chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; High Heart rate; Coughing; Sore arm after injection that got worse; Fever; Felt fatigued; Hard to lift; Couldn't get warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift), FEELING COLD (Couldn't get warm), HEART RATE INCREASED (High Heart rate), COUGH (Coughing) and VACCINATION SITE PAIN (Sore arm after injection that got worse) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 01-Dec-2020.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift), FEELING COLD (Couldn't get warm), VACCINATION SITE PAIN (Sore arm after injection that got worse), PYREXIA (Fever) and FATIGUE (Felt fatigued). On 13-Jan-2021, the patient experienced HEART RATE INCREASED (High Heart rate) and COUGH (Coughing). On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift), FEELING COLD (Couldn't get warm), HEART RATE INCREASED (High Heart rate), COUGH (Coughing), VACCINATION SITE PAIN (Sore arm after injection that got worse), PYREXIA (Fever) and FATIGUE (Felt fatigued) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 100.3 (High) Fahrenheit. On 13-Jan-2021, Body temperature: 99.7 (High) Fahrenheit. On 13-Jan-2021, Heart rate (Unknown-80s): 125-130 (High) BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received wrong vaccine. They received the 5-11 year old vaccine when they should have received the 12+ vaccine.
Mom called stating child's arm was swollen and red-red raised area-lemon sized. Lo grade fever today.
On 10/16 received Fluzone and allergy shots. On 10/18 developed rash over entire body, papular, red. Faded with Lorataine over 2-3 days.
Donor came into center on 1/25/18 with a hot, itchy, reddened area 4 in. by 4 in. on right upper arm at the immunization site for tetanus vaccine. Donor was immunized 1/22/18. Donor states she was "using the right arm a lot that night and was crocheting."
acute onset headache, vertigo, nausea, started approx one day after  vaccination , lasted approximately 2 months
Information has been received from a nurse practitioner concerning a 52 year old male smoker with no allergies who on 13-DEC-2009 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 665300/1314Y) into right deltoid. There was no concomitant medication. On approximately 14-DEC-2009 ("a few days after 13-DEC-2009"), the patient developed pain at the injection site when he moved his arm. He went to see the nurse practitioner to seek medical attention. There were no laboratory diagnostics studies performed. The nurse practitioner would like an investigation of the lot number to see if other people had similar reactions. At the time of this report, the patient had not recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Approx. 2 days after the vaccine was administered the patient reports that she broke out in hives, all over her body but consentrated on the abdomen.  She also had a blochy rash in addition.  She reports itching, no fever.  She did not seek medical attention.  The hives lasted approx. 2 wks and the itching continued for approx. 1 month.
administering expired Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAV (Havrix 720 adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th October 2022, the patient received Havrix 720 adult and Havrix Pre-Filled Syringe Device. On 24th October 2022, unknown after receiving Havrix 720 adult and Havrix 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: 24-OCT-2022 Reporter's comment : reported administering expired Havrix to patient today (on the date of reporting). The reporter consented to follow-up. Additional supportive information: The patient had received an expired dose of Havrix 720 adult, which had led to expired vaccine used. This case had been linked with case US2022153119, reported by the same reporter.; Sender's Comments:  US-GSK-US2022153119:same reporter
Abdominal pain and Vomiting followed by diarrhea. Repeated vomiting and diarrhea for an hour and half, then exhaustion and sleep for now.
Very long and painful periods; spotting 3  months after the vaccine.; Very long and painful periods; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The 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. The concomitant medications included losartan (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, 3 months after the vaccine, the patient had a very long and painful periods and spotting. She had never had this before. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received any treatment for the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event very long and painful periods and spotting were not resolved at the time of this report   No follow-up attempts are possible. No further information is expected.
Information has been received from a Medical Assitant referring to a multiple unspecified patients of unknown age and gender. The medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies of the patients were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX lot # M043581 and expiration date 28-OCT-2018 for prophylaxis (route of administration, dose and anatomical location were unknown), reconstitued with a properly stored sterile diluent (Lot number and expiration date were unknown). No adverse events were reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature of 34 Fahrenheit for 1 hour and 24 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. There was not product quality complaint involved. Additional information has been requested.
Pt recvd 3 doses of Engerix-B 19FEB91, 19MAR91, 5SEP91 & it was determined that pt did not convert p/vax series;
Sudden onset of right upper back pain with radicular symptoms radiating to right pinky on afternoon of 3/5/2021. Discovery of right pinky weakness in extension and abduction with EMG confirmation of Parsonage Turner Syndrome on  6/8/2021
I started to feel dizzy and feel very lethargic two days after the covid vaccine, Pfizer, 1st shot. It has been 12 days and am still dizzy.; The fatigues and low energy are still continued.; The fatigues and low energy are still continued; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included joint inflammation and backache. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), Multivitamins (MANUFACTURER UNKNOWN), Probiotics (MANUFACTURER UNKNOWN) and omega-3 NOS (OMEGA-3) from an unknown date and for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Vicodin for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced to feel dizzy and feel very lethargic two days after the covid vaccine, Pfizer, 1st shot. Even after 12 days she was still dizzy. The fatigues and low energy are still continued. The dizziness was mild to moderate still able to do daily chores but with low energy. Due to being dizzy she avoided driving or walking outside. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events dizzy and feel very lethargic two days after the covid vaccine, Pfizer, 1st shot. Even after 12 days she was still dizzy. The fatigues and low energy are still continued. The dizziness was mild to moderate still able to do daily chores but with low energy were not resolved at the time of report.  No follow up attempts are possible. No further information is expected.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt was given 1 shot of epipen 0.3 mg , called 911 , pt symptoms improved right after the epipen shot , his mom drove him to emergency room to monitor and follow up , the kid was ok before leaving the pharmacy
Breakthrough case admission after 2 vaccines Moderna 3/23/21 Lot# 008B21A; Moderna 4/20/21 Lot# 002C21A
moderate to severe muscle pain; moderate to severe joint pain; increase in weakness and fatigue; chills; vaccination site pain; vaccination site swelling; This is a spontaneous report from a contactable consumer, the patient.  A 67-year-old non-pregnant female patient received second dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: unknown), via an unspecified route of administration in the right arm on 13Mar2021 at 15:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation.  Medical history included chronic disabling illness like Myalgic encephalomyelitis, Fibromyalgia, Lyme disease, CFS. The patient was allergic to versed. The patient received concomitant medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: unknown) via an unspecified route of administration in the right arm on 23Feb2021 at 14:30 for COVID -19 immunisation. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. After vaccination on 14Mar2021 at 06:00 patient experienced moderate to severe muscle and joint pain all over, increase in weakness/fatigue, some chills, pain at injection site, some swelling. The patient did not receive any treatment for the reported events. The clinical outcome of all events moderates to severe muscle and joint pain all over, increase in weakness/fatigue, some chills, pain at injection site, some swellings were Recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. On unknown dates, the patients received dose of (Oka/Merck) VARIVAX that had been improperly stored (lot #, expiration date, route, dose and frequency not provided). No adverse experience was reported. A telephone attempt to obtain follow-up information on 23-MAR-2015 was unsuccessful. The nurse could not supply the information regarding lot numbers, expiration dates and patient identification information at the time of the call. The reporter confirmed that there had been no reports of adverse events following administration of the vaccinations. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician referring to a 24 year old male patient with chronic neutropenia as concurrent condition. The patient had none drug reactions or allergies. On 17-MAR-2017, the patient was vaccinated with VARIVAX (lot#, dose, frequency and route of administration were unspecified) for prophylaxis with sterile diluent (manufacturer unknown). After vaccination, the patient developed rash approximately in March 2017. Then, the patient underwent a polymerase chain reaction (PCR) on the skin lesion which resulted positive and was hospitalized on 21-APR-2017. It was reported that the patient was responding to acyclovir. It was also reported that the adverse events were not significant disability, incapacity or life threatening. At the time of the report, the outcome of varicella virus test positive and rash was unknown. Additionally, it was stated that the patient remained hospitalized. The relatedness assessment of the aforementioned adverse events with VARIVAX and sterile diluent (manufacturer unknown) was not provided. Additional information has been requested.
8 days after vaccine I developed a delayed allergic reaction to the vaccine. My arm had stopped hurting days before, but I woke up Friday 2/5 morning and it was slightly sore again. By Friday evening, I had noticed that I was really tired and starting to get sore/fatigued, which is a common symptom of fevers for me. I also noticed that my vaccine arm was several degrees warmer than the rest of my body. I went to bed around 9:30 pm that evening and woke up around 12:00am with diarrhea and vomiting (1x). My whole body was sore at this point and it hurt to move (again, a common fever symptom with me, but it hurt to get up and actually find my thermometer to check). I woke up Saturday morning with a rash on my vaccine arm (several quarter sized red blotches), no itching or soreness at this point but at this point my body had no fever, but my arm was around 99-100 Fahrenheit for several days. By Sunday evening, my arm was still hot but started to get sore (like a sunburn) and itchy. The rash had grown in size so that my upper arm above the shoulder was red about 5 x 5 inches. The itching/ soreness continued to grow in size by about an inch before I went to the doctor on Tuesday afternoon. She prescribed me prednisone and it started working about about 3 hours (large spot of redness gone) and by next morning only a slight discoloration remained.
Pt complained that the shot really hurt and was worried that it was given too high.  The RPH recommended the for the first 24 hours, ice packs applied to affected area in 20  minute cycles and take Ibuprofen or Tylenol.  They were told to contact their PCP if the pain worsened after 3 days or the symptoms lasted longer than 7 days. The patient called seven days later and was still experiencing pain. The RPH on duty recommended That she see a doctor.
I had my first J&J dose in September 2021, then a Pfizer booster in February 2022. My menstrual cycle has changed since November 2021: first it got shorter (28-29 days instead of my usual 33-35 days). However this cycle (April 2022) I?m more than 5 days late (and not pregnant).
experiencing burning pain at the vaccine injection site; This is a spontaneous report from a contactable consumer.   A 19-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 28Aug2021 (age at vaccination was 19-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was included covid 19 infection in May/end of April. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 04Aug2021 (age at vaccination was 19-year-old) as dose 1, single for COVID-19 immunisation. Caller reports that since this Sunday (29Aug2021), she has been experiencing burning pain at the vaccine injection site. Caller reports that specifically it doesn't feel like its on the outside but feels like its on the inside. At the time of this report event outcome was unknown.   Lot number for the vaccine, was not provided and will be requested during follow-up.
She said that she normally gets half of a 0.5 mL prefilled syringe in one dose and then she comes back three days later and gets the remaining of the dose (of the syringe) with no AE.; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 74 years old female patient who normally gets half of a 0.5 ml prefilled syringe of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in one dose and then she comes back three days later and gets the remaining of the dose (of the syringe) (lot: unknown, expiry date: unknown), via unknown route, On an unknown date (inappropriate schedule of product administration).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  It was an actual medication error due to the Inappropriate schedule of vaccine administered (latency unknown).   At the time of reporting, the patient had no 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.  There will be no information available on the batch number for this case.
Swelling, itching, pain to right arm. Feeling sick to stomach. Sent to clinic 10/17/02. 10/23/02 14:45 Placed called to patient; doing fine; no problems.
Patient received the Pfizer vaccine in the morning, then woke at about midnight. He went to get a drink of water, and was holding a glass of water in his hand. He started to feel as if the room was spinning, became very sweaty, had ringing in both ears, and lost consciousness, striking his head on the counter. The event was unwitnessed. He reports waking approximately 1 hour later with a bad headache. He had a headache and felt disoriented. He denies urinary/bowel incontinence or tongue biting. He was able to walk back to his room without difficulty, took ibuprofen, and went back to sleep. He woke the next morning with nausea and vomited, but this did not impact his headache. He has not had any notable neurologic symptoms since that time, but continues to have a minor headache. He has not had any further vomiting. Headache has not subsequently woken him from sleep and does not worsen with recumbent positioning. He denies visual changes, memory changes, difficulty swallowing, shortness of breath, ringing in his ears, or dizziness. He says his headache is located mostly around his forehead and at the top of his head that is now mild and feels like pressure ?like a tension type headache.? His mother is a nurse, and evaluated him the next day. The family did not feel that he needed to be seen in the emergency department, or prior to this visit. He has not had any previous episodes that were similar. Patient was evaluated in my clinic. Complete neurologic exam was within normal limits. He has been referred to neurology for further assessment.
This spontaneous report as received from a healthcare worker refers to a 19 week old female patient. On 06-MAY-2013 the patient was vaccinated with first 2 ml dose of ROTATEQ (lot# J000034, expired date 23-APR-2014) orally. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Extreme Jaundice (yellowing of eyes and skin) )Onset 10 days post Vaccine. Initial treatment sought 07/12/21 Tiredness and shortness of breath (Autoimmune Hemolytic Anemia)   Onset 10 days post Vaccine. Initial treatment sought 07/12/21 Enlarged Spleen. Onset 10 days post Vaccine. Initial treatment sought 07/12/21
after vaccination, put pressure at the injection site for 30 seconds then after 2 minutes upright, patient passed out on the floor and hit their head on the dry wall.  blood pressure was low so taken to the hospital for further evaluation.
Developed DVT Blood clot in leg-lung noted during hospital stay from 12/10/2021-12/22/2021 Death-01/02/2022
22hrs p/vax raised red rash noted on trunk, sparse;later in day large raised, hot to touch area @ vax site noted;latter inc over the next 4 days; rash spread over entire body also over next 4 days then both started to fade; no itching
Pt received 1st dose of Moderna Lot # 012M20A on 2/3/21 and then received 2nd dose of Pfizer Lot # EN6202 on 02/25/21.
swollen, warm large area in the site of injection; swollen, warm large area in the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (swollen, warm large area in the site of injection) and VACCINATION SITE SWELLING (swollen, warm large area in the site of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced VACCINATION SITE WARMTH (swollen, warm large area in the site of injection) and VACCINATION SITE SWELLING (swollen, warm large area in the site of injection). At the time of the report, VACCINATION SITE WARMTH (swollen, warm large area in the site of injection) and VACCINATION SITE SWELLING (swollen, warm large area in the site of injection) had not resolved.            No relevant concomitant medications were reported. Treatment includes cold in the area.