chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administering expired PENTACEL with no reported AE; Initial information received on 23-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient who was administered expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for prophylactic vaccination (Immunization).  On 16-May-2023, the patient received 0.25 ml 1x (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) Frequency = once, Strength = standard (lot UJ671AAA and expiry date: 13-May-2023) via unknown route in Left Vastus Lateralis administration site for immunization.  On 16-May-2023, the patient was administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE with no reported adverse event (expired product administered) (latency: same day).  It was reported that"Nurse is asking if there's any side effects that go along with administering expired PENTACEL to a patient."  Action taken: Not applicable.  Outcome: Unknown   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 guidelines. 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.
Initial symptoms were chills, fatigue, and muscle pain throughout body. These symptoms lasted about two days following my second dose of the Moderna vaccination. Symptoms subsided on the third day.   On the fourth day following the vaccination I woke up at 6am with nausea and chest pain.  As a result I was taken to the ER where I discovered that I had myocarditis.
Information has been received from a physician concerning a 15 year old male who on 30-MAY-1995 and 13-FEB-1998 was vaccinated with a first and second dose of MMR II respectively.  On 18-NOV-2009 the patient experienced mumps.  The patient was afebrile.  Parotitis was on the right.  The first blood work on 20-NOV-2009 revealed serum IgM <1:10, serum IgG 5.23, and serum amylase 76.  The mumps was diagnosed on 20-NOV-2009.  At the time of the report, the outcome was not reported.  Additional information has been requested.
Extreme pain in left arm, felt like arm was going to explode or break a bone. Lasted 2.5 days. Rash up and down both arms. Continues to this day (June 26 2021). Rash comes in flares. Difficulty breathing. Coughing. Extreme fatigue. Inability to do daily work. Chills. Sweating. Slight fever but went away in an hour starting at 8 pm day of injection, ending at 9 pm day of injection. Nausea. Headache. Malaise. Chest pain nearest sternum and left armpit near heart. Woke up from chest and left arm pain. Extreme menstrual pain at ovaries- far more that a usual menses. Blurred vision. Ringing in ears and partial deafness that went away after a few days (3-4).
Red raised erythemic area 2 inches in diameter, site hot too teh touch - RL lateral tricept
Soreness/ pain; Limited range of motion; Lack of strength; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2019, the patient received the 1st dose of Shingrix. On 15th June 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, joint range of motion decreased, weakness and pain. The patient was treated with ibuprofen. In June 2019, the outcome of the pain in arm was recovered/resolved. On 17th June 2019, the outcome of the joint range of motion decreased and weakness were recovered/resolved. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain in arm, joint range of motion decreased, weakness and pain to be related to Shingrix.  Additional details were provided as follows: The lot number and expiration date could not be provided. The patient received Shingrix at approximately 0200-0300 hours. The patient experienced soreness, limited range of motion and pain. The soreness was described as the arm being so sore it had to be picked up to move it. Soreness began the day after dose one. At approximately 0600 hours, the patient took ibuprofen and experienced relief from the pain and soreness. By 1500 hours, the patient was beginning to be able to move her arm but did not have a lot of strength. The following day, on 16th June 2019, it took all of the patients strength to lift a mug of water into the microwave at eye level. The following day, on 17th June 2019, full strength and range of motion returned. The soreness and pain resolved within one week of receiving dose one of Shingrix. No additional information was provided. The reporter consented to follow up.
This is a spontaneous report from a contactable physician. A 2-year-old (gender and race unknown) received a dose of PREVNAR 13 on 10Mar2011. Relevant medical history, concomitant therapy and past product history was not provided. Three days after being administered the vaccine, the patient developed an allergic reaction. The patient was treated in the Emergency Room with BENADRYL and ibuprofen. The patient currently has vasculitis that resembles purpura and involves entire body. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
6 hrs post immun, temp 104.2, screaming episode for 3hrs;
This spontaneous report as received from a pharmacist refers to a 26 years old female patient. No information about medical history, concurrent conditions was reported. The patient was not pregnant. On 01-OCT-2014 the patient was vaccinated with RECOMIVAX HB first dose and on 07-OCT-2014 with second dose (lot #, dose, route not specified for both doses). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint. The outcome is unknown. Additional information has been requested.
I woke up this morning and I still feel a little abnormal.; I had severe tremoring throughout my entire body.; I could not stand up and my speak was extremely slurred as my jaw was tremoring too.; I could not stand up and my speak was extremely slurred as my jaw was tremoring too.; It was like my entire body was shivering uncontrollably but I did not even feel like I had the chills.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 29Apr2021 at 10:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 at 12:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 23:45, the patient had severe tremoring throughout his entire body. He could not stand up and his speech was extremely slurred as his jaw was tremoring too. It was like his entire body was shivering uncontrollably but the patient did not even feel like he had the chills. It came on very suddenly as he got into bed 13 hours after getting the vaccine. The first 10 minutes were very frightening and intense, the next 5 were rather mild then they suddenly went away. The patient woke up on 30Apr2021, in the morning of the day of report and still felt a little abnormal. The patient had very miniscule tremoring in his arms and hands. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events had severe tremoring throughout his entire body; he could not stand up and his speech was extremely slurred as his jaw was tremoring too; it was like his entire body was shivering uncontrollably but the patient did not even feel like he had the chills; it came on very suddenly as he got into bed 13 hours after getting the vaccine; the first 10 minutes were very frightening and intense, the next 5 were rather mild then they suddenly went away; the patient woke up in the morning of the day of report and still felt a little abnormal; had very miniscule tremoring in his arms and hands resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
About 1 hour after receiving injection in (L) arm patient became severely nauseated. 6 hours after injection she developed hives on (R) neck and abdomen. Fever of 99.3.
declined in energy and stamina; declined in energy and stamina; barely can get to bathroom by self; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Aug2021 (Lot number: FC3182) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes II" (ongoing); "arthritis" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "post hero neur" (unspecified if ongoing); "recent ILD" (unspecified if ongoing); "St 3 CKD" (unspecified if ongoing). Concomitant medication(s) included: NABUMETONE; VIT D [COLECALCIFEROL]; ALLEGRA; DEXILANT; ALLOPURINOL. Vaccination history included: Bnt162b2 (verbatim: First diagnosed with pneumonia 23Feb2021 (subsequent multiple times), Dose number: 1, lot number=EL9269, Expiration date: 31May2021), administration date: 06Feb2021, when the patient was 71 years old, for Covid-19 immunization, reaction(s): "pneumonia"; Bnt162b2 (verbatim: hospitalized with low oxygenation/high pulse, Dose number: 2, lot number=EN6203, Expiration date: 30Jun2021), administration date: 25Feb2021, when the patient was 71 years old, for Covid-19 immunization, reaction(s): "hospitalized with low oxygenation/high pulse", "hospitalized with low oxygenation/high pulse", "interstitial lung disease".  The following information was reported: ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 31Aug2021, outcome "not recovered" and all described as "declined in energy and stamina"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 31Aug2021, outcome "not recovered", described as "barely can get to bathroom by self". The events "declined in energy and stamina", "declined in energy and stamina" and "barely can get to bathroom by self" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, fatigue, loss of personal independence in daily activities.  Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Antibiotic received as treatment for events.  No follow-up attempts are possible. No further information is expected.
Within 2 minutes of receiving the vaccine I felt very confused and disoriented. I was  dizzy and unable to speak for several minutes. I was  told to sit  in a chair for a few minutes prior to returning to my  in surgery.  I sat there for at least 30 minutes before I started feeling better. I left and walked back to the main building and within the hour started running a high temp and chilling along with an intense headache. I left and went home and started having body aches and continued chills and fevers through out the evening and night . This continued for 4 days.
LEFT ARM BEING RED, SWOLLEN, HOT AND HARD. REACTION STARTED THE DAY AFTER THE SHOT WAS GIVEN.
Patient received both BOOSTRIX and PNEUMOVAX 23 in right arm. At time of injection there was no site reaction. Approximately 6 hours later her whole right side of her body went numb (body locked.) The numbness lasted 3 days and the most intense numbness was within the first 24 hours. Patient states her muscles would not extend, she could hardly walk, she had no appetite, and could hardly speak. She was very sore for at least a week. She had a fever for 3-4 days over 103 degrees fahrenheit. She has had the Tdap vaccine 3 times before with the last one being in 2007. Patient states she had a postule on the tetanus site on the day of injection and was there for 7 days. She states it looked like a whitehead but was not sore and she had redness less than the size of a dime.
FLUKE HEART ATTACK; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age and unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: Atrial fibrillation (AFIB), and dual ablation, and concurrent conditions included: asthma, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced fluke heart attack. The patient also said that he started getting a tickle in the back of the throat which was normal and by monday it did not got worse but he did lost his sense of smell and he got tested which was positive (suspected covid-19 infection and suspected clinical vaccination failure). The patient also stated that he had congestion and cough but never had fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fluke heart attack, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000196328. This case, from the same reporter is linked to 20211007486.; Sender's Comments: V0: 20211007273-covid-19 vaccine ad26.cov2.s-fluke heart attack. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211007273-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a licensed practical nurse concerning a baby whose a 16 year old female was vaccinated in January 2010 with a dose of GARDASIL (Lot # not reported). Concomitant therapy included DEPO-PROVERA. Subsequently the patient was found to be pregnant (WAES 1003USA03536), with last menstrual period (LMP) on approximately 28-DEC-2009, and estimated delivery date (EDD) on approximately 04-OCT-2010. On 08-OCT-2010 the patient was born. The patient had to be placed on apnea monitor for apparent life threatening event (ALTE), but no structured defects were found. At the time of the report, the patient's outcome was unknown. Apnea monitor for apparent life threatening event (ALTE) was considered life threatening by the reporter. Additional information has been requested.
Itchy at site right of immunization. Woke up with upper left thigh reddened. Seen by doctor at 14:00. Reddened area localized to left anterior thigh, 6"x4", outlined. Area was iced and medications ordered.
Within 12 hour, area was swollen and red, hot to the touch, burning sensation, pain from wrist to shoulder, couldn't move arm, said she was in agony. Treated with KEFLEX 500 mg TID and was better within 16 hours.
shingles; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. In February 2020, more than 2 years after receiving Shingrix and between 1 and 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had both doses of Shingrix in 2018, six months apart. A week before time of reporting, the patient was diagnosed with shingles. The reporter consented to follow up. The patient asked if there were times the vaccine did not work. The patient also wanted to know should he get another round of the vaccine.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 10:30 (Batch/Lot number: EW0187) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "short episode of Vertigo", start date: 2019, stop date: 2019. Concomitant medication(s) included: ALLOPURINOL; HYDROCHLOROTHIAZIDE;LOSARTAN POTASSIUM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 29Apr2021, when the patient was 42 years old, for Covid-19 immunization, reaction(s): "lightheaded"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 29Apr2021, when the patient was 42 years old, for COVID-19 Immunization, reaction(s): "headache".The following information was reported: DIZZINESS (non-serious) with onset 20May2021, outcome "not recovered", described as "lightheaded"; HEADACHE (non-serious) with onset 20May2021, outcome "not recovered", described as "headache"; VESTIBULAR MIGRAINE (non-serious) with onset Aug2021, outcome "not recovered", described as "Vestibular Migraines". The events "lightheaded", "headache" and "vestibular migraines" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness, headache, vestibular migraine.Additional information: Other concomitant medication included vitamin. The facility type vaccine was pharmacy or drug store. With both shots the patient was almost immediately lightheaded and got a headache. Both times the lightheaded symptoms lasted maybe 15 mins or so, but the headaches for a couple of days. As the months past he had a couple of occasions when he would get light headed but again it didn't last to long. In Aug2021 he got what he thought was signs of vertigo but had turned out to be vestibular migraines. He had never had migraines in his life, but he did have a short episode of vertigo in 2019. He was not sure if this is a direct affect of the vaccine but he would like to find out if there is a link and a solution to this. The adverse event start date was also reported as 24Apr2021 10:30 AM. There was no COVID prior vaccination.
Information has been received from a 22 year old female nurse consumer who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced stomach ache and flu-like symptoms "for about a week'. The patient recovered. No further information is available.
Patient complained of light-headedness/dizziness and saw spots. Local reaction was reported as well (hot, elevated, sore inject. site, lasted several days).
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe
Information has been received from a physician concerning an 18 year old female who was vaccinated with a dose of Gardasil. The physician reported that the patient fainted after receiving Gardasil. No further information about the AE available. Unspecified medical attention was sought by the patient. The patient recovered "either on 25-JUL-2007 or 26-JUL-2007". The physician reported that one other patient fainted after receiving a dose of Gardasil. Additional information has been requested.