chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Licensed Nurse Practitioner (L.P.N) referring to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 19-FEB-2016 the patient was inadvertently vaccinated with a dose of expired RECOMBIVAX HB (lot # J012567, expiration date 30-JAN-2016 (dose number, dose and route were not reported) in the immunization series. Concomitant drug was not reported. No adverse effect was reported. Additional information has been requested.
Dizziness; headache; Muscle pain/stiffness; Muscle pain/stiffness; This is a spontaneous report from a contactable health professional (patient). A 55-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231, vaccine location: left arm) via an unspecified route of administration on 12Jan2021 05:00 pm at hospital at single dose for COVID-19 immunization. Medical history included high blood pressure and migraine. Concomitant medication in two weeks included atenolol, furosemide, bupropion hydrochloride (WELLBUTRIN), hyoscyamine and magnesium. Patient had not had COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. The patient was not pregnant. No other vaccine was received in four weeks. The patient previously took first dose of bnt162b2 (lot number El0140, vaccine location: left arm) at the age of 55 years on 22Dec2020 05:15 pm for COVID-19 immunization. Known allergies included tetracycline, montelukast sodium (SINGULAIR), nifedipine, hydrochlorothiazide (HCTZ), erythromycin and sumatriptan. The patient experienced dizziness, headache, muscle pain or stiffness on 12Jan2021 06: 00 pm. No treatment was received for all events. The outcome of the events was not recovered.
No adverse event; Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received either the 4th or the 5th dose. No concomitant medication was reported.  The expiry date for the suspect was reported as 01-JUN-2023. It was also reported that one of the patient had COVID-19.  No treatment information was reported.  This case was reported for elderly patient out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-728519 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728519: Case(Patient 1)
left-sided Bell's palsy. Referral to the facial palsy clinic for further work-up.
Patient experienced aching, fever, diarrhea that started 12/30/20. Symptoms continued adding chills , body aches, and vomiting over the next several days leading to an Emergency Room visit on 1/4/20.
PATIENT REPORTS THAT HIS ARM STILL HURTS (REPORTED TO PHARMACIST ON 4/19/19) AFTER GETTING THE FLU SHOT. PATIENT RECEIVED THE FLU SHOT ON 03/23/2019
client received moderna for first dose and is back today and received second dose of moderna and is 17yo.
Headache, Myalgia, INJECTION SITE ARM PAIN, CHILLS, FATIGUE
Developed hives/facial swelling, local itching within 5 minutes of vaccine. Required EpiPen administration.
expected 2-2:30 vaccine and later the right deltoid was sore, 5am woke up to 101 temp, took Ibuprophen and Tylenol but it kept going to several hours, then on hour 36 i had feeling like i was crawling out of my skin and I'm anxious about all of this, I felt clamy and decided to make an appointment about all of this. I got blood work today with  it showed my WBC was down to 4 and my normal WBC is usually at 6 and I am frequently checked and always normal. because of kidney stones I get checked regularly. I was told to get a covid test and will have the blood test run again on Monday to see if its back to normal. I wonder if this has anything to do with my auto immune disease as well. also back and neck aches and pains.
3 hours after taking the 3rd dose of VIVOTIF, I began having stomach cramps in waves that were painful enough that I had to leave work. I also was sweating and shaking (I had a 100 degree fever later that night). 2 hours later I vomited, following by another instance of vomiting an hour later. Taking anti-nausea medication helped with the vomiting, but extremely painful stomach cramps continued over the next roughly 30 hours.
6 hours after receiving vaccines (and immediately after intense football practice on hot day) patient developed fever to 102.2, chills, and aches, symptoms lasted 2 1/2 hours, then resolved after IV fluids, and ibuprofen. No further symptoms.
Large, raised red patch covering most of upper left thigh where vaccine was administered. Hot to the touch, though no fever is present. Child says it does not itch or hurt.
This is a spontaneous report from a contactable female consumer reported for her husband and one other person. This case is for her husband. An 83-year-old patient received PREVNAR 13 via an unspecified route of administration at 0.5 ml, single in the arm on 30Jun2015. Medical history included ongoing short of breath. The patient's concomitant medications were not reported. The patient experienced coughing on 01Jul2015 or 02Jul2015 that required hospitalization with outcome of recovering, due to extreme coughing, airway to his right lung was collapsed 90% and to his left lung 80% on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of coughing included acetylcysteine nebulizer. Reporter mentioned that her husband was doctored four days and there was tried to clean out his (consumer) lungs, but because of his bad coughing they could not get it all done.
suspected vaccination failure; got it; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The case was reported for the reporter's grandmother. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient was in misery for months. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Left leg swollen from mid thigh to just below knee, afebrile, no redness at site, no pitting edema - child denies pain.  Instructed mother to use cold compresses, Motrin every 8 hours.
Went to bed fine,  became restless and couldn?t sleep. Chilled throughout body for 2 and 1/2 hours, had a headache and body aches all over. Rated 8/10. Mostly slept for three days.  Felt like I had the flu yet tested negative for Covid and flu on Thursday, Dec.3rd.  Low grade fever for three days with body aches.  Body aches and headache 10/10 on Friday, day 2.  Had a frontal headache daily through yesterday.
Initial report was retrieved via a search of scientific literature on 14 May 2014. This case contains information for 1 of 5 patients whose clinical data were provided. Information regarding the other 4 patients are captured in case numbers 2014SA063502, 2014SA063511, 2014SA063512, and 2014SA063514. Verbatim from the abstract: Background: Fever, leukocytosis, and large local reactions following the pneumococcal polysaccharide vaccine (PS23) have been described only in isolated case reports in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experiencing this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. Observations: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arms had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. Conclusions: This case series highlights potential side effects of the PS23 vaccine that are not well described in the adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. A 43-year-old female patient (referred to as "patient 4"), received the following vaccines on an unspecified date: a left arm injection of Influenza Vaccine (manufacturer and lot number not reported); a right arm injection of Tdap (manufacturer and lot number not reported); and a left arm injection of Pneumococcal (Polysaccharide) (23 Serotypes) Vaccine (manufacturer and lot number not reported) The patient had a history of asthma. Within 24 hours of vaccination, she experienced systemic symptoms including fever of 102.8 degree Fahrenheit and rigors, with local inflammation including erythema, swelling, and warmth. Within three to four days post-vaccination the local reaction extended well beyond the immediate injection area. She sought medical care for her symptoms, and was found to have significant leukocytosis with white blood count of 22. She was not admitted to the hospital; treatment was not reported. Within five to seven days all systemic symptoms had resolved, and the patient experienced improvement of skin findings. Documents held by sender: None.
vial was exposed to 9-10 °C for 3 - 4 days with no reported adverse event; they did administer one vaccine to one person with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient with unknown demographics they did administer one vaccine to one person after influenza quadrival A-B multidose vaccine preserved [Fluzone Quadrivalent Multidose] vial was exposed to 9-10 °c for 3 - 4 days with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved Suspension for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and vial was exposed to 9-10 °c for 3 - 4 days with no reported adverse event (product storage error).  On an unknown date they did administer one vaccine to one person with no reported adverse event (poor quality product administered) on the same day following the administration of Influenza Quadrival A-B Multidose Vaccine Preserved.  Reportedly, She states that they normally keep the Fluzone Quadrivalent MDV in the refrigerator but it "went bad" according to the temperature gauge and they did administer one vaccine to one person, and she would like to know what side effects the patient might experience. She states that the MDV vial was exposed to 9-10 °C for 3 - 4 days. It was not confirmed that it was an opened MDV. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event vial was exposed to 9-10 °c for 3 - 4 days with no reported adverse event and was Unknown for the event they did administer one vaccine to one person with no reported 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 the 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.
patient received both the adjuvant and a full dose of Shingrix; patient received both the adjuvant and a full dose of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-JUN-2023, the patient received Shingrix. On 20-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received both the adjuvant and a full dose of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient received both the adjuvant and a full dose of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 3-JUL-2023 A nurse practitioner called in to report that a patient received both the adjuvant and a full dose of Shingrix and wished to know if there was any information. The Vaccine Administration Facility was the same as primary reporter. Partial information about vaccine, patient and event collected.  Follow up was declined. Did not consent to follow-up.
The injection site swollen and painful; The injection site swollen and painful; That side felt a little heavy; This is a spontaneous report from a contactable consumer(patient). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration at left arm on 09Feb2021 11:30 as single dose for Covid-19 immunization. Patient was 39 years old at the time of vaccination. Medical history included Lupus, autoimmune arthritis, vitamin D deficiency, anemia and high blood pressure. Patient was tested positive for covid-19 prior to vaccination. The patient previously took Reglan and experienced allergy. On 09Feb2021 at 05:30 PM the patient had injection site swollen and painful and that side felt a little heavy. Outcome of the events was recovering.
Sore right arm, but not too much, after 2nd dose; Patient felt so tired , like she could not function,like was drunk; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right arm, but not too much, after 2nd dose) and FATIGUE (Patient felt so tired , like she could not function,like was drunk) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M70A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Asthma, Dust allergy, Grass allergy, Allergy to molds, Allergy to plants, Drug allergy (to Catfcan, sulfites, Tylenol, Sulfar, Codeine, Erythromycin, Vancomycin, Doxycycline, and very sensitive to Epinephrine.) and Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, CLOPIDOGREL BISULFATE (PLAVIX), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLOVENT), MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), FLUTICASONE PROPIONATE and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore right arm, but not too much, after 2nd dose). 19-Mar-2021, the patient experienced FATIGUE (Patient felt so tired , like she could not function,like was drunk). On 20-Mar-2021, VACCINATION SITE PAIN (Sore right arm, but not too much, after 2nd dose) and FATIGUE (Patient felt so tired , like she could not function,like was drunk) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) but her antibodies were incredibly low, on 11 instead of hundreds..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided   This case was linked to MOD-2022-474541, MOD-2022-474731 (Patient Link).
Narrative:  Patient received Moderna COVID-19 vaccine via drive thru clinic. The patient was in his vehicle with his wife, when he became diaphoretic and passed out for a couple minutes. Rapid response was called. Patient was removed from the vehicle. He was becoming obtunded and was placed on the pavement. 911 was called. He was given EpiPen at 10:41. His vital signs at 1042 were: saturation 98% on room air, pulse 59, blood pressure 138/80. Patient received Solu-Medrol 125 mg IM a couple of minutes after EpiPen. After the EpiPen the patient became more alert, denied shortness of breath or wheezing, he was nauseated without vomiting. His saturation at that point dropped to 88% on room air, he was started on oxygen with nonrebreather mask. Rescue truck arrived at approximately 1047, and the patient was taken to emergency room. Discharged same day.
pt recd imz fri night. arm started to swell some and get red and painful. over the next 72 hrs symptoms remained the same and pt developed a slight fever. pts husband came in today 10/19/2020 monday and reported the reaction and showed me a pic on his phone. directed caregiver to reach out to the md to rule out infection.
Left thigh 15 cm round area swelling. Tx with Augmentin, Benadryl and Motrin.
Tested COVID-19 positive, resulted in hospital admission. Symptoms include  shortness of breath and fatigue. Illness caused pnuemonia and acute respiratory distress syndrome.
Provider dischage summary "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) is a 67 year old male with history of ALS, T2DM, HTN, HLD presents to ED via EMS for evaluation of weakness. Patient lives at home alone and has home health care, he is established with staff. Patient unable to provide history for me during evaluation as he is nonverbal, HPI provided by chart review of ED note. Per ED note Per EMS, they are familiar with the patient and he is able to ambulate usually with a walker.  However today, they got called to his house 4 times today for list assist due to ongoing falls.  The patient can hear but he cannot speak.  He can write somewhat to help communicate.  He is complaining of a mild headache.  Denies chest pain, abdominal pain, vomiting or other complaints.  I spoke with staff, they state that the patient has been progressively worsening due to his ALS and is not doing well at home during the hours that he is by himself.  He does live home alone with his home health care which is approximately 40 hours of home health care week.  They feel that he does need a higher level of care and ultimately he will be transitioning to hospice but he is not quite at that level yet. (HPI per, PA)   Hospital Course: No notes on file Failure to thrive in adult, Hx of ALS, increased weakness, falls, COVID 19  - CXR no acute pulmonary disease  - Oxygen Therapy per protocol - Received Regeneron - Continue Supportive Care with Tylenol - poor PO intake - PT/OT/SLP recommendations reviewed and appreciated,  NDD I with Nectar thickened liquids, meds whole or crushed in puree. Refusing to eat - Suction prn - Discharged on 12/29 with hospice   Discharge Exam: General - Elderly male, severe debility HEENT - NC AT Heart - S1 S2 RRR Lung - Moderate air entry Ext - No LE edema Neuro - Largely non-verbal, awake and able to move limbs and suction self"
Four days post vax, the pt complained of a funny feeling in the arm into which the vaccinee was injected. The symptoms progressed to weakness in the injection arm, which persisted as of 7/19/99. The pt was seen by a neurologist.
Pain and swelling in the left axilla.; Pain and swelling in the left axilla.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 09:45 (Lot number: EW0217) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mitral valve replacement", start date: 1982 (unspecified if ongoing); "prophylaxis artificial heart valve" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for prophylaxis, start date: 1982 (ongoing); METOPROLOL taken for prophylaxis, start date: 2019 (ongoing); ASPIRIN taken for prophylaxis, start date: 1990 (ongoing); VITAMINS NOS; MINERALS NOS. Vaccination history included: Bnt162b2 (Dose:1, Anatomical site of injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 03Mar2021, when the patient was 47 years old, for COVID-19 Immunization; Bnt162b2 (Dose:02, Anatomical site of injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 24Mar2021, when the patient was 47 years old, for COVID-19 Immunization.  The following information was reported: SWELLING (non-serious) with onset 30Sep2021, outcome "recovered" (03Oct2021), AXILLARY PAIN (non-serious) with onset 30Sep2021, outcome "recovered" (05Oct2021) and all described as "Pain and swelling in the left axilla.". Therapeutic measures were taken as a result of swelling, axillary pain.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No known allegies. Booster dose due to high risk of frequent or occupational exposure to coronavirus (and at risk of serious COVID-19 Complications)  No follow-up attempts are possible. No further information is expected.
Only 1 dose was listed on clinic administration form; reviewed immunization information system and was unable to find completed initial series; appears this is only dose 2 for patient