chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she got an accident; This is a spontaneous report received from sponsor program. A contactable consumer (patient reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; tetanus vaccine (TETANUS VACCINE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Reporter was calling on behalf of his wife his wife got the 1st dose last 19Feb2021 unfortunately she got an accident before the 2nd dose last 12Mar2021 her husband mentioned that she got tetanus shot so she needs to wait 1 week for her to get the 2nd dose of the vaccine. (She missed the 2nd dose). They want to know what procedure they would do for his wife to get the vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient came in for primary series Infant Moderna 2nd dose. Patient was accidently given Infant Moderna Bivalent Booster.
vaccine that underwent temperature excursions could have been administered to patient; No adverse event; vaccine that underwent temperature excursions could have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 2:36 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 2:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient).    Patient received vaccine in deltoid.  No concomitant product reported by the reporter.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported for the patient. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion.  No treatment medication reported by the reporter.
24 hours post vax, child developed fine rash all over body. Parents state no fever, states child was scratching his face. 5/26/00 attempted to contact parents by phone, # discontinued. Letter sent no response.
Patient had a palm sized area of swelling a couple hours after receiving flu vaccine. She has used TYLENOL and ice. There is no pain. Patient has no difficulty breathing, no swelling anywhere else, and has not ever had a flu shot reaction.
1st dose on 13Aug2020, has not received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 13th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.  No symptoms was reported. The health care professional did not have the lot/expiry date of the 1st dose The reporter consented to follow up.
10/21/15 - patient received influenza injection. 10/26/15 - patient developed lower body numbness, MRI thoracic spine revealed transverse myelitis. 10/30/15 - IV SOLU-MEDROL treatment started (x 3 days), pt currently on oral taper.
received shipment of Fluzone High-Dose four days late and the product is considered expired/no AE; received shipment of Fluzone High-Dose four days late and the product is considered expired/no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves four patients of unknown demographics who received dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] after the product was received late due to delay in shipment.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ284AB (expiry date: 05-May-2025) via unknown route in unknown administration site.  It was of actual medication error case due to incorrect product storage (Product storage error) and Product shipment delay (Product distribution issue).  It was unknown whether any adverse event was noted or not.  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 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.
Expired doses administered; Vaccine put in the fridge on 07Feb2022 and doses were administered on 18Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Vaccine put in the fridge on 07Feb2022 and doses were administered on 18Apr2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Vaccine put in the fridge on 07Feb2022 and doses were administered on 18Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Vaccine put in the fridge on 07Feb2022 and doses were administered on 18Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   On 07-Feb-2022 this vial was put in refrigerator and was administered on 18-Apr-2022.
This spontaneous report was received from a licensed practical nurse and refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates. the patients were vaccinated with improperly stored doses of VARIVAX subcutaneously, lot # M028553 and expiration date 07-JUN-2018 (doses and anatomical locations were not reported) for prophylaxis. No adverse effects were reported. The doses of VARIVAX were stored in the temperatures from 15 Fahrenheit degrees (F) to 46 F (23.2 F) for 96 hours (dates were not reported). There were no previous temperature excursions. The digital data logger was not involved. Additional information has been requested.
Beginning about 12 hours after injection, for apporximately 36 hours after injection, I had a fever (high of 101), chills, pounding headache, body aches, vomiting, diarrea. I felt incredibly tired and slept, restlessly, on and off for 24 hours. I was unable to even drink anything for about the first 15 hours. Finally I was able to eat two crackers and tea and take tylenol which took the edge off the headache. All of these sympoms persisted for 36 hours.  It was miserable and I honestly have never felt so sick. That is coming from someone who has been through labor, childbirth, c- sections, and several major surgeries. I don't think I could do another vaccine without being supervised in a health care facility to help manage the side effects for the first few days. Also, I had a mild case of Covid beginning November 9, 2020 that lasted about 2 weeks.  I was only exposed to one person who had covid that I am aware of. When I was with that person for about 15 minutes, we were masked and 6 feet apart. I do not go anywhere but work and am always masked,  as is everone else I work with and we are always at least 6 feet apart.
Pt brought to ER via ambulance w/CPR in progress; pt found by mom not breathing; pt recvd vax 31MAR92 & had been running fever; Resp distress;
I have experienced multiple days of dizziness. No other symptoms are visible, my heart rate isn?t elevated, etc. It comes and goes but I have had It at least five days of the past two weeks.
Second varicella vaccine given 2/27, mild rash broke out 3/4. Pt has mild runny nose, but otherwise feels fine. No fever. Rash is scattered on trunk and extremities - pink bumps, smaller than normal. Chickenpox lesions, and pt reports they do not itch.
w/in 60-90 min p/vax pt c/o flushing & chills;felt like had temp (temp was 98) site of inj was reddened & swollen;
The liquid portion of MENVEO was given only because there was only one bottle in the box. The bin was labeled "it take two" but I thought that was referring to the number of doses a child had to get not the # of bottles used for a single injection. The patient had no reaction.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 22-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004379:Original Case : 1808USA001261, US-009507513-1808USA004376:Original Case : 1808USA001261, US-009507513-1808USA004377:Original Case : 1808USA001261, US-009507513-1808USA004378:Original Case : 1808USA001261, US-009507513-1808USA004380:Original Case : 1808USA001261, US-009507513-1808USA004381:Original Case : 1808USA001261, US-009507513-1808USA004382:Original Case : 1808USA001261, US-009507513-1808USA004383:Original Case : 1808USA001261, US-009507513-808USA004384:Original Case : 1808USA001261, US-009507513-1808USA004385:Original Case : 1808USA001261, US-009507513-1808USA004386:Original Case : 1808USA001261, US-009507513-1808USA004362:Original Case : 1808USA001261, US-009507513-1808USA004387:Original Case : 1808USA001261, US-009507513-1808USA004388:Original Case : 1808USA001261, US-009507513-1808USA004363:Original Case : 1808USA001261, US-009507513-1808USA004364:Original Case : 1808USA001261, US-009507513-1808USA004389:Original Case : 1808USA001261, US-009507513-1808USA004390:Original Case : 1808USA001261, US-009507513-1808USA004391:Original Case : 1808USA001261, US-009507513-1808USA004392:Original Case : 1808USA001261, US-009507513-1808USA004365:Original Case : 1808USA001261, US-009507513-1808USA004393:Original Case : 1808USA001261, US-009507513-1808USA004394:Original Case : 1808USA001261, US-009507513-1808USA004395:Original Case : 1808USA001261, US-009507513-1808USA004396:Original Case : 1808USA001261, US-009507513-1808USA004397:Original Case : 1808USA001261, US-009507513-1808USA001261:Original Case : 1808USA001261, US-009507513-1808USA004367:Original Case : 1808USA001261, US-009507513-1808USA004368:Original Case : 1808USA001261, US-009507513-1808USA004398:Original Case : 1808USA001261, US-009507513-1808USA004399:Original Case : 1808USA001261, US-009507513-1808USA004400:Original Case : 1808USA001261, US-009507513-1808USA004369:Original Case : 1808USA001261, US-009507513-1808USA004370:Original Case : 1808USA00126.
R lateral thigh 3x9cm swelling/redness; suspect DTap; counseled ice pack, motrin prn; discussed with mom still ok for future DTaP per schedule; will file report on VARES
I started feeling itching 8/1-ish  and developed a rash.  I went to the doctor a few weeks later and was diagnosed w/Shingles.  They gave me an anti-viral and pain medication.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-SEP-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-JUN-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster. On or about 20-JUN-2016, the patient sought subsequent treatment for ongoing and worsening symptoms of shingles pain, which was diagnosed as post-herpetic neuralgia. The patient was prescribed famciclovir and gabapentin to manage her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
RED DOT ON ONE LEG AND BECAME LARGER OVER TWO DAYS; DOT WAS PAINFUL WHEN WATER HIT IT UPON SHOWERING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced red dot on one leg and became larger over two days, and dot was painful when water hit it upon showering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the red dot on one leg and became larger over two days and dot was painful when water hit it upon showering was not reported. This report was non-serious.
Patient noticed a slightly raised rash under arm, around to breast and up shoulder two days after injection. Patient went to physician 6 days after injection and at visit it was undetermined if was an allergy to vaccine or not. Patient received an oral steroid - stated rash was better after first day of treatment.
Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient previously took ampicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (VITAMIN D), cetirizine hydrochloride (ZYRTEC), amlodipine besilate (AMLODIPINE BESYL) and multi-vitamin (MANUFACTURER UNKNOWN); all from unknown date and for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 05Feb2021 at 13:00 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. On 10Mar2021 at 13:30 the patient experienced diarrhea. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was recovered on 10Mar2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, low grade fever, body aches, headache behind eyes, weakness, fatigue, tiredness. This lasted an entire week. I was bedridden one full day on 9/29/2015 and a partial day on 9/28/2015. On 09/30/2015 I resumed normal activities.
pt recvd 2nd dose of Hep B vax on 4OCT91 & on 15JAN92 pt noted to have inc liver enzymes however was asymptomatic; in MAY92 repeat lab eval showed SGOT & SGPT nl; No further details were provided;
Called to pt's car where he was unresponsive with thready pulse. Sternal rub given by staff. Pt then began with decerebrate posturing, eyes rolled back, and not responsive to name for several seconds. After which, patient stopped with these activities and was awake but agitated. Oxygen via NC and cool cloth applied to patient until EMS services arrived and took over care of patient and transported him to hospital.
Extremely tired after receiving afternoon shot. Came home and slept for two hours. (normal temp) Sore/tender left arm/shoulder that evening (normal temp) Morning of Saturday, March 6 joints ached and mild nausea and extreme fatigue. (normal temp) By afternoon achy joints and extreme fatigue was joined by chills (normal temp) Rested most of the day. No concentration for any task. Went to bed at 9 pm with chills and aches...slept, restlessly till 6:30 a.m. Sunday March 7. Felt fine. No residual impact. Feel fine today.
Employee received the H1N1 Flu Vaccine around 5:30 PM.  She began itching soon after the vaccination.  It continued to worsen, then numbness and tingling on face.  25mg of Benadryl administered.  Escorted to ER where an additional 25mg of Benadryl, 20 mg of pepsin and 60 mg of prednisone administered.  Employee sent home.
Developed muscular aches; Pain; Headaches; When to bed and slept for ~12 hours; This case was reported by a physician and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, pain, headache and sleep excessive. On an unknown date, the outcome of the muscle pain, pain, headache and sleep excessive were recovered/resolved.   The reporter considered the muscle pain, pain, headache and sleep excessive to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The physician stated that upon receiving the 2nd dose of Shingrix, the patient developed muscular aches and pain and headache and when to bed and slept for approximately 12 hours and this resolved the next day. The patient was not hospitalized. The physician believed that this was related to the vaccine. The reporter consented to follow-up.
Severe pain, swelling, heat, redness and inability to move left arm normally for 10+ days. Had antibiotics because secondary infection a possibility (no fever). Severe contraction of muscles in arm, axillary shoulder and up left side of neck to chin and jaw. Some trouble swallowing, nerve pain, weakness, neuromuscular problems. Brachial neuritis. As per annual follow up report: I still have weakness and pain in my left axillary deltoid area, collar bone area, etc. ti still swells in the area of the symptoms. In fact, if someone hugs me and places their hand on the site where I had the tetanus, it still hurts, alter 11 months. I am increasing my strength and returned to work 4 months ago. It is painful for me at work (repetitive lifting, pulling etc).
Patient received first dose of Pfizer vaccine at 10:35 am. At 10:47 am, patient felt dizzy and stated that she " didnt feel well". RN assessed patient, Vitals : BP 107/60, HR 84 Spo2: 100 %.  Heart and lung sounds clear. RN gave 1 orange. 10:50 am, patient still feels dizzy, patient is pale in color. RN gave another orange. Patient is starting to present initial signs of syncope, patient is layed on the floor feet are put up on a chair. Vitals : BP 92/40, HR 56 SPO2 94%. Patient is sternal rubbed to wake up. RN gives ammonia inhalant to patient.  Patient is in and out. RN calls 911. 11:05 paramedics arrived, vitals 90/50, Glucose check 73. Patient still feels dizzy. Patient is taken by ambulance
Patient reported warmth and hardness to left deltoid approximately 1 day and a half after vaccination. 5/10 pain. Visual presentation included 2in hematoma around vaccination site, area from site to elbow was Indurated and Erymatic  with skin warm/hot to touch.  Pooling decreased around the elbow joint. Vital signs WNL.  PT stated no history of any reaction with prior dose (2018).  PT given Tylenol and Ibuprofen and directed to follow up in the afternoon prior to departure to ensure swelling did not extend pass the elbow or any significant signs of cellulitis. Hardness disappeared within 2 days with no deformity.