chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of acthib was inadvertently administered 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 a 3-year-old male patient for whom expired dose of HIB (PRP/T) vaccine [ACT-HIB] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received an expired dose inadvertently at dose 0.5 ml dose 4 (frequency: once) of suspect HIB (PRP/T) vaccine of standard strength (lot UJ802AA, Expiry date: 14-Aug-2023) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event  (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was 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 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.
Bexsero reached 18 °F and administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2022 15:28, the patient received Bexsero. On 18th October 2022, the patient started Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 19-Oct-2022 Reporter's comment: The nurse reported that temperature excursion occurred with several vaccines reaching below freezing temperatures. After reviewing medical records, the nurse called and reported that the patient received the dose of Bexsero after dose had reached 18 degrees Fahrenheit.  The reporter did not have age or date of birth.  At the time of reporting, the dose had not been repeated.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  This case had been linked with US2022150652, reported by same reporter. Additional supportive information: The patient received Bexsero after this dose temperature excursion 18 degrees Fahrenheit, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022150652:same reporter
NEUROPATHY PERIPHERAL; CONDITION AGGRAVATED; This spontaneous report received from a patient via a Regulatory Authority (ID: 1471293) concerned a 72-year-old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfonamide allergy, high blood pressure, and peripheral neuropathy. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) frequency 1 total, dose was not reported, administered on 11-Apr-2021 for prophylactic vaccination. All required follow-up attempts have been made. The Batch number for COVID-19 Vaccine Janssen AD26.COV.2.S has not been provided. Concomitant medications included lisinopril, and nifedipine.  On 11-Apr-2021, the patient stated that most intense bout of peripheral neuropathy in both legs and feet (condition aggravated) which patient frequently gets from degenerative disks and pinched nerves, from which patient had been suffering for years. The patient mentioned usually had one sided stabbing at night after patient lays down which lasts all night. The patient stated that the event lasted all night long but the intensity was hard to deal with. The patient mentioned that it stopped the next day but was really shocked. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neuropathy peripheral, and condition aggravated on 12-Apr-2021. This report was serious (Other Medically Important Condition).  Additional information was received on 28-Sep-2021.The following information was updated and incorporated into the case narrative: All required follow-up attempts have been made. The Batch number for COVID-19 Vaccine Janssen AD26.COV.2.S has not been provided.; Sender's Comments: V1: The follow up information in this version updates: All required follow-up attempts have been made. The Batch number for COVID-19 Vaccine Janssen AD26.COV.2.S has not been provided. This updated information does not alter the causality of previously reported event.  20210750560-COVID-19 VACCINE Ad26.COV2.S-Neuropathy Peripheral-This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
On Monday, May 10th I felt nauseous, had a headache, and fatigued. I went to bed at 7PM without eating and slept until7AM. On Tuesday I still felt fatigued and nauseous and did not eat. I slept from 2PM-8PM  . I went to be at 10PM and slept until 6AM. On Wednesday, I still felt nauseous and fatigued. On Thursday I felt ok. On Friday I again felt nauseous and fatigued. That feeling continued for several weeks. I lost 10 pounds. Although the fatigue has gone away, my stomach still feels squeamish and I am careful about what I eat.
Then how come i haven't had the flu since i stopped taking it; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional via social media.  This case involves patient (unspecified gender and age) who had the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient reported that not had the flu since he/she stopped taking it (influenza) (non-serious).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Got that shot, is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience 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 near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was not recovered/not resolved.   The reporter considered the near death experience to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and now it was killing him/her. Additional Supportive Information: Follow-up would not possible as no contact details were available.
? Fatigue, lethargic ? Sleeping twelve hours at night and napping in the afternoon ? Loss of appetite, unable to eat, stomach discomfort ? Weight loss ? Lightheadedness, shortness of breath, fainting spells ? Disorientation ? Sweats accompanied by violent tremors ? Mental confusion ? Vomiting ? Sudden decline in visual and auditory acuity ? Bad taste in mouth ? Bad breath ? Memory loss ? Always cold ? Salt deficient (at least I crave it) ? Hallucinations in peripheral vision ? June 6, overnight to the 7th, my sleep was constantly disturbed by vivid nightmares
Information has been received from a licensed practical nurse concerning a 78 year old female with no relevant medical history or illness at the time of vaccination who on 05-DEC-2006 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Pneumovax 23 (lot 655152/0889F).  It was reported that on 24-OCT-2006, the patient was vaccinated in the left deltoid with a fifth dose of influenza vaccine (lot U2195AA).  Concomitant therapy included hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), and TOPROL.  On 05-DEC-2006, the patient presented with localized swelling and redness to the injection site.  The patient was advised to apply ice topically to site.  Subsequently, the patient recovered.  The nurse requested a lot check be performed on lot 655152/0889F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  No additional information is expected.
Headache, Myalgia, c/o chills,sore throat. Told to visit primary care physician if problems persist Narrative:
Narrative: COVID infection following COVID vaccine series 01/09, Pfizer, dose #1 01/30, Pfizer, dose #2 08/05 pt cc: DIARRHEA, MYALGIAS exposure: unknown 08/07 COVID swab, results: detected 08/12 SARS-COV-2 LINEAGE results: AY.12 08/12 SARS-COV-2 CLADE results: 21A Delta
Sore throat lasted less than 24 hours. The fatigue was around the same time as the sore throat and I still have it now so it's ongoing. The nasal congestion that started about 24hours the sore throat. The cough that started on the 2nd day was a dry cough that started in the evening. The 3rd day is when I had the pain in my left arm. I still have stuffiness and occasional cough. The pain in my left arm lasted 24hrs.
Light headedness, dizziness immediately upon injection body aches, chills, headache following 48 hours
Patient received 3rd dose of COVID-19 vaccine in right leg; Vaccination site pain (right leg); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Aug2022 at 16:30 as dose 3 (booster), single (Lot number: FL2757) at the age of 5 years intramuscular, in right leg for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: IRON. Vaccination history included: BNT162b2 (Prev dose lot number: FK5127,, Prev dose administrator route: Intramuscular, Prev dose dose number: 1), administration date: 09Nov2021, when the patient was 5-year-old, for COVID-19 immunization; BNT162b2 (Prev dose lot number: FK5127, Prev dose administrator route: Intramuscular, Prev dose dose number: 2), administration date: 02Dec2021, when the patient was 6-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 09Aug2022 at 20:00, outcome "recovered", described as "Patient received 3rd dose of COVID-19 vaccine in right leg"; VACCINATION SITE PAIN (non-serious) with onset 09Aug2022 at 20:00, outcome "recovered" (10Aug2022 at 19:30), described as "Vaccination site pain (right leg)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of product administered at inappropriate site, vaccination site pain.
Adverse events-Immed felt pain and weakness in all four extremities - no energy/stamina - increased sleeping (12 hrs/day) - reports normal is 10 hrs/day. Treatment -reports received Cortisone injection in LD @ PMD's office some time after. Reported improved energy/stamina and decreased pain. Outcome- states "I am 10% worse off than before the shot". Copy of record given so he can take to his PMD.
Large red hot hives bilateral legs, thighs abdomen and truck/back Benadryl po 50 mg and then to ED for more aggressive workup and treatment. Employee report to RN Office 09/28/16 at 12:25am .No respiratory distress or airway problems noted.
headache, fatigue, chills (worse so on the day after vaccine) lasting about 24 hours
Information has been received from a registered nurse refers to a 16 years old male patient. On 07-NOV-2012, the patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot number not provided) intramuscularly in his left deltoid. No other co-suspects were reported. No concomitant medications were reported. On 07-NOV-2012, seconds after received the vaccine, the patient reported that his left arm felt numb and heavy. Within next 10 to 20 minutes, the patient commented that he felt dizzy. No treatment information was reported. The patient did not seek medical attention. At the time of the report, the outcome of left arm felt numb and heavy and felt dizzy was reported as recovering/resolving. The relatedness for felt dizzy and left arm felt numb was unknown for GARDASIL. Additional information has been requested.
rash on left arm that spread to wrist, itching on face and head, headache, dizzy spells, rash in mouth on Saturday following vaccine.  Still have rash and headache
pt awoke from nap 2hr p/vax cried for more than 3hr w/only temp, stopping, inconsolable by mom;taken to MD who dx as r/t DTP/HIB rxn;
Started out as 2 very small hives that then spread to head to toe, very large, extremely itchy hives. Booster was on 11/22, reaction started on 12/1. Benadryl and Hydrocort cream were not working so I went to urgent care and got a prescription for a steroid cream. That started working about 2 days after I started it and all hives were gone after the 6 days of the steroid cream.
Now experiences weakness; 2nd Booster made him sicker; Diarrhea; Nausea; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Now experiences weakness), ILLNESS (2nd Booster made him sicker), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060a21a, 076c21a, 019n21a and 013a21a) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine on 13-Nov-2021. Past adverse reactions to the above products included Pneumonia with Flu vaccine.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Now experiences weakness), ILLNESS (2nd Booster made him sicker), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Now experiences weakness) was resolving and ILLNESS (2nd Booster made him sicker), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved.            Patient's height was reported as 6 foot 2. Concomitant medications were taken but not reported. Patient did not remember the exact treatment taken. Patient had not experienced similar events in the past. Patient felt pretty weak but going to recovery. All symptoms were gone except Weakening.   This case was linked to MOD-2022-609577, MOD-2022-609593 (Patient Link).
I had an initial feeling of being high. My vision became distorted.  My fingers became tingly.  My breathing felt heavy. I felt heavier and heavier.  They asked me if I wanted to lay down. I said yes.  I was also very dizzy. My blood pressure was 135/83 and pulse was 125. my blood sugar was 102. I drank a bottle of water and laid down for 20 to 30 mins. Then sat in the chairs. I had to wait for the vision disturbance to wear off so I could drive.  it also gave me ADD symptoms for 48 hours. Very hyper.  Then I had the flu for 5 days. The dizzy wore off on the 6th day.    Should I get the 2nd shot?
Ischemic stroke 2 days following vaccine administration resulting in hospitalization.  Symptoms began with left lower extremity weakness. The patient also reported a low-grade fever as well as fatigue and generalized weakness following vaccine.
83 yo M with large L thalamic IPH with intraventricular extension;  family made it clear they would not want intubation, CSF diversion, or artifical feeding. Patient was transitioned to Hospice scattered bed on 11/1  -he was treated with prn IV morphine, Ativan, and Robinul  -continue prn IV Ativan and Robinul  - he passed away at 08:39 on 11/5.  Cause of death was left thalamic IPH
pt recv vax & was 30wk pregnant & 6wk later pt gave birth to an infant who seemed OK;
1 year old male patient received an expired dose of VAQTA; This spontaneous report as received from a medical assistant refers to a 1-year old male patient. The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.  On 09-FEB-2021 the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) 1 dosage form, lot # S030587, expiration date on 06-JAN-2021 (expired vaccine used) for prophylaxis (strength, dose, frequency, route of administration, and anatomical location, were not reported).
TINGLING IN ARMS, THEN MIGRATED DOWN TO LEGS.  RANDOM TIMING AND WAS ABOUT THE SAME AS OF 8-3-2021.
Softball size soft bursa like sac developed on the evening of the injection.  Following morning joint pain was in left shoulder and elbow.  Fatigue was significant 1 and 2 days post vaccine.  Rest, massage and warm compress was applied and swelling is decreasing at this time.
On day 7 after 1st shot, the site of the shot became red, hot, swollen (about the size of a half dollar).  Throughout the next 7 days, it expanded to the width of my arm and then faded away.  No lasting marks on arm at all.
Injection site swollen, tenderness, warm to touch, red, itchy, and pain when there is pressure.
Called into clinic to report he tested positive 9/21/21. Symptoms started about 2 weeks ago
According to mom patient had loose stools with blood streaks and fever of 101.6 which started on the same day of getting 6 month shots.
Information has been received from a pharmacist concerning female patient currently 66 years old. Patient was not taking any concomitant medication, and had no medical history, drug reactions or allergies. In approximately April 2016, (reported as "approximately one year ago") the patient received a dose of ZOSTAVAX with a concentration of 19,400 plaque-forming units (PFU) for prophylaxis (route of administration, dosage information, lot number, expiration date and anatomical location were not provided). On an unknown, date the patient had laser surgery to her eye (not specified if one eye or both eyes), then developed shingles around one of her eyes (unspecified which eye), which involved swelling and itching (Ophthalmic herpes zoster). It was reported that the patient had received treatment for those events. Upon internal review ophthalmic herpes zoster was considered to be a medically significant event. At the time of reporting the patient had not recovered from the events. Additionally, the reporter provided no causal relationship between the events and vaccination with ZOSTAVAX. Additional information has been requested.
7 days after dose 1 of injection, redness and swelling presenting like a rash spread from injection site down the upper arm.  Noticed it the evening of the 14th and by the 15th it had doubled in size. It was painful to the touch and warm. Called the vaccination help line and they directed me to be seen at urgent care. During the ER visit they told me it was presenting like cellulitis but may also just be a local reaction at the injection site. I was given a 5 day course of Keflex and my arm returned to normal once the course was finished. Got the 2nd dose on 2/4/21 and opted to receive injection in the right arm instead of the left.
pt recv vax; had febrile sz; to ER, sz activity lasted almost 10 min;MD stated no further pertussis;progressed to kidney infec;
5/4/21: Foul smelling bowel movements and gas. All bowel movements and gas have smelled the same since this date. Doesn?t matter the consistency or frequency, the smell has not changed. Continues to this day.
Patient reports adverse event was mild. Approximately 5 minutes after vaccination patient's tongue felt thicker and she reports feeling a sensation. Patient's throat also felt scratchy. Benadryl 25 mg was given to patient at 2:27 PM.
Onset of shingles rash and pain on the chin and peri-articula area on the right side also red right eye
Loss of taste; Loss of smell; Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and PAIN IN EXTREMITY (Soreness in her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025X20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included SIMVASTATIN (CHOLESTROL) for Hyperlipidemia, LISINOPRIL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). On 26-Jan-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) had not resolved and PAIN IN EXTREMITY (Soreness in her arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Follow up received on 28-MAY-2021 and it contains No newinformation