chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient admitted for DKA and new diagnosis of T1DM. Admitted on 8/27/21 with BG of 408, AG of 24, and serum and urine ketones. Anion gap closed on hospital day #1 and he was transition to subcutaneous insulin. Has been learning to manage diabetes in terms of administering insulin, count and cover carbs, etc in the interim. At discharge, patient and mother felt comfortable with administering insulin at home. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Patient reported feeling fine until today, (1/2/2021), running low grad fever, slight headache, and nausea.
Info has been received from a physician concerning a 6 year old female who in approx. 2000, at 12 months of age, was vaccinated with a dose of varicella virus vaccine live. On 4/4/05, the pt presented to the office with a mild case of chickenpox. The outcome was reported as recovering. No other info was available. Unspecified medical attention was sought. There was no product quality complaint. Additional info has been requested.
Unable to eat; Appetite lost; Nausea; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Unable to eat), DECREASED APPETITE (Appetite lost), NAUSEA (Nausea) and ILLNESS (Sickness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Gout, Blood pressure high, Skin cancer, Non-smoker and Alcohol use (variety and occasionally) since 1976. Concomitant products included AMLODIPINE for Blood pressure high, ALLOPURINOL for Gout.   In 2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. In 2020, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced FEEDING DISORDER (Unable to eat), DECREASED APPETITE (Appetite lost) and NAUSEA (Nausea). In 2021, the patient experienced ILLNESS (Sickness). In April 2021, FEEDING DISORDER (Unable to eat), DECREASED APPETITE (Appetite lost) and NAUSEA (Nausea) had resolved. In 2021, ILLNESS (Sickness) had resolved.            The reporter did not have the lot number information and expiration date of Covid-19 vaccination because it was not on the vaccination card.  Action taken with Skyrizi for the event of sickness was unknown and that for the rest of the events was dose not changed.  The reporter did not provide any causality assessment for the event of sickness with Skyrizi and assessed the rest of the events to be not related to Skyrizi.  The reporter assessed the event of sickness as not related to Moderna vaccine and rest of the events as probably related to Moderna vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt refused 2nd dose stating has had an intractable headache since receiving the first dose.
received a second dose of VAQTA approximately two months after the first dose; No additional AE reported/ Patient has not had any symptoms or adverse effects from receiving this dose of VAQTA; This spontaneous report was received from a medical assistant referring to a 48-year-old patient of unspecified age. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On an unspecified date, the patient was vaccinated with the second dose of hepatitis A vaccine, inactivated (VAQTA) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis, approximately two months after the first dose (inappropriate schedule of product administration).   The patient did not experience any symptoms or adverse effects (no adverse event).
My right arm was sore the day of the vaccine. The next day it was more sore but all the soreness was gone by the 3rd day.  I felt tenderness on day 10 or 11 and it felt a little raised. I tried looking down my arm but didn't see anything. The next day it was itchy again so I looked in the mirror and it was red and raised. I put cortisone 10 on it and it seemed a little better the next day.
@ about 730PM p/having hsot had shaking spell for 2-3 minutes; felt it looked like a sz; sl temp elevated; cried 1 hr cont p/shots;
Fever, body aches, chills on 4/17/21. Large red swelling under vaccination site 4/18
Exhaustion; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOXYL; LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 13May2022 at 09:00, outcome "recovering", described as "Exhaustion". Therapeutic measures were not taken as a result of fatigue. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
she was so sick after the second dose; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 77-year-old) as single dose for COVID-19 immunization. Medical history, concomitant medications of the patient were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on an unspecified date in Feb2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. On an unspecified date after receiving second dose of vaccination patient was so sick. Patient was interested in getting the booster dose and asked if the there was a special diet or certain medications she should avoid before getting the dose. Patient asked if she should receive a smaller dose for her weight and height and how long she should wait to get the dose. Outcome of the event was unknown.
Discharge summary  HPI: Pt is a 61 y/o male with a past medical history significant for DMII, HTN, HLD, asthma, sleep apnea, pulmonary HTN and pulmonary nodules (per record review) who presents with bilateral lower extremity weakness beginning yesterday. Pt reports that sxs began 5 days ago with constant burning sensation in BUE located in his bilateral wrists and shoulders, not throughout his arms. He reports yesterday he woke up and his legs felt very heavy and this has progressed today to the point that he feels ?can?t walk quite right.? States that it feels like he has bilateral foot drop. COVID-19 vaccine (J&J) was received 15 days ago. Was stung by a bee 8 days ago. Denies any significant symptoms after either of these events. He was seen in the clinic 2 days ago for the burning sensation, he was given voltaren gel, which he has been taking without relief and Valtrex, which he was instructed only to take if he develops a rash, which he has not and so has not taken it. Pt denies unilateral weakness, slurred speech, nausea, vomiting, diarrhea, chest pain, shortness of breath, fever, chills, neck stiffness, vision changes or any other complaints.  Hospital course: Patient was admitted on 21 November 2021 due to bilateral lower extremity proximal muscle weakness. LP was performed which was consistent with Guillain-Barre Syndrome with no organisms. He was started on IVIG therapy with neuro checks and respiratory status remaining stable. Symptoms remained localized to his hip flexors and extensors and demonstrated mild improvement prior to discharge. While admitted, he completed 4 doses of IVIG and he was able to walk independently without significant difficulty. Also, three MRIs of Brain, Cspine, Lspine were performed without acute findings to explain symptoms. A DVT US was negative as well. He was discharged with instructions for close follow up with neurology as well as PT and OT referrals.   While inpatient, his glucose remained persistently elevated, A1c revealed 8.6%. He was discharged to change and increase his 500mg Metformin XR daily to 1000mg XR twice daily (with instructions for titration). He was instructed to follow up with his PCM for further management.
Child had shots on Monday.  Came in on Wednesday with swollen, red, hot to touch area on left thigh area.
1st dose: 08Mar2021, 2nd dose: 25Mar2021; legs did not want to hold her up; Both legs from the hip down to the calves very painful and weak; Both legs from the hip down to the calves very painful and weak; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received second dose of BNT162B2 via an unspecified route of administration, administered in arm left on 25Mar2021 10:45 (Batch/Lot Number: ER8732) as single dose for COVID-19 immunisation. The patient had known allergies: statins. Concomitant medication included carvedilol. The patient previously took first dose of BNT162B2 at arm left on 08Mar2021 10:45 (Lot: EN6199) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and the patient did not test for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It reported both legs from the hip down to the calves very painful and weak and patient had to use a walker because legs did not want to hold her up on 27Mar2021 05:30. The patient took paracetamol (TYLENOL) every four hours and it did not help the pain. On 30Mar2021 (5 days later), the pain was less and just below her hip above her knee. The patient was using the walker helped her keep upright without having to limp. No treatment received for the above mentioned leg weak. The events required doctor or other healthcare professional office/clinic visit. The outcome of at risk event (inappropriate schedule of vaccine administered) was unknown. All other events were not recovered.
Has not received a Second dose, 6 months after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received a Second dose, 6 months after the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received a Second dose, 6 months after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received a Second dose, 6 months after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Soreness from the first injection and that was all; This is a spontaneous report received from a contactable consumer. A 20-year-old male patient received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EW0176), via intramuscular route of administration in Arm Left 03May2021 at 16:00 (at the age of 20 years old) as 1st dose single, dose for covid-19 immunisation at school. Medical history included seasonal allergy. Family medical history included "his mom has Meniere's disease, it comes in rare spurts". Concomitant medication included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for seasonal allergy, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for seasonal allergy. The patient experienced soreness from the first injection and that was all in May2021. The events assessed as non-serious. Outcome of the event were unknown.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient fainted shortly after injection.  She recovered quickly, but felt confused, sweaty, and tingling in her arms after.  She felt better after about 15 minutes, but we had to stay to observe for 30minutes after.  She was feeling better by the time she left the store.
asthma within 5 minutes of receiving vaccine; used xopenex inhaler - two puffs; symptoms decreased but within ten minutes symptoms increased; received intramuscular injection of solumedrol and was transported by ambulance to Medical Center emergency. Was monitored in ER, used xopenex inhaler four more times in ER per MD instructions. Was better, so discharged at 10:30 pm on 3/4/2021 and given RX for prednisone 20 mg once a day for three days.
Felt pretty terrible; Very Sleepy; Very sore; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt pretty terrible), SOMNOLENCE (Very Sleepy), PAIN (Very sore) and PYREXIA (Fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No specified medical history has been reported.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (Felt pretty terrible), SOMNOLENCE (Very Sleepy), PAIN (Very sore) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Felt pretty terrible), SOMNOLENCE (Very Sleepy), PAIN (Very sore) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: TCR received on 08-jul-2021 contains significant information i.e. AE outcome
Patient spoke to me this morning regarding some symptoms he had after his Pfizer COVID 19 vaccination yesterday.  He said he had some pain at the injection site and mild headache in the afternoon; however, around 12 to 1 am in the morning, he was feeling heart palpitation and he felt his muscle twitching from his upper torso which went down to his thigh and no loss of consciousness.  He said he checked his heart rate and it was 70 and he did not have any problems breathing.  He said his heart palpitation felt better after taking some deep breaths.  He said he no longer had heart palpitations or muscle twitching any more.  He denied any other symptoms.   Generally, he appeared well, no facial drooping, awake, alert, oriented, speech clear, and normal gait. (Today)
Joint pain in her hands next day; patient felt shaky same day of vaccine and described it "like when you do very heavy exercising, but you didn't fuel/eat enough so you feel a bit shaky; patient felt pain behind her ear/neck area like fluid pressure; patient felt pain behind her ear/neck area like fluid pressure; a few days later had a nose bleed. After the nose bleed neck pressure was gone; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 04Feb2021, as single dose for COVID-19 immunization, at workplace clinic. Patient had allergies to Soy, nuts and seasonal and history of Cancer. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Patient felt shaky same day of vaccine and described it "like when you do very heavy exercising, but you didn't fuel/eat enough so you feel a bit shaky". Joint pain in her hands next day (05Feb2021). Few days post (3-4 days) boost, patient felt pain behind her ear/neck area like fluid pressure and then a few days later had a nose bleed. After, the nose bleed neck pressure was gone. Patient was not received treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
First, I had nausea. Then, I vomited 3 or 4 times, and then had some constipation. I was taking stool softeners and the I tried suppositories and nothing was working. I finally had some relief after I got home. This lasted for several days.
Swollen right arm Always develop a knot about the size of an egg Redness/ big welt around the injection site Very sore
The last time we gave this patient the PCV 13 in May, it did not flow over to database so when I looked at database on 8/4/23 it looked like he was due for the PCV 13. I gave it to him and when I went to chart it in our system I noticed that we did not have all his vaccine records in our system and that the one from May had not flowed over to database. In turn he got an extra dose of the PCV 13.
This a 89y.o. male is well known to me and we recently received a message from the facility that  was coming into the ER and that he was increasingly SOB. His  history of HTN, hypothyroidism, CAD, NSTEMI is a concern and his BP and nutritional status is a concern.    Per chart review, he was hospitalized from 11/9/21-11/12/21 for AKI and UTI. He was discharged home with home care. He has been on 4 L home O2 since a hospitalization in October. He has family members that recently tested positive for COVID. He states that he has felt SOB ever since his hospitalization in October, so he is unsure when his current symptoms started. He admits to a nonproductive cough, wheezing, and SOB. He states that he has chills currently and has rigors on exam but has not had fever or chills previously. He denies diarrhea to me but told the ED that he has had nonbloody diarrhea. He denies HA, abdominal pain, N/V, or chest pain. He states that he has been fully vaccinated "ever since they first came out with the vaccine."   ER notes reviewed and  his BP has been low and is again with BP  86/54, HR 112, SpO2 92-95% on 6 L nasal canula. His COVID-19 swab was positive and his CXR showed small pleural effusions with passive atelectasis and superimposed airspace opacities in the right lower lung. His EKG showed sinus rhythm with sinus arrhythmia and PVCs and his troponin was 0.04, 0.04. His BNP was 83. His d-dimer was > 10,000. His WBC was 13.1 but his procalcitonin was 0.05. His chest CTA was negative for a PE but showed scattered groundglass opacities in both lungs concerning for an acute infectious/inflammatory process and moderate pleural effusions with passive atelectasis. ID was consulted and he was given 325 mg ASA, 6 mg Decadron, and Albuterol.
Pt recv vax on 11/19/98; 1/2 hr later pt exp rash/hives over body & facial swelling; tx=Epinephrine -SC & Prelone syrup
injection site reaction; body aches; fever; stomach ache; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction, general body pain, fever and stomach pain. On an unknown date, the outcome of the injection site reaction, general body pain, fever and stomach pain were recovered/resolved.   It was unknown if the reporter considered the injection site reaction, general body pain, fever and stomach pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced body aches, fever, stomach ache, and an injection site reaction all of which lasted approximately 12 hours. The reporter was not calling about her adverse event, just happened to report it in passing but said she expected all these side effects so had never reported them.
On Friday, am, patient awoke with a half dollar size, slightly red, raised rash approximately 2" by 1.5" at injection site of ZOSTAVAX on her right arm. Spoke with patient to follow-up on morning of 11/4/17, and patient reported that rash is now twice the size, red, itchy and blistering slightly and appears to be spreading. Advised patient to report to an Urgent Care facility to follow-up to see if further treatment, other than OTCs are warranted.
tenderness at injection site; flat hives rash; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site tenderness and hives. On an unknown date, the outcome of the injection site tenderness and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness and hives to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband. The patient received dose of Shingrix in the right deltoid. After vaccination with Shingrix, the patient experienced tenderness at injection site and flat hives rash along bicept and tricept of right arm that has not resolved. The reporter consented to follow up This is 1 of the 2 cases reported by the same reporter.