chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccination failure; shingles; Injection site pain; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (over 20 year before). Previously administered products included Zostavax (received on an unknwon date).   On 1st December 2018, the patient received the 1st dose of Shingrix. On 4th February 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 122 days after receiving Shingrix and 60 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and injection site pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and injection site pain to be related to Shingrix and Shingrix.   Additional details were provided as follows: The patient received 1st dose on right deltoid and 2nd dose on right deltoid. The reporter stated that even after receiving two doses of Shingrix, the patient experienced shingles. The reporter stated that 2 to 3 months after receiving dose two, the patient broke out again, although he does note the area of flaring was much smaller and less painful than previous flares. The patient had injection site pain that felt like he had been hit with a baseball bat. The pain at the site lasted for about 7 days after both doses and resolved with over the counter pain medication (not otherwise specified). The batch number was not available at the time of reporting.
Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomit; Both hands went numb with pins and needles; Both hands went numb with pins and needles; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration from 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization.  Medical history included known allergies: latex, high blood pressure, hypothyroidism, and mitral valve prolapse. There were no concomitant medications. At 11am, 2 hours after receiving the first COVID19 vaccine, my reactions occurred simultaneously. The patient experienced Strong chills, Bad headache, Abdominal Very painful abdominal cramping, Heavy salivating, Nausea, Both hands went numb with pins and needles, the patient felt like she was either going to vomit or have a bowel movement, ultimately it was the latter. This is when both her hands went numb. These reactions lasted 15-20 minutes and then dissipated with the exception of a lingering less painful headache through Friday and Saturday. The patient did not receive treatment for the events. The outcome of the events was recovered.
Patient became syncopal within seconds of receiving the shot. Passed out for about 10 seconds.  Felt dizzy and nauseous after. Lay pt down on cot, elevated feet. BP supine 110/68 P 66 R 16.  Postural drop when seated, lay back down. After about 20 minutes pt maintained pressure when seated and standing, dizziness subsided. Pt declined further treatment or transport and friend drove him home. Advised to call 911 if began to feel worse.
SWOLLEN ON THE INJECTION SITE. REDNESS AND WARM TO TOUCH. PAINFUL AND SORENESS TO SITE. PLACED COLD COMPRESS.
For about 1 week, red, swollen area on arm & flu-like symptoms. For about 1 day - right side of body aches.
Friday 02/11/11 c/o tenderness of arms bilat with erythema. Sat 02/12 (L) arm noted to have swelling of back of arm down to the elbow with bright red "hard" to touch area. This cont. throughout the weekend client felt like he had fever - caretaker reports "afebrile". Insulin depend. DM - BS elevated 200-400 throughout weekend. This AM 02/14 FBS - 245, no keytones. Client lethargic. (L) arm cont swollen, erythema 3h area "now more dk colored; like bruise" cont. to have area firm/hard to touch. No temp obtained. Stayed home from school. 02/14/11 resolving mom sent a picture a few hours after the initial call. Notes "looking better already".
Expired vaccine administered to newborn, exp date 9/15/06 vaccine given on 9/19/2006.
pain in her arm that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ( pain in her arm that comes and goes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY ( pain in her arm that comes and goes). At the time of the report, PAIN IN EXTREMITY ( pain in her arm that comes and goes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported  Treatment medication information were not reported   This case was linked to MOD-2021-098370 (Patient Link).
maculopapular rash to trunk, no confluent 1-2mm diameter; fever; eczema to face-tx w/hydrocortinsone; 21FEB95 sl rash;
This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 8th of 15 reports. A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
evening of 1/15 mild sore throat and mild malaise morning of 1/16 awoke with extreme dizziness and true vertigo (room was spinning to the right), persisted over 40 min, followed by nausea and vomiting.  Several bouts of emesis and dry heaves.  Remained dizzy with continued nausea and attacks of dry heaves.  Went to emergency room to rule out stroke (onset of severe dizziness , vertigo and vomiting.   No prior history of vertigo).  ER workup had negative brain CT scan.  Was discharged after 6 hrs.  Dizziness and nausea and vomiting were controlled with Zofran and Meclizine.  Other than being very sleepy symptoms had resolved prior to discharge from the Emergency Room.
p/vax notice redness & swelling 9/29/99 told to mark area & go to ER if worsens;area of redness increased w/bullous lesion over central area/redness 5x4cm that easily blanches/put on Keflex, Zyrtec then atarax for age & weight;
Numbness in right hip/leg that continues  as of April 13, 2021 Walking & Kneeling hard , afraid of falling.
pt recv vax 16fAPR97 mom reports pt shaking on rt side of body for approx 1hr;pvt MD notified @ that time & DPH given;no further sx noted;pt presented for 3rd vax 19JUL97-immun deferred;
Swelling, erythema, extreme pain over vaccination site. Full body myalgias. Night sweats.
received an extra dose of ADACEL with no adverse event; Initial information was received on 21-Jun-2021 regarding an unsolicited valid non-serious case from other health professional (Agency Inquiry number: 00649777).  It was reported that a 12-year-old male patient received an 0.5 ml extra dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Oral solution) (lot number: C5631AA, expiry date: 27-Nov-2021)on an unknown date for prophylactic vaccination (extra dose administered).  It was a case of actual medication error due to extra dose administered.  The patient took his last ADACEL vaccine in January of this year (2021).  At the time of report, no adverse event 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 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.
Headache the evening of.  Woke up several times throughout the night with headache. The next day, 2/14, body aches, fever, fatigue, headache, arm pain. Monday, 2/15, severe headaches for the entire day. On Tuesday, 2/16, at 2 am, severe abdominal pain and nausea.  Presented to the ED, had elevated WBC s and CT of abdomen revealed an ileus or early bowel obstruction. Was hospitalized from 2/16 to the afternoon of 2/18.  Abdominal pain and nausea continued until the next week.
A 75 year old male pt was started on combined Oncotice/Interferon treatment (unapproved combination) on 12/1/05 for T1 bladder cancer with CIS. Since 2/23 he presented with an increased urinary frequency, mostly at night. On 2/24 the pt developed contact dermatitis, which was mostly located at the bilateral upper posterior thigh area behind the knees, which resolved after treatment. Corrective treatment Celestone injection and local cream.
Dizziness, headache, diarrhea, nausea, feeling of weakness. Elevated BP 160/100.
Patient presented to office for her second covid vaccine. Pt received covid vaccine and was waiting in the check out area with her Father. Pt's father was talking to one of the Providers when patient passed out. Pt was lowered to the floor by the provider and did not hit her head. Provider was able to be arouse patient after about 20 seconds. 911 was immediately called by clerical staff at the front desk. Pt was taken by ambulance to Med Center to be evaluated. VS-99.0-100-22-97/67. Blood sugar was 84.
At 1412, RRT was activated for a 46 y/o M with c/o feeling warm. 5 minutes after this complaint, he threw up about 100 cc of yellowish emesis. Client stated he felt better after vomiting. Vaccinated at 1350 on the L arm. Vitals: BP ? 118/72, 0/0 pain. Head-to-toe assessment completed. No PMH, NKA, and did not take any medications today. During monitoring period, client?s condition improved. At the end of observation period, client was in stable condition and did not feel warm anymore. Client left vaccination clinic at 1432 ambulatory, in stable condition, accompanied by his family (Wife and daughter).
Narrative: Covid+, J&J vaccine 8/11/21; fever, cough, weakness, fatigue, pneumonia Patient remains inpatient in the ICU, continues on Remdesivir, Solumedrol, abx., +foley, afebrile, high flow oxygen AVAPS NRB PEG tube, ICU, Vent. Discharged to select specialty
pt recv vax 14AUG96 & devel rash described as an itchy rash that looked like poison ivy, that started @ toes & is working it way up;
No additional adverse events reported; she found out she was 6 weeks pregnant so pregnant when received GARDASIL 9; This spontaneous prospective pregnancy report was received from a 38-year-old female patient referring to herself. The patient had no pertinent medical history. Her drug reactions/allergies and concomitant medications were not reported. The patient's concurrent conditions included multigravida.    On 22-OCT-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) initial dose, as routine vaccination (route of administration, anatomical location, lot # and expiration date were not reported).      On 05-NOV-2020, she went to the physician office and a pregnancy tests was performed which was positive. It was found that the patient was 6 weeks of pregnancy. The patient's last menstrual  period was calculated to be 24-SEP-2020 and the estimated date of delivery was calculated as 21-JUL-2021. The pregnancy outcome was pending and the fetal outcome unknown. No additional adverse events were reported.
Flue shot was given on upper arm. Appeared to be bruised the following day.  Over the next several days , skin around injection site turned black and peeled off like a bad sunburn.
Information has been received from a physician concerning a female patient who in 1994 (the licensure date of VARIVAX (Merck) was in spring of 1995), was vaccinated with a dose of VARIVAX (Merck). In March 2010, the patient experienced contracted chickenpox. Her case was full-blown with a significant number of vesicles that scabbed in the classic manner. It is unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. The physician questioned whether the patient actually received the vaccine but that the parent had merely given a fictitious date. Possibly there was no vaccine ever given. It was also reported that the patient's sister experienced chickenpox after receiving VARIVAX (Merck) (WAES# 1004USA01684). Additional information is not expected.
Within 20 minutes of receiving her Booster dose, patient reported via email to me that her lip was twitching. The lip is where she had a dermal filler injected a few years ago. She had no other symptoms and was planning to monitor at home.
I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day). The patient was treated with VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency; CALCIUM at an unspecified dose and frequency; MAGNESIUM at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; IBUPROFEN ongoing since an unknown date for Joint surgery, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Every test that they took for blood sugar, Cholesterol, every test they had was in the normal range, there was nothing abnormal in the blood test..     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  On 25-Sep-2023, the patient received TOZINAMERAN (COMIRNATY) for an unknown indication and on an unknown date, received INFLUENZA VACCINE for an unknown indication.  The patient reported for the Pfizer COVID-19 Vaccine. Received the dose on 25-Sep-2023 and 3 days after started experiencing joint pain which still has today at the time of report.  The patient was taking Vitamin supplements, Vitamin D, Calcium, Magnesium, Vitamin C and I am taking Ibuprofen and extra strength Tylenol.  Lab work: The patient had a complete physical about a week and half ago had a complete lab, for blood sample.  Treatment information included Ibuprofen and Naproxen which, 3 months ago he had a shoulder surgery that the doctor wanted patient to take the Ibuprofen as part of his therapy.  Anatomical location of administration was right arm.  This was the first vaccine gotten of Pfizer.  The patient has had several, had the original, then had a booster and then had another booster and this says that it was a Moderna COVID-19 vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-748655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748655:Same repoter
pain down the left side of my neck from the base of my scull to my shouder. chilles ,fever ,vomiting  .for 2 days my neck still has pain in it.
some chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (some chills) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021 at 11:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021 at 9:00 PM, the patient experienced CHILLS (some chills) and HEADACHE (Headache). On 16-Dec-2021, CHILLS (some chills) and HEADACHE (Headache) had resolved.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient went to bed and slept if off and felt pretty good on 16-Dec-2021.
received only the first dose on Twinrix on December 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 30-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in December 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The patient was late for the second dose of Twinrix. No adverse event was reported. The vaccine lot number, vaccine expiration date and vaccination date was not provided. The VAERS information was reported for 1st dose of vaccine. The reporter consented to follow up.
Note that this case meets vaccine breakthrough criteria. KNOWN FAMILY EXPOSURE,  SXS INCLUDE GENERALIZED WEAKNESS, CHILLS, SUBJECTIVE FEVER
12 adults were inadvertently given the Moderna monovalent when they should have received the Moderna Bivalent vaccine. All Patients were notified, no one has reported an adverse event and all said they would just come back in 2 months to receive the Moderna Bivalent vaccine.
Patient had swelling and redness in the injection site. She still has a red mark at the injection site 2 months later that is painful and will also itch.
6 month old admitted for observation because of jerky movements noted by dad last night. His son had questionable reaction. He would cry with pertussis vaccine. Had seizure at 15 months with left sided paralysis. No seizure activity through the night. Adverse reaction to vaccine possible seizure. Will discharge, be slow on giving further vaccines.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 26-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Pain at injection sited and involving entire upper arm with red area 10cm x 7cm, initially raised ~3mm Improved with ibuprofen. Additionally oral antihistamines provided
INADVERTANTLY GAVE MMRV(PROQUAD) INSTEAD OF MMR TO A PATIENT OF 52 YEARS OLD. PROQUAD IS OUTSIDE AGE RANGE FOR THIS PATIENT. NO REACTIONS NOTED.
This spontaneous report was received from a Nurse refers to a 4 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX (Merck) Lot # H014074 (dose, route and frequency were not reported). The nurse reported that on 24-OCT-2013, VARIVAX (Merck) was stored for -13.9 C for 8 hours. On 29-OCT-2013, the VARIVAX (Merck) was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX (Merck) was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX (Merck) was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX (Merck) was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX (Merck) was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA015841, 1405USA015842 and 1405USA008798 (same reporter link). Additional information has been requested.