chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product storage error; Patient received its 30-days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Product storage error) in a 47-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022 at 4:47 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 15-Mar-2022 at 4:47 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received its 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not reported.   A Series of patients approx. 540 patients received lot number 066H71A past its 30 days expired date. Vaccines went into 2-8 degree Celsius thaw state on or above 24-Dec-2021. This vaccine was administered up until its Mfg Exp date of 04-Apr-2022.   Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to a 80 year old female patient. There was no relevant medical history. On 16-SEP-2013 the patient was vaccinated with ZOSTAVAX lot # J001008, subcutaneously. Dose and frequency were not provided. Concomitant therapies included aspirin (manufacturer unknown), losartan (manufacturer unknown), diltiazem CD (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), pravastatin (manufacturer unknown), ropinirole (manufacturer unknown), TEKTURNA 300 (manufacturer unknown), tramadol (manufacturer unknown) and TRAVATAN Z eye drop (manufacturer unknown). On an unspecified date in October 2013, reported as 3 weeks after onset of therapy the patient experienced shingles. Treatment with Acyclovir 800 mg was given. The outcome of shingles was reported as not recovered/not resolved. The reporter causality was unknown. Additional information has been requested.
15 hours after injection severe chills, migraine headache followed by 5 hours of the dry heaves every 20-25 minutes. After last episode I was left exhausted and headache continued for 10 more hours.
This spontaneous report as received from a pharmacist refers to a 11 year old male patient with restrictive pulmonary disease and no history of allergies or drug reactions. The patient's medical history included bone marrow transplant. On 21-APR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, lot number K020215, expiration date 15-MAY-2016, 0.5 ml, intramuscular. No concomitant therapies were reported. On 21-APR-2015, the patient experienced injection site erythema, injection site swelling and injection site pain. On 22-APR-2015, the patient experienced unspecified "septic-like" symptoms, vomiting and pyrexia. That same date the patient sought medical attention at the emergency room of an unspecified hospital. The patient was then admitted to the pediatric intensive care unit (ICU) of that hospital on 23-APR-2015, where fluid resuscitation, dopamine and unspecified broad spectrum antibiotics were given as treatment. The patient was discharged from the hospital on 28-APR-2015. The outcome of sepsis, vomiting, pyrexia, injection site swelling, injection site pain and injection site erythema was reported as recovered on 28-APR-2015. The reporter considered the events to be life threatening. The reporter considered sepsis to be medically significant. Additional information has been requested.
Headache, Arthralgia, NauseaVomiting, fatigue, Narrative:
Information has been received from a RN concerning a patient who in 1999 was vaccinated with 2 doses of varicella virus vaccine live. The reporter said she thinks the recommended interval was observed. The patient failed to seroconvert on her titer test given 09/27/2000. The patient sought unspecified medical attention. Follow up information from the same RN indicated the titer was drawn on the patient, a qualitative test was done instead of a quantitative test. Hence, the most accurate results were not obtained. The nurse did not feel that an adverse event had occurred. No further details were provided.
Hypermenorrhea (menstrual periods every 2 weeks) after her first dose of GARDASIL 04/01/08.
Information has been received from a pharmacist concerning a female patient in her eighties who was with a second dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient had received her first dose three years prior to the second. The pharmacist reported that seven days after the patient had received the second vaccination with pneumococcal 23v polysaccharide vaccine she was hospitalized for two weeks with pneumonia. The pharmacist reported that the patient was vaccinated at either a clinic or a senior center, but had no other information regarding the lot number, dates or information regarding the patient's treatment. There was no product quality complaint reported. No further information has been requested.
We discovered the product was not stored according to the labeling and was kept in the refrigerator longer than the manufacturer requires
Indication: Treatment of COVID-19; Indication: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product- COVID 19 Treatment, Brand: Pfizer, Treatment start date-29Apr2022, Treatment stop date- 03May2022, Indication- Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccines at 10:30 am 12/10/18. By 1:30 pm, my right arm was extremely painful.  Excruciating pain in arm and shoulder all night. Returned to doctors office 12/11/18 and saw nurse practitioner who was no help whatsoever. Said to take anti-inflammatories  twice a day. Rt. arm and shoulder continued to be extremely painful for the next 5 weeks.....limited use of Rt. arm; unable to lift arm overhead..  Arm, shoulder (including injection site) continue to be painful. This is not getting better.
Developed red swollen arm in 12 hrs 4 x 3 inch. Due to previous reaction ask Drs. they said give. Started ADVIL and cold compress over next few days but give shot I cleared with Dr first.
Per patient secure message (email) to primary care physician: "I had a rather (for me) severe reaction to the PNEUMOCOCCAL vaccine I was given on Friday (June 17) AM.  I experienced NO PROBLEM until early evening, at which point, my right arm started to ache.  By the time I went to bed the ache had grown worse and my entire arm hurt clear down to my fingers.  My fingers actually became numb.  I was so uncomfortable I had to get out of bed and sat in the recliner for the next few hours.  The pain decreased in the early morning hours and I was able to return to bed.  I have never reacted to any kind of injection this way.  "
Extreme lethargy.  Slept 8 hours during the day and another 9 hours that evening.  this reaction is not life threatening but I thought I should report it anyway.
Patient said he had a rash spreading from his arm to elbow for weeks after receiving vaccination. It occurred within 2h hours after vaccination but do no remember exact time. He also acknowledges that the area was painful and inflamed with chills and fever.
Date Time Symptoms medicine Thursday, May 13, 2010 1-2pm Chickenpox Vaccination  Friday, May 14, 2010 Day cranky, tired  Friday, May 14, 2010 9-11 pm crying, high fever 2tsp Motrin Saturday, May 15, 2010 5-8 am  wheezing, difficult breathing, fever, pale. 2tsp Motrin Saturday, May 15, 2010 4-6 pm Napping with eyes half open, high fever, flush skin (red cheeks), clammy hands, trouble breathing. 2tsp Motrin Sunday, May 16, 2010 9-11 am Napping in stroller, trouble breathing, coughing, vomit  from cough.   Sunday, May 16, 2010 Day cranky, tired, coughing Motrin Sunday, May 16, 2010 Night trouble breathing - wheezing  Monday, May 17, 2010 11:00 AM Dr. office. Diagnosed with pnemonia. Antibiotic shot and breathing treatment. RX- Albuterol, Pulmicor used with Nebulizer. Prednisone and anitibiotics (10 day treatment).  Monday, May 17, 2010 Day cranky, tired, coughing  Monday, May 17, 2010 Night coughing, fever. Tylenol    Tylenol for the next few days as needed Saturday, May 29, 2010 Day Noticed rash and small bumps on body, face  Sunday, May 30, 2010  Rash contiues for a few days and more bumps appear in face, body, hands.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medications in two weeks were reported as no. The patient received covid-19 treatment of Paxlovid, from 29Dec2022 to 03Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cellulitis; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20ZA) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism (10 years. Started during pregnancy. Treated with methimazole for 3 years.), Hives (Under stress), Asthma (Under stress), Pregnant (Twice.  One pregnancy at the age of 25.), Radioactive iodine therapy (Ablation with radioactive iodine 3 years ago.) and PPD skin test (First one done when young.  Another test at 23 years old. The reaction was 10 inches, warm and swollen at the test site. The third time, 25 years old and pregnant. Whole arm was swollen, red and painful.). Concurrent medical conditions included Hypothyroidism (Has been taking Levothyroxine.). Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Polymerase chain reaction: negative (Negative) Nasal. On 22-Jan-2021, SARS-CoV-2 antibody test: pos and reactive Total Ab w/rflx IgG.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Treatment medication also included an antibiotic.; Sender's Comments: This case is under data review.
chills; fever; itching on bottoms of feet; dyshidrotic dermatitis flare; muscle spasms in all extremities and fingers,but intense in the right leg,; nausea; stuffiness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included dyshidrotic dermatitis, attention deficit hyperactivity disorder and childhood history of kidney issues. The patient had known allergies to numerous antibiotics, codeine, peanuts, walnuts, and pecans. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), from unknown date and for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration in the left arm on 08Mar2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Jan2021, at 00:00 the patient experienced chills, fever, itching on bottoms of feet (dyshidrotic dermatitis flare), muscle spasms in all extremities and fingers, but intense in the right leg, stuffiness, and nausea. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fever, itching on bottoms of feet (dyshidrotic dermatitis flare), muscle spasms, stuffiness, and nausea were not recovered.  No follow-up attempts are needed. No further information is expected.
Itching to entire body, no rash, hypotension or respiratory symptoms. Treated with 50 mg diphenhydramine IM, right deltoid.
Bad diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Bad diarrhea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (LOT: GR8734) on 09-Apr-2021 and Pfizer (LOT: ER8735) on 30-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included MACROGOL 3350 (MIRALAX) for an unknown indication.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced DIARRHOEA (Bad diarrhea). At the time of the report, DIARRHOEA (Bad diarrhea) outcome was unknown.            Patient took no treatment medications but she drank some amount of water.  The reporter states that sometimes the patient take Miralax, and it catches up to her sometimes and are hoping that the diarrhea is from the Miralax.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2021: Follow up received contains non significant information.
This spontaneous case, initially received from a pharmacist on 29-Oct-2018 concerns a 46-year-old, adult, male patient. The patient had no relevant medical history. The patient's concomitant medications were reported to be unknown. On 24-Oct-2018, the patient under age of 65 years was accidentally administered FLUAD TIV [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the event as non-serious. This case (201805051) was cross-linked to the source case: 201805049 reported by the same reporter.
Per Patient - she had muscle weakness, was unsteady/ wobbly, had trouble walking , said she felt "drunk" (happened in the middle of the night). She contacted her Dr via phone the next morning, but symptoms have since resolved
Fatigue, Chills, Low Grade Fever, Headache, Nausea for 20 hours beginning early am of the next day following the adm of vaccine. Minor in intensity, treated with rest, Acetamenophen . They resolved without further incident.
Case received from a healthcare professional in the USA on 24-OCT-2005 via the MIS/VIS under the reference number 05-0567. A 41-year-old female patient with a medical history of environmental allergy, asthma and hypothyroidism had received a dose of FLUZONE, batch number U1762AA in the left deltoid and a dose of PNEUMOVAX (batch number 0790P) in the right deltoid on 21-OCT-2005, and 24 hours post-vaccination, i.e. on 22-OCT-2005, she developed injection site cellulitis at left upper arm with raised red rash, fine rash on shoulder and back and with injection site pain. The patient did not complain of shortness of breath or chest pain. The cessation date of each symptom was not reported. The patient was receiving concomitant treatment as budesonide, Thyroid, albuterol, aciclovir (ZOVAREX) and cetirizin (ZYRTEC). The patient required a doctor visit. No relevant laboratory tests. She received intramuscular ceftriaxone (ROCEPHINE) and diphenhydramine hydrochloride (BENADRYL) per oo. Further details were requested. Follow-up information received on 03-FEB-2006 from a health care professional. Per the reporter, the patient received one dose of Rocephin for treatment of the event and then was started on Duricef by mouth. The patient had no history of food or drug allergy in the past. The patient did not return. Per the reporter, the patient recovered from these events at the time of this report.
patient was administrated with an expired dose of Twinirx; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received HAB (Twinrix) (batch number x239d, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 12th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's comment: The manger reported that the patient was administrated with an expired dose of Twinirx. The vaccine expired on 7th August 2022. No adverse event was reported. The consent to follow up. Additional Supportive Information: The patient was administrated with an expired dose of Twinirx, which led to expired vaccine used.
This spontaneous report as received from a licensed practical nurse refers to multiple patients of an unknown age and gender. No information regarding the patients' concurrent conditions and medical history was provided. On an unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored PEDVAXHIB lot# K019701, expiration date: 17-JUL-2015 or lot# K008874, expiration date: 23-FEB-2017 (dose and route of administration were not reported). The patients' concomitant therapy was not reported. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Patient under 65 received Fluad QIV; Rash; Fatigue; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04823) and concerned a 33-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influneza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed rash and fatigue. The patient did not receive any corrective treatment.   The outcome of events was not reported.  The case was assessed as non-serious.  The case is linked to 202004845, 202006068, 202006069, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (due to same reporter).  Company comment: The events of rash and fatigue are assesed as related to Fluad Quadrivalent , while the event of  'Inappropriate age at vaccine administration' is assessed as not related to Fluad Quadrivalent.; Sender's Comments: The events of rash and fatigue are assesed as related to Fluad Quadrivalent , while the event of  'Inappropriate age at vaccine administration' is assessed as not related to Fluad Quadrivalent.
Pt wife called and said pt went to walkin clinic with infection - cellulitis due to vaccines in arm where vaccines given on 10/24. Pt needed ROCEPHIN shot and course of antibiotics.
Woke with flu-like symptoms. Noted right upper arm soreness with swelling, redness and itching on right upper arm. Next day, 24APR09, noted increase in severity of all symptoms as well as fatigue. Muscles and joint aches noted. Unable to complete work duties in second day; needed to go home to rest. Treated with ALEVE and rest. Flu like symptoms resolved in 2 days, while local complaint (redness, itching and swelling) resolved after 7 days.
At unspecified times, the patient received the first two injections of Lymerix for prophylaxis, with no untoward effects. On 04/01/2000 he received the third dose, and two days later, 04/03/2000 experienced back pain. No treatment was given. The information received on 04/08/2000 does not provide an outcome.
The pt experienced an eccymotic lesion over right foot, multiple petechia up to the knees. Rest of exam was normal. Lesions almost resolved.
Fatigue, minor swelling feet and hands occurred a week or two after second doses of vaccine. Hands and feet symptoms seem get a bit relieved in motion. Occasional heart pressure.