chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arthus reaction; necrosis; redness; swelling; induration; heat; bruising; Dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 18:00 (Lot number: FH8030) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, lot number: EL9267, administration time: 10:00 AM,  vaccine location: Left arm), administration date: 09Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, lot number: EN6200, administration time: 10:00 AM, vaccine location: Left arm), administration date: 16Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: TYPE III IMMUNE COMPLEX MEDIATED REACTION (medically significant) with onset 16Nov2021, outcome "recovering", described as "Arthus reaction"; NECROSIS (medically significant) with onset 16Nov2021, outcome "recovering", described as "necrosis"; ERYTHEMA (non-serious) with onset 16Nov2021, outcome "recovering", described as "redness"; SWELLING (non-serious) with onset 16Nov2021, outcome "recovering", described as "swelling"; INDURATION (non-serious) with onset 16Nov2021, outcome "recovering", described as "induration"; FEELING HOT (non-serious) with onset 16Nov2021, outcome "recovering", described as "heat"; CONTUSION (non-serious) with onset 16Nov2021, outcome "recovering", described as "bruising"; IMMUNISATION (non-serious) with onset 15Nov2021 18:00, outcome "unknown", described as "Dose received: 3". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) negative: Other. Therapeutic measures were taken as a result of type iii immune complex mediated reaction, necrosis, erythema, swelling, induration, feeling hot, contusion. The patient self medicated with cold pack and acetaminophen. Arthus reaction (redness, swelling, induration, heat) began several hours after booster inoculation. This reaction peaked about 4 days later (with bruising - necrosis) and spreading of "red" zone. The area of the redness/swelling peaked with a circumference of 10 cm or about 4 inches in diameter. Red area persists but seems to be resolving somewhat one week later.  Follow-up attempts are completed. No further information is expected.
5/27 This is a 49y.o. male here for dysphagia and point toward throat - he was agreeable to try a quick EGD to rule out esophageal etiology. There are no active hospital problems to display for this patient.
Approximately 1 - 2 hours after receiving I had numbess and soreness to my neck.  A few days later  started experiencing tingling, buzzing, weakness and heaviness to my right arm and leg.  I reported this to my MS doctor who ordered an MRI of the brain and told me to report to you
On 5/17/2013 rec'd Prevnar, Dtap and Hib as well as oral Rotateq. See OU 05/24/2013. Parents reported after vaccines at sites of injections skin colored rash c/w folliculitis diagnosis. No hives no respiratory distress.
Osteoporosis after receiving  1st dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of osteoporosis in a elderly female patient who received Herpes zoster (Shingrix) (batch number 9AB33, expiry date 6th December 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced osteoporosis. The patient was treated with denosumab (Prolia). On an unknown date, the outcome of the osteoporosis was unknown.   It was unknown if the reporter considered the osteoporosis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was reported. The patient started taking Prolia for osteoporosis after receiving the first dose of Shingrix. The reporter consented to follow up. This case has been linked to the case US2020002529, reported by same reporter.
neuropathy; lymphadenopathy; muscle weakness; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team and a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose:, Unknown manufacturer), for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "recovered", described as "neuropathy"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymphadenopathy"; MUSCULAR WEAKNESS (non-serious), outcome "recovered", described as "muscle weakness". The patient reported experiencing extensive lymphadenopathy and neuropathy, muscle weakness after dose two which lasted 3 months.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA308762, 2018SA308765, 2018SA308766 and 2018SA308767 (same reporter). This case involves a 56 years old patient (gender unspecified) who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE lot UJ029AB via intramuscular route instead of FLUZONE QUADRIVALENT on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and accidental overdose. It was not reported whether the patient experienced any adverse events or not. 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 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. List of documents held by sender: none.
General Flu-Like symptoms: Except for headache, lasted until 12 pm following day when I took a meloxicam. Now much better. Symptoms: headache, muscle ache, light fever, chills, light headedness, lack of energy.
A 70 year old female patient has been receiving OncoTICE a "maintenance" series of one instillation per month for 3 months, intermittently.  When seen on 05/27/2003, 20 days after her last instillation, her labia were very blistered, with open lesions near the labia, on the external skin.  Her treating physician has diagnosed her condition as a "delayed hypersensitivity reaction".  Patient is being treated with Levaquin, Diflucan, and a third (unnamed) medication; the lesions are now resolving.
patient given Pfizer gray cap 12yr+ vaccine instead of Pfizer orange cap 5-11yr vaccine. Observed patient for 30 minutes, no side effects or adverse event.
vertigo twelve hours after receiving the first shot and it lasted about ten hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: VERTIGO (non-serious), outcome "recovered", described as "vertigo twelve hours after receiving the first shot and it lasted about ten hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported with warmth and a rash near the injection site about 5 minutes after receiving vaccination.  Patient was given some water and Benadryl and asked to stay for an additional 10 minutes.  After the additional time was up the patient had no further rash or symptoms and left the pharmacy.  We told her to contact us if any additional symptoms occurred.
ABOUT 5:00PM ON 11/6 BECAME CHILLED AND WEAK,  ABOUT 4:00AM ON 11/7 ON TRIP TO THE BATHROOM HAD TROUBLE STANDING AND EXTREME NAUSEA,  8:00AM ON 11/7 JUST SLIGHTLY WEAK AND IMPROVING.  NO TREATMENT OCCURRED FOR THE REACTION.  REPORTED REACTION TO THE PHARMACY WHO WILL REPORT TO MY DOCTOR AND DISCUSS PLAN FOR THE 2ND SHOT.
3JUN91-MMR given-36 hrs later. Rash in face. 5JUN91-face swollen, red & flat rash. T 102 called MD. 6JUN91 Rash all over body--Also c/o of sore throat. refused to go to MD. 7JUN91-rash diminishing-feeling better.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Jan-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Jan-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2022 at 1:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jan-2022 at 1:59 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's Ethnicity was reported. No concomitant medications information was reported. No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Soreness at injection site; injection site which she said was her hip; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced injection site soreness after the dose of Shingrix. The reporter mentioned that the injection site was hip and the patient moved when she was injected and she beleived that, this was why she experienced pain. As per the patient, the injection was given on hip instead of deltoid, which led to vaccine administration at inappropriate site. The reporter did not consent to follow up.
I have pain all over; my arms are burning, my legs are burning, my skin hurts.; illness; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (my arms are burning, my legs are burning, my skin hurts.), ILLNESS (illness) and MYALGIA (I have pain all over) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Degenerative arthritis peripheral joint. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.   On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced BURNING SENSATION (my arms are burning, my legs are burning, my skin hurts.) and ILLNESS (illness). On an unknown date, the patient experienced MYALGIA (I have pain all over). At the time of the report, BURNING SENSATION (my arms are burning, my legs are burning, my skin hurts.), ILLNESS (illness) and MYALGIA (I have pain all over) outcome was unknown.            Action Taken of the Drug mRNA-1273  (COVID 19 VACCINE MODERNA) of associated  with the event was Not Applicable Treatment medication information  was not provided  by the reporter Patient could not sleep. patient was drenched herself in alcohol. Is like a burning.     This case was linked to MOD-2021-261513 (Patient Link).
Initial report received 17 February 2009 from a health care professional. A 27-year-old female patient had received an injection of FLUZONE (lot number, route and site of administration not reported) on 16 February 2009 and one day later, she developed a swollen arm, a golf ball size know and a "reddened fleshy part of her arm". The patient's recovery status was unknown. No additional information was provided at the time of the report.
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 10:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 10:54 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 32.41.  No concomitant medication was reported by reporter.  On 27-Apr--2021, Excursion time was 9 AM, temp was 35, total doses given for the day was 42, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 19-APR-2021, vial was moved to clinic on 27-APR-2021. Vaccine BUD date was 19-MAY-2021.Number of vials sent to clinic was 8 .   It was reported that patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vial was punctured right before administration.   No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
tremendous headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (tremendous headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 014M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGGRENOX) for Clot blood, LUBIPROSTONE (AMITIZA), ACETYLSALICYLIC ACID (BABY ASPIRIN) and PRAVASTATIN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (tremendous headache). The patient was treated with ACETAMINOPHEN at a dose of morning. At the time of the report, HEADACHE (tremendous headache) outcome was unknown.
Patient was given the childhood dose of pfizer 5 - 11 year old dose. She recently turned 12.
Low grade constant 24:7 head ache on right side if forehead. Began within 24 hours of vaccine. Going on  21 days. Difficult to sleep with pain. If I?m active It masks the pain and I do not  notice it as much. But when I stop an activity iand just sitting or lying down , the pain is must prevalent.
Fever, chills, body aches. Fever would break during sleep and come back by 3 pm next day for five days straight
COVID 19 (MODERNA) 1ST dose AdministeRed 4/20/21 PT Asked to SiT & wait 10-15 min After Vaccine. Within 5 min PT SlumpeD oveR iN ChAiR. Went to AssEss, Eyes opEN, Sweating distant glaRE for few min, 9-1-1 cAllED, pt becAme AleRT ASking WhAT hAppened in a few min - unawaRe of whAT hAppened
7cmx6cm erythematous macular reaction right upper anterior thigh (no cellulitis).
Redness expanding in two inch circumference around injection site, soreness, hard lump under skin, fever, injection site sensitive to touch.
Information has been received from a registered nurse concerning an 8 year old healthy female who on 02-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) instead of a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient was supposed to receive second dose of varicella virus vaccine live (Oka/Merck) (MSD) and received her first dose of vaccine when she was 2 years old. It was reported that the nurse was in rush and did not read the vial correctly. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated that the patient was vaccinated with wrong by mistake. The doctor had checked her and there were no ill effects. Follow up information that the reporter interpreted the difference in potencies of zoster vaccine live (Oka/Merck)and varicella virus vaccine live (Oka/Merck) to be overdose and did not recall an overdose in the amount of zoster vaccine live administered. Additional information has been requested.
This event applies to three separate people - same event, same day, same description.  Other individuals: DOB:  4-25-2000  AND;  DOB: 3-31-1987 Same immunization, same manufacturer, same lot number.   "Vaccinator was giving the patient him/her second dose of the vaccine and said the plunger of the syringe malfunctioned and the needle retracted into the syringe before the entire dose was given. this resulted in vaccine spilling out onto the outside of the patient's arm. vaccinator was informed by team lead to give the patient another dose in order to be sure pt receives the entire dose, per CDC guidelines. a full dose was then given without malfunction. VanishPoint syringes was used. "
Scalp started itching along with small bumps in May and have continued nonstop since then. No change in shampoo, conditioner or other hair care products.
Small rash on his arm; Fever; Really bad chills; Small rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small rash on his arm), PYREXIA (Fever), CHILLS (Really bad chills) and VACCINATION SITE RASH (Small rash at the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Small rash on his arm), PYREXIA (Fever), CHILLS (Really bad chills) and VACCINATION SITE RASH (Small rash at the injection site). At the time of the report, RASH (Small rash on his arm), PYREXIA (Fever), CHILLS (Really bad chills) and VACCINATION SITE RASH (Small rash at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102F, 101.3 (High) 101.3F and 100.2 (High) 100.2.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-216618 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-JUN-2021, contains reporter information(middle name), patient age, vaccination details (start date of both first and second dose), events (chills, rash), updated action taken. On 18-Jun-2021: Follow-up information received on 18-Jun-2021 contains updated laboratory details.