chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered Fluzone High Dose to a patient who is 56 years old, with no reported adverse event; administered Fluzone High Dose to a patient who is 56 years old, with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from other health professional and consumer or non-health professional via Medical Information (Reference number: 00812383) and transmitted to Sanofi on 14-Oct-2021.  This case involved a 56-year-old patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On 13-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Solution for injection in pre-filled syringe, frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test 0.7ML, Strength: standard except for fluzone HD, lot UJ769AC, expiry date: 30-Jun-2022]  via an intramuscular route in the right deltoid for prophylactic vaccination.  This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose.  It was reporter "caller reported last night a family of 4 who are all under the age of 65 were giving the FLUZONE HIGH-DOSE VACCINE. Caller reported there are no AE's at this time, but wanted to make sure there was nothing to expect and what they should do from here."  no other vaccines.  At the time of this report the patient was fine and had no adverse events after the vaccination.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.
Moderna COVID-19 Vaccine EUA  I got the 2nd Vaccine on February 19th. When I got the 1st vaccine on January 22, 2021 and after 8 hours I began to feel nauseated and it progressed into what I remember feeling when I had COVID-19 in November.  I was sick all night and at 12 noon it lifted and I felt normal. When I got the 2nd shot on February 19, 2021 again I go ill around dinner time but this time it has lasted into the third day. It started off feeling like I felt when I had COVID-19 for the first day. Day 2 and 3 I feel like I have the flu. The severe aches and pains are gone but I feel stuffiness and  very lethargic.
Morbilliform rash appeared on legs; "rash had spread to trunk and arms"; "Temperature 97.7 F"; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153) via an unspecified route of administration in the right arm on 06Apr2021 at 13:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension controlled with medications. The patient had no known allergies. Concomitant medications were reported as "yes prescribed medications". The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 15Mar2021 at 13:45 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 vaccines within four weeks prior to the vaccination. On 08Apr2021 at 06:30, approximately 30 hours after second dose of vaccine, the patient experienced morbilliform rash appeared on legs approximately. On 08Apr2021 at 06:30, the patient had the "rash had spread to trunk and arms" and "temperature 97.7 F", no itching or discomfort. As of 10Apr2021 at 07:30, rash persists and temperature remains normal (97.7 F) and there was no itching or discomfort. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events morbilliform rash appeared on legs, "rash had spread to trunk and arms" and the event "temperature 97.7 F" were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Uncontrollable shaking as from chills, fever up to 101.6 (possibly was higher before checking), fatigue, no interest in food or drink. Symptoms came on quickly, and subsided in 8-9 hours. (Almost exactly 24 hours after the shot.)
Injections site is red; looks like rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No reported medical history.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Jan-2021 and was forwarded to Moderna on 01-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No reported medical history.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported.   No treatment information was provided.
tested positive for covid-19 after first dose of vaccine.; headaches; Second dose over 42 days later; A spontaneous report  was received from a consumer, concerning herself, a 38-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced tested positive for COVID-19 after first dose of vaccine headache, and second dose over 42 days later.  The patient's medical history, as provided by the reporter, included migraines. Concomitant medications were unknown.    On 24 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route  in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient experienced tested positive for COVID-19 after first dose of vaccine and headache. Treatment for the events included vitamin C and hot teas  On 22 Feb 2021, over 42 days had passed since her first dose, and she had not scheduled her second planned dose yet.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, tested positive for COVID-19 after first dose of vaccine, headaches, and second dose over 42 days later, was unknown.; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # unknown with associated AEs: headache and COVID positive test. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Fever, Chills, Muscle Aches, Lost taste and Smell, Fatigue, coughing,  Whezzing , Nausea
Case number PHEH2014US011971 is an initial spontaneous report from a nurse received on 12 Jun 2014. This report refers to a 10-year-old female patient. Medical history and concomitant medications of the patient were not reported. On 09 Jun 2014, this patient received MENVEO (batch number: M13017) that experienced a temperature excursion up to 14C for 85 minutes. No adverse event was reported. No additional information was available.
2-3 days later after the 2nd dose, my lymph nodes and breast was swollen under my left arm. That swelling lasted for almost a week. At the same time, I also have fatigue, palpitation, pressure on my chest, and SOB. I did go see my PCP and they did lab work and echo and everything came back normal except low vitamin D and high vitamin B12. My PCP has referred me to a cardiologist. The fatigue is constant and everyday. I can get out of breath from just walking from one room to the next. I am waiting for my appointment to see the cardiologist on 7/21/2021.
Severe arm pain starting 4 hrs after injection. Headache. Next morning woke up with severe headache, stomach ache and diarrhea. Generalized fatigue that lasted all day. Woke up 1/7/2021 symptom free.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. It was reported that on 06-Dec-2021, the vial with Lot 012H21B was placed in the refrigerator, upon receiving. No treatment information was provided. This case was linked to MOD-2022-448109 (Patient Link).
Wife reporting that within hours after her husband got his 1st dose of pfizer vaccine. He was rushed to downtown and treated for heart failure. Hospitalization lasted 9 days. He also recently recovered from covid.
the M<a grabbed the wrong tray in and administered Hep B and Patient was not due for Hep B at the time of that visit
On Wednesday evening  April 21st around 11:00 pm i could not catch my breath while trying to lye down or sit up, i went to the Hospital ER on Thursday morning at 8:00 am and they did a cat scan with contrast and found multiple blood clots (PE ) in my right lung.
pt exp severe diarrhea w/flu vax last year; pt ate eggs 24 hrs following flu vax; pt has no h/o allergies to eggs
I woke up on the second day after first dose (not the very next day) and my face was swollen and eyes swollen, Right eye swelling more prevalent. I itched all over at various times and took Benadryl for 3-4 days. I also had slight headache, nausea, malaise.
The first day I was coughing with mucus and very tired. I was very tired the next day. That night I had 100 degree fever and just had coughing, runny nose and fever. The next day, I was tired day I did not have fever. 99 was oxygen level. I spoke to the nurse and they said there is no point taking any medication. I still am having cough, runny nose and mucus. I saw the doctor about 2 weeks ago on 13MAR23 and gave me antihistamines and it did not work. I called the doctor again after a week. They gave me a stronger antihistamines, and she said it does not sounds like Long haul COVID-19. It is still not working. She told me to take steroids which is prednisone for 40 milligrams which I have to get.
1-2 days after injection was administered patient experienced inflammation/redness at site of injection - soreness, warm feverish knot around injection site. All symptoms have subsided at area around injection site still slightly red.
Forty-eight hours after administration of vaccine, patient developed sudden onset of severe abdominal pain, muscle aches, diarrhea, and fatigue.  Symptoms lasted for 5 days.
they both tested positive; they both tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: His wife takes Clonidine for her high blood pressure. Concomitant medication(s) included: CLONIDINE taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "they both tested positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High, notes: His wife takes Clonidine for her high blood pressure; Reduce, notes: the medication he knows brings down high blood pressure; 207/115, notes: blood pressure sky rocketed to over 200 and registered 207/115; 205/112, notes: go her blood pressure down to 205/112; SARS-CoV-2 test: Positive, notes: 3 days later got COVID; Positive, notes: they got Covid back from him; Negative, notes: both tested positive and negative 3 time's; Positive, notes: both tested positive and negative 3 time's. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She said previous to this her husband and her contacted Covid because they were silly and went where people were and 3 days later got Covid. Was a very mild reaction if anything and they went about their daily business and they are retired and not going to work. They confined their activities to walking in the park away from people for exercise and fresh air until they tested negative. Their son lives with them and he got Covid from them and then they got Covid back from him. They don't want to keep passing Covid back and forth forever and she said they don't build up antibodies and they can get as many times as exposed and they are healthy and her husband and her are in their 70's and their son is in his 50's and they are active and healthy. She didn't want to get Covid back and she said the more times getting Covid can then get lung Covid and said who wants lung Covid. Her husband said they are both vaccinated and boosted all with Pfizer vaccines and received two vaccines and two boosters and the second issue is they both tested positive and negative 3 time's and by the third time they decided to try this antiviral drug and at that point they were in desperation. The third piece of information is his wife did do five days of medication and and stopped on Friday evening at bedtime. Patient received Paxlovid for the treatment of COVID-19.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Narrative: COVID infection following COVID vaccine series 12/31/2020, Pfizer, dose #1 01/21/2021 Pfizer, dose #2 04/25 COVID swab, result: NOT detected 08/16 pt cc: cough, myalgias, sore throat, headache, rhinorrhea exposure: unknown 08/17 -08/26 pt symptoms continue 08/19 COVID swab, result: detected 08/26 clinically resolved
Patient went to pharmacy to have her shingles shot done, 2 days later patient developed blisters all  up her left leg. blisters were burning and itchy. Shingles vaccine given 10/15/2019
Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old male patient who was received an expired dose vaccine PENTACEL (lot C5382AA, expiry date: 22-Jun-2018, dose and route of administration were not reported) in the thigh NOS on 26-Jun-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was also a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Elevated heart rate heart was racing it was diagnosed as Afib and I was then placed on a blood thinner.
(L) arm (upper) red, swollen, itchy. Treated for possible cellulitis and possible allergic reaction.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 02-NOV-2016, the patient was inoculated with ZOSTAVAX (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy (by an unspecified health care professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-JUN-2017, the patient was treated by an advanced practice registered nurse (APRN) at an immediate health care facility for a blistering vesicular outbreak, which was diagnosed as a herpes zoster. On or about 23-JUN-2017, the patient sought subsequent treatment from a physician for ongoing and worsening symptoms of shingles, which was diagnosed as a herpes zoster dermatitis. The patient has been prescribed valacyclovir and FAMVIR to manage her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reported considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (unspecified if ongoing); "leukemia survivor" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
This spontaneous report was received from the consumer's father on a newspaper article and refers to a 15 year old female patient. The patient's medical history and concurrent condition were not reported. The patient on an unknown date was vaccinated with Quadrivalent HPV vaccine (manufacturer unknown) (dosing information not provided). Concomitant medication were not reported. The patient on an unknown date five months ago had collapsed on GAA pitch and was out cold for thirteen minutes. After that on an unknown date the fits kept occurring even when she was sitting on a chair. The patient would sleep for 20 hours a day and could no longer go to school. Medical tests had revealed low blood pressure but no definite reason had been uncovered for the dramatic change in her health. The reporter reported that the patient's personality had changed completely. She could not do anything now. Action taken with quadrivalent HPV vaccine (manufacturer unknown) was not applicable. The outcome of loss of consciousness, seizure and personality change were unknown. The reporter did not provide the causality assessment between the events and quadrivalent HPV vaccine (manufacturer unknown). Upon internal review the event seizure and loss of consciousness were considered serious as medically significant. This case is linked to the case 1512USA000013 and 1512USA001053. Additional information has been requested.
That night, arm was sore and painful; so had problems sleeping.  Next day, area was more tender, warm and painful to touch. Patient had problems with arm mobility, felt weak, had problems standing up and was trembling. Patient could not sleep well on 2nd and 3rd day also.  Patient did not take any medicine or treated area.  Patient called doctor on 4th day and was encouraged to take Advil  or ice area.  Friday patient did not feel good enough to leave the house.   Symptoms resolved after 4th day but decided to file a report since symptoms lasted longer than expected.
my wife got a little nervous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose number unknown (booster), single (Lot number: GH9693) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: NERVOUSNESS (non-serious), outcome "unknown", described as "my wife got a little nervous".  Additional information: Reporter stated that "my wife and I both got the, that what we thought was the Pfizer, the Bivalent COVID-19 Vaccine and then my wife just started asking me she was a little concerned if we get the right thing. So, we got the batch number. Yeah, I am it is right but my wife got a little nervous. You know, because the first we got it and she said that is what it is. Okay, what is that number".   No follow-up attempts are possible. No further information is expected.