chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a female patient who on 02-OCT-2009 was vaccinated with her first dose of PNEUMOVAX 23 (Lot number: 662839/1089X). The reporter mentioned that after administration of the vaccine the patient had an "unusual adverse reaction". At the time of reporting, reporter was requesting a lot check be conducted. It was unknown if the patient sought medical attention. Patient outcome has not been reported. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Injection site on left deltoid turned pink and was size of quarter at 12:30 pm Friday 5/20, about 3 hours after injection. Took Clairitin and Motrin. Sat am, spot was about 3 inches across, and wheezing was noted. Since pt has experience with asthma, he self administered Albuterol every 4 hours starting Sat am, and 400 mg Motrin every 6-8 hrs. Pt felt weak and nauseous all day Sat and Sunday, when parents were alerted to situation and started monitoring pt. Sunday am the spot was 4 inches diameter and very pink. Monday, the bright pink spot continued to grow to a max of 9 in long and 5 in wide, and appeared to mother to be an inch higher than other deltoid. MD office consulted, who advised continuing Claritin and adding Benadryl at night. Pt visited doc on Tues 5/24, spot had receded an inch around, and was slightly pink but still raised. Doc advised this was a severe localized reaction and to delay further Td.
27FEB92 1 hr p/recvd 1 dose of Engerix-B devel dizziness (lightheadedness) & sl inc in BP (usually has low BP but it was 120/70 when checked); no tx given;
Approximately 10 minutes post vaccination patient jaw and molar began throbbing. Tongue began to tingle and mouth became numb. Felt like the glands up to both ears began hurting. Developed headache encompassing full head. Patient reported symptoms to administrators on 12/31/2020.
Information has been received from a nurse and the patient's mother for the pregnancy registry for GARDASIL, concerning a 15 year old female with Amoxicillin allergy and psoriasis who on 21-OCT-2008 was vaccinated with the first dose GARDASIL (Lot not provided). Concomitant therapy included hepatitis A virus vaccine (unspecified). On 23-DEC-2008 the patient received the second dose of GARDASIL (Lot not provided). Subsequently the patient discovered that she was pregnant via pregnancy test (LMP: 08-NOV-2008, EDD: 15-AUG-2009). As of 15-JAN-2009 the patient was fine. Follow up information has been received on 29-JAN-2009 from the patient's mother concerning her 15 year old daughter who on 25-JAN-2009 had a miscarriage. Upon internal review, miscarriage was considered to be an Other Important Medical Event. Additional information has been requested.
Localized injection site rash.  Patient was given PO Benadryl 25mg
This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 12-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiration date 17-JAN-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
The pt experienced ear pain, throat dryness and was diagnosed in the ER with cellulitis of the left thigh. 2 blisters at the site were aspirated and a culture was sent out. IV antibiotics started and told to start antibiotics by mouth later that day. Thigh was very swollen.
CBG = 110; Syncopal episode w/ shot.  BP 94/54, HR 71, RR 19 -- > 101/63, 72.  Patient stable and released from the vaccination site.
Elevated resting heart rate, fever, fatigue, nausea, diarrhea, lethargy, shortness of breath. Lasted a full 10 days.
Had a fever then with chills, fever was 100.3; Had a fever then with chills, fever was 100.3; Fatigue; Headache; sinus pressure; Severe chills; Aches; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the arm left on 02Apr2021 (at the age of 44-year-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine and sulfa antibiotic allergy. Concomitant medications included galcanezumab gnlm (EMGALITY [GALCANEZUMAB GNLM]) taken for an unspecified indication, start and stop date were not reported; buspirone hydrochloride (BUSPAR) taken for an unspecified indication, start and stop date were not reported; sumatriptan (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 11Mar2021 at 09:00, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe chills on 02Apr2021, aches on 02Apr2021, fatigue on 02Apr2021, headache  and sinus pressure on 02Apr2021, had a fever then with chills, fever was 100.3 on 03Apr2021. Details were as follows: On 02Apr2021 (12 hours after the vaccination), the patient had severe chills and aches. It was stated that the chills were so severe it seemed body shut down. The chills and aches continued overnight into the next day (03Apr2021). On 03Apr2021, the patient had a fever then with chills, it was stated that the fever was 100.3 for most of the next day. On 02Apr2021, The aches and fatigue continued for the entire day after injection. On 02Apr2021, the patient also had a headache and what seemed like sinus pressure. It was stated that the chills were the worst. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. On 03Apr2021, the patient underwent body temperature and the result was 100.3 (unspecified units). The clinical outcome of severe chills, aches, had a fever then with chills, fever, fatigue, headache  and sinus pressure was unknown.   No follow-up attempts are needed. No further information is expected.
Slight rash began 03/11/21 at around 9pm. Soreness and pain started a around 11/12pm the same night and into the early morning. Upper arm was very sore and woke me up from my sleep. Ibuprofen resolved the soreness. Slight red patch still visible at 9am on 03/12/21
I was diagnosed for sinus infection on 08APR2023, I was feeling like i had a cold. Sinus pressure, one side of my face got swollen.  I saw my doctor and he prescribed some medication to take for it. I am starting to feel better.
A non-serious, spontaneous report of asthmatic patient given FLUMIST was received from a physician assistant concerning a seven year-old female patient.  No medical history was reported.  The patient also received varicella vaccine on the same day as receipt of FLUMIST vaccine.  There was no adverse event associated with this medication error;  therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Tinnitus - It started within 2 hours of receiving the vaccine.  It still continues (now 5 days later) and has not diminished.
Home AG-Positive; dose 3; Home AG-Positive; fatigue; HA congestion; trouble sleeping; tight chest; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 15Oct2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 05Jan2022, outcome "unknown" and all described as "Home AG-Positive"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "fatigue"; UPPER RESPIRATORY TRACT CONGESTION (medically significant) with onset 2021, outcome "unknown", described as "HA congestion"; INSOMNIA (medically significant) with onset 2021, outcome "unknown", described as "trouble sleeping"; CHEST DISCOMFORT (medically significant) with onset 2021, outcome "unknown", described as "tight chest". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of fatigue, upper respiratory tract congestion, insomnia, chest discomfort.  Clinical information: It was reported, + covid exposure 1/1 then sx 1/4 and + Ag test 1/5 sx include fatigue, HA congestion and trouble sleeping and tight chest. Patients did not received any other vaccine in four weeks was unknown. It was unknown patient had covid prior vaccination. Patient tested covid post vaccination. It was unknown did the patient was diagnosed with COVID-19.  Device Date was 07Jan2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events , Immunization, fatigue, upper respiratory tract congestion, insomnia, chest discomfort  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
gets the flu; Initial information received on 22-Feb-2022 regarding an unsolicited valid non-serious case received from Social Media via consumer/non-health care professional(non-hcp).  This case involves Adult and unknown gender patient who experienced gets the flu while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer at unknown dosage(formulation and strength: unknown) once( lot number and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number is requested.  On an unknown date the patient developed a non-serious gets the flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  It was reported by reporter that one should have gone to a holistic doctor and have never gotten the flu. Further reported as the flu vaccine will eventually make them a sick person. His coworker gets the flu vaccine every year and gets the flu. Also, reported that if he had never got it he would have never got sick.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event Influenza.  At time of reporting, the outcome was Unknown for the event gets the influenza.
Friday 10/28/2005 hurt but no swelling, Sat 10/29/2005 swelling, aching, redness appeared in blotches, course of day redness increased to elbow front and back. Sunday 10/30/2005 swelling, Monday 10/31/2005 swelling subsided continues to have some aching inside with some swelling to right arm. DR saw patient and instructed pt to use ice pack to area. Pt denies SOB.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications details were reported.  Patient received vaccine at Pharmacy.  Beyond use date of the vaccine was 17-Feb-2022.  No treatment medications details were reported.  NDC number was reported as 80777-273-10.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received wherein patient and vaccination details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Information has been received from an RN concerning a 16 year old Hispanic female pt who on 10/03/00 was vaccinated with a 2nd dose of MMRII, a 2nd dose of DT, a 2nd dose of poliovirus, and a 2nd dose of Hep-B. "Client received 3 vaccines (TD, HEP-B, IPV) and while receiving MMRII, the client became unresponsive, jerked back and experienced fine motor tremors. Blood pressure was 100/40, RR were shallow, pulse was thready a 100 BPM. On admin. at 51. Pt placed in trendelenberg. Pt experienced nausea without emesis. Pt remained pale, diaphoretic with knowledge of event until transported via 911 to hospital. No tests or laboratory work done." Subsequently, the pt recovered. Additional information has been requested. F/U upon internal review, the pt's experience of fine motor tremors/seizures activity with clonic movement of upper arm was considered to be an important medical event. The pt's 12 year old sister had a similar experience after vaccination with a first dose of MMR (WAES00100792). It has been determined that WAES00100590 is a duplicate report of WAES00102026. Therefore WAES00100590 is being deleted from our files and the reports consolidated into WAES00102026. This is an amended report. Upon internal review of the pt's information it was determined that hospitalization was not required as previously reported. This is a corrected report as amended.
Patient complains of soreness at sight of injection.  Needs over the counter medicine to relieve pain.  States he takes tylenol each morning for the pain.
17apr90 pt vax hepta B.  12 hrs later pt ex pharyngitis. low grade fever and hay fever like sx.  pt recovered w/in 72 hrs
was given the H1N1 vaccine, approx 20 min after given, my left side lung felt heavy and a cough. Was taken to our emergency room and was treated. Symptoms were gone w/in about an hour.
Pt. C/O flushing, sweating and feeling feverish, an exaggeration of her reaction to the first vaccine. She denied pain, difficulty breathing or other complaints. She lay down, got a cold compress and felt significantly better
Vaccine given in high upper shoulder, since then c/o pain R shoulder- stated the shot was given very high up by bone. Unable to lift arm up. Called to call center regarding issue 12/11/17, evaluated by NP. 12/12/17, x-ray ordered, PT ordered.
This spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 25-OCT-2013, the patient received an expired dose of PNEUMOVAX lot number 0217AE, expiration date 22-AUG-2013 (dose, and route were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
pediatric patient,/ received engerix-b /adult doses; pediatric patient,/ received engerix-b /adult doses; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 8-year-old male patient who received HBV (Engerix B adult) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th August 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 5th August 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were 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 pediatric patient received Engerix B adult dose, which led to adult product administered to child and overdose. The reporter consented to follow up. For tolerance of Havrix adult dose, refer linked case US2021166993, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021166993:same reporter
Presented to urgent care clinic with shortness of breath, pale, lightheadedness, labs drawn, IV normal saline 500ml.
Buzzing of molars; Eyes stared feeling buzzy; Cheeks, shoulder, arm became warm; Felt light headed; Felt kind of groggy; Heart stepped up a little bit / Heart sultry; Did not feel normal; Slept rest of day; Left side stared buzzing; Buzzing at the site of injection; Head ache; Chills; Joint ache; Rash at injection site; Exhausted; Lungs were over stressed / Difficulty breathing; Heart going crazy / Heart rate quite went up a bit; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Buzzing of molars), OCULAR DISCOMFORT (Eyes stared feeling buzzy), FEELING HOT (Cheeks, shoulder, arm became warm), DIZZINESS (Felt light headed) and ASTHENIA (Felt kind of groggy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Atrial fibrillation and Thyroiditis NOS.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced DYSPNOEA (Lungs were over stressed / Difficulty breathing) and HEART RATE INCREASED (Heart going crazy / Heart rate quite went up a bit). On an unknown date, the patient experienced TOOTHACHE (Buzzing of molars), OCULAR DISCOMFORT (Eyes stared feeling buzzy), FEELING HOT (Cheeks, shoulder, arm became warm), DIZZINESS (Felt light headed), ASTHENIA (Felt kind of groggy), PALPITATIONS (Heart stepped up a little bit / Heart sultry), FEELING ABNORMAL (Did not feel normal), SOMNOLENCE (Slept rest of day), PAIN (Left side stared buzzing), VACCINATION SITE PAIN (Buzzing at the site of injection), HEADACHE (Head ache), CHILLS (Chills), ARTHRALGIA (Joint ache), VACCINATION SITE RASH (Rash at injection site) and FATIGUE (Exhausted). At the time of the report, TOOTHACHE (Buzzing of molars), OCULAR DISCOMFORT (Eyes stared feeling buzzy), FEELING HOT (Cheeks, shoulder, arm became warm), DIZZINESS (Felt light headed), ASTHENIA (Felt kind of groggy), PALPITATIONS (Heart stepped up a little bit / Heart sultry), FEELING ABNORMAL (Did not feel normal), DYSPNOEA (Lungs were over stressed / Difficulty breathing), HEART RATE INCREASED (Heart going crazy / Heart rate quite went up a bit), SOMNOLENCE (Slept rest of day), PAIN (Left side stared buzzing), VACCINATION SITE PAIN (Buzzing at the site of injection), HEADACHE (Head ache), CHILLS (Chills), ARTHRALGIA (Joint ache), VACCINATION SITE RASH (Rash at injection site) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications include Thyroid pill, Inhaler and Pill for blood thinner. No treatment information was provided.
Death; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received Covid 19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunization.The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter was calling about the Covid 19 Vaccine. Reporter stated that she gets information every day from the nursing home. Reporter stated that she will provide the name of the Nursing home, she just forgot to put it down. The patient, within 2 days dead from it, he was perfectly healthy. The patient died on an unspecified date. It was not reported if an autopsy was performed.   Information on Lot/batch number has been requested.; Reported Cause(s) of Death: Death
Fever/chills/night sweats for 1 day, body aches, injection site pain, nausea for 3 days, headache for 3 days, all resolved. Two doses of 1000 mg acetaminophen needed to resolve fever.
This spontaneous report as received from the patient's wife refers to her 76 year old male husband with Diabetes Mellitus and hypertension without drug reactions and allergies. On unknown date in 2007 the patient was vaccinated with ZOSTAVAX when he first came out of seniors (dose, route of administraiton and lot # were not reported). It was reportd that the patient took a lot of concomitant medications. On 21-FEB-2015 the patient developed rash and went to an urgent care center on 27-FEB-2015 where he was treated for an unspecified herat condition. Patient was ordered generic VALTREX and a patch for pain. He was also diagnosed with singles on 27-FEB-2015 (also reported as 23-FEB-2015). It was also reported that the patient just returned from urgent care and continued in pain until start of treatment. The patient's wife consulted an unspecified pharmacist who advised contact the pharmaceutical compnay. The outcome of unspecified heart condition and shingles was reported as not recovered/not resolved. Additional information has been requested.
I was pregnant in my 1st trimester when I received the H1N1 vaccine. I woke up on 11/25/2009 bleeding and felt pain and pressure in my abdomen. I called my doctor and she advised me to come in the following day for another ultrasound. I had an ultrasound the day before I received the vaccine and there were no problems. The day after Thanksgiving I went to see my doctor as advised and she tried to hear the babys heartbeat, but could not find it. I then was sent to radiology for an ultrasound and was told the baby died the week I received the vaccine. I had to go that evening for an emergency D&C because I was having such severe cramping and pain.