chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immunization Coordinator reporting administered improperly stored GARDASIL 9, Temperature above 46F (48F); This spontaneous report has been received from an unspecified reporter, concerning a 13-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 04-MAY-2022, the patient was vaccinated with an one improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe, for prophylaxis, lot number reported as T028929 and expiration date 08-MAR-2023 (anatomical location, exact dose, frequency and route of adminstration were not provided).   The temperature excursion was above of 46 Fahrenheit (F) (48F), during a time frame of 2 hours, 3 minutes and 0 seconds. There were previous temperature excursions reported as follows: 3 hours, 36 minutes, 0 seconds at 34F degrees; 6 hours, 4 minutes, 0 seconds at 34F degrees; 0 hours, 23 minutes, 0 seconds at 34.3F degrees; 0 hours, 21 minutes, 0 seconds at 34.3F degrees; 0 hours, 22 minutes, 0 seconds, at 34.3F degrees; 0 hours, 18 minutes, 0 seconds, at 34.5F degrees; 0 hours, 19 minutes, 0 seconds at 34.7F degrees; 0 hours, 5 minutes, 0 seconds at 34.3F degrees; 0 hours, 18 minutes, 0 seconds at 34.3F degrees; 0 hours, 16 minutes, 0 seconds at 34.9F degrees; 0 hours, 19 minutes, 0 seconds at 34.7F; and (33.1F) degrees for a time frame of 7 hours, 31 minutes and 0 seconds.
Patient felt chilled and light headed. She was brought to a room and laid in a bed. She complained of nausea and dizziness with standing. Vital signs were monitored. Oxygen saturation remained at 100%. BP 120s-130s/80s. She did not complain of any shortness of breath or wheezing. She did not complain of any itching. No skin or mucocutaneous findings. She was monitored for 4 hours and given 1L of IV fluids, zofran and ativan. She returned to baseline over the monitoring period.
Initial and follow up information has been received from a registered nurse and a licensed practical nurse concerning a 7 month old male with asthma and no known drug allergies who was respectively vaccinated with the first, second and third dose of ROTATEQ, 2ml, oral on 08-FEB-2010, 05-APR-2010 and 23-JUL-2010 (Lot no. 664782/1441Y, expiration date: 23-APR-2011 (1st), lot no. 664884/1524Y, expiration date: 23-APR-2011 (2nd), lot no. 667461/0500Z, expiration date: unknown (3rd).  The third dose was given 15 weeks after the second dose when the patient was 33 week old.  On 14-MAR-2011, the patient presented to the emergency room for bronchiolitis, diarrhea and flu like symptoms.  He was hospitalized and was found bilateral ear infections, asthma exacerbation, flu (determined by a nasopharyngeal wash), and Rotavirus (determined by stool culture); chest x-ray was negative.  The patient was treated with fluids and albuterol.  On 24-MAR-2011, the patient discharged home on ORAPRED and amoxicillin.  At the time of report, the patient's outcome was recovering.  Rotavirus was considered to be an other important medical event by the registered nurse.  Additional information has been requested.
Patient received Pfizer COVID vaccine on 5/19/21 and 6/9/21. Patient presented to our facility on 9/3 with  severe weakness, fatigue, increased cough, SOB, increased confusion, and positive COVID test. He was found to have COVID pneumonia with no O2 requirement. He was initially in shock required pressors. He improved and diuretics were able to be resumed. He was found to have significant acute kidney injury and atrial fib with RVR. Patient was admitted from 9/2/21 to 9/6/21 and discharged home with hospice.
administration of an expired first dose of Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AB, expiry date 31st May 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 10th June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows:  The patient received expired first dose of Bexsero, which led to experienced expired vaccine used. No further events were reported. The reporter consent to follow up.
pt recvd vax;approx 11 hr later,devel rash around lt upper arm;highly pruritic;devel petechiae p/ scratched the area;pt described rash as hot,itchy,uncomfortable;high t;,lasting several hrs;6jul94 seen by MD;prescribed methylpred,cortazon ;
a cardiac stress test and the results"came back not normal, but not terrible; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2 nd dose), for COVID-19 immunization.  The following information was reported: CARDIAC STRESS TEST ABNORMAL (non-serious), outcome "unknown", described as "a cardiac stress test and the results"came back not normal, but not terrible". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reports they missed 4 weeks of Xeljanz for their initial COVID19 vaccine doses, then 2 weeks for their 3rd dose of COVID19 vaccine. Patient reports they recently had a cardiac stress test and the results "came back not normal, but not terrible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a patient received Menactra Subcutaneously instead of IM; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a office staff in.  This case involves a patient of unknown demography who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that a patient received Menactra subcutaneously instead of intramuscular route.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6179AA and expiry date: 20-Mar-2020 via subcutaneous route in unknown administration site.  It was a case of actual medication error due to inappropriate route of vaccination.  It was not reported if any adverse event occurred 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.  List of documents held by sender: none.
Right shoulder - erythema spread from injection site, well defined borders, raised, tender 4 x4cm. Left shoulder - erythema - red macules x 2 toward axilla with warmth well defined borders, raised, tender 5 x 5cm. Dx cellulitis. Rx KEFLEX 500mg cap, 1 PO TID X 7 days.
3mins post vaccination pt had a near syncopal episode and abdominal pain with associated flushing/sweating Vitals: 101/63, 73, 19, 99% Pt stable and released from the vaccination site @19: 25 (28mins post vaccination).
Pityriasis rosea on stomach and back and arm; She had tiny spots on her stomach that have spread and gotten bigger.; itchy; looks awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 37-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: PITYRIASIS ROSEA (non-serious), outcome "unknown", described as "Pityriasis rosea on stomach and back and arm"; MASS (non-serious), outcome "unknown", described as "She had tiny spots on her stomach that have spread and gotten bigger."; PRURITUS (non-serious), outcome "unknown", described as "itchy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "looks awful".  Additional information: The reporter stated that in the last few weeks the patient (daughter) got a condition of Pityriasis rosea on stomach and back and arm. It's itchy and looks awful. She's had 3 doses of the Pfizer covid 19 vaccine - booster dose was on 14Feb or Feb15. The condition started a few weeks ago. She had tiny spots on her stomach that have spread and gotten bigger. Daughter was 37 years old. There are studies that connect people with this condition who received the mRNA vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine administered in car at HD.  Called to car at 1:17pm per husband.  C/O upset stomach and lightheadedness.  B/P 162/82 pulse ox 98% pulse 88 and reg.  Patient took Benadryl 25mg (liquid) at this time per her own request. C/O mouth itching slightly.  Continued to monitor remained alert and oriented .  at 1:25pm c/o right arm pain and right jaw pain refused ambulance.  Husband asked to transport to Dr. office, staff at HD agreed husband was asked to contact HD after Dr. visit or ER visit.  Did go to ER but refused to go in was evaled in care per hospital staff
Pt received vaccination on 10/08/03 and on 10/09/03. Pt experienced swelling above (on arm vaccinated) elbow region and radiating toward (vaccinated arm) to wrist.
12/29/20 -Sore arm, 12/30/20-12/31/30  sore arm and headaches  1/4/20- 1/5/20 - body aches and headaches, coughing  1/6/20-1/7/20 head aches, body aches, congestion, tiredness, no taste or smell Tested positive for COVID 19
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 05Jun2021 as dose 1, single (Lot number: EW0H6), in left arm, on 26Jun2021 as dose 2, single (Lot number: EW0180), in left arm and on 13Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Known allergies: Shea butter" (unspecified if ongoing). Concomitant medication(s) included: DEXAMETHASONE; ALVOGEN ALMAGATE oral, start date: 31May2022, stop date: 04Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details: Product: Covid 19 Treatment, Brand: Paxlovid, Treatment start date: 31May2022, Treatment stop date: 04Jun2022, Lot number: Fw4118, Indication: Treatment of Covid-19, Administrator route: Oral.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
BROKE OUT IN HIVES ON HAIRLINE, EARS, FACE & ARMS. COMPLAINED OF ITCHING. NO SOB. FELT HIS HEART WAS GOING FAST. TREATED WITH ALLEGRA AND BENEDRYL WITH RELIEF. NO KNOWN ALLERGIES TO VACCINE COMPONENTS.
Information has been received from a registered nurse concerning a 72 year old male with sulfonamide allergy, who in 2002 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 12-FEB-2008, the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. On 12-FEB-2008, the patient experienced pain and developed swelling at the injection site. The patient called the office. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Intra nasal flu mist given 10/17/2005. Preceptal cellulitis on left eye. Medical records state conjunctivitis. msv
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-JUN-2007, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
headache; terrible body aches; feels so bad; This is a spontaneous report from a contactable consumer. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 19Dec2020 at a SINGLE DOSE then via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 07Jan2021, the patient took the second vaccine and feels so bad (headache, terrible body aches) and had to go home from work. The outcome of the event was unknown.   Information about Lot/batch number has been requested.
I started feeling chills and headache about 10 hours after the booster dose and went to bed. Through the night, I had trouble sleeping with fever and chills. In the morning I woke up tired with joint pain, fever (100.8), chills, and headache. I experienced some dizziness and nausea a few hours after waking up, and my fever broke then came back. After treating with acetaminophen and sleeping for most of the day, I started feeling much better around 5:30 p.m., about 27 hours after the dose.  Notably, I received two Pfizer vaccinations before this but chose a pharmacy which offered Moderna (and the staff made sure I realized this)
Urticaria on the neck one hour after immunization.  (MMR, HEP B, DTAP).  Benadryl and Calamine lotion.
This spontaneous report as received from a medical assistant refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness in arm lasted 12 days, longer than any shot had ever before. Muscle in shot area very hard to the touch.
Sixteen year old patient was given FluBLOK when it is only approved for 18 years of age or older.
patient reported that she tested COVID positive on 12/22/2021. She recovered on 1/6/2022
WOKE UP WITH HEADACHE, ARM WAS SORE AND SWELLING AT THE INJECTION SITE, REDNESS WAS 1 INCH WIDE AND 2 INCHES LONG AND IT ITCHED MILDLY. FOR THE NEXT 3 DAYS I WOKE UP WITH A HEADACHE, IT STAYED SORE AND THE REDNESS KEPT MOVING DOWN MY ARM AND STOPPED AT MY ELBOW TODAY. THE REDNESS IS MUCH BETTER TONIGHT AND NOT NEAR AS SORE. I DID NOT REPORT THIS TO MY DOCTOR.
Patient brought to Emergency Department due to knee pain after sustaining a fall 2 days prior to arrival- patient tripped over bump on sidewalk. No loss of conciseness. XR showed right patella fracture, received surgical intervention- ORIF.
Pt's mother called 5/27/11 & reports child has 2" x 2" hardened welt area. Child c/o itching. Has call MD & awaiting call back from them. Mom states child tensed muscle when getting shot.
States that after leaving MD, injection site started itching. Approx. 20:00, she noticed 6 or 8 welt-like areas (red and raised) and itching around upper deltoid area where injection had been given. States she is allergic to adhesive and she did not tell nurse when she put a bandaid on. Client left the bandaid on until 20:00. Client has not been changed to a new seizure medicine. (She doesn't know the name). Client to call MD to notify him of what occurred. Denies itching today. States muscle is "a little sore".
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient presented to pharmacy on 7/30/22 with redness, swelling, itching, and pain on back of arm above elbow. Pt reports first symptoms starting on 7/28 with headache and neck stiffness then on 7/29 her arm began showing swelling/inflammation/redness and woke up on 7/30 with redness spreading and beginning to itch and feverish to the touch. Recommended taking otc benadryl by mouth and using either topical benadryl or hydrocortisone to help with itching/redness. No other symptoms at this time
It was reported that a pt (2 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested.
This spontaneous report was received from a medical assistant referring an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates since 01-AUG-2016, the unspecified patients were vaccinated with improperly stored doses of GARDASIL lot # K011562 with expiration date 08-APR-2017 for prophylaxis (dose and route were not reported). It was stated that the temperature excursion was between 32 and 36 Fahrenheit degrees for 4 days. No previous temperature excursion was reported. No adverse effect had been reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA004137: US-009507513-1701USA004138.
Patient received 1st dose of Pfizer vaccine on 1/25/2021. On 2/2/2021, patient c/o right knee joint pain and non-painful and non itchy circular reddened lesions on bilateral lower legs and b/l feet. No drainage of the skin noted. No fever and no flu like sx noted.
received the second dose / on the 29th July, 2021 / first dose / back in May 2018; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix in May 2018).   On 29th July 2021, the patient received the 2nd dose of Shingrix. On 29th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details provided were as follows: The case was reported by the reporter for herself. Health care professional called to report that the patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The patient was not sure at the time of call that she received the 1st dose from Shingrix or Zostavax. No further events were reported at the time of call. Health care professional consented to follow-up by email.
Pt recv vax on 3/9/99; on 3/15/99 pt exp erythema/ itchy/ warm/ tender area on LA; tx=Benadryl
A report was received from a health professional on 11/06/03, concerning a 66 year old vaccinee who experienced localized redness at the injection site two days after receiving Fluvirin on 10/30/03. On 11/01/03, the vaccinee experienced localized redness about 10mm in diameter at the injection site. There was no other symptoms. The event had not resolved at the time of report and the vaccinee is seeing his physician for a follow up visit. The vaccinee has previously had the flu vaccine without any such reaction. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/08/2003: Follow up information received from a health care professional indicated that on 11/06/03, the vaccinee experienced irritation and redness at the injection site and appeared to have a large scab. The vaccinee was admitted into the monitoring area. On 11/10/03, the vaccinee informed his doctor that the large scab was in fact a tick. The tick was removed on the same day and there were no further problems. The redness resolved on 11/10/03. No follow up pending.
This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent conditions were not reported.  Since 01-MAR-2017, the patients were vaccinated with VARIVAX lot # M041079 (expiration date, dose, route and site of administration were not reported) for prophylaxis. Information regarding concomitant medication was not provided. No adverse effects were reported. There was no product quality complaint involved. It was also reported that the vaccines experienced temperatures from 6 F degrees to 14 F degrees for 22 days. There was no previous temperature excursion. The call was not because of a "data logger". This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014463: US-009507513-1704USA000004: US-009507513-1705USA013512: US-009507513-1705USA013513:
Extremely sore arm started a few hours after I received the injection. About 8 hours after receiving the injection I experienced flu-like symptoms: fever, chills, body aches, headache, upset stomach, malaise, overall ill feeling. Those lasted for 24 hours and started to subside on day 2 after the injection. On day 3 after the injection I was feeling better with only some minor aches and a little bit of a decreased appetite.
Evening of injection site became raised, warm, red. The following day (L) arm became (painful 6 to 10 rating & redness moved up to shoulder, couldn't raise arm at all. Sx's are somewhat improved today. 4-24-12 arm continues to be hot, red & 4/10 painful.
adm to hospital w/t103 R, irritability some neck rigidity; hx temp 105 R prior to admission; recvd ped vax HIB on 30JUN92 w/onset of sx 1JUL92;