chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: swelling of knot in arm around injection site, 8 days after injection. Also radiating heat, area very warm.-Severe, Additional Details: Patient has full mobility in arm
on 4/16/21 (event reported): severe chest pain, shortness of breath, lightheadedness   previously, on 4/14: fever, aches, chills, congestion, limited to eight hours
Erythematous raised rash around injection site on Upper L thigh, non tender no warmths no edema.
6-25-21 with first dose/  second dose was administered today (07/16/21); This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number DS754, expiry date 18th December 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 16th July 2021, the patient received the 2nd dose of Shingrix. On 16th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional case details were reported as follows: The Shingrix 1st dose received in 25th June 2021, batch number 5454X and Expiration date was 25th October 2022.  Health care professional reported regarding a patient vaccinated 2nd dose of Shingrix, on the day of reporting that was later than recommended schedule which led to shortening of vaccination schedule. The reporter consented to follow up.
Pain at injection site  3+ months, Constantly tired and lower energy, Stiffness and achy joints.
Narrative:  72yo male patient residing at REHAB with the following problem list: M13.0 Polyarthritis (SCT 416956002) K21.9 Gastroesophageal reflux disease without esophagitis (SCT 266435005) K59.04 Chronic constipation (SCT 236069009) K63.5 Polyp of colon (SCT 68496003) E929.0 Late Effects of Motor Vehicle Accident (ICD-9-CM E929.0) I65.21 Right carotid artery stenosis (SCT 285201000119100) V71.89 Observation for other specified suspected Condition (ICD-9-CM V71.89) R06.00 Dyspnea (SCT 267036007) 786.7 Abnormal chest sounds (ICD-9-CM 786.7) N18.6 Dependence on hemodialysis due to end stage renal disease (SCT 428982002) 443.1 Thromboangiitis Obliterans (ICD-9-CM 443.1) V56.0 Hemodialysis (ICD-9-CM V56.0) 780.6 Fever (ICD-9-CM 780.6) N18.6 End stage renal disease (SCT 46177005) V42.0 Kidney Transplantation (ICD-9-CM V42.0) I10. Benign essential hypertension (SCT 1201005) Z72.0 Tobacco user (SCT 110483000 ALso per mD note:ESRD : On dialysis Monday Wednesday and Friday and seemed to be stable. - Pericardial effusion: Not new we will go for pericardial window sometime soon. - Hypertension: Not new. - Hypothyroidism. - Status post pacemaker in place. -Anemia: Continue - Status post pacemaker placement. - GERD." "Pt died at rehab facility with no info given in cause of death. Pt had received covid vaccines on 1/26/21 & 2/23/21. Likely pt's death is not related to covid vaccines given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations.
Red Papular rash on chest, abdomen, back, anus, diaper area, lasted 3 days.  Fever - max 103.6, lasted for 3 days.  Symptoms began 8 days after immunizations.
This case was reported by a physician and described the occurrence of should discomfort in a 5-year-old male subject who was vaccinated with combined KINRIX (GlaxoSmithKline). On the afternoon of 9 December 2009 the subject received 1st dose of KINRIX at 0.5ml in the left arm. On 10 December 2009, at 07:00, the subject experienced shoulder discomfort, facial flushing and throat swelling. The subject was treated with Benadryl and Tylenol and shoulder discomfort and throat swelling improved. Facial swelling was unresolved at the time of reporting. The physician considered the events were probably related to vaccination with KINRIX.
Fever; Cold like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm right on 25Apr2021 at 00:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in Apr2021 the patient experienced fever and cold like symptoms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever and cold like symptoms was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Regulatory Authority deleted from Intermediary.
Became very tired evening of 2 October, on 3-4 October had low grade fever 101, severe body/joint aches, migraine and fatigue, 5 October moderate migraine, normal temperature, started getting congested, coughing/wheezing and sneezing. On 6 October had sever runny nose, nausea from drainage going into stomach, diarrhea, fatigue, bad headache, 101 temperature and followed up with Physician. They thought it was sinus infection or bacterial infection and told me to use OTC meds and put me on Azithromycin 250mg.  On 7 October mild headache, tired, mild cough and very nauseous. Feeling a little bit better.
This spontaneous report as received from a medical assistant (also reported as a nurse), referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # M027343 and expiration date on 01-JUN-2018, (dose and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent (MRK), used for reconstitution of the vaccine and which was properly stored. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (7.5°F), during a time frame of 35 minutes which was detected by the data logger. There was not prior temperature excursion and no adverse events were reported.
Pt reported receiving 1st Pfizer dose in September and was not in system when checked by another staff member prior to vaccine appointment. However, after the J&J vaccine was given on 11/23 when I went to document the Pfizer vaccine was listed and was not greater than 28d from the first shot, it was given on 11/10. So, he got a second shot too soon
Information has been received from a pharmacist concerning a patient who on 14-May-2008 and 04-JUN-2008 was vaccinated po with the first and second doses of ROTATEQ. It was reported that the patient did not experience any known symptoms. The outcome is unknown. Additional information has been requested.
Patient is not 18 and received a dose of Moderna today, Patient feels fine, I instructed the patient to call me with any development of symptoms, 60 days short of being 18
pt recv vax in lt arm; area immed got a nickel size bump w/surrounding redness approx 6" diameter area;
Flu-like symptoms started at 12 hours post injection of 2nd dose.; severe body aches; shivering; significant fatigue; This is a spontaneous report from a non-contactable physician (patient). A 37-year-old male patient started to received the second dose of bnt162b2 (COVID 19 vaccine, brand: Pfizer) lot no: EK9231, intramuscular in left arm on 06Jan2021 at single dose for COVID-19 immunization in a hospital. Medical history included asthma from an unknown date and unknown if ongoing. No known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2, lot no: EH9899, on 18Dec2020 intramuscularly in left arm for immunization. No other vaccines were administered in four weeks. The patient had no COVID-19 prior to vaccination was not tested for COVID-19 post vaccination.  The patient experienced flu-like symptoms started at 12 hours post injection of 2nd dose. Started with severe body aches, then shivering and significant fatigue. The patient improved only a little with paracetamol (TYLENOL). After 24 hours symptoms onset, symptoms mostly resolved. The adverse events were reported as non-serious. The patient recovered from the events.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a non-clinical-study-program from a contactable consumer. A 14-months-old male patient of an unspecified ethnicity received PREVNAR 13, on an unspecified date, via an unspecified route of administration. The patient medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The patient was hospitalized for two days. It was reported that the patient had received three doses of PREVNAR 13 at the time of the event. Therapeutic measures included antibiotics and albuterol. The patient recovered. Follow-up (18FEB2014): Follow-up attempts completed. No further information expected.
Fever, body aches, lump on arm, nausea, headache less than 24 hours, treated with meds
All over body chills; Fever; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 16:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Concomitant medications included magnesium (MANUFACTURER UNKNOWN), vitamin b (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), fish oil (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 31Mar2021 at 16:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 04:00, the patient experienced all over body chills, fever and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as the result of events. The clinical outcome of the events all over body chills, fever and headache were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
A covid vaccine vial was reconstituted twice, this patient received a diluted dose of the vaccine, the patient was contacted about the issue, and came into to be revaccinated today, 3/5/21.
Mid back pain; Itchy neck; 6-7 welts on the right arm where the vaccine was injected; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Mid back pain), PRURITUS (Itchy neck), VACCINATION SITE URTICARIA (6-7 welts on the right arm where the vaccine was injected) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced BACK PAIN (Mid back pain), PRURITUS (Itchy neck), VACCINATION SITE URTICARIA (6-7 welts on the right arm where the vaccine was injected) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) on 27-Jan-2021 for Pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Mid back pain), PRURITUS (Itchy neck), VACCINATION SITE URTICARIA (6-7 welts on the right arm where the vaccine was injected) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  events occured about an hour after receiving the vaccine and that the patient used Tylenol to try to alleviate the pain, but it did not work.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow-up information received on 10-Jul-2021, contains significant information. Updated event outcome as Recovered/Resolved.
Menveo MenA Lyophilized conjugate was mixed with sterile diluent instead of  MenCYW-135 liquid conjugate. Patient was given the invalid vaccine. Per mother patient did not have any symptoms from invalid vaccine.  Mother stated that patient will come back in to get valid vaccine.
Janssen COVID-19 Vaccine EUA: twelve days after vaccination patient presents to emergency department with a headache that started seven days prior to arrival. Patient describes headache as different than normal headaches: worse with movement and episodes of dizziness. Patient also has rash/redness on right cheek of the face. Vital signs within normal ranges except blood pressure 141/96 mmHg. Patient admitted to hospital for further testing and management.
This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced eye swelling (serious criteria hospitalization), pustule (serious criteria hospitalization) and allergic reaction (serious criteria hospitalization). On an unknown date, the outcome of the eye swelling and allergic reaction were unknown and the outcome of the pustule was recovering/resolving. It was unknown if the reporter considered the eye swelling, pustule and allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The reporter was patient's daughter. The age at vaccination was not reported. The patient received 2nd booster of SHINGRIX just a few weeks ago before the date of reporting. On 30th November 2018, the patient was hospitalized for pussy lesions on one side of his face and his eyes swelling shut. On 4th December 2018, the patient was released from hospital. The lesions has cleared up but not fully resolved.
Usually only 1-2/day BM's-now since HIB 4-5BM's/day; stools really loose & sometimes really runny; Green color; poor appetite; Cranky off & on; No fever;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, (lot # K009106, expiry date 25-FEB-2016) (dosing regimen, route and frequency unknown) that had been exposed to temperatures above 46 degrees Fahrenheit for an unspecified amount of time. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. There was no product quality issue reported. This case is linked to case 1410USA016183 via same reporter link. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender.  In approximately August 2015 (reported as since 06-AUG-2015), the patients had been administered doses of improperly stored GARDASIL lot # K011562, expiration date reported as 08-APR-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
PER MOM, PATIENT WITH AUTISM COMPLAINING OF ITCHING AND PAIN ON LEFT THIGH.  MOTHER NOTICED A SMALL RED AREA 24HOURS AFTER VACCINE ON LEFT THIGH ONLY (MENVEO).  DAY 2 HAS COMPLAINTS OF PAIN, INCREASED REDNESS, HARD AND WARM TO THE TOUCH.  DENIES FEVER.  THIS WAS THE FIRST TIME GETTING THE MENVEO.  EXAMINED BY DR ON 1/13/21.  AREA WARM TO THE TOUCH WITH SWELLING NOTED.  CURRENT MEASUREMENTS 13 X 9 CM WITH INDURATION.  TREATMENT PLAN:  TOPICAL HYDROCORTISONE AND BENADRYL.
needing to take naps during the day, never had the problem before; arm was sore, but stated it was normal (after second vaccine); Three days following the second vaccine he started feeling extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (needing to take naps during the day, never had the problem before), PAIN IN EXTREMITY (arm was sore, but stated it was normal (after second vaccine)) and FATIGUE (Three days following the second vaccine he started feeling extremely fatigued) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (needing to take naps during the day, never had the problem before), PAIN IN EXTREMITY (arm was sore, but stated it was normal (after second vaccine)) and FATIGUE (Three days following the second vaccine he started feeling extremely fatigued). At the time of the report, SOMNOLENCE (needing to take naps during the day, never had the problem before), PAIN IN EXTREMITY (arm was sore, but stated it was normal (after second vaccine)) and FATIGUE (Three days following the second vaccine he started feeling extremely fatigued) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.    This case was linked to MOD-2021-181920 (Patient Link).
Pt had chill like sx w/shaking of extremities. Gazed look w/eyes. sighing respirations some grunting 99 temp.
chills; headache; fatigue; pink rash on body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Mar2021 (Lot number: EN6205) at the age of 71 years as dose 2, single and intramuscular, administered in arm left, administration date 14Feb2021 (Lot number: EL9269) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to penicillin (rash)" (unspecified if ongoing), notes: I am allergic to penicillin (rash). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 23Sep2021, outcome "recovered" (28Sep2021), described as "chills"; HEADACHE (non-serious) with onset 23Sep2021, outcome "recovered" (28Sep2021), described as "headache"; FATIGUE (non-serious) with onset 23Sep2021, outcome "recovered" (28Sep2021), described as "fatigue"; RASH (non-serious) with onset 23Sep2021, outcome "recovered" (28Sep2021), described as "pink rash on body". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Mother called on the afternoon of 8/21/08 and described fever and "fluid filled bumps" on child's legs. She said they "looked like cigarette burns".
Patient had just had a blood draw before immunizations were administered (Tdap, was given first patient tolerated IM well and then HPV was administered 45 seconds later) 30 seconds after HPV administration patient turned pale, and his eyes rolled up and he began to become rigid and to hyperextend back and neck. Patient lost consciousness for about 45 seconds and had erratic arm movements. Patient regained consciousness after being laid on the floor and O2 was administered. Patient complained of headache and was sleepy and did not remember his last name or age. Vital signs where always stable. Paramedics arrived and patient was transported to Hospital for evaluation and treatment.
Pt had covid-19 vaccination. Unknown if Pfizer or Moderna. Unknown lot number, vaccine route or site. Pt reported difficulty swallowing and numb lips 30 minutes after vaccine
Patient received Flu vaccine - left with uncle - uncle called 10-15 min later - child having seizure - Seizure lasting about 5 minutes.
Expired Engerix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 25th January 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comment: The reporter reported that a patient received an expired dose of Engerix-B. The reporter consented to follow up. Additional Supportive information: The reporter reported that a patient received an expired dose of Engerix-B, which led to expired vaccine used.
patient received only the menA component of Menveo reconstituted; patient received only the menA component of Menveo reconstituted; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA926A) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient received only the menA component of Menveo reconstituted) and inappropriate dose of vaccine administered (Verbatim: patient received only the menA component of Menveo reconstituted). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-AUG-2023 The reporter consented to follow up. The reporter reported that a patient received only the menA component of Menveo reconstituted with a saline solution, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.