chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigued after the first vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued after the first vaccination.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigued after the first vaccination.). At the time of the report, FATIGUE (fatigued after the first vaccination.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient had passed away on 24OCT2021 (after second dose of moderna) . Cause of death was Covid-Pneumonia. No relevant concomitant product were reported No treatment medication was provided   This case was linked to MOD-2021-366293 (Patient Link).
Information has been received from a consumer concerning her 19 year old daughter with no medical history and drug allergies, who in approximately "September 2008" was vaccinated with her 1st dose of GARDASIL. The 2nd dose was unspecified. On 29-MAY-2009, the patient received the 3rd dose of GARDASIL, 0.5ml, IM. Subsequently, the patient had a seizure when she was sleeping on 25-JUN-2009. She was sent to ER but was not admitted. There was no concomitant medication. Lab diagnostics studies included EEG, CAT scan, and MRI. The patient had seen a neurologist about the seizure. The patient had recovered from seizure on 25-JUN-2009. Follow-up information had been received through a phone call, a nurse concerning that the patient was vaccinated with her 1st dose of GARDASIL (Lot#660391/0063X) on 16-JUL-2008, concomitantly received ADACEL (lot# C2994AA), HAVRIX (lot# AHAVB235BA), and tuberculin purified protein derivative (PPD) (LOT#C2907BA), results negative. The 2nd dose of GARDASIL (lot# 659184/0843X) was administered on 10-OCT-2008, and concomitant therapy included FLUMIST (lot#50545P). On 28-MAY-2009, the patient received the 3rd dose of GARDASIL (lot# 662300/0100Y), 0.5ml, IM. On 25-JUN-2009, the patient had a seizure and was taken to hospital but not admitted. The patient's CT scan was negative and EEG results were pending. The patient mother felt that the patient's seizure and was taken to hospital but not admitted. The patient's CT scan was negative and EEG results were pending. The patient mother felt that the patient's seizures were linked to GARDASIL vaccinations. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.  7/21/09 ER records received DOS 6/25/09. Assessment: New Onset Seizure. Parent witnessed patient's seizure in bed. Lost consciousness, unresponsive, confusion. Patient presents with trace swelling of tongue, tachycardia. To have MRI with Gandolinium.  9/11/09 Medical records received DOS 7/16/08 to 7/14/09. Generalized seizure. Tongue bitting. Went to ER. Neurology consult. ENT consult for otitis externa. Fever.  9/18/09 Neurology consult received DOS 7/8/09. Assessment: New onset one-time generalized seizure. Witnessed gneralized tonic-clonic seizure while asleep. Recent bilateral ear infections.
shingles after the shot/Suspected vaccination failure; Shingles; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in an unspecified number of a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional details were reported as follows: The age at vaccination was not applicable for this case. The patients got shingles after they had the shingles vaccine. The doctor stated that many people do get. The follow up would not possible as contact information was not available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case had been linked with US2021AMR224136, reporter by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224136:Same reporter
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:57 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:57 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 67.91.  Concomitant products were not provided.  Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD dates was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines 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.  Treatment medications were not reported.
The arm at the site of injection was slightly red, looked mildly swollen, and the patient stated that it felt hot. Patient was informed at the time of injection that if discomfort occurred to take either TYELNOL or Ibuprofen. When patient came in to show us the reaction he was informed to take an anti-histamine, to use a cold compress, and if the reaction got worse to contact his doctor.
Vasovagal syncope post injection lasting a few seconds, no injuries helped to floor, complete recovery.
High fever, cold-sweat,  hammer-shake chills, severe body aches, severe headache, shortness of breath, palpitations, nausea, diarrhea, fatigue, general discomfort, and (the best way I can describe it) feeling the worst that I've ever felt in my entire life (felt like I was dying), for a period of about 36 hours, with severe vaccine reaction symptoms tapering-off over the following 72 hours.  Be aware that I was hospitalized for COVID-19 in November 2020 and had lung-damage that required supplemental oxygen for 8 weeks during recovery.  My pulmonologist cleared me for the Modera mRNA vaccine dose that I received on February 18, 2021.
6 days after 1st dose lymph nodes in left arm became enlarged and painful. Lasted 3 days and responded to NSAID treatment. On day 10 red rash with itchiness appeared at injection site.
(+) hive like skin lesion noted after administration to injection site-proximal, given BENADRYL-checked site after. Hct and Lead done in lab-site now just erythematous, firm, no other hives noted.
A non-serious report of administration of expired FluMist was received from a physician concerning a 23-year-old female.  No medical history or concomitant medications were reported.  The patient received FluMist on 11-Feb-2008.  The patient was administered expired FluMist.  Per the physician, no adverse events were associated with the medication error.  No dechallange or rechallenge occurred.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Red, swollen, tender/hot around injection site. Patient has tried applying cold compress. As of today 2/1/21, patient reported the swelling has gone down. Redness still present.
After 11 hours post shot, extreme pain and sensitivity at injection site, inability to move arm without pain.  I took two extra strength acetaminophen.  14 hours post shot, I began shivering. Blankets did not help.  20 hours post shot, I  began feeling  general nausea and Loss of appetite until the evening, the day after the shot. I also felt like I was laying on a heating pad, a hot back, while my hands remained  ice cold. I also had a mild headache throughout the next day in my temples.  I had a fever that got up to 100.3 the evening of the next day after my shot. At that time I took two more extra strength Tylenol. Once that kicked in I felt totally back to normal.
Twinrix 1st dose, 2nd dose Engerix B only; Twinrix 1st dose, 2nd dose Engerix B only; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 54-year-old male patient who received HBV (Engerix B) (batch number 7xy23, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 27th January 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 27th January 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device and an unknown time after receiving TWINRIX, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination were 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: 31-JAN-2023 Reporter's Comments: Nurse reported that patient received Twinrix on 29th December 2022 as a first dose and on 27th January 2023 patient received just HepB (Engerix B).  The reporter asked how to proceed. The reporter consented to follow up.  The vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received 1st dose of Twinrix and then Engerix B, which led to wrong vaccine administered. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination for hepatitis A antigen.
318 patients received dose from vials beyond 30-day use by date; 318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided. Vaccine was refrigerated o 07-May-2021.   This case was linked to MOD-2021-363792 (Patient Link).
Information has been received concerning a 38 month old Native American/Alaskan Native non-Hispanic male who on 8/11/93, 11/2/93 and 7/6/94, was vaccinated with the 1st, 2nd and 3rd dose of haemophilus b conjugate vaccine respectively. The pt developed bacteremia related to vaccine failure. Upon medical review, the pt's experience was considered an 'Other Medical Event'. The reporter indicated that the pt's outcome was 'yes'.
Information has been received from a physician concerning an "8 year old" male who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) (LOT# not reported). Subsequently, on an unspecified date the patient experienced shingles. Unspecified medical attention was sought. The patient recovered from shingles after on unknown therapy. After experiencing shingles, on an unspecified date, the patient was administered the second dose of VARIVAX (Merck). This is the first of two sibling cases received from the same source. Additional information has been requested.
Urticaria evening of office visit on legs and lower back. No SOP, no dyphagia. Rx - Benadryl.
A-fib onset evening, ended approximately 7 hours later. Also, Onset of tinnitus the morning of 03/21/2023. Tinnitus continues.
16 years old female received J&J Janssen. Pt came in with mother and requested Janssen. Vaccinatorr administered J&J. No known adverse effect noted.
Transient quadrilateral space syndrome. Imaging features on MRI and accompanying pain and paresthesias correlate; Transient quadrilateral space syndrome. Imaging features on MRI and accompanying pain and paresthesias correlate; Transient quadrilateral space syndrome. Imaging features on MRI and accompanying pain and paresthesias correlate; Transient quadrilateral space syndrome. Imaging features on MRI and accompanying pain and paresthesias correlate; This is a spontaneous report from a non-contactable physician, the patient. An adult male patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an intramuscular route of administration in the left arm on 20Aug2021 at 16:15 as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 20Aug2021 at 19:30, the patient experienced transient quadrilateral space syndrome, imaging features on magnetic resonance imaging (MRI) and accompanying pain and paresthesias correlate. On the same day, the patient underwent MRI and the result correlate transient quadrilateral space syndrome. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events transient quadrilateral space syndrome, imaging features on MRI and accompanying pain and paresthesias correlate was resolved on an unknown date in Aug2021.  No follow-up attempts are possible. No further information is expected.
MOTHER CALLED TUES 4/24/18 9:50 AM TO REPORT THAT MONDAY 4/23/18 AROUND 9 AM SON FELT NAUSEATED, COLD SWEAT, HYPERVENTILATING, ANXIETY, NOT FEELING WELL, SHE THINKS IT WAS POSSIBLY FROM SHOT ON FRI, DID NOT GO TO DR; SHE JUST MONITORED HIM AT HOME. SHE REPORTS HE IS BETTER NOW.
Severe and debilitating lower back pain that lasted roughly 3 hours. Use of a heating pad for an extended period of time assisted with recovery.
pt rcvd vax; w/ 2nd inject, pt devel shortness of breath & palpitations;
The patient reported tinnitus that began shortly after receiving the vaccine.  It is lightening, but has not full resolved by 8/6/21.  He said that he has a history of tinnitus in the past.
After second vaccine - Pfizer Lot #EW0196 - I experienced Pleurisy, Shortness of breath, extreme fatigue, weakness, malaise, widespread Lymphadenopathy - Swollen lymph nodes under left armpit, left jawline and essentially a necklace of lymph nods popped out across chest and eventually both sides of neck, neck pain, headache, back pain, armpit pain, jaw pain.  This lasted for a few weeks.
Pain in all my bones; I feel weak; I feel feverish; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in all my bones), ASTHENIA (I feel weak) and PYREXIA (I feel feverish) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-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. In May 2021, the patient experienced BONE PAIN (Pain in all my bones), ASTHENIA (I feel weak) and PYREXIA (I feel feverish). At the time of the report, BONE PAIN (Pain in all my bones), ASTHENIA (I feel weak) and PYREXIA (I feel feverish) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Dizziness, wanting to throw up, couldn't stand felt like I was going to fall over.  These symptoms would not go away.
HR usually in 80s (via watch).  Increased to 109..  Felt Anxious.  Placed in a wheelchair for patient safety and rolled to a private area for monitoring.  Blood pressure checked 166/76.    Gave water and nutragrain bar.  HR decreased back to 80s within 5 minutes and anxiety resolved.    Patient is a dietician.  However she did not eat breakfast this AM.  Also stated she gets anxious with shots.
Patient claimed that she couldn't move her arm or pick up anything for 2 days after she got the shot. Also, her hand got swollen and she had to take TYLENOL.
one year old patient was given ActHIB with expired diluent with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (MI) (Reference number- 00515331) and transmitted to Sanofi on 11-Mar-2021.  This case involves a 1 years old male patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for Immunisation.  On 11-Mar-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UJ181AAA/U6601AA, expiry date-Diluent- 07-MAR-2021/ Powder-18-MAR-2021 via intramuscular route in the left thigh for prophylactic vaccination.  Additional Description of event Adverse events :HCP reporting one year old patient was given ActHIB with expired diluent.  It was not reported if the patient experienced 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 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.
Started with a fever and concentrated, smelly urine, fever has lasted for 7 days to present, generally run down, difficulty coughing some phelgm. Doctor ordered chest xray to rule out pneumonia and gave Doxycycline 100mg 2x daily.
Brachial neuritis - same arm as injection. Pain began at time of TDAP injection, with swelling and pain in the whole arm, which has worsened for 3+ weeks.
Approx an hour after employee received flu vaccine from occupational RN she stated that she felt numbness in her left arm, nausea with vomiting x1, dizziness, and "feet hot". Vaccine given to L deltoid. Vitals taken 911 called.
PT STATES THAT SHE HAS BEEN IN A STATE OF MANIA OR MANIC SINCE JUST AFTER HER LAST SHOT.  SHE SUFFERED FROM MANIA ABOUT 20 YEARS AGO BUT HAS NOT NEEDED ANY MEDICAL GUIDENCE FOR SEVERAL YEARS.  CHIEF COMPLAINT IS MANIA AND RACING THOUGHTS. RECOMENDED THAT PT BE SEEN THROUGH HER PRIMARY MD BUT SHE DOESN'T HAVE ONE.  INCOURAGED HER TO SEEK MEDICAL ATTENTION FOR EVALUATION.
headache, body aches, very large swollen lymph nodes under arm (swelling is the size of my fist), racing heart
7 days after vaccination developed erythematous tender itchy swollen/indurated late local reaction at site of vaccine administration in her left upper arm
w/in 24 hrs of vax pt devel high fever & productive cough; x-rays showed bilateral infiltration on both fields;
patient describes lightheadedness, sweating and an overall feeling of unwell.  patient laid on table until the ambulance was called.  patient stated that he fell later at home and has weakness in his left hand.  patient states that he has had a stroke but was unconfirmed with tests from hospital.
Patient hospitalized on 4/12/21 for 8 days. Patient presented to the ED and was subsequently hospitalized on 4/23/21. These visits were within 6 weeks of receiving COVID vaccination.
This is a spontaneous report from a contactable pharmacist (intern). A female patient of unspecified age received PREVNAR 13 at 0.5 ml single. Medical history and concomitant medications were not provided. On unknown date the patient experienced ache in her stomach muscles, her lungs were burning, she was unable to move even to sit down, had trouble breathing and had a headache 3 days after getting the vaccine. Event outcomes were unknown at the time of report.