chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient cried all day Friday after shots. Then he went to sleep at 7PM. Patient woke up crying, and continued to cry while feeding. Patient slept through the night. Then woke up Saturday morning and went back to sleep at 11AM. Patient woke up crying and stopped breathing upon arrival to hospital with swollen legs & arms. Transported via car. Patient was transferred. 1/18/08 Reviewed vax record which confirms RO dose & lot as reported. 3/5/08 Reviewed hospital medical records of 1/7-1/15/2008 which reveal patient experienced lethargy, hypothermia, apnea & respiratory failure.   Had been seen in outlying ER where rectal temp was 92.3 & O2 sats was 82%.  Parent admitted to feeding large amounts of H2O in addition to formula.  Intubated in outlying ER, septic w/u initiated & started on IV antibiotics prior to transfer.  Admitted to PICU where exam revealed small thin patient w/coarse breath sounds, cool periphery & lethargy. Consults done: ophthalmology, endocrine, PICU, nutrition & MSW.  Extubated w/o & restarted feeds w/o difficulty.  Progressed well & d/c to care of maternal cousin to f/u w/pcp & endocrine. FINAL DX: failure to thrive; hyponatremia; hypothermia; & respiratory failure. 3/7/08 Reviewed ER medical records of 1/6/2008 which reveal patient experienced cough, lethargy, listless, apnea spells, accessory muscle use, retractions, decreased air movement & breathing difficulty.  Pulse ox 85%.  Rectal temp 92.3.  LP done. Tx w/IVF, IV antibiotics & intubated prior to transfer to higher level of care. ER Final DX: fever, sepsis, hyponatremia, hypotension, bradycardia.
Metallic taste in mouth, Diarrhea, Gas, Vomiting, Dizziness, Felt warm but no fever, head ache
pt devel progressive numbness & tingling of extremities;progressed to limbs (weakness);
Severe burning sensation when injected. Extremely sore arm once injection removed. Directed to park car for to be monitored for 15 minutes. Parked the car. Car was in park but still running. Attendant at the clinic instructed me to move my car forward. I put the car in Drive and as I moved forward I lost consciousness. Completely blacked out. Unconscious in the car, the car carried on moving forward and crashed in parked car. I came to once someone tried to wake me up. Presently have no smell and have been very tired with the chills. I was sweating in my sleep, shivering and woke up in a wet bed from all my sweat. The next day I am just weak.
There was no adverse event noted, patient was monitored for 30 min post injection.  Vitals at shift changes and no abnormalities were noted.   Reason for report is to document that this patient had Pfizer vaccine on 12/29/2020 and 1/19/2020 to complete their vaccine course.  Moderna was administered on 5/13/2021 but there have been no adverse events noted. (6/1/2021)
Began with itching at injection site, some redness; anxious. No issues breathing/swallowing. c/o heart racing, "whoosh" as sat down after vaccine. Recent visit to MD for heartburn/stomach issues and high BP. Patient notes high anxiety of late/re: vaccine. Gave 25 mg po benadryl. BP 148/90; HR 120; p ox 98. Rapid response called; to ED for further monitoring.
Pt c/o weakness, HA, dizziness, and Nausea.  BP 121/76, HR 112, RR 22 -- > HR 98 -- > 108/62, 90.  Patient stable and released from vaccination site.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol
Patient was given J&J on 8-10-21 and when Shots was pulled up to enter information it was discovered that she had already recived (2) doses of Moderna in Jan & Feb of this year. I asked her if the profile I showed her on shots was correct and she admitted that yes she had received the Moderna already. I called her on 8-11-21 to ask how she was feeling and she stated she was not having any side effects. She again apologized for not being forthcoming the previous day and admitted she was wrong for doing this.
Patient came in to get 2nd Pediatric Pfizer dose. Patient received 0.2ml of Pediatric Pfizer dose from expired vial, which was reconstituted more than 12 hours prior to injection.
BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple female patients of unknown race and ethnicity.  No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported 1 total, administered 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 consumer mentioned that women were having blood clots from the covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210840534-Covid-19 vaccine ad26.cov2.s-Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Expired Product Used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 05-OCT-2023, the patient received Twinrix. On 05-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired Product Used).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter reported that the vaccine was administered by someone else and the reporter did not had any patient information at the time of call. The vaccine administration facility was the same as primary reporter. The patient received Twinrix vaccine which was already expired, which led to expired vaccine used. The reporter did not consent to follow up.
No other adverse events reported; seven doses of improperly stored GARDASIL 9 were administered to 7 different patients; This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-MAR-2022, the patient was administered improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 dose, lot number: U008899, expiration date: 12-AUG-2023 (strength, dose, formulation, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The vaccine was improperly stored at 33.4 degrees Fahrenheit for 2595 hours. There were no previous temperature excursions reported. No other adverse events reported (no adverse event).  This is one of seven reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007997:02134086 US-009507513-2203USA007825:02134097 US-009507513-2203USA007812:02134094 US-009507513-2203USA007915:02134094 US-009507513-2203USA008053:02134093 US-009507513-2203USA008097:02134087
Acute exacerbation of amyopatis dermatomyositis.  Prominen heliotrope rash and swelling of eyelids, "shawl" sign eruption, scalp dermatomyositis flare
Digestive issues, dry eyes and skin and hair, tachycardia , brain fog  I.e. processing and memory complications.  Thyroiditus. These are the symptoms I had with long haul and they have been exacerbated with the vaccine.
Information has been received from a physician assistant concerning a female who was vaccinated with GARDASIL 0.5ml. Subsequently the patient experienced rash down her arm. On an unknown date, the patient recovered from rash down her arm. The patient sought unspecified medical attention. Additional information has been requested.
pt recv vax & 45" later exp severe flushing & coughing, hypotension;
episode observed by babysitter;pt was well until this time when looked gray colored across the bridge of nose;seemed to gasp for air, stared;lasted only for few seconds;nl since then;adm to hosp x 2 days for observation;no tx
Developed trigeminal neuralgia.  Went to dentist after first and second shots.   After third Moderna shot on 8/14/21 the symptoms became significantly worse.  Was diagnosed with trigeminal neuralgia and now taking medication to control the neuralgia.
Diarrhea approximately 4-6 PM 1 day x 2 wks after 1st ROTATEQ.  Resolved without treatment.
Very swollen lymph node near collar bone on right side, so far lasting more than 2 weeks after first dose (is currently visibly swollen).; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8729) via an unspecified route of administration in the right arm on 09Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. The patient had received concomitant medication within two weeks of vaccination which included birth control pill (unspecified) on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced very swollen lymph node near collar bone on right side, so far at the time of report lasting more than two weeks after first dose and was currently visibly swollen. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event very swollen lymph node near collar bone on right side, so far at the time of report lasting more than two weeks after first dose and was currently visibly swollen was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
I feel a little dizzy sporadically; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I feel a little dizzy sporadically) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I feel a little dizzy sporadically). At the time of the report, DIZZINESS (I feel a little dizzy sporadically) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I am reporting that I had a Rebound and retested positive) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Drug allergy. Concomitant products included ATORVASTATIN for an unknown indication. On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced COVID-19 (I am reporting that I had a Rebound and retested positive). At the time of the report, COVID-19 (I am reporting that I had a Rebound and retested positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative, Tested negative on two antigen tests on 2 consecutive days around day 10, negative (Negative) Negative, Tested negative on two antigen tests on 2 consecutive days around day 10, positive (Positive) Retested positive and negative (Negative) Negative, also negative PCR test A few days later. The birth date of patient was reported as unknown of JUN-1949. Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 25-May-2022. Company comment: This is a spontaneous case concerning a 72-year-old female patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date on the next month after the 4th dose of mRNA-1273. It was reported that the patient had a Rebound. Tested negative on two antigen tests on 2 consecutive days around day 10 and also negative PCR test. A few days later she had mild sneeze symptoms, and retested positive. The patient had completed 5 days treatment with Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 72-year-old female patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date on the next month after the 4th dose of mRNA-1273. It was reported that the patient had a Rebound. Tested negative on two antigen tests on 2 consecutive days around day 10 and also negative PCR test. A few days later she had mild sneeze symptoms, and retested positive. The patient had completed 5 days treatment with Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Approximately 4 hours after recieving H1N1, pt. began to experience muscle jumping and tremors in both lower extremities, unable to ambulate without being entirely supported. Upon arising the following morning reported nausea, vomiting with abdominal discomfort and severe vertigo. Admitted as inpatient to Hospital for management of symptoms and IV fluids.
The night/next morning after receiving the vaccine I was awoken by a racing heart rate that I measured at a resting heart rate of 200 bpm. After 5 minutes of trying to assess what was happening, I recognized that my heart rate was not slowing down. I woke my wife because I was worried and had difficulty breathing. It continued to be in the 180-190's, I called an ambulance. On the way to the hospital my resting heart rate was 180. After I got to the hospital they ran blood work, a CT scan and a chest x-ray. I was in the hospital until 10 am. My heart rate steadily fell to about 110 beats per minute after 9 hours in the hospital. They released me because my tests had come back normal. Upon being released, I came home, had lots of fluids and rest. After 1 week, my heart rate went back up to 160's. My chest started to feel tight again and I had difficulty breathing again. I called my PCP emergency number and they advised me to go back to the ER at 10 am on 05/15/2021. They did another EKG, a D-Dimer and I received saline. My heart rate dropped to 120 and they released me. I was given an all clear from all tests performed. Sunday-Wed that week, I had a slightly elevated resting heart rate, have had difficulty getting a full breath, general stomach pains and I had felt fatigued. Thurs-Sat, my resting heart rate returned to normal (60 bpm) minimal difficulty breathing, but continued pressure in my abdomen and chest. Saturday I fell asleep because I was having a migraine. I woke up at 10 pm and the cycle started again. My heart rate went back up into the 160's. I called the emergency line for my PCP and was told to go back to the ER (05/22/2021). They performed a chest x-ray, an EKG and some blood work. My resting heart rate went to 90 bpm around 3 am and was sent back home. The rest of Sunday, I had difficulty getting a full breath and my resting heart was higher than usual. I had an echocardiogram on Wednesday and it came back normal. I wore a heart monitor for 24 hours, but I have not received the results yet from my doctor. I have never experienced any sort of cardiac episode in my life.
felt chest heaviness, funny sensation in throat almost immediately after injection. checked blood pressure, monitored for 30 minutes with resolution of symptoms.
BONES HURT; SO TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced bones hurt, and so tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bones hurt and so tired was not reported. This report was non-serious.
Got vaccine Saturday night. By Tuesday, he had stabbing heart pain and shortness of breath when running for cross country. I have him IBProfin.
PT PRESENT TO THE CLINIC ON THE 17OCT2017. PT STATED THAT AFTER HIS VACCINE HE DEVELOPED A BLISTER AND WANTED TO KNOW IF THAT WAS NORMAL. PT STATED HE HAD NO OTHER SIGNS OR SYMPTOMS.
2 days after varicella injection developed swelling and redness at injection site and from shoulder to elbow. Seen by ER provider. Dx = cellulitis.
Total loss of hearing in left ear. 3 week prednisone treatment, no change, ct scan. no cause found.
Patient  presented with abdominal pain, nausea and malaise. She was diagnosed with acute idiopathic pancreatitis 2 days after 1st moderna vaccination. Imaging of gall bladder is normal. Triglycerides are normal. No offending medications identified.
erythematous rash to let leg 24hr p/vax; tx w/ice packs;
pt recv vax 9AM 9AUG96 & sister called 1030AM states pt has hives on rt arm w/no other problems;pt is told to come in MD gave instructions;pt to take DPH elixir q 8hr;apply ice pack, watch for 4 to 5 days & take APAP if fever occurs;rash
Extreme flu like symptoms. Bed bound for two days (so far). The whole bicep on the left arm is swollen and red and hot. Splitting headache. Skin all over my body hurts to the touch, not just the injection site. A sharp shooting pain through my left bicep (injection site) multiple times a day.
Patient did not experience any adverse events related to the vaccine.  Upon presentation the patient both written and verbally denied having received a prior COVID-19 vaccine of any kind.  She was administered the Janssen vaccine.  Upon processing the vaccine, it was discovered that she had actually received the first dose of the Pfizer COVID-19 vaccine on 5/17/21.  She never received the 2nd dose to complete the series and upon questioning as to why she had not disclosed this information to pharmacy staff, the patient stated because it had been more than 30 days since that vaccine had been administered she didn't think it mattered to disclose that information.  Thus the patient was administered a Janssen COVID-19 vaccine outside of our protocol and the current recommendations of the FDA and CDC.
Client received HPV vaccine that expired on 07/27/2021. Client did not have any complications.
pt recvd vax & 3 days p/vax exp severe joint pain which resolved in 5-7 days;
Date reaction started is approximate.  I had a lot of small itchy bumps appear around the injection site on my left arm that over the span of a week or so, popped and then scabbed over. They were like little pimple blisters with fluid in them where my left arm kind of felt like sandpaper when you rubbed your hand over it, versus a smooth arm on my right.
huge hematoma moved down in to the wrist; huge lump at patient's injection arm; arm was painful; arm became black in color; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMATOMA (huge hematoma moved down in to the wrist), VACCINATION SITE MASS (huge lump at patient's injection arm), PAIN IN EXTREMITY (arm was painful) and SKIN DISCOLORATION (arm became black in color) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure inadequately controlled. Concomitant products included METOPROLOL and LISINOPRIL for Blood pressure inadequately controlled, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (BABY ASPIRIN), IRON, LEVOTHYROXINE, VITAMIN D3, FUROSEMIDE (LASIX [FUROSEMIDE]) and NAPROXEN for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE HAEMATOMA (huge hematoma moved down in to the wrist), VACCINATION SITE MASS (huge lump at patient's injection arm), PAIN IN EXTREMITY (arm was painful) and SKIN DISCOLORATION (arm became black in color). At the time of the report, VACCINATION SITE HAEMATOMA (huge hematoma moved down in to the wrist), VACCINATION SITE MASS (huge lump at patient's injection arm), PAIN IN EXTREMITY (arm was painful) and SKIN DISCOLORATION (arm became black in color) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included application of a cold compress over the hematoma. The patient contacted her physician on 05-Apr-2021 who advised the patient to apply cold compress over the hematoma.
PATIENT STATED SHE WAS HAVING CHILLS WITH NO FEVER, ACHES AND PAINS, AS WELL AS SHE FELT PRESSURE IN HER CHEST.
A 90 y.o. male patient of, CNP with history of CKD, Parkinson disease, HTN, HLD, and recent COVID infection presented with weakness, cough. Left lower lobe pneumonia, possible aspiration. Sepsis present on admission due to pneumonia. CTPE showed no PE but showed mucous impaction with left lower lobe opacity Patient has improved clinically, he tested positive for COVID infection and is on isolation for total of 10 days before he can be transitioned to skilled nursing facility.  Anticipated discharge date is October 22. Completed course of Rocephin and azithromycin during hospitalization last dose 10/19. Patient has generalized weakness, continue physical and Occupational Therapy. Speech therapy evaluated, at risk for aspiration and started precautions, instructed his wife at bedside today. CKD stage 3; Anemia, stable. Serum creatinine 1.6 on admission. Lower than previous on record Continue to monitor blood chemistries, repeat on 10/22; Hgb stable, follow up as outpatient HTN; Continue Norvasc; Continue hydralazine as needed. Parkinson disease with related dementia, hallucinations, and delusions. Continue Aricept, Namenda, and Sinemet.
FEVER LAST NIGHT 103.1 AUX, RED SPOT ON THE INJECTION SITE