chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site red/swollen/weeping pus/scabbed over. Arm sore.
Jynneos dose was administered intramuscularly instead of subcutaneously; Case reference number US-BN-2022-001812 is a spontaneous case report initially received from a pharmacist via agency (reference number: USBAV22-0884) on 09-Aug-2022 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided) intramuscularly (IM), at an unknown dose or site of administration, for unknown indication (explicitly coded as 'Inappropriate route of vaccination').  At the time of this report, it was unknown whether the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 09-Aug-2022 included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Patient reported intermittent chest pain and numbness in her extremities that began approximately 12 hours after receiving the vaccine and ceased after 24 hours.
Rash on hands and feet.  Itchy.  "Looks like hives" per patient.  No SOB, swelling, DIB, CP.
warm to touch; Redness the size of a sliver dollar on arm of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE ERYTHEMA (Redness the size of a sliver dollar on arm of the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 03-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE ERYTHEMA (Redness the size of a sliver dollar on arm of the injection site). At the time of the report, VACCINATION SITE WARMTH (warm to touch) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness the size of a sliver dollar on arm of the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Developed paroxysmal tachycardia approximately 4 hours after Hepatitis B vaccine and Typhoid vaccine.  This lasted 1 1/2 hours and self-resolved.  She still went to the ER and was given a one-time dose of Lopressor.  She has been well since, with no recurrence.
Infant with rash on both legs. Fever and vomiting within 12 hours of receiving vaccines. T max 102 degrees F.
Cellulitis; treated with Keflex 500mg bid X 7 days.
Client has sx of fever, sinus congestion, & facial edema, (L) side of face. She states congestion started almost immediately after receiving FLUMIST. She states that she has been seen by her dentist, but sx were not related to dental problems. She has been referred to PMD.
None- vaccine given 12 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for an unknown indication.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-395985 (Patient Link).
IPOL vaccine was administered to a patient who was suppossed to get an ActHIB; Initial information received on 16-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 5 months old male patient who received vaccines HIB (PRP/T) VACCINE [ACT-HIB] and IPV (VERO) [IPOL] and Ipol vaccine was administered to a patient who was suppossed to get an ActHib.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  On 14-May-2019, the patient received a dose of suspect IPV (VERO) lot P1A242M and expiry date: 26-Apr-2020 via unknown route in unknown administration site.  It was a case of actual medication error due to wrong vaccine administered.  It was unknown if the patient had any 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 Directive and Module VI of the 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.
Pt has appointment on 8/26/22 ran ystem for his appt and notice that the wrong vaccine was given at his 11 yr well child
a 39 year old woman who got blood clots from the vaccine and died; This is a spontaneous report from a contactable consumer or other non hcp received from a Regulatory Authority. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection; Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient who got blood clots from the vaccine and died. It was reported that patient had no history that got blood clots after receiving the Pfizer Covid vaccine and died. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: a 39 year old woman who got blood clots from the vaccine and died
seen in ER 3MAR97;seemed in pain, grabbed belly, then eyes rolled back;no LOC, out of it for <1min;to ER where was fine, observed & released;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain and touch sensitivity increased. On an unknown date, the outcome of the injection site pain and touch sensitivity increased were not recovered/not resolved. The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the touch sensitivity increased to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid over a month ago in 2018 but did not recall the exact date. The patient was still experiencing extreme pain at the injection site when touched. The whole arm, especially the shoulder area was sensitive. The patient visited her physician 2 days ago because of the pain. The patient did an X-ray which came back normal. The patient stated the pharmacy had previously reported the adverse event which told her someone would call her.
On Tuesday morning ( the day after the vaccine ) all of my joints ached badly & I had a bad headache. I also had little energy. The  day after that- I was feeling better. I still had a slight headache. Then on Saturday January 30th- I had a severe rash on my back & chest-that looked like sun burn . On Sunday January 31st I went to Hopital .The doctor confirmed my rash was due to the covid shot.
Patient feeling burning (sunburn) sensation on right arm/armpit. No rash. Left arm where shot was given is fine. MD started VALTREX therapy.
Client came by to receive the Bivalent booster made by Moderna. They received the monovalent booster in error. The client has been notified, waiting on call back to consult.Contributing factors include high volume, similarities between the two packages, improper workflow by the pharmacist, and storage of the two similar medications directly next to each other.
Patient felt warm, increased heart rate, chest tightness, nausea 10 minutes after receiving vaccine
This case was reported by a healthcare professional and described the occurrence of accidental overdose in a 4-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), ENGERIX B pediatric. On 5 June 2014 the subject received unspecified dose of PEDIARIX (unknown route and injection site) and unspecified dose of ENGERIX B pediatric (unknown route and injection site) which led to an accidental overdose of Hepatitis B.
really itchy rash all over their chest/shoulders/back/ left arm; swelling on both legs from mid-calf down to toes; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (really itchy rash all over their chest/shoulders/back/ left arm) and SWELLING (swelling on both legs from mid-calf down to toes) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (really itchy rash all over their chest/shoulders/back/ left arm) and SWELLING (swelling on both legs from mid-calf down to toes). At the time of the report, RASH PRURITIC (really itchy rash all over their chest/shoulders/back/ left arm) and SWELLING (swelling on both legs from mid-calf down to toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products - Thyroid pill and high blood pressure pill Treatment medications include Kenalog shot and night time itch pill   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up received on 12-may 2021 and contains no new information
Large area of erythema & swelling from shoulder to elbow on left arm.  Began with 24 hours of administration of vaccine.  Remained swollen and red for 5 days.
Swelling under left arm; Limited range of motion; Rotator cuff tendonitis, left; Acute pain of both shoulders; Fatigue; Achiness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swelling under left arm), MOBILITY DECREASED (Limited range of motion), PAIN (Achiness), ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left) and ARTHRALGIA (Acute pain of both shoulders) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Grass allergy, Pollen allergy, Allergy to plants (Pine), Allergy to animals (Rabbit hair), Allergic to cats, Hypothyroidism since 19-Jul-2017, Seasonal allergic rhinitis (Acute) and Hypercholesterolemia since 19-Jul-2017. Concomitant products included CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC-D) for Allergy, BUPROPION from 09-Dec-2020 to an unknown date for Depression, ATORVASTATIN from 17-Jul-2017 to an unknown date for Hypercholesteremia, LEVOTHYROXINE from 17-Jul-2017 to an unknown date for Hypothyroidism, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 17-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Achiness) and FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling under left arm), MOBILITY DECREASED (Limited range of motion) and ARTHRALGIA (Acute pain of both shoulders). 19-Feb-2021, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form; ACETAMINOPHEN at a dose of 1 dosage form; Physical therapy (Exercises daily) for Mobility decreased; Physical therapy for Rotator cuff syndrome and Physical therapy for Arthralgia. On 21-Feb-2021, PERIPHERAL SWELLING (Swelling under left arm) had resolved. At the time of the report, MOBILITY DECREASED (Limited range of motion) was resolving, PAIN (Achiness) and FATIGUE (Fatigue) outcome was unknown and ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left) and ARTHRALGIA (Acute pain of both shoulders) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Additional information received on 05-Jun-2021 had updated patient details, other relevant history. Added concomitant and treatment medications. Added second dose details of a patient. Added new events fatigue, pain, rotator cuff tendonitis of the left shoulder. Updated the time of first dose.
From an initial report received on 01/04/2001, it was reported an 18 year old female pt received Menomune on 11/09/2000. "Meningitis left arm around 2pm 11/09/2000 and at 4:30pm experienced sharp back and left arm pain. Also muscular aching. Pain in lower back worse by 8pm. Called police station and they advised she go to ER. Gave Benadryl and Ibuprofen at 11:30pm. Felt better by 12:30am. Next day sluggish, but better and feels 95% with slight backache."
A nurse reported that a 50 year old female received an injection of Flu shield on 12/10/2001. The next day, she developed fever, chills and generalized body aches which persisted for 3 days.
The information has been received from a literature article below which stating as: We identified a male surgeon with HBV infection and a high viral load (HBeAg positive) during evaluation of a needle-stick injury. Herein we report the results of an investigation of patients who had undergone operative procedures by the surgeon to evaluate potential provider-to-patient HBV transmission. In 2009, a surgeon was identified as being unknowingly and asymptomatically infected with HBV following baseline evaluation during an exposure workup. Laboratory results included a positive B surface antigen (HBsAg), positive HBeAg, negative immunoglobulin M (IgM) anti-hepatitis B core antibody (anti-HBc), and normal liver enzymes. The source patient of the exposure had negative HBV serology (HBsAg and antiHBc) results. The surgeon was removed from performing operative procedures after testing revealed a viral load of > 17.9 million IU/mL (Versant HBV bDNA 3.0 assay, Siemens Healthcare Diagnostics) while an investigation of potentially exposed patients was conducted. The surgeon completed orthopedic residency training before being employed by Facility A. Having previously completed 2 hepatitis B (manufacturer unknown) vaccination series without achieving a protective level of hepatitis B surface antibody (anti-HBs >= 10 IU/L), the provider declined further vaccination upon hire at Facility A. No additional evaluation of nonresponder status (ie, testing for the presence of HBsAg) had been performed prior to the tome of the needle-stick injury. A retrospective cohort study was conducted to Facility A to determine whether the surgeon had transmitted HBV to patients. On the basis of all available evidence, surgeon-to-patient transmission of HBV appears to be a rare event. However, our understanding of the epidemiology is limited owing tot the lack of a systematic surveillance and reporting systems. Therefore, healthcare facilities should assess their employee vaccination, blood and body fluid exposure, and infected provider oversight programs to ensure that they are sufficiently robust to identify healthcare workers with chronic HBV infection and that HBV-infected healthcare workers are evaluated and monitored appropriately. These measures are crucial to minimize the risk of HBV transmission to patients and help prevent the serious sequelae of chronic liver disease. Additional information has been requested.
The age is 12 years old, and the patient was given the kids dose for ages 5-11
Extra Boostrix and Menveo administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Boostrix (received 1st dose on 9th November 2022) and Menveo (received 1st dose on 9th November 2022).   On 02-MAY-2023, the patient received the 2nd dose of Boostrix and the 2nd dose of Menveo. On 02-MAY-2023, an unknown time after receiving Boostrix and Menveo, the patient experienced extra dose administered (Verbatim: Extra Boostrix and Menveo administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 Reporter's Comment: The nurse practitioner reported that the patient accidentally received a dose of Boostrix and Menveo, which led to extra dose administered. The reporter wished to ask how to proceed. The reporter only had information about the patient and vaccination date. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Information has been received from a physician concerning  a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient developed severe fatigue. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Shot given approx. 0800. Patient began to have "moderate" itching from "Head to Knee's." No c/o SOB, no rash. This "comes and goes, and is not becoming worse." She has been "itching" before and has taken BENADRYL. "Itching" started approx. 1100. Patient left at 1605. Verbal understanding to seek medical help if sx's do not go away, and or increase in severity.
A little over a week after my second dose, I developed very sharp pain shooting down my left arm and on my shoulder and chest area. My hand falls asleep regularly. I went to the urgent care just to ensure it wasn't heart related and I was assured it was not and the doctor recommended I see a Neurologist. I have an appointment, however I cannot be seen until 8/9/2021 because I am a new patient. So for now I am struggling with how to function every day with this pain and numbness.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 72 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "prostate cancer", start date: 2014 (unspecified if ongoing), notes: prostate cancer s/p treatment and cure (2014); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Feb2019; FEXOFENADINE, start date: Feb2019; SERTRALINE, start date: Oct2018; TERBINAFINE, start date: Oct2021. Past drug history included: Chlorhexidine, reaction(s): "Known allergies: Chlorhexidine".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood cholesterol: High; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 05Jun2022 to10Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
lump in throat , difficulty swallowing's. Treated with  EPi and obsevation.
0.5 mL was administered, should have been 0.25 mL for booster dose
headache; This is a spontaneous report from a Pfizer-sponsored program. Two contactable consumers reported for a female patient (one of the reporter was reporter's mom) of an unspecified age received first dose BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 Immunisation. Patient medical history and concomitant medications were not reported. It was told her mom got the vaccine on an unspecified date and reported last she was asking if her mom could take Tylenol, penitent experienced headache on an unspecified date. Outcome of event was unknown.  Information on Lot/Batch has been requested.
Macular rash on face, neck and trunk. No Koplik spot. Child had MMR 2 weeks ago.