chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered 2 doses at the same time; This case was reported by a physician via call center representative and described the occurrence of accidental overdose in a 21-year-old female patient who received HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.  Additional details were provided as follows: The age at vaccination was unknown. The reporter stated that, the patient was inadvertently administered 2 doses of adult Engerix-b at the same time, couple of months ago from the day of reporting, around fall, which led to accidental overdose. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up via phone. No other detail was available. Note: As per the convention only one suspect was coded for same Brand of vaccine.
Patient was given Dtap/Polio ( Kinrix). Patient is age 14. Patient should have received Tdap
Woke with fever and chills, extreme arm pain, could not move arm.  Took ibuprofen and called Dr. office at 6 am, told not usual reaction, come in if want to.  Went in, diagnosed "allergic reaction". Prescribed ibuprofen 800 MG. Continued to worsen, called again, still Dr. not concerned.  Second day headache and continued to worsen. Third day 9/18/2014 returned to dr. office, now diagnosed with Cellulitis. Given Cephalexin 500mg QID.  Dr. still not caring or concerned.  Missed 3 days of work and a paid weekend vacation.  Started to feel better on 9/19/14.  Symptoms lessened and cleared and finished med.
exhibited COVID-19 symptoms of congestion, fatigue, cough, vomiting on 1/28/2021, followed by loss of taste and smell on 1/30/2021.  Taste and smell returned on 1/31/21.  Cough and SOB worsened 2/4/21 necessitating ED eval that was unremarkable.  Mostly recovered by end of 10-day isolation period, but with persistent occasional cough and SOB. Was afebrile throughout the course of the disease.
pt recvd vax 3APR91 & 3 days later began coughing; adm to hosp 12APR91 w/x-ray showing pneumonia; no etiologic agent identified @ time of report;
Swelling, redness, itching, hardness 4 inches in diameter from injection site.  Rash in both armpits covering entire out areas lasting six days!
patient came in with a red rash on her left upper arm not warm to touch but about 2 1/2 inches in length on her arm.  that is the arm she had received the RSV  and the flu vaccine.  other arm she received   Moderna (Spikevax). It doesn't hurt  we drew a line around it and she decided if it gets bigger or does not go away by tomorrow she will seek medical attention.
Doses administered after more than 1 temperature excursion; Doses 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 (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 11:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 11:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses 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 46.40  Concomitant medication was not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  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 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Booster for COVID vaccine to be administered for 13yo. Dose administered was for 5-11yo.
I started having parathesoas of bilateral lower extremities the evening of my second dose.; The next day I saw my pop and my pulse and blood pressure were elevated.; The next day I saw my pop and my pulse and blood pressure were elevated.; I am also having headaches; stuffy nose; sinus pressure; brain fog; my vision is blurry; tinnitus; This is a spontaneous report from a contactable Nurse (Patient). This 68-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Ec3302) via an unspecified route of administration, administered in left arm on 03Feb2021 at 08:15 AM (at the age of 68-years-old) as single dose for COVID-19 immunisation. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EI8982) via an unspecified route of administration, administered in left arm on 15Jan2021 at 08:00 AM as single dose for COVID-19 immunisation. Patient received no other vaccine in four weeks prior vaccination and was not tested for COVID prior vaccination. The patient medical history included known allergies like airborne allergies, grasses, molds, trees, pollen, dust and had controlled hypertension. Concomitant medications included Losartin 50 mg. On 03Feb2021 (at evening, same day of vaccination), patient started having parathesias of bilateral lower extremities. Patient saw pop and pulse rate and blood pressure were elevated. This had continued for the past five days. Patient also had headaches, stuffy nose, sinus pressure, brain fog, vision was blurry and tinnitus. Patient not tested for COVID post vaccination. Outcome was not recovered for all the events.
Patient died after getting the Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died after getting the Moderna COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported. Caller stated her mother died after getting the Moderna COVID-19 Vaccine and that a lot of people was dying from the vaccine (caller did not provide more details about other people or his mother's case). Patient mentioned Moderna was hiding information and lying about people dying from the vaccine. Treatment information was not provided.  Company Comment: This is a spontaneus case concerning a female patient of an unknown age with no medical history reported, who experienced the serious unexpected event of Death, reported as patient died after getting the Moderna COVID-19 Vaccine. The date of mRNA-1273 BIVALENT vaccine dose and death date were not provided. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273 BIVALENT) is not affected by this report.; Sender's Comments: This is a spontaneus case concerning a female patient of an unknown age with no medical history reported, who experienced the serious unexpected event of Death, reported as patient died after getting the Moderna COVID-19 Vaccine. The date of mRNA-1273 BIVALENT vaccine dose and death date were not provided. Very limited information regarding this event has been provided at this time, the cause of death was not reported and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273 BIVALENT) is not affected by this report.; Reported Cause(s) of Death: Patient died after getting the Moderna COVID-19 Vaccine
Pain at injection site, ongoing muscle pain. Difficulty using left arm, raising it or laying on while in bed. A dull  throbbing pain that has never stopped to date.
Joint pain and rash starting within week after vaccine administered. Pericarditis diagnosis on 5/7/2021. Was hospitilized. Rheumatoid Arthritis probable with elevated RA factor, positive ANA, and High ANA titer. Awaiting other autoimmune test results to verify diagnosis.
sore are, night chills, nausea, headache, muscle aches,  feeling unwell for one day
severe pain in the arm in which vaccine was administered, (could not move the arm) high fever, difficult breathing, redness, swellness, injection site hot to the touch, chest pain.  Treatment of albuterol breathing treatment, course of steriods, course of antibiotics administered.
pt recv vax 2MAY97 & 5MAY97 pt devel a fever of 102.8 & 7MAY97 pt devel a rash on the leg where vax was administered & cold sx w/runny nose;
Information has been received from a registered nurse concerning a 14 year old female patient who on 16-OCT-2008 was vaccinated with the first dose of GARDASIL (lot# 659184/0843X) 0.5ml intramuscularly.  Subsequently the patient developed sharp, intermittent abdominal pain, which resolved without treatment in an unspecified length of time.  On 18-DEC-2008 the patient received her second dose of GARDASIL (lot# 659184/0843X) 0.5ml intramuscularly.  On 22-DEC-2008 patient developed intense abdominal pain as well as pain in her lower extremities.  Patient's parent sought medical attention by calling the health department.  The nurse is unsure if the pain had resolve at the time of this report.  On 05-JAN-2009 patient was hospitalized with a diagnosis of pneumonia and was discharged on 07-JAN-2009.  This is one of several reports received from the same source.  Additional information has been requested.  3/23/09 Received ER & Clinic medical records of 1/19-2/26/2009. FINAL DX: constipation; chronic abdominal pain Records reveal patient experienced crampy intermittent severe abdominal pain & nausea since 10/08 which had worsened in 12/08 & now included muscle tenderness when seen in ER 1/19/09.  Had been using narcotic pain meds, dx w/constipation, & tx w/laxative.  Had missed several days of school due to pain & the pain would awaken her at night.  Seen in GI clinic 1/19/09.  Tx w/laxative & enema w/resolution of abd pain.  Psych counseling started.  RTC 1/26 dx w/functional dyspepsia & meds adjusted.  RTC 2/4/09 w/right back/shoulder pain, vomiting, HAs, abdominal pain improved, classes 1/2 days & exhaustion when completed.  RTC 2/26 w/20# weight gain, continued missed school although abdominal pain & HA less but continued daily.
woke up with weakness of eye opening of the right eye, has been occurring every morning, now less frequently in the last few days  exam shows a subtle right bell's palsy
Bottom lip swelled up and had red tiny pin dots inside of bottom lip. my lip felt as though I had novacaine from the dentist. Continues to have a puffy feeling today and has a slight numbness after 2 months. Feels as if novacaine is wearing off but still there.  My arm developed a red hard circle after a few days and lasted for about one week,  I was extremely tired for over one month.    I reported to my PCP and she advised to take 50 mg of Benadryl  the night before and 50 mg in the morning before next dose.  I have not gone back because my lip is still funky.
she has an arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1283, Expiration date: Not reported), via an unspecified route of administration on 27Jan2021 (at the age of 58-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications/other products. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140, Expiration date: Not reported), via an unspecified route of administration on 05Jan2021 (at the age of 58-years-old) as dose 1, single for COVID-19 immunization. The patient was diagnosed with arrhythmia after first two doses of vaccine in Feb2021. There was no investigation assessment reported. The outcome of the event was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
my arm at the injection site is red and swollen in 3 inches in diameter it spread hot as swollen; my arm at the injection site is red and swollen in 3 inches in diameter it spread hot as swollen; my arm at the injection site is red and swollen in 3 inches in diameter it spread hot as swollen; my lymph nodes are swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), administration date 21May2021 (Lot number: EW0185) at the age of 62 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 21May2021, outcome "unknown" and all described as "my arm at the injection site is red and swollen in 3 inches in diameter it spread hot as swollen"; LYMPHADENOPATHY (non-serious) with onset 21May2021, outcome "unknown", described as "my lymph nodes are swollen". The event "my lymph nodes are swollen" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site warmth, lymphadenopathy. Additional information: The patient's arm at the injection site was red and swollen in 3 inches in diameter, it spread hot as swollen. The patient did not know what that would be in centimeter or nanometer but it was 3 inches being measured it they even drew black wine around it like watch it pro. Patient's my lymph nodes were swollen. Patient went to the doctor, they had it checked (Not further clarified). The patient just took Benadryl. No Investigation Assessment was performed.  No follow-up attempts are possible. No further information is expected.
Area around injection site became red, hot to touch, sore. Continued to spread down the arm for 48 hours and became focused below injection site, almost circling upper arm to below elbow. Itching began about 24 hours after injection. Gradually improved beginning day 3. Looked like images of ?Covid arm?
This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA, Lot# M018644, expiration date: 20-SEP-2017 for prophylaxis, which had a temperature excursion 32°F for 45 days. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009044: US-009507513-1702USA006132: US-009507513-1702USA009043: US-009507513-1702USA009040: US-009507513-1702USA009041.
Paresthesia and hyperesthesia of extremities up to elbows/ knees and perioral as well as hyperesthesia of trunk and scalp; Paresthesia and hyperesthesia of extremities up to elbows/ knees and perioral as well as hyperesthesia of trunk and scalp; Paresthesia and hyperesthesia of extremities up to elbows/ knees and perioral as well as hyperesthesia of trunk and scalp; This is a spontaneous report from a contactable physician, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Jun2021 at 09:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included viral infection, paresthesia, hyperesthesia, perioral paresthesia (reported as had similar symptoms after a viral illness that started in November and worsened in January to above but had completely resolved (negative Covid testing and antibodies during work up)). The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination were not reported. 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 04Jun2021 at 04:00 the patient experienced paresthesia and hyperesthesia of extremities up to elbows/ knees and perioral as well as hyperesthesia of trunk and scalp. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date, the patient underwent COVID- 19 test and the result was negative. The clinical outcome of the events paresthesia and hyperesthesia of extremities up to elbows/ knees and perioral as well as hyperesthesia of trunk and scalp was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient was given an immunization with an expired Pfizer Covid-19 vaccine. The labeling for this vaccine indicates that the multi-dose vial must be discarded 12 hours after first puncture when stored at room temperature. The administering RPh thought that the vial had been opened at 10:35 am on 2/23, but it had actually been opened at 10:35 am on 2/22. The administration was at 5:30 pm on 2/23. There have been no adverse effects thus far.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lethargy on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information on the batch number cannot be obtained.
On March 16, 2022 at 5 PM I arrived at pharmacy to receive my booster shot the following day on March 17 the same thing happened with side effects like shaking uncontrollably night sweats fever etc. to which I got in the shower again and took Tylenol this seem to help. This all occurred at 8 AM which made me late for work when I arrived I was sent home early again due to appearance and feeling lethargic. I would like to also say this year of 2022 I?ve  Been sick three times but tested negative for Covid this is more illness I?ve dealt with in my entire life in one year. I am very worried that the side effects that I experienced may play a role in this thank you for reading
2 days after vaccination she started with diarrhea all the time very full of mucous, lost 25 lbs and just started getting better about two days ago.  Treated by Dr with probiotic and drink ensure.
Abdominal pain - patient was diagnosed with acute RUPTURED APPENDICITIS . I am not sure if this is related or not but given prior reports of similar issue after  the vaccine  and the fact this happened right after the vaccination I thought it might be related.
My dad received the same shot at the same location the day before. He told me his left shoulder was hurting real bad, like arthritis. I recived my shot the day after. I, now, have a bad pain in my left shoulder and left side neck.
Hospitalized (02.28.2022-03.06.2022); COVID-19 positive (02.28.2022); fully vaccinated plus booster  BRIEF OVERVIEW: Discharge Provider:  MD Primary Care Provider:  MD Admission Date: 2/28/2022 Discharge Date: Mar 6, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE:   51-year-old lady with past medical history significant for chronic encephalopathy history of brain tumor status post resection in childhood, history of seizure disorder, history of dysphagia with feeding tube in place, hypothyroidism hyperlipidemia history of asthma was admitted on 2/28 with complaints of worsening respiratory status increased secretions.  Patient was tested positive for COVID-19 during the hospitalization patient was noted to have acute respiratory distress from COVID-19 patient was started on dexamethasone and remdesivir secondary to hypoxia.  CT chest was obtained during the hospitalization which was negative for pulmonary embolism.  Patient was also startedon Rocephin and azithromycin due to worsening respiratory status due to concerns for possible superimposed bacterial pneumonia.  During the hospitalization patient was accompanied by her mother who helped with review of system and patient progresses patient is nonverbal.  Patient does not use oxygen at baseline.  Weaned oxygen requirements from high-flow nasal cannula to nasal cannula.  Patient's clinical status improved.  Was able to maintain saturations between 2-3 L of nasal cannula comfortably.  Pulmonary consulted and will arrange for home oxygen.  Will complete an additional 2 days of steroids at home.  Completed antibiotics while in the hospital.  Patient discharged in stable condition back home, where she routinely is cared for by her mother.  COVID at home to follow up.