chrisvoncsefalvay/vaers-outcomes huggingface dataset:
horribly sick; nurse stated she accidentally gave the patient a double dose of the Moderna booster: She gave 0.5ml instead of .2.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (horribly sick) and ACCIDENTAL OVERDOSE (nurse stated she accidentally gave the patient a double dose of the Moderna booster: She gave 0.5ml instead of .2.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 001A21A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (nurse stated she accidentally gave the patient a double dose of the Moderna booster: She gave 0.5ml instead of .2.). On an unknown date, the patient experienced ILLNESS (horribly sick). On 06-Nov-2021, ACCIDENTAL OVERDOSE (nurse stated she accidentally gave the patient a double dose of the Moderna booster: She gave 0.5ml instead of .2.) had resolved. At the time of the report, ILLNESS (horribly sick) was resolving.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient had her booster shot and flu shot at the same time.
Patient was given 0.5ml of booster 3rd vaccine and patient was called on 1/18/2021 and denies any problems since vaccine. Letter was sent to patient notifying of dosage given
got vaccine, had shingles/Suspected vaccination failure; Had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got vaccine, had shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-MAR-2023 The case was received from the consumer  interactive digital media. The reporter stated that everyone he/she ever known who had shingles got the vaccination after to try to prevent ever getting them again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
you don't make reporting  this easy. i had to search for a method of reporting.  I had a degree of fever, body aches, joint pain and headache for about 12 hours
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 01-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter..; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 6:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 6:45 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient ethnicity reported as unknown. The patient received Moderna vaccine on 12-Feb-2022 18:45:43, past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
Elbow, wrist, knee, hip, ankle, proximal finger joints, proximal toe joints throbbing aching pain
A 14-year-old male patient with no known history received a right deltoid intramuscular injection of Menactra (lot number U2171AA) on July 2007. On 07 July 2007 he developed left neck pain and stiffness, and treatment included Tylenol and Motrin. On 11 July 2007 he was evaluated by his physician and prescribed Motrin 600 mg and heat to the left side of the neck. Outcome was unknown.
Patient received 2nd dose expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HAV (Havrix pediatric) for prophylaxis.   On 14th February 2023, the patient received the 2nd dose of Havrix pediatric. On 14th February 2023, unknown after receiving Havrix pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-FEB-2023 Reporter's Comment: The patient received Havrix pediatric dose after the expiration date. No information on lot number and expiration date of Havrix was available at the moment of the call. The reporter consented to follow up by email Additional Supportive Information: The patient received Havrix pediatric dose after the expiration date, which led to expired vaccine used.
Case number PHEH2011US03701, is an initial spontaneous report received from a physician on 07 Sep 2011: This report refers to 11-year-old male patient. He was administered only the MenCWY liquid conjugate component of MENVEO (batch number M10053) without being reconstituted with the MenA conjugate component, 0.5 ml, intramuscularly on 24 Aug 2011. No adverse event occurred following this administration.
Johnson & Johnson Janssen COVID-19 Vaccine EUA  Since 4/11/2021 I have had reoccurring headaches which are persistent. Minor vertigo, nausea, light sensitivity have accompanied each headache series.   In healthy condition, rarely ever have headaches. Have had more headaches in the past week than I've had in many  years combined.  No treatment outside of consuming adequate hydration
I had got something on my torso that felt like a thorn stuck into my skin. I had skin irritation. I had a deep fiery nerve pain. I was diagnosed with shingles. I was prescribed Valacyclovir 1gm tablet and Methylprednisolone 4mg.
Donor stated feeling dizzy and faint within seconds of receiving tetanus shot. Pt appeared pale during reaction. Ice packs applied to neck region. About 200cc PO fluids given. Pt reported feeling better within 3-5 minutes.
Pt is a 56-year-old female who presents to the urgent care clinic with concerns of generalized weakness and cough.  Patient has a history of hypertension, hyperlipidemia, and type 2 diabetes coming in feeling sicker over the last few days, has been sick for at least about 7 days she notes upon history taking.  Patient notes that her cough has gotten so bad it "makes it hard for her to cough or walk."  She notes she has been feeling more generally weak and fatigued over the last few days.  It is getting a lot harder to do her ADLs at home.  The patient denies any other symptoms and notes she is otherwise well on complete review of systems.  Patient admitted to inpatient level observation.
Headache, Fever, NauseaVomiting, fatigue, dyspnea, congestion, injection site pain/arm pain, rigors Narrative:   Other Relevant History:
10 minutes after vaccine, leg itching, checked for redness. Between 2200-2330 swelling of tongue, and lips swelling, administered epipen  and prednisone. No 911 or did not notify her PCP. Today she feels fine but still has fine pink rash over body.
This is a 76yo male with a PMHx significant for chronic diastolic heart failure, CKDIII, cirrhosis of the liver, hepatocellular carcinoma, and HTN admitted on 9/4/2021 with increasing shortness of breath. He was tested positive for COVID and received the monoclonal antibodies on 9/2. His shortness of breath continued to worsen. He was admitted to Hospital and was originally requiring 10L nasal cannula. His troponin was mildly elevated with a maximum of 0.21. He received ceftriaxone and azithromcyin. His d-dimer was elevated and he was started on enoxaparin BID because CTA could not be obtained to rule out PE because of his renal function. He was transferred here to the medical unit. Cardiology, Vascular surgery and Nephrology were consulted. ECHO was obtained and showed no right heart strain, normal EF and increased right systolic pressure. Vascular surgery advised no thrombolysis therapy and to continue treatment dose enoxaparin. Cardiology felt his troponin elevation was due to supply demand mismatch and not ischemia. He was kept on dexamethasone but increased to BID dosing, ceftriaxone and azithromycin. Due to a CRP >4, he was started on baricitinib, renally dosed. In the early morning of 9/6 his Optiflow cannula came out while he was sleeping. The nurse found him saturating in the 50s and pulse was thready. Rapid response was called and then he went into PEA and vfib. ACLS protocol was followed and patient received 2 rounds of epinephrine. He was not defibrillated because he came out Vfib prior to shocking. ROSC was achieved in 9 minutes. He was intubated and moved to the ICU. He was following commands and opening his eyes after the incident. Pulmonary/CCM was consulted. His hemoglobin dropped to 6.3 so was transfused 1 unit. Heme + stool, so PPI BID ordered. Baricitinib discontinued due to worsening renal function. He was extubated on 9/8 to high-flow nasal cannula. Unfortunately, he did not do well overnight with tachypnea and was re-intubated. His kidney function continued to worsen due to ATN from his cardiac arrest. Trialysis catheter was placed, and dialysis was initiated 9/10. Patient with hemoptysis 9/13. He underwent bronchoscopy, which revealed proximal clot but no active bleeding, and no active bleeding or endobronchial lesions in either lung. Patient started on high-dose steroids for alveolar hemorrhage. Pathology shows atypical cells suggestive of malignancy. CT chest performed shows extensive bilateral infiltration verses edema with consolidative airspace disease in bilateral lung bases, large bilateral pleural effusions, large subcarinal lymph nodes, left 1-7 rib fractures with right 4-6th rib fractures. Repeat bronchoscopy performed 9/17, showing some evidence of nodularity. No biopsies done due to risk of bleeding, washings were performed. CRRT started 9/17. Patient was not showing sign of improvement. Family presented to bedside to discuss goals of care. They ultimately chose to proceed with withdrawal of care and transition to comfort measures.
This spontaneous report was received from the patient's mother referring to her daughter a 16 year old non-pregnant female patient with seasonal allergy and drug allergy to sulfa as concurrent conditions. The patient's medical history was not reported. There was no concomitant medication reported. On an unspecified date in September 2017, the patient was vaccinated with the first dose of GARDASIL 9. Later, on an unspecified date, the patient received the second dose of GARDASIL 9 both doses intramuscular for prevention of HPV. The reporter stated that after each dose of GARDASIL 9, the patient developed on unspecified dates, injection site pain and swelling, headache, fever, and nausea. The reporter mentioned that the patient "felt worse" after one of the doses, but could not specified which dose. Although, the patient talked with her physician, no treatment was given for the adverse events. The outcome of the events was reported as recovered (unspecified dates).
BODY ACHES; CHILLS; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fatigue, fever, body aches and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20210329989.
His left side part of the face became swollen when he woke up - It is like a size of a golf ball as he described going from nose to his lips (left side); His left side part of the face became swollen when he woke up - It is like a size of a golf ball as he described going from nose to his lips (left side); This is spontaneous report received from a contactable consumer (patient) reported for himself.  A 56-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0175; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Deltoid left on 06May2021 as 2nd dose, single for COVID-19 immunisation. The medical history was Covid-19 immunization for first dose. The patient's concomitant medications were not reported. After 2 days of vaccination, left side part of the face became swollen when he woke up - It is like a size of a golf ball as he described going from nose to his lips (left side) on May2021. Patient was asked for recommendations on what to do. Report transmit - Unable to warm transfer the call to Reporter due high call volume - Caller is willing to wait on the line - Provided INT for reference. Seriousness of event was unspecified. Outcome of the patient experienced his left side part of the face became swollen when he woke up - it is like a size of a golf ball as he described going from nose to his lips (left side) (lip swelling) was unknown. upon Follow-up on (08May2021): This is spontaneous report received from a contactable consumer. This male consumer (patient) reported for himself that included Advised to see doctor for treatment guidance and Report - Previous INT E-transmitted upon follow up on Follow-up 2 (PRD 08May2021/ SRD09May2021): This is spontaneous report received from a contactable consumer. This 56-year-old male consumer (patient) reported for himself that included patient age at time of onset of reaction, weight, height, onset date was unknown, medical history, outcome of events.  No follow-up attempts are possible, information on batch numbers cannot be obtained.
Red dot appeared between nose and top lip, next morning my top lip was fully swollen and unable to close completely
Administration error. Patient was 16 when vaccine was administered. It's authorized for 18 and older. No known adverse events.
Breakthrough case admission after 2 vaccines Moderna 8/23/21 Lot# 005C21A;  Moderna 9/20/21 lot# 005C21A
Pt experienced large local reaction in the left triceps region of the arm. Pt went to the ER the following night of administration and c/o intense pain, hot to the touch and irritation. pt was given steroid and iced the area.
Patient had a severe reaction two days after the 2ND COVID vaccine was administered and this resulted in a hospitalization. More information will be forth coming when the patient returns to work and is seen at facility as part of that process.  Narrative: Had COVID infection several months prior to receiving vaccine. "Patient had a severe reaction two days after then vaccine was administered and this resulted in a hospitalization. More information will be forth coming when the patient returns to work and is seen at facility as part of that process. We have not been able to reach patient by phone.
Approximately 3 to 4 hours after flu shot, I began experiencing shortness of breath, tightening of the chest and deap breaths caused dry coughs.  When symptoms progressed I contacted nurse triage and was told to take benedryl and breathe in moist air (hot shower running).  Approximately 40 minutes after taking the benedryl, sypmtoms began to clear.  No symptoms were present upon awakening the following morning (today).
Patient came in today (9/12) to report that around 2-3 days after this 3rd Moderna COVID vaccine (immunocompromised booster), he got a red, raised rash on his arm. The rash appeared consistent with the "covid arm" being reported for Moderna vaccines that we have seen in the past.  It started at mid deltoid and went down to about 1 inch above the elbow.   I advised he use an over the counter oral antihistamine (benadryl) and topical hydrocortisone cream.  I told him if it didn't resolve over the next 2-3 days to call his doctor.
Couldn't eat, very sore over whole body, needed to sleep most of days, very weak, nauseous, headaches, felt at times I might have been having a heart attack, very hard to breathe deep & felt like chest constricting.  Lasted for a full 5 days.
Information has been received from a registered nurse, for GARDASIL, A Pregnancy Registry product, concerning a 20 year old female with no pertinent medical history and no drug allergies, who on 22-MAY-2009 was vaccinated with her 1st dose of GARDASIL (LOT# 658271/0558X), IM, 0.5ml, and the 2nd dose on 22-JUL-2009 (LOT#662404/0312Y), IM, 0.5ml. Concomitant therapy included NUVARING. The patient called the office and reported that she was eight weeks pregnant. Labs and diagnostic tests included home pregnancy test. The result was positive. The patient's LMP was 10-JUN-2009, and EDD was 17-MAR-2010. There were no adverse effects reported. The patient had not been in the office for medical attention. At the time of the report, the patient's status was pregnant. Follow-up information was received from a registered nurse who reported that this is a female patient with no previous pregnancies. The patient's LMP was reported as June 2009 (date unknown), estimated date of conception was June or July 2009 with an unknown estimated date of delivery. Follow up information received from a registered nurse indicating that the patient had delivered a normal female baby (weight 7 lbs, 13 oz, length 52.1cm, Apgar score 8/9, head circumference 14 inches) on 08-APR-2010 at 40 weeks 3 days gestation. There are no congenial anomalies and no other complications or abnormalities. The patient had was positive for Group B streptococci. Other medication used during pregnancy were ZOFRAN, iron (unspecified), KEFLEX. Lab test included ultrasound, non-stress test (NST) and Amniotic Fluid Index test (AFI), results not reported. No further information is available.
Pt vaccinated with Pneumococcal/Flu experienced pain, then swelling at site.