chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 18-DEC-2009, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-FEB-2013, she was treated by a physician at the same clinic for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
10/14/2004: raised pink spots with deep pink border noted on groin, then back , abdomen, extremities. 10/15: Mycolog cream; Benadryl 50 mg TID. No improvement. 10/19: Medrol dose pack. Resolved 10/25/04.
Information has been received from a physician concerning her 12 month old female daughter with no known allergies or medical history, who on 10-Jul-2006 at approximately 09:00 was vaccinated SC in the left thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#652329/1130R).  Concomitant vaccination included a first dose of hepatitis A vaccine (inactive) (lot#653144/0602F) IM in the left thigh, and a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot#B08651F) IM in the right thigh.  There was no illness at the time of vaccination.  On 10 Jul 2006, approximately 8-9 hours after vaccination the patient developed hives, which was also described as a urticartial rash.  She then had significant eye swelling which responded to diphenhydramine hydrochloride (BENADRYL).  The patient was treated with scheduled diphenhydramine hydrochloride (BENADRL0 four days.  The patient's rash resumed for an additional two days 24 hours after the diphenhydramine hydrochloride (BENADRYL) was discontinued.  On 17 Jul 2006 the patient recovered.  There was no product quality complaint involved.  Additional information is not expected.
J96.00 ACUTE RESPIRATORY FAILURE 4/2/2023 ANEMIA J96.00 ACUTE RESPIRATORY FAILURE 4/2/2023 ACUTE MYELOID LEUKEMIA J96.00 ACUTE RESPIRATORY FAILURE 4/2/2023 THROMBOCYTOSIS, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 4/2/2023 ACUTE MYELOID LEUKEMIA J96.00 ACUTE RESPIRATORY FAILURE 4/2/2023 ANEMIA OF CHRONIC DISEASE J96.00 ACUTE RESPIRATORY FAILURE 4/2/2023 ACUTE MYELOID LEUKEMIA J96.00 ACUTE RESPIRATORY FAILURE 4/2/2023 HEMODIALYSIS DEPENDENCE
I got a warm feeling like a hot flash and get nauseous and tachycardia with each vaccine. However, with the booster, on December 14, I started having pain in my sciatic nerve. I tried warm compress and other methods to relieve. I contacted the medical practice to ask if I was able to take Tramadol and Meloxicam which I had previously been prescribed which helped. The condition is still ongoing but pain level is being controlled.
Extreme Stomach Pain; Vomiting; Really sick; Nausea; This is a spontaneous report from a contactable consumer (patient's husband). A 79-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on Wednesday (19May2021) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had a COVID-19 test on 29Apr2021 with a result of negative. The patient previously received dose 1 of BNT162B2 on 28Apr2021 for COVID-19 immunization. On 22May2021, the patient experienced extreme stomach, vomiting, and nausea. She was really sick. The patient received treatment with bismuth salicylate (PEPTOBISMOL) 2 tablets to try to stop nausea. The outcomes of extreme stomach pain, vomiting, really sick, and nausea were unknown.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
I did have and still have soreness of shoulder where I got the injection. That I can expect to stay. When I woke up at 1:00 am my lips and my tongue were in lots of trouble. Its hard to describe, somewhere between numbness and whatever. They sent an ambulance, they looked at it and had me move my tongue and said the area wasn't swollen so they said it would be ok sooner or later. The second day that was a little bit improved but even until now my lips are not normal. By the second day i was having a swallowing problem, the back of my throat feels like the top of my throat. Even when I swallow saliva its not good. But i am still able to eat. So lips and throat are still a problem. When I went to get the shot I was quite able to walk but not long distance. By the second day i began to have a problem in my back, I assume just muscular unless something is wrong in the vertebrate. I can barely walk now, I just shuffle one foot ahead of the other. At any moment if I move I just collapse. I'm always using a cane and always have something to hold on to because I don't know the next minute I'm going to go down, it is very bad.
SEVERE CHEST PAIN AFTER JNJ; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced severe chest pain after JNJ. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe chest pain after JNJ was not reported. This report was non-serious.
worried; crying; Confused; upset; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (crying), CONFUSIONAL STATE (Confused), EMOTIONAL DISORDER (upset) and ANXIETY (worried) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced CRYING (crying), CONFUSIONAL STATE (Confused) and EMOTIONAL DISORDER (upset). On an unknown date, the patient experienced ANXIETY (worried). On 13-Apr-2021, CRYING (crying) and EMOTIONAL DISORDER (upset) had resolved. At the time of the report, CONFUSIONAL STATE (Confused) and ANXIETY (worried) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Hot swollen face red; Hot swollen face red; Have sort of puff in my eardrums and my hearing was like I was in an Echo chamber; Right eye is red; Hot swollen face red; Dizzy; I had extreme tremor in right arm; Had throat swell; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 68-years-old via an unspecified route of administration, administered in arm left on 12May2021 (Batch/Lot Number: ER8735; Expiration Date: 12May2021) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she had her first vaccine and she had throat swell, was dizzy and then had very extreme tremor in her right arm immediately after the vaccine on 12May2021.  She stayed in the supervisory section for about 20 minutes and then they transferred me to an Emergency room. She had very hot swollen face red and now a days after quite a while as she have sort of puff in her eardrums and her hearing was like she was in an Echo chamber on unspecified dates. The patient further reported that her face is red and her right eye is red on unspecified dates. She asked how many milligrams in the vaccine has the Propylene glycol. When probed for vaccine expiration date, consumer stated, it says that date she got it 12May2021 and on sticker it says expired on 12May2021 and queried if she received expired vaccine. The outcome of the events was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 23-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
rash and hives on my hands, arms, legs, neck and face.  Turning into blisters. A large red area around a cluster of those located below the site of the injection
Problem swallowing and mastication problem feeing therapy as of Jul2022; Problem swallowing and mastication problem feeing therapy as of Jul2022; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 8-year-old male patient received BNT162b2 (BNT162B2), on 09Dec2021 as dose 2 (orange cap), single (Lot number: FK5618) at the age of 7 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: FK5618, Anatomical Location: Left deltoid), administration date: 15Nov2021, when the patient was 7-year-old, for COVID-19 Immunization. The following information was reported: DYSPHAGIA (non-serious), MASTICATION DISORDER (non-serious) all with onset Jul2022, outcome "unknown" and all described as "Problem swallowing and mastication problem feeing therapy as of Jul2022". Additional information: Problem swallowing and mastication problem feeing therapy as of Jul2022.
pt exp acute localized react (3rd dose) 6x5 cm erythema, tender to touch
Pt had shot 10/20/06. Dtap #4, Prevnar #4, Varivax. Pt went to visit with Dad 2 days later Sat at 9:00pm child returned home to mom who took her to ER. RX Keflex for Cellulitis. Mom didn't give it, but swelling subsided.
no adverse event; A patient was administered improperly stored VARlVAX; This spontaneous report was received from a medical assistant concerning a currently 3 year old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 19-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot number S012040, expiration date 17-APR-2021 for prophylaxis (dosage schedule and anatomical location were not reported) (product storage error). The diluent that was used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was properly stored (lot number and expiration date were not reported).   The administered dose of the vaccine experienced a temperature excursion of 5°F to 46°F (17.6 F) for 6 hours and 15 minutes. No previous excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1910USA007021:
had fluctuating blood sugar readings (going up and down); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: BLOOD GLUCOSE FLUCTUATION (non-serious), outcome "unknown", described as "had fluctuating blood sugar readings (going up and down)". The patient underwent the following laboratory tests and procedures: blood glucose: fluctuating/ (going up and down), notes: had fluctuating blood sugar readings.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dyspnoea Exertional; Dyspnoea; Gait Disturbance; Diarrhoea; Fluid Retention; This is a spontaneous report received from contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 19078300 (US FDA). Other Case identifier(s): US202103012733 (Eli Lilly And Company), 2021OCT19122306309 (United Therapeutics).  A 85 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; macitentan (OPSUMIT) (Batch/Lot number: unknown) for pulmonary arterial hypertension; tadalafil (ADCIRCA) (Batch/Lot number: unknown) for pulmonary arterial hypertension; treprostinil sodium (TYVASO) (Batch/Lot number: unknown) for pulmonary arterial hypertension. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DYSPNOEA EXERTIONAL (non-serious) with onset Jan2021, outcome "unknown", described as "Dyspnoea Exertional"; DYSPNOEA (non-serious) with onset Jan2021, outcome "unknown", described as "Dyspnoea"; GAIT DISTURBANCE (non-serious) with onset Jan2021, outcome "unknown", described as "Gait Disturbance"; DIARRHOEA (non-serious) with onset Jan2021, outcome "unknown", described as "Diarrhoea"; FLUID RETENTION (non-serious) with onset Jan2021, outcome "unknown", described as "Fluid Retention". The action taken for macitentan, tadalafil and treprostinil sodium was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT HAD SYNCOPY 15 MINUTES AFTER RECEIVING VACCINE. THERE WAS A FEW SECONDS OF CONVULSION BUT PATIENT regained consciousness right after, breathing was normal. patient was alert and not disoriented. no medical treatments were given.
She got her vaccine, and within a day or two she had a feeling that her mouth was pulling sensation, and has had shingles in the paste.  She started using lip balm, and it would loosen up at the beginning.  Then, it started getting worse after a couple of days, and started circling her mouth.  On 3/5/21 she had a crust around her mouth and went to a doctor and said that she had psoriasis or eczema and told her that she could not treat it.   She has a band-aide on her face from the biopsy and has a picture for that.  She went to her for 4/5 visits and gave her a hydrocortisone cream and a cold tar treatment, and it stopped for about a week.   The cold tar burned to put it on her face, but was doing it, then that stopped.  She had an APT on 4/30/21 that she cancelled.  Then within the last 7 days it has recurred again.    She then went on 6/3/21 to Dr., which was a referral from her PCP, Dermatologist.  She demanded her records and he has marked off COVID screen and shingles in a circle and to FU in one month.   He has sent her to have patch testing, and to go see a Dr.  She informed the doctor of what she has been using for the rash, and he sent her to the other doctor.  She has a crack on her nose, and the cream made that area sore.  She has had shingles twice in the past.  The only place that she has the rash is on her neck upward, her face and seems to be moving to her forehead.  The other day it was on the side, and now has moved to the entire forehead.   She wears wigs due to the alopecia and seems to be moving up under the wig.  She has scaly skin, and crusty skin.    He did not diagnose her with shingles, but had it written on his form.  She asked if she had shingles and he told her that the Pfizer one had some symptoms of shingles.  She has tried eliminating foods, using other problems, and has been taking Benadryl and it's not helping the reaction.  He told her to go home and wash her face and not to be put anything on it and that it might go away on it's own, but she has had it for 3 months now.    She was very slight near the eyes.  Her right eye has had two detached retina and a cataract repair as well, and is worried that if it goes into her eye that she will be blind.  The rash is on both sides of her face not one sided.  She has put  cocoa butter cream on her lips and it seems to be helping her, but was told not to use it.  Told her to wash her face frequently and has an APT in a month to  have the patch biopsy.
One eye swollen and red; One eye swollen and red and the other one itchy and red.; Other one itchy and red; This is a spontaneous report from a non-contactable consumer (parent) or other non-health care professional. A female patient (her daughter) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. On an unspecified date, (Hours after vaccination), the patient had one eye swollen and red and the other one itchy and red. The outcome of the events was unknown.   No follow-up attempts are possible information about lot/batch number cannot be obtained.
Runny & Stuffy nose, chills,fatigue, coughing w/ phlegm  production, general malaise, feeling like I was coming down w/ "something bad"
Dermatological:  rash (mild redness, inflammation, itching) mostly on upper body.  On areas of front upper neck, back, chest, and sides of upper torso.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 13th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th June 2018, 3 days after receiving SHINGRIX, the patient experienced shingles and weird feeling. The patient was treated with Valacyclovir and TYLENOL. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the weird feeling was unknown. The reporter considered the shingles to be possibly related to SHINGRIX. It was unknown if the reporter considered the weird feeling to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX on the right arm. On 16th June 2018, the patient felt weird, and went to the emergency room (ER) and was diagnosed with shingles. The patient was treated with valacyclovir 1 gram TID and TYLENOL since 18th June 2018. A MEDROL dose pack was also ordered, but was not administered. The healthcare professional stated of not being aware of a previous diagnosis of shingles and unsure of previous ZOSTAVAX vaccination.
I ran a fever, was in cold sweats all night long, vomited, and had an extremely high heart rate. I have honestly never been so sick in my life but it did settle out a bit. Now I just feel exhausted and have a headache. I've been feeling better and better but I felt as though it was worth reporting.
CHIEF COMPLAINT:   pt covid + on thursday, to ed for increased back pain, body aches and shortness of breath pt 93% on RA temp 102, 650 tylenol given in field FS 60, D10 admin IV 4 IV zofran given as well   HISTORY OF PRESENT ILLNESS:     Patient is a 59-year-old female.  Complaint is body aches myalgias shortness of breath and positive for COVID.  The patient was exposed to COVID in her family.  She is not vaccinated for COVID she had a positive test on Thursday.  She does have diarrhea she has some vomiting and weakness.  She continuously feels nauseous here.  No chest pain.  Location as above quality as above severity moderate duration as noted context as above associated symptoms none modifying factors none.
ED Discharged  3/14/2021 (1 hours)  Hospital ED Treatment team Providers COVID-19 Clinical impression Covid-19  Emergency Medicine Expand AllCollapse All        ED PROVIDER NOTE        Date: 3/14/2021    This note was partially completed using voice recognition technology, and was scanned for gross errors; however some errors may still exist.  Please contact the author with any questions or requests for clarification.      Medical Decision Making     56 y.o. male patient who presents to the ED for COVID-19 screening. Patient reports PMH of sarcoidosis. Symptoms include nasal congestion, cough, and malaise. Vital signs as documented and stable. Exam reveals well appearing person in no acute distress.  No accessory muscle use, speaking in full sentences. Slight rhonchi noted in left lung base. Heart sounds normal with normal rate and rhythm.  Limbs warm and well perfused.  No edema noted.  Abdomen is soft and non tender.  X-ray negative for acute process. Patient did test positive for COVID-19.   Considered alternative causes such as ACS, PE, pneumothorax, pneumonia but unlikely given constellation of symptoms and exam findings.  Assessment is likely viral syndrome caused by COVID-19. I have directed the patient to self monitor at home.  Advised not to leave home and minimize contacts in home as much as possible for the next 10 days. Advised on symptomatic treatments for home. Patient was advised to follow-up with primary care physician and pulmonologist by telephone and to come back to the emergency department if symptoms worsen.      Chief Complaint      Chief Complaint Patient presents with ? Covid-19 Screening      History of Present Illness     Patient is a male who presents to the ED with for COVID-19 screening.  Patient has been experiencing nasal congestion, cough, and malaise since earlier today.    No specific aggravating or alleviating factors.  No treatments tried at home.  Reports sick contacts of father in law, son, and wife. Denies recent travel..