chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 4 year old female who on 04-AUG-2010 was vaccinated subcutaneously with ZOSTAVAX (Merck) (lot number 665431/1744Y). It was reported that the patient was intended to receive the second dose of VARIVAX (Merck), and was inadvertently administered a dose of ZOSTAVAX (Merck). No adverse symptoms reported. The nurse added that the first dose of VARIVAX (Merck) was administered on 22-MAY-2007. Additional information has been requested.
Per patient's daughter, her mother experienced shaking and chills and confusion about 3 hours after injection. The daughter described what she thought was cellulitis down her arm past her elbow. She also had a rash on her torso. She had no fever. No medical treatment was sought and symptoms resolved on their own.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Both childs thighs were red and swollen within 24 hours of injection.  Treated with Keflex and Benadryl on 1/25/07 at PCC Wellness.
Got my 2nd dose yesterday and now I am feeling really bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got my 2nd dose yesterday and now I am feeling really bad) 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.    In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced VACCINATION COMPLICATION (Got my 2nd dose yesterday and now I am feeling really bad). At the time of the report, VACCINATION COMPLICATION (Got my 2nd dose yesterday and now I am feeling really bad) outcome was unknown.            Concomitant medication were not reported. Treatment information was not reported.
Approximately 8 hrs after vaccination, pt developed a 9 cm X 6 cm raised, indurated, erythemic localized injection site reaction which worsened over the next 24 hrs. to include subjective c/o right upper arm numbness. Pt advised to take Claritan, benadryl, and HCT 1% cream with modest improvement, Once seen at Hospital Occupational Medicine Center today, pt was advised to take Claritan 10 mg in the morning, apply Triamcinolone  0.3% ointment to affected area TID. to QID, then take benadryl 25 mg at HS until follow-up on 7/6/2020. Pt advised she may also apply cool compresses to area for comfort. Pt denied CP, SOB, fever, facial edema, difficulty breathing or swallowing.  DTRs 2+ and intact to RUE. 2 point discrimination intact to RUE.
Abdominal pain.    Diarrhea.     Vomiting.     Headache
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during peak of flue season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
shivers; body aches; nausea; loss of appetite; "sick feeling and in bed all day"; "sick feeling and in bed all day"; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, shivers, general body pain, nausea, appetite lost, feeling unwell and bedridden. On an unknown date, the outcome of the pain in arm, shivers, general body pain, nausea, appetite lost, feeling unwell and bedridden were recovered/resolved.   It was unknown if the reporter considered the pain in arm, shivers, general body pain, nausea, appetite lost, feeling unwell and bedridden to be related to Shingrix.  Additional details were received as follows: The reporter reported, that his wife's aunt, had dose 2 of Shingrix and developed a sore arm, nausea, loss of appetite, stayed in bed sick for a day, shivers, and body aches. He states she told him this lasted for twenty-four hours and resolved. The reporter consented to follow up. The reporter had no additional details for this AE. This case was linked with case US2020049313, reported by the same reporter.
During the first attempt vaccine leaked from the injection site, and a complete dose was not administered. A second attempt was completed, and was successful. Physical adverse event occured.
received 0.25 ml instead of 0.5 ml; First dose on 13-NOV-2021 and second dose on 18-Jan-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml instead of 0.5 ml) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-NOV-2021 and second dose on 18-Jan-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21A and 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 13-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-NOV-2021 and second dose on 18-Jan-2022). On 18-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml instead of 0.5 ml). On 13-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-NOV-2021 and second dose on 18-Jan-2022) had resolved. On 18-Jan-2022, ACCIDENTAL UNDERDOSE (received 0.25 ml instead of 0.5 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Double vision (specifically seeing multiple lines of text above and below each other) Extreme "brain fog", suddenly unable to remember words or how to spell them, difficulty doing work related tasks due to such ringing in ear
pt brought to ED via EMS; pt unresponsive when EMS arrived; found to have low blood sugar; given IV D5W; had an episode like a seizure before getting to ED, shaking and pink, frothy sputum noted; intubated in ED; admitted; experienced hypertensive crisis; found to be positive for COVID; given ABX, steroids; AKI on CKD stage III; hemodialysis; suffered PEA arrest; poor prognosis; inpatient hospice GIP; palliatively extubated and pt passed away in the hospital; med records and death certificate sent per VAERS request
Pain at injection site and in shoulder since 2 days past injection until now (2 1/2 months). Probably SIRVA is my guess (shoulder injury related to vaccine administration). Pain is getting worse not better and will be following up soon with primary doctor. Hurts to move left arm when utilizing muscle at injection site.
This spontaneous report as received from a registered nurse refers to an unspecified number of children. The patients were vaccinated with a dose of improperly stored GARDASIL (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This case is lined with AER # 2013-08998 (same patient who developed injection site redness, warmth and itching after taking FLUZONE High Dose on 14 AUGUST 2013 and same reporter). Initial report received from a healthcare professional on 19 AUGUST 2013. A female patient whose age at the time of event, medical history and concomitant medications were not reported, had received a dose of FLUZONE  SV 2012-2013 (batch number,  exact dose number, route and site of administration were not reported) on 30 JULY 2012. On an unspecified date, the patient had an unspecified adverse event. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Patient returned to pharmacy counter within 5 min of receiving vaccination complaining of itching/tingling sensation.  Very flushed neck & face with rapid breaths & difficulty breathing.  Condition was not improving after several months, so I called 9-1-1 & administered 1 dose of EPINEPHRINE.  EMS arrived & transport to ER.
This is spontaneous report received from a contactable consumer. This consumer (other non-HCP) reported for 48-year-old male patient that who received bnt162b2 (BNT162B2) solution for injection, dose 2 (Batch/Lot Number: EN6203) via an unspecified route of administration in arm left on 28Feb2021 08:00 (at the age of 48-years-old) as dose 2 single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. No seriousness criteria results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Disabling/Incapacitating, Congenital anomaly/birth defect. Historical Vaccine dose 1 BNT162B2 (Lot number=EM9809) via unspecified route of administration on 07Feb2021 08:30 AM as a dose 1 single for COVID-19 immunisation. The patient reported the symptoms to me when he started experiencing the symptoms on Sunday night, Feb28th (on 28Feb2021 22:00) and also when they worsened by Monday, Mar1. He is still experiencing some fatigue, and dizziness/light-headedness today, but says symptoms have improved. On 01Mar2021 we received a safety report from you for a patient named (initial) about experiencing some adverse event after COVID-19 vaccination. As the awareness date sometimes is not specified in the reporting system; he is asking could you please confirm on which date you became aware of the events and. who provided the first-hand knowledge of the events to you. This will help with the processing of Pfizer safety report and follow up activities. Please refer to the report in attachment for more information. Thanks in advance. Outcome off the events was not recovered. No follow-up attempts are needed. No further information is expected.
The place where I received my flu shot is very sore. It has been over 2 weeks and it is painful to lift my arm.
Information has been received from a health professional concerning an 18-week-old patient who on 01-SEP-2006 was vaccinated with a subcutaneous injection of a dose of MMR II instead of hib conj vaccine (OMPC). The health professional states this was not "confusion" between the two vaccines. No problems were reported. It is unspecified if medical attention was sought. No product quality complaint was involved. Follow up information received from a doctor states "inadequate patient information. We know of no adverse reaction recently". No more information is expected.
High fever 103.2 (rectal) X 2d very fussy - high pitch screaming
vomiting "non stop/ she puked too; diarrhea; always sleeping/ sleeping a lot; not really eaten anything because when she does she vomit it back up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 21 year-old female patient received bnt162b2 (BNT162B2), administration date 18May2021 10:00 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: verbatim: Diabetes. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: VOMITING (non-serious) with onset 18May2021, outcome "unknown", described as "vomiting "non stop/ she puked too"; DIARRHOEA (non-serious) with onset 18May2021, outcome "unknown", described as "diarrhea"; SOMNOLENCE (non-serious) with onset 18May2021, outcome "unknown", described as "always sleeping/ sleeping a lot"; FEELING ABNORMAL (non-serious) with onset 18May2021, outcome "unknown", described as "not really eaten anything because when she does she vomit it back up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, diarrhoea, somnolence, feeling abnormal.  Additional Information: Reporter stated, "Orally, one in the morning and one in the afternoon. It is a tablet. After she got the Pfizer vaccine(Further not clarified hence captured as unspecified vaccine) and ever since she has been vomiting non stop and she's diabetic(Confirmed as other medical condition) as well. She is been like she is going high then she has been vomiting non stop and she is been sleeping a lot, she has not really eaten anything because when she does she vomit it back up and that's the another thing I want to ask if she can eat? What can she eat specifically like a soup or something on to keep her on, she's been drinking water and ginger. What? She vomited it back up. Reporter stated, "No, She hasn't just her Metformin the medication has been started for her diabetes." Still experiencing: Reporter stated, "No, no because she vomited four times yesterday then check her arm temperature it was fine and then we were actually driving in and on a highway she was vomiting again and we have to like park the car have it on."  No follow-up attempts are possible. No further information is expected.
Arm pain, numbness in fingers, extreme fatigue, raising temperature 99.8-100.2 with Tylenol and Advil, vomiting following morning 2x, back pain following afternoon, followed by neck pain and stiffness for 48 hours and counting, sore throat started after 36 hours and still remains, headache followed after 48 hours.
experienced covid vaccine made patient faint; Lost weight; This is a solicited report from a Study (FACILITATED COLLECT) based on information received by Pfizer from AbbVie, manufacturer control number:21K-163-4138882-00). A contactable 41-year-old male consumer (patient) reported that:  Solicited report by a consumer of a 41-year-old male with events of non-serious covid vaccine made patient faint and lost weight with HUMIRA(ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced lost weight. On 01Jun2021, the patient experienced covid vaccine made patient faint. On an unknown date, covid vaccine made patient faint resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Jun2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 22 Jun 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of covid vaccine made patient faint and lost weight was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
symptoms earlier and tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (symptoms earlier and tested positive for COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced COVID-19 (symptoms earlier and tested positive for COVID). At the time of the report, COVID-19 (symptoms earlier and tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported. No treatment information was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine (unknown dose number and schedule of vaccination). SARS-CoV-2 test was positive as on 29-Sep-2021. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was unknown. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine (unknown dose number and schedule of vaccination). SARS-CoV-2 test was positive as on 29-Sep-2021. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was unknown. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Same day post vax, the pt experienced a severe headache and vomiting. The reportedly went into anaphylaxis. Pt became dehydrated and was admitted to the ER. Physician prescribed Alleve.
Pt received three vaccinations at time of visit. Immediately after receiving final vaccine, patient fainted from treatment bed. Patient lost consciousness and hit face on the floor knocking out two front right teeth. Patient took approximately 30 seconds to rouse but was still somnolent. Patient oriented to person, place, and time. Vital signs taken BP 130/76 HR 81 PaO2 100% on room air and 14 breathes/min. Rapid response called, ER arrived to evaluate patient. Pt escorted onto gurney and brought to ER to be further evaluated.
DONOR REPORTS HA AND NAUSEA APPROX 1 HR FOLLOWING IMMUNIZATION. NO OTHER C/O.
Received call from patient on 3/3/2021. She reports that approximately 1.5hrs after receiving her COVID vaccine, she began having pain in the top of her head, neck, between her shoulder blades, down both arms to her fingertips, and down her spine.  Reports also began having swelling in her feet. Reports having nausea and pain in her chest with walking. She reports she already had trouble with ambulation prior to vaccine, but it has been worse since receiving the vaccine. She reports as of 3/3/21, the pain is still occurring and not getting better.  She has not seen her primary doctor since being vaccinated. I encouraged her to speak with her doctor or schedule a visit with them as her pain is not improving.
The patient received the vaccine indicated for 6 to 11 years old.  So she received half of the recommended dose.
No adverse effects were reported in the patient.; a patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.           On 29-OCT-2019 the patient was vaccinated with one dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, route, strength, lot # and expiration date were not reported) for prophylaxis.  Administered dose of vaccine experienced temperature excursion of below 36 Fahrenheit degrees (2 Celsius degree) (also reported as 35 Fahrenheit degrees) for 430 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported in the patient.
Fever approx. 100.5 degrees from 3:00, 11/15/02 until 11/17/02, treated with Children's Ibuprofen; Vomitting 2:30AM 11/16/02; Acted dizzy 11/15/02;
Pt states having an allergy to mercury. States in the past she has received flu shots that didn't have mercury in it. States symptoms started approx 10 minutes after receiving the flu shot in L deltoid. No noticeable redness or rash localized to area of injection. Pt states her lips, tongue and lower jaw feels tingly. States that she feels like the lymph nodes in her neck feel swollen. Pt denies any problems swallowing. States her throat is a little sore from snoring last night. Speaking in full sentences, denies any trouble breathing. In no noticeable respiratory distress. Lung sounds CTA. SpO2 97% RA. Diphenhydramine 25 mg once, ranitidine 50 mg once, methylprednisolone 125 mg once.
Within 15-minutes of vaccination, the patient reported a tingling sensation in their tongue. There were no signs of swelling or airway changes. Patient was supervised on-site by EMS.
I had no significant adverse reactions after the vaccine except a little sore arm.  About 2 to 2.5 weeks later,  a rash appear on my left hand.  It was large, red with blisters that started between the index and middle finger and spread across the palm of my hand and up the little finger.  It was red patches with blisters.  It was not painful and just a little itchy.  I went to see my doctor and was advised that it may be an immunological reaction and treated me with steroids- Prednisone.  Within a day of starting prednisone, it started to significantly improve.   It took about 10 days for the rash to resolve.