chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#15152630) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
The next morning when my baby woke up he had a red rash on his chin and jaw line. Within the next 2 weeks he had severe fever and a measles type rash all over his body!
Subsequent to receiving one dose of varicella virus vaccine live, the pt experienced a chickenpox rash outbreak with greater than 50 lesions all over her body. She also experienced fever and vomiting.
pt recv vax; pale & lethargic 8 hr p/ vax; inc sleep; afebrile, irritable x 2 days, shallow breathing;
On Aug 8th, I started having head congestive and sore throat. I had a fever. Then next day I chills and sneezing. I had headaches as well. I contact my primary doctor, but they could get me in. And they told us to get to the walk-in clinic to get tested for Covid-19, tested positive. That same day, I also contact my pulmonary doctor. I had brain fog. I took about 10 days for the symptoms to clear up. I had to use an inhaler and they gave us antibody infusion.
Left arm pain that radiates down worsens at night described as an "achy" pain.
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for community-acquired pneumonia. Vaccination took place 4/14/2009. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.
The first shot didn't affect her much; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The first shot didn't affect her much) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (The first shot didn't affect her much). At the time of the report, VACCINATION COMPLICATION (The first shot didn't affect her much) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-404167, MOD-2021-404182 (Patient Link).
left arm is still sore and when she moves it it brings her to tears/her arm is so painful; left arm is still sore and when she moves it it brings her to tears; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 25Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization, reaction(s): "she got hot and cold"; Bnt162b2 (Second dose), for COVID-19 immunization, reaction(s): "she got hot and cold". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "left arm is still sore and when she moves it it brings her to tears/her arm is so painful"; LACRIMATION INCREASED (non-serious) with onset 2021, outcome "not recovered", described as "left arm is still sore and when she moves it it brings her to tears".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional for the Pregnancy Registry for GARDASIL concerning a 24 year old female who on 26-AUG-2008 was vaccinated with a first dose of GARDASIL (lot # 660620/0571X). There was no concomitant medication. On an unspecified date, she became pregnant. The date of last menstrual period was 09-SEP-2008. On 05-NOV-2008, approximately 7 weeks from the date of last menstrual period, the patient experienced spontaneous abortion. No product of conception was examined. Additional information has been requested.
Disrupted menstrual cycle starting after 2nd dose. Starting 21Apr2021 Extreme Menstrual bleeding for more than 50 days.; Disrupted menstrual cycle starting after 2nd dose. Starting 21Apr2021 Extreme Menstrual bleeding for more than 50 days.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) (at the age of 47 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included none. There were no concomitant medications. No other vaccine in four weeks. No known allergies. The patient experienced Disrupted menstrual cycle starting after 2nd dose from Mar2021. Starting 21Apr2021, Extreme Menstrual bleeding for more than 50 days from Mar2021. (despite taking progesterone, which has slowed, but not stopped it). Doctor says this is not within normal for perimenopause. The outcome of events was not recovered. Therapeutic measures were taken for the events. Events resulted in Doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Chills headache nausea vomiting still vomiting and nausea five days later
difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma; chest pain; chronic cough since receiving/ and is coughing; pain; diarrhea after the vaccine; chills; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (chronic cough since receiving/ and is coughing), CHEST PAIN (chest pain), DYSPNOEA (difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma), PAIN (pain) and DIARRHOEA (diarrhea after the vaccine) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21-21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient was asymptomatic. No treatment received and no hospitalization) on 31-Dec-2021. Concurrent medical conditions included Asthma.    On 10-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced CHEST PAIN (chest pain). On 11-Mar-2022, the patient experienced DYSPNOEA (difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma). In March 2022, the patient experienced COUGH (chronic cough since receiving/ and is coughing), PAIN (pain), DIARRHOEA (diarrhea after the vaccine), CHILLS (chills) and FATIGUE (Fatigue). In March 2022, PAIN (pain), DIARRHOEA (diarrhea after the vaccine), CHILLS (chills) and FATIGUE (Fatigue) had resolved. At the time of the report, COUGH (chronic cough since receiving/ and is coughing), CHEST PAIN (chest pain) and DYSPNOEA (difficulty breathing/trouble breathing/difficulty breathing is because she has Asthma) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient did not went to see a Physician about these symptoms so no cardiac work up was done. Patient was yet to receive a second dose of the Moderna Covid-19 vaccine. Patient did not had a history of Myocarditis/pericarditis.
Dose administered after a temperature excursion; Poor quality product administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the reporter had a temperature excursion of about 20 doses of Moderna, it got down to 32°F, then went up to 34°F, then up to 36°F, then up to 37°F over the course of an hour. The doses were put in a portable transport unit and left at 32° and the transport unit was not prepared for enough time to maintain the temperature. Expiration date of the dose administered was on 30-Oct-2021.  No concomitant medication was reported. No treatment information was reported.
The report had been received from a health professional. The report concerns a 7 years old male patient. Concomitant medications, concurrent diseases and medical history were not reported. The patient was received nasal FLUMIST QUADRIVALENT on 02-Jan-2014. After received FLUMIST QUADRIVALENT, the patient was diagnosed with flu Type A which started on 28-Jan-2014. At the time of reporting, the event was improving. The event was considered to be non-serious by the reporter.
Less than a week after I had a partial vision loss in my left eye that lasted 2-3 hours then it cleared up.
suspected vaccination failure; shingles; This case was reported by a nurse via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The reporter stated that, the patient had milder case than she had seen working as a nurse. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Second shot 3/31/21 injection site same as the first tender and swelling at the injection site.   Had to take Benadryl and other allergy OTC medicine for two weeks because of severe itching and rash-like symptoms.
Approximately 4-6 hours after pneumovax given, started having pain, swelling, redness at site.  Appears to be more allergic reaction then cellulitis.  18 hours later redness and swelling.  Improving.
Pt did not develop "protective titers" p/3 injects of Engerix-B; "Plan to revax" pt; Reporter states the non-protective titers can be possibly disabling and/or life threatening "if person contracts Hepatitis";
2 days p/vax pt devel a fever of 104 & painful retroauricular adenopathy; 4 days post vax pt began to improve;
This male subject was enrolled in the 2nd year of the prophylactic observation study 106372 (FLU NG-006). On 12 October 2009, he received a 2nd dose of FLUARIX or influenza vaccine adjuvanted with half dose of AS03 (FLU NG). This subject received FLUARIX (lot AFLUA445A). On 13 October 2009, one day after the 2nd dose of Blinded vaccine, this 73-year-old subject developed vestibular disorder. The event was clinically significant (or requiring intervention). The subject was treated with meclozine hydrochloride. The event resolved on 16 October 2009. The investigator considered that there was a reasonable possibility that the vestibular disorder may have been caused by investigational product. Investigator Comments: Subject called subinvestigator October 13 with complaints of vertigo. Subject had vertigo since 0700, 17 hours after injection with vaccine. Subject was unable to get out of bed and was cold and clammy. He vomited twice. He had no visual changes, thinking problems, nor speech changes. No focal neurological symptoms. No cold symptoms. Subject has no history of ENT problems nor CVAs. Subject called primary physician who prescribed MECLIZINE. 14Oct2009 in the AM subject felt better. No dizziness when lying down, but still dizzy when moving. No more vomiting. Has regular appointment with primary MD on 19OCT2009 MD did not feel it was necessary to see him now. Investigator feels it may be due to vaccine because the event was temporally related and there is no other explanation for the event as subject has no history of middle ear problems or colds. Spoke with subject on 14OCT2009, 15OCT2009, AND 16OCT2009, each day subject was less dizzy and by the 16th he was back to normal. MECLIZINE was prescribed at 12.5 mg TID, but subject only took it BID. Last dose was 16OCT2009 in the AM. Subject has appointment with primary MD on 19OCT2009. History of alcohol abuse was many years ago. The GI and hepatobiliary disease is GERD. The genitourinary disease is history of kidney stones. The endocrine disease is hypercholesterolemia. Subject has no history of vertigo nor any history of problems with vaccinations. Spoke with subject on 20OCT2009 after MD appointment. Subject is fine. MD states he probably had a viral infection. No further follow-up needed. MEDICAL HISTORY AT STUDY START: Alcohol abuse, Ischemic heart disease, Myocardial infarction, Other Endocrine system disorder, Other gastrointestinal and hepatobiliary system disorder, Other genito-urinary system disorder, Malignant neoplasm of respiratory and intra thoracic organs.
She got her vaccine, she did not have any reaction at first.  Four days later she was driving the car down the street around the corner where she lives, it came on her all of the sudden with noise in her head, thought it was from outside, and stopped to ask the neighbors if they heard a lot of loud noise and they told her no.  She has been like that since that time, and has not let up.  She has been to 6 ENT's, neurologist, to the hearing institute, and is going to an Audiologist Clinic.  She also went to an eye doctor who they were telling her about it, and he told them that there is no cure for it.  He also has it from other things.  She wooshing sounds, buzzing, ringing, and several different sounds that she has.  Some days it is worse than others.  Her husband retired early to stay home with her as he feared she would hurt herself to the noise.  They have not been able to travel like they had planned on due to this condition.    She went to the ear place for hearing aides and paid over $5000.00 for them, which did not help with the sounds, and has tried white machines.  Says that the only things that helps is that the microwave noise tends to drown it out some.
extreme pain and stiffness in my joints; extreme pain and stiffness in my joints; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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 complete; unknown manufacturer) for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset Feb2022, outcome "unknown" and all described as "extreme pain and stiffness in my joints".  Additional Information: Patient reported that since the day of vaccination had extreme pain and  stiffness in joints. Especially the left side of the body. The patient don't know what to do to get better.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown gender and age. The healthcare worker reported, that unspecified patients received improperly stored PROQUAD (Merck) (lot # L005293, an expiration date: 17-SEP-2016) and PROQUAD (Merck) (lot # L008354, an expiration date: 11-SEP-2016) (dose, frequency, route of administration and indication were not reported). No adverse effects were reported for the additional unspecified patients. This is one of the several reports received from the same source. Additional information has been requested.
Moderate chills; Nausea; Vomiting; This is a spontaneous report from a contactable other HCP. A 24-year-old non-pregnant female other HCP (Patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an Intramuscular route of administration on left arm on 07Feb2021 at 11:15 AM as single dose for COVID-19 Immunization. The patient's medical history and concomitant medication was not reported. The patient received other medications for Birth control in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Feb2021at 01:15 AM patient experienced Moderate chills, Nausea, vomiting, patient had not received any treatment. The outcome for the events was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
approx 6 minutes after receiving vaccine to Left deltoid IM site: marked tachycardia HR 180 with associated dizziness, nausea, hypotension and subsequent severe lethargy and feeling of syncope.  placed on stretcher at hospital facility and ultimately fell asleep for unknown amount of time. After waking approx 2 hours later majority of severe symptoms subsided but residual tachycardia of 120s and orthostatic hypotension throughout the day for next 16 hours. associated dry flushed skin of face and dry itchy eyes throughout day as well
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: 3302680) at the age of 52 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Negative, notes: Tested negative on day 9; (22Jun2022) Negative, notes: Tested negative on day 10; (25Jun2022) Positive, notes: Tested positive asymptomatic; (02Jul2022) Positive, notes: positive and symptoms remain. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. No follow-up attempts are possible. No further information is expected.
Pt received VARIVAX vaccine on 09-22-01 at clinic & now is seen at other clinic & developed a rash that was cultured & positive for varicella zoster.
I had a heart attack like occurrence and for a week after had strong chest pain. I am writing this today as I am highly concerned, I have heard of other people facing the same issue. I am a young woman In outstanding health. I feel the vaccine is causing heart and chest issues much more frequent than we are being told. I have had people near me die of heart attacked recently and think it?s a result of the vaccine
Patient complains of hives, chills, vomiting that began within a few hours after receiving the vaccine, she also complained of her injection arm "falling asleep" while driving the next day.
This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.