chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 69-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 10:52 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 04-Mar-2022 at 10:52 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date and time of vaccine administered provided as 04-MAR-2022 10:52:11. Patient received booster dose. Patient ethnicity reported. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022 and they no longer possess this lot number.  No treatment medications were reported.
This case was reported by a other health professional via call center representative and described the occurrence of autism in a 2-year-old male patient who received PEDIARIX (batch number AC21B201AA, expiry date March 2011). Previously administered products included PEDIARIX with an associated reaction of no adverse event (Batch number AC21B201AA, expiry date March 2011), PREVNAR with an associated reaction of no adverse event (Batch number D06803, expiry date 01 May 2011), ROTATEQ with an associated reaction of no adverse event (Batch number 1271X, expiry date 23 May 2010) and Hepatitis B vaccine with an associated reaction of no adverse event. Concomitant products included PEDIARIX, PREVNAR, ROTATEQ and ranitidine. On 23rd April 2009, the patient received the 3rd dose of PEDIARIX (unknown). On an unknown date, the dose was an unknown dose. In July 2011, 2 years and 69 days after receiving PEDIARIX, the patient experienced autism (serious criteria disability, GSK medically significant and clinically significant/intervention required). On an unknown date, the outcome of the autism was unknown. The reporter considered the autism to be probably related to PEDIARIX. Additional information: A patient received a first Hepatitis B vaccine at birth and then later received 3 doses of PEDIARIX at 2, 4 and 6 months. The dates of PEDIARIX administration were 12/17/2008 (upper thigh), 02/26/2009 (right upper thigh), and 04/23/2009. The dosages were unknown. The patient was diagnosed with autism in July 2011. The patient's mother is not sure if PEDIARIX caused the autism but she thinks it probably at least contributed. She was never told by the doctor office that her son would be receiving additional doses of Hepatitis B and therefore extra aluminum with the PEDIARIX. She would feel more comfortable if GSK had actual studies that infants getting extra Hepatitis B is safe. Instead, our data is limited and yet we still market the vaccine to physician offices to administer in children like her son. The reporter reported another case of autism after vaccination with PEDIARIX. See case US2014011246.
Started with joint soreness and then pain, sharp shooting pains throughout body, feel sick like I have the severe flu, fever, swollen are that is red about 3 inches wide across arm at injection site, eye soreness and pressure, feeling like I'm getting a chest cold in my chest, muscle weakness
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-DEC-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 02-JUN-2016, the patient was treated at an urgent care center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The patient was prescribed VALTREX and NORCO for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Pt had vaccine about 12:50 pm on 6/10/2016. That evening she her symptoms started swollen arm, vomiting, dizziness, low grade fever, increased thirst, dry throat, drowsiness. She called pharmacy 6/11/2016 advised pt to got to ER. Pt went to patient first and then by ambulance to er due to AFIB. ER gave fluids and cartia xt 120/24, tramadol, and metformin prescriptions.
Patient fainted approx 5 minutes after receiving Gardasil vaccine. Pt. recovered and was checked by doctor. Normal blood pressure, normal temperature.
Follow-up information was received in patient demographics, test results and outcome of events. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced rash, tactile fever, limping left leg, decreased appetite, redness at injection site and swelling at injection site. At 3 years of age, the patient received the first dose on 17-Jun-2010. The patient experienced rash, tactile fever, limping left leg and decreased appetite in Jun-2010 and redness at injection site and swelling at injection site on 19-Jun-2010. Injection site redness and swelling resolved in JUN-2010. The other events resolved on unknown dates. No additional information was available at the time of this report.
Information was received from a nurse referring to a 30 years old patient of unknown gender. The patient received both first and second doses of GARDASIL (dose, route, lot # and expiration date unspecified) in 2006 (at 21 years old). On 08-JUN-2015 the patient received the third dose in series of GARDASIL (lot # K010574, expired on 08-APR-2017), 0.5 ml intramuscularly at 30 years of age. No adverse effect was reported. Additional information has been requested.
2 mo old M with swelling from shots today, got Tdap, Hib, rotavirus , Pneumococcal , OPV, now has a knot in the R thigh; R thigh- local firm knot palpated by mom may be Tdap here she thinks , eraser head size knot and redness mid R thigh and a knot palpable by mom
Swelling, redness, warm to touch. Resolved on its own. No medical treatment needed.
A physician reported the occurrence of an injection site reaction in a 5-year-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The vaccine provider submitted this report directly to VAERS. There was no relevant medical history, concurrent conditions or concomitant medications. On 06/20/2002 the vaccinee received his 5th injection of Infanrix. On that date he also received an injection of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). At an unspecified time of the day of immunization, he developed an injection site reaction characterized by a 12.5cm by 20cm area of rash with an edematous area inside the rash area. The injection site reaction resolved 4 days later. The reporter stated that the injection site reaction was related to Infanrix administration.
HYPOTENSION 6/1/2022 ANEMIA HYPOTENSION 6/1/2022 SEVERE PROTEIN CALORIE MALNUTRITION HYPOTENSION 6/1/2022 OCCULT BLOOD IN STOOL HYPOTENSION 6/1/2022 CHEST PAIN HYPOTENSION 6/1/2022 SUPRAVENTRICULAR TACHYCARDIA
pt called 24OCT in AM c/o swelling & pain @ inj site;pt told to use cold compresses & could try DPH & see MD if not better by PM;pt to clinic 3PM area is red, warm to touch, swollen but not firm;
Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
Fever, severe fatigue, nausea, facial swelling around right eye and visual impairment in right eye, (flashing white light) Severe fatigue and aching-had to have friends take dog out, unable to walk any distance.  I am very healthy with no health issues, so for me this was very unusual.  I did not seek any medical assistance, I was too sick to even consider.
Swelling, erythema, and tenderness at the site with swelling of the soft tissue at the site
8/13/13 Swelling to Bilateral Upper Eyelids, Vomited x 1. Time: 5;30 PM duration 2 hrs. TX: Benadryl 0.5 ml PO at home by mother.
ABOUT ONE HOUR AFTER THE INJECTION MY ARM BEGAN TO FEEL HEAVY, SORE AND APPEARED RED/SWOLLEN...I READ THE NORMAL REACTIONS ON THE HANDOUT PROVIDED AND FELT THIS WAS NORMAL.  NO TREATMENT.  THE NEXT DAY MY ARM WAS MUCH MORE HARD TO MOVE ..IE  RAISE MY ARM UP OR SIDEWAYS...IT WAS SORE, STIFF AND I FELT FATIGUED, AND OUT OF SORTS.  I AGAIN READ THE SIDE EFFECTS AND THIS WAS LISTED AS A MILD REACTION BUT NOT SIGNIFICANT TO REQUIRE ATTENTION.  THE NEXT DAY/TODAY IN THE EVENING, I BEGAN FEELING ILL, BODY ACHES, HEAD ACHE, A SORE THROAT, HOARSENESS AND GENERAL MALAISE...AS IF I WAS COMING DOWN WITH THE FLU... I AGAIN READ THE HANDOUT AND DID NOTE THAT THE GENERAL MALAISE/FATIGUE WAS NORMAL; BUT DID NOT SEE SORE THROAT, HOARSENESS OR GENERAL BODY ACHES/PAINS...THAT IS WHY I FELT THAT I SHOULD AT LEAST REPORT THIS.  I WAS TOLD BY THE MEDICAL ASSISTANT THAT GAVE ME THE INJECTION THAT THIS VACCINE FOR INFLUENZA CONTAINED 3-4 DIFFERENT STRAINS OF THE FLU VIRUS.  SHE ALSO ASKED ME IF I WAS ALLERGIC TO EGGS.  I SAID NO.
Swelling in upper left arm at site of injection.  Lump about size of baseball.  Redness and inflammation.  Discomfort when lifting arm.
Hives developed after flu vaccine 10/5/16. Developed mild sense of swelling in the back of throat and mouth. Skin rash/hives. Erythema and inflammation of the eyes. Vomiting. Presented to ED and was admitted as inpatient for treatment.
pt recv vax & on 23JAN97 pt devel 18 pox & mild fever;
Felt very tired since last night; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt very tired since last night) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Tetracycline allergy) and Multiple sclerosis since 28-Jun-1977. Concomitant products included CALCIUM, VITAMIN D NOS, ALENDRONATE SODIUM (FOSAMAX) and ANASTROZOLE (ARIMIDEX) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt very tired since last night). On 01-Apr-2021, FATIGUE (Felt very tired since last night) had resolved.            No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-May-2021 included patient details, past medical history, additional concomitant medications, outcome of event with stop date.
developed head to toe rash, swelling to ears and eyes, itching, feels lightheaded
Side effects as follows: nausea- muscle aches- fatigue- shivering- overheated- headache-body aches head to toe including teeth- injection site pain.
first dose in 8May2018, did not receive further doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 8th May 2018).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: Pharmacist reported that a patient received the first dose of Twinrix and did not receive any further doses of the vaccine. The reporter consented to follow up. Additional Supportive Information: : Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
No adverse event; Caller reported GARDASIL 9 was administered to a pregnant patient; This spontaneous report was received from a registered nurse concerning a 32-year-old female pregnant patient. Information concerning the patient's pertinent medical history concurrent conditions and concomitant medications was not provided.   On approximately 13-OCT-2022, the patient became pregnant. The patient's last menstrual period (LPM) was not provided, however it was calculated as 29-SEP-2022.  On 31-MAY-2023, at 33 weeks and 6 days of gestation, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL, administered intramuscular in the deltoid (not specified which one) as prophylaxis, lot #W017539 and expiration date reported as 04-JAN-2025 (strength and frequency were not provided) (Maternal exposure during pregnancy). No adverse additional adverse event was not provided.   At the time of reporting, the outcome of patient's pregnancy was pending.
Patient noted tightness in her left arm and found it hard to take her jacket off. She noticed that the injection site appeared to be swollen and felt warm to the touch. She took ibuprofen which did seem to help a little. The next morning she noticed a rash. Her mother put ice on the injection site and patient wore a sling. The next day the rash appeared worse so Mother circled the swelling with a marker ( 02/01/2020). Today, 02/03/2020, the redness is noted to have spread beyond the marker.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL (dose and route unknown) on 28-MAR-2013 (lot number, dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Patient received vaccine on 9/6/23; patient called us on 10/5/23, saying that since she received the vaccine, her shoulder has been hurting, & that she's had to take Tylenol frequently, though that provides limited relief; she said her range of motion in vaccinated arm is limited
Headache, Myalgia, SkinRash, Light sensitivity,  Narrative: Received 1st dose 1/5/21 - 1 week later noted arm pain, and swelling/redness at injection site - with a welt 4 inches in diameter. Received 2nd dose 2/2/21. Awoke the next morning with arm pain, otherwise feeling fine. Noted onset of headache with light sensitivity as day progressed, as well as neck and low back/pelvic pain. Symptoms improved later in the day 2/4/21. On 2/6/21 ate at a restaurant and had a margarita - shortly after felt face burning, a little short of breath and noted hives on face and neck. Also developed hives on her torso. No history of food/alcohol allergy. Treated with diphenhydramine with resolution within several hours. Missed work x 1.5 days. No known prior COVID infection.
She has facial atrophy and has to use fillers; Face is still puffy; the lump on her face is smaller and does not look as bad; This spontaneous case was reported by a consumer and describes the occurrence of PROGRESSIVE FACIAL HEMIATROPHY (She has facial atrophy and has to use fillers) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0031A21A, 013B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol (Generic Lipitor for cholesterol). Concurrent medical conditions included Hypothyroidism (takes Synthroid) and Seasonal allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DOXYCYCLINE for Red rash.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, the patient experienced PROGRESSIVE FACIAL HEMIATROPHY (She has facial atrophy and has to use fillers) (seriousness criterion medically significant), SWELLING FACE (Face is still puffy) and MASS (the lump on her face is smaller and does not look as bad). At the time of the report, PROGRESSIVE FACIAL HEMIATROPHY (She has facial atrophy and has to use fillers) and SWELLING FACE (Face is still puffy) had not resolved and MASS (the lump on her face is smaller and does not look as bad) was resolving.            Treatment reported as Steroid shot (Unknown name), Antibiotic Doxycycline 100mg BID, Saline injections, Another round of antibiotics.  Concomitant medication reported generic Lipitor. Patient reported her existing rash or lump on the face did not get worst.   This case was linked to MOD-2022-482189, MOD-2022-482209 (Patient Link).
noticed localized rash on chest upon waking up in the morning. Describes as burning sensation. Symptoms improving by Benadryl PO and topical steroids.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 12/17/2022 Discharge Date: Dec 20, 2022 COVID positive 12/18/2022 PRESENTING PROBLEM: Duchenne muscular dystrophy (HCC) [G71.01] Elevated troponin [R77.8] COVID-19 [U07.1] Pleuritic chest pain [R07.81]   HOSPITAL COURSE: Patient is a 21-year-old male with a history of Duchenne's muscular dystrophy with known cardiac involvement, he has a nonischemic cardiomyopathy with a historical ejection fraction around 45 50%.  He had a cardiac MRI in August that showed muscular dystrophy affects on myocardium in the form of late gadolinium enhancement with an ejection fraction of 38%.  He is on chronic Toprol and Entresto.  Presented that was ultimately admitted for pleuritic chest pain.  His presentation is most consistent with pericarditis, in the setting of COVID-19 infection.  He has an elevated troponin which is persistent.  He has been started on colchicine and ibuprofen 600 mg 3 times a day for 5 days.  He has had significant improvement in his symptoms and today is stable for discharge.
Woke up early morning on March 27, 2021 with my entire leg numb, tingly and rubbery on my right-side. Called the nurse on the back of my insurance card and was told to go to the emergency room. CT scan indicated slight bulging disc. Later that day, the numbness and tingling moved up into my stomach and ribs. The feeling of numbness was around the back of my body on my right-side in the next few days. I had tingling in my left foot which has now moved into the calf area.   Also, numbness in the private areas. Was sent home with instructions to see my primary care doctor, which I did, and was sent to physical therapy. I have also been going to the chiropractor.     Continue to have numbness and tingling in all these areas. I am using a cane. I am unable to drive.
Received above listed vaccines on 10/11/11 and the following day 10/12/11 in evening developed hives on stomach & near the band-aids (latex-free) of injection sites; hives became widespread on 10/13/11. No resp. symptoms - no cough, no wheeze. No fever. Evaluated by Dr. in office & started on Hydroxyzine for itching/hives on 10/13/11. Hives reported by mom resolved 10/16/11 and no new concerns presently.
Patient return to clinic with symptoms of flush and warm feeling on face, some swelling. No reaction on other part of body only face. Pt developed itching and facial erythema.
Nausea and dizziness within an hour of vaccination; reports chills and body aches x2.5 days.
This case was reported by a physician via a nurse and described the occurrence of allergic reaction in a subject of unspecified and and gender who was vaccinated with ENGERIX B, GlaxoSmithKline.  On an unspecified date the subject received a dose of ENGERIX B, the subject experienced an anaphylactic reaction.  The outcome of the event was not reported.
Extreme swelling of the left arm, knotting under the skin at injection site, nerves in arm are highly sensitive,  fever, stomach discomfort,  diarrhea, headache, fatigue, muscle aches
This spontaneous report was received from a medical assistant and refers to a 11 year old patient. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2015, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not reported). On an unknown date in August 2017, the patient was vaccinated with the second dose of GARDASIL 9 (lot#, expiration date, dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved.
Pt said she received TDAP on 8-11-10. She said she had no problem until 8-16-10 when her (RT) arm started throbbing & a lg. red, hard, hot area was noted at inj. site. Pt said she took TYLENOL yesterday & last night. Inst pt to cont. TYLENOL x 2 days, & apply cool cloth or ice.
After developing a bright red rash at  the injection site(upper left arm) a week after receiving the booster shot, the rash got better, but I started itching at constantly changing spots on my body.  I still have these terrible ,itches (without outward signs) which are preventing me from sleep and are terrible during the day.  This is now 5 weeks after the vaccination, and