chrisvoncsefalvay/vaers-outcomes huggingface dataset:
systematic allergic reaction that is still on going; Exactly two weeks after taking the first shot my body broke out in systematic rash; welts with swelling of face.; welts with swelling of face.; This is a spontaneous report from a contactable Other HCP (patient himself). A 38-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EH9899, expiration date not reported) intramuscular on left arm on 28Dec2020 at a single dose, then second dose (lot no. EK9231, expiry date not reported), intramuscular on right arm on 18Jan2021 at a single dose for covid-19 immunization. Medical history included known allergies: penicillin. (no major history of allergic reactions except penicillin as a baby). The patient's concomitant medications were not reported.  The patient reported that on 11Jan2021 15:00 (03:00 PM) "exactly two weeks after taking the first shot, my body broke out in systematic rash and welts with swelling of face. My doctor thought two weeks was two long of a delay for the reaction to be from the vaccine. My doctor thought it might have been some antibiotics I had been on and they gave me prednisone. The prednisone cleared up the reaction before the second shot. I received the second shot (on 18Jan2021 with lot no. EK9231, intramuscular on right arm) and within two hours I had an even worse systematic allergic reaction that is still on going as of today 04Feb2021. The Prednisone is not clearing up the reaction. I am going to have to take short term disability." The adverse events resulted to patient had clinic visit, disability or permanent damage. Patient took prednisone, famotidine, hydroxyzine, and XANAX (because of the prednisone) as treatments. The vaccine was given in the hospital. No other vaccines were given in four weeks.  Outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported allergic reaction manifested with "systematic rash and welts with swelling of face" and the administration of the COVID-19 vaccine, BNT162B2.    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 RA, IEC, as appropriate.
suspected vaccination failure; they still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a unspecified number of patients 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 age at vaccination was not reported. The reporter stated that he/she knew the patients received the dose of Shingles vaccine and they still got shingles. The reporter stated that shingles could not be prevented unless you are completely stress free 100 percent of the time. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Subsequent to receiving vax, the pt experienced elevated blood pressure and heart palpitations. Additional information received from the reporter on 12/28/2000 stated that the pt also experienced achiness, mild fever and tenderness at the injection site. The pt was monitored in the ER until his blood pressure returned to normal. The reporter stated that Hib-Titer was administered in place of HBIG. The pt recovered.
patient is a 6 year old patient given flublok which is meant for ages >18. He should have been given fluarix. Patients guardian has been notified regarding this error and has been told to monitor their child for the next several days for any adverse reactions. If anything occurs guardian was told to take patient to the emergency room.
2days p/vax pt c/o hip pain, temp 101.2 & stomach ache, positive point tenderness in bilateral trochanters per MD exam.
back pain; This case was reported by a consumer and described the occurrence of back pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced back pain. The patient was treated with steroids nos (Steroid Shot (Nos)). On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Mar-2022 Reporter's comment: The case was self-reported by the patient. The patient enquired how long should he/she wait between steroid shot and second shot of Shingles vaccine.
Went to ER with sore, red arm, warm to touch, went into armpit & left chest. C/o pain when lifting arm & chills.
Fever. Chills. Nausea. Fatigue. Dizziness. Pain in arm. Hives. Hot skin. Stronger menstrual cramps. Irregular period.
On 10/24/2005, a 5 inch red area formed like a band around arm where injected, left upper extremity swollen, tender and warm.
DEVELOPED NAUSEA AND VOMITING THE FOLLOWING DAY THAT LASTED 12 HOURS
Local injection site reaction.  Patient was told to use over the counter Benadryl and hydrocortisone 1% cream.
Right after leaving the clinic son called stating recipient vomited; returned to clinic. RN from clinic went out to car and assess patient who was dizzy all day and had just vomited. Denied chest pain, dyspnea, fever. Recommended being seen in ED for evaluation and offer to call EMS declined but family decided to go to ED and son drove/EMS not called.
Patient received first dose 23APR2021 and is now at the pharmacy to get the second dose (>35 days); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose 23APR2021 and is now at the pharmacy to get the second dose (>35 days)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose 23APR2021 and is now at the pharmacy to get the second dose (>35 days)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose 23APR2021 and is now at the pharmacy to get the second dose (>35 days)) 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.   No concomitant medication was reported.  Treatment medication was not provided.
LOST ANOTHER ONE TO THE JAB; This spontaneous report received from a consumer via media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose and start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. The reporter stated that "Lost another one to the jab ". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20220118906-COVID-19 VACCINE AD26.COV2.S-Lost another one to the jab. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Area where vaccine was given developed a "blister" then opened up and now looks like a wound, area around red. The area is covered and bacitracin applied, advised warm soaks.
pt recvvd vax & devel chills & flu like symptoms; pt failed to seroconvert after 3rd dose of vax;
01/23/2003: Telephoned office to say child has a rash that looks like chicken pox.  Noted that yesterday child was not feeling well, some diarrhea and vomitings and low fever.  Advised this is possible reaction to vaccine, instructed regarding symptomatic treatment.  Verbalized understanding of instructions.  Advised to contact family Doctor if not improved in next 3-4 days.  Family Doctor notified.
pt was given the original vaccine instead of the bivalent booster, pt was notified, no harm to patient was involved, just primary series given by accident, notified patient to get bivalent booster in 2 months
Vasovagal event. Pt fainted and immediately came to. Pt felt better after about 15 minutes and was able to walk.
Acute rhabdomyolysis, nontraumatic. Possible reaction to COVID-19 booster while on statin therapy. Rheumatology also following for possible PMR/myositis. Symptoms and lab work improving.
a lump in that arm/Second dose: lump stayed about the same; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8732), via an unspecified route of administration in left arm on 29Mar2021 at 9:00AM or 10:00AM (at the age of 68 years old) as dose 2, single for covid-19 immunisation. Medical history included thyroid disorder, paroxysmal nocturnal hemoglobinuria. Concomitant medications included ravulizumab cwvz (ULTOMIRIS [RAVULIZUMAB CWVZ]) infusion every 8 weeks taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (Lot number: EN6206), via an unspecified route of administration in left arm on 08Mar2021 at 10:00 AM (at the age of 68 years old) for covid-19 immunisation and patient experienced swelling in her left arm, her left arm hurt, lump in her left arm at the injection site, arm was hurting at the injection site, benign lump on that left side, lump in left arm is like a mass or oval, swelled a little, not a lot but it was swollen for about 2 weeks, having pain in her left arm off and on, sometimes the lump in her left arm feels larger than other times. The patient previously received flu vaccine, pneumonia vaccine, meningitis vaccine and has never gotten a lump or anything like that. She received her second dose at the end of Mar2021 and she didn't have any side effects. no pain or anything. After the second Covid 19 vaccine the a lump in that arm/lump stayed about the same, it didn't get worse. She has had the second dose of the vaccine in the left arm as well but in a slightly different area, no date was provided by caller of the second dose. Sometimes the lump in her left arm feels larger than other times. She doesn't know. She reports she received both doses in her left arm but the second dose the site was a little upper, a different part in her left arm. She had the ultrasound of the injection site in her left arm on 17Jun2021 and it came back that the lump was benign but she did not get any other information. The doctor told her if it gets worse than to call back. The nurse at the health department mentioned that there have been side effects with lymph nodes but the caller has never had a lump in her arm before. The patient underwent lab tests and procedures which included ultrasound scan: unknown on 17Jun2021. The outcome of event was not recovered.  Follow-Up (02Aug2021): Follow-up attempts are completed. No further information is expected.
This is a spontaneous report from a contactable nurse through a Pfizer sales representative. This nurse reported similar events for 2 patients. This is the first of two reports. A patient of an unspecified age, gender and ethnicity received on an unspecified date TRUMENBA at single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient developed redness and blotchy swelling at the vaccination site. Clinical outcome was unknown. Follow-up (24Mar2016): Follow-up attempts completed. No further information expected.
This pt was administered MMR #1 and HEP B #4.  Pt's grandmother was instructed to wait 15 min and at that time injection sites would be checked by myself.  When checking injection sites pt's grandmother noted a rash on pt's face and chest.  Pt was given 12.5 mg liquid BENADRYL per Dr. and was sent home.  Also noted at injection site of MMR red/warm, silver dollar sized.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from a sales representative. A 13-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: MULTIVITAMIN [VITAMINS NOS]. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID-19 Vaccine booster dose"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site"; PYREXIA (non-serious), outcome "recovered", described as "mild fever"; MALAISE (non-serious), outcome "unknown", described as "general malaise". Therapeutic measures were taken as a result of pyrexia. The lot number for bnt162b2 was not provided and will be requested during follow up. Additional information: The patient was 98 lbs. and 5 ft 4in. The patient experienced some expected side effects from her booster dose, pain at the injection site, mild fever, and general malaise. Treated fever with Advil and it resolved. The patient was a healthy 13-year-old with no underlying conditions. She takes a daily multivitamin (when she remembers). Event took place after use of product.
Several days after my second dose I developed double vision. My right eye has moved upward and to the side (strabysmus) and I can?t see without. Patch on that eye. I am seeking care from a neuro-ophthalmologist, hoping to be treated with a newly approved drug, Tepezza.
Starting 06/13/2022, I woke up with the need to use the restroom and I passed out. So, I had Orthostatic Syncope. I was taken to the hospital and monitored. I was determined to be dehydrated and my blood pressure meds were cut in half. I was discharged the next day on 06/14/2022. My blood pressure has been doing well with the lower doses of medication and I have been drinking more water lately. Since then, I have had no other issues.
Patient experienced flu symptoms for a period of time lasting more than 36 hours. There was no fever. She was treated with aspirin and bed rest.
joint pain, swelling (arms, hands, knees & ankles), fore throat (1 day); fluid had to be drained from joints;
The patient complained of extreme pain after receiving shot that was unusual and cause for concern. He felt as though he may have had a reaction to the vaccine.
Chills; Soreness at injection site; Headache (migraine like); This is a spontaneous report from a contactable consumer (Patient).  A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL3247), via an unspecified route of administration on 11Feb2021 10:30 AM (at the age of 48-year-old) as a dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient did not receive any other vaccines within four weeks. Patient does not have COVID prior vaccination and was not tested to COVID post vaccination. Patient had no known allergies. On 12Feb2021 12:00 AM the patient experienced chills, Soreness at injection site, Headache (migraine like). Patient had not received any treatment for the events reported. The outcome of the events was recovered on unspecified date in 2021. Follow-up attempts completed. No further information expected.
35 weeks pregnant lady was administered Arevy; 35 weeks pregnant lady was administered Arevy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number t3m4m, expiry date 05-MAR-2025) for prophylaxis.   On 26-OCT-2023, the patient received Arexvy. On 26-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 35 weeks pregnant lady was administered Arevy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 35 weeks pregnant lady was administered Arevy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 30-Oct-2023 The reporter consented to follow-up. An pregnant patient received a dose of Arexvy at an inappropriate age, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration.
Patient began experiencing symptoms at 7am post vaccination. She described symptoms of shooting radiating pain starting at the nape moving upward through the back of skull (occipital bone) and ending around the parietal region. This pain was consistently throughout the day followed by nausea and dizziness when standing. The patient went to her medical Doctor for examination. The pain persistented until 10pm on the 22nd. Lasted 2 days and got better the following day.
ACUTE MYOCARDITIS ABOUT 3 DAYS FOLLOWING 2ND DOSE OF 5 0 COVID-19 VACCINATION.  TREATED WITH ANTI-INFLAMMATORY.
Are has round red rash near injection site - itcy and slightly painful.  Occurred after week of first dose
Information has been received from a nurse concerning a 9 year old male who on 11-JUN-2009 was vaccinated with the second dose of VARIVAX (Merck), 0.5ml/SC (Lot# 663948/0360Y). Concomitant medication was unspecified. On 12-JUN-2009 the patient experienced tenderness, swelling and pain in his left arm pit that was 9 and 1/2 by 9 and 1/2 cms. There was no palpable ancillary swelling and it appeared to be a tissue reaction. On 13-JUN-2009 the patient to the office and was prescribed AUGMENTIN. As of 16-JUN-2009, the outcome was unknown. Follow up information was received from the nurse concerning the 9 year old male: The patient was well at the time of the second vaccination on 11-JUN-2009. The patient had reaction two days after received vaccine (AE onset date reported as 11-JUN-2009 while previously reported as 12-JUN-2009). His arm was warm to touch. He was given BENADRYL (PRN) and AUGMENTIN 875 BID if worsen. the patient recovered on approximately 23-JUN-2009. No further information is available.
Sore right arm on 10/22/2020 at 12pm. Swollen right arm at 7:00am on 10/23/2020. At 7:45pm on 10/23/2020 right arm twice the size of left arm, warm to the touch, hard and painful to slightest touch, redness to site about baseball size. Applied ice pack and gave 2 Tylenol. Spoke with on call pediatrician and was advised to go to the Emergency room to have it looked at. Went to ER around 9pm, was seen, given some medications to help and sent home with a script of prednisone and benadryl.
Approximately 24 hours after the injection the patient's right arm became swollen, painful, red and warm.
APPROXIMATELY 20 MINUTES AFTER RECEIVING VACCINE PATIENT COMPLAINING OF CHEST PAIN WITH DIFFICULTY BREATHING V/S 148-96 R20 P82 CLEAR BREATH SOUNDS ON AUSCULTATION ANTERIOR AND POSTERIOR AND RASH COMPLAINED OF TINGLING TO BOTH HANDS.  HAD PATIENT BREATHE IN PAPER BAG WITHOUT RELIEF.  CLIENT STATES CP TOO BAD TO AMBULATE.  EMS CALLED AND PATIENT TRANSFERRED TO LOCAL HOSPITAL.  PATIENT RELEASED SAME DAY FROM ER DX: PLEURISY.  11/4/08 PUBLIC HEALTH OFFICE HAD FLU CLINIC ON THIS DATE.  INFLUENZA AND MCV4 WAS PROVIDED.  PATIENT 14/8 RECEIVED INFLUENZA INJECTION TO L DELTOID AND MCV4 TO R DELTOID.  HE THEN WENT BACK TO HIS CLASSROOM.  APPROX. 20-30 MIN LATER HE CAME BACK TO C/O BURNING SUBSTERNAL CHEST PAIN AND DIFFICULTY BREATHING.  VS: 148-96 P82 R20, CLEAR BREATH SOUNDS ANTERIORLY/POSTERIORLY NO RALES, WHEEZING, RHONCHI, NO RASH.  DURING ASSESSMENT CLIENT BEGAN COMPLAINING OF NUMBNESS/TINGLING TO BOTH HAND AND FINGER.  TRIED TO GET CLIENT TO BREATHE IN BROWN PAPER BAG.  HE BEGAN TO CRY SAYING CP WAS INCREASING.  A MALE EMPLOYEE AND I TRIED TO HELP HIM TO A VEHICLE TO BE TRANSPORTED FOR EXAM BUT CLIENT STATED HE WAS TOO WEAK TO WALK SO EMS WAS NOTIFIED.  WHILE WAITING FOR EMS ARRIVAL, V/S RETAKEN BP 152/92 P90 R20 BREATHING SOUNDS REMAINED CLEAR, NO RASH NOTED TO INCREASE ABD/BACK, NOTED R HAND BEGAN TO CONTRACT AND CLIENT CONTINED TO CRY.  STAFF UNABLE TO COMFORT CLIENT.  EMS ARRIVED AT SCENE, CLIENT WAS TRANSPORTED TO ER FOR ASSESSMENT.  RECEIVED REPORT AT APPROXIMATELY 4 PM THAT CLIENT WAS RELEASED WITH WITHOUT MEDS AND DX: PLEURISY.
8-23-12 at 1600 redness, raised warm to touch: 2" length 1"width. To (R) arm where varicella inj was administered. Pt denies itching, N/V, stinging, burning to site. Pt stated she noticed spot around 12 pm today when fixing hair.