chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not showing immunity; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 4-year-old female patient who received HAV (Havrix) (batch number J34DR, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number A9RM9, expiry date 27th May 2021) for prophylaxis.   Previously administered products included Pediarix (1st dose received on.19th September 2018), Pediarix (2nd dose received on 29th November 2018), Pediarix (3rd dose received on 30th January 2019) and Infanrix (1st dose received on 27th December 2021).   On 22nd July 2020, the patient received the 2nd dose of Havrix. On 29th August 2019, the patient received the 1st dose of Havrix. On an unknown date, unknown after receiving Havrix and Havrix, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Linked case(s) involving the same patient:  US2023031972   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The registered nurse (RN) reported that patient received the 2 doses of Havrix vaccine and did not show any immunity. The nurse consented to follow up Additional supportive information: The patient received 2 doses of Havrix and showed no immunity, which led to therapy non-responder. This case is linked with US2023031972, reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2023031972:same reporter
Pt received immunizations and about 5 minutes afterwards the school nurse brought pt in to where shots were being given stating that pt was having a possible reaction.  Nurse who administered pt examined patient and he was found to an area of redness at site of varicella injection.  Pt was flushed and sweating.  Denied any SOB.  After several minutes pt developed hives and swollen lips.  Parent/family MD was contacted and child was sent to ER via family
Mom stated pt slept for an hr or so p/vax & woke up crying; Pt was stiff & cried very hard for approx 3 hrs (fr about 4PM to 7PM); He wasn't self for 5-7 days; crying off and On fussy & feverish; mom gave APAP & DPH;
Pt recv vax on 1/6/98; subsequently pt exp headache,nausea, & injection site rxn of redness &swelling.  Two wk later pt exp pneumonia; tx=IV antibiotics.
PATIENT 61 WAS GIVEN THE HIGH DOSE FLUZONE, PT WAS CONTACTED LATER IN THE EVENING AND FEELS FINE WITH NO SIDE EFFECTS
This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 17-year-old male patient of an unspecified ethnicity received the first dose TRUMENBA, at single dose, and second dose of MENACTRA, at unknown dose and frequency; both via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The patient received second dose of meningococcal vaccine a/c/y/w conj (dip tox) and first dose of meningococcal group b rlp2086 during an office visit. The physician also ordered an RPR blood test for an unprotected sexual encounter. RPR Blood test was drawn 1 or 2 days later, and test result showed positive for Syphilis, but a repeat RPR showed negative. The physician said the vaccines caused a seroconversion. No adverse events were reported other than anxiety due to an initial positive test result. The outcome of the events was unknown. Information on the batch number has been requested.
patient was administered an IPOL vaccination that had expired with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid non-serious case received via Licensed Practical Nurse (LPN).  This case involves 5 years old male patient who was administered an IPV (VERO) [IPOL] vaccination that had expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jan-2023, the patient received fifth dose of suspect IPV (VERO) Suspension for injection at dose 0.5ml once (lot TIE871M, expiry date: 10-OCT-2022) via subcutaneous route in the left arm for immunization that had expired with no reported adverse event (expired product administered) same day latency.  LPN inquired if that would count as a valid dose or if the patient would need to be re-vaccinated?   Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was administered an IPOL vaccination that had expired with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient was administered an ipol vaccination that had expired 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 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.
I?ve been passing out since the day I got the second shot and it hasn?t stopped since. It happens very frequently almost every day and I?ve tried calling to report it but I never got a response back. I went to the ER and told them I thought it was vaccine related and they said no.
pt resides in nursing home; pt had a positive COVID test on 9/27/22 in nursing home; 10/2/22 brought to the hospital with AMS; DNR/DNI; pt in ED with hypoxia, multifocal pneumonia, hypoglycemia, and positive for COVID; O2 supplementation; given ABX and dexamethasone; rapid response called due to hematemesis, hypotension and agonal breathing; pt passed away in the hospital
She says that she is still experiencing pain in her arm; muscle pain since the injection in her left arm; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 86 years old female patient who pain in her arm (pain in extremity)  and muscle pain since the injection in her left arm (myalgia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 04-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE in the left arm, lot number not reported via unknown route.  On an unknown date, the patient developed a non-serious event of pain in her arm (pain in extremity)  and muscle pain since the injection in her left arm following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Final diagnosis was pain in her arm and muscle pain since the injection in her left arm.   The lab data was not reported.   It was not reported if the patient received a corrective treatment.  The patient outcome is not reported for pain in her arm and muscle pain since the injection in her left arm.
This is an instance of COVID-19 breakthrough disease after which death occurred. The individual was vaccinated with the Pfizer product on 03/19/2021 and 04/08/2021. They tested COVID-19 positive via PCR, out of state on 12/23/2021 and were hospitalized out of state; they died out of state on 01/02/2022. Since the hospitalization and death occurred out of state, I have limited information on clinical course and admit/discharge dates. Alternate location issued the death certificate but this individual was a current resident.
On 7-5-09, child developed raised pink areas on face, legs, arms, torso which increased by 7-7-09. Denies fever or swelling; continues to eat and urinate normally. Areas disappeared over the next day or two; child remained active during this period.
Per hospital event reporting system " The patient developed signs and symptoms of allergic reaction. Rash, coughing, sweating, flushing."
1st dose in 2021, 2nd dose in 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th Dec 2021.).   On 29th September 2022, the patient received the 2nd dose of Shingrix. On 29th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 05-DEC-2022 Reporters comment: The pharmacist reported that the patient did not get second dose until 29th September 2022. At that time of call, reporter did not have the lot number/ expiration date information of the two doses The reporter consented to follow-up. Additional Supportive information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule.
After the SHINGRIX 1st shot in the morning, I developed 101.6F temperature and joints pain. At about 10 pm, I developed itchy hives on my face, neck, check and both arms, tongue felt a little tingling. I called Insurance 24 hrs. nurse line, she advised me to call 911 to ER. I finally called car service to go to med. ctr. ER at. I arrived ER at about 12:15 am on 8/18/2018. ER doctor gave me three medications and observed me for 5 hours until hives went down then sent me home. I still had hive the next few days here and there on my face and body. I texted my Primary Dr., she advised me to continue to take BENADRYL if itchiness occurred. After a few days, condition still on, I texted to Dr. again and she advised me to take ZYRTEC 10 mg a day. I took it for three days and everyday I still have hives so I stopped it just took BENADRYL. I went to see Dr. On 9/5/2018, she gave me some blood test and told me to get SARNA lotion to apply on the itchy spots. Up to today, I still have itchiness on my face. She told me she will report my reaction to the authority.
This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 syringes, lot # L040181, expiration date 18-AUG-2017, lot # M005287, expiration date 18-OCT-2017, lot # M018766, expiration date 15-OCT-2017 and lot # M020521 expiration date 17-NOV-2017 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperature and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Additional information has been requested.
Guillain Barre syndrome; honestly thought she was going to die; This case was reported by a consumer via media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and impending doom. On an unknown date, the outcome of the guillain barre syndrome and impending doom were unknown.   It was unknown if the reporter considered the guillain barre syndrome and impending doom to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by patient's close friend. The age at vaccination was not reported. The patient received shingles shot earlier this reporting year (2021) and immediately developed Guillain Barre syndrome. The patient honestly thought she was going to die. No contact details were reported.
Redness, swelling, pain, itching on injection site, left deltoid since pm of day of injection 5/2/06 left arm from shoulder to elbow, red appears swollen and warm to touch FNP prescribed Benadryl 12.5/5 cc 2tsp !6 for itching, redness, amoxicillin susp 250cc/5cc = 1 3/4 tsp BID x 10 days. RTC if s/s increase or ER.
Fatigue, decreased PO intake, cough, low grade fever. "Urinating all the time"
Day1 moderate redness, soreness, heat at injection site immediately. moderate swelling and hardness in 2-3 inch diameter at injection site within hours. Day 2 continued symptoms, not increasing or decreasing. Day 3 continued symptoms, not increasing or decreasing. Day 4 soreness subsided to mild, hardness subsided to mild.  redness increased to 4 inch diameter and itchy.
1/7/21: Patient is a 74 y.o. male presenting with hematuria at MD office. Wife of pt states pt had Covid Vaccine yesterday and today appears to be confused. Wife states he is usually ambulatory. Pt has hx of Kidney cancer and renal stones. Pt is having trouble ambulating and wife states does not appear to be his normal self. presenting with hematuria onset 2 days ago. Gradual onset, progressively worsening, moderate severity, associated urinary urgency, fever, chills, confusion, fatigue. Wife reports pt was dx with a UTI on 1/5 but no abx were given. Seen in the ED, Abx started for possible UTI. VS significant for T 101.4F. PEx WNL
Patient states having a severe low blood sugar event during the evening after receiving Shingrix.  Shingrix given around 1:30pm, and event was overnight.  The event caused her to fall and cut her lip.  The lip cut required stiches.
Started with pain at the sight of injection within hours of receiving injection. Progressed to sore left side of neck, then headache and sinus pain with nausea. Woke up around 11pm feeling achy all over with chills. Temperature was 100.8F. Through the night and the next day, the fever fluctuated with the highest temp recorded being 102.7F. Other symptoms experienced overnight and continuing to present include headache, body aches, sinus pain, nausea, ear pain, slight sore throat, pain at the injection site.
This infant had a fever of 103, maculopapular rash, diarrhea for 10 - 14 days. Supportive care.
The initial case was missing the following minimum criteria: unspecified number of patients. Upon receipt of follow-up information on 06Dec2018, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. This consumer reported 10 similar reports. This is the 1st of 10 reports. A patient of unspecified age and gender received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at the clinic at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was exposed to a temporary low temperature excursion that reached 33.5 degrees Fahrenheit for 11 hours. The vaccine did not freeze during the low temperature excursion, but it was administered to the patient. Information on the lot/batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018512578 same reporter/drug/events, different patients;US-PFIZER INC-2018512579 same reporter/drug/events, different patients; US-PFIZER INC-2018512580 same reporter/drug/events, different patients; US-PFIZER INC-2018512581 same reporter/drug/events, different patients; US-PFIZER INC-2018512582 same reporter/drug/events, different patients; US-PFIZER INC-2018512583 same reporter/drug/events, different patients; US-PFIZER INC-2018512584 same reporter/drug/events, different patients; US-PFIZER INC-2018512585 same reporter/drug/events, different patients; US-PFIZER INC-2018512586 same reporter/drug/events, different patients.
I woke up with Severe abdominal pain, diarrhea, vomiting in the early morning.  I took some tramadol and layed back down.  My back started to hurt too.  My husband drove me to the hospital. I am having surgery to remove my gallbladder on Friday.
This spontaneous case, initially received from the other health professional on 05-Dec-2017, concerns a 36-year-old adult male patient. The patient's concomitant medication included long and short acting benzodiazepine for an unknown indication. On 30-Nov-2017, the patent was administered with FLUCELVAX QIV (dose 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195233, expiry date: 31-May-2018). On the same day immediately after vaccination, the patient experienced a vasovagal response with tunnel vision, ringing sound in his ears and shaking hands. It was reported that, he did not take any food and had been provided with nutritional bar and water. Later, he sat for 30 minutes and then walked store for 20 minutes. At the time of this report, he completely recovered (before leaving store) from the event and symptoms (tunnel vision, ringing sound in his ears and shaking hands). The reporter assessed the reporter as non-serious. Follow-up received with IRD 05-Jan-2018: No further information available and considered the case lost to follow-up.
Extreme fatigue, muscle aches, chills, soreness at injection site, loss of appetite, unable to participate daily activities for 24 hours.
Within 20 minutes of receiving Hep A vaccine, patient noted to have diffuse hives. No wheezing or airway involvement. BENDARYL given. Well appearing.
Information has been received from a medical assistant concerning a 66 year old male with benign prostatic hyperplasia, coronary artery disease, lyme disease and actinic keratosis who on 13-AUG-2007 was vaccinated with Zostavax (lot # 658081/0743U). Concomitant therapy included BENICAR, FLOMAX, LIPITOR. On 27-AUG-2007 the patient experienced tingling and loss of feeling in his hand and fingers. The patient was on vacation at the time and went to the ER to be evaluated. In the ER, he was given a diagnosis of epididymitis and treated with an unspecified antibiotic. As of 30-AUG-2007, the patient was recovering. Additional information has been requested.
After first injection on 1/18/21- starting 1/19/21- intense joint/ muscle pain in both shoulders- under collar bone and running down to elbow on both sides. Lasted 3 weeks. After second injection on 2/13/21- starting on 2/14/21- intense joint / muscle pain in both shoulders down to elbow on both sides. Lasted approximately 4 weeks. Office visit to Dr 4/7/21 (shoulder specialist) at Clinic- x - rays, two steroid injections into left shoulder area.
Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Low back pain since 25-May-2011, Peripheral vascular disease since 25-Aug-2020 and Asthma since 05-Nov-2008. Concomitant products included ALBUTEROL SULFATE from 18-Feb-2021 to an unknown date for Asthma, CAPSAICIN from 04-Mar-2021 to an unknown date for Low back pain, GABAPENTIN (NEURONTIN) from 04-Mar-2021 to an unknown date for Peripheral vascular disease.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  On 20-NOV-2021 an appointment was scheduled for each patient that was administered an expired Moderna Covid-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: HCP details, concurrent conditions, patient demographics and medical history was added.
Patient apparently received a second dose 5/6/2021 from a clinic and then came to our pharmacy 5/10/2021 to receive his 2nd dose from us again after we did his first dose 4/9/2021. We filled his COVID vaccination record card out with our 2 doses and billed his medicaid for both. Found out 6/22/22 he had received a vaccine 5/6/21 from a different clinic. Patient has not reported any adverse events from this.
Vaccine was given from  vial which had been open for 10 hours, the vial was kept in the refrigerator during the 10 hours at appropriate temp.
Pt was due for DTaP, Hep B, IPV and HIB. Clinical staff member grabbed the combination vaccine PEDIARIX (DTaP, HepB, IPV). What was supposed to be administered with that was an HIB but staff member grabbed an additional HepB instead. Pt. received two HepB's and no HIB. Age of patient at time of event: 5 months.
Evening of 2nd approximately 6pm diarrhea began with increasing frequency throughout the night. Lasted through the night several times an hour into the next morning.  Around midnight dizziness,, faint and muscle weakness set in with feeling of extreme pressure on neck, especially right side where shot administered. Arms became tingly, tongue became tingly, hard to keep awake.  After 12 hrs of extreme diarrhea, passed out for 12hrs straight. Awoke dehydrated, extreme muscle weakness unable to walk or stand, light headed, nauseous, dizzy, unable to grip or exert force. Felt like head was detached from body due to extreme pressure on neck. Rapid resting heart rate in 90s (usual testing HR in 50s).   Constant rolling waves of abdominal cramps brought dizziness with each cramp, acid reflux, bloating and gas.  These symptoms lasted through the evening of the 3rd into the 4th. Considered going to ER for help, as extreme dizziness and muscle weakness prevented walking. Fell asleep.  6am March 4th developed fever of 101. Continued extreme dizziness, pressure on neck, muscle weakness and feeling faint and extreme lethargy throughout day.  Fever subsided to 99 by evening of 4th.  Ate plain rice evening of 4th, 1st time eating in over 48hrs. Immediately passed out.  Match 5th still feeling weak, hard to stand, limited walking. Diarrhea has subsided, less pressure on neck and less dizziness. Feeling exhausted overall. Fall asleep easily and randomly.