chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an investigator (Number 045/263) as part of a business agreement, concerning a 14 month old male who entered a study. On 11-DEC-2011 (also reported as 12-DEC-2011), consent was obtained and the subject was randomized to be vaccinated with DTaP-HepB-Hib-IPV, PREVNAR 13 and ROTATEQ at 2 months, 4 months and 6 months of age or ROTATEQ, PENTACEL, PREVNAR 13 at 2, 4 and 6 months of age and modified process HepB vaccine at 2 and 6 months of age (study vaccine information not provided by the site). On 19-DEC-2012, the subject experienced bronchiolitis (intensity reported as 3) and on 23-DEC-2012 pneumonia (intensity reported as 3) and was hospitalized. The subject was seen in primary medical doctor (PMD) office on 19-DEC-2012 and diagnosed with ear infection, wheezing (not reported as SAE/NSAE/symptom) and bronchiolitis. On 19-DEC-2012, subject was treated with OMNICEF po for ear infection (dosing information not reported), CIPRODEX otic suspension, ear drops for ear infection (dosing information not provided) and albuterol aerosol for wheezing in office and at home and improved (dosing information not provided) (also reported as concomitant therapies). On 20-DEC-2012, subject started with high fevers 104 to 105 (unit of measurement not reported as SEA/NSAE/symptom) and was treated with TYLENOL and ibuprofen at home (dosing information not provided). On 23-DEC-2012, subject was brought to the emergency room (ER) for increase work of breathing and fevers. In the ER subject was treated with nasal cannula oxygen and ampicillin IV (dosing information not provided). Per PMD subject was in hospital for about 48 hours. On 26-DEC-2012, subject was seen in PMD office, no further information provided. At the time of reporting, subject was recovering from bronchiolitis (grade3) and pneumonia (grade3). Action taken with study therapy was not reported. At the time of reporting, the investigator did not provide a causal relationship between study vaccine therapy and bronchiolitis (grade3) and pneumonia (grade3). Additional information has been requested.
No additional AE reported; The consumer was supposed to receive MMR-II in the right leg; however, PROQUAD was inadvertently administered instead; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 13-JUL-2021, the patient was vaccinated once with 0.5 milliliter (ml) of varicella virus vaccine live (oka/merck) (VARIVAX) in the left leg (lot number and expiration date was unknown). The consumer was supposed to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in the right leg, however, a dose of 0.5ml of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number T027294 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA), expiration date reported as 08-FEB-2023, but upon internal validation established as 08-FEB-2022) was inadvertently administered instead (wrong product administered). No additional adverse event was reported.
This is a spontaneous report from a contactable nurse. An infant male patient of an unspecified ethnicity received PREVNAR 13, at single dose, and PENTACEL, at unknown dose; both were administered on the same date (unspecified) at the primary pediatrician's office, via an unspecified route of administration for immunization. The patient's medical history and concomitant medications were not reported. The reporting nurse worked at an allergy and immunology office and was requesting on information regarding ingredients of the vaccines so she could do the skin test to the patient. The patient experienced total body rash with hives which began 24 hours after the vaccines were administered. The nurse was requesting for the specific ingredients in the product and to get those separate ingredients to test patient for allergies. The nurse stated that they were possibly performing a skin test. The patient had recovered completely from the events.
DULL ACHE TO RIGHT ARM/ PAINFUL TO SLEEP ON THAT SIDE; INJECTION SITE PAIN- RIGHT ARM; This spontaneous report received from a consumer concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic lymphocytic leukemia, and sulfa allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced injection site pain- right arm. On 17-MAY-2021, the subject experienced dull ache to right arm/ painful to sleep on that side. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site pain- right arm on 04-MAY-2021, and had not recovered from dull ache to right arm/ painful to sleep on that side. This report was non-serious.
Extreme cough; Nasal congestion; Sick for two weeks; This serious case was reported by a consumer and described the occurrence of sickness in a 76-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 01-JUN-2023, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick for two weeks) (serious criteria clinically significant/intervention required), cough (Verbatim: Extreme cough) and nasal congestion (Verbatim: Nasal congestion). In JUN-2023, the outcome of the sickness was resolved (duration 2 weeks). The outcome of the cough and nasal congestion were not reported.   It was unknown if the reporter considered the sickness, cough and nasal congestion to be related to Shingles vaccine.     It was unknown if the company considered the sickness, cough and nasal congestion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023. This report was submitted via the online direct entry reporting system. Please process using the related. This report was submitted by public reporting. The patient was the reporter. Reporter seriousness for Sick for two weeks intervention required. Shingles vaccine manufacturer was unspecified. The patient did not receive other product. The patient was very sick with doctor's report and pills. The reporter gave permission to contact by email address.
This spontaneous case, initially received on 02-Nov-2016, was reported as a health professional and concerns an 84 year old patient. Weight: not provided, Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # N002202, expiry date: 04-NOV-2019, (dosing details were unknown) (incorrect product storage) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 0 C to 1C for 15 Hours and below 0C (-1C) for 47 Hours 30 Minutes. There was no previous temperature excursion. No data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006518.
muscle soreness, injection site pain, neck sore, achy Narrative:  Took OTC Tylenol and Motrin
Patient returned to pharmacy ~30 minutes after the immunization. Patient states he had an outbreak on his forehead (could see bumps on head) starting ~25 minutes after immunization; patient noticed the outbreak while waiting in car and while talking to his mother on the phone (patient left pharmacy waiting area after sitting there for 10 - 15 minutes. Patient stated the outbreak was slightly itchy. When asked if patient had difficulty breathing or experienced swelling, he denied it. Advised patient to take Benadryl for the rash and go to the ER if necessary. Called patient ~30 minutes after he left pharmacy to see how he was doing, patient stated he was doing okay and did take a Benadryl, still had the outbreak (still slightly itchy and bumpy, but also occurred partially around the chin/mouth area). However, patient also denied having difficulty breathing or experiencing swelling. Then advised patient to go to ER for further evaluation to be extra safe.
Pts recvd 3 doses of Engerix-B & titers were checked 6 wks p/series was completed; 1 booster dose was given; titers will be rechecked in 6 wks; it pt still has not responded then complete 2nd series will be given; 2 pts recvd 6 doses no res
AFTER RECEIVING THE VACCINE TODAY, SHE COMPLAINED OF A HEADACHE AND CHEST PAIN.  ON SITE EMS RESPONDED. VITALS ARE BELOW.  SHE DID NOT TAKE ANY OF HER MEDICATIONS TODAY.  SHE RECOVERED AND RELEASED TO HOME
Got flu shot 9/14/11 immediately 15 mins. later fever, chills, sweaty, cramping in LE's, pain shoulders. Next 2 days started with confusion, some hallucinations - all lasted from 9/14-9/19 given Doxycycline on 9/19/11 - hasn't been back in for re-evaluation.
Began face numbness across cheek bones, eye pressure, dizziness when stood. Went to ER , everything in normal limits, CT clear. 3 days later blacked out driving,  husband in car took me back to er labs still normal values had PVCs. Now wearing cardiac monitor waiting for cardiac consultation.  No previous cardiac issues nor cardiac family hx.
Tingling in the fingers and the hands went numb. Patient eventually got back pain. Bladder slowed down.
Abdominal pain, Vomiting, diarrhea. Treated at Hospital.
Pain in arm, staggered walking, spinal tap, dizzy, delusions, headaches, weakness, high fever-103.9, frequent urination, confused, 2 grand mal seizures, incoherent speech, ventilator-3 days, tiredness.
This spontaneous report as received from a consumer refers to his/her 17 year old daughter. On 19-JUL-2013 the patient was vaccinated with first dose of GARDASIL (lot number, strength, dose, frequency, indication, route and site unspecified) along with a meningitis vaccine (manufacturer unknown) (lot number, strength, dose, frequency, indication, route and site unspecified). The patient experienced shortness of breath and headache from 24-JUL-2013 to 27-JUL-2013. She began feeling well on 28-JUL-2013. The outcome of shortness of breath and headache was reported as recovered/resolved on 28-JUL-2013. The patient had sought unspecified medical attention. Additional information is not expected.
sinus congestion, body aches, chills, nasal congestion, fever 101 yesterday. starting 12/27/21
diagnosed with shingles/2 months later/shingles; This case was reported by a other health professional via(Shingrix GSK Chatbot) interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose and then was diagnosed with shingles 2 months later. The reporter asked how long till he or she could get their second dose. No further information was reported.
Pt was supposed to receive ped. DT & was given DTAP.  Father came in with Pt. & did not tell nurse supposed to get ped DT.  No reaction reported.  Previously rec. "4" DTAP's.  Father reported "spasms", none since 6 mo. old.
Pt was healthy prior.  Approx 4-6 weeks after the 2nd vaccine injection the pt was noted to have joint stiffness in the R shoulder which then progressed to knuckles, wrists, and legs with weakness at his artificial knees.  Stiffness was initially worse in the am and was without relief with NSAIDS.   Pt had trouble with ambulation and getting up and down from chairs/sitting.  He became significantly debilitated and f/u with MD ensued.  Steroid dose pack helped but after several days post completion the s/s returned.  C-RP & ESR were elevated but all other RA and autoimmune markers were neg on his labs.  Repeat f/u with MD a Ketorolac Injection was given that didn't touch the s/s.  As the s/s continued the pt was then put on Celebrex 200mg bid and instructed to f/u with Rheumatology.  The pt gets relief with the Celebrex bid but if the dose is decreased to 200mg x 1 q day > the pt has immediate return of s/s.  Repeat C-RP and ESR were again elevated on the second set of labs also.  We are in the process of follow up with Rheumatology who after first visit said he didn't know what was wrong with him.  We are pending additional labs and xrays this week. The pt has always been very active and healthy with no medical problems other then slight hypertension.  His body has gone into a systemic inflammatory response acutely for no reason.
six months ago after second shot, it was 150/85-88.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization.  The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "six months ago after second shot, it was 150/85-88.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states that another friend who has taken "maybe two" vaccines, not sure of booster, now discovered she has high blood pressure. Caller states his most recent blood pressure 140/80, and six months ago after second shot, it was 150/85-88. Caller asks for any association with the Covid vaccine and carpal tunnel syndrome or high blood pressure, and guidance for treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt c/o overall flushing of skin, extreme itchiness of the trunk, arms, head and legs. Administered BENADRYL P.O.
violent, delayed reaction; This case was reported by a consumer via other manufacturer and described the occurrence of delayed type hypersensitivity in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included allergy, bee sting hypersensitivity and allergy. Previously administered products included Epipen.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 12 hrs after receiving Shingles vaccine, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On an unknown date, the outcome of the delayed type hypersensitivity was unknown.   It was unknown if the reporter considered the delayed type hypersensitivity to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had allergies to preservatives,any drug that ends in "caine" (lidocaine, prilocaine etc),bee stings, and tar. Patient carried Epipen and had a hesitation to receiving the Covid 19 vaccine It was reported that patient received the 1st dose of Shingrix and 12 hrs after the vaccination patient had a violent, delayed reaction and patient was sent to the hospital.
Patient received her initial dose of Materna vaccine and approximately 10 minutes later began to have shortness of breath, wheezing and was brought down to the emergency department for evaluation.  Patient initially was fairly tachypneic, wheezing throughout all lung fields and was given duo nebs.  Patient improved significantly afterwards.  She did not show any other signs of allergic reaction including hives, urticaria, oral swelling, diarrhea.  She was discharged to follow-up with allergist as an outpatient.
A non-serious report was received from a 46-year-old female consumer coincident with FluMist therapy. No medical history or drug history was reported. The consumer received FluMist from the clinic on 03-Dec-2007. She stated that she had a burning sensation in her nose since receiving the vaccination, a headache since the day of the vaccination and a fever the day after the vaccination. Outcomes for the reported adverse events were not reported. Additional dosing of FluMist is not indicated for current season. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
A pre-diluted grey-top Pfizer covid vaccine vial (adult) was further diluted with 1.8 mL of normal saline. Subsequently an over-diluted 0.3 mL vaccine was administered to the patient for her first vaccine. The patient was notified of this, and informed that the CDC recommendation is to receive an additional dose of the vaccine immediately. She returned to the clinic on the same day and received the correct dose/concentration of the vaccine. There were no adverse events or clinical consequences reported.
Pt was standing in waiting room a few min after vaccine was administered. She took gauze off the injection site. Cried out "Oh blood!" - staggered across waiting room and fell into window ledge. Cutting forehead & knocked out tooth.
large swelling and bump on pts right forearm. skin is peeling and pt claims it feels hot
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 29-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sharp pain at injection site in left deltoid, followed by increasing pain and limited range of motion in left deltoid.
JOINT PAIN; This spontaneous report received from a consumer concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered on an unspecified date in MAR-2021 for prophylactic vaccination. On an unspecified date after vaccination, the patient was tired (dose number in series 1). The patient received booster of covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date after vaccination in DEC-2021, the patient experienced joint pain (dose number in series 2). The patient had not contacted her doctor about her adverse effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of joint pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20220341319 (dose number in series 1).
Patient  had vaccine 1/28/2021. Two days later developed left sided abdominal pain that was severe enough to warrant multiple ER visits, one admission, multiple negative tests including but not limited to CT scan and endoscopy. He lost 30 pounds. In the beginning of March he began noticing tingling and numbness in arms and legs which has progressed to paralysis of his bilateral lower extremities. He is now hospitalized for same and has a working diagnosis of CIDP (chronic inflammatory demyelinating polyneuropathy).
Malaise, fatigue followed by neck and shoulder stiffness and pain the next 2 days requiring BR, NSAIDA and moist heat. Contacted Employee health, directed to see PCP, saw chiropractor with some relief -continue with current regime.
Information has been received from a registered nurse concerning a 7 year old male child who on 09/28/1995 was vaccinated with a first dose of varicella vaccine. On 04/01/2001 the pt experienced varicella that included head to foot lesions. The lesions began on the head and were "all over the body." The number of lesions were not reported. The pt was treated with Tylenol, Benadryl and calamine lotion. The pt recovered. No further info is expected.