chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated rash began to develop 15 days after receiving vaccination. She did have red bumps (some appeared to have fluid in them) on her face and arms (that I could observe) and on her torso. She stated they did itch. She asked about putting calamine lotion. I told that could help soothe the itching. I also referred her to her PCP.
sore arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm after second dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AXILLARY PAIN (sore arm after second dose). At the time of the report, AXILLARY PAIN (sore arm after second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-069647 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069647:
This case was received from a consumer on 06 November 2008. A male patient (date of birth 13 September 1954) reported that in 1995 he received DIPHTHERIA AND TETANUS TOXOIDS (lot number reported as UI217AA, not a valid sanofi-pasteur lot number). The patient was hospitalized for high blood pressure, and received the vaccine during his hospitalization. According to the patient, he subsequently developed severe psoriasis, and the event remained ongoing. He had been evaluated by dermatology. He was taking medication for high blood pressure concomitantly. Documents held by sender: None.
Lightheadedness, paleness, light focus in vision field.  Provided lollipop, animal crackers, water.  Patient recovered within seconds; patient had not eaten breakfast.
fever, muscle aches, confusion, significant increase seizure, body aches, extreme fatigue, change in red blood cells, inflammation of vascular structure of organs, multiple autoimmune symptoms, headaches, loss of appetite, testosterone levels declined
Rash; Painful Blister; Nerve pain on one side of torso; "Sounds like Shingles"; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 3E7B2, expiry date 4th March 2022) for prophylaxis.   On 31st December 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash, blister, nerve pain and shingles. On an unknown date, the outcome of the rash, blister, nerve pain and shingles were unknown.   It was unknown if the reporter considered the rash, blister, nerve pain and shingles to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and few days experienced rash, painful blisters and nerve pain on one side of torso. The reporter stated sounds like Shingles. The reporter asked was this common after 1st dose. Adverse event was collected. The reporter did not consent to follow up.
Inappropriate Schedule of Vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose last year).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Aug-2023 The consumer called in to report that never came back to get the second dose. The reporter asked how to proceed with Shingrix series. Attempt to warm transfer to Agent to further assist.  Phone transfer difficulties, patient/consumer consented to Agent to return call. Consumer unable to provide any vaccine details. Did not consent to follow-up. Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination.
This spontaneous report was received from a female patient of unknown age, who is also a Nurse Practitioner reporting on herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. Approximately in 2014 "reported as: "About three years ago"), the patient was vaccinated with a dose of ZOSTAVAX intramuscularly (strength, dose number, lot number and expiration date were not provided) for prophylaxis. It was reported that the dose of ZOSTAVAX reconstituted with sterile diluent(manufacturer unknown). No adverse event was reported. Additional information has been requested.
Red Rash 4in x 4in  10 pm 2/16/2021 Nickel size blisters 7:00am 2/17/2021 spoke w dr  Blisters continued to grow in size to quarter/ half dollar size , then would ooz and continue to refill thru out 2/17 and 2/18    Looked like a flesh eating disease on upper left arm  2/19  dr visit rcvd medical treatment dr  had to open and fully drain the blisters and the dressed the area  Raw skin  Dr prescribe prescriptions for   silver sulfadiazine    and  triamcinolone  Area looks like it will be scared
PATIENT STATED THAT HER ARM STARTED TO SWELL IN THE AREA INJECTED, IT BECAME RED, AND STARTED TO BECOME ITCHY.
Patient reported having redness and hot for both of her eyes. Patient described the adverse effect lasting roughly a week.  Nothing was done for treatment.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6207), in right arm and on 02Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 25 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG, start date: Dec1999; LEXAPRO, start date: Jun2017; LISINOPRIL, start date: Feb2017; LIPITOR, start date: Feb2017, stop date: 16May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (29May2022) Positive; (17May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Other medication in 2weeks. Anti viral details: product-COVID 19 Treatment, brand-Paxlovid, Treatment start date-17May2022, Treatment stop date-22May2022, Indication: Treatment of COVID-19. The patient Tested positive for COVID 5 days after completing the 5 day course of Paxlovid. The patient had no Known allergies.
Became very restless, anxious, twisting and turning, could not settle down. Was cold, Generalized weakness, Headache, Next day, loss of balance. symptom's lasted until 12/01/2005. Symptoms developed all at once approx 4 hours after vaccination. Encouraged to discuss with PMD.
Was given a lesser dose; A spontaneous report was received from a healthcare professional and a consumer concerning 70 year old male patient.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 12Feb2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12Feb2021, the vaccine provider (pharmacist) performed an accidental underdose.  The pharmacist informed the patient to go back and receive the full recommended dose.  No treatment was reported.  Action taken with the mRNA-1273 was not reported.  The event, accidental underdose, was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error of accidental underdose for mRNA-1273(lot number 031M20A), with no associated AEs
approximately 6pm on 2/18 I began having severe chills, high fever, nausea, muscle weakness, headache, whole body pain lasting 3.5 days.  I took aspirin to start for my symptoms first day, 2nd-3rd days Ibuprofen for the fever, chills.  IS TAKING DIFFERENT LOT NUMBER WHAT MADE ME ILL???
Information has been received from a physician concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  On an unspecified, following vaccination, the patient was seen by her rheumatologist and the patient's rheumatologist stated the vaccine caused the patient to develop arthritis.  The physician reported that she had been in contact with the rheumatologist and it was noted the patient's arthritis is improving.  A product quality complaint was not involved.  The reporter felt that arthritis was related to therapy with Zostavax (Oka/Merck).  Additional information has been requested.
6/11/07 Beginning at 8:00-9:00pm, child had watery eyes, crying (parent says she was able to comfort child) and decreased appetite. 6/12/07 Child went to babysitters. Babysitter tells mom he vomited twice during the day. Mom says child had red, puffy eyes when she picked him up at 4:00. Child was somewhat better at 4:30 pm with puffy eyes and a decreased appetite. Tylenol was given for comfort and according to mother on 6/12/07 5:00pm appetite increased and feeling ok.
itchiness/itchiness on different parts of her body; rash; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 23Feb2021 (at the age of 95-year-old), as dose 1, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itchiness on different parts of her body and sometimes there was rash and other times there wasn't. It was reported that, it started on the top of her feet and now on her arms. The patient was a nurse years ago, so she knows stuff. The patient washed all her clothes and there have been no changes in detergent and no changes in medication. If that was the case, it would have gotten better in three days. It has been everyday but in a different part of the body. It was also reported that, the patient was able to get a hold of her doctor, and the doctor told patient to go to the pharmacist and get an allergy medication over the counter. The outcome for itchiness was unknown while the outcome for rash was recovered with sequel. The patients might get second shot possibly on 08Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician refers to a currently 5 month old (former 29 week preemie) patient with gastroesophageal reflux disease. The patient was one of twins born at 29 weeks gestation. The patient's medical history included intraventricular hemorrhage. In 2013 the patient received 2 doses of Hib (manufacturer unknown) (exact dates unspecified, doses and route unknown). Concomitant therapies included ZANTAC. In 2013 the patient experienced haemophilus influenzae b meningitis, considered as potential vaccine failure. On unknown date in 2013 the lab test were performed and results were provided as: positive CSF culture; HIB positive by latex agglutination on cerebrospinal fluid (CSF). The patient was hospitalized in 2013. At the time of this report the patient was recovering but remained hospitalized. The causality between Hib vaccine (manufacturer unknown) and Haemophilus influenzae meningitis was unknown. Additional information has been requested.
Pain, dysesthesia left ear and jaw and left side of tongue.  No visible abnormalities left face and ear.  She indicates her lips (bilateral, upper and lower) had become swollen the day after her 2nd immunization 1/12/21, the lip swelling resolved when I saw her 1/14/21
2 month old developed fever to 103.4 within 24 hrs of receiving vaccines.
COVID 19 Moderna first dose (March 12, 2021): pain and discomfort at injection site for 4 days  COVID 19 Moderna second dose (April 9, 2021): pain and discomfort at injection site for 2 days; chills, headache, myalgia, arthralgia for 24 hours; severe stomach pain with no other gastrointestinal symptoms on day 2 after vaccine that required admittance to Emergency Room
vertigo; This is a spontaneous report from a contactable Physician. A 78-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in arm left on 03Mar2021 as a 2nd dose, single for COVID-19 immunisation. The patient's medical history included HTN, dyslipidemia. Age at vaccination was 78 years. The patient's concomitant medications in two weeks included atorvastatin, hydrochlorothiazide, triamterene (TRIAMTERENE-HCTZ). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in arm left on 10Feb2021 as a 1st dose, single for COVID-19 immunisation. It was reported that, no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 05Mar2021, the patient experienced vertigo. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment medication included was meclizine. The outcome of the event was recovering.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Patient presented to the pharmacy with a site reaction that spread down her arm and up her neck towards her lymph nodes.
The pharmacist on duty accidentally drew up a dose for Moderna Pediatric instead of the Moderna Bivalent dose. No adverse reactions.
DT booster large 2mc wheal w/surrounding erythema-seen 31MAY95, 2JUN95;
Injection site soreness; body aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration into the left arm on 17Feb2021 11:15 at a single dose for COVID-19 immunisation. Medical history included allergies. Patient was not pregnant. The patient was taking unspecified concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. On 18Feb2021, patient experienced injection site soreness, body aches and fatigue. The events were reported as non-serious and patient did not receive treatment. Outcome of events recovered on Feb2021.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to an unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # were not reported) which this single dose was exposed to -1C for 22 days. The nurse stated that she was not sure if dose may had been administered to the patient. No adverse effects reported. Follow-up information has been received from the registered nurse and refers to a 49 year old female patient. On 20-MAY-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot # K003074, expiration date 13-MAR-2015) that was stored improperly. The diluent was exposed to lower than 2C for more than 15 days, the lowest temperature was -1C for 5 days. No symptoms were reported. No PQC (product quality complained) involved. The reporter asked if the patient had to be revaccinated. This is one of several reports from the same source. Additional information has been requested.
A physician reported the occurrence of a hypersensitivity reaction in an 7-month-old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not reported. On 02/07/2003, the pt received an injection of Engerix-B. 24 hours post-immunization, the pt presented to the physician with "intense" urticaria and a progressive ecchymosis of the the right thigh around the injection site. The area of ecchymosis measured 3.9" x 2.7". The physician made a diagnosis of hypersensitivity reaction. No treatment was provided. The physician considered the hypersensitivity reaction to be related to Engerix-B administration. As of 03/10/2003, the hypersensitivity reaction was slowly improving.
Redness,swelling,heat and firmness at site.  Dark red for quarter-sized area around site and then lighter pink for an area the size of a grapefruit. No treatment.
Hospitalized 9/20/22-9/23/22 Weakness, confusion, fever,  hyperkalemia, body ache, debility
pt recvd vax 9MAR93 & devel a rash on chest, abdo, back & buttocks as well as a h/a & fever; No further details were provided;
transient, moderate injection site pain that has persisted for four (4) months. physical activity, including typing triggers a cramping pain in left deltoid, localized at injection site. pronounced, unbalanced muscle weakness when compared to right arm during physical exercise
A red spot, some swelling and pain around the injection site.  The pain never subsided and I returned to the pharmacy on December 12, 2022 to report the incident.  The range of motion in my arm was decreased substantially.  I used ice and heat and didn't use my arm.  I called for an appointment with my doctor concerned there might be some damage to tissue inside my arm and went to see the doctor on January 10, 2023.  She gave me a perscription for Meloxican and I am recovering.
She reacted badly once to pneumo vax and was hospitalized.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ADVERSE EVENT FOLLOWING IMMUNISATION (hospitalization), outcome "unknown", described as "She reacted badly once to pneumo vax and was hospitalized.". The clinical course was reported as follows: During the phone call received, Name (withheld) stated: "We have a patient referred to us as immunologist for a Prevnar 20 challenge. For reaction. She reacted badly once to pneumo vax and was hospitalized. So. it's recommended that she have a drug challenge." The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Warm to the touch; white areas and redness injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch) and VACCINATION SITE ERYTHEMA (white areas and redness injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch) and VACCINATION SITE ERYTHEMA (white areas and redness injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch) and VACCINATION SITE ERYTHEMA (white areas and redness injection site) 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.   Reporter did not allow further contact
4AUG92 sz & loss of consciousness abut 15 mins p/leaving clinic; dad reported incident lasted about 1-1 1/2 mins; pt taken to clinic seen by MD;
Patient was given vaccine around 2:30pm. Arm was checked at 2:48pm and she had a 1/4 inch red circle at injection site. Patient called on 9/20 and came to pharmacy around 5:15pm to have pharmacist look at it. The red area was 4 inches in length and 1&1/2 inch in width. Patient had been taking diphenhydramine to help. She stated that it started itching today.
Mom contaced clinic & states having bites not red & not warm to touch, no swelling; MD advised DPH;
Received PREVNAR 13 on 4/20/15. On 4/21/15 had chills, felt cold, face was very red. Wednesday, she slept all day. Friday (4/24/15) had red rash at injection site down arm, halfway to elbow. 4/27/`5 legs hurt, dyspnea with exertion, no energy.
Shoulder/upper arm soreness.  Soreness is described as being to in the muscle and into the bone.
Pt was waiting for 10 min after flu vaccine because it was a question of receiving vaccine for 1st time. Approx 10-15 min after vaccine. Pt. c/o not feeling well color pale diaphoretic. I placed him on the floor in supine position and placed a coat under and over legs. Pt. was pale and diaphoretic 10:35 BP 100/62.
approx 2-3 hrs p/vax pt noticed warmth & swelling below elbow; ice packs applied w/relief; client visited MD 26JUN92; pt also stated that immed p/receiving vax worked out by lifting weights;
Patient started to feel light-headed after shot was administered and lost consciousness for less than a minute while sitting in chair behind pharmacy privacy screen. He came to after verbal and physical stimulation to the arm. He appeared pale and began to sweat. He showed no signs of hives or difficulty breathing. We gave him water, cool damp cloths to wipe his face with, and sat with him for 20-30 minutes. After an hour, patient still looks pale and feels tired/fatigued.
Very Dizzy; Unsteady; A spontaneous report was received from a Consumer concerning a 88-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very dizzy, unsteady.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events very dizzy. unsteady.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, very dizzy, unsteady was not reported.
Pt came in to pharmacy on 9/22/16 with a large red area on upper left arm that was warm to the touch, and pt felt as if it was burning. Pt stated the area had gotten larger and appeared 2 days after vaccine given.
Received H1N1 at school (2nd dose) Tuesday afternoon. Developed facial swelling and diffuse red rash later that night. Vomited that night. Fever to 102. Fever now gone. Gave ibuprofen. Remaining symptoms now (1/28 12pm)include the diffuse rash and facial swelling, decreased appetite and some vomiting.