chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case previously recorded as MA2009-4587. Initial case report received from a physician on 17 NOV 2009. A patient 3-year-old or younger was vaccinated with FLUVIRIN 2009/2010 i.m on 13 NOV 2009. No adverse effect was reported. Reference no: NA09-008308
Approximately 18 hours after injection employee noticed bruising in her left inner upper arm 3 " from injection site in deltoid. Area was noted to be tender and inflamed. Area of bruising increased over the next 24 hr and continued to be tender and inflamed over bruised area NOT at injection site
had to poke the patient twice when administering; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process in a 58-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) (batch number XY5Z2) for prophylaxis.   On 04-OCT-2023, the patient received the 1st dose of Fluarix Tetra 2023-2024 season (intramuscular). On 04-OCT-2023, an unknown time after receiving Fluarix Tetra 2023-2024 season, the patient experienced wrong technique in drug usage process (Verbatim: had to poke the patient twice when administering).  The outcome of the wrong technique in drug usage process 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: 04-OCT-2023 A pharmacist reported that they had to poke the patient twice when administering the GSK injectable medication which led to Wrong technique in drug usage process. The reporter Consented to follow up.
Two weeks after getting the vaccine, I had 2 days where I was extremely "out of it" with some balance issues, lack of energy, and minor headaches.  I had been surfing and thought that I had a concussion.  I did not recall any specific event while surfing that would have caused the concussion but i had bumped my head a few times.   I am reporting this now because two weeks after my second dose, I had the same reaction except it was much worse and I was not surfing, so I now thing the original side effect was from the vaccine.
Developed large colon intussusception involving 2/3's cecum to transverse colon. Onset a.m. with sudden onset crying and arching intermittent with severe lethargy, with acidosis, resolving air contrast enema, with small bowel 12/2016.
Reaction began 1 hr after injection.  Today Right inner and anterior thigh- diffuse swelling from 1 1/2 above knee to groin crease.
suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
first dose 17Jun2019, has not yet received another; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th June 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comments: Pharmacy Intern reported that the patient received first dose of Shingrix on 17th June 2019 and had not yet received another dose.  The lot number and expiration date of the first dose was not available to the reporter at the time of call. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
shingles on the left chest, side and back; Low grade fever; This is a spontaneous report from a contactable healthcare professional. A 58-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 26Feb2021 08:00 (at the age of 58 years old) (Lot Number: EL9267) at 2nd dose, single for covid-19 immunization. Medical history included known allergies to kiwi, penicillin and sulfa drugs; all from an unknown date and unknown if ongoing. The patient did not have covid prior vaccination. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number: EL9269), intramuscular in left arm on 05Feb2021 08:00 AM for COVID-19 immunization. The patient experienced low grade fever on 28Feb2021 15:00 and shingles on the left chest, side and back on 01Mar2021 15:00. Patient had low grade fever 30 hours later that lasted for 14 hours, 24 hours later, shingles on the left chest, side and back. It was reported that this was definitely caused by the vaccine. The patient has not been tested for covid post vaccination. The events resulted in Physician Office Visit. Therapeutic measures were taken as a result of low grade fever and shingles on the left chest, side and back included Famciclovir 500 mg. tid. The outcome of the events not recovered.
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA414A, expiry date 30th September 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: Age at vaccination was not reported. Nurse reported that a patient received an expired dose of Menveo. No further details were provided at the time of the call. The reporter consented to follow up by phone.
I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 8/15/2022 ATRIAL FIBRILLATION, UNSPECIFIED    MITRAL VALVE REGURGITATION J96.00 ACUTE RESPIRATORY FAILURE 8/15/2022 ATRIAL FIBRILLATION, UNSPECIFIED    MITRAL VALVE REGURGITATION I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 8/15/2022 ANEMIA DUE TO CKD J96.00 ACUTE RESPIRATORY FAILURE 8/15/2022 ANEMIA DUE TO CKD I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 8/15/2022 ESRD (END STAGE RENAL DISEASE) J96.00 ACUTE RESPIRATORY FAILURE 8/15/2022 ESRD (END STAGE RENAL DISEASE)
Started to feel lightheaded and passed out while standing in the kitchen of my home. My daughter was able to ease my fall.  I had just taken my usual morning vitamin D and Iron tablet with a class of juice.
Narrative:  81 year-old male patient with a PMH of Gi bleed, HTN, afib presented to outpatient hospital ED for weakness/dizziness and multiple falls. He received COVID 19 booster at a facility. In the ED, his BP 134/84, HR 125, RR 16. CT head was unremarkable. He was given fluids, decadron and meclizine for symptoms relief. The team believed the vaccine caused dehydration and worsening of his chronic condition. He was then deemed stable to discharge
I was in for a routine exam with my neurologist, he found that I had polyneuropathy. He sent me to have bloodwork done to confirm that his findings. I have a follow bloodwork draw scheduled in May to see if my levels have stayed the same. Once the bloodwork comes back in May the doctor will then proceed as to how to treat me.
Pt. vaccinated 10/24/22. 10/26/22, pt. had seizure during school, history of petite mal seizures. 10/26/22  Mother of pt. notice redness and swelling on right thigh. Pt. and mother presented to clinic 10/26/22 for symptoms. Tech examined leg and drew line of demarcation around redness and advised mother to monitor to see if changes in size occur. Sent message to Pediatrician team marked urgent for symptoms. RN followed up with pt. 10/26/22 and Pt. had appt. 10/27/22 for same symptoms. Pediatrician further assessed pt. and provided treatment and had vaers report filed.
Information has been received from a physician concerning a female patient who in "the week of 22-JAN-2007" was vaccinated IM with a 0.5 ml dose of HPV vaccine (yeast). After vaccination, the patient fainted.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted 02/14/2007. Information has been received from a physician and a nurse concerning a 15 year old female patient who on 07-MAR-2007, at 2:10, (previously reported as approximately 22-JAN-2007) was vaccinated IM, left deltoid, with a 0.5 ml dose of GARDASIL (lot # 657006/0188U). The patient reportedly had one prior dose of GARDASIL (date unknown). On 11-MAR-2007, late at night/early AM, the patient got up and on the way back to bed, she felt numbness and tingling in her legs then "blacked out for a few minutes". The patient said a friend woke her up. She felt tired all day. Later that afternoon, the patient went to her room, she didn't feel right. She complained of tingling and numbness in her legs and arms, which lasted 5-10 minutes. Subsequently, the patient recoverd from her symptoms. No product quality complaint was involved. Additional information is not expected.
I'm feel like I got hit by a bus; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15th April 2022, the patient received the 2nd dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Apr-2022 Reporter's comment: The case was received by the patient via interactive digital media. The patient got his/her second vaccine a day before of reporting date and darn he/she was feeling like got hit by a bus. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Patient came into clinic to received Pfizer booster dose,  had to enter first two dosages into computer system, miscalculated for when patient was due for booster dose.  Patient had no side effects after 15 minutes of administration.  Followed up with patient through phone who reports still no adverse reactions.
3 to 4 hours after shot, very very severe pain in arm. Severely swollen. Unable to move arm. Given steriod shot. Prescribed steriods and physical therapy. Told that injection was given to high on arm.
irregular/breakthrough menstrual bleeding/spotting. I am currently on extended birth control (where I skip the placebo week to skip my period). I have been doing this for over 2 years with no irregular bleeding or spotting. Around a week after receiving my first dose and for about 3 days, I had breakthrough menstrual bleeding.
This spontaneous report was received from a healthcare worker refers to a 3 year old male patient. Concurrent conditions, medical history and allergies were not reported. On 11-NOV-2014 the patient was vaccinated with (Merck) VARIVAX, 0.5 ml, subcutaneous injection in the left thigh (strength, dose number, lot number and expiration date were not reported) which was exposed to warmer temperatures. Other suspect and concomitant therapies were not reported. No adverse effects were reported. No further information was provided. This is one of several reports received from the same reporter. Additional information is not expected.
After administration of vaccine, the pt complained of left arm soreness, returned to school and possibly fainted. Pt complained of a knot, nausea and dizziness, left arm pain, neck pain, headache. Pt was taken to ER. Pt was diaphoratic, had left arm pain, headache. Pt was released, pt was complaining of a headache.
Patient woke up next AM with fatigue, went to go to the bathroom and on the way had a syncopal event, with loss of consciousness.  The next thing she knew she was somewhere else in the house and no longer had to go the bathroom.  Paramedics were called and no cause found in the ER.
Progressive increased erythema. Edema to (R) peri-orbital (R) eyelid area with slight tenderness (10/3/10) on palpation. Sent to workers comp-> CONCENTRA.
Developed shingles.  Was vaccinated against shingles in 2021.  Still suffering pain.
Very sore arm. Also, developed flu-like symptoms (cough, fever of 101.4, fatigue, loss of appetite, stuffy nose). The stuffy nose and cough had ben present off and on before due to seasonal allergies, but they increased in severity. The rest was new today.
PATIENTS WIFE CALLED THE NEXT DAY STATING THAT HE RAN 103 FEVER AFTER RECEIVING FLU SHOT AND HE HAS NEVER HAD FLUAD BRAND BEFORE. HE TOOK TYLENOL AND IT CAME DOWN AND HAS BEEN DOWN AT 98.6
Initial report received on 30 May 2012 from the Investigator participating in the post-marking study under the reference number M5A16. A case of pertussis disease in a three-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C2881AA received on 23 March 2009, lot number C3304AA received on 16 June 2009 and lot number C3579AA received on 25 February 2010 and 1 dose of DAPTACEL; lot number C3157AA received on 24 August 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 04 May 2012, approximately one year and eight months after the last dose. On 08 May 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 14 May 2012. Corrective treatments consisted of azithromycin starting on 16 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 24 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Pt passed out after 2nd vaccine 2 minutes after administration she started to loose consciousness. RPh helped lay her on bench, eyes remained open patient was sweaty and answered immediately when her name was spoke. Arms were turning red, 911 was called. Assessed her breathing and pulse. Took blood pressure which was low, and took pulse ox; which was normal. Breathing was fine and color returned soon after. No swollen lips or tongue. Pt stated that she didn't eat anything all day and it was around 5pm. Mother stated that she has hx of syncope after any use of needles. EMS cleared pt, gave her a glucose tablet and he left on her own accord with her mother.
Itching at injection site, redness, warmth, swelling. Started 2 hrs after injection.
Patient received an influenza vaccine at a work clinic, unsure which specific vaccine. Woke up the next morning with severe left shoulder pain (same side as injection given). He has had continued and worsening shoulder pain since then >7 days with associated decreased ROM and weakness, which he presented to my clinic for evaluation for. Concerning for possible Shoulder Injury Related to Vaccine Administration. Instructed to take ibuprofen, and referral sent to orthopedic specialist for further evaluation.
Reports received first dose of Moderna COVID vaccine on 10/12/21 in left arm.  That night began to have trouble sleeping and pain in left arm.  The next day left shoulder began to swell, per patient not at injection site but the whole shoulder.  Pain began to radiate down left arm and he felt his arm becoming weaker.  Patient denies taking any medication for symptoms as doesn't like meds.  Called out of work past 2 days as feels can't use his left arm to full potential.  Today, patient reports the swelling has resolved, the pain is very diminished, but still having some weakness that per patient is slowly improving.  Patient reports that he does not feel safe receiving second dose of vaccine in arm as feels it will cause more damage to his shoulders, inquiring if possible to get in gluteal area.  Patient denies any incident of fever, chills, shortness of breath, rash.  Denies need to seek medical care for issues.
Hardness and swelling at injection site (L) deltoid (PNEUMOVAX 23). Went to clinic and rec'd antibiotic.
Vaccine failure. Patient had received 2 doses of PCV-7. Diagnosed and hospitalized with meningitis (streptococcus pneumoniae). Discharge summary states septicemia. Follow up states CDC lab results for strep pneumoniae serotyping, result was A8 which is not covered by Prevnar.
Patient reported feeling usual arm soreness for a couple of days post - immunization. Soreness improved and went away. A couple of weeks later soreness returned in the left deltoid muscle.
On 07/07/2001 the patient awoke complaining of a stomach ache, vomited one time, and had an oral temperature of 105F. The patient was treated with Tylenol and was able to tolerate liquids and small amounts of solid food. The fever never dropped below 100F. The patient did go outside to play at 6:30pm and experienced vomiting again. The patient slept through the night with no further vomiting. On 07/08/2001 the patient had developed a sore lump at the injection site. Treatment with Tylenol continued. A physician visit was not required.
Myalgia myalgias for 48 hrs, injection site pain for 72 hrs both doses Narrative:
sick; sweats; Had a temperature; Chills; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ILLNESS (sick), HYPERHIDROSIS (sweats), PYREXIA (Had a temperature) and CHILLS (Chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by reporter.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-Jan-2021 and the estimated date of delivery was date. On an unknown date, the patient experienced ILLNESS (sick), HYPERHIDROSIS (sweats), PYREXIA (Had a temperature) and CHILLS (Chills). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), HYPERHIDROSIS (sweats), PYREXIA (Had a temperature) and CHILLS (Chills) had resolved.            Concomitant medication included prenatal vitamin.   This case was linked to MOD-2021-281095 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jun2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.with Paxlovid from 24Jun2023 to  28Jun2023.  Clinical Course: The patient had no known allergies. The other medications received in 2 weeks of Paxlovid are: Tamulosin, Atenolol and Hydrochlorothiozide.
cellultis on left arm swollen, red down to the wrist 3 IV treatments and oral antibiotics
Pt devel hives and injection site warmth, redness, and swelling following being vaccinated with pneumococcal vaccine 23 polyvalent.
Information was received on 27-OCT-2015 from a registered nurse. The nurse reported that the patient might have received GARDASIL 4 after 26 years of age at an unspecified time in the past. The patient is not exhibiting any adverse effects. No other information was provided. Additional information has been requested.
Headache, inability to stay awake, chills and fever.  Treated with Paxlovid.  Lasted about 5 days.
pt received an extra dose of Hepatitis B vaccine (Heplisav-B) on 6/27/22. Pt has been getting vaccines per alternate  vaccination schedule. He received his first dose of Heplisav-B on 11/30/21 per PCP office. A second dose of Hep B (Engerix B) was given on another office visit on 2/10/22 (note: this is not the formulation that uses per their protocol). d/t different formulations/doses required for each one, d/w Dr. and we completed his 2 dose Heplisav-B on 6/13/22. Another dose (3rd dose) of Heplisav-B was ordered on 6/24/22/verified and given on 6/27/22 in our clinic
I had open heart quadruple bypass surgery on 06/11/2021. However, I don't think this had anything to do with vaccination
Within 18 hours of Covid vaccine, patient developed quarter size hives on B/L arms, and torso.  No angioedema.  No SOB.  Hives have been continuous since the vaccine.  Patient is on a daily Claritin and Benadryl.  When Claritin and Benadryl are discontinued, the hives return.  Patient has NKDA or Food Allergies.
I contracted Shingles the day after the first dose.  My doctor prescribed Valacyclovir and I took one course.  The Shingles symptoms have subsided but have not completely disappeared.
Headache, Sedation, Myalgia, Arthralgia, Fever,  NauseaVomiting,  Chills Narrative: