chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 77 years old male patient who received vaccine FLUBLOK QIV instead of vaccine FLUZONE HIGH DOSE. The patient's past medical history, concomitant medication and family history were not provided. On 07-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number, expiry date not reported via unknown route in the right arm instead of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported. It was an actual medication error due to wrong vaccine administered. It was reported that patient received FLUBLOK, but he wanted to get to receive FLUZONE HIGH DOSE, a nurse administered to him. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Information has been received from a medical assistant concerning a female with no medical history and no drug reactions/allergies, who on 14-MAR-2008 was vaccinated with her first dose of GARDASIL (lot# unspecified). It was reported that 30 minutes after vaccination the patient had rash. Unspecified medical attention was sought by contacting physician. At the time of this report the patient was still recovering from her experience. No other information was available. Additional information has been requested.
Diagnosed with COVID-19 about 4 weeks after first dose of Moderna vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Diagnosed with COVID-19 about 4 weeks after first dose of Moderna vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE, BISOPROLOL, AMLODIPINE and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.    On 08-Mar-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 SARS-COV-2 TEST POSITIVE (Diagnosed with COVID-19 about 4 weeks after first dose of Moderna vaccine). The patient was treated with PREDNISOLONE for COVID-19, at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Diagnosed with COVID-19 about 4 weeks after first dose of Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.
Urticaria at injection site (R) thigh noted shortly after vaccines given. "BENADRYL given". Rash was resolving by time baby left clinic.
Fever; Flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (unknown manufacturer; Lot Number was not reported) as single dose and influenza vaccine at an unspecified dose and frequency; both via unspecified routes of administration, in Oct2020, for immunization. The patient's medical history included being allergic to penicillin with reaction including hives from 1985 (last time she had it); and high blood pressure, overweight, and fatty liver, all three were ongoing. The patient's concomitant medications were not reported. The patient had the flu and pneumonia vaccine in Oct2020 (last October) and she had fever and flu like symptoms on an unspecified date then it went away. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.
INCOMPLETE DOSE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced incomplete dose administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incomplete dose administered and off label use was not reported. This report was non-serious.
Case number PHHY2011IN44349 is an initial literature report received on 24 May 2011. The authors discussed a rare case of calf muscle injury due to dog bite leading to deep vein thrombosis. This report refers to a 32 year old man presented with a history of unprovoked bite by a stray dog causing a penetrating, lacerated wound on his right calf and thigh, and bleeding from the site of wound. He was treated with local antiseptic and was vaccinated with rabies virus vaccine (manufacturer and batch number: unknown). Two days later, the patient experienced a swelling of the right calf which was ignored. Over the next 10 days, the swelling worsened and progressed from the calf to the thigh and was associated with pain in the right leg while walking. He also had acute onset of breathlessness, uneasiness, restlessness, palpitations and intolerable pain in the right leg for which he was hospitalized. On examination, the patient was restless and writhing in pain. His vital parameters were normal except for tachycardia and tachypnoea. No other abnormality was found on chest and cardiovascular examination. Local examination revealed swelling and tenderness over the right calf and thigh. Pratt sign and the Homan's test were positive. A differential diagnosis of deep vein thrombosis (DVT) with pulmonary embolism and cellulitis with septicemia were made. The patient was investigated and a Doppler of the right leg showed total occlusion of the right common femoral vein below the saphno-femoral junction by a thrombus with partial occlusion above the junction. His D-dimer level was 5131 ng/ml which was significantly raised. no evidence of pulmonary embolism was found on further investigations. The patient was treated with low molecular weight heparin and then shifted over to oral warfarin after overlapping the treatment for 4 days. The pain, swelling and dyspnoea improved during hospital stay and he was discharged with a target international normalized ratio (INR) between 2 and 3. On follow up, his symptoms, prothrombin time (PT) and INR were monitored. No contributory thrombophilic factors (cardiolipin antibody, C-reactive protein, lupus anticoagulant, factor V Leiden, anti-thrombin, antinuclear antibody (ANA), protein C and protein S) were found during the 6 months post-injury examinations. The author commented that the patient's only identifiable major thrombotic risk factor was the traumatic injury due to the dog bite.
Alerted by vaccination RN at 12:01 PM that the first 8 doses administered of the day had been given in insufficient amount. The RN stated she realized with the last patient of the morning (receiving dose #9) that the syringe was not the 3mL syringe she was used to using, and was in fact a 1mL insulin syringe. She noted that she had been drawing up the vaccine up to 5 (meaning 5 unit, equivalent to 0.05mL) rather than to 50u to give the full dose (0.5mL).  She stated she recognized her error with patient #9 and administered the correct amount (0.5mL) from a 3mL syringe she was used to using.  In addition to contacting COVID-19 provider, the patient was attempted to be contacted, but did not provide a phone number. Viewing the vaccination information for the patient, this RN noted the first dose of Moderna was given by A Community Health Clinic. A call was made to the clinic to see if the patient's contact number is available or if the vax clinic contact information could be passed on. A VM was left but a follow-up phone call will be made 5/19 in the AM. If the patient cannot be reached using this method, a letter will be written informing of the incident and requesting a callback to schedule an appointment to readminister the booster dose.  At the end of the day, when counting dose administered and factoring in the estimated amount of vaccine wasted due to insufficient dosages, there was just under 9 doses accounted for. The vaccinating RN was questioned again to see if there was any possibility any of the initial 8 patients received a full dose of the vaccine without her realizing it. She stated she did not believe she ever drew up the 1mL syringe to 50u nor administered a 0.5mL dose using the 3mL syringe, though she stated she couldn't say for sure. She said the container holding the syringes had each type divided in one compartment and separated from each other. The COVID-19 provider was informed of this information and additional guidance was requested.
An expired Ipol was asministered to the patient, no AE; Initial information received on 16-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 20 months old female patient who was vaccinated with an expired 0.5 mL dose (4th dose) of IPV (VERO) [IPOL] (lot P1A251M and expiry date: 02-May-2020) via an intramuscular route in the left thigh on 16-Jun-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation.  It was an actual medication error case due to expired vaccine used.  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.
Mom called stating patient's body was covered with little tiny red bumps 7 days after immunization was given. No blistery, no itchy. 2 days following rash, she became feverish of 102, then resolved.
pt recv vax 3AUG98 & became weak & was adm to hosp 18AUG98 w/dx of GBS;
Co-Lead Ancillary alerted Lead RN over waki taki at 13:25 that a mother and her minor daughter were on site so the minor could receive her 2nd dose of Moderna vaccine.   The minor had received her first Moderna dose on 04/20/21 at another facility.  Lead RN check-in RN to assist mother and minor once they had completed the check-in process and came upstairs to be vaccinated.  Once upstairs, Check-in RN escorted minor and mother to an RN vaccination station so the minor could receive the vaccine.  RN performed verification procedures regarding minors who are accompanied by a parent and reviewed the minor?s vaccination card to confirm the minor had been vaccinated inappropriately on 04/20/21.  The minor had received Moderna dose #1 COVID vaccine, Lot# 001C21A.  Lead RN confirmed it was appropriate for the minor to receive the 2nd dose of Moderna to complete the series, per CDC Guidelines. RN vaccinator educated the minor and her mother regarding Moderna's suggested application of 18 years and older only.  RN vaccinator then confirmed with the minor and mother that the minor had not experienced any type of adverse reaction to the first dose.  The minor and her mother also denied the minor having any significant medical history, current medications, supplements, or allergies. The minor and mother verbalized understanding and expressed a desire to proceed with the second vaccination.  RN vaccinator reinforced to the minor and her mother to please stay for the full 15 minutes in the observation area, and explained that both a VAERS and VERP report would be submitted to document the incident of the minor receiving Moderna as an unauthorized age group. The minor received Moderna vaccination #2 lot# 027C21A at 13:39. Minor and mother proceeded to the observation room at 13:43.  Lead RN checked on minor client in the observation room at 14:00 where both the minor and her mother denied any side effects and left the observation room.  Lead RN observed the minor was ambulating independently with a steady, even gait, with when exiting with her mother.
Started at 2am muscle and joint aches, continued through out the day and took IBUPROFEN and Tylenol to treat every 4 hours. Fatigue and exhaustion took 3 hour nap. Mild nausea off and on all day.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding to the patients' medical history, concurrent condition and concomitant medication was not reported. On unknown dates in 2016 (reported as since 01-JAN-2016), the patients were vaccinated with improperly stored doses of ROTATEQ (orally, dose was not reported, lot# 004466 with expiration date of 02-AUG-2016 and lot# reported as L029615 with expiration date of 15-MAY-2017). No adverse effects had been reported. The oral, ROTATEQ vaccines underwent a temperature excursion of -3 Celsius degrees for 19 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Red, swollen, warm to the touch injection site; Red, swollen, warm to the touch injection site; Red, swollen, warm to the touch injection site; Injection site with pain and itching; Injection site with pain and itching; Administration date 18Nov2021; dose received =3; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33026BD) via an unspecified route of administration in the right arm on 18Nov2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included clotting disorder and hypertension. 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 received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GN6197) via an unspecified route of administration in the right arm on an unknown date in 08Mar2021 (at the age of 62-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient previously took butorphanol tartrate (STADOL) and erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 21Nov2021, the patient experienced red, swollen, warm to the touch, injection site with pain and itching. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events red, swollen, warm to the touch, injection site with pain and itching which included treatment with unspecified antihistamines, paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN) on an unknown date in 2021. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red, swollen, warm to the touch injection site and injection site with pain and itching was recovering at the time of this report.
24 hrs post injection pain, itchiness, swelling, fatigue, redness noted L arm.
16 hours post shot was woken by severe throbbing pain at injection site and general flu symptoms. Transient low grade fever. Symptoms largely better after 24 hours from onset (roughly 36 hours after shot). 3 days post arm still sore (but better) but injection site still red, warm, and slightly swollen. Slight globus sensation in throat
soreness; chills; fever; sweat; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8732) via an unspecified route of administration in the right arm on 05Apr2021 at 10:30(at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 15Mar2021 at 16:00 for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 09:00, the patient experienced chills, fever, sweat and soreness. The patient did not receive any treatment for the adverse events. The clinical outcome of the events chills, fever, sweat and soreness were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recvd vax;screaming episode lasting 1 hr; apap given; cool wet compresses to rt thigh;
"A physician reported that a 2 month old female was vaccinated on 1/6/99 and 2 days later, she developed a generalized macular rash which resolved within 72 hours. From follow-up #1 information received on 01/19/00, additional patient and vaccine information was provided. From mailed follow-up #2 correspondence received on 05/31/01, it was stated that the patient recovered from this expereince. No further information is anticipated for this report. Case is closed.
Vaccine 4/7/21 PM  Dull ache in vaccine arm begins 4/13/21 AM Dull ache mostly subsides by 4/14/21 AM Red raised itchy rash at injection site begins 4/15/21 PM
Nodule at injection site, purple discolored band approximately 13 cm wide covering anterior/lateral upper arm. Mild tenderness of left upper arm pt. C/O ache/dull pain L shoulder and left upper arm and L forearm.
Patient presented to the ED on 3/29/21 for epigastric and chest pain. Patient presented to the ED on 4/22/21 with common bile duct stone and was admitted to the hospital.
Tinnitus in both ears 9 days after 1st vaccine.  Going on for 30 days straight
At the clinic today had who suffered an adverse reaction. When she came in for the vaccine she was extremely nervous due to a hatred for needles. She got the vaccine and within 5 minutes she turned red and her blood pressure sky rocketed to 203/104. She had no difficulty breathing, no rash, just flushed skin and high blood pressure. Her pulse was also elevated to 103. Due to, the ambulance was called. She expressed her wish to not go to the hospital multiple times due to being afraid of missing work and hating the hospitals. By the time the ambulance came her blood pressure was 203/104 with a pulse of 104. Her pulse ox remained at 98 on room air.  From the minute she felt ill to the minute they left made sure she was breathing ok and showed no signs of anaphylactic shock. She had a history of panic attacks and GERD, with no blood pressure problems. She did also report an allergy to latex and penicillin prior to the vaccination. All products again were double checked to show her they were latex free. Patients blood pressure decreased at the hospital and was discharged with directions to follow up with her primary. They stated they aren't sure why her blood pressure increased so high.
I have never had fever blisters until June 1,2016 when I developed a fever blister. Not once in 60 years have I had this problem, the only change is the ZOSTAVAX.
Breakthrough case admission after 3 vaccines Pfizer 3/4/21 Lot# EN6202;  Pfizer 3/25/21 Lot# ER8727;  Pfizer 12/10/21 Lot# FH8028
Patient has pain on her right arm . Based on history it shows vaccine was left arm. She has complain of having soreness /pain. She states she cannot move her arm seen her pcp, her doctor things might be given on her wrong spot. Patient is seeing her orthopedic   on 08/29/2023
This spontaneous report was received from healthcare professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-MAR-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L03106, expiration date: 18-AUG-2017, (dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. Also was reported that the time frame of the excursion of VARIVAX (Merck) was 4 hours and the vaccine had not had a previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested.
5/2-darkening vision, visual disturbances, nausea, chills at night  5/3-7/31- feeling of passing out, hot flashes, vertigo, darkened vision, visual disturbances   8/1- today -chronic migraines (pounding pain on left side of head front and back affected by light, noise, motion as well as continued visual disturbances and darkening vision)
W/in 24hrs p/recvd vax pt devel fever of 100 to 101F, redness & swelling @ inject site & was described as lethargic & limp; sx improved 24hrs later & subsequently recovered; No further details were provided;
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 04-DEC-2015 at time- 02:07, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.7 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Rash on injection arm; Redness on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on injection arm) and VACCINATION SITE ERYTHEMA (Redness on injection arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) 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 04-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash on injection arm) and VACCINATION SITE ERYTHEMA (Redness on injection arm). At the time of the report, VACCINATION SITE RASH (Rash on injection arm) and VACCINATION SITE ERYTHEMA (Redness on injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications not provided.
On 3/7/03, in the office, pt had red and swollen right deltoid (4 1/2" X 3 3/4"). No temperature. Treated with Tylenol and Benadryl.