chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache has consistently increased recently to a 4/10 than previously 2/10; left ventricle hypertrophy; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VENTRICULAR HYPERTROPHY (left ventricle hypertrophy), FATIGUE (Fatigue) and HEADACHE (headache has consistently increased recently to a 4/10 than previously 2/10) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VENTRICULAR HYPERTROPHY (left ventricle hypertrophy). On an unknown date, the patient experienced FATIGUE (Fatigue) and HEADACHE (headache has consistently increased recently to a 4/10 than previously 2/10). At the time of the report, VENTRICULAR HYPERTROPHY (left ventricle hypertrophy), FATIGUE (Fatigue) and HEADACHE (headache has consistently increased recently to a 4/10 than previously 2/10) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Ultrasound scan: left ventricle hypertrophy (abnormal) Heart ultrasound-left ventricle hypertrophy.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced fatigue x 3 days post 2nd dose of Moderna Covid 19 Vaccine 17 Apr 2021. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
This report is regarding a vaccination administration error, not an adverse event.  The patient received a Moderna vaccine (ages 6-11) as a booster by mistake instead of the Pfizer (ages 5-11) booster.  The dose given was 0.5 ml.
8 inch round red circle on her left arm (the site of injection); circle was warm, not hot, warmer than her skin; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2020, 5 days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On 4th September 2020, the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. Then 5 days later, the patient developed an 8 inch round red circle on her left arm (the site of injection). The circle was warm, not hot but warmer than her skin. It went away by 4th September 2020. The reporter consented to follow up
No adverse reactions, but error occurred. Patient received Pfizer Maroon Monovalent 3mcg/0.2ml for the 1st and 2nd dose, 10/6/22 & 11/23/22 and should have recieved this same vaccine for the 3rd dose.
Local rxn characterized by 9x9cm erythematous, sl. swollen, painful area on lt anterior thigh 2 days post inject-afebrile, alert, playful & active;
9/25 Patient presents to ED complaining of left sided throbbing headache 9/28 Patient presents to ED with facial droop 10/4 Patients primary care doctor diagnosis Bell's Palsy
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unspecified dates in 2015, the patients were vaccinated with doses of PNEUMOVAX 23 (administration routes, lot numbers and expiration dates were not provided), which were exposed to a temperature outside of the recommended range since an unspecified date in "early February 2015". There was no adverse events reported. This is one of several reports from the same reporter. Additional information has been requested.
PREVNAR 13 given to right deltoid. Pt caled 4 days later, c/o of sore arm, couldn't lift arm. Saw Dr. Oct 20, 2015 for arm.
Patient experienced injection site reaction 10 days post injection.  Area around injection site was oval, red, hot, and itchy.  Treated with hydrocortisone.  Did not require treatment by medical professional.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: Patient Reported Difficulty breathing. 911 was called, Patient was moved to sitting position to assess breathing. Breathing became progressively worse until severely short of breath. Epinephrine given, then EMS arrived and continued assessment. Breathing stabilized, EMS said it was likely a panic attack.
Pt feeling lightheaded post vaccine administration. BP 88/60,HR 57, O2 99%
eczema gone, unexpected benefit; This case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date), Steroids, Lotion and cream. Concurrent medical conditions included eczema.   On 3rd March 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: This case was reported by the patient. The patient would like to report a possible good side effect of the vaccine. The patient had been living with a moderate case of eczema for many years now. The patient used every cream, steroids and lotions the doctors given and some the patient bought over the counter, and nothing had worked for any length of time. The patient gave up and just resigned to a life of long sleeves and long pants. Then one day the patient was at doctor's office and asked about a follow-up Shingles shot at which time was given Shingrix. The patient did not give it another thought until a couple of days later he or she was talking to his or her daughter about this really expensive medication that son in law was given for Psoriasis and the patient looked down at legs to see eczema and it was gone. The patient looked at arms and not a spot there either. The patient started thinking about what, if anything, was different that he or she had done or taken and the only thing was that Shingles shot. Now, nearly 4 full months later and not a single mark of eczema was anywhere. The patient hope it was gone forever but, for now, could only attribute it to vaccination. The patient believed this was something that company should explore, if have not done so already. The patient stated that other might already be aware of this unexpected benefit of the shingles vaccination.
Patient received first dose of Moderna COVID-19 vaccine on 4/7/2021. Vaccine given at 0935. In the observation lot, patient noted clear colorless fluid accumulating under bandage. Fluid did not appear serous or bloody. The fluid appeared to be uninjected vaccine. We agreed to re-vaccinate patient in right deltoid. Dose given 0942. Patient observed for additional 15 min and no reactions noted.
High fever- 103.5, rapid heart beat, extreme shaking and body chills on every part of body.  feeling cold weak, and blood shot red sclera in both eyes
The patient had 2 emergency department visits for this problem.  The first visit the patient presented with urticaria.  The patient was treated with antihistamines (H1 and H2 blockers) and corticosteroids.  He was discharged home on prednisone twice daily and over-the-counter Benadryl.  He represented to the emergency department with worsening of symptoms.  The urticaria were much more diffuse and the patient also had angioedema of the lips.  There was no angioedema of the tongue or throat.  The patient had no wheezing or shortness of breath.  He was treated with H1 and H2 blockers again, IV corticosteroids and IM epinephrine.  The symptoms improved and the patient was discharged on fexofenadine twice daily, famotidine twice daily, the prednisone was increased to daily and hydroxyzine  as needed for breakthrough pruritus or rash.
sepsis; respiratory failure; Fever; Unresponsive; A spontaneous report was received from Pfizer concerning a 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory failure, sepsis, fever and sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient began to have a fever. She was sent to the emergency room for evaluation. That evening, she died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 11 Jan 2021. The cause of death was reported as respiratory failure and sepsis. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This is a case of 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sepsis, fever, respiratory failure and sudden death. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Respirtory Failure; Sepsis
Pt states sweating, weakness, localized pain to right deltoid. Symptoms occurred 10:30 approximately 30 minutes after shot given. Returned to clinic 02/16/2000 at 10:07. No treatment needed.
Post shot 2 reaction was minimal: arm soreness, headache, body ache; I submit this for the following reaction which is clearly to me relational to the Co-Vid shot(s). In about a weeks time I began to experience labored breathing. It felt similar to an oncoming asthma attack (which I have not had for at least ten years. I was taking asthma maintenance meds but have not had the need for at least five years. As though my asthma went away. I could even be up close with cats and had asthmatic reaction. cats were long a number 1 aggrivator to my asthma). Then I wondered if it was related to my CHF. Over a weeks time I became ill feeling, extreme low energy, difficulty breathing. When albuteral did not garner any improvement and I knew I was in a consistent state of poor breathing and very concerned I went to the emergency room of a nearby hospital. It was clear to me I was in uncharted waters and needed an answer. The ER physician said my lungs did not hold fluid, pacemaker was pacing properly, but lungs were a bit expanded I believe he said and his best call until I could get to a Pulmonologist was that it could be COPD. I am now on a nebulizer multiple times a day!
Runny nose, cough, body aches, headache, a lot of drainage and congestion, lost of taste and smell. Symptoms lasted about a week. Then I felt better but still had loss of taste and smell, was still coughing with lots of drainage and congestion.
started getting dizzy about a week after the shot. about two weeks after the shot the dizziness is worse. I fell at work when I was just standing by my desk when I suddenly became extremely dizzy. At home I am having to hold onto things to help with balance. I am also having headaches, tinnitus, confusion, some mild congestion, and extreme tiredness. The vaccine is the only thing thing that is different the last couple of months. None of my medications have changed. I am due for the second shot next week, but I am not getting it due to the side effects I am experiencing.
developed chills late afternoon (11-26-01); 5:00-6:00 pm increased chills, body aches, 102 fever, shooting pains t/o body with breathing-continued into 1/27-no fever as of 3:30 pm & starting to feel better. mild soreness @ both injection sites.
pt recv vax & pt placed in car & pt fell asleep;mom said pt slept until 10PM when awakened noted to move extremities & had nl breathing but could not be awakened;mom did not call until had recovered;
Vaccine received Monday morning. On Wednesday I started feeling tired and a little ?off?. By Friday I was not able to stand up I was so fatigued, short of breath, weak, tingling all over and lightheaded. My blood pressure was elevated. I felt nauseous and was not able to walk or drive until Saturday.  On Monday June 21 I began having angina and the angina episodes have continued intermittently. My menstrual cycle has also not started since I received the vaccine.
patient may have died due to the Pfizer Booster dose of the covid vaccine; Booster; This is a spontaneous report from Pfizer from a contactable consumer. A male patient of an unspecified age received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first and second dose of bnt162b2 via an unspecified route of administration on an unspecified date both as a single dose for COVID-19 immunization. On an unknown date it was reported that patient may have died due to the Pfizer Booster dose of the covid vaccine. Cardiologist that may have died was alleged to social media and he would not put too much credibility on that and states the cardiologist did die and the reporter did internet research, and he had no verification from the vaccine, but it was a claim they are after. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be request during follow-up. ; Reported Cause(s) of Death: patient may have died due to the Pfizer Booster dose of the covid vaccine
use of IPOL that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event; Initial information received on 03-Jun-2022 from other Health Care Professional regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves 6 patients who used ipol that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a  dose of suspect IPV (VERO) (batch lot U1A601M) (Unknown dosage, strength, formulation and expiry date ) via unknown route in unknown administration site for immunization.  On an unknown date the patients developed a non-serious event of use of ipol that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event use of ipol that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Moderna Vaccine- patient had allergic reaction- 12 minutes later from receiving vaccine, began to feeling hot and started fanning, denied any SOB, no wheezing noted. B/P 142/83 HR 105. Benadryl liquid 25 mg given. Enroute to ED employee became nauseated and gaging. HR 113 at ED, coughing more, was treated in ED with Solumedrol and Pepcid prior to discharge
Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included erythromycin, solution, topical.  On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized.  On 05-AUG-2008, the patient experienced myocarditis and died.  Diagnosis was myocarditis but the doctor said it was not related to GARDASIL.  The last time she was seen in this office was 2005.  No additional information at this time.  Additional information has been requested.  10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor.  9/22/08 Reviewed PCP medical records.  Reveals patient experienced abdominal pain, chest pain & aching everywhere.  Expired 8/5/08 w/viral infection of the heart.  Concomitant med was erythomycin topical solution for acne.  Patient noted to be in good health on day of vaccination.  4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days.  Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB,  respiratory distress w/hypoxemia, azotemia,  shocklike symptoms.  EKG w/diffuse ST changes & ST elevations.  Dx w/acute anteroseptal MI  Emergent cardiac cath revealed EF 23% & balloon pump placed.  Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed.
C/O being dizzy/weak.  B/P 132/62, color pale, diaphoretic.  Had worked outside all day, overheated, not drank fluids.  Alert, no pain at injection side or other side effects.  Given 2 bottles of water & Gatorade, and crackers.  Walked around, color improved, stated "I feel much better".  B/P 124/74.  Left with s/o as driver.  Instructed to rest, continue with fluids, contact primary care provider if and further symptoms occur.
Inflamed, hard and red welt about 3" x 2".  Went from very tender to itchy. Have never had a reaction to any vaccination. This was the first Moderna vaccination. The rest have been Pfizer with no reaction.  I am on day three and it is finally starting to get better. It was nasty enough friends and family were encouraging me to report.
May 10th, 103+ fever and signs of dehydration observed out of nowhere.  Watched into the evening, with worsening conditions, took to ER by 7am on May 11th.  Went from fully functioning adult to sudden and complete muscle loss within 24 hour period.  No control over motor functions, unable to walk, talk, stand on own.  Watched in ER for almost 10 hours, ran several tests but couldn't determine anything, diagnosed with dehydration and fatigue and sent home that evening, told to alternate Tylenol and IBprofen to reduce fever, rest and return if symptoms not better after 7 days.   Fever of 103 persisted, no muscle control persisted, could barely walk to restroom, sit to eat minimal food and by May 18th took back to hospital as 103+ fever was still persisting.   After more blood tests, chest x-rays, and monitoring, decided to admit to hospital as slight infection was observed in prostate.  Fluids given, more tests, and more aspirin/IBprofen but not much change in symptoms.  By May 20th, discharged from hospital with 21 day antibiotics (for prostate inflammation/ possible infection) and physical therapy prescribed at home.   Fever began to dissipate after an additional 10 days on antibiotics and muscle control returned slightly after the first 4 sessions of physical therapy (2 weeks).  Took an additional 2 weeks of physical therapy, daily exercise routine, and mostly sleeping all day to gain any motor control back and begin to feel even a little stronger.  By mid-June, able to walk half way around the block and by mid-August able to walk around the block 2x a day.  Prior to these events, walked routinely all day with no issues.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.