chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described a 55 year old male subject who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). The subject does not consume alcohol and occasional cigar smoker. On 11/12/2002, the subject received the 1st dose of Engerix B (lot ENG3231D6). On 12/17/2002, the subject received the 2nd dose of Engerix B (lot ENG5371A4). On 4/28/2003, the subject received the 3rd dose of Engerix B (lot ENG5377A4). This represents an interval of five months between the first and third dosed of Engerix B. The recommended interval between the first and third doses of Engerix B is six months. On June 19 2003, a hepatitis B surface antibody titer was less than 2 mIU/ml which indicated that the subject was non immune. On 12/21/2004, the subject received the 4th dose of Engerix B (lot ENG5466A4). On 2/2/2005, the subject received the 5th dose of Engerix B (lot AHBBA059BA). This is longer than the recommended interval of one month between the first two doses of the Engerix B booster series. On July 20 2005, the subject received the 6th dose of Engerix B (lot AHBVA059BA). On 8/17/2005, a hepatitis B surface antibody titer was less than 2 mIU/ml which indicated that the subject was non immune.
had a stroke with in a month or two after getting vaccine.; This is a spontaneous report from a Pfizer sponsored program- General Company Information.   A contactable consumer reported for a male patient (reporter's friend's brother) that: A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, unknown dose (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. His mom had a stroke within a month or two after getting vaccine. She was fine now, and the doctors found no indication of legs or other area throwing off clot. A friend of his brother had same issue. He would suggest you make and inquiry on both cases. Contact his if you want. Just trying to help. Outcome of event was unknown.    The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow up.
Morning after immunization entire right upper arm bright red, firm and hot to touch.  Swelling and redness continued through the third day after immunization.
p/vax pt devel diarrhea;pt was seen by MD & a stool specimen obtained for cult;4/12/99 stool cult was reportedly positive for rotavirus antigens;
Hives and itching, wheezing, fever, sore throat. Took Benadryl OTC. Returned to clinic one week later (12/11/2014) for treatment.  Given Kenalog 40 mg IM and Prednisone dosepak.  Reported on 12/11/14 visit she was allergic to egg. Prior to this visit, she had reported NKA.
Information has been received from a licensed  practical nurse concerning a 19 year old female with medical history unspecified who on an unspecified date was vaccinated with GARDASIL vaccine ( Lot#, route was not provided) (where in the series this dose was not known at the time of reporting. There was no concomitant medication. In September 2008, the patient developed muscle and joint pain. The patient had been seen by the physician. And she had blood work on 30-Oct-2008 (results were pending). The physician mentioned to the nurse a possible diagnosis of rheumatoid arthritis. At the time of reporting, the outcome was unknown. Additional information has been requested. 01/13/09 Reviewed Rheumatology medical records of 10/30-11/14/2008. FINAL DX: rheumaoid arthritis, seronegative. Records reveal patient experienced joint pain & swelling of multiple joints beginning 9/08 along with morning stiffness, bluish discoloration of fingers when cold, nose bleeds, .  Also had crepitus of TMJs, difficulty opening/closing mouth, spine pain & crepitus x 3-4 years.
Nurse dropped syringe on the ground (underground parking lot) but cap was still on syringe. Gave injection way too far up the arm, almost at the top. Immediate redness. After getting home, there was significant swelling, more redness, soreness, burning and itching. Next day, massive fatigue, headache and chills. About 36-48 hours later, stomach issues began. Swelling and redness at injection site went away by morning of 11/30. Chills, headache, fatigue and stomach issues still ongoing.
This is just for doucmentation reasons, this reaction has happened in the past to patient when giving blood or getting vaccines, patient has fainted. We were well aware of this, unfortunately, patient's doctor's office does not do in office. Patient got both vaccines and was about to faint, head went back, and asked for ammonia inhalant. Once inhalant under nose, patient startled and was fine. Got her to breathe and talk to me. We sat for 20 minutes and patient was fine and walked out of pharmacy. I do believe this was not a vaccine related reaction, but patient being extremely nervous and anxious.
left side of my face is starting to droop and the beginning signs of Bell's-palsy are starting; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: ENG6202; expiration date: unknown), at vaccination age 36-year-old via an unspecified route of administration in the left arm on 02Mar2021 17:00 as a single dose for covid-19 immunisation. Medical history included pecans allergies. The patient was not diagnosed with Covid prior to vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), desogestrel, ethinylestradiol (ISIBLOOM), citalopram and vitamins nos (MULTIVITAMINS reported as WOMANS MULTI-VITAMIN). The patient did not receive other vaccine in four weeks The patient received the latest vaccine dose in a hospital. The patient had left side of my face is starting to droop and the beginning signs of Bell's-palsy are starting on 03Mar2021 06:00 AM. The patient did not received treatment for the adverse event. The patient has not been covid tested post vaccination. The outcome of the event was not recovered.
Vaccination adverse reaction/Bad reaction; This is a solicited report from a non-contactable consumer.     A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ibrutinib (IMBRUVICA) taken for an unspecified indication from 22Aug2014, then from an unspecified date and ongoing. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced vaccination adverse reaction/bad reaction to PFIZER VACCINE on an unspecified. The patient was hospitalized for bad reaction for 7 days. Stated he's doing better now and able to move around. The outcome of the event was recovered.   The reporter's causality for the event Vaccination adverse reaction was Possible. The reporter's causality for the event of Bad reaction to PFIZER VACCINE was not provided. The opinion is that there is no reasonable possibility that the event of vaccination adverse reaction/bad reaction to PFIZER VACCINE is related to IMBRUVICA(IBRUTINIB).  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event vaccination complication cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Vaccine given 45 minutes after began to leak fluid pregnant due date was 9/19/15. Water broke membranes. Was sent from hospital to medical. Was (31 w 3 days).
Swollen, red knot (size of softball), hot to touch, severe pain. No tx from physician. Sx's lasted 3 days.
chills; headache; feeling tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231 and expiry date unknown) intramuscular at left arm on 06Jan2021 08:00 at single dose for Covid-19 immunization in a hospital facility. Medical history was none. The patient previously took cephalexin and experienced allergies. Historical vaccines included first dose of BNT162B2 (lot number EH9899) on 16Dec2020 08:00 (29 years old) and was administered in a hospital facility intramuscularly at the left arm; the patient did not receive any other vaccines in four weeks prior to Covid-19 vaccination and has no Covid prior to the vaccination. On 06Jan2021 21:00 several hours after taking the second vaccine, the patient developed chills, headache, and was feeling tired. The patient was not Covid tested post vaccination. The patient did not received treatment due to the events. The outcome of the events chills, headache, and feeling tired was recovering. The reporter considered the events non-serious; did not result in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
Pt said the injection stung a lot at injection and kept hurting. The next day she removed the Band-Aid and had a red circle and pain at the site to touch. Pt has not done anything for the pain, but it is getting better with time. Shot received 01/11/18 - reported 01/16/18 there is still an approximate 1 inch red circle and painful to touch.
Minimal issues tolerating doses 1 and 2; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Minimal issues tolerating doses 1 and 2) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Minimal issues tolerating doses 1 and 2). At the time of the report, IMMUNISATION REACTION (Minimal issues tolerating doses 1 and 2) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-604306 (Patient Link).
Headache, NauseaVomiting, FURTHER C/Os FATIGUE Narrative:
MODERNA COVID-19 VACCINE EUA  PER PATIENT SHE STARTED TO EXPERIENCE RASH , SWELLING AND ITCHING IN THE INJECTION SITE ON 2/16. PATIENT RECEIVED HER VACCINE 2/9. SHE WENT TO THE DOCTOR'S OFFICE 2/17 AND THE DOCTOR GAVE HER BACTRIM. SHE STARTED TO TAKE THE BACTRIM HOWEVER HER ARM WAS NOT GETTING BETTER BUT WAS ACTUALLY GETTING WORST. AND THE SWELLING SPREAD EVEN LOWER CLOSE TO HER ELBOW. PATIENT SAW HER PRIMARY CARE DOCTOR AGAIN TODAY 2/19 AND THE PROVIDER GAVE HER CLINDAMYCIN.
This spontaneous report as received from a medical assistant refers to 10 unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of PROQUAD (Merck) (lot number reported as L024122 and expiration date 30-DEC-2016; lot number L023113 and expiration date 24-DEC-2016) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Narrative: Pt presented to the ED on 6/2/2021 c/o mid upper Abd pain and n/v. PT States she has not been able to keep anything down x1 week. reports h/o gastroparesis. Per lab testing pt. was covid positive. Pt was hydrated with IV bolus of NS X2 and given promethazine ivpb x 2 doses. Pt was hydrated with IV bolus of NSX 2 and given promethazine ivpb x doses. Pt had previously received both doses of Moderna covid vaccine on 3/31/21 and 4/26/21. Approximately timed. Pt was discharged from the ED with instructions same day. Not deemed a serious infection requring admission, although pt was threating to leave AMA if not allowed to leave once feeling better.
This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unspecified day in September 2017, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency, dose number and administration route were not reported) lot number M032495, expiration date 06-JUL-2018, for prophylaxis. Concomitant therapies included a properly stored sterile diluent used for reconstitution (lot number and expiration date were not provided). On an unspecified date in 2017, the vaccine was exposure to a temperature excursion; the data logger registered a temperature range between 6 Fahrenheit (F) and 14 F (13.1 F) for 2 hours. The previous temperature excursion registered was 6 F to 14 F (9 F)  for 1 hour. No adverse effects were reported. This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA009695: US-009507513-1711USA009696: US-009507513-1711USA008021:
PFizer Covid shots and booster: I took the first 2 shots in March and April 2021, and the booster in December 2021. It caused a severe case of frequent urination and nocturia. Then in 2022, after I stopped taking the vaccinations, the problem went away completely.
A call was received 2-26-13 from patient's wife stating he had been having a high fever ranging from 100-102 degrees. She asked if this was normal, after the immunizations, and if not what they should do. She said she had given him OTC medications to reduce the fever, but they weren't working. I told her that a high fever is not a normal reaction and she should take him to his primary provider, or to the ER if the fever did not go down. Patient's wife is a prenatal client with the Health Office, who had a return appointment 2-27-13. She stated during her visit that she took her husband to the ER 2-26-13 because he couldn't get in to see his provider at the Health Center and his face started twitching. She said in the E.R. he was given medication to reduce the fever and also given antibiotics and released the same day. The patient came into the clinic 2-27-13, during his wife's visit. He said the Tdap, which was given on the left arm had not bothered him, and was told by the E.R. staff that it was most likely the pneumonia shot that caused the reaction. Redness and swelling noted to right upper arm. Patient stated it hurt to lift that arm. No other complaints related to the immunizations were given by patient.
Patient had first Hep B vaccine 06-16-2015. Presented to clinic for second one with a rash over the initial injection site. She states it appeared within 3 days of injection and it is still present. Rash is red with about 8-10 raised bumps. No illness or fever.
I would get a cough and it would be like a runny nose. It would start to get better after having it a couple of weeks and then it would come back. It was like 2 weeks on and 2 weeks off. I went to see my ENT and they gave me Benzonatate and took over the counter Delsym to treat the symptoms. It would help but it was always temporary. I went to the ENT, and he noticed that I had fluid in the left ear. They did a hearing test to see if they needed to lance my ear. My hearing was not normal as I already wear hearing aid. They determined they did not need to lance my ear. All thru the rest of 2022 I would continue feeling bad with this cough that would go on and on. It would get better then worse. After the 1st of the year, I went to see a pulmonologist and he ran a battery of blood test. I was positive for RSV and prescribed ivermectin for 5 days. I started to feel better in about 2 days. The doctor also wanted me to take Vitamin D, Vitamin C, Melatonin, and an Iodine Mouth Spray.
patient received Pedvax Hib at age 2 mos and at age 4 mos. Pedvax Hib dose #3 is recommended to be administered over 12 mos of age.  Also pediarix was only partially administered. Needle came off of syringe during admin. Parent and staff agree that little to no vaccine actually was injected. Dose will be repeated ASAP.
PHYSICIAN ORDERED THE INCORRECT VACCINE.  NURSE GAVE A 3RD MONOVALENT DOSE INSTEAD OF GIVING THE PATIENT BIVALENT BOOSTER DOSE.
Reactivation of herpes virus....shingles on face approximately 2 weeks after second shot of moderna. Eruptions on nose, area above nose, area above inside eyebrow.
This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. She was not pregnant at the time of reporting. On 02-MAY-2017, the patient received a dose of properly stored VARIVAX, administered subcutaneously in the abdomen (which was not one of the area of administration listed in the prescribing information) for prophylaxis. The Lot # was M028551, with an expiration date of 07-JUN-2018. On 02-MAY-2017, the reporter stated that the patient tolerated the vaccination well but then stated that the patient was lightheaded. Subsequently, the vital signs were taken and were normal. The outcome of the event of lightheadedness was not reported. The causal relationship of the event and the VARIVAX vaccine was not provided. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
The pt experienced a headache, fever of 101.9 for 15-20 hours. Fever began 24 hours post vax. The pt took Advil for the fever. The pt also experienced muscular aches. 3 days post vax, the pt experienced diarrhea, queeziness, nasal discharge and a cough for 2 weeks
No additional AEs were reported.; male patient received 3 doses of either GARDASIL or GARDASIL 9 in the past and now recently received additional 2 doses of GARDASIL 9; This spontaneous report was received from a physician and refers to a male patient of unknown age. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.  On an unknown dates (reported as "in the past"), the patient was vaccinated with 3 doses of either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (dose, strength, route and site of administration, lot # and expiration date were not provided) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, strength, route and site of administration, lot # and expiration date were not provided) for prophylaxis [it was not possible to verify if they were quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection].  On an unknown date in 2022 (reported as "now recently"), the patient received additional 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, strength, route and site of administration, lot # and expiration date were not provided) for prophylaxis (extra dose administered). No additional adverse events were reported (no adverse event).
Administration error - Vaccination (booster)- was administered to 13 year old before it was approved for that certain age group.
patient never received the second dose; she got the two shots of Pfizer; Patient was so ill; Patient was positive for covid; high fever; Horrific headache on the lower right side of head / headache never stopped; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Patient was so ill), COVID-19 (Patient was positive for covid), HEADACHE (Horrific headache on the lower right side of head / headache never stopped), PYREXIA (high fever) and PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Gout.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Horrific headache on the lower right side of head / headache never stopped). On 20-Jan-2021, the patient experienced COVID-19 (Patient was positive for covid) and PYREXIA (high fever). On 29-Jan-2021, the patient experienced ILLNESS (Patient was so ill). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) and INTERCHANGE OF VACCINE PRODUCTS (she got the two shots of Pfizer). On 08-Feb-2021, COVID-19 (Patient was positive for covid) had resolved with sequelae. At the time of the report, ILLNESS (Patient was so ill), HEADACHE (Horrific headache on the lower right side of head / headache never stopped) and PYREXIA (high fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) and INTERCHANGE OF VACCINE PRODUCTS (she got the two shots of Pfizer) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 08-Feb-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received monoclonal antibodies on 29 Jan 2021 The neurologist made her wait 100 days after receiving the monoclonal antibodies and she got the two shots of Pfizer and the patient is now taking migraine medicine. Patient taking Medicine for Gout as concomitant.  The neurologist of the patient made her wait 100 days after receiving the monoclonal antibodies and then patient got two shots of Pfizer.
Swollen, warm, itchy rash around injection site approximately 6 inch circle around site