chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slow healing / Wound healing delayed; Activities of daily living impaired; Few of plaque spots/skin really blew up/psoriasis skin flare ups have continued to come in waves; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED HEALING (Slow healing / Wound healing delayed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired) and PSORIASIS (Few of plaque spots/skin really blew up/psoriasis skin flare ups have continued to come in waves) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's past medical history included Hip replacement. Concurrent medical conditions included Plaque psoriasis.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced IMPAIRED HEALING (Slow healing / Wound healing delayed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired) and PSORIASIS (Few of plaque spots/skin really blew up/psoriasis skin flare ups have continued to come in waves). At the time of the report, IMPAIRED HEALING (Slow healing / Wound healing delayed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired) and PSORIASIS (Few of plaque spots/skin really blew up/psoriasis skin flare ups have continued to come in waves) had not resolved.            No concomitant medications were provided by the reporter.  Patient had taken SKYRIZI in the form of Solution for injection in pre-filled pen.  No treatment information was provided.  For co-suspect SKYRIZI product reporter causality was given as not reported for all the events.   This case was linked to MOD-2022-597480 (Patient Link).
Mom noticed a bump under her skin about 10 days after VARIVAX was given at the site of administration.
Patient called pharmacy and stated that after she received the vaccine the previous Thursday, she started to develop COVID symptoms (fatigue, headache, aches, fever). She described the symptoms as having COVID again. It was recommended that she not wait and get tested for COVID. Not sure if she went to seek diagnosis/treatment.
Severe Chills, body aches and joint pain, low grade fever 99.8 , nausea and headache.
Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth; Received first dose on 25Jan2021 and second dose on 11Feb2021; Received first dose on 25Jan2021 and second dose on 11Feb2021; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), intramuscularly in Left arm on 11Feb2021 17:15 at single dose for covid-19 immunisation. Medical history included allergy to dairy products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) at the age of 43 years old and Intramuscularly in Left arm on 25Jan2021 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth on 12Feb2021 12:00. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02Feb2021 with result Negative. Therapeutic measures (reported as 'IV Epinephrine, Solumedrol, 'Pepcid', 'Benadryl', prednisone) were taken as a result of red flat itchy rash on torso, face, arms, legs, facial swelling, eyes swollen, itchy throat, cotton mouth. The outcome of the events was not recovered. This case reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
patient came in to receive the updated covid19 pfizer booster (bivalent) but ended up receiving the monovalent one.
flu symptoms; she felt sick; patient had cold in the body; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Nov-2021 and was forwarded to Moderna on 07-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms), VACCINATION COMPLICATION (she felt sick), FEELING COLD (patient had cold in the body) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, HYDRALAZINE, FLUOXETINE HYDROCHLORIDE (PROZAC) and LORAZEPAM for an unknown indication.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced INFLUENZA (flu symptoms), VACCINATION COMPLICATION (she felt sick), FEELING COLD (patient had cold in the body) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA (flu symptoms), VACCINATION COMPLICATION (she felt sick), FEELING COLD (patient had cold in the body) and FATIGUE (fatigue) was resolving.            Reporter did not allow further contact
Systemic: Other- High blood pressure (198/123) pulse (106bpm), palpitation -Medium
This spontaneous report as received from a physician assistant refers to a 13 years old female patient with bees and wasps allergy and no pertinent medical history. The patient was vaccinated with 0.5 ml GARDASIL intramuscularly on 05-OCT-2012. Lot# was unspecified. No other co-suspects were reported. Concomitant medications included vitamin B and vitamin D. On 05-OCT-2012, the patient received GARDASIL and 2-3 hours after the vaccination had diarrhea. In the days following the vaccination the patient had malaise, fatigue, headache, low grade temperature and pain behind both eyes. The patient might be admitted to hospital. No treatment was given for the events. The patient did a complete blood count (CBC) and basic metabolic profile at outside facility. The reporter was waiting for the information from the other facility and no lab resulted was provided at reporting time. The patient was not recovered. The patient also visited primary care physician and visit to emergency room to seek medical attention. Additional information has been requested.
Patient received MMR on 6/22/07. Parents report diffuse macularpapular rash began 6/29/07. Arrived in ER after 6 days of rash and fever >102.1
Hives, short of breath, swollen Rt. eye, fever 101 degrees F, pressure on chest, headache, sore throat. TX hydroxyzine 25 mg. 11/10/2009 PCP note from 10/20/2009. Patient with c/o's rash, hives, arthralgias and eye swelling. Tx'd with Vistaril. Dx Allergic reaction. l
Hives broken out on left arm. Red and very sore to the touch. Radiating heat.  Since June 4th to present
Severe burning that spread along arm to right anterior posterior chest. onset within 10 sec. Duration app 15 minutes. 2 weeks after right arm still has pins/needles sensation with heavy feel.
Red, raised area about 2" long x 1 1/2 " wide. Treated with Benadryl and Advil.
large red mark around vaccination area that lasted 9 days; A spontaneous report was received from a Consumer concerning a 2021--years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events large red mark around vaccination area that lasted 9 days.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events large red mark around vaccination area that lasted 9 days.  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, large red mark around vaccination area that lasted 9 days was not reported.  Based on comment Injection site erythema coded as Vaccination site erythema
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A, A0756484, A0756486A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received KINRIX (batch number 75F53, expiry date 9th December 2019). In January 2018, the patient received KINRIX. In January 2018, unknown after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The health care professional reported that the 4 months old patient received KINRIX, which led to inappropriate age at vaccine administration. No side effects was reported. No additional information was provided. Follow up information was received by a other health professional via call center representative on 22nd February 2018: The patient received the 0.5 ml dose of KINRIX intramuscularly. Less than a month after receiving KINRIX, the patient experienced low grade fever. The registered nurse who administered KINRIX did not knew that it was for certain ages and certain dose of DTAP/Polio. Warning labels were put on every boxy of KINRIX in their clinic. It was unknown if the reporter considered the low grade fever to be related to KINRIX. This was an accidental medication error associated with an adverse event. The VAERS details were updated.
2.5 x 3cm area of redness, density right mid anterolateral thigh, No fluctunce swelling notch approximately 1 week later
UNKNOWN VACCINE MANUFACTURER OR LOT NUMBER. PATIENT ADMITTED TO HOSPITAL DIAGNOSED WITH COVID BREAKTHROUGH
Patient under the age of 18 when he received the Moderna COVID vaccine. Patient had no adverse side effects or symptoms.
pt recv vax & devel gastroenteritis;pt exp vomiting & diarrhea on 15OCT96;seen for office visit 16OCT96 dx gastroenteritis;T103;hosp for IV fluids;exp watery diarrhea & vomiting;acute weight loss, intake was better;BP 86/71
"Rash" arms/feet headaches. Vomiting/fatigue (erythema multiforme).
Since the vaccination ive been to the dr or hospital and they keep telling me I have "anxiety" bla bla bla but ive been diagnosed with heart murmur since then and heart palpatations.
Rheumatoid arthritis aggravated; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) (seriousness criterion medically significant). On 24-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding the event has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 26-year-old male. Neither medical history nor concomitant medications were reported. On 17-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
Chills, headache, debilitating fatigue, nausea, loss of appetite, acute arm pain at injection site, elevated temp
my breathing  started in February/March of 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 12:00 as dose 2, single (Lot number: EL9266) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: coviD-19 vaccine (Dose Number: 1, Batch/Lot No: El9262, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 21Jan2021, when the patient was 70-year-old, for COVID-19 Immunization. The following information was reported: RESPIRATION ABNORMAL (non-serious) with onset 15Feb2021 at 12:00, outcome "not recovered", described as "my breathing  started in February/March of 2021". Therapeutic measures were not taken as a result of respiration abnormal.  Additional information: He had copd and was managing it with the copd medicine But his breathing started in February/March of 2021 after the booster the breathing became very bad. there was no other medicine or treatments during this time.
body ache; flu like symptoms; not feeling well; diarrhea; soreness; nausea; headache; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, 1 day after receiving Shingrix, the patient experienced nausea and headache. On 24th August 2019, the patient experienced pain in arm. On 27th August 2019, the patient experienced general body pain, influenza-like symptoms, feeling unwell and diarrhea. On 27th August 2019, the outcome of the pain in arm was recovering/resolving. On an unknown date, the outcome of the nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea were recovering/resolving.   It was unknown if the reporter considered the pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced a sore arm for three days. The patient also experienced nausea and headache. On 27th August 2019, the patient experienced general body pain, influenza-like symptoms, feeling unwell and diarrhea. The patient overheard a co worker speaking about another patient who had similar side effects, however, she had no details to provide. The reporter consented to follow up.
approximately 1 hour after recieving flu vaccine hives appeared on trunk of body and spread to extremities over the course of next 5 hours.  Took antihistimine and used topical cream to relieve itching and swelling.  Swelling was reduced by next morning but hives returned when antihistimine wore off.
Feeling dizzy upon getting up from bed; Daily frontal headaches; Eye twitching; This is a spontaneous report from a contactable reporter (Physician).  A 11-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Dec2021 at 10:15 (Lot number: FK5127) at the age of 11 years as dose 1 (tris), single for COVID-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication included: FLUZONE taken for Immunization, start date: 23Nov2021, stop date: 23Nov2021. The following information was reported: DIZZINESS (non-serious) with onset 04Dec2021 at 08:00, outcome "not recovered", described as "Feeling dizzy upon getting up from bed"; HEADACHE (non-serious) with onset 04Dec2021 at 08:00, outcome "not recovered", described as "Daily frontal headaches"; MUSCLE TWITCHING (non-serious) with onset 04Dec2021 at 08:00, outcome "not recovered", described as "Eye twitching". The events "Feeling dizzy upon getting up from bed", "Daily frontal headaches" and "Eye twitching" were evaluated at the emergency room visit and physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The known allergies was not applicable. Prior to vaccination, the patient was not diagnosed with COVID-19. After 24 hours of vaccination, patient started feeling dizzy upon getting up from bed and has daily frontal headaches with eye twitching. Since the vaccination, the patient had been tested for COVID-19.
Fever, chills, lethargic, extreme pain and swelling at injection site, widespread body pain.
3 doses of Prevnar given. Pt developed clinical pneumonia about 6/22/01. (Vaccine failure). Inpatient overnight and prolonged po ATB caused thrombocytopenia (9/01-10/01). Platelet count less than 10K and transfused X 1; Rx-PCN; cefotaxime. This physician states that he does not intend to report the ITP as a UEX AE. He believes it is related to the infection. No serotype of the pneumococcus.
Patient stated after the 3rd (booster) dose 10/22/2021, she experienced symptoms 10/24/2021 of headache, fatigue, pain at the injection site, red mark below the injection site (lasting 24hrs) and swelling throughout the shoulder area of the injection site.
DTAP was ordered by Dr. (Pediatrician), DTAP-IPV was administered IM to RVL site by Medical Assistant.  No adverse reaction was noted.  Dr. was notified and stated that there should not be any adverse harm to the patient.  The mother was notified of the incident.
very sore and swollen upper arm / upper arm is still painful; very sore and swollen upper arm; upper arm is still painful, to the extent that I have trouble raising it above my head, fastening my bra; overall muscle aches; upset stomach; nausea; temp between 99.5 and 100.; This case was reported by a consumer and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1dose received on unknown date. please refer the case US2020AMR219429).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, swelling arm, mobility decreased, muscle pain, upset stomach, nausea and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved and the outcome of the swelling arm, muscle pain, upset stomach, nausea and fever were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, mobility decreased, muscle pain, upset stomach, nausea and fever to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The patient had a full-blown reaction of upset stomach, nausea, very sore and swollen upper arm, overall muscle aches, temperature between 99.5 and 100 degree F. Most of these reactions lasted for about 3 days. The reporter stated that now, 6 weeks later, the patient's upper arm was still painful, to the extent that she had trouble raising it above her head, fastening my bra, etc. The patient asked if it was normal.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR222147:1st dose
pt reports waking up the next morning with "amnesia" "didn't know where I was, forgetful, " numbness radiating down her vaccinated arm, neck soreness