chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; the patient received an improperly stored dose of PROQUAD (S008578, expiration 9/16/2020) on 10/15/2019; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. The patients' concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.      On 15-OCT-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #: S008578, expiration date: 16-SEP-2020) and sterile diluent (lot #: S007959, expiration date: 19-AUG-2021)  (strength, dose, frequency and route of administration were not provided) as prophylaxis (product storage error). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and sterile diluent were exposed to temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours and 35 minutes, and 15  degrees Fahrenheit to 46  degrees Fahrenheit  (16.3  degrees Fahrenheit) for 44 minutes. No previous excursions were reported. The data logger was involved. No adverse effects were reported.
Nausea. Overall muscle aches. Migraines that responded to the 2 different drugs lists, but manifested repeatedly such that the nausea and very severe head pain woke me. My response was to take a different drug in each 24 hour period. Using sumatriptan first and then 24 hours later after the pain ceased and then reestablished itself, using Migrainol, and so on. The drugs worked, but the projectile vomiting and head pain consistently came and went. Injection #1 was a bit shorter and slightly less intense, but the last time I experienced projectile vomiting due to migraines was in 1999.
Dermatitis on left arm 3 inch radius around injection site. Stomach pain and diarrhea 3 days after shot.
15March2021: 10:30 am, received 1st dose, no reactions  12April2021: 10:30 am, received 2nd dose. 9:00 pm, 100 degree fever, took Advil (1 tablet), slept well 13April2021: 7:00 am, 101.5 degree fever, body aches, took Advil (1 tablet every 3 hours), low appetite, fatigue all day and into night  14April2021: 7:30 am, recovered
Mother describes prolonged bouts of crying and screaming up to 36-48hr from vaccines.
Intermittently in the weeks to months after the vaccination I would have days of increased joint pain and fatigue more than before the vaccine.  I will occasionally feel fatigued and ill, as if I am going to have a moderate to severe viral infection, but will feel better after 1-2 days.  This feels more intense than before the vaccine.
Over 35 days since 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Over 35 days since 1st dose of vaccine) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Over 35 days since 1st dose of vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Over 35 days since 1st dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.
Tested positive for COVID-19 on 3/7, likely an incidental finding. Died of liver cancer 3/17.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. Later in 2014, the patient was treated for the onset of severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
accidently used before realizing the shipment was frozen with no AE; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/Non-healthcare professional via call center via Medical Information (reference number- 00814783).  This case is linked to cases 2021SA345065, 2021SA345236, 2021SA345205, 2021SA345076 and 2021SA344344(CLUSTER).  This case involves a 70-year-old male patient who accidently received frozen vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 15-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ716AA and expiry date: 30-Jun-2022) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to product storage error temperature too low.  It was reported "Can you please contact this customer re the stability of Influenza vaccines. Customer received their Influenza vaccines and a portion of the doses were frozen. They have administered some of the doses that they claim were not frozen. To Whom it May Concern, I am requesting information on how to return the flu vaccines that we received this year. We have 9 boxes of high-dose flu vaccines and 4 boxes of regular flu vaccines. They came to our office frozen, and therefore are no longer viable. We need to return these vaccines and get a refund."  At the time of reporting, no adverse event was reported.  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.
"Four hours after getting vaccinated he started to feel really cold and began shaking. At 6 hours he was very cold, violently shaking and had a temperature of 102.3. I got his temperature down to normal 6 hours later. He was exhausted the next day, but is fine now."
Patient had 2 doses of Moderna on 2/16/21, and 1/19/21, and was hospitalized with COVID on 1/14/22, and remains hospitalized today, 1/17/22
Fever, chills, body aches, severe headache, nausea, vomiting
Suspected bursitis with prolonged arm pain and weakness 2 weeks after first Pfizer dose. On the day of vaccination, I had a panic attack and nearly blacked out after vaccination, something that had never happened to me after a vaccination. Once the pain started a few hours after vaccination, it significantly increased. I experienced excruciating pain in my left arm like I had never felt after any other vaccination. Complete inability to move my arm without pain; the pain persisted even with zero movement whatsoever. Within the first 12 hours the pain spread to my entire left shoulder, and within 24 hours the pain spread to my neck, and general upper left quadrant of my body to the point where inhaling deeply would cause chest pain on my left side. This extreme pain persisted for about 3-4 days. After about the 5th day, my left arm still felt different and weaker than my right arm but little pain remained. After the 7th day, pain started back up whenever I tried to use my arm in any way. The days went on and the pain and arm weakness is not passing. It is minor pains, aches, and occasional throbbing compared to those first few days after vaccination but chronic pain nonetheless. My left arm continues to feel weak and I have a concentrated area of pain directly where the vaccination site was, it's as if I could still feel exactly where the needle went through my body. My arm feels okay pain-wise upon waking most days but I am unable to do anything as simple as chopping vegetables or washing dishes without feeling pain for the rest of the day. I am unable to even wear a backpack for more than 10 minutes without my left shoulder hurting and feeling fatigued.
expired dose of Menactra was administered to patient, no AE; Initial information was received on 23-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 11 year old female patient who received a 0.5 ml expired first primary dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U6219BA, expiry date: 16-Jun-2020) via an unknown route in the right deltoid for prophylactic vaccination on 01-Jul-2020.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE (HPV VACCINE) for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of reporting, no adverse event reported.  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.
A nurse reported that a 71 year old male received an injection of Pnu-Imune 23 on 01/18/01. The following day, the patient developed "severe" swelling at the injection site extending from the shoulder to below the elbow. The reporter stated that the reaction "progressed to a cellulitis". He recovered.  This is 1 of 2 patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 469-401. Follow-up info received on 06/26/01 indicated that the patient developed "increased" swelling. He was seen in an ER and treated with Rocephin and doxycycline. The patient was diagnosed with cellulitis and an allergic reaction. He recovered in 1 week.
Information has been received from a health professional concerning a patient who was vaccinated with a dose of Varivax. It was reported that the patient experienced slight stinging or a little pain. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Migraine, light headed, severe chills,  severe nausea, fever 104.3. Severe asthma attack / almost anaphylaxis,  severe sweating, passed out 3 or 4 times, could not eat or drink,
Headache,  (Gave Tylenol for headache & Temp) small rise in temp 99.9 Ache in body ( slept earlier than usual due to feeling really exhausted) cold & hot feeling throughout body.  woke up spitting up mucus and stating throat feels a bit uncomfortable. feeling hot and is fanning self.
Patient reported pain traveling up from injection site on arm up through shoulder and neck and a white bump that developed under the vaccination site and traveled down the arm. The patient also reported hives developing on the arm and leg below. She reported symptom resolution by day of report on 10/3/2019 and hive resolution 2 days after treating with Benadryl at home.
My symptoms started on 03/15/2021 I started to feel dizzy and blood pressure was elevated right after the injection.  I was prescribed Hydrochlorothiazide for my symptoms.
This case was reported by a physician via a sales representative and described the occurrence of GUILLAIN BARRE syndrome in a subject of unspecified age and gender who was vaccinated with Tdap (with small D & P) (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Tdap (with small D & P) (unknown). At an unspecified time after vaccination with Tdap (with small D & P), the subject experienced GUILLAIN BARRE syndrome. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. No additional details were reported.
9 year old female patient was inadvertently administered with Flublok vaccine, no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with case 2019SA262697 (same reporter)  This case involves a 9 years old female patient who was inadvertently received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1913, expiry date: 29-Jun-2020) via intramuscular route in the deltoid NOS on 16-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) on 16-Sep-2019, for Immunisation.  It was an actual medication error due to inappropriate age at vaccine administration.  Flublok is not FDA-approved for use in pediatric patients. Nurse stated that neither patient has experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Information has been received from a pharm D that a medical assistant stated that a 17 year old female patient who on 21-NOV-2008 was vaccinated with PNEUMOVAX. On 21-NOV-2008 the patient developed "serious cellulitis" and was treated with IV antibiotics in the Emergency room. The patient was completely symptom free as of 25-NOV-2008. This is one of several reports from the same reporter. Additional information has been requested.
Admission Date: 7/28/2022 Discharge Date: 8/2/2022  HOSPITAL COURSE: Pt is a 35 yo G7P3033 at 36wk admitted to hospital with sepsis due to covid pneumonia. She was started on antivirals and steriods. She did require oxygen. By hospital day 5 she was no longer requiring supplemental oxygen. She was discharged home in stable condition to complete her course of azithromycin and methylprednisolone. She will need to complete another 5 days of prophylactic heparin.   Patient did not deliver during hospital stay and is currently still pregnant. Fetal well being: -  Cat I: baseline 150 bpm, moderate variability, accels present, decels absent              - initially had fetal tachycardia in 160s for 20 minutes but resolved - US 7/6/22: EFW 2213, 57%ile | AC 63%ile | AFI 10cm | anterior placenta  EDD:    08/24/22
101 fever; arm site pain; body ache; scratchy throat; chest pain; headache; no appetite; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 at 17:45 as dose 3 (booster), single (Lot number: GJ6739) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "rheumatoid arthritis fingers" (unspecified if ongoing), notes: rheumatold arthritis fingers; "sickle cell trait" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "allergy to unspecified drug" (unspecified if ongoing), notes: unspecified drug used for nerve pain; "nerve pain" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing); "food allergy" (unspecified if ongoing), notes: unspecified variety of food. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number=EW0181,, Administration time=03:30 PM,, Vaccine location=Left arm), administration date: 16Jun2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number=EW0181,, Administration time=12:30 PM,, Vaccine location=Left arm), administration date: 07Jul2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "101 fever"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "arm site pain"; PAIN (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "body ache"; CHEST PAIN (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering"; HEADACHE (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "no appetite"; THROAT IRRITATION (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "scratchy throat"; FATIGUE (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vaccination site pain, pain, throat irritation, chest pain, headache, decreased appetite, fatigue. Additional information: other medications in two weeks included blood pressure medicines, multi vitamins and minerals.
Tested negative on last day of treatmentTested positive following day Symptoms returned Still symptomic; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested negative on last day of treatmentTested positive following day Symptoms returned Still symptomic) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) from January 2001 to an unknown date, ESZOPICLONE (LUNESTA) from January 2014 to an unknown date and ATORVASTATIN CALCIUM (LIPITOR) from January 2005 to an unknown date for an unknown indication.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022 at 2:00 PM, the patient experienced COVID-19 (Tested negative on last day of treatmentTested positive following day Symptoms returned Still symptomic). At the time of the report, COVID-19 (Tested negative on last day of treatmentTested positive following day Symptoms returned Still symptomic) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: negative (Negative) negative. On 26-Apr-2022, SARS-CoV-2 test: positive (Positive) positive.          Co-suspect product included non-company product, unspecified Pfizer medication for treatment of COVID-19. The patient received an unspecified Pfizer medication (unknown route) from  21-Apr-2022 to 25-Apr-2022 at an unspecified dose.  Treatment was not received.  Company comment- This spontaneous case concerns a 63-year-old female, with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19  approximately 5 months after vaccination with a third dose of mRNA-1273. No further information was provided. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old female, with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19  approximately 5 months after vaccination with a third dose of mRNA-1273. No further information was provided. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a registered nurse via a company representative referring to a female patient of unknown age. No concurrent or historical conditions were reported. On an unknown dates, the patient was separately vaccinated with 3 doses of RECOMBIVAX HB (strength, dose, route, lot# and expiration date unknown). There was no concomitant medication reported. On an unknown date, the patient was performed the lab test of Hepatitis B antibody titers and had been determined to have negative Hepatitis B antibody titers. The patient sought unspecified medical attention and no treatment was performed to her. At the time of reporting, the outcome of the event was unknown. Causality between the event and RECOMBIVAX HB was not reported. Additional information is not expected since the reporter would not like to be contacted.
Post-influenza vaccination myelitis per the patient's neurologist and various other doctors. Patient lost sensation in lower extremities and was paralyzed for several days. Patient has since regained some strength and is able to walk for now. Patient estimates that he has about 30% sensation in lower extremities, but will never regain 100% sensation. Patient also unable to engage in sexual functions at the present time.
6/25/2022 Sounded nasally with chest congestion, 6/26 early woke up with body aches, headache, and felt feverish.  6/27 Tested with At Home COVID 19 Test, positive.  Televisit with  doctor who prescribed Azithromycin, and delsym cough syrup.  Over the next couple of days I developed an ear ache, sore throat,  eye swelling.  Symptoms have been improving since 7/23, but there is lingering congestion and athsma.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild
Within 15-minutes of vaccination, the patient became lightheaded. EMS managed their condition on-site.
23JUL96 11AM mild local raised welt over TB skin test;t100, achy joints, puffiness around eyes & both hands;later in day mouth & throat felt thick;24JUL96 saw MD, rx DPH, APAP & fluids;25JUL96 sting like sunburn to touch (hot & sore);
Information has been received concerning a 10 year old patient who was vaccinated with the first dose of VARIVAX (Merck) (Lot # not reported). Currently, the patient presented with mild case of the chickenpox after receiving the first dose of VARIVAX (Merck). The patient did not seek medical attention. At the time of reporting, the patient was recovering. The patient's sibling also presented with a mild case of the chickenpox after received the first dose of VARIVAX (Merck) (WAES#1009USA00534). No further information is available.