chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old female patient to whom inadvertently administered a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f 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 HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 08-Feb-2023, the patient received 4th dose at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation: unknown) (lot number: UJ682AAA and expiry date: unknown) via intramuscular route in the right thigh (leg) for Immunization and on the same day inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (poor quality product administered), (product storage error).  It was reported. Registered nurse (RN) called for information on how to manage patients who were administered vaccines that had undergone temperature excursion, due to a refrigerator malfunction. This situation is reported as a medication error due to administration to the patient of a vaccine that had exceeded the stability data documented in the local labelling and additional supporting stability data. First time product used : No Still using product : No.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for both events.  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.
-pt was found to have acute hypoxic respiratory failure secondary to COVID19 and severe hyponatremia - 8/6/21 pt received monoclonal antibodies but not a candidate for remdesivir d/t duration of symptoms -d/t minimal improvement symptoms, Palliative care was consulted. per family wishes pt was transitioned to inpatient hospice on 8/12/21  pt pronounced deceased at 1148 on 8/13/21
Narrative: 04/19/2021 ADDENDUM STATUS: COMPLETED S/0: ON 4/16 AT 15:17 WHILE PATIENT WAS IN THE MONITORING AREA, HE BECAME DIAPHORETIC WITH DIZZINESS AND NAUSE. HE IS ALERT AND ORIENTED X3, ABLE TO TALK DURING OBSERVATION. PATIENT WORKS NIGHTS AND ONY GOT ABOUT 3 HOUR SLEEP PRIOR TO VACCINATION, PATIENT ALSO FASTING FOR RELIGIOUS REASONS. PATIENT LAID DOWN ON STRETCHER AND VS TAKEN AS FOLLOWS" 15:17 BP: 115/75 HR 66 02 SAT 97% 15:23 BP: 131/92 HR 75 O2 SAT 97% FACIAL COLOR IMPROVED 15:28 BP 130/92 HR 66 O2 ST 98% TREATMENT: OBSERVATION, ICE PACK AND JUICE. A PATIENT IMPROVING IN VS AFTER ADMINSTRATION OF ICE PACK AND JUICE. PATIENT REPORTED HIS NAUSA AND DIZZINESS RESOLVED AND HE WAS FEELING BETTER. NO DIZZINESS. PATIENT ADVISED TO SEEK ADDITIONAL MEDICAL CARE IF HE WERE TO HAVE SIMILAR SYMPTOMS OR WORSENING SIDE EFFECTS. RN SIGNED: 04/19/2021 16:38
No additional AE reported; vaccine was administered after the expiration date; This spontaneous report was received from a registered nurse and refers to a child patient of an unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 29-JUL-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # R030453 was confirmed to be valid, expiration date 23-JUL-2021, for prophylaxis in a mobile clinic away from the office (route and site of administration were not reported). No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Fever, rash. On 3/20/13 area of injection red & painful, was extending from (L) upper arm to elbow with warmth, redness & swelling. Refusing to move arm. Hospitalized & started on antibiotics for cellulitis possibly x 36 hours. Discharged 3/22/13.
Describes dull arm pain at site of injection lasting 6 weeks. No site reaction or infection. Just pain.
really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm in her armpit/Incredibly sore arm; Fever and chills; Red at injection site; Very tired; Bad headache; This is a spontaneous report from a contactable other health professional reported for herself. A 46-year-old female patient received the first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer, lot number: EL9262,) via unspecified route of administration at age of 46 years old on 21Jan2021 10:15 AM at single dose and vaccine location at left arm, for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included: prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications reported as there had other medications the patient received within 2 weeks of vaccination. The patient past drugs included: allergies to prochlorperazine (COMPAZINE) and amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported really swollen and sore underneath her arm in her armpit. Patient presented fever and chills. Red at injection site. Incredibly sore arm. Patient was very tired and bad headache, the adverse events reported started on 21Jan2021. It was reported the non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. There was no treatment received for the adverse event. Outcome of events were not recovered.
EPILEPSY, PARTIAL IDIOPATHIC 10/14/2021 ANEMIA  EPILEPSY, PARTIAL IDIOPATHIC 10/14/2021 ANEMIA
I contracted COVID-19 on 05/23/2022 with symptoms of congestion, fatigue, and a mild cough. I was instructed to take over the counter Mucinex by my healthcare provider. My symptoms began to abate after 5 days, but I am still feeling fatigued at this time.
The Vaccine was administered on the high side of the right shoulder of a 41 year old male with a build.  The patient felt immediate pain during and after the injection.  Swelling became prominent with limited range of motion to the right arm laterally and at different angles.  Patient followed up with primary DR who ordered tests to determine what occurred due to the continuous pain, limited mobility and swelling in the right arm shoulder region.
Neuropathy In Lower Body; Numbness appeared in her calves/hips and glutes; tingling appeared in her calves/hips and glutes; she was unable to walk correctly; A spontaneous report was received from a 78-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neuropathy in lower body, numbness in calves, hips and glutes, tingling in calves, hips and glutes, and unable to walk correctly.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included trandolapril, zolpidem tartrate, daily vitamins, magnesium, zinc, EPA and vitamin D3.  On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  About one week after administration of the vaccine, the patient began to experience neuropathy in her lower body. Numbness and tingling appeared in her calves, hips and glutes. This progressed to a point where she was unable to walk correctly. After seeking treatment the condition began to resolve itself in a few weeks and is no longer present at this time. Treatment for the events included Flexural and Aleve.  Action taken with mRNA-1273 in response to the events was not provided.  The outcomes of events, neuropathy peripheral, hypoesthesia, paresthesia, and gait disturbance, were considered recovered on unspecified date.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
no further ae reported; product storage error temperature too high; This spontaneous report was received from a nurse referring to a 34 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  The vaccine was improperly stored on 23-NOV-2021 and on 07-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, in the left arm; measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, in the right arm; diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) intramuscularly, in the right arm (lot number QFAA21, expiration date 30-JUN-2021), influenza vaccine rha 3v (baculovirus) (FLUBLOK) in the left arm (lot number C5787AA, expiration date 01-OCT-2022) (strength and dose were not provided for any vaccine).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Red itchy "welt" at injection site, along with small pustule. Quarter-size diameter.
FLUZONE HIGH-DOSE QUADRIVALENT arrived frozen. The caller reported that the doses were accidently used before realizing the shipment was frozen with no ae; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer non-healthcare professional and physician via Regulatory authority number: 00814971.  This case is linked to case 2021SA345065(CLUSTER).  This case involves a 66 years old male patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.    On 24-Sep-2021, the patient received a 0.7 ml of dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ716AA and expiry date: 30-JUN-2022 via intramuscular route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to product storage error temperature too low (latency: same day).  It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time."  At the time of reporting, no adverse event was reported.  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.
Within an hour the lymph nodes on the left side of my neck were swollen as was the left side of my tongue.  Later that night I had body aches and a mild headache for a couple of weeks.  In May my neck was hurting on the left side.  Mid June I could not move my neck as well and there was constant low grade pain.  It got worse so I had an x-ray and there is a mass on the left side of my neck that will not go away and is getting worse.  I have elbow, shoulder, wrist and foot pain on the left side of my body.
Bilateral / elbow and distally- hives, erythema - runny nose, headache.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, current conditions and concomitant medications were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L027733, expiry date: 13-SEP-2017 and lot # L044694, expiry date: 04-FEB-2018. Medical assistant reported that the vaccine underwent temperature excursion at 50 degree Fahrenheit for 14 hours. There were no previous temperature excursion. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Gastroschisis; My daughter is now pregnant and we recently learned that her baby has gastroschisis; This spontaneous report was received from a consumer concerning a child patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported.   On 16-JAN-2014, the the patient's mother started on etonogestrel (+) ethinyl estradiol (NUVARING), in place for three weeks, remove for one week, then replace. On that day, 03-APR-2014 and 11-AUG-2014, the patient's mother received 3 doses (respectively) of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscularly (IM) for prophylaxis (vaccine exposure before pregnancy, # 1801USA004493). On 12-JUL-2016, 20-SEP-2016 and 12-SEP-2017, three additional doses (respectively) of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis were administered to the patient's mother (fetal exposure during pregnancy). On an unknown date, the patient experienced gastroschisis as result of the six doses of the vaccine, but no causality assessment was provided to etonogestrel (+) ethinyl estradiol (NUVARING). The outcome of the event of gastroschisis considered as not recovered.   Upon internal review, the event of gastroschisis was determined to be serious due to medically significant and congenital anomaly.; Sender's Comments:  US-009507513-1801USA004493:1801USA004493
Patient came in Oct. 14, 2021 at around 2:00 pm for his 2nd Pfizer vaccine.  The patient was perfectly fine after receiving the shot and left the pharmacy with no problem.  However, patient's wife called the next morning and told us that he was taken to the ER last night bc he woke up covered in sweats, had rapid heart beat, and eventually passed out at home.  According to her, patient has no underlying condition and the ER concluded that it must be from the vaccine and reported the incident to VAERS.
Pruritic rash - diffuse over whole body. Exam at office 9/27/11: diffuse rash with erythematous papules & significant excoriations.
pt recvd 1st dose of vax 2dec89;17feb90 pt inadvertently recvd 2nd dose of HEP B;at time of report, no problems noted;
Between 1-2 days after receiving the vaccination, the patient experienced fever, aches, headaches, and fatigue. Tylenol was taken to relieve symptoms.
I am not sure if this is related to the vaccine, but I had it a week ago, and last night (day 6), my body became itchy, without any hives or rash. It did not itch at the vaccination site. The itching began in both forearms and was quite intense. Over the next few hours, the itching spread down my body, mild on my torso, mild on my upper legs, worse on my lower legs (comparable to arms) and worst at the ankles and lower leg. As it moved down my body, the upper itchiness seemed to ease. I took a single capsule of Benadryl which had little effect. After four hours, I took two Benadryl capsules and finally fell asleep. The itching has mostly stopped today.
Redness and slight itching. The redness started around the injection and gradually spread to  a 12 cm X 10 cm by day 6. Slight warm on surface, Chills in hands and feet for the first 48 hours, then gradually become normal.
Onset Persistent Atrial Fibrillation / Flutter with rapid ventricular response 2/14/2021 as indicated on my PPM.  I developed heart failure symptoms and no longer was able to Jog or rode bike due to DOE, lightheadedness and on hills had chest pain and feeling of near syncope demanding immediate rest.  Increased Toprol Xl 100 mg daily and Flecanide 100 mg bid didn't help and the latter likely contributed to "Flecanide Flutter" and my new heart failure with EF of 46%.  My heart failure symptoms immediately improved off flecanide and on Digoxin, but my symptoms totally reversed after elective cardioversion and Atrial Ablation therapy 6/10/2021.
Persistent dizziness on getting out of bed followed by repeated dizzy spells every few minutes throughout the day.  Repeated spells lasting several seconds each throughout the entire day. Less frequent and less intense by evening. Resolved entirely by waking on following morning. No nausea, lightheadedness, or blood-rushing in ears experience. Just visual spinning.  No history of this symptom ever before. Or since.  No obvious correlation that was unusual or different in health or environment other than the vaccine earlier in that week.
1st dose in 2018, 2nd dose not given yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in October 2018 intramuscularly).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2018, 2nd dose not given yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-MAR-2023 The reporter was the patient's husband.  The patient had not received the second dose of Shingrix yet, which led to incomplete course of vaccination. She did not realized a second dose was needed.  The patient planned to receive the second dose.  Nothing else was reported. The reporter did not consent to follow-up. This case is linked with US2023037533, reported by same reporter.; Sender's Comments:  US-GSK-US2023037533:same reporter
Patient complained of not being able to read 1 week after vaccine. 1 week and one day, became very disoriented. Taken to ER on 1 week and 2 days after the shot and diagnosed with a stroke in the left occipital lobe of brain. Also diagnosed with atrial fibrillation same day. (for first time.). Patient had no history of blood clotting disorders nor heart problems.  This stroke rendered patient with restricted vision. She is now unable to drive, and still quite foggy, though she is likely to recover almost fully.
rash over arms; This case was reported by a consumer via call center representative and described the occurrence of rash in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gastrointestinal ulcer. Previously administered products included Shingrix (1st dose received on March 2019.). Concomitant products included hydrocortisone (Topical Hydrocortisone).   In June 2019, the patient received the 2nd dose of Shingrix. In July 2019, between 3 and 4 months after receiving Shingrix, the patient experienced rash. The patient was treated with hydrocortisone. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. On 20th July 2019, the patient started to experience rash on both the arms running down the elbow.  The patient had been applying hydrocortisone cream to it. The reporter gave permission to follow up.
Within 24 hours of the second shot I started shaking uncontrollably. I was very cold and felt like I had the flu. I had many visuals in my eyes and still over 6 weeks later do not feel normal. My eye sight is blurry and when I close my eyes it feels like someone is holding flash lights in my eyes. At night I have heart palpitations regularly now.  I am beyond disappointed that our government would approve something like this. I have a BMI of 21, work out daily, and eat a healthy diet. I have had no medical issues my entire life until this vaccine.
"splotchy" rash 2 inject site which was about the size of a softball. No fever or pain, walking fine.  18Jun90 F/U: 3rd DTP. Rash & hives & local rxn /w some fever not measured
pt recvd vax & 2 days following vax pt dx as having arthralgia which persisted for a wk; a wk later pt devel chicken pox which also devel again later in the year; pt devel sinus problems & severe h/a
70 yo M with PMH CAD, HTN, HLD who presents on 8/6 for n/v, decreased appetite x 1 week. He was evaluated by PCP who noted elevated LFT and was found to have liver lesions. Also with L lumbar back pain since June so he was taking 2 extra dose tylenol Q2-3H. On day PTA, took 6 tablets of tylenol at once. Pt was reading on tylenol OD so he came to EC for evaluation. Also notable for 20lb weight loss. On arrial to EC, CT a/p w lung nodules, severe liver cirrhosis and splenomegaly, ascites, R hepatic lobe and L hepatic lobe mass consistent with multifocal HCC, upper abdominal adenopathy indicating mets, lytic lesion L1. CBC, BMP unremarkable. HFT markedly elevated. Pt admitted for further w/u and oncology consult. Oncology, GI, hepatology consulted. AFP and CA-19-9 wnl. S/p CT guided bx of L1 on 8/12. FPRS consulted, started on methadone with improvement. Biopsy results pending at the time of dc. Pt instructed to f/u with oncology team for pathology results and further plan of care. Pt remained hemodynamically stable. He was discharged home in stable condition.