chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lipschutz ulcers; pain; oral pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24May2021 11:30 (Batch/Lot number: unknown) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VULVAL ULCERATION (non-serious) with onset 27May2021, outcome "not recovered", described as "Lipschutz ulcers"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain"; ORAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "oral pain". The event "lipschutz ulcers" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vulval ulceration, pain, oral pain.  Additional information: Patient was not pregnant at the time of vaccination. The patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the 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. Therapeutic measures were taken as a result of event lipschutz ulcers and included treatment with topical steroid and pain, oral pain, antibiotic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flu like symptoms Sunday morning, knees hurt - by Sunday afternoon every thing hurt so bad I was crying and it was indescribable. Monday I was some better - not sure if would have been able to drive to work, Tuesday better - Wednesday all good.
Inpatient rehab pt who was hospitalized from 7/18/21-8/3/21 for left lower extremity gangrene/arterial occlusion s/p L below-the-knee amputation (7/26). During rehab stay, roommate tested positive on 8/4. Pt presented w/altered taste, chills on 8/6 and ultimately tested positive for COVID on 8/8. Upon exam, chest sounds clear (no wheezes) and was asymptomatic w/in 24hrs.  Pt has not required any additional therapies and will continue to monitor.
AT TIME OF SCAB FORMATION, PATIENT BEGAN TO NOTICE UNUSUAL FEELING IN LEFT DELTOID.  SENSATION PROGRESSED TO INABILITY TO LIFT LEFT ARM.  WAS REFERRED TO PRIVATE PHYSICIAN.  ORTHOPEDIC PROBLEM RULED OUT AND SHE WAS BEGUN ON ANTI-INFLAMMATORY AGENTS...PROGRESS TO BE MONITORED.
Had  trouble walking  for a day, it hit like a tone of brick.; Extreme back pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Had  trouble walking  for a day, it hit like a tone of brick.), BACK PAIN (Extreme back pain) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003a21a and 031l20a) for COVID-19 vaccination.     Previously administered products included for Vaccination: Flulaval Quad on 07-Oct-2021 and Shingrix on 07-Oct-2021. Concurrent medical conditions included Blood pressure high, Reflux gastritis, Penicillin allergy and Allergy to antibiotic (Septra). Concomitant products included LISINOPRIL for Blood pressure high, PANTOPRAZOLE SODIUM for Reflux gastritis.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced GAIT DISTURBANCE (Had  trouble walking  for a day, it hit like a tone of brick.) and BACK PAIN (Extreme back pain). On an unknown date, the patient experienced CHILLS (Chills). On 09-Mar-2021, GAIT DISTURBANCE (Had  trouble walking  for a day, it hit like a tone of brick.) and BACK PAIN (Extreme back pain) had resolved. At the time of the report, CHILLS (Chills) had resolved.            After the 2nd Moderna shot, the symptoms were there for about 2 days and then disappeared. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-377083 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Added patient demographics, concomitant drugs, medical history, historical vaccine, updated vaccine details and added two events - Back pain and Chills.
Burning sensation up neck and head after vaccine; severe pain in left arm in underarm area; fatigue
chills, injection site pain   Narrative: Pt completed 1st dose of Moderna COVID vaccine on  19FEB2021, he reported right arm soreness, chills and muscles aches on  20FEB2021. no sob. no cp. no headaches.
Swelling; redness; warmth; tenderness; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 8-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number Y5X93, expiry date 30th June 2020) for prophylaxis.   On 3rd October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site tenderness to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient received vaccine by different vial with same batch number. The reporter did not link this case with product complaint. The reporter did not consent to follow up. This case was 1 of 5 linked cases reported by same reporter.
09/15/22 presents to Birth Center Triage for "scheduled IOL". PMHx of "asthma, back pain" "morbid obesity"
Information has been received from a nurse referring to a 56 year old female patient who had allergy to sulfa. No information regarding pertinent medical history or concomitant medication was provided. On 25-FEB-2016 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous in the left arm, dose, dose# and lot# unknown). On 26-FEB-2016 the patient experienced onset of reaction which was descripted by the patient as that her left arm began to burn starting at injection site, around the left arm, which turned into a huge long red welted up hardness knot for a good week. She also stated she developed headache and chills. The Nurse stated that she iced the site and the patient was recovering and the redness was fading. No treatment was given for the events and the patient did not seek medical attention. Additional information is not expected since there was no consent to contact physician.
FLARE UP OF EHLERS-DANLOS SYNDROME TO ENTIRE BODY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: ehlers-danlos syndrome. 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced flare up of ehlers-danlos syndrome to entire body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flare up of ehlers-danlos syndrome to entire body. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Unable to type in above- but he received both COVID and RSV that day.   Following day the decline began - which by at 2 weeks led to hospitalization for what appears to be PRES- bilateral significant edema of parieto occipital lobes- with corresponding neurological decline (ie ataxia, neglect to the left, confusion, inabilty to see left or coordinate use of left hemibody).
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of an unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. Since 25-NOV-2015, the patients were vaccinated with an improperly stored doses of VARIVAX (Merck) lot # L016125 expiration date: 06-MAY-2017, (dose and route were not provided). No adverse effects were reported. The temperature stability information was reported as follows: Temperature 19F; time frame: 2 hours; there was no previous temperature excursion, it was back in range and there was no call because of a "data logger". This is one of several reports from the same reporter. Additional information has been requested.
Patient called pharmacy on Tuesday 9-10-2019 to report severe fatigue, nausea, malaise and following vaccination on the morning of 9-9-19. Per follow-up conversations, symptoms took about seven days to resolve.
My symptoms started at evening after being vaccinated. I had got blister all in my mouth and on my tongue. I had it for 7 days. I could barely eat.
Covid Vaccination Monitoring Documentation: PT admit 10//5/21 ? 10/12/21. POC SARS COV2 ANTIGEN POS 10/5/21. Pfizer 2/17/21 Lot EN6200, Pfizer 3/10/21 Lot EN6204.
Hair loss; Sick; Legs wanted to give out; Arm was sore; Body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALOPECIA (Hair loss), ILLNESS (Sick), LIMB DISCOMFORT (Legs wanted to give out), PAIN IN EXTREMITY (Arm was sore) and MYALGIA (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ILLNESS (Sick), LIMB DISCOMFORT (Legs wanted to give out), PAIN IN EXTREMITY (Arm was sore) and MYALGIA (Body aches). On 30-Jan-2021, the patient experienced ALOPECIA (Hair loss). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 times. On 23-Jan-2021, ILLNESS (Sick), LIMB DISCOMFORT (Legs wanted to give out), PAIN IN EXTREMITY (Arm was sore) and MYALGIA (Body aches) had resolved. At the time of the report, ALOPECIA (Hair loss) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Patient took Tylenol 2X and felt better  The patient reported that the physician said alopecia was due to COVID which she had in October.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Added historical condition. The outcome of the event alopecia changed from unknown to not resolved.
an adult patient between 12 and 64 years of age received the 1st dose of the primary series monovalent Moderna COVID-19 Vaccine on DEC2021 and they never got a 2nd dose of the primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (an adult patient between 12 and 64 years of age received the 1st dose of the primary series monovalent Moderna COVID-19 Vaccine on DEC2021 and they never got a 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history, allergy, concomitant diseases and risk factor or received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In December 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 PRODUCT ADMINISTRATION INTERRUPTED (an adult patient between 12 and 64 years of age received the 1st dose of the primary series monovalent Moderna COVID-19 Vaccine on DEC2021 and they never got a 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (an adult patient between 12 and 64 years of age received the 1st dose of the primary series monovalent Moderna COVID-19 Vaccine on DEC2021 and they never got a 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (an adult patient between 12 and 64 years of age received the 1st dose of the primary series monovalent Moderna COVID-19 Vaccine on DEC2021 and they never got a 2nd dose of the primary series).    No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact
Felt pretty sick; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 72-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that the vaccine made her felt pretty sick on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a 14 months old patient. On 04-SEP-2012 the patient was vaccinated with a 0.5 ml dose of ZOSTAVAX (Lot # 672675/0068AE, expired date 03-APR-2013) (route not reported). No adverse symptoms reported. It was not known if the patient sought for medical attention. Additional information has been requested.
2-3 days after 2nd vaccination, Client experienced swelling in her hands, feet and legs. She then developed an itchy rash, including hives, which spread all over her body. Her face also became swollen, red and itchy which prompted her to seek medical attention. She went to see her physician and was given a steroid shot, oral steroids, and instructed to take Benadryl.
High fever of 103 x 2-3 days followed by a rash over entire body on day 5.
Severe neck/arm/hand pain; unable to move arm; chills and fever of 102. Chills and fever throughout the evening of the shot administration; pain lasted about 3 days, gradually lessening.
This spontaneous report was received from a nurse and refers to a currently 18-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # R002344, expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA007946: US-009507513-1811USA001303: US-009507513-1811USA007947.
Approximately 1 1/2 weeks after I received my booster shot, I started having major chest pressure (evening of 12/18). I rested in hopes it would get better, as pain got worse, we went to emergency room early the next morning. I had a heart attack while in the emergency room.
She was feeling nausea and hot. She got up around 2 in the morning not feeling good. She got up from the bed and fainted in the kitchen.
5 weeks 5 days pregnant when received first covid shot. Had ultrasound on 4/8/21 at 8 weeks pregnant and found out I had a missed miscarriage. Had a D&C on 4/21/21 and we had genetic testing done on the tissue that showed no chromosomal abnormalities.
pt states 3 hrs p/vax devel neck stiffness then bilaterally; denies fever any other sxs but neck stiffness x 3 days; pt referred to PMD;
small shingles rash; This case was reported by a consumer and described the occurrence of vesicular rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were reported as follows: This patient self reported the case. The patient's 5 years old nephew got shingles from the chicken pox vaccine. He got shingles on his neck. It started the day after the shot. They took him to the doctor to confirm. He was 22 and had shingles 2 more times. The patient received Shingrix vaccine and got a small shingles rash the next day. The patient commented that, shingles are very painful though so did not regret his/her decision.
Initial report received from a health care professional on 09 October 2012. A 48-year-old female patient, whose medical history was not reported, received a intramuscular dose of FLUZONE vaccine (dose number not reported, Lot number UH713AB) in left deltoid on 05 October 2012. The patient took yearly flu shots and reporter unsure however patient does take inhalers. It was reported that on 06 October 2012 i.e. 01 days after vaccination the patient experienced redness and swelling that extended 20cm from injection site down the left arm with hardness and pain at the injection site. She also reported chills and sweats. Also reported that patient felt as if the muscle was dissected as the shot was administered. At the time of vaccination patient was not acutely ill. The patient self-treated with MOTRIN, and symptoms had resolved and site was prepped with alcohol. Laboratory investigations and relevant diagnostic test were reported as none. On an unspecified date the outcome of the events was recovered. Documents held by sender: none.
dob was listed correctly and parent thought it was ok to get a booster shot. the age written was a bit illegible and looked like 14 or 17. noticed the mistake of booster shot to unapproved age group at pharmacy typing vars
below my left eye became red; my left cheek became very puffy; below my left eye became very puffy; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (below my left eye became red), SKIN SWELLING (my left cheek became very puffy) and PERIORBITAL SWELLING (below my left eye became very puffy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced ERYTHEMA (below my left eye became red), SKIN SWELLING (my left cheek became very puffy) and PERIORBITAL SWELLING (below my left eye became very puffy). At the time of the report, ERYTHEMA (below my left eye became red), SKIN SWELLING (my left cheek became very puffy) and PERIORBITAL SWELLING (below my left eye became very puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment information was not provided.
She experienced pain and aching s/p injection. The next morning, she noticed a rash surrounding injection site with moderate swelling. The affected area measured 2.5 x 5 cm. She was examined by above named Provider, and advised to apply ice packs qid until resolved.
No additional AE reported.; Temperature excursion of 47.9°C for 47 min; This spontaneous report was received from an other health care professional and referred to a 4-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-DEC-2022, the patient was vaccinated with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (dose, strength was not provided).   The administered dose of the vaccine experienced a temperature excursion (product storage error) on 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009088:
localized erythema/swelling.  also reports mild headache, history of chest tightness but does not feel this is related
Significant redness and swelling of her left upper arm. She states this started after getting the pneumonia shot in that arm. She noticed redness and swelling that has gotten progressively worse. Examination of the left arm shows redness encircling the entire upper arm approximately involving the distal two thirds of the upper arm. It's warm and minimally tender. Assessment and plan: Cellulitis of the left upper arm. Started on cephalexin and recommended warm compresses and keep elevated as much is possible. Follow-up with her primary physician if symptoms persist or worsen after 2-3 days on the antibiotic.
I may have misunderstood the last question.  The vaccine was administered at a pharmacy. I experienced left arm pain which resolved.  I also experienced pain in my chest wall/ribs/sternum on the left, as well as breast tenderness in the left.  Initially, the pain woke me up at night.  Although that went away, I stopped wearing a standard bra and am wearing a bra with less support.  The pain has persisted.  It seemed to flare a bit when I had the third Pfizer vaccination on 10/04/2021.   The condition is an annoyance at times but has not changed my relatively active lifestyle.
On 2/9/11 after imz pt right shoulder became red rashy & swollen. On am of 2/10/11 spread to back chest & face.