chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from the mother of a consumer refers to a 17 year old female patient. The patient's medical history included heart defect at birth and heart surgery at 1 years old. On 31-JUL-2013 the patient was vaccinated with GARDASIL dose 1, intramuscular in the left arm. The second dose of GARDASIL was received on an unspecified date in October 2013. Five days later on an unspecified date in 2013 the patient experienced frequent headaches for a few weeks, which eventually dissipated. The patient received the third dose of GARDASIL on 17-FEB-2014. The patient did not use any concomitant medication and no known previous drug reactions/allergies. As of approximately 20-FEB-2014 the patient maintained a constant headache sometimes accompanied by nausea. The patient returned to the physician's office on an unknown date and was prescribed steroids (brand and manufacturer not specified). Unspecified blood work was performed on an unknown date. It was reported that the patient was still experiencing the headaches. The outcome of the nausea was unknown. Additional information has been requested.
temperature Jan 13, 2022: 100/ Jan 14, 2022:101.5/ usual normal 97.7. Jan 13, 2022: swelling left: arm pit, deltoid area of arm, large hard lump in breast, swelling of left chest and neck which intensified and traveled into face. Very painful, especially in left deltoid area, arm pit and breast. Jan 15, 2022- present date/ March 2, 2022: swelling of left side of face/ mouth turns downward. Has not returned to normal. March 2, 2022: left deltoid and breast still painful. Doctor said it could take 2 - 3 months to return to normal.
Patient presented with a red rash on her left arm this morning after receiving the influenza vaccine yesterday. Patient is an employee of our office and was receiving the influenza vaccine as part of our annual health fair.
arm swollen and spreading; itchy; Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), PERIPHERAL SWELLING (arm swollen and spreading) and PRURITUS (itchy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL, ATORVASTATIN and PAROXETINE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced NIGHT SWEATS (Night sweats). On 25-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm swollen and spreading) and PRURITUS (itchy). The patient was treated with CORTISONE at an unspecified dose and frequency and BECLOMETASONE DIPROPIONATE (BECLOMETHASONE COX) at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (Night sweats), PERIPHERAL SWELLING (arm swollen and spreading) and PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Updated events outcome as recovered/resolved.
This spontaneous report was received from a licensed practical nurse (LPN) and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. On 26-JUL-2017, the patient was vaccinated with improperly stored dose of PROQUAD injection (lot # M044718, expiration date: 07-MAY-2018; dose and route of administration were not reported). The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of PROQUAD was stored at temperature between 15 to 46 degrees Fahrenheit (17.8 degrees Fahrenheit) for 2 hours. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
I had mastitis in my left breast which included painful feeding when my baby latched on, swollen armpits, soreness, and red splotches (leading to my armpits). I took antibiotics to treat the condition because I caught it really fast. I also used an over-the-counter treatment on my nipple to treat the pain as well.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 06-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Great Pain from shoulder to elbow and loss of movement in the arm for 36 hours approximately. Headache lasting into the third day after vaccincation. Am of the opinion the shot was administered incorrectly ie too high up on arm into shoulder.
Swelling and redness close to the site of the vaccination on left arm. Sensitive bump in armpit
She received Zoster Vaccine 09/20/2007. She contracted shingles 7/3/2012. She went to hospital clinic. She took antiviral pill for > 20 days. Lesions are around middle of abdomen. They have scabbed over at present and bumping has decreased.
Fever for 28 hours of 102+ entire time, next morning, woke up to left side of body swollen especially on the left arm down to mid back with red rash all over trunk area including behind ears and neck.  Radiating pain from left shoulder down to lower back left side.
sudden onset of headache, neck pain and back pain. the head and neck pain subsided over the course of 24 hours with no pain relieving medication needed. the lower back pain has been constant since then and today it reached it's highest level of discomfort. I cannot climb stairs, bend over and have limited walking. I have taken 800 mg ibuprofen with in the last 30 minutes with no relief.
78 year old man without prior DVT/PE history, who had first Moderna vaccine dose on 12/29/20 (lot 011J20A) and second Moderna vaccine dose on 02/02/21 (030L20A) (information from patient provided vaccination card) who presented to the ER on 02/20/21 with one week of subjective dyspnea and palpitations. Chest CT with bilateral pulmonary emboli. There were also groundglass opacities in the right upper lobe. Rapid test for COVID 19 on 02/20/21 was negative. Subsequent antibody testing for COVID19 on 03/01/20 (IgG, IgA. IgM) also interpreted as negative. The pulmonary embolus was considered to be unprovoked and an association with prior COVID19 vaccination is interpreted as possible but unproven. The patient was initiated on anticoagulation. Further workup for underlying thrombophilia hematological disorders is pending at this time however the current assessment remains as an unprovoked pulmonary embolus occurring 18 days after second Moderna vaccine dose. Current CT imaging without evidence of recurrent malignancy and there are no identifiable risk factors for pulmonary embolus. The physician submitting this report is a Hematologist Oncologist.
Rash, itching, irritation occuring at the site of injection and still continuing currently (as of 06/11/2018); patient reports doctor has prescribed both topical steroids and oral steroids and that it has improved some after using/taking those, but that it then always recurs after discontinuing.
rash came on the inside of her elbow on the other arm; rash on the arm of the shot, near the elbow on the underside of her arm; dizzy; trouble with acid reflux; lost of gas; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (trouble with acid reflux), FLATULENCE (lost of gas), VACCINATION SITE RASH (rash on the arm of the shot, near the elbow on the underside of her arm) and RASH (rash came on the inside of her elbow on the other arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included PROGESTERONE and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (trouble with acid reflux) and FLATULENCE (lost of gas). On 14-Feb-2021, the patient experienced VACCINATION SITE RASH (rash on the arm of the shot, near the elbow on the underside of her arm). On 15-Feb-2021, the patient experienced RASH (rash came on the inside of her elbow on the other arm). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (trouble with acid reflux), FLATULENCE (lost of gas) and VACCINATION SITE RASH (rash on the arm of the shot, near the elbow on the underside of her arm) outcome was unknown and RASH (rash came on the inside of her elbow on the other arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include thyroid medication, implant with hormones. Treatment medication included diet.
Patient had mild symptoms after the second dose, classic fever, body aches, etc. which resolved after 1-2 days. Then 1 week later, he had more fevers and chills with worsening body aches, particularly right leg pain and worsening headaches and nausea. Rash developed on right lower extremity in an S1 dermatomal distribution, with severe neuropathic pain associated. PCR panel revealed Varicella Zoster Virus. Patient also presented with meningitis symptoms including headache, nuchal rigidity, and photophobia. PE positive for Kernig and Brudzinski signs.
This spontaneous report has been received from a registered nurse referring to an unspecified number of unspecified patients. No concurrent or medical history was reported. On unspecified dates were administrated unspecified number of improperly stored doses of MMR II (lot number J006137 - expiration date 24-MAY-2015 and lot number K008814 - expiration date 19-JUN-2016), dose, route, frequency and anatomical location were unknown. No adverse event was reported. No further information was provided. No product quality complaint was reported. This is one of several cases received from the same source. (MARRS numbers 1507USA010114, 1507USA010881, 1507USA010882, 1507USA010883). Additional information has been requested.
This serious literature report (initial receipt 09-Jul-2015) concerns a 25 year-old female patient who was a dermatology nurse. On an unspecified date, the patient received H1N1 (manufacturer and batch number not provided). On an unspecified date, three weeks following the vaccine administration, the patient experienced left shoulder pain. The pain was persistent and moderate. She denied any other injury, any skin reaction at the site of the injection, fever or chills. The pain is significantly worsened after moving a desk several days prior to presentation. She could not lift her arm beyond the height of her shoulder without severe pain. She commented that "?" was the most painful shot "?" ever gotten and that the injection was given using a 1.5 inch needle, which penetrated all the way to the hub when the injection was given. On physical examination, the patient was afebrile and well-appearing. Her neck showed full AROM (active range of motion) of the left shoulder with approximately 90 degrees abduction, 60 degrees internal rotation, 90 degrees external rotation. In comparison, her right arm demonstrated 130 degrees abduction, 80 degrees internal rotation, and 100 degrees external rotation. She had positive "?" and "?" supraspinatus testing, positive Speed's (?) test, positive Neer's (?) sign, and negative cross-arm test. There was exquisite tenderness to palpation at the lateral aspect of the proximal humerus, consistent with the reported site of the injection. There was no overlying erythema or edema or at the injection site. The broad differential diagnosis included subacromial bursitis, rotator cuff tendinopathy, biceps tendinopathy, inflammatory periosteal reaction (secondary to the injection), humeral fracture, osteomyelitis, and tumor. According to the laboratory studies, her CBC (complete blood count) showed elevated WBC (white blood cell) of 14.2 with 8.7 PMN, otherwise normal. The sedimentation rate was normal, CRP (C-reactive protein) was elevated at 13.8, and blood cultures showed no growth. Other studies included an AP and outlet x-ray images of the left shoulder which were normal. An MRI (magnetic resonance imaging) of the left shoulder was obtained due to severe pain. This showed localized non-specific humeral edema of the greater tuberosity with no internal derangement or tearing/inflammation of the rotator cuff musculature. There was a concern for possible osteomyelitis and was not recommended to start on antibiotics since the patient was afebrile and blood cultures were negative. She was diagnosed with periosteal reaction secondary to influenza vaccination. Treatment included meloxicam and tramadol for pain control, and advised to rest her arm when possible. She was instructed to notify the office if she developed a fever or any signs of systemic infection. The patient's shoulder pain gradually improved. She was re-evaluated five months post-injection and still had mild pain at the injection site. Repeat MRI was obtained at the time which showed decreased periosteal reaction compared with prior imaging. The outcome was unknown (recovering for shoulder pain).
Child in clinic to receive 1 yr shots. Instead of 4th dose of DTaP, the child received TdaP. No adverse reaction noted, none reported to clinic. Attempt to contact mother for follow up but wrong phone number was provided by the mother.   No adverse event reported.
Pt had sore arm for 2 days after shot. Headache began in 2 hrs and lasted 5 days. Stomach pain and nausea began after 2 days and lasted 1 day. Fever of 103 degrees 4-5 days later. Lethargic, hard to arouse, talking without making sense, blood shot and puffy eyes for 1 day when she had the fever. Recovered about day 6, still had loose stools.
Fever/chills, low temperature (up to 100.2F), feeling faint (fainting one time); symptoms lasted for 3 days
After pt received 3rd shot of Rabies series, and nurse applied bandaid, pt noticed site was starting to itch. Once she got home site was itching a lot. About 1/2 to 1 hour after receiving shot. That evening, site was extremely red, raised and hot to touch, swelling all over left arm, approx 2-3 inches in diameter around injection site. Now, Thursday AM, site still red, warm to touch, raised area. Site bigger than palm of hand. Still itches a little. She apparently had a similar reaction when an IV was started in a hospital due to tape at the site. But no to this degree. Also had a very bad rx to a Td 4 years ago. Was advised to take Benadryl should itchiness continue, to take Benadryl/Tylenol if needed, to take Benadryl prior to next (last) Rabies shot, not to use Bandaids, and if any further problems, contact her doctor.
pt vax in 1995 & in 1999 pt devel full blown chickenpox.
Information has been received from a medical assistant referring to a patient of unknown age and gender. On 07-JUN-2016 the patient was administered an improperly stored (11.7 Fahrenheit (F) for 30 minutes) dose of VARIVAX (dose and frequency were unknown). There were four improperly stored lots of VARIVAX (lot L028277, expiration date 28-JUL-2017; lot L042264, expiration date 26-OCT-2017; lot L042267, expiration date 27-OCT-2017; lot M000762, expiration date 06-JAN-2018), but the reporter didn't known which dose was administered. No adverse effect was reported. No previous temperature was excursion. Additional information has been requested.
Rash papular erythematous lesion 2-3 mm (about 4 lesions) on left thigh 11/4/03.
Administration date=04Feb2021, Administration time=03:45 PM; Administration date=28Dec2020, Administration time=01:00 PM; right side underarm was swollen and painful; arm pain; Fever; Body aches; This is a spontaneous report from a contactable Other Health Care Professional (patient). A 46-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9265/Batch number was not reported) via an unspecified route of administration, administered in arm right on 04Feb2021 at 15:45 (at the age of 46-years-old) as dose 2, single for covid-19 immunization. Medical history included headache, covid-19 from 08Jan2021 to an unknown date (COVID dx. 08Jan2021 (mild sx) recovered) and known allergies Sulfa. Concomitant medications included vitamin c [ascorbic acid] (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; zinc (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; vitamin b complex (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; famotidine (PEPCID [FAMOTIDINE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication;magnesium (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; meloxicam (MEL) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. Patient didn't receive other vaccinations within 4 weeks prior to vaccination patient had COVID prior to vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL1284) via an unspecified route of administration in arm right on 28Dec2020 at 15:45 as dose 1, single for covid-19 immunization. On 05Feb2021 (Friday) at 02:00 AM, the patient experienced body aches and at 07:00 PM, fever began. On 06Feb2021 at 06:00 AM, felt arm pain and noticed my right side underarm was swollen and painful. Reviewed side effect profile and saw that some people did have lymphadenopathy and therefore I decided to wait it out. I did not seek medical attention. As of 08Feb2021 (Monday), the swelling has diminished considerably on its own and the pain reduced to only if I touch it. On 09Feb2021, the swelling is gone and the pain only when deeply touch is almost gone. The clinical outcome of the right side underarm was swollen and painful, body aches, fever, arm pain was recovering and of the administration date=04Feb2021, administration time=03:45 PM; administration date=28Dec2020, administration time=01:00 PM was unknown.  Follow-up attempts completed. No further information expected.
On 03/13/04, child here for 4 month physical.  Stated child was very fussy.  Uncontrollable for 2 days after 1st set of immunizations 01/10/04.
Fever, irritability. Some rhinorrhea and cough pink morbilliform rash on chest and back. Day 3 fades to pinpoint Petechiae. Also has Bilateral Otitis Media.
All symptoms ongoing and have not stopped  Bi-lateral tinnitus (high pitched ringing) Ear Ache both ears Swollen Lymph glands in neck Fatigue Body Aches
VACCINE WAS PUT IN SYRINGE AND LEFT AT ROOM TEMPERATURE; VACCINE ADMINISTERED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; .This spontaneous report received from a health care professional concerned a 63 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was new at clinic and no medical history on file. the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 202A21A expiry: 07/AUG/2021) dose was not reported, administered on 14-JUN-2021 13:36 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced vaccine was put in syringe and left at room temperature. On 14-JUN-2021, the subject experienced vaccine administered outside of the recommended storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of the recommended storage conditions and vaccine was put in syringe and left at room temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210629846.
STARTING 48 hrs LATER PAIN RT HIP. THEN WEAKNESS RT LEG ONLY. LED TO 9 FALLS OVER THREE DAY PERIOD. IMPROVED AS OF 1/20/21 HEADACHE ON NIGHT ON VACCINE ONLY.
Pt developed itching to face,scalp and chest as well as tingling and numbness in her tongue withinn the first five minutes of receiving the vaccine.Pt denied difficulty breathing,.pt started to  develop hives to the chin while taking history. Pt was given epinephrine .3mg  per epi autoinjector. Pt also used her albuterol inhaler 2 puffs.  Paramedics were  called and pt taken to hospital.
Pain in arm; Glucose increased; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and BLOOD GLUCOSE INCREASED (Glucose increased) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included GLIPIZIDE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and BLOOD GLUCOSE INCREASED (Glucose increased). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and BLOOD GLUCOSE INCREASED (Glucose increased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided by the reporter.