chrisvoncsefalvay/vaers-outcomes huggingface dataset:
27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter was reporting a 12 years old patient received Kinrix.  The reporter did not have additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional Supportive Information: The reporter was reporting a 12 years old patient received Kinrix, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019066:Same reporter. US-GSK-US2023AMR020880:Same reporter US-GSK-US2023AMR020895:Same reporter. US-GSK-US2023AMR020893:Same reporter. US-GSK-US2023AMR020894:Same reporter. US-GSK-US2023AMR020891:Same reporter US-GSK-US2023AMR020892:Same reporter US-GSK-US2023AMR020896:Same reporter.
Went to pharmacy to get my booster on a Saturday.  The next day, Sunday, I felt very cold, my arm injection site was sore and had a bad headache, and I couldn't get warm.  As the day went on my left ear felt full and became painful.  My ear kept hurting and I was not able to hear from my left ear.   I also experienced dizziness
Body aches, dizziness, chills,  fatigue started around 5pm on 4/9/21 and resolved completely by 4/11/21 7am. Tylenol 1000mg relieved aches and chills. No fever.  No other symptoms.
Could not raise arm over shoulder height weakness when reaching for anything in upper arm, slow motion ability after a certain distance was reached, very painful when touched, but does not seem related to muscles, can't reach behind my self, or reach up without extreme thought process before doing the deed.
The child's third hepatitis B vaccine was administered 8/14/03. In early October 2003, parents noted bruises on child's arm and legs. Initially thought that these were from playing hockey. He was taken to the clinic and saw private physician. Blood was drawn and family was told he was anemic. Placed on multivitamins with iron, but took them inconsistently per mom. Parents also noted what they thought was a rash around child's waist where pants would rub against skin. On 10/5/03, child was taken back to same clinic and was seen by the doctor. Blood was drawn. On 10/6/03, mother received a phone call to pull child from school immediately, as platelet count was 15,000. Child was sent to hospital and platelet count was 4,000 at this blood draw. Child was noted to have a large hematoma on his stomach. X-rays were taken of his spleen, liver and kidneys. He was diagnosed with Idiopathic Thrombocytopenic purpura and given the drug Winrho one time. Platelet count went to 50,000. Seen again 1 week later and platelet count was 4,000. IVIG was given, but no improvement was noted. A bone marrow was done to check for leukemia and results were negative. Child placed on chemotherapy treatment with Rhitoxin times 4 weeks, 1 week apart. By the second treatment his platelets had dropped to 3,000. Prednisone was added to the chemotherapy regimen for 1 week and platelets rose to 140,000. He completed treatment with the Prednisone and Solu-Medrol. The platelets dropped again and he was placed on Vincristine for 2 weeks. Treatment was completed 1/3/05. Child is currently taking 650mg. Cyclosporin every day and will be weaned from this after 6 months of treatment. He also takes an antibiotic 3 times per week. Doctors at the clinic see him every 1-2 weeks. Follow-up: I spoke with patient's father who states patient had his spleen removed at hospital on 4/22/06 rather than undergo a second chemotherapy protocal. The physicians recommended surgery to reverse the ITP effect. Since the surgery the bruising has stopped and the platelet count has returned to normal.
Non-blanching rash on leg- looks slightly purpuric. Afebrile. CBC,PT,PTT                   Followed up  in office in am. WBC repeated       Sustained elevated platlet count requiring hemotology visits- to be rechecked in 3 months
About 30 minutes post vax, the pt developed hives over elbows, knees, buttocks. No wheezing was noted. Given Benadryl by mouth and observed at the health center for 2 hours before releasing.
Severe abdominal cramping and severe vomiting. Started late night on 11/14/2011 and lasted until early AM 11/15/2011.
Pt given high dose flu despite being ineligible due to her age.  Pt notified denies any problems at this time
On 5/16, 2.5 days after receiving #2 Moderna vaccine on 5/13, I experienced a reoccurence of Shingles with a small rash in the exact same location as the first time I had Shingles (1st case was near my right clavicle in Sept 2019).  A visit to doctor on 5/16 confirmed diagnosis and I was prescribed Valtrex.  The rash is still present but now resolving. I never got the Shingles vaccine after my first episode, but will now in the next few months.
Migraine headache ( pain described as ring around the top of the head with the greatest pain at the top of forehead) Excessive heat and sweating Low grade fever Temporary sore throat
Area of shot red hot itchy and swollen.  Pt c/o discomfort at sight, feeling lightheaded and feverish.
Dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient had dizziness more than four days and was concerned about the same.  Treatment information was not provided.   Reporter did not allow further contact
-Received shingles vaccination to L arm on 1/6/23 at pharmacy -Pain to R shoulder blade developed on 1/7/23 with progressive symptoms on 1/8/23 -Rash developed to right side of chest and shoulder blade on 1/9/23. -Vesicles developed to right side of chest, right shoulder blade, and R axillae on 1/11/23 -Seen in office on 1/11/23 and diagnosed with herpes zoster. Rx for Valtrex and Neurontin provided.
Patient lost consciousness, nystagmus, and twitching of body. Head jerked back. Patient sneezed and returned to consciousness. Unconsciousness lasted <1min.  EMS called, patient determined to be okay to go home instead of hospital.  Recommended he follow up with his primary care provider. He remained seated for about 15min before leaving the premises.
About 12 hours after receiving the second Shingrex dose, I experienced fever, chills, body aches, nausea and a severe headache. This lasted about 48 hours. However, four days later I started experiencing tinnitus which has continued to this day.  I have seen an ENT physician who diagnosed mild hearing loss and bilateral tinnitus. I also saw a hearing specialist who determined the same diagnosis. The tinnitus is very bothersome and I have been advised by my ENT to obtain hearing aids to mitigate the tinnitus.
This spontaneous report as received from the patient's mother refers to her 18 year old female daughter. Medical history and concurrent conditions were not reported. On an unknown date in 2007, the patient was vaccinated with an unspecified dose of GARDASIL (administration route, dose, lot number and expiration date were not reported). No concomitant medication was reported. On an unknown date the patient experienced stomach and leg pains. The patient also developed a bruise on her leg (in 2008 or 2009, specific date was not known) and later became "wheelchair bound" (date unspecified). The reporter stated that her daughter the patient spoke with the physician. The outcome of events was reported as not recovered. Upon internal review, "wheelchair bound" was considered disabling. Additional information has been requested.
This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, since approximately 2011 (reported as "over the past 6 years"), the patients were vaccinated with doses of GARDASIL (doses, routes of administration, lot numbers and expiration dates were not provided). On unknown dates, the patients experienced injection site hurt. Product quality complained was not involved. The outcome of the event was unknown. Causality assessment was not specified. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014282: US-009507513-1705USA014280: US-009507513-1705USA014281:
Arm Swells Up; poor hand circulation; Felt like she had a slight cold; Lost sense of taste; Body Aches throughout body, especially in legs; Chills; This is a spontaneous report from a contactable consumer (patient) or other non hcp.  A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8730 via an unspecified route of administration, administered in Deltoid Left on 26Mar2021 (at the age of 63-years-old) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure, ongoing. Concomitant medication included influenza vaccine (FLU) taken for an unspecified indication, start and stop date were not reported. No investigation assessment was performed. No prior vaccinations (within 4 weeks). On an unspecified date in Mar2021, the patient felt like she had a slight cold, lost sense of taste, body aches throughout body, especially in legs, chills and poor hand circulation. On an unspecified date, the patient's arm swells up. The patient was due for her second dose on 16Apr2021 and was asking if she would be able to take the second dose on that day. The outcome of the events felt like she had a slight cold, lost sense of taste, body aches throughout body, especially in legs, chills and poor hand circulation was recovering. The outcome of the event arm swells up was unknown.  No follow-up attempts are needed. No further information is expected.
01-29-2021 started to feel sick. I went to see my doctor on 02-02-2021. I started to get a rash on my lower forearm, right side. I started to use tea tree oil as a topical, it seemed to get better and after the 4th day it started to get red and swollen. The next day I went to see my doctor who prescribed a steroid cream and probably within three days my symptoms were dissipated.
Client was nervous prior to vaccination. Once the vaccine was administered, patient quickly became light-headed and nauseous. She was taken to a cot via wheelchair to lay down. No loss of consciousness was reported.
This spontaneous report as received from a non-healthcare professional concerning a 10 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 05-JUL-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N021720 with expiration date: 10-AUG-2019 (dosing details and route of administration was not reported), for prophylaxis (Product storage error). The sterile diluent (lot# R002715 with expiration date: 20-FEB-2020), used for reconstitution of the VARIVAX, was stored at the proper temperatures. No adverse effects were reported. The storage temperature was minus (-) 9 degrees centigrade (C) to 8 degrees C for 8 minutes (multiple excursion). There was no previous temperature excursion. Digital data logger was involved. This is one of several reports received from the same reporter.
headache; excessive sweating profusely dripping off of my face; shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 30Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious) with onset 2022, outcome "unknown", described as "excessive sweating profusely dripping off of my face"; HEADACHE (non-serious) with onset 2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "shortness of breath".  Additional information: the patient reported that "I received the Pfizer influenza vaccine via Excel clinical research. I got my shot on 30Nov2022. About 5 hours later I had a headache that has not stopped and it is 05Dec. Also I've had excessive sweating profusely dripping off of my face and shortness of breath. I contacted Excel clinical research on the day after 01Dec and told them I was having symptoms. I was told that I would have to wait until 24 hours to be able to be seen by a doctor. 3 days later it's unchanged.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was provided with extra dose of Varivax as I was unaware that the MMR vaccination I pulled was ProQuad.
pt recv vax 22JUL97 & 25SEP97 7PM pt devel a mild rash w/redness;the next day pt was dx w/chickenpox;pt recovered;
Patient received 2 doses of vaccine Dose 1  01/24/2021 Dose 2  02/20/21 Covid + on 4/9/21.   Mild symptoms Community acquired - family members
initially patient had no symptoms with Moderna vaccination, no pain worked out at gym in week after shot, initially felt well then started having throbbing severe pain in right deltoid area of arm where vaccine was placed reports no falls, no accidents to this body region noted as well a rash over the area, itchy, 1 week duration, with red vesicles that are now older pain is worsened with palpation of deltoid muscle, acromioclavicular joint and passive abduction and flexion at shoulder and range of motion was limited incidentally patient also had new-onset hypertensive urgency at that time, possibly secondary to pain
Left thigh with 4cm x 4cm area of edema and inflammation of upper leg- localized reaction only.
Redness on site of vaccine, vaccine was given 2 days ago, unknown if fever. Advised to take BENADRYL and MOTRIN TID.
Antiphospholipid antibody syndrome after Hep B. (also states received several AVA but no documentation).
Feeling a little achy when I went to bed the night of getting the TDAP vaccine, then woke up at 2:00 AM feeling like I had been run over and I was very cold. The next day, I had the achiness off and on, and a slight headache all day. Ibuprofen helped a bit. This is the type of reaction I used to have with the flu shot. No achiness or headache today (48 hours post vaccine), but I still have a sore arm, with the injection site being hard and warm, but not discolored. I noticed in the leaflet that the nurse gave me that this is an "uncommon" reaction, so I wanted to report it.
This spontaneous report as received from a nurse refers to an approximately 66 years old female patient. No information about medical history, concurrent conditions were reported. On 23-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (25/0.5y) (lot # K007773, expiration date- 01-MAY-2015) (dose strength, route not reported) in the left arm (also reported as left deltoid) 01-MAY-2015. The concomitant medications included unspecified seasonal allergy medications. The reporter stated that the patient, returned to the office on 24-SEP-2014 because she experienced redness, swelling and pain at the PNEUMOVAX 23 injection site on her left deltoid which developed approximately on an unknown date in September 2014. No lab diagnostic studies were performed. The physician suggested the patient to take Oral BENADRYL, LOTRISONE and Ibuprofen to address the symptoms and the patient symptoms subsided. The outcome events was reported as recovered/resolved approximately on an unknown date in September 2014. Product quality complaint was involved. The physician also stated that, does not want to use the other vaccines in the office with this same lot number as this result has recently happened to another patient in the office. This case is linked to the case 1409USA014229 via same reporter link. Additional information has been requested.
The pt experienced swollen lymph glands, purple like bumps, within 24 hours of vax. No fever was experienced, the pt was just uncomfortable. The bumps spread from arm to groin to knees. Swollen lymph nodes were under the arm.
3 weeks after receiving varivax, developed vesicular rash, fever and cough, diarrhea.  Imp varicella like rash >10 lesions 2 hours right otitis media.
Within 5 days of receiving the Jansen Covid 19 shot I began to experience tightness in my chest and a feeling of decreased lung capacity. There were no other symptoms at the time or since then. Both at rest and while exercising I have more labored breathing. This has continued for 2 months.
As this was the patent's first dose of her primary series.  Pfizer COVID MONOVALENT for ages 12 and older should have been given.  However, Pfizer COVID BIVALENT for ages 12 and older was given by accident.
It was reported that a 50 year old female received a Fluzone SV '99-'00 vaccination on 11/3/99. Reportedly, on 11/8/99, the pt developed Bell's Palsy on left side of face. From additional information received on 12/8/99, additional pt, vaccine and responsible physician information was provided.
Caller's son received measles, mumps and rubella half a dose and then received other half dose and ant bodies went up; Caller's son received measles, mumps and rubella half a dose and then received other half dose and ant bodies went up; This spontaneous report was received from Consumer (the patients's mother) and refers to a male patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient received measles, mumps and rubella half a dose and then received other half dose (wrong technique in product usage process) and antibodies went up (antibody test abnormal ). At the time of reporting, the outcome of the events was not known.  The relatedness between the event of antibodies went up and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  was not provided.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022; patients were vaccinated with expired vaccine doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the pharmacist thought that the expiry date of the vaccine was JUNE 2022, However the vaccine expired on 01-Apr-2022. It was confirmed that the vial didn't undergo temperature excursion issue. Vaccine was placed in refrigerator on 04-Apr-2022.  No treatment medication were reported.
On day 8, patient reported a bright red, large, round  irritated area on injection site. Also, complaining  of itching and tenderness on that area. Patient had no issues except sore arm prior to the 8th day
foot numb and tingling; left side face little numb and tingling; left arm from elbow down to fingers (numb); left leg from knees to foot (numb); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (foot numb and tingling), HYPOAESTHESIA (left side face little numb and tingling), HYPOAESTHESIA (left arm from elbow down to fingers (numb)) and HYPOAESTHESIA (left leg from knees to foot (numb)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included FINASTERIDE for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HYPOAESTHESIA (foot numb and tingling), HYPOAESTHESIA (left side face little numb and tingling), HYPOAESTHESIA (left arm from elbow down to fingers (numb)) and HYPOAESTHESIA (left leg from knees to foot (numb)). At the time of the report, HYPOAESTHESIA (foot numb and tingling), HYPOAESTHESIA (left side face little numb and tingling), HYPOAESTHESIA (left arm from elbow down to fingers (numb)) and HYPOAESTHESIA (left leg from knees to foot (numb)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information not provided.
Red warm swelling (L) deltoid not painful. Developed within 24-48 hrs.
This is a spontaneous report from a non-clinical study program. The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow up information on 08Nov2012, this case now contains all required information to be considered valid. A contactable consumer reported that her daughter (age and Ethnicity unknown) received PREVNAR 13 on an unknown date for immunization. Consumer reported that the vaccine was crossed out and then a new one was written in (she stated that a first number was crossed out 4998092 and the other number written next to it 4988715). The reporter later stated that she was not sure what type of the vaccine her child received. The consumer reported that when she brought her child home "she blank out on her".
MD called 1NOV91 states pt admitted to Hosp 48 hrs post immun w/?sz activity; t100 R pt referred to Hosp for EEG 19NOV91;