chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (dose, expiration date, route and site of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Patient received pfizer vaccine on 2/15/21, 3/8/21 and 9/27/21. Presented to ER on 6/12/22. At midnight 6/13/22, COVID positive. He comes to the emergency room complaining of a couple days  of worsening shortness of breath and cough productive of clear sputum.  He had  some chills at home, but no fever.  No nausea, vomiting, or diarrhea.  As per  the ER, his 1st EKGs showed heart rate in the 150s and they thought it was  SVT, so the patient was given multiple doses of adenosine that did not help  him.  The repeat EKG showed possible AFib with RVR and the patient was started  on a Cardizem drip and since now, the patient is complaining of some chest  discomfort.  They also put him on nitroglycerin, which made his blood pressure  go down into the low 90s and then both of them were stopped.  The patient  also tested positive for COVID-19. Received doxycycline, remdesivir and ceftriaxone. Was on NC 1 L throughout stay. Discharged on 6/16/22 on room air
large swelling (4"x3") , redness, itchiness and pain at injection site Started 8 days after 1st vaccination Prior to that extreme tiredness, trouble concentrating, joint pain at various parts and lowed back pain.
Acute Cerebrovascular Accident; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 21-AUG-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered generalized weakness, facial paresthesias, and was ultimately diagnosed with an acute cerebrovascular accident which required hospitalization. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The event was considered to be related to zoster vaccine live (ZOSTAVAX).  The event of acute cerebrovascular accident was considered to be disabling by the reporter.
Information has been received from a certified medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Information has been received from a physician concerning an 8 week old ("2 month old") baby boy with a history of some difficulties around the birth who on approximately 17-JAN-2011 ("sometime in the last week") was vaccinated orally with the first standard dose of ROTATEQ (lot # not reported). Concomitant therapy included other vaccines but the reporter did not know which ones. On approximately 17-JAN-2011 ("In the last few days") the baby had an adverse experience after receiving the vaccines (product unspecified) that day including ROTATEQ. The baby had become quite red. No treatment was given to the patient. There was no time for the patient to have another dose yet. The patient had sought unspecified medical attention. At the time of reporting, the baby's adverse event had improved. There would be some sort of follow up. Additional information has been requested.
Information has been received from a healthcare professional concerning a 15 year old female student who on 9/14/06 at 3:00 pm was vaccinated in the right hip with her first dose of HPV vaccine, lot 654540/0800F. On 9/18/06 the pt developed low grade fever and swollen glands. Her outcome was unk. The reporter indicated the pt would be evaluated at her next vaccination. Additional information has been requested.
fever; This is a spontaneous report from a Pfizer Sponsored Program Support. A contactable consumer (patient herself) reported that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on 22Mar2021 as a DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The patient experienced fever on an unspecified date. It was reported that, the patient had the 2nd dose vaccine (22Mar2021). Reporter said, felt that she had a little fever after the 2nd dose. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
both shots yrs ago, got shingles on February/ suspected vaccination failure; I got shingles. They were terrible; the worst pains; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included chemotherapy. Concurrent medical conditions included non-hodgkin's lymphoma and immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In February 2022, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The reporter said shingles shots did not mean that you won't get shingles. The patient said he/she got both shots about 2 years ago and got shingles this past February.  They were terrible. He/she would still get the shots again if it would lessen the chance of getting shingles.  They really were one of the worst pains that could have.  The patient had Non-hodgkin's lymphoma and am therefore immunocompromised.  Chemotheraphy saved patient life but killed his/her immune system. The patient said not complaining he/she truly blessed to be alive. Additional supportive information: Follow up would not possible, as no contact details were available. This case was considered as suspected vaccination failure since details regarding laboratory confirmation of shingles was not reported.
Systemic: patient described as pressure in sinuses, and increased urge to go to the bathroom-Mild, Systemic: Shakiness-Mild
This case was reported by a consumer (the subject's mother) and described the occurrence of fever in a 8-year-old female subject who was vaccinated with DTaP vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of DTaP vaccine (details unknown). At an unspecified time after vaccination with DTaP vaccine, the subject experienced fever and increased heart rate. At the time of reporting the events were resolved.
migraine, severe, x 2 days fever (101 F) x 3 days, requiring use of antipyretic axillary lymph node swelling, same side as injection, severe, lasting 2 days and requiring  upper extremity sling use rigors/chills x 3 days, moderate arthralgia, severe x 3 days myalgia, severe x 3 days vomiting x 1 day, mild injection site pain/swelling, moderate, x 4 days fatigue, severe preventing daily activity or work attendance, x 4 days
I had two doctor appts in July - at both my blood pressure was higher than normal. The reading for the second one was: 170/90 for the second one - your normal was 120/70 or even 60. I was put on Losartan. It did bring my blood pressure down initially but then it started creeping back up. I have been keeping track of my blood pressure and have another appt with doctor in a few weeks. Working on getting it down.
respiratory infection; rash; This spontaneous report was received from a registered nurse and refers to a 13 year old male patient. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.      On 20-FEB-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N025429, with expiration date on 21-JUL-2020 for Human Papilloma Virus (HPV) prevention (strength, dose and route were unknown). On 23-SEP-2019, the patient developed a respiratory tract infection and a rash. The patient sought medical attention and was treated with unspecified corticosteroids. The events were no cancer events and did not produce a significant disability or incapacity, hospitalization or was life threatening.     The outcome of the events and the causal relationship between vaccination with of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events were not reported.        Upon internal review, the event respiratory tract infection was considered to be a medically significant event.
shingles; Rash; pain/pain in the right quadrant of her chest; Numbness and tingling; Numbness and tingling; Skin very sensitive; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 64-years-old via an unspecified route of administration, administered in arm left on 13Mar2021 10:00 (Batch/Lot Number: EN6200) as 1st dose, single. Medical history included ongoing Grave's disease and ongoing hypothyroid (about 4 years ago, still have it), was under a lot of stress and immune system was way way down in 2012. Concomitant medication included levothyroxine taken for thyroid from an unspecified start date and ongoing. The patient previously received a flu shot in 2012 and experienced flu symptoms. The patient received pneumonia shot and flu shot on an unspecified date (reported as in the fall). The patient reported she had the first dose of the vaccine on 13Mar2021 and came down with pain on the 23Mar2021; she started to experience a lot of pain. She had pain in the right quadrant of her chest. It was like a stabbing pain with a lot of tenderness and numbness to the touch of her skin. It was very sensitive. The skin was very sensitive on 23Mar2021. It may be an odd coincidence, she doesn't know.  One is closely associated with the other.  She went into the doctor and got a Cortisone shot. She got the Cortisone shot because there was no breakout at the time. She had done some yardwork on Monday and thought it may be just a pulled muscle. On Saturday (27Mar2021) she noticed the rash, it broke out and she had about 6 spots on her back. Sunday she had a couple small ones underneath her right breast. On Monday, 29Mar2021, she went back into the doctor and found out that she had Shingles; she was diagnosed with shingles and is on an antiviral medication, Valacyclovir. The actual infective site on her back has gone down some. The patient also experienced numbing and tingling on 23Mar2021. The tingling is not to the amount it was. The patient underwent lab tests and procedures which included blood test: fine on an unspecified date. Therapeutic measures were taken as a result of pain/ pain in the right quadrant of her chest which included cortisone shot, Gabapentin 100mg (can take up to 3 before bedtime, but actually she has just been taking Ibuprofen) and for shingles, valacyclovir. The outcome of rash was unknown, the patient did not recover from shingles and was recovering from the other events. The next dose of the vaccine is due Saturday. Her dosage for the antiviral doesn't expire until Sunday. She asks if she should get the next course of the vaccine or delay.  No Follow-up attempts completed. No further information is expected.
Information has been received from a health professional concerning a female who, "a couple of weeks ago," was vaccinated with a dose of Gardasil.  It was reported that after vaccination the patient fainted in the parking lot of the physician's office.  The patient's outcome was unknown.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a registered nurse concerning a 13 year old white female with exercise-induced asthma who on 26-JUL-2007, at 9:30, was vaccinated IM in the left arm with a dose of GARDASIL (lot #656372/0243U). It was reported that after vaccination, at 9:45, the patient fainted in the parking lot of the physician's office. The patient's blood pressure was noted to be 98/60. The patient was obseved in the physician's office until asymptomatic. On 26-JUL-2007, the patient was recovered. No additional information is expected.
On 1/21/12, had neck pain & loss of taste.  States following day, developed Left-sided facial weakness.  Diagnosed by her PMD 1/24/12 with Bell's Palsy, and treated with high dose prednisone & Zovirax, which she had completed.  Currently states "90-95% better", but still has mild symptoms.
he had COVID and he just found out a week later after he received the 1st dose; he had bad chills; didn't feel good; This is a spontaneous report from contactable consumer (patient) from a male patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date was not provided) via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On unspecified date, patient had COVID and he just found out a week later after he received the 1st dose and he had bad chills the night after and didn't feel good. On unspecified date, patient had COVID test and result was positive. Patient was due for the 2nd dose on 13Apr2021 and wants to know if can get it right away or needs to wait for days or weeks before getting it. The outcome of events was unknown.  Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: Yes.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
This spontaneous report as received from a other health professional (Registered nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date in 2014 (reported as since September 2014) the patients were vaccinated with PROQUAD (Merck) for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Since September 2014, the patients were administered improperly stored PROQUAD (Merck). No adverse effects were noted. Outcome and causality assessment was not reported. Product quality complaint was not reported. No additional information was reported. This is one of several reports received from the same reporter. Additional information has been requested.
1/2hr p/vax pt started coughing & devel profuse rhinitis w/edema of the eye lids & periorbital area & diff breathing;
Site of immun lt arm red firm, warm from deltoid area to wrist, swollen so skin shiny tight by hx of mom; no fever; Pt seen 11SEP91 & swelling had dec to deltoid & part of upper arm; Advised no further Pertussis;
patient missed their dose, no AE; twisting the new needle in where the plastic part is the plastic part came off the syringe and all ofit fell into the floor, no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 54 years old male patient who was supposed vaccinated with RABIES (HDC) VACCINE [IMOVAX RABIES] lot P1E522M expiry date: 30-Oct-2020 via unknown route in unknown administration site.  It was reported that twisting the new needle in where the plastic part is the plastic part came off the syringe and all of it fell into the floor. The patient missed their dose since they only had the one to administration prophylactically for traveling.  It was also the case of syringe issue.  It was a case of potential medication error due to product dose omission since patient missed their dose since they only had the one to administer prophylactically for traveling.  At the time of reporting, it was reported if the vaccine was not administered   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 and Module VI of the 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.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2009, a healthcare provider at a physician's office administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-OCT-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the zoster vaccine live (ZOSTAVAX), and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Unable to lift arm above shoulder level next day. 2nd day out able to lift arm but felt severely bruised within the arm. Upon inspection noticed large red rash in circular to oval pattern 2 - 3 inches below vaccine injection site. Sore and hot. 5th day after vaccine, red rash starting to dissipate.  7th day after vaccine, red rash returned, greater in size, raised, feeling and look of swelling beneath surface of skin along upper arm muscle.  Severely itchy, red, and warmer than surrounding skin.
Patient has a "tic" since receiving Tdap and MENACTRA on 9-26-2014. Symptoms started 10-20-14 mom questions relationship to MENACTRA or Tdap.
arm pain at the injection site and into the elbow; arm weakness; arm pain at the injection site and into the elbow; This spontaneous report was received from a physician referring to a 90-year-old male patient. The patient was allergic to tetracycline. The patient had no concomitant medication and no pertinent medical history.  On an unknown date in MAY 2018 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, frequency, lot# and expiration date were not reported) intramuscularly for routine prevention.  On an unknown date in MAY 2018 the patient began experiencing arm pain at the injection site and into the elbow, and arm weakness after the administration of the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).   The patient sought medical attention in the physician's office and received treatment methylprednisolone(MEDROL) pack for the events. There was no lab diagnostics/studies performed. The outcome of the events was reported as not recovered. The causality assessment was not provided.
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Expired vaccine was administered to total of 24 patients including 15 males and 9 females. It was reported administrations were mostly for booster shots. No side effects were reported.  Treatment medication was not provided.
Local reaction on right thigh around vaccination puncture site. Redness and swelling, noticed on Tuesday evening the size of a dime, grew continuously until Thursday morning when it was size of quarter or bigger. Small hematoma formed and still present at this time. Simultaneously, patient developed an URI requiring nebulizer albuterol treatments for 3 days.
Narrative:  Fully vaccinated, admitted for weakness , h/o COPD and found to be COVID positive