chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Full body rash; tightness in chest; sensation of skin swelling; neuropathic skin pain; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date in Feb2021, as dose 1, single, for COVID-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. It was unknown if patient had any known allergies. The patient medical history and concomitant medications were not reported. It was unknown if patient received other vaccine in four weeks. It was unknown if patient experienced COVID prior vaccination. It was unknown if patient was tested for COVID post vaccination. It was reported that, 30 min after first dose she developed full body rash, tightness in chest, and a sensation of skin swelling/ neuropathic skin pain. Patient's husband was physician and recommended her to take levocetirizine. The patient visited doctor or other healthcare professional office/clinic visit due to the events. The patient was treated with diphenhydramine. The outcome for the events was resolved. The patient took second dose and experienced no discernable symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea, headache, dizziness. BP 121/73 (pulse 75), O2 sat 99%.  Stable.
intense fatigue; fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7533) via an unspecified route of administration in the left arm on 02Apr2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma since unknown date. It was reported that the patient had no allergies to medications, food, or other products. Concomitant medications included escitalopram oxalate (LEXAPRO) 10mg received within two weeks of vaccination for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 18:00, a day after the vaccination, the patient experienced headache. On 04Apr2021, two days after, the patient experienced intense fatigue and fever. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. On 06Apr2021, the patient underwent two nasal swabs and the result of PCR test was pending and negative for other one. The clinical outcome of the events headache, intense fatigue and fever was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vaccine was placed in refrigerator on 29-OCT-2021 after the date of expiry on 13-OCT-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 29-OCT-2021 after the date of expiry on 13-OCT-2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 29-OCT-2021 after the date of expiry on 13-OCT-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 29-OCT-2021 after the date of expiry on 13-OCT-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Vaccine was placed in refrigerator on 29-OCT-2021 Vaccine had not undergone any temperature excursion. No Adverse events were reported.
Patient receiving her immunizations, 2 injections and 1 nasal flu mist.  After flu mist and Tdap administered while sitting on the exam table, patient stated she didn't feel well. Patient pale in color, diaphoretic. Patient was laid back on exam table, BP-97/65, HR-56, ice pack applied to forehead. Patient stated she had not eaten or drank any fluids prior to coming in for her office visit. Small sips of water given along with a sucker, mother at table side. Monitored patient for 15 minutes, asymptomatic. Patient was discharged from the office per order alert, ambulatory, and in stable condition accompanied by her mother
Administered with an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.
Large itchy rash (~2.5 inches in circumference) noticed at injection site 8 days after vaccination.  Rash was red in color, mildly swollen, bumpy, itchy, and mildly painful when pressed.    Rash was treated at home with Benadryl to alleviate symptoms.   Rash cleared up after 2 days without additional treatment.
he experienced injection site pain; Mild abdominal pain; Some mild diarrhea; Caller reports the stool to be a darker, unusual color; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9265, Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (at the age of 53-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient received the first dose of the Covid vaccine on 09Feb. Patient reported for the first 2-3 days he experienced injection site pain (Feb2021) and on the 4th day, he started getting mild abdominal pain and diarrhea (Feb2021). Patient reported on the 5th day he was still experiencing those symptoms and stated that was not normal for him. Patient reported the stool to be a darker, unusual color (Feb2021). Patient again reported that in the last 4 days kind of mild abdominal pain, some mild diarrhea but mostly it's just the darker stool than normal. I was not sure if that was something that had been reported before. Therapeutic measures (Imodium and Pepto-Bismol) were taken as a result of mild abdominal pain, some mild diarrhea, caller reports the stool to be a darker, unusual color. There was no investigation assessment. The clinical outcome of events vaccination site pain, abdominal pain, diarrhea was not recovered and event stool discolored was unknown.  Follow-up attempts completed. No further information expected.
Redness around mouth and cracked lips experienced for more than 3 weeks,  Similar symptoms recurring after the 2nd dose of COVID-19 Moderna vaccine 010M20A
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 19th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: In 2018, the patient experienced redness and swelling of 3 mm at the injection site. In 2018, injection site erythema and injection site swelling lasted for 3 days and resolved. No additional information was provided.
Vaccine was diluted incorrectly - diluted with 0.7ml of saline water
Patient was given first dose of Moderna  on 07/22/2021 and her second dose of Moderna on 08/19/2021.  Per the CDC guidelines, this patient was not eligible to receive a Pfizer booster as it had not been at least six months since her second dose.
Information has been received from a licensed practical nurse concerning a 7 year old female birth twin with no pertinent medical history who on 25Apr02 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. In approx Apr 2004, the pt experienced break through chickenpox. She was exposed to her unvaccinated sibling and he had a bad case of natural varicella around that time. The pt was afebrile and had approx 10 lesions sporadically over her body. Unspecified medical attention was sought and no treatment was required. No diagnostic lab studies were performed. The pt was noted to be recovering with sequelae. A product quality complaint was not involved. Additional information has been requested. The licensed practical nurse also reported that the pt's twin had a similar experience after therapy with varicella virus vaccine live (lot 0404USA01851) as well as an increase in break through varicella after therapy with varicella virus vaccine live (lot 0404USA01852).
A few weeks after receiving my Moderna Bivalent vaccine, I received a flu vaccine on 10/18/2022. Later in October, I began waking up feeling a little bit lightheaded and some tingling and mild numbness in my hands and feet. It was nothing that would keep me incapacitated, I could take walks and do my daily activities. It actually gets better in the evening, but it has been persisting for 2 weeks or so. I would say that it may have gotten a bit worse, the numbness has slightly increased, but the lightheadedness has improved to a degree. I've also noticed some slight fatigue. I spoke with my doctor through my patient portal who advised that I monitor my symptoms for a week and get back with him if it persists. In May of 2022, I had a mild heart attack and had a blockage from a stint I received 10 years ago that needed to be cleared out and was at first concerned that my symptoms were associated with that. However, I have had no other related symptoms like shortness of breath or chest pain. I may follow up with my doctor this week if these symptoms persist.
First dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported by reporter. No treatment medication reported by reporter.
Losing use of left arm; arm is still painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is still painful) and INJECTED LIMB MOBILITY DECREASED (Losing use of left arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm is still painful). On 13-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Losing use of left arm). At the time of the report, PAIN IN EXTREMITY (arm is still painful) and INJECTED LIMB MOBILITY DECREASED (Losing use of left arm) outcome was unknown.            Treatment details included ibuprofen and steroids. Concomitant medications were not provided.
Covid 19 vaccine given 3 weeks early, patient was due 1/21/2022.
Patient was nervous about getting her flu shot but did calm down to receive it while holding her moms hand.  I administered the shot and asked if she was ok and she said she was then I walked away.  Another patient in line told me that we had a problem and I walked over to her and she was laying on the floor and had urinated herself.  She was breathing but in and out of responsiveness.  She never stopped breathing nor did she show signs of anaphylaxis so I did not administer epinephrine.  I called 911 and they arrived and she alert and oriented and able to talk to them and they took her to the ER.
1. After 10 minutes of Vacination, warm feelings in lower limbs. Subsided after 2 minutes or so 2. Again the same feeling came as wave in the lower limbs after a few minutes. 3. It repeated 3 or 4 times. 4. 5th time it started to my torso, the feeling of warmth and suddenly i started to breathe heavily 5. Started to sweat and had difficulty in breathing. 6. Weakness of whole body and a sort of numbess over whole body. 7. Felt very very weak. Called out for help from the nurses, We were asked to wait for 15 minutes after the injection. 8.Admitted to Short stay ward.  Physician attended me but no other medication was given.(Surprisingly) 9. After more than an Hour i was discharged. But no one called to enqu
PATIENT PRESENTED WITH COVID ARM-RASH AT SITE OF INJECTION. PT ADVISED TO TAKE ANTIHISTAMINE AND APPLY ICE ON THE AFFECTED AREA
03/23/21: Patient presented and was admitted through the ED forof breath that has been present for a week, getting worse with productive cough of whitish sputum's but in large amounts throughout the day.  PMH significant to COPD.  Stated she is been doing her neb treatments without improvement.  Has had some constipation and left lower quadrant abdominal pain.  on day of admission, chest x-ray showed bibasilar atelectasis with possible pneumonia. Rapid Covid 19 came back positive.  Her D-dimer was elevated.   Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
my heart hurt so bad/terrible pain in my heart; I thought I was gonna die; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (my heart hurt so bad/terrible pain in my heart) and FEELING ABNORMAL (I thought I was gonna die) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) and METFORMIN for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CHEST PAIN (my heart hurt so bad/terrible pain in my heart) and FEELING ABNORMAL (I thought I was gonna die). At the time of the report, CHEST PAIN (my heart hurt so bad/terrible pain in my heart) and FEELING ABNORMAL (I thought I was gonna die) outcome was unknown.            No treatment medications were reported.  Concomitant medication includes: Thyroid pill
Patient developed fever, myalgias, chest pressure, 3-4 days after Moderna booster (shot #3).  Visited PCP, then an urgent care, and finally the ER, after which he was admitted to the hospital.  Found to have elevated inflammatory markers and pleural and pericardial effusions.  No tamponade on echo.  No other clear explanation for the effusion besides vaccine. Note that the patient was hospitalized.  At the time of this report, he is still hospitalized and is not being discharged.  So I would love to check the box "hospitalization" below but the system will not let me proceed until I say how many days he was hospitalized, and that is currently undetermined.  So to be clear: he was hospitalized.
Seizure - Status epilepticus hospitalized pediatric ICU for months. Treated with steroids, IVIG, Anti viral meds, antibiotics, AED drugs, medical induced coma.
Approximately 15 minutes following the administration of a dose of Tdap, MCV and HPV, child developed rash on the face which eventually spread to both arms and trunk. Upon assessment child was pale and verbalized feeling weak. Child was placed on medical recovery bed on a prone position, based on standing protocol and child's weight, 0.5 mL of epinephrine (0.5mg of a 1:1000 dilution) and 1 mL (50 mg) of BENADRYL were administered intramuscularly. EMS was called while vital signs continued to be monitored which remained stable. Child remained alert and oriented to place, person and time and was transported via ambulance to emergency room for further evaluation and treatment. Mother was advised to deviate from continuing vaccination series until it was cleared by attending physician. Mother verbalized understanding. Upon follow up on 5/27/2017, mother explained that child had fully recovered and had been released from the ER on that same day, 5/26/2017 late in the evening.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a parent concerned a 21 year old male. 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: 202A21A and expiry: not reported) 0.5 ml, at a frequency of 1 total, administered on 27-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, at the end of Jun or start of Jul, patient got fully developed Covid-19 with all the symptoms including cough and diarrhea. Covid-19 infection were clinically confirmed by the PCR test and Nasal test. Both test results were positive. On an unspecified date, patient was positive for Covid-19 (coded as Confirmed covid-19 infection). Exact date of tests were not reported. It is reported that, test were performed within the last week and half (at the end of Jun or start of Jul). Patient went to the urgent care and was in the quarantine. On an unspecified date, the patient experienced confirmed clinical vaccination failure. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) Positive, and COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000185403. The suspected product quality complaint has been confirmed to be Void: N based on the PQC evaluation/investigation performed.; Sender's Comments: V0:- 20210722298- covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
full body rash from neck all the way down to upper thighs and a little on arms; Headache; This is a spontaneous report from a contactable consumer, the patient. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: not reported) via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 06Apr2021, the patient had one attack of a strange headache, which the patient normally did not get. On 09Apr2021, the patient developed almost a full body rash (from the neck all the way down to the upper thighs and a little on the arms too), which had gone down into the legs. The patient questioned what they should do about the rash and if they should get the second shot on 23Apr2021. The clinical outcome of headache was resolved on Apr2021 and of rash was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Narrative: Fatigue - resolved in 24 hours Injection Site Reaction - resolved in 48 hour  Symptoms: & fatigue, injection site reaction
Information has been received from a pharmacist concerning a 75-year-old female patient. No information was reported regarding the patient's concurrent condition and medical history. Concomitant therapy included unspecified cholesterol medication. On 12-SEP-2018 the patient was vaccinated with PNEUMOVAX 23 (dosage, lot number and expiration date unknown), intramuscularly in the left arm to prevent pneumonia. On 13-SEP-2018, the patient called the pharmacist to report that a few hours after receiving the vaccine her left arm became red, severely swollen and she had complaints of mild pain and itching. At the time of the call, no medical treatment had been provided. The outcome of the events was reported as not recovered. The casual relationship between the events and the vaccine was not reported.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 27th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 27th September 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain and difficulty sleeping. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the difficulty sleeping was unknown. It was unknown if the reporter considered the injection site pain and difficulty sleeping to be related to SHINGRIX. Additional details were provided as follows: The patient reported that a few hours after the injection he experienced sore arm where injection was given. The caller stated that he had difficulty sleeping due to the soreness and that it was a little worse this morning.
I have had severe diarrhea every single day since taking the vaccine, 3-6x daily and with abdominal pain. Have never had this problem priory
Runny nose, facial pain, body ache. Received flu shot, not Flumist. My son received Flumist at the same time. Duration of my symptoms >36 hrs.