chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suicidal ideation; Mouth blisters; Anxiety; Depression; Insomnia; Major changes in mood, demeanor and thought; Irrational behavior; Took his own life Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of COMPLETED SUICIDE (Took his own life Apr2021) and SUICIDAL IDEATION (Suicidal ideation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced COMPLETED SUICIDE (Took his own life Apr2021) (seriousness criteria death and medically significant). On an unknown date, the patient experienced SUICIDAL IDEATION (Suicidal ideation) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (Mouth blisters), ANXIETY (Anxiety), DEPRESSION (Depression), INSOMNIA (Insomnia), MOOD ALTERED (Major changes in mood, demeanor and thought) and BEHAVIOUR DISORDER (Irrational behavior). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) at an unspecified dose and frequency. The patient died in April 2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, SUICIDAL IDEATION (Suicidal ideation), ORAL MUCOSAL BLISTERING (Mouth blisters), ANXIETY (Anxiety), DEPRESSION (Depression), INSOMNIA (Insomnia), MOOD ALTERED (Major changes in mood, demeanor and thought) and BEHAVIOUR DISORDER (Irrational behavior) outcome was unknown.            No concomitant medications were given by the reporter.   Patient went to the hospital to have these side effects checked for about 5 times. He was diagnosed to have Depression, Anxiety, Insomnia, and Suicidal Ideation and was prescribed with Vistaril.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death
AT  APPROXIMATELY 48 HOURS POST RECIVING VARICELLA VACCINE, A RED, WARM AREA APPEARED ON SURFACE OF RIGHT ARM WITH ITCHING COMPLAINTS. PARENT STARTED OFFERING IBUPROFEN AND BENADRYL ORALLY AS DIRECTED BY PACKAGE INSTRUCTIONS.  BY 72 HOURS AFTER RECEIVING SHOT, AREA HAD INCREASED TO DIAMETER SIZE = SOFTBALL, WITH TENDERNESS AND ITCHING. TO ER 8/9/07, RX GIVEN
Left arm pain, axillary adenopathy, fever 106, hands numbness, bodyaches
Patient was given a Pfizer pediatric dose by mistake.  Event was corrected by giving the adult dose immediately afterwards.  Patient presented on 1/20/22 to clinic with complaints  of not feeling well with nausea/vomiting
Patient presents to ED with a 3 day history of shortness of air and productive cough with blood tinged sputum. Pt reports her roommates have been treated for bronchitis this week, but she was not aware that any of them had tested positive for COVID. Pt does not use supplemental O2 at baseline. She endorses chills, but has not had fever. She denies any bright red blood in sputum, or large volume bleeding.  Constitutional:  Positive for chills. Negative for activity change, fatigue and fever.  Respiratory:  Positive for cough and shortness of breath. Negative for chest tightness and wheezing.    Hospital course:  #Acute hypoxic respiratory failure 2/2 SARS CoV2 pneumonia and COPD exacerbation - RESOLVED. - Pt. O2 sat stable on 2 liters NC. VBG 7.41/32/51/87.  - CXR showing interval development of diffuse groundglass opacity through the left hemithorax and right lower lobe - Afebrile with WBC (10), procal minimally and CRP pending, d-dimer (1.18) PLAN: - sputum cx pending  - 08/24: s/p solumedrol 125 mg IV x 1 in ED  - 08/24: starting Remdesivir x 3 days and dexamethasone 6 mg PO daily x 10 days   Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
I developed a moderate continuous frontal headache all afternoon on 10/17/2015.  I felt as though I was feverish, but temperature was normal. As the day progressed, I developed generalized aching in my legs and neck (but I also have arthritis and am on a steroid burst).  In the evening developed abdominal feeling of impending diarrhea.  Had a loose stool before bedtime.  By 5am on 10/18/2015 I was having hourly or less episodes of moderate diarrhea.  I was unable to eat or drink, slept all day except to get up to have diarrhea. I wasn't in pain, just so sleepy.  I felt cold and used heated blankets.  I did NOT have fever or shaking chills throughout any of this.  I was dizzy and felt so weak on 10/18/2015 from the continuous diarrhea episodes.  My last episode was 8pm 10/18/15.  Today, 10/19/15, I awoke feeling just a slight headache (may be from slight dehydration and caffeine withdrawal of yesterday).  I had one soft loose BM this am, but can tell by my body that this will not be diarrhea.  I am drinking coffee and fluids and feel stronger with totally resolving symptoms.  My major side effect not listed in your symptoms article was significant diarrhea, with potential for dehydration.  I am a nurse, did not need treatment.  MD office not imformed, as it was a weekend.
Janssen COVID-19 Vaccine EUA Shivers and a low grade fever developed at nighttime (around 11 pm), followed by headache. Acetaminophen (500 mg) taken at 4 am. Symptoms subsided by 11 am.
Case number PHEH2014US025119, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 49-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this administration (incorrect storage od drug).
after second dose, erratic period for 3 months; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP6955) via intramuscular route of administration on an unknown date in Apr2021 (age at vaccination: 30 years) in left arm (at 30-year-old) as dose 2, single dose for COVID-19 immunization. Medical history included penicilin allergy from an unknown date and unknown if ongoing. It was mentioned that patient did not receive any other vaccine in four weeks, no medications in two weeks, the patient was not diagnosed with COVID-19 prior to vaccination and the patient had not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient previously took lactose and experienced lactose intolerant-drug allergy and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP6955) via intramuscular on 23Mar2021 at 11:30 AM in left arm (at 30-year-old) as dose 1, single dose for COVID-19 immunization. On 14Apr2021, the patient experienced after second dose, erratic period for 3 months (medically significant). The patient administered COVID-19 vaccine at Workplace clinic. The patient did not take treatment for the event. On an unknown date in 2021, the outcome of the event was recovered.  Follow-Up (12Jul2021): Follow-up attempts were completed. No further information was expected.
Patient with history of food allergy with throat tightness/sore throat symptoms at baseline (only required epi pen once due to exercising after food). Developed similar symptoms 5 minutes after Pfizer dose 1 lot# EN6205. Initially became more tachypnea with "ball stuck in throat" but improved  after observation for 45 min. Exam with no wheeze/stridor. VS with BP 131/60-- >129/84 O2 sat 100% throughout.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 18-OCT-2013 the patients were vaccinated with M-M-R II lot number H011907. Dose, route and frequency were not provided. On 18-OCT-2013, the patients were vaccinated with M-M-R II stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Received the 1st dose of Moderna vaccine in error due to child is under 18 y/o; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-May-2021 and was forwarded to Moderna on 09-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st dose of Moderna vaccine in error due to child is under 18 y/o) in a child patient of an unknown gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st dose of Moderna vaccine in error due to child is under 18 y/o). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st dose of Moderna vaccine in error due to child is under 18 y/o) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.
Patient complained of being dizzy and then suddenly developed headache and chest tightness approximately 10-15 minutes after vaccine (Moderna) given. Blood pressure 152/100, pulse 89 bpm, 98% O2 room air, and 18 resp. Cot was brought over and client placed in lying position. Blood pressure 144/108, pulse 82 bpm, and 18 resp. Patient remained alert and oriented. Patient spoke to staff appropriately. EMS arrived at 1405 - Report given, patient transferred via stretcher to ambulance.
Itchy red raised warm  firm area swelling just at and below injection site.  4 inch circle On early morning 8th day.
Temp of 101.8, severe body aches, chills, fatigue, headache for 36 hours body aches, headache, fatigue and temp below 100.8 for 8 hours.  Injection site swelling, redness and pain for 72 hours
Dizzy. Tired. Sore arm. Ache. Itchy eye watering. Sore bones. Chills.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history was reported. On 11-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 second dose (Lot#, dose, route were not reported) for an unknown innidiation. No concomitant medication was reported. The first dose of PNEUMOVAX 23 was given on an unknown date. On 11-NOV-2014, 2nd dose of PNEUMOVAX 23 administered inadvertently a few weeks later. No adverse effects were repotted. No product quality complaint was involved. Additional information has been requested.
Pt called on 12/15/2014 asking how long does the pain last for Zostavax.  I responded a few days.  Pt said she received Zostavax shot on 11/3/2014 and she is still having pain on the arm she received the shot (not at the injection site).
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild
Non Hodgkin's Diffuse Large B-Cell Lymphoma. This letter is in regards to Number 7 on the Reporting System questionnaire. I was diagnosed with Non Hodgkin's Diffuse Large B-Cell Lymphoma on March 21, 2011. I believe the onset of this disease is somehow linked to the flu shot I received on October 3, 2010. I do not know if it directly caused the lymphoma or if something was going on with my immune system that interacted with the flu vaccine that set off the lymphoma, but I believe they are connected. I distinctly remember, as well as friends and family noticed, that I just never felt quite right last fall. I would always reference my flu shot, saying "I just haven't felt quite right since my flu shot". I caught every cold and virus that would pass by. I was tired all the time and just had general feeling of malaise. Prior to this I was extremely healthy. I did not go to the doctor with any of this, I just passed it all off on being too busy, not taking care of myself, or I just don't know what. By February I was really not feeling well. I did go to my doctor and was on a couple rounds of antibiotics and still felt poorly. My doctor did a chest xray on March 21, 2011 and they saw something suspicious so ordered a CT scan. The CT scan showed a 10 cm mass in my left lung that invaded the mediastinum and narrowed the left main pulmonary artery and left mainstream bronchus. It also showed multiple renal masses. A biopsy showed Non Hodgkin Diffuse Large B Cell Lymphoma. After several more tests my chemotherapy began on April 1, 2011. I have done some research on lymphoma and discussed with my doctor possible causes of lymphoma, especially since I am not the typical candidate to contract lymphoma. I keep coming back to the fact that I can pinpoint the day I began to feel poorly. I asked my oncologist if he thought there could be any correlation and he did not really know. He did state that the timing would be about right for the stage of my disease and the date of my flu shot. I just thought someone should be aware that this link might possibly exist in my case. Truthfully, there is no doubt in my mind, that in my case, they are somehow linked together. I appreciate the opportunity to report this.
I received the vaccine in the left upper arm within 2 finger breaths of the shoulder. Noticed discomfort in the shoulder within one hour following the vaccine. The discomfort continued to worsen extending down the arm. It became extremely painful to move the arm and specifically certain pulling or pushing motions such as pulling a shirt off  over my head. The discomfort continued to worsen for 3 days and then began to subside after the third day. Today is day 5 following the vaccine. I continue to have discomfort with pulling and pushing motion however much improved overall.
Mom noted pinpoint rash on abd on 4FEB; by evening had generalized raised, hive like rash; Seen by MD-MD unsure if react secondary to vax or allergic rxn to another item;
urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (urticaria) in a 32-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced URTICARIA (urticaria) (seriousness criterion medically significant). At the time of the report, URTICARIA (urticaria) had not resolved.            No concomitant drug information was provided. No treatment drug information was provided.  Company comment: This case concerns a 32-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Urticaria. The event occurred at an unknown interval after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after the booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 32-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Urticaria. The event occurred at an unknown interval after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after the booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Patient received Pfizer #1 on 3/18/21. Patient registered for second dose Moderna pod on 4/9/21 Contact was attempted and unsuccessful on 4/8/21 to inform patient she had registered for the wrong pod. Patient came to Moderna pod on 4/9/21 and inadvertently received Moderna as her second dose. Patient was observed for 30 minutes for any reaction . After her observation waiting period patient was feeling fine and no reaction noted and patient was allowed to leave. Advised to seek medical care if any symptoms develop.
It started extreme shortness of breath for a long time even before, it started bad around 10 Jul 2021 and then the pain in my chest started with adding into it on that evening of 10 Jul and 11 there was a burning pain that extended out arms. Out of breath and it hurts by any activity and in the middle of the night on the 12 Jul, it caused me to go to the ER on the 13 Jul.
Imms given mid - day 10/5. Returned to clinic late aft. with left thigh red and hot to knee and crying inconsolably. TYLENOL was given at home. MOTRIN given in office with instruction for BENADRYL and cold compresses. Still crying on departure from RR 10/6 without further s/s. No additional meds were required. Slept well.
When the patient got sick she got a rash that didn't itch all over her body; Chills; aching; fever; This is a spontaneous report from a contactable other health professional (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 06:45 AM at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was no. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unknown lot number and expiration date), via an unspecified route of administration on 18Dec2020 06:30 AM at left arm, at single dose for covid-19 immunization. The patient experienced chills, aching and fever 10 hours later at 08Jan2021 18:30. When the patient got sick she got a rash that didn't itch all over her body and it happened 24 hours after the vaccine, on 09Jan2021. No treatment was received for all events. The outcome of the events was recovering. Prior to 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 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  Information on lot number/batch number was requested.
Initially the patient was injected; however the plunger would nor depress, so absolutely no vaccine exited the vial. The needle was retracted from the patient's arm and there was no evidence of vaccine exiting the syringe. A new dose was prepared and the patient's arm was swabbed again with an alcohol wipe and the vaccine was administered with no problems. About 2 weeks later the pt. came in complaining of arm pain and eventually saw her doctor and he stated the shot should not have been given in the muscle (according to the pt., which is completely untrue). As a side note the pt. was very frail and didn't weigh very much. I spoke to her on 11/23/2018 and told her we would contact the manufacturer to inquire if any other adverse reactions were attributed to the, aforementioned, lot number. We have to call them on 11/26/18 when they open.
She has lost the range of her left arm [and no longer to extend the arm due to pain]; Her arm was very painful after the administartion of the vaccine and gradually got worse; This is a spontaneous case initially reported by other non-health professional to Company (reference number: SEQ19-05254) on 22-Oct-2019 concerning a female patient of unspecified age.   The patient's medical history and concomitant medications were not reported.   On 02-Oct-2019 the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported] for prevention of seasonal influenza.  On the same date, an unknown amount of time after vaccination, the patient's arm was very painful and gradually got worse.  On an unspecific date, the patient had lost the range of her left arm and she could no longer extend the arm due to pain.  The outcome of the events was not reported.   The reporter assessed the case as serious and did not provide causality assessment.  Company comment: The patient experienced vaccination site pain and injected limb mobility decreased, after administration of the suspect vaccine Flucelvax QIV. Chronology is plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient experienced vaccination site pain and injected limb mobility decreased, after administration of the suspect vaccine Flucelvax QIV. Chronology is plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.
pt recv vax 22NOV96 9AM & had temp of 102-103;APAP & Ibuprofen given throughout day, along w/DPH because of prev mild rxn;temp down to 100-101;site red, swollen w/rash;530PM began to c/o severe stomach pain & began to vomit;c/o muscle pain
Rash and itching developed over arms, legs, neck, trunk, stomach, crotch, scalp. Persisted for weeks and would not abate with several prednisone treatments. Blisters arose at each point of irritation along with red splotches. Begins with burning, then itching, followed by visual eruption. Inflamed sites are hot and swollen. About 15-25% of body affected at any given time, mostly upper body and arms. Rashes moved over time to various locations.    Patient began to feel badly around June 15 2021, with symptoms including: extreme weariness, novel tinnitus, severe itching an burning at night, novel severe brain fog and confusion, inability to drive or accomplish household tasks, novel ocular migraines/loss of vision, headache, loss of appetite.