chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This prospective pregnancy case was reported by a physician and described the occurrence of jaundice in a unk neonate exposed to INFANRIX (batch number F43Z7, expiry date 31st October 2016) in utero. The mother received the product. On 6th November 2014, the 24-year-old mother received INFANRIX .5 ml. The mother's last menstrual period was on 20th May 2014 and estimated date of delivery was 24th February 2015. The neonate was exposed to INFANRIX at week 24 of gestation and during the second trimester of pregnancy. At 37 weeks and 4 days, the neonate was born via unknown delivery. The neonate was diagnosed with jaundice (serious criteria hospitalization), feeding disorder and maternal exposure during pregnancy, second trimester. On an unknown date, the outcome of the jaundice, feeding disorder and maternal exposure during pregnancy, second trimester were unknown. It was unknown if the reporter considered the jaundice, feeding disorder and maternal exposure during pregnancy, second trimester to be related to INFANRIX. See case US2014GSK023695 for details regarding the mother case.
metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198) via an unspecified route of administration on 08Mar2021 (73-year-old at the time of vaccination) as first dose, single dose for COVID-19 immunization. The patient medical history included breast cancer survivor. The patient concomitant medications were not reported. The patient past medication included Tamoxifen and Femara those were pills that she took for 10 years. She took Tamoxifen for 5 years and Femara for 5 years. She remembers the first initial of one of the drugs for the actual chemo, it began with a C if she heard it, she would know it, but she cannot remember it. On 08Mar2021, about 2 hours after receiving the first dose, the patient had a metallic taste in her mouth, which did not last long and went way after she ate food. The patient thought that she had a metallic taste again today but went away. Patient stated that event made her think of her chemotherapy treatment which she went through with breast cancer, and she always had a metallic taste in her mouth. The patient tried to go online to find the fact but could not find anything and was not able to determine whether or not it could happen or if there was anything to be concerned about. The patient confirmed that she was calling to know whether the event was associated with the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to unknown number of patients of unknown age and gender. The Nurse reported that GARDASIL (lot # and expiration date unavailable at time of the call), has had multiple excursions since 14-MAR-2013 reaching the lowest temperature of 30F (Fahrenheit). She was unsure of the total amount of hours for the excursions. The nurse believed that since the start of the excursions on 14-MAR-2013, the patients were vaccinated with this GARDASIL (Lot number, expiry date, route and dose were not reported) since an unknown date in 2013. No adverse effect reported. Additional information has been requested.
64 yo male was given High Dose Flu which is indicated for patients over the age of 65.
Severe, continuous left arm pain that has been present since time of first injection. Limits arm movement, weight-bearing  ability and involves nerve pain. Have applied ice and heat, used suggested stretches & taken ibuprofen with no improvement.
Six to 8 weeks post vax, loss of speech, loss of eye contact, self injurious behavior, social withdrawal. Child was dx with developmental delay in 12/96 and Autism in 7/98. He continues to be severely delayed in all areas of development which he not before the DTaP vax on 5/96.  Follow-up: 7/27/00 Call to mom to clarify what role each of the 5 HCP's had in her son's eval. and tx for Autism. She has and will Fax to me the dgx of Autism from Dr - ped neuro. 7/28/00 Rec'd Fax'd copy of 7/8/98 eval. of pt. by MD. which confirms dgx of Autism - mod to severe. Awaiting current ped. record and then will close case. 8/16/00 Records rec'd from ped. develop. and behavioral MD. Autistic spectrum diagnosis w/ recent deterioration re: self deterioration behavior.
Pt recv vax on 11/5/98; 4 hr post vax pt exp fever, chills, sweats & body aches, dehydration & drained
Information has been received from a physician concerning a 6 year old white male pt with a history of jaundice at birth who on 14Jun02 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included vaccination at 9:00AM on 14Jun02 with a second dose of with measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 639914/0023M) given SC. The physician reported that the pt received the varicella virus vaccine live and the measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) concomitantly. On 22Mar04 at 8:30AM the pt experienced break through chicken pox times one week.  The physician reported that the pt's case of chickenpox was mild. The pt recovered on 29Mar04. The physician stated that It was interesting since 3 or 4 other students who attend the same school also developed chickenpox. No further information is available. The physician also reported that the pt's brother experienced breakthrough chickenpox following concomitant vaccination with varicella virus vaccine live and measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (WAES0404USA01730) (someone at physician's office confirmed that WAES0404USA01730 pertains to the pt's brother).
PATIENT RECEIVED VACCINE IN LEFT DELTOID ON 10/02/23. MOM REPORT PATIENT WAS NOT TO FEEL ANYTHING ON HIS LEFT ARM THE NEXT DAY. TOOK CHILD TO HOSPITAL FOR EVALUATION. DETERMINED THAT CHILD HAS FULL ROM BUT NOT FEELING. MD TOLD PARENTS THAT IT COULD BE DUE TO VACCINE OR ADMINISTRATION OF VACCINE AND THAT IT MAY TAKE SEVERAL WEEKS TO HAVE FEELING IN ARM AGAIN.
Chicken pox 4/16/01, rash times 1 month improving papules with vesicles on trunk and extremities.  4/27/01 ears hurting - cough - new outbreak rash - has MD appointment today, @ 4:15P. Rash began 6 weeks ago.
Apneic/limp in mom's arms/lethargic. Resolved completely in a few minutes. Apnea/limp muscles resolved in minutes - Apnea resolved in seconds.
wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml).    No concomitant medications were reported.   Physician reported that, the nurses had no standing order other than what they had for the second booster and assumed the same dose as the second booster (administered 0.25 milliliter instead of 0.5 ml to uncompromised adults). The patient did not experience any adverse events. It was reported that, recommended to revaccinate the patient with full dose of 0.5 mL. No treatment details were reported.
The patient became short of breath and decreased oxygen saturation at home around 2000 on 01/18/2021. He reported to the ED on 01/19/2021 at approximately 0500. The patient was found to have bilateral pulmonary emboli.
Information has been received from a licensed practical nurse concerning a 48 month old patient who on 02-MAY-2011 was inadvertently vaccinated subcutaneously with 0.65 mL of ZOSTAVAX (Merck) (Lot# and expiration not reported). No adverse effect was reported. At the time of the reporting the patient's outcome was unknown. Additional information has been requested.
Do not have much information other than date of positive test   1-25-22      and date of death   3-11-22                                      .
Numb right foot continual since first Moderna shot. In 1995, after heart attack, right foot was numb but went away. It would only return for a half hour or so from time to time through the years. Now for almost one year, continual numb right foot. In 2012, started getting tendinitis in left hand after hard yard work, but would go away after several days of rest. Now since the COVID-19 shots, tendinitis is almost continual, even when I don't work hard.
9 hours later and continuing through the next day: Fever, chills, headache, body aches, could not sleep
After vaccine was administered at 1035, a completed series of Pfizer vaccine on 3/07/21 and 3/28/21 was shown. Patient denies having ever received any other covid vaccine. Patient was educated that he will not be able to receive 2nd dose of series until this is corrected.
Insomnia, joint and muscle aches and pain, earache, exhaustion, swollen glands. Desperately tired and could not sleep all night. Aches, pain and fatigue continue the day after shot.
Approx. 10 cm area of warmth, swelling and mild induration anterio/laterla thigh. Doesn't appear painful.
MD reports antigenemia in a pt who is 13wk pregnant;pt had complete course of 3 doses of Engerix-B (dates unk);the reporting MD did not vaccinate the pt;
Within 2 hours of receiving vaccine I began feeling achy and cold; within the next two hours was experiencing hard chills, fever of 101.7; muscle aches and pain.  This lasted 33 hours; chills stopped, aches lessened and fever began dropping.  By 40 hours  after shot temp was normal, no chills or body aches.  At 44 hours after event, am back to normal.
chest pain; swollen lymph nodes; red rash; itchy rash; chest congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EN 6208), via an unspecified route of administration in the left arm on 13Mar2021 at 10:00 AM (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to 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 vaccine within four weeks prior to the vaccination. Concomitant medications included dextromethorphan HBr and guaifenesin (Mucinex DM), pseudoephedrine (Sudafed), levocetirizine (Xyzal), fexofenadine (Allegra). On 15Mar2021, the patient experienced chest pain and congestion, swollen lymph nodes, red itchy bumpy rash on both of my ankles. Therapeutic measures were not taken for the events. The clinical outcome of the chest pain, chest congestion, swollen lymph nodes, red itchy bumpy rash were recovering at the time of report.  No follow-up attempts are needed. No further information is expected
Information has been received from a physician's office concerning a 10 year old female who in 2000 was vaccinated with varicella vaccine. On approximately 05/04/2001 the pt developed "full-fledged chicken pox." The pt sought medical attention. Additional info has been requested.
Received FLUMIST on 11/13/13. Started to developed hives on 11/15/13. Took BENADRYL 25mg po PRN. 11/19/13 - rash spread - referred to Dr. received DEPO-MEDROL.
Left arm pain and tenderness at injection site.  It was getting better but it never went away. Now it is more tender to the touch and hurts when moving arm.
Went to hospital ER for swollen leg, no treatment provided other than don't stand for long time, had to see a doctor to for rapid loss of weight, and referred to a gastrologist and Endocrinologist
Patient received vaccine 4/10, patient began experiencing bodyaches, headache, and redness/swelling at injection site on 4/11, that lingered till 4/15.
Patient experienced swelling in arm down to elbow. Pt told to take BENADRYL and TYLENOL for pt. Pt received antibiotics and steroid for swelling and infection prevention.
shingles; Information has been received regarding a case in litigation from an attorney reporting on a patient (pt) of unknown age and gender. There was no information about the pt's concurrent conditions, medical history or concomitant medication.  In 2009, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider at the office of a physician for the long-term prevention of shingles and/or zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently to the pt vaccination with zoster vaccine live (ZOSTAVAX), on an unknown date, the pt was treated by a healthcare provider (HCP) for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome shingles was not provided.
Moderna vial does not have an expiration date on the vial.  Nursing scans vial NDC auto fills.In lot # field click on magnifying glass for drop down of lot numbers.  Normally when lot number is chosen expiration date auto fills. The lot number of this vaccine was not found. So lot number was manually entered and beyond use date (BUD) that was written by pharmacy on packaging was entered in as expiration date because patient was waiting. Vaccine was administered and message sent for a lot # to be entered into system. Recieved reply back that this lot was expired on 3/25/22. Imm. coordinator and NM notified and Moderna contacted for advice.
Upon arrival, pt noted to be nervous/anxious. On screening checklist, noted he was anxious about his shots. Screening completed and mother denied any past adverse events related to vaccination. Discussed what I would be doing and to help with him being nervous, discussed use of ice pack during vaccination. First 2 injections given in rt arm and pt stated "is that it?" I told him yes and that we had one more to give on the left. I walked from his right side to his left. During this time he continued to talk. I applied ice pack to arm and prepped area with alcohol pad and prior to me being able to give injection, pt became rigid and laid back. Eyes remained open and his left arm went up and was stiff. Episode lasted approximately 5 seconds and he began to blink and ask what happened. I sat him up as additional staff retrieved a cool damp cloth and water for him to drink. Pt confused as to what had happened but able alert to self, place, and why he was there. Visited with pt for 3-5 minutes as he drank his water. Reports no intake since lunch. Assisted him to a standing position and ensured balance was adequate and visualized a steady gait.
PATIENT WOKE UP THE DAY AFTER RECIEVING VACCINES WITH A SEVERE HEADACHE, STIFFNESS, FEVER, AND SWOLLEN FACE. COMPLAINS THAT HEADACHE WAS RELENTLESS AND NOTHING WAS HELPING INCLUDING OTC MEDS. MOM STATED HE FELT SOME NAUSEA DUE TO HEADACHE AND ARM AT INJECTION SITE WAS VERY SORE. NO REDNESS OR WARMTH TO INJECTION SITE NOTED. HEADACHE PERSISTED THROUGH SUNDAY AFTERNOON.
Eczema flare-up Severe Dandruff Facial bumps beneath skin Brown Spots chest Rash
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 15:00 as dose 2 (booster), single (Lot number: 301458A) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. There were no concomitant medications. Vaccination history included: Janssen (product=COVID 19, brand=Janssen, brand unknown=False, lot number=1805022, lot unknown=False, administration date=06Mar2021, administration time=09:00 AM, dose number=2, vaccine location=Left arm), administration date: 06Mar2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant) with onset 01Sep2022, outcome "recovered with sequelae", described as "I am concerned I had heart swelling after Pfizer MNRA booster which caused Right Bundle Block". The event "I am concerned I had heart swelling after Pfizer MNRA booster which caused right bundle block" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: (Sep2022) no signs of heart problems or disease; Electrocardiogram: (Jul2021) Normal; (Sep2022) Right Bundle Block. Therapeutic measures were not taken as a result of myocarditis. Clinical Course: It was reported that Facility type vaccine: Pharmacy or Drug Store. If other vaccine in four weeks: No. Other medications in two weeks: No. EKG Jul2021 was normal. Pfizer Booster Oct2021 (prior vaccine J&J Mar2021). EKG Sep2022 shows Right Bundle Block. ECHO Sep2022 shows no signs of heart problems or disease. I am concerned I had heart swelling after Pfizer MNRA booster which caused Right Bundle Block. I had no other health changes between the Pfizer booster (Oct2021) and the latest EKG (Sep2022). If Covid prior vaccination: No. If Covid tested post vaccination: No. No follow-up attempts are needed. No further information is expected.
Daily hives on the back of her head and neck/ tiny hives in weird places; Skin inflamed; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Daily hives on the back of her head and neck/ tiny hives in weird places) and DERMATITIS (Skin inflamed) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included PROBIOTICS NOS and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced URTICARIA (Daily hives on the back of her head and neck/ tiny hives in weird places) and DERMATITIS (Skin inflamed). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) ongoing since an unknown date at a dose of 1 dosage form twice a day. At the time of the report, URTICARIA (Daily hives on the back of her head and neck/ tiny hives in weird places) had not resolved and DERMATITIS (Skin inflamed) outcome was unknown.            Patient stated that a week after hives she had a dental procedure done and they put her on a steroid Dexamethasone and she thought it would help the hives too but it did not help or change after.   This case was linked to MOD-2021-416924, MOD-2021-416976 (Patient Link).
itching at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.  Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received 0n 06-MAY-2021. Reporter contact information updated.
Pt reported soreness night of vaccine, next morning came into clinic, arm red, warm, tender approximately 5x6 area.  Pt will take Benadryl.
Left arm ache, sore with slight bruising. Headache and mild fever. Pain ful menstrual cycle with abdominal cramping and heavy bleeding with the cycle lasting for 6 days ( more than normal ).
Numbness: legs and arms, rectal bleeding, mood: anxious, nasal: nose bleeds, diarrhea: bloody, headaches, cramps legs, blood pressure: varies, sneezing, weight gain, sleep: problems.
Five days after 2nd dose of pfizer vaccine, patient presented to Urgent care with substernal chest pain, found to have elevated troponins concerning for myocarditis, no evidence of heart failure, transferred to hospital for serial troponin measurements, which were down trending and echocardiogram which was normal.
This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. Approximately in 2016 (reported as "starting 23-AUG-2016 to present, 08-SEP-2016"), the patients were vaccinated with improperly stored doses of VAQTA, which had a lot # of M002268, with an expiration date of 20-SEP-2017 (route, concentration, dose number, dose and anatomical place of vaccination were not provided). Which were reported because of data logger. Nevertheless, no adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Woken up by continuous chest pain at 5:30 AM, 2 days after vaccination. Breathing was also painful. Other symptoms: lightheadedness and fatigue continuing from 1 day after vaccination. Chest pain continued; going to a clinic was advised by multiple sources. At 9:00 AM, went to a clinic and got a CKG. The CKG was normal. I concluded that the problem was chest wall inflammation, and took ibuprofen. With ibuprofen, the chest pain was mostly gone by 8:00 PM.