chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe internal /external rash; Blistering at site on chest and face; Swollen lymph node; Heart palpitations; Fatigue; Itchy and blotchy skin; Itchy and blotchy skin; Burning skin; Neck cramp; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 17Aug2021 at 17:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin, egg, pork, nickel, pollen, dust, mold, and most alloy metals. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 18Aug2021 at 19:45, the patient experienced severe internal/external rash, blistering at site on chest and face, swollen lymph node, heart palpitations, fatigue, itchy and blotchy skin, burning skin, and neck cramp. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events severe internal/external rash, blistering at site on chest and face, itchy and blotchy skin and burning skin and included treatment with unspecified steroid and dermal ointment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe internal/external rash, blistering at site on chest and face, swollen lymph node, heart palpitations, fatigue, itchy and blotchy skin, burning skin, and neck cramp were resolved with sequelae on an unknown date in 2021.
fever; fatigue; myalgia; headache; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose in July 2018, refer case US2019AMR092966).   In September 2018, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever, fatigue, myalgia and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, fatigue, myalgia and headache were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue, myalgia and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by a medical assistant. The patient received 2nd dose and had fever, fatigue, myalgia, headache 2 days after lasting 1 day with vaccines. Symptoms were greater with the 2nd dose.
Local site reaction to left leg, increasing redness and warmth for several days, some hardness to skin reported by family but not noted in clinic. Pt came to me 3 days s/p vaccine, still with local redness and warmth, almost with bulls-eye appearance as a few rings of light and dark redness. No induration. Pt reports itching but no pain. Family has tried BENADRYL and TYLENOL. I gave BACTRIM antibiotic for 5 day course, instructed to use ibuprofen for swelling and inflammation. Mark borders and watch closely, and follow-up if not improving.
Client developed tingling of face, hives to neck/chest, dizziness approx 20 min after receiving flu vaccine. No respiratory distress. Ambulance called - client received BENADRYL in ER and sent home shortly after - no further issues.
sore arm immediately. then 10 hours after the shot, chills, headache, and back pain followed by fever up to 104.7, abdominal pain, nausea and vomiting, myalgia, and cough.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 53-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of covid-19. Patient did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Perfect circle around injection site measuring 4.1 long and 3.5 wife. Severely itchy, complaining of pain. Mom gave detox bath (epson salt/baking soda bath). Mom gave 2.5ml of Zyrtec on 04/10/2018 @ 4pm. Called Dr numerous times on 04/10/2018 and was told to give Tylenol and ice pack. Site proceeded to get worse. Called Dr again on 04/11/2018 and as of 04/12/2018 mom is still waiting to hear from Dr. Mom gave second detox bath on 04/12/2018 and gave Zyrtec at 8am on 04/12/2018.  As of 04/12/2018 @ 9:53am, the area around the site has faded and swelling has gone down.
Information has been received from a physician concerning a 11 year old bi-racial male with environmental allergies, amoxicillin allergy, asthma and reactive airway symptoms who on 24-APR-1998 was vaccinated in the arm with the first dose of varicella virus vaccine live (Oka/Merck) (lot# 625046/1569E). On 06-NOV-2007 "not quite 10 years after varicella", the patient developed a full blown case of varicella with many skin lesions, no fever, and little to no itching. There were no other complications at 3 days into infection. At the time of report the patient's full blown case of varicella was still in an acute phase. The patient's outcome is unknown. Follow up information was received from a physician who reported that on 06 DEC 2007 the patient had completely recovered.
complains of tingling in left forearm, into left hand,  no numbness.  Full ROM and normal strength.  Denies shortness of breath, no trouble swallowing, no swelling of lips or tongue, no rash. BP- 127/79, p-102, O2 sat-97% Examined by Dr Discharged home with ER precautions.  Will follow up with PCP if symptoms persist.
fluzone quadrivalent vaccine was administered instead of fluzone high-dose quadrivalent vaccine that was indicated with no adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA288621 (CLUSTER).  This case involves a 71 years old male patient who was administered the influenza quadrival A-B vaccine [Fluzone Quadrivalent] rather than the Influenza Quadrival A-B High Dose HV Vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Sep-2023, the patient received a dose 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection lot UT8055JA expiry date: not reported via intramuscular route in unknown administration site for immunisation rather than the Influenza Quadrival A-B High Dose HV Vaccine with no reported adverse event (wrong product administered) (latency same day).  Action taken was unknown.  At time of reporting, the outcome was Unknown for the event administered the fluzone quadrivalent vaccine rather than the fluzone high-dose quadrivalent vaccine with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I have some tingling on the bottom of my feet and my toes of both feet.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Mar2021 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "I have some tingling on the bottom of my feet and my toes of both feet.".  Additional Information: In about 2 days after the shot, patient had some tingling on the bottom of feet and toes of both feet and just wondered how long that last and also if the 2nd shot was going to make it worse. Patient enquired if more problems occur with this tingling that was already having.  No follow-up attempts are possible. No further information is expected.
pt recv vax 17OCT96 & devel itching & swelling all over body & eyelids the following day;went to MD who prescribed Pred;
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-SEP-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
COVID-19/OMICRON; Psoriasis aggravated; Wearing off effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/OMICRON), PSORIASIS (Psoriasis aggravated) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19/OMICRON), PSORIASIS (Psoriasis aggravated) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, COVID-19  had resolved, PSORIASIS (Psoriasis aggravated) had not resolved and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. It was reported, since received injection patient skin was significantly improved.  Patient had covid, the only symptoms were the loss of smell and taste.  On 13-Dec-2021 patient had monoclonal antibodies. Patient had an outbreak and noticed more spots developing roughly about five to six spots.  Patient had spots that were accumulating on the lower leg area during a lapse in the administration frequency when started. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  Company comment: This spontaneous case concerns an elderly female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred unknown days after the administration of an unspecified dose of mRNA-1273 vaccine in COVID 19 vaccination series. The event had resolved. Further details regarding number and specifics of COVID 19 vaccines, therapy dates, concomitant medications, investigations, and treatment are not provided.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Follow-up received event verbatim for COVID-19 updated,  outcome of event Psoriasis aggravated updated as not recovered/not resolved, I narrative updated. On 31-May-2022: Follow-up received outcome of event COVID-19 updated as recovered/resolved, I narrative updated.; Sender's Comments: This spontaneous case concerns an elderly female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred unknown days after the administration of an unspecified dose of mRNA-1273 vaccine in COVID 19 vaccination series. The event had resolved. Further details regarding number and specifics of COVID 19 vaccines, therapy dates, concomitant medications, investigations, and treatment are not provided.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Symptoms:  Light headed, nausea, shaky and pain at injection site, history anxiety.  History of nausea an syncope episode when getting any vaccine, asthmatic and didn't have any albuterol and baclofen today and didn't have it with her on site.  Pain started at the injection site (left arm) and over 5-7 minutes the pain increase and radiated  to the left clavicle.  We pulled EMT from already on site to further evaluated cardiac concerns.  EKG was normal that was performed by EMT on site.  EMT administered: 4mg Zofran, 100 micro sublimaze for pain 1st VS: 158/110, RR 22-24, Oxygen 98%, pulse 88 15 minutes later 2nd VS: 150/110, RR 22-24, Oxygen 98%, pulse 88 Transported by EMT to hospital Will follow up with phone call tomorrow
PATIENT STATES THAT SHE HAD REDNESS,SWELLING,WARM TO TOUCH AND SORENESS BELOW SITE OF INJECTION ON 10/16/03. SHE STATES THAT SIGNS AND SYMPTOMS HAD INPROVED BY 10/17/03 AND THAT SHE HAD TAKEN IBUPROFEN FOR TREATMENT. LOCAL REACTION ONLY.
Shortness of breath for 2 weeks, then numbness started on left knee and traveled down to the left foot, eventually over the course of several weeks my entire left side of my body became numb and ice cold. Eventually my right side developed the numbness. Till this day i can not feel 6 of my toes and i have continued numbness and muscle twitching throughout my body. There is no way to describe the coldness and pain, it is unbearable at times.
Initial unsolicited report received from a health care professional on 24 November 2015. This case involves a female patient (age: unknown) who was vaccinated with a [route not reported] first dose of FLUZONE ID (batch number, expiry date site and site of administration were not reported) on an unspecified date (2014-2015). Illness at time of vaccination was none and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was no known allergy (NKA) and anxiety. Patient had no vaccinations within 4 weeks of vaccinations. On an unspecified date, few minutes following the vaccination patient had developed facial numbness and tingling especially around the lips. Patient had no laboratory investigation. Corrective treatment was not reported. It was reported that, the events were resolved on it's own after a few minutes of rest. List of documents held by sender: none.
This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (very advanced Alzheimer's disease), BEDRIDDEN (can't move to get out of the bed, bed bound) and GAIT INABILITY (stopped walking completely) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Alzheimer's disease (Diagnosed 10 years ago). In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DEMENTIA ALZHEIMER'S TYPE (very advanced Alzheimer's disease). In July 2021, the patient experienced BEDRIDDEN (can't move to get out of the bed, bed bound) and GAIT INABILITY (stopped walking completely). The patient was treated with Hospice care for Dementia Alzheimer's type and Hospice care for Bedridden. At the time of the report, DEMENTIA ALZHEIMER'S TYPE (very advanced Alzheimer's disease), BEDRIDDEN (can't move to get out of the bed, bed bound) and GAIT INABILITY (stopped walking completely) had not resolved. Company comment: This is a spontaneous case concerning a male patient of an unknown age with Alzheimer´s disease (diagnosed ten years ago), who experienced the non-serious unexpected events "very advanced Alzheimer´s disease", after receiving second dose of mRNA-1273. The reporter assessed the event as unlikely related to the vaccine .The benefit-risk relationship of mRNA-1273 is not affected by this report. Concomitant medications were not provided. It was reported that one year ago patient was able to move around with help, now he can't move to get out of the bed and is under hospice care. It was also reported that none of the events were related to Moderna COVID-19 vaccines received by the patient. Reporter did not allow further contact. Sender's Comments: Company comment: This is a spontaneous case concerning a male patient of an unknown age with Alzheimer´s disease (diagnosed ten years ago), who experienced the non-serious unexpected events "very advanced Alzheimer´s disease", after receiving second dose of mRNA-1273. The reporter assessed the event as unlikely related to the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Dizziness roughly 5 hours post-administration. Onset of severe malaise, widespread severe myalgia and arthralgia rougly 10 hours post-administration. Severe pain continued and did not begin to subside for roughly 48 hours. Pain was so bad that patient was unable to complete normal day-to-day activities and struggled to even get out of bed.
The HCP was given 2 doses of the Flu vaccine on 10/6/2021 & 10/11/2021. As of 10/12/2021, the HCP did not have any reactions to both vaccines given.
I have a large softball size lump, it?s red and hot, my lymph nodes under my arms are very swollen, the second day felt like I got run over by a Mack truck all my muscles and joints and bones continue to hurt. Major fatigue. The symptoms are still current so as of the 16th starting at 12:30 PM to now which I still have
Redness, induration, swelling Right upper are.  Laterally 3"X2" adenopathy; mild; fever.  treated with Motrin; rest & reassurance
but a slight headache started/headaches got extremely strong and unbearable; I had two days of muscular and joint pain.; I had two days of muscular and joint pain.; Around May 7th the body pain was mostly gone; it was determined I had a CSF leak.; This is a spontaneous report from two contactable consumer. A 43-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 04May2021 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: not reported), on 13Apr2021 (at the age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunization. On May2021, After the 2nd dose of Pfizer vaccine patient had two days of muscular and joint pain. Around May 7th the body pain was mostly gone but a slight headache started. During the week of May 10th to 14th the headaches got extremely strong and unbearable, and patient went to the emergency room on the 15th of May. After coming back to the Emergency room again a couple days later, many tests and seeing a few neurologists, it was determined patient had a CSF leak. The patient was initially treated with steroids, the headaches subsisted, one blood patch at lower back that solved 50% of the issue. Finally, a second blood patch at upper back by July 29th, that solved the problem. The outcome of the event CSF leakage was recovered, while the events Muscular pain and Joint pain was unknown, body pain was recovering, and Headache was not recovered at time of report.   The lot number for BNT162B2, was not provided and will be requested during follow up
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-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 EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment drugs were provided.
Pt. c/o itchiness at 10:32. Pt. was observed, vitals taken, 25 mg Benadryl given PO with water.  Pt. symptoms improved, vitals stable.
IMMIDIATELLY AFTER THE THIRD VACCINE GIVEN, PATIENT STARTED FEELING DIZZY, NAUSEA, & DIMINISHED VISION. SECONDS LATER STATES FEELING A WEIRD SENSATION IN HER THROAT. BP LOW 70/43. PULSE: 43 R: 20
Complained of chills (no fever detected), tingling in arms and legs, "feel like I'm getting sick." Felt very tired, took an Advil and fell asleep for 2 hrs. in the middle of the afternoon (very unusual). No GI or respiratory symptoms developed. Gradually improved over the next day or two.