chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu-like symptoms; right arm heavy and sore; right arm heavy and sore; clammy and sweaty; sweaty; lethargic; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 6 months ago).   On 16th April 2019 19:00, the patient received the 2nd dose of Shingrix (intramuscular). In April 2019, 8 hrs after receiving Shingrix, the patient experienced pain in arm, heaviness in arm, clamminess, sweating, lethargy and fatigue. On 18th April 2019, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the heaviness in arm, clamminess, sweating, lethargy, fatigue and influenza-like symptoms were unknown.   It was unknown if the reporter considered the pain in arm, heaviness in arm, clamminess, sweating, lethargy, fatigue and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: On 16th April 2019 about 7 pm  the patient was vaccinated with 2nd dose of Shingrix. The patient experienced pain in arm and heaviness in arm after 8 hours of vaccination. The patient also experienced clamminess, sweating, lethargy and fatigue. On 18th April 2019, the patient experienced influenza-like symptoms. The patient was feeling fine at the time of reporting.
17-month-old patient received Kinrix.; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-month-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th May 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 7th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 physician reported that the 17 months old patient received Kinrix, which led to inappropriate age at vaccine administration.  The reporter consented to follow up.
CHILD WAS GIVEN ADULT DOSE HEP B INSTEAD OF CHILD DOSE HEP B. NO NOTED ADVERSE REACTION UPON RECEVING VACCINES.
3-13-2010, 24 hours after having the vaccine administered, his mother took him to the hospital because he had developed very high fever.  At the first hospital she took her son, they decided to transport him to another hospital that had a pediatric Neurologist.  He was seen by the doctor, he determined that the reaction was due to all the vaccines that were administered to him on that day.  They gave him DTAP, Hepatitis B and the Polio Vaccine.
Severe pain at injection site.  A large ring of red surrounded the injection site.  It became as large as 6" x 4".  A hard lump of app. 3" diameter also.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The invidudual was vaccinated with the Janssen product on 12/13/2021. They did not have a specific symptom onset date available, but tested positive via antigen test on 01/20/2022 as part of on-going testing at the HCF at which they were a resident. They died on 01/22/2022. It does not seem this individual had COVID-19 symptoms.
Sunday May 22, 2022: sore throat, temp 98.2F     Monday May 23: sore throat, temp 98.9F, home covid-19 test positive     Tuesday May 24: sore throat, sneezing, runny nose, congestion, deep cough, temp 99.8F     Wednesday May 25: deep cough, runny nose, watery eyes, sore throat, temp 99.2F, video Dr appointment, Respiratory Clinic appointment, positive covid test, started on Paxlovid for 5 days     Getting better daily till feel much better since Tuesday May 31.
11OCT91 TC from parent pt crying w/pain in rt thigh; immun given 3OCT91 no problems -started crying 11OCT91-no fever-no edema or redness; 11OCT91 MD visit -BOM;
Six weeks post vax, which was administered intramuscularly instead of subcutaneously by the nurse, my healthy daughter started experiencing stiff neck, headaches, burning in her neck and tingling, numbness and stiffness in left arm and hand. Also experienced rash on upper chest. Went to physician. A cervical spine MRI, and head MRI. Diagnosed with multiple sclerosis. Neurology put her on intravenous Solu-Medrol for 5 days. Symptoms padded. After initial diagnosis she was placed on Beta Seron which gave her flu symptoms and raised her liver enzymes so it was discontinued. As of 02/20 she has had two bouts of optic neuritis. 60 day follow-up dated 09/27/00 provided no additional data.
On 1/10/11 employee's arm became red, hot, and swollen 3 inches distal and medial of injection site. On 1/11/11 employee went to emergency room and was diagnosed with cellulitis. She received SOLUMEDROL and ROCEPHIN IV for 4 days.
Information has been received from a physician concerning a retired 70 year old white male pt with hypertension, diabetes and arthritis and has an allergy to penicillin, who on 08OCT2003 at 10:30 AM was vaccinated in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant medication included Glucophage, Accupril, Flomax. The physician reported that he believes this was the pt's first dose of pneumococcal 23v polysaccharide vaccine. The physician reported that on 09OCT2003 at 10:00 AM the pt developed redness, a rash, and swelling of the left arm where the vaccine was administered. Also the left arm was reported to be painful and tender where the vaccine was administered. The pt was given a prescription for Benadryl 25mg, one tablet PO ever 12 hours as needed for treatment of the left arm. It was noted that the pt's condition had improved. The physician reported the pt's outcome as unknown. Medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sharp headache up the middle of my head that got progressively worse as the day went on. By early evening was more like a migraine, with slight nausea and aversion to lights. Extra strength Tylenol didn't really help. Also joint aches and slight chills, but no fever. Was  better by the next day, but still a mild headache and some joint aches.
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient by a partner on 06-APR-2021 was received on 06-APR-2021 and 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination.   Batch number was not reported. The company was unable to perform follow up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
When walking to observation area immediately past receiving H1N1 c/o being hot and not feeling well. Face was red and he was diaphoretic. Helped to mat. Refused to lie down and refused to take off sweatshirt over his shirt. C/o pain over L eye. Ice pack applied to back of neck. Transported to clinic by school nurse via w/c. Returned to gym class.
SOB started Saturday 01/02/2021 continued SOB Sunday 01/03/2021 and on Monday 01/04/2021 went to clinic and saw a provider.  Resulted in bilateral pulmonary emboli treated with Lovenox and Coumadin.
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated orally with doses of oral ROTATEQ (lot number K011952 and expiration date 17-JUN-2016, lot number L008997 and expiration date 04-DEC-2016, lot number reported as L013232 and expiration date 27-JAN-2017, lot number L008053 and expiration date 30-NOV-2016, lot number L000431 and expiration date 11-AUG-2016, lot number K006456 and expiration date 08-MAR-2016, dose was not reported) which were exposed to temperatures outside of the recommended range. Concomitant therapy was not reported. No adverse experience was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a patient in eighth grade who was vaccinated with a dose of Varivax. Subsequently the patient experienced chickenpox. Additional information has been requested.
swollen neck glands on left side which lasted for 3 weeks.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 13:30 (Lot number: EWO217) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "hashimoto's" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC; ARMOUR THYROID. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Aug2021 14:30, outcome "recovering", described as "swollen neck glands on left side which lasted for 3 weeks.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient received second dose on 24Aug2021. No other vaccine in four weeks. Other medication in two weeks: Bystolic, Armour Thyroid. After she got first shot on left side which caused swollen neck glands on left side which lasted for 3 weeks. No covid prior vaccination. Covid was tested post vaccination. No known allergy.  No follow-up attempts are possible. No further information is expected.
Arm is very painful. The day after achy, muscle pain, head ache fatigue and chills. Just lasted 4 to 5 hours.
Upper right abdominal discomfort.  Early diagnosis is gallbladder attack. Awaiting test results.
Approximately 1 1/2 hours after administration student present w/diffuse urticaria on face and back. Medicated with 50 mg of PO BENADRYL.
Patient received injection then after one min. Patient had Band-Aid applied then walked out to pick out a sucker and went out to lobby with her dad to wait on school excuse and passed out falling forward hitting head on table. Color pale and skin cool and moist aroused in approx. 15 sec. Tearful. PERLA. Moving all extremities. Exam done by FNP (feels patient vasovagal, family history of vasovagal by older brother). 0942am skin warm and dry vs 114/78 t 97.9. P94, r22, spo2 100% ra no n/v no dizziness. No c/o.
Pt vaccinated with Influenza, next day had redness, increased swelling 2 1/4 X 3 1/4 X 1/4 induration - MD called.
This is a 49y.o. female with a history of pre-diabetes and obesity who presents to the emergency department for feeling off, nausea, vomiting, and shortness of breath for the past couple days. The patient tested positive for coronal virus about a week ago at an urgent care and did not receive any steroids. The patient states that she has had increase in urinary frequency, increased thirst, and increased dry mouth. Patient is also had some associated diarrhea. No blood noted in stool or urine. Patient also states she has a large fibroid that is sitting on her bladder. She has multiple GYN surgeries including a bladder sling. Patient denies any chest pain, abdominal pain, headaches, change in vision, numbness or tingling, or any extremity edema.   In the emergency department patient arrived had a blood sugar elevated in the 500s with an anion gap of 24 patient was hypokalemic at 3.6. Patient was started on 5 units of insulin subcutaneous. Patient was also given a bolus of normal saline and started on a 100 mL/kg per hour infusion. The patient was admitted to the progressive care unit.
Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 19-Apr-2022; Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 19-Apr-2022) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022. The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo temperature excursion.  No treatment medication was provided.
Pt states she is feeling nauseous. Pt seated and vital signs obtained 120/78, rr 18, hr 60, 96% on room air. Sips of water given. Pt offered to receiv additional medical attention, pt refused. States the water helped and no longer feeling nauseous. Son is accompanying pt and will be  driving her home advised son to monitor pt and symtpoms to look for. Son verbalized  understanding.
Redness, swelling, and itching at dose sight developed one week after injection.  Treated with antihistamines and anti itch cream.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient recieved Pfizer vaccine on 8.27.2021 and reported seeing welts on 8.28.2021. Rash appears right bicep towards axilla, left wrist, back, and right leg with extreme itchiness. Patient started on steroids and diphenhydramine but itchiness still persists.
Patient reports "kidney pain" that began one day after receiving these vaccines and continues today, 10 days after vaccine. Patient does not report any signs or symptoms of UTI and requests that this adverse event be reported.
patient did not get a full dose (0.25ml); A spontaneous report  was received from a healthcare professional concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and the patient did not get a full dose.  The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On an unknown date, the patient did not get a full dose (0.25mL) during their immunization.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, did not get a full dose 0.25mL, was considered resolved.; Reporter's Comments: This spontaneous report refers to a case of a patient who experienced non-serious event of patient did not get a full dose (0.25ml) (Incomplete dose administered) for mRNA-1273 (lot # unknown, Exp date-unknown). There were no reported AEs associated with the event of a patient did not get a full dose.
Information has been received from a consumer concerning her son, an 11 year old male who was born prematurely and was diagnosed with cerebral palsy, who on an unspecified date was vaccinated with a dose of MMR II (lot # not reported). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown), VAQTA (unspecified) (manufacturer unknown) and ROTATEQ (unspecified). It was reported that the patient were given a lot of vaccines for his age that included the MMR II. The patient's mother reported that the patient was diagnosed with autism later after receiving the MMR II. The patient sought an unspecified medical attention. At the time of reporting, the patient's outcome was Not Recovered/Not Resolved. Upon internal review, autism was determined to be an other important medical event. No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8729), on 06May2021 as dose 2, single (Lot number: EW0172) and on 13Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 21 years for covid-19 immunisation. The patient's relevant medical history included: "hashimotos hypothryroid" (unspecified if ongoing), notes: hashimotos hypothryroid; "Obesity" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The patient received other medications in 2 weeks after vaccination. Past drug history included: Zithromax, reaction(s): "Known allergies: zithromax", notes: Known allergies: zithromax. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Positive, notes: First day of Positive test; (Jul2022) Positive, notes: but still rapid positive; (20Jul2022) Positive, notes: Day-21 still showing positive rapid testing. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: First day of positive test, second day of bad symptoms. Took 5 days treatment. Around day 9-10 of COVID infection, symptoms returned serious head congestion, sinus pain. Day 21 and still showed positive rapid testing. Symptoms were much better, but still rapid positive. The patient received Paxlovid as treatment from 30Jun2022 to 04Jul2022 for COVID 19. Doxy antibiotic for sinus infection. Patient assumed this was rebound. Device Date reported on 21Jul2022.  No follow-up attempts possible. No further information expected.
Throbbing, constant pain with burning from L) shoulder joint to fingertips plus shoulder joint up to left neck; nausea, dizziness, headache, joint pain (all body), muscle aches, throwing up, loss of appetite
No adverse reaction. Fridge temps went out of range; found out several days when checking hitek logs.
Information has been received on 11/15/01 from a registered nurse concerning a 12 month old female who was vaccinated with a dose of varicella virus vaccine live (site unknown). Subsequently, the pt developed swelling at the injection site, described as being "about 3 - 3.5 inches in diameter". the pt sought unspecified medical attention. It was also reported that another 1 year old female had a similar reaction (WAES01112379). Additional information has been requested.
LIMITED RANGE OF MOTION OF RIGHT ARM DUE TO SIGNIFICANT PAIN.  VACCINE GIVEN 1-2 FINGER WIDTHS BELOW SHOULDER JOINT.
I completed the 2nd round of the shingles vaccination on Tuesday, 27 November. I experienced some pain and tenderness at the injection site an hour or two after receiving the vaccination --that seemed normal and I also experienced it after first round. On the night of 27 November, about 12 hours after the injection, I became chilled and a fever came on sometime during the night. I experienced moderate tachycardia that night as well. I took my pulse and it was 100-110 bpm. I woke on Wednesday 28 November with the mild fever (I didn't measure it) and a bad headache; the tachycardia was gone and ibuprofen relieved the headache and took down the fever. I missed two days of work but after sleeping for two days I'm close to 100% again.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In 2016 (reported as from starting from 17-JUN-2016), the patients were vaccinated with improperly stored doses of M-M-R II (lot #, expiration date, therapy type, dose and route of administration were not reported). There was no adverse effect reported. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax & 5 days later exp arthritis of the knees & elbows;
Tingling back of head. Numbness cheeks, upper lip, gums, nose. Loss of peripheral vision right eye. Taste like lidocaine in saliva. Fluid retention. Extreme thirst and lack of urine. Brown urine. Swelling tongue. Lacy red rash on abdomen and legs. Headache. Dry skin with itching forehead.
All the joints in my body swelled.  I had issues walking because it hurt my joints to much.  It lasted about 7 days and then started to reduce.
Extreme fatigue, swollen lymph node on left side of neck, sore jaw, sore nasal cavity, headache. No treatment and still recovering. Feeling a little better each day.
This spontaneous report as received from a nurse refers to a 33 year old male patient with no pertinent medical history and no drug reactions/allergies. The nurse reports that her son received two doses of VARIVAX (merck). The first on 24-AUG-2012 and the second on 30-OCT-2012 (dosing information and route were not provided). No concomitant medication. She reports that two weeks after VARIVAX (merck) administration, he developed red, raised, itchy rash on his left pelvic bone which spread down to his peri area, over his right pelvic bone, and began in his axillary region as well. She stated that the papules in the axilla are lighter, a peachy color and look "like chickenpox". The patient was seen at an unspecified clinic on 26-DEC-2012, and was diagnosed with tinea cruris. He was given Nystatin, which was ineffective. On 25-APR-2013 he was given Ketoconazole which was ineffective and a Typhoid vaccine. In May 2013 he was given DIFLUCAN and Clotrimazole, which were ineffective at treating the rash. On 07-OCT-2013 a biopsy was performed and he was diagnosed with subcutaneous T cell lymphoma. He is having a secondary biopsy done and is currently being treated with a "steroidal cream" and they are considering light therapy. The outcome of tinea cruris and T-cell lymphoma was reported as not recovered/not resolved. No reporter causality provided. Upon internal review T-cell lymphoma was considered medically significant. Additional information has been requested.