chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix vaccines were administered to two infants; administered to two infants instead of Pediarix.; Kinrix vaccines were administered to two infants; administered to two infants instead of Pediarix.; Kinrix vaccines were administered to two infants; administered to two infants instead of Pediarix.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old female patient who received DTPa-IPV (Kinrix) (batch number 273C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number 273C4, expiry date 17th January 2023) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number 273C4, expiry date 17th January 2023) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th May 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 10th June 2021, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 11th August 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 4th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, not applicable after receiving Kinrix, Kinrix Pre-Filled Syringe Device and Kinrix and an unknown time after starting Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On 10th June 2021, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On 11th August 2021, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered, inappropriate age at vaccine administration, wrong vaccine administered, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Practice Manager reports that, it was recently discovered that Kinrix vaccine was administered to the infant patient instead of Pediarix, which led to inappropriate age at vaccine administration, wrong vaccine administered.  The patient was administered three separate doses of Kinrix, all from lot number 273C4. The reporter consented to follow up. This case has been linked to US2022001229, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001229:same reporter
Guillain Barre syndrome, axonal form. Per doc 214332, 60 day follow-u, patient was discharged to a rehabilitation facility. He reportedly died several days later. I am unsure at the cause of death, though I suspect he may have suffered a massive pulmonary embolism.
Substantially decreased mobility, cannot lift arm to side/front/across body sometimes cannot elevated arm inches. Constant pain in shoulder, arm, forearm, fingers, back/scapula, neck pain level so high, unable to sleep.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus (Lupus), Immunosuppression (Immunosuppressed) and Kidney disorder (Kidney disease).    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided          Concomitant medication were not reported  Treatment medication information were not reported  Action taken with mRNA-1273 in response to the event was not applicable
Headache and right otalgia on day of vaccination (4/25/21), and then development of right sided Bell's palsy on 4/29/21.
ER visit on 1/30/01 at 19:00. Temperature was 105.9F (R). Doctor state may be from viral infection. He did have Advil on 1/29/01 and 1/30/01 for low-grade fever. Had temperature increase until 2/2/01 with no other symptoms.
This spontaneous report was received from a 64 year old female pharmacist, who was reporting on herself. The patient's medical history and concurrent conditions were not reported. On an unknown date, a 64 year old patient was vaccinated with the first dose of GARDASIL 9 (route of administration, lot number and expiry date were not reported). Two additional doses of GARDASIL 9 were scheduled for later for pharmacist to complete the series. Concomitant therapy was not reported. No adverse effect was reported. Additional information is not expected, because there is no consent to follow up.
No adverse event; HCP calling to inquire about immunogenicity for 65 y/o male pt. that inadvertently received PEDVAXHIB prior to splenectomy which is scheduled on 10/24/2023.  No adverse effects reported.  No additional AE.  No PQC.; This spontaneous report was received from a nurse, concerning a 65-year-old male patient.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 06-OCT-2023, the patient was vaccinated with an inadvertently single dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection,(lot #W028535, has been verified to be valid, expiration date: 10-MAY-2025, administered for prophylaxis (strength, and route of administration were not provided) prior to splenectomy which was schedule for 24-OCT-2023. No adverse event reported. The patient was 65-year-old when vaccinated (Inappropriate age at vaccine administration)
Patient received vaccine and was asked to move to observation area.  Shortly after sitting down the patient came back to pharmacy counter and stated he was feeling dizzy.  Just as the pharmacist was telling him to sit back down he fainted and fell on the floor.  He recovered rather quickly (matter of seconds?) and tried to sit up right away.  Pharmacist asked him to stay on the floor for a moment, the store's first responder (MIC) was called over to pharmacy.  After a minute of sitting on floor the patient got up on his own accord and transferred to a nearby chair.  His BP was taken twice per emergency protocol of pharmacy.  Patient initially appeared calmmy and BP  was 132/81, pulse 44, respirations 18 at 12:25p.   BP was 142/89, pulse 48, respirations 16 at 12:35.  Patient was given both a water and a Gatorade while he was seated.  Patient stated he had not eaten anything yet for the day.  Patient was repeatedly offered medical services (i.e. "Do you want a medic? Do we need to call an ambulance?") The patient repeatedly refused any further medical treatment.  After further observation patient was able to stand, check out at the pharmacy and left the store on his own accord.
Dizziness; Hypertension; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN6198) via an unspecified route in the left arm on 22Feb2021 at 12:00 PM (at the age of 62-years-old), as a second single dose for COVID-19 immunization. The patient's medical history included hypertension, depression and anxiety. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lisinopril HCTZ (hydrochlorothiazide) and fluoxetine (PROZAC) for unknown indications received on unknown dates. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN5318), via an unspecified route in the left arm on 30Jan2021 at 12:00 PM, as a first single dose for COVID-19 immunization. The patient got the COVID-19 vaccine administered at the hospital. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient experienced dizziness and hypertension. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with meclizine and increased dose of lisinopril for the adverse events. The clinical outcome of dizziness and hypertension was not recovered. No follow-up attempts are needed. No further information is expected.
Fever which steadily rose to 100.3 degrees F as night progressed, joined by severe shivers at 2:00AM (but no coldness) Fever lessened but remained for all of the following day, shivering ceased Fever was addressed on first night with wet paper towels on head and extremities, and a refrigerated water bottle Max recommended daily adult dosage of Tylenol taken by time fever dissipated
Total amount of time the vial was exposed to room temperature after first puncture was more than 24 hours; dose given greater than 12 hour post-puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given greater than 12 hour post-puncture) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature after first puncture was more than 24 hours) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 13-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given greater than 12 hour post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature after first puncture was more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given greater than 12 hour post-puncture) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature after first puncture was more than 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The date the vial was initially stored in the refrigerator was unknown. The vial was first punctured on 12-Mar-2022 at 10:18 AM. The vaccine was administered around 11:30 AM on 13-Mar-2022. It was reported that the vial was stored at room temperature post puncture. The vial had not went under temperature excursion.  No treatment medications were reported.
received in 2017 the complete schedule. In 2020 had shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of herpes zoster.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and 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 details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the 1st case of shingles after the Zostavax vaccine. In 2017, about 4 years prior to the reporting, the patient received the complete vaccination schedule of Shingrix vaccine (the 2 doses 6 months apart) and in 2020, she had the mild case of shingles. The patient wanted to know if it was possible to get Shingrix twice in a lifetime. The different health care professionals (HCPs) told the patient different things and the last one said that it was not possible to get the Shingrix twice and refused to vaccinate the patient. The physician recommended revaccination after 5 years from the last Shingrix shot. The reporter was rushing to get off the phone and was looking for a yes or no to the question she asked about Shingrix booster dose. Upon asking the questions to document safety report, the reporter asked if she could get off the phone and thus, no vaccine information was provided at the time of the call. The reporter did not consent to follow up with the health care professional and therefore, did not collect the health care professional contact information. The reporter did not consent to follow up.
Patient received Pfizer pediatric dose 0.2 mL (orange cap), instead of Pfizer 0.3 mL for her second dose.  No reported adverse events
Pt came into clinic today (4 days since vaccine administration) reporting that she has had severely limited ROM after her inj. Upon inspection, pt had obvious bruising that was too high of placement for an IM deltoid injection. Pt reports gradual improvement and declined wanting to be seen by physician or having any further work up.
Shingles (confirmed by Hospital on 11/18/09).  12/4/09 OB/GYN consultant records received. Service date 7/9/09 to 12/3/09. OB visits.  12/1/09 ED records received, service dates 11/18/09. Assessment: Shingles. Patient presents with rash around (R) breast going around to back, abdomen. Tingling feeling. Itching. Feels like back is on fire. Zoster rash.
Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 29-JAN-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Pt was given a H1N1 vaccine on 10/20/09 and received a 2nd one on 10/28/09.
headache, severe body pain and joint stiffness, arm pain, hard lump where the shot was given along with large area of warm redness,  Chills, diarrhea, facial tenderness,  extreme fatigue. Nausea, loss of appetite, sore throat and swollen lymph nodes in neck, temperature, loss of taste.
Nurse drawing up Moderna doses drew up and administered 0.3mL doses instead of 0.5mL. Patient was notified the 10/06/21 and offered to received the additional 0.2mL to receive the full dose.
congestion; Sore throat; extreme tiredness, extreme fatigue; Low grade fever; This is a spontaneous report from a contactable consumer (Patient). A 32-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0158; Expiration Date: 31Jul2021, patient was 32-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 06Apr2021 at 05:00 PM as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing borderline high blood pressure. Concomitant medication(s) included ongoing hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for to regulate his blood pressure from an unspecified start date, taking this for maybe 6 months; ongoing lepidium meyenii root (MACA 2H) taken for supplementation therapy from an unspecified start date, he started taking this 3 weeks ago. He said it was just a good supplement. No previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior vaccinations within 4 weeks, no AE(s) following prior vaccinations. No illnesses at time of vaccinations. No family medical history relevant to AE(s). It was reported that patient had symptoms for the last 7 days now. He asked that if it was normal or should he go into urgent care. Not really sure what to do. On 07Apr2021, the patient experienced extreme tiredness, extreme fatigue, low grade fever, sore throat on 09Apr2021, congestion on 10Apr2021. Reported that low grade fever which was 70 to 80% improved at the time of report, a little every morning when he wakes up its sore. The outcomes of events were recovering.  No follow-up attempts are possible. No further information is expected.
Pfizer Dose 1 4/18/21 (lot NA) Pfizer Dose 2 5/13/21 (lot NA) COVID Positive 1/4/22  1/4/22: 50 year old female with PMHx of laparoscopic cholecystectomy 8/2018 followed by diagnostic laparoscopy, cecopexy with appendectomy 10/2018. She has chronic nausea, slow gastric motility and reoccurring small bowel obstructions. She presented to the emergency department with increase in abdominal pain, nausea and vomiting. Onset of symptoms: Sunday. Intermittent abd pain until yesterday when it became more constant. Passed small loose BM yesterday, was passing gas, and heard bowel sounds so patient did not get concerned until symptoms progressively worsened despite home remedies including Gas X, magnesium, a probiotic, peppermint tea, positioning, and clear liquid diet. Emesis X 2. Pain described as cramping/twisting in lower abdomen similar to prior obstructions. Reports 7 prior bowel obstructions since 2018. Pain radiates throughout abdomen. Pain is aggrevated by eating and alleviated with pain medications. She follows a low fiber/low residue diet. She underwent a full examination including a CT scan of her abd/pelvis which is concerning for a small bowel obstruction.  She denies recent illness and has received COVID-19 vaccine.  1/6/22: Patient presented to the ED on January 3, 2022 with complaints of severe nausea, abdominal pain, and vomiting x 1 day.  Imaging showed partial small bowel obstruction.  NG tube was placed.  Patient was admitted for observation. Oral triple therapy was started.  Her COVID-19 test result was positive.  The hospitalist service was consulted. Patient began passing flatus and eventually passing stool. NG tube was removed and clear liquid diet was ordered and tolerated well.  The NG tube was removed and a low-fiber diet was ordered.  Patient was ambulating and voiding well. She was tolerating solid foods.  She voiced readiness for discharge.
Malaise, headache, dizziness; rash on arms and legs but no fever.
This is a spontaneous report from a contactable pharmacist. A 61-year-old female patient received PREVNAR 13 (unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for vaccination; obeticholic acid (OCALIVA), oral from 19Nov2018 to an unspecified date at 5 mg, three times a week for primary biliary cirrhosis; and influenza vaccine (FLU VACCINE), via an unspecified route of administration on an unspecified date at an unspecified dose for vaccination. Medical history included primary biliary cholangitis from an unknown date and unknown if ongoing.  Concomitant medication included vitamin b complex; aloe vera oil; ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER); hydrochlorothiazide, losartan potassium (HYZAAR); levothyroxine sodium (SYNTHROID); calcium, colecalciferol, magnesium, zinc (CALCIUM MAGNESIUM ZINC FORTE); folic acid; ascorbic acid (VITAMIN C); nicotinamide (VITAMIN B3); fish oil (FISH OIL); and curcuma longa rhizome (TURMERIC [CURCUMA LONGA RHIZOME]). On an unspecified date, the patient experienced chills, muscle ache, pain, injection site pain, nasal drip, head cold, injection site redness, upper respiratory infection, and fever. The events were reported as non-serious. The action taken for obeticholic acid was permanently withdrawn (reported as stopped). Outcome of the events was unknown. Information on the batch number has been requested.
My 2nd Covid vaccine has caused internal inflammation (seen on a CT scan) causing me unending diarrhea resulting in 2 trips to the ER and is still ongoing for more than 5 months now. It makes my BP drop, I am lightheaded and cannot eat enough to sustain. I have lost 20 lbs, gained 10 back, and am now losing again from more uncontrolled diarrhea. Doctor has once again put me on prednisone to help the inflammation. I was perfectly fine before my 2nd Covid vaccine. Don?t feel like I will ever get better at this point.
Seven days after injection 2.5 x 3.5 inch red swollen area appeared on left arm at injection site with intermittent intense itching
A non-serious, spontaneous report of H1N1 administered to a 57 year old has been received from a registered nurse concerning a 57-year-old female patient. The patient's medical history and concomitant medications was not reported. The patient received H1N1 on 16-OCT-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.