chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 12 month old female patient who on 02-AUG-2010, was vaccinated with a dose of VARIVAX (Lot # 666765/0088Z). Concomitant vaccinations included a dose of MMR II (MSD) and a dose of PNEUMOVAX 23 (manufacturer unspecified). It was reported, that the patient developed a varicella-like rash at the injection site of VARIVAX, immediately after the administration. At the time of the report, the patient's outcome for varicella-like rash at the injection site was not reported. Additional information has been requested.
This is a not serious spontaneous case from a consumer other non health professional in the USA of Headache. The reporter causality is not provided to FluMist. A consumer reported headache, abdominal pain, 100 degree F temperature, vomiting, diarrhea, chills fatigue, muscle ache, and malaise in her husband three days after receiving the FluMist vaccine. The 37 year old male received FluMist on Nov 19 2004. On the Morning of Nov 22 2004, the patient awoke with a headache that became worse by the afternoon. He had chills severe fatigue that became worse in the evening. Later, on the evening of Nov 22 2004, he had general muscle aches, malaise, and abdominal pain. he began vomiting about 9:00 pm on Nov 22 2004. The reporter stated on Nov 23 2004, her husband felt a little better. He still had fatigue, minor diarrhea, and a mild headache. No further information is available.
I got the Pfizer bivalent booster. This was my 4th Pfizer shot (2-dose primary, 1 booster shot). I got the shot at 4pm, and around 12am I had pretty severe abdominal pain, followed by flu-like diarrhea and nausea. The next morning I felt very achy,  feverish, chilled, and lack of appetite.  Also had arm pain at injection site through all of this.
fully vaccinated but contracted Covid about 1 week ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (fully vaccinated but contracted Covid about 1 week ago) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (fully vaccinated but contracted Covid about 1 week ago). At the time of the report, COVID-19 (fully vaccinated but contracted Covid about 1 week ago) outcome was unknown.            No Concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow-up information included no new information.
IM given in left arm 3rd dose. Moderna COVID-19 vaccine lot 045C21A given was removed from freezer on 10/6/2021 at 11:45 AM. Given on 11/5/2021, out of range. Patient contacted that evening. Moderna manufacturer called. Patients called the following Monday letting them know that Moderna was looking into this and would be getting back to us. Also let them know I would be following up with them once we heard back from them. Called patient today 11/17/21 and let him know that Moderna let us know the vaccine was viable, no additional booster vaccine is required.
Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder and Hypertension.   On 18-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.            Concomitant medications included heart med, high blood pressure. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information received on 13 Jul 2021 contains no new information
a platelet problem; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer was interested in the ingredient of the Pfizer COVID19 vaccine since she has a platelet problem, and she has seen patients die from the vaccine from the 1st and 2nd dose. Consumer wanted to know what in the ingredient was causing this. The outcome of the event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a nurse referring to an 18-year-old female patient. Information regarding the patient's pertinent medical history and drug reactions/allergies was not provided.  On 26-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported; lot # T002848 and expiration date 23-JAN-2022) for prophylaxis (product storage error). The administered vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S008566 and expiration date 16-NOV-2021).   The administered dose of the vaccine experienced multiple excursions in temperature range -14 Celsius degree to -10 Celsius degree (-12.1 Celsius degree) for 3 hours, and -9 Celsius degree to 8 Celsius degree (-7.5 Celsius degree) for 8 hours and 30 minutes recorded by a data logger. There was no previous temperature excursion.  This is one of multiple cases sent by the same reporter.; Sender's Comments:  US-009507513-2008USA014014: US-009507513-2008USA014069: US-009507513-2008USA014076: US-009507513-2008USA014108: US-009507513-2008USA014134: US-009507513-2008USA014180: US-009507513-2008USA014182: US-009507513-2008USA014186: US-009507513-2008USA014577: US-009507513-2008USA014634: US-009507513-2008USA014648: US-009507513-2009USA004106:
dizzy spells nausea episodic mild to moderate chest pain mild tingling in fingers on left hand fatigue/energy loss Pt c/o chronic substernal chest pain of atypical nature he felt was due to anthrax vax. In Oct04, he was diagnosed with acid reflux at military hospital overseas. He is on antacids and doing well. He was not hospitalized and missed 0 work days due to this AE. Anthrax vax was only vaccine pt rec'd on 7/22/04.
Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-337484 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-337484:Master case (same reporter)
swollen lip, or lips.  When waking one very swollen lip. It might be half of one one day. The half or all of another. This happens at least twice weekly for the last 6 months. Always happens in the evening. Have changed all topicals and have been tested for allergies to foods.  Just got booster. Now both lips are swollen, quite large, and my left side of my face is swollen. It is not hot or painful. But I cannot move my lips naturally when this is occuring. That included speaking and closing my lips to drink.
Raised red spot at vac. site. Applied cold compress, swelling to approx. size of a lemon, arm red from shoulder down 48 hours post vac., med. attn. at urgent care, script for steroid and antibiotic, cellulitis suspected. Swelling reduced after 5 days post vac. 14 days post vac. swelling resolved. Some redness persists, skin peeling at inj. site.
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 01-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
Pt experienced nausea and vomiting after  the vaccine but she also did not eat all day and did not sleep well the night before per her statements
A report was received from a consumer on 10/22/03 concerning a 39 year old female vaccinee who experienced Guillain-Barre syndrome requiring hospitalization, with nausea, weakness of the arms and legs with difficulty controlling her muscles, and difficulty speaking 3 days after receiving fluvirin on 10/9/01. On 10/12/01 the vaccinee felt sick and her arms and legs became weak and she had difficulty controlling her muscles. By 10/26/01 the vaccinee was completely paralyzed and she was hospitalized. She was admitted to hospital and was diagnosed with Guillain Barre syndrome. During the 17 days in hospital the vaccinee received two and a half weeks of inpatient rehabilitation, with another 7 months outpatient rehabilitation. The vaccinee has not recovered and she still has residual effects of the Guillain Barre syndrome including difficulty speaking. No follow-up. Permission not granted to contact physician.
Pfizer vaccine was administered, reported by patient- ? NO LOT NUMBER WERE SUPPLIED HYPOVOLEMIC SHOCK 9/29/2021 PANCYTOPENIA W SIGNIFICANT THROMBOCYTOPENIA HYPOVOLEMIC SHOCK 9/29/2021 CANCER METASTATIC TO INTRAABDOMINAL LN
she has a patient who's symptoms sound like they have Hashimoto's and it started after the Pfizer COVID vaccine was given in 2 days; This is a spontaneous report from a contactable Nurse via Pfizer sponsored program. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient who's symptoms sound like they have Hashimoto's and it started after the Pfizer COVID vaccine was given in 2 days. Reporter also asking if the Pfizer COVID vaccine could trigger a flare up for a patient with Hashimoto's disease. Reporter stated she had a 14 year old patient with muscular dystrophy (specifically Becker Muscular Dystrophy) and is on preventative a cardiac medication lisinopril for 5 years. Reporter was requesting if there is any data regarding vaccine use in patients with muscular dystrophy and if the vaccine would be recommended for young men with those conditions. In response provided disclaimer that Pfizer is unable to make treatment recommendations on a case by case basis for individual patients and mentioned Contraindications in EUA PI. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information given in narrative, the causal relationship between the event Hashimoto's disease and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Information has been received from a lab specialist and nurse practitioner concerning a 2 year old patient who on 16-AUG-2006 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 650232/0911R). Subsequently, the patient developed "a flaming case of the chickenpox." The patient was seen for unspecified medical attention. The outcome was unknown. There was no product quality complaint. Follow-up information from a questionnaire indicated that the 27 month old male with no past history of chickenpox or no other medical history or drug allergies who on 16-AUG-2006 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 650232/0911R). There was no concomitant medication. On 05-DEC-2007, the patient developed herpes zoster dermatome at the 5th position of the lumbar region. The vesicular rash hand scab/skin lesions distributed to 4 areas: the lumbar area, right leg, thigh and calf. There was no recent exposure to chickenpox or shingles noted and the time interval since exposure was the date of vaccination. On approximately 14-DEC-2007 the patient had a maximum temperature of 98.8 and no other systemic symptoms. The patient was enrolled in VZIP: Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on approximately 14-DEC-2007. The sample was taken from a vesicular lesion on the right leg. Additional follow-up information indicated that the on 02-JAN-2008 PCR results for the specimen from a vesicular lesion on the right leg revealed that VZV OKA/MERCK Vaccine Strain. Additional follow-up information indicated that the specimen was obtained on 14-DEC-2007 by a lesion from a scab on the patient's skin (also reported as vesicular lesion: as the source, sent on 17-DEC-2007 and received by the laboratory on 18-DEC-2007. The results revealed an adequate specimen with amplified VZV DNA, vaccine-type strain. Additional information has been requested.
PATIENT WAS NOT 12 YEARS OLD AND I GAVE HIM THE PFIZER SHOT AND REALISED IF AFTERWARD
My husband received the Moderna vaccine. The first dose on the 27th of March. The second dose three weeks later.. A few days later began having moth sores, which came in pairs and took two weeks to dissapear. Close to the end of this my lymph nodes were swollen, first the right, then the left. At the same time a rash mostly on my face , but covering my whole body. Now I have my period for three days. I am in menopause. I am 55 years old.
pt recv vax & that evening the pt exp numbness on the lt side of the face; The next morning the pt was fine; No further details were provided;
pt recvd Engerix-B vax & exp sweating, weakness, joint pain, tingling, lymphadenopathy, neck & back pain, somnolence, migraine, fever, sore throat, urine coffee colored, Liver enzymes had doubled & tripled since the prev day;
Lt arm red & swollen 7.5x7 cm - round erythematous, warm to touch outer aspect of lt arm.
PATIENT DEVELOPED RED SPLOTCHES ON NECK AND FACE, COMPLAINED OF ITCHING, GIVEN 2 DOSES OF 25MG BENADRYL ORAL (50MG TOTAL), THEN REQUESTED TRANSPORT TO HOSPITAL VIA AMBULANCE
A rash on the upper right arm (which is the same arm I received the vaccine). Rash is slightly raised and slightly warmer than surrounding skin, but does not itch.
left arm is swollen and left arm is all red was reported as worsened.; left arm is swollen; left arm is all red; This is a spontaneous report from a contactable consumer (patient).   A 85-years-old female patient received second dose of  bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0191) via intramuscular route, administered in Arm Left on 15Jul2021 10:00 (85-years-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN0178), via intramuscular route, administered in Arm Left on 24Jun2021 (85-years-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunization. There were no concomitant medications. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). On 16Jul2021 17:00, the patient experienced left arm is swollen and left arm is all red, left arm is swollen and left arm is all red was reported as worsened. This began late on Friday, 16Jul2021. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Outbreak of herpes simplex. I'm only reporting bc I saw a published paper that these might be related. This outbreak is bad. Multiple clusters on nose and lip. Valtrex and lysine as treatment. Getting better.  Also, normal flu like symptoms for 48 hours, massive fatigue for at least 4 days.
body aches throughout the day on 1/28 that turned to rigors, chills and worsened body aches at 5 PM on 1/29/2021. Felt like a bad flu. I woke up 1/29/2021 feeling back to normal
Left arm was sore from shot on the first day and then was fine.  However, approximately 48 hours the arm began hurting again, but the pain was spreading down throughout the entire arm.  As each day has passed since April 22nd, when the pain began again, it has gotten progressively worse.  The pain is at a level 10, it starts out feeling like a stabbing pain and then the whole arm feels like it's going to explode the pain is so bad.  I am now losing feeling in my left hand.  I lost feeling in my left thumb, pointer, and middle fingers.
On 3/3/00, the pt developed breakthrough chickenpox. The following day, the pt was seen by a physician. The pt presented with six lesions, rash located on stomach, back, and face.
Child got faint and slumped over within 5-10 minutes of receiving the flu shot. Assisted to a reclining chair, juice given. BP was 80/40, and blood sugar 102. EMS called, and client was stabilized, and did not go to hospital. Told to have something to eat and drink next time before shots.
pt recv vax 7/9/99 & devel fever 102 on 7/11/99;pt vomited 7/12/99;hematochezia 7/12 - 7/13/99;intussusception reduced by radiography 7/14/99;
Patient with Moderna (booster) vaccination 3 days prior to hospitalization who admitted after cardiac arrest and a positive COVID PCR done upon admission (routine admission testing, patient with no COVID s/s).  Patient discharged home, provider discharge note below:  "59 year-old with past medical history of hypertension, hyperlipidemia, coronary artery disease status post NSTEMI (05/2021), and peripheral vascular disease s/p stenting (x2, 2018) admitted after witnessed cardiac arrest. She was resuscitated in the field. She has an extensive cardiac history with multiple cardiac stents, in stent thrombosis, chronic occlusion of right coronary artery, had multiple cardiac interventions, HFrEF with EF 20-25%, history of severe peripheral vascular disease, had multiple surgeries off left lower extremity and also has amputation of the great toe, on eliquis, aspirin and Plavix, continues to smoke, history of alcohol abuse.   Brief Summary of Hospital Stay: She underwent hypothermia protocol. Cardiology was consulted and started amiodarone and placed AICD on 3/29. She had LHC with PCI- 2x DES, mid and distal LAD 03/25/22. Medications reconciled per Cardiology instructions. ASA/plavix/eliquis to proceed for 1 month, then can be de-escalated per cardiology. Will defer this management to their expertise. She is to see  Cardiology in close follow up. Imdur held for borderline low BP. Cardiology/Dr. has cleared the patient for discharge at this time.   I did recommend that she go to a SNF, which the pt declined in favor of going home. She understands that not going to SNF could render additional risks including not limited to falls, medication noncompliance, or worsening of disease which could be life threatening. She still wants to go home despite discussion of these risks.    She required 2 units PRBC for acute anemia which has now stabilized. Iron low, supplementation initiated.   A1C was 6.2. Would recommend this be monitored as she was hyperglycemic with her acute illness.    She was noted to be COVID positive but asymptomatic. "
Patient received PREVNAR 13 injection on 8/22/15; patient states woke up on 8/23/15 not feeling well; said had body aches; Left arm swollen near injection site. Small bruise next to injection site. Patient states stayed in bed most of the day. Two days later, a red rash appeared over a 3-4 inch area below the injection site. Arm painful to the touch. Six days post injection a small red spot 1cm in diameter appeared in the middle of the rash area.
Patient received a booster dose of Pfizer today. The patient is not 18 years old and does not have any immuno-compromising conditions so he did not qualify to receive the booster. The patient's father was made aware that he had received the booster, even though it has not been approved for this age group, and explained that we will follow up with the pediatrician's office tomorrow.
Diagnosed with acquired mitochondrial phosphorylation; Seizure; This case was reported by a consumer via interactive digital media and described the occurrence of mitochondrial cytopathy in a male patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced mitochondrial cytopathy (serious criteria GSK medically significant) and seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the mitochondrial cytopathy and seizure were unknown.   It was unknown if the reporter considered the mitochondrial cytopathy and seizure to be related to dTpa vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter was patient's wife. The reporter trying to informed how the DTP vaccine injured every member of her family. The patient experienced seizures right after one he received at work and later was diagnosed with acquired mitochondrial phosphorylation. The follow up was not required. This is 1 of the 4 linked cases reported by the same reporter.
10/23: Fatigue, fever of 102', chills, generalized body aches (fever slowly subsided over following 2 days along with other symptoms. 10/30: fever of 102' 11/13: redeveloped all initial symptoms including fatigue, body aches, RUQ pain, chills along with fever of 104'.