patients who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination of the patients was not reported. The physician stated that she had seen many kids with the flu on the date of reporting and some had already received the flu shot. The exact flu vaccine manufacturer and flu vaccine was unknown. It was unknown if there was any seriousness criteria (death, hospitalization, disabling, congenital anomaly, life-threatening and clinical intervention required) associated with the reported event. This case was considered as the suspected vaccination failure, since the time to onset, laboratory test confirmation of influenza were unknown. The reporter did not want any follow-up forms.
15 x 10 cms erythematous noted on lt upper arm. Outbreak noted in AM p/inject was given, no fever was noted. Severe itching & burning like "her arm was on fire". Sensation extended down arm into fingers. Very hot & tender to touch.
Swelling and hard "knot" at the injection site that hasn't gone away yet, but is subsiding slightly. Large red spot - oval - approximately 2" x 3" that is just today lessening in intensity.
Sore/stiff arm and tenderness at the injection site. Started fading in 24 hours
Right upper arm/shoulder pain and decreased range of motion ongoing for >4 weeks. First 3 weeks, treated with TYLENOL, ALEVE and application of hot and cold packs to injection site (right upper arm). Now, currently on FLEXERIL, MOTRIN and NORCO and have off work order for 2 weeks. Symptoms still present.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 30-MAR-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 through intramuscular route (lot # K010465, expiration date 23-MAR-2016). There were no known adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Tightness around tongue 15 minutes after vaccination. About 45-50 minutes after vaccination a nickel size red splotch appeared on top of tongue. 50mg of Benadryl was taken and within a few hours symptoms subsided.
pt recvd vax; had a life threatening hypotensive-hyporesponsive episode 5 hrs p/ recving vax; required stabilization in pedi ICU in WPB;
Patient complaining of redness, itching, increased skin temperature, and swelling about 3 inches around site of injection. Advised patient to try benadryl to counteract the supposed allergic reaction. Also advised patient to seek medical attention if condition does not improve or worsens - patient has a history of cellulitis following allergic reactions.
pt fell asleep p/vax & slept about 3 hrs; awakened & fed & back to sleep for about 1 1/2 hrs; pt awakened crying & having 10-15 second epiosdes of gasping & tiwtching of head & upper body; sobbing; t98.5 R; sobbing & inconsolable crying;
injection site - hot; injection site - red; soreness at the site of the injection; A spontaneous report was received from a healthcare professional concerning a 84-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness at the site of the injection, injection site - red, injection site - hot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 014M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) soreness at the site of the injection. On 4 Mar 2021, the patient experienced the event(s) injection site - red. On an unknown date, the patient experienced the event(s) injection site - hot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 25 Feb 2021 the outcome of event(s), soreness at the site of the injection was resolved. On4 Mar 2021 the outcome of event(s), injection site - red was resolved. The outcome of event(s), injection site - hot was unknown.
I went to my doctor yesterday  because my left calf muscle had acute pain.  He did an ultrasound to verify that it was not the result of a blood clot which was negative;  so he gave me pain pills and instructions to use hot/cold compresses.  After getting out of a tub of warm water I noticed blotches of redness (rash) above my right knee which had already begun to swell.  I also noticed that my right calf muscled is beginning to be sore and a rash was developing on my arm below my elbow.
This spontaneous report as received from a pharmacist refers to a male patient "greater than 65 years of age" with a pertinent medical history of "asthma and chronic obstructive pulmonary disease". The pharmacist reported that the patient had been administered PNEUMOVAX 23 (unspecified lot/expiration date) annually at multiple locations described as "a health department, unspecified physician's office, and other places". On an unspecified date in the year 2011, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were not reported). The dates of administration were unspecified for years: 2012, 2013, and 2015 (drug use for unapproved schedule). The pharmacist reported that the patient also received a dose of PNEUMOVAX 23 (unspecified lot/expiration date) on 27-DEC-2014 and had written documentation. The pharmacist stated that the patient was present to receive his 2016 annual vaccination in a pharmacy on 14-SEP-2016 because his physician told him to get it. The pharmacist had not administered the 2016 annual dose of PNEUMOVAX 23 at time of the report. No adverse effects were reported. Additional information has been requested.
Patient states she got a breast infection on the side the vaccine was given. She reports symptoms a very sore breast, pain, inflammation in breast. Her doctor did not think it was related to the Shingrix vaccine. She was treated with Penicillin. She still reports soreness.
PATIENT HAS A BRUISE AND A LITTLE HARD SPOT ON BACK OF HER ARM WHERE SHE SAID THE SHOT WAS GIVEN. IT HAS BEEN ALMOST 2 MONTHS SINCE THE VACCINE. SHE ALSO REPORTS A LITTLE BIT OF SORENESS AT THE SITE.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication. On or about 10-JUL-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a health department as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-APR-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Tested positive for COVID-19 after previously receiving two doses of the Pfizer vaccine.; Tested positive for COVID-19 after previously receiving two doses of the Pfizer vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 44 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022 07:00, outcome "recovering" and all described as "Tested positive for COVID-19 after previously receiving two doses of the Pfizer vaccine.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom reported today that last noc at bath time she notice 4 hives like welts to L thigh around vaccine (Dtap) site. Child c/o itching area tender to touch, slightly swollen. Today areas were swollen c/o discomfort when climbing stairs, acting fine otherwise.
Information has been received from a physician concerning a female who was vaccinated with an unspecified number of GARDASIL. After receiving the vaccine the patient presented with CIN 2. The physician did not specify if the patient completed the series of GARDASIL. At the time of the report, the outcome was unknown. Additional information has been requested.
Swollen glands; Extreme tiredness; Joint pain; Severe head pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 51-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Aug2021 at 16:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis/psoriatic arthritis. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Aug2021, the patient experienced swollen glands, extreme tiredness, joint pain and severe head pain. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events swollen glands, extreme tiredness, joint pain and severe head pain was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Within 30 minutes: extreme vertigo. Within 1 hr low fever, extremely painful arm,  Slept on sofa for 6 days. Extreme Fatigue continues "Brain Fog" continues Constant raging Tinnitus in rt ear
Fri eve t103; Sat - runny nose, fever; Sun - t105; Mon - saw MD, put on children's Advil, gave Tylenol til Mon;
On 09/15/2021 at or about 9:30 am, I felt numbness on the left side of my face. The next day I had difficulty drinking from a cup or bottle. Later on during the day I couldn't blink my left eye. I noticed because my left eye was extremely dry.
PFIZER GIVEN TO 14 YEARS OLD BY RN AT THE VACCINATION CLNIC
09/22/2020 - I received a Flucelvax Quad 2020-2021 flu vaccine via syringe in my left shoulder at the pharmacy.  The vaccine site was swollen and hot for about 7 days.  Deep shoulder pain began along with excessive Ibuprofen use to try to manage pain.  Sleep difficulties due to waking with severe, deep shoulder pain that lasted for hours.  10/05/2020 - Office Visit with PCP/NP due to shoulder pain. Diagnostic tests and referrals were discussed.  Cause was unknown at the time.  No previous history of shoulder pain and/or injury.  X-rays were taken in the office to determine if a fracture or dislocation had occurred.  Neither were present on the x-ray.  PCP/NP prescribed Gabapentin and Lidocaine for pain.  She instructed me to discontinue Ibuprofen due to concern that I was experiencing possible abdominal symptoms related to the overuse of Ibuprofen.  PA discussed options, including MRI and PT, if pain continued.   10/23/2020 - Follow-up office visit with PCP/NP. Gabapentin was discontinued after first day due to side effects. Referred to a pain specialist. Flu vaccine prior to the shoulder pain was addressed.  12/03 - MRI completed as ordered by Pain Specialist, Dr. MRI Findings are:  FINDINGS: *Moderate Supraspinatus and Infraspinatus Tendinosis with mild adjacent fluid in the subdeltoid subacromial bursa suggesting bursitis.  *A 13 mm x 14 mm tear of the supraspinatus tendon. *Mild atrophy of the supraspinatus muscle. *Type 2 curved acromial configuration without undersurface spurring. *Advanced cartilage loss in the acromioclavicular joint with mild adjacent spurring. *Mild to moderate capsular thickening and increased signal suggesting adhesive capsulitis.  12/08/2020 - Follow-up visit with Dr. - recommendation of Physical Therapy 2-3 times weekly for 8 weeks to support self-healing of the supraspinatus tear if possible.  Dr. stated that the "almost full thickness supraspinatus tear with absence of attachment distally" may require surgery.  I continue to experience deep, left shoulder pain. Limited range of motion.  Severe pain and "crunching" sound when arm is lifted or when it receives any pressure against it (lifting self from tub/bed, etc.).  Follow-up appointment with Dr. will be scheduled for February 2021.
My heart rate go up; An illness where I ended up having a procedure and surgery; I never received my 2nd dose due to issues at the time not getting them where I lived.; I never received my 2nd dose due to issues at the time not getting them where I lived.; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (My heart rate go up), ILLNESS (An illness where I ended up having a procedure and surgery), PRODUCT ADMINISTRATION INTERRUPTED (I never received my 2nd dose due to issues at the time not getting them where I lived.) and PRODUCT AVAILABILITY ISSUE (I never received my 2nd dose due to issues at the time not getting them where I lived.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (My heart rate go up), ILLNESS (An illness where I ended up having a procedure and surgery), PRODUCT ADMINISTRATION INTERRUPTED (I never received my 2nd dose due to issues at the time not getting them where I lived.) and PRODUCT AVAILABILITY ISSUE (I never received my 2nd dose due to issues at the time not getting them where I lived.). The patient was treated with Surgery for Illness. At the time of the report, HEART RATE INCREASED (My heart rate go up), PRODUCT ADMINISTRATION INTERRUPTED (I never received my 2nd dose due to issues at the time not getting them where I lived.) and PRODUCT AVAILABILITY ISSUE (I never received my 2nd dose due to issues at the time not getting them where I lived.) had resolved and ILLNESS (An illness where I ended up having a procedure and surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their first dose in Jan-2021 and never received their 2nd dose due to issues at the time not getting them where the patient lived. The patient was also concerned because the first dose they received made their heart rate go up but did not experience chest pains or shortness of breath. Reportedly, once 2nd dose was available, but the patient tends to an illness where they ended up having a procedure and surgery. Now it has been 10 months, the patient still didn't get their second dose. At the time of report the patient didn't had issues with their heart.  No Concomitant product use was reported. No treatment information was provided.
inconsolable crying for 2 hours. back to baseline(normal) the following day. 04/13/2005
After Zostavax injection, patient's arm from shoulder to injection site started aching (within 15 minutes). By the next day, the injection site was surrounded by a red circle (1 inch diameter), and surrounding that was a 4-5 inch diameter swollen area. He had flu-like symptoms, lethargy, fuzzy thinking, sore/achy muscles, but no fever. The redness lasted 3-4 days, swelling and lethargy/flu-like/muscular symptoms lasted around a week.
55 year old female client arrived to vaccination site requesting Booster dose of Pfizer vaccine.  Client reports that a few days after receiving 2nd Pfizer dose, she began to experience minimal arm discomfort upon opening and closing of fist.  Client reports that discomfort is not debilitating, lasts for a minute and subsides.  Client reports that discomfort continues to occur occasionally present day.  Elevated issue to Clinical Supervisor, who receives approval from Dr. to administer Pfizer booster, and recommends client to follow up with Primary Care Physician regarding arm discomfort.  Client verbalizes understanding, and provides consent to receive booster dose.  Pfizer Booster administered by RN to client's left arm on 11/13/2021 at approximately 2:57 PM, Lot # FF8841.   VAERS completed on 11/19/2021.
At 3:30 pm pt. was given HPV #1, pt was in the room for 5 min then went to the waiting area to make an appointment. Around 3:45 pt felt sick and fell to the floor where she hit her head. We notify the Dr. laid her down on the bed took the PB 116/63.