chrisvoncsefalvay/vaers-outcomes huggingface dataset:
massive heart attack; hypoglycemic; kidney failure; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (kidney failure), MYOCARDIAL INFARCTION (massive heart attack) and HYPOGLYCAEMIA (hypoglycemic) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced RENAL FAILURE (kidney failure) (seriousness criteria hospitalization, medically significant and life threatening) and HYPOGLYCAEMIA (hypoglycemic) (seriousness criterion hospitalization). On 22-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (massive heart attack) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized until 01-Apr-2021 due to HYPOGLYCAEMIA, MYOCARDIAL INFARCTION and RENAL FAILURE. At the time of the report, RENAL FAILURE (kidney failure), MYOCARDIAL INFARCTION (massive heart attack) and HYPOGLYCAEMIA (hypoglycemic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  On 24-Mar-2021 patient had a heart surgery. Company Comment: This  case concerns a 62-year-old male patient with no details on past medical history, presented with unexpected events of Myocardial Infarction, Renal failure and Hypoglycemia , these events happened on the same day of the 1st dose of vaccination with Moderna .Patient was hospitalized and underwent heart surgery. The benefit risk relationship of  Moderna vaccine  is not affected by this report.; Sender's Comments: This  case concerns a 62-year-old male patient with no details on past medical history, presented with unexpected events of Myocardial Infarction, Renal failure and Hypoglycemia , these events happened on the same day of the 1st dose of vaccination with Moderna .Patient was hospitalized and underwent heart surgery. The benefit risk relationship of  Moderna vaccine  is not affected by this report.
vertical lines at different angles that look like neon colors happens periodically; when I touch hair it is sensitive; weird psychological sensations; cold chills and I am sitting in front of heater but it is hot outside; cold chills and I am sitting in front of heater but it is hot outside; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (vertical lines at different angles that look like neon colors happens periodically), SENSATION OF FOREIGN BODY (when I touch hair it is sensitive), FEELING ABNORMAL (weird psychological sensations), the first episode of CHILLS (cold chills and I am sitting in front of heater but it is hot outside) and the second episode of CHILLS (cold chills and I am sitting in front of heater but it is hot outside) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced PHOTOPSIA (vertical lines at different angles that look like neon colors happens periodically), SENSATION OF FOREIGN BODY (when I touch hair it is sensitive), FEELING ABNORMAL (weird psychological sensations), the first episode of CHILLS (cold chills and I am sitting in front of heater but it is hot outside) and the second episode of CHILLS (cold chills and I am sitting in front of heater but it is hot outside). At the time of the report, PHOTOPSIA (vertical lines at different angles that look like neon colors happens periodically), SENSATION OF FOREIGN BODY (when I touch hair it is sensitive), FEELING ABNORMAL (weird psychological sensations) and the last episode of CHILLS (cold chills and I am sitting in front of heater but it is hot outside) had not resolved.            concomitant and treatment drugs were not provided
Experiences waves of depression that would come on for an hour or up to a few hours at a time. Usually once or twice a day following the vaccine. After 3 weeks it started settling into feelings of depression all the time instead of these sudden waves. With the depression, I was started getting suicidal thoughts throughout this time  which worsened and is why I reached out to my doctor. I was concerned for my life and thoughts for taking it continued to increase.  Also, experienced chest tightness especially with activity and intense anxiety for a couple weeks after vaccine. The chest tightness has subsided, but I feel like my cardiac abilities are less. I get tired more easily with exercise.
Dx Headache ? Vomiting ? Nasal Congestion ? Chills ? Generalized Body Aches ? Sore Throat
adacel that was exposed to a reported temperature excursion was administered to a patient with no reported adverse event; Initial information was received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] that was exposed to a reported temperature excursion was administered to a 25 years old male patient with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 28-Aug-2023, a dose 2 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (strength: standard) at dose of 0.5 ml (lot number: U78708A, expiration date: 23-Aug-2025) via intramuscular route in Deltoid NOS for Immunization (immunisation) that was exposed to a reported temperature excursion was administered to a patient with no reported adverse event (poor quality product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event adacel that was exposed to a reported temperature excursion was administered to a patient with no reported 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.
Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). It was reported that the two vaccines were stored in the same freezer and the pharmacist "just pulled out" the wrong vaccine. The nurse then gave the vaccine though she "knew something wasn't right." The patient had no adverse event. There was no product quality complaint involved. On an unspecified date since this event the patient was correctly vaccinated with zoster vaccine live (Oka/Merck) (MSD). No further information has been requested. The patient's husband had the same experience with vaccination (WAES # 0704USA01344).
CAN'T CLOSE RIGHT HAND ALL THE WAY, NUMBNESS, TINGLING AND ITCHING.
Patient has large 4 inch swelling in area of injection on right arm with itching and pain.
developed COVID 10/06/2021 including myalgias, chills,  and confusion. Admitted to hospital on 10/07/2021. Discharged to home on room air on 10/09/2021
Swelling and pain surrounding injection site. Induration of about the size of a quarter. Pain and swelling lasted  x 10 days and resolved without treatment.
Nausea; Headache; Feeling unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 16Apr2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 17:00, the patient experienced nausea, headache and felt unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, headache and felt unwell was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Pt. developed tenderness/firmness at site of injection within 10 mins of injection - no purulence, felt SOB, took albuterol every 6-8 hrs - resolved.
This spontaneous case, initially received on 23-Nov-2016, was reported by a health professional and concerns an adult female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT56507. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the plunger rod stuck when trying to administer AFLURIA (outcome: not reported, special circumstances: medication error) and only a partial dose (AFLURIA) was given (outcome: not reported, special circumstances: underdose). The patient did not want to be given another dose. Reporter comments: The healthcare professional considered all events as non-serious.
FEELING COLD; SHIVERING; SHORTNESS OF BREATH; FEELING WARM AND HOTNESS WITH A TEMPERATURE OF 95.5; This spontaneous report received from 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, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 95.5 F. On 06-MAR-2021 08:00, the subject experienced feeling cold. On 06-MAR-2021 08:00, the subject experienced shivering. On 06-MAR-2021 08:00, the subject experienced shortness of breath. On 06-MAR-2021 08:00, the subject experienced feeling warm and hotness with a temperature of 95.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering on MAR-2021, was recovering from shortness of breath, and had not recovered from feeling cold, and feeling warm and hotness with a temperature of 95.5. This report was non-serious.
No adverse events, the vaccination was given to a 14 year old before research confirmed it's safety.
Our medical assistant had mixed 1.8mL of 0.9% NS with the Moderna Vial. Thereafter, she had given 0.5mL IM X 1 dose to the patient - left deltoid.  Moderna and DOH contacted.  Patient informed. Called patient on 8/18/2021, experienced fatigue and mild diarrhea for one day.  8/19/2021: Called patient, symptom resolved.  DOH/CDC recommendation to readminister the dose immediately in the opposite arm. Patient would be fully vaccinated 2 weeks after the final dose.   Patient has been informed and refusing the additional dose at the moment
950 am-patient had lip and tip of tongue swelling.  No face swelling.  Vitals stable.  Patient was given 50mg of PO Benadryl  10 am-patient stared with increased tongue tingling and hands shaking.  No face swelling.  Code team at the hospital called.  Patient taken to ER.  Per patient she was given IV Benadryl.  Symptoms progressed to burning throat and chest.  She was then given Epi pen.  Observed for 4 hours and symptoms improved with the exception of lip tingling.  One more dose IV Benadryl prior to discharge at 1700.  Prednisone prescribed for at home  Per conversation with patient today she was feeling back to normal.  Fatigue yesterday.  Follow up with allergist on 1/24/22
Myalgia, Fever, Chills Narrative: fever and chills x24 hrs, muscle pain x 1 week. PMH of blood clots.
Feeling weak, lips numb and tingly progressing up face and to right ear.  Hot burning sensation right side of face to right ear.  Became numb and tingly from chin to eyes within 5-10 min of shot.  Nurse game me Benadryl.  Numbness reduced within 30 minutes.  Very tired.  Slept  for 3 hours.  Woke up with headache.
Achy, flu like, feeling run down, head ache (which I rarely get),hot and sweaty. However, I can still function and work. Just feel awfully run down.
Inconsolable scream for 3hrs onset approx 4-6hrs p/vax;
Intermittent burning sensation in a circular area approximately 4" in diameter on client's right upper side between axillary and subscapular areas. Client denies erythema or other discoloration, rash, or induration; reports skin to be intact. Client reports sensation to be improving; worsened when clothing rubs against impacted area.   Initial side effects experienced starting 12/3/19 and resolved by 12/4/19 included: Feeling feverish, fatigue, erythema & induration at injection site, and flu-like symptoms.
Development of chest pain with evaluation consistent with pericarditis. Started on aspirin 325 mg BID at ED and then switched to ibuprofen 800 mg TID with colchicine 0.6 mg BID with symptom improvement after a week when seen by Cardiology and tapered off ibuprofen by July 5th with plans for colchicine to complete a 3 month course
pt states that she developed the chills and then the hives on her legs which went away.  She developed chills again and then they went away.  She woke up the next day her left arm was very sore.  The only symptom she has left is a fever.  Her temp is 100.1.  Pt is not taking any medicine but plenty drinking fluids.
I was running on the treadmill and all of the sudden my feet started tingling. I got off the treadmill to try to massage my feet. Then, I felt nauseous and vomited. After vomiting I could not move and I had very hard time walking. I noticed that my face had swollen, my throat was closing, and my vision was blurry. I also broke out in hives. Once I could get mobile (about two hours after the adverse reaction started) I took a Benadryl and that helped ease the swelling.
CLIENT CAME IN TO CLINIC FOR 2ND COVID VACCINE. SHE ANNOTATED ON HER PAPERWORK THAT SHE RECEIVED MODERNA FOR 1ST DOSE. MODERNA WAS ADMINISTERED FOR 2ND DOSE. PATIENT DID NOT HAVE IMMUNIZATION CARD ON HAND DURING VISIT. LATER REVIEW OF IMMUNIZATION RECORD IN DATABASE LISTED PFIZER AS 1ST DOSE. THROUGH USE OF TRANSLATOR, CLIENT WAS THEN NOTIFIED OF ADMINISTRATION ERROR.
pt recv vax 21FEB96 & teacher noted that pt had sz @ school (eyes rolled back & drooled) on 25FEB96;mom denies fever or hx of prev neuro problems;pt taken to pvt MD on 26FEB97;parent states that pvt MD arranged for neuro eval;
Temp 104F PM of 23JUL; 3cm of induration, not especially tender; Child is alert;
I received the Covid 19 Moderna vaccine on 5/14/2021; approximately at 6pm.  I experienced about 5 hours later adverse reactions.  I went to be around 11pm.  Upon laying down I began to get dizzy and my heart began to pound rapidly.  This strong heart pounding would last 5 hours straight. An hour later my throat started to get a tight feeling with tingling under the chin area and my saliva production began to slow drying out my mouth.  Breathing became more labored and difficult.  At this time my heart was still beating strong.  I had intense Insomnia.  The one time that I tried to lay down; when my body would try to doze off for a second; my body would suddenly jolt me awake with an intense shaking and heart pounding.
I am over 100 hours since vaccination and have no upper body strength. I used to do a set of 40 push-ups every day for years. Since Friday, March 5th , I struggle to complete ONE PUSH-UP!! I'm concerned.
Injection site was raised with a red circle about 2 inches in diameter.  oral Benadryl and topical hydrocortisone applied to site. The signs and symptoms did improve the following day.
TDAP given in left arm 7-13-2009. Pt states arm became red, hot, swollen, tender to touch. Pt started taking Tylenol on 7-14-09. Pt went to ER on 7-16-09. Doctor assessed injection site + diagnosed with cellulitis ER physician gave RX for Bactrium tid.
Had roller coaster crying for 25-30 minutes nonstop about 1 hour after administration of HIB vaccine.
No additional AE reported; temperature excursion and administered to patient; This spontaneous report was received from a medical assistant referring to a 12-month-old male patient. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 07-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot# W006412, expiration date upon internal review was established as 23-FEB-2024, dose and strength were not reported) intramuscularly in right thigh for prophylaxis at a private doctor's office/hospital, after a temperature excursion. Total time in the range of -14 degree Celsius to -10 degree Celsius was 1 hour. Total combined excursion time was 1 hour (product storage error). This adverse event was previously reported to manufacturer. No additional adverse events were provided (no adverse event).  This is one of several reports reported by the same reporter.
Low appetite; Diagnosed with central sleep apnea; high blood pressure and high heart rate; Mucus blocking windpipe; Trouble breathing at nighttime; > 35 Days past first dose; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Low appetite), SLEEP APNOEA SYNDROME (Diagnosed with central sleep apnea), HYPERTENSION (high blood pressure and high heart rate), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Mucus blocking windpipe) and DYSPNOEA (Trouble breathing at nighttime) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Low appetite), SLEEP APNOEA SYNDROME (Diagnosed with central sleep apnea), HYPERTENSION (high blood pressure and high heart rate), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Mucus blocking windpipe), DYSPNOEA (Trouble breathing at nighttime) and PRODUCT DOSE OMISSION ISSUE (> 35 Days past first dose). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency and AZELASTINE for Adverse event, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Low appetite), SLEEP APNOEA SYNDROME (Diagnosed with central sleep apnea), HYPERTENSION (high blood pressure and high heart rate), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Mucus blocking windpipe), DYSPNOEA (Trouble breathing at nighttime) and PRODUCT DOSE OMISSION ISSUE (> 35 Days past first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Blood sodium: low (Low) Low sodium. On an unknown date, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.Treatment medication  was reported as Sterile Saline 3%.
Felt generally sick.  Intestinal distress, violent BM.  Nauseous. Sweating. Then chills, vomiting, high fever of 102.1 for several hours despite Tylenol and 2 hours later aspirin. Gave fever reducers two more times. At 2:00AM fever was down to 101.1. By 8:00AM on following morning, 9/16/10 fever was normal.
No AE/PQC reported at this time; PROQUAD was involved in a prior excursion and was administered to five patients; This spontaneous report was received from a medical assistance regarding a 4-year-old patient whose gender was not specified.   Information about the patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies was not provided.  On 01-JUN-2021, a Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) was improperly stored at a temperature of 6 degrees to 14 degrees Fahrenheit (10 degrees Fahrenheit) for 7 hours. There was a previous temperature excursion from 6 to 14 degrees Fahrenheit (6.10 degrees Fahrenheit) for 1 hour and 30 minutes.   On 21-JUN-2021, the patient was vaccinated with the improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (dose and vaccination scheme frequency were unknown by the reporter; route and anatomical location of administration were not provided; with lot number T027112 and expiration date 07-FEB-2022, which were verified to be valid) for prophylaxis (product storage error). No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA000174: US-009507513-2107USA000121: US-009507513-2106USA008058: US-009507513-2106USA008067:
Within days of receiving my second Pfizer shot, I began to notice a constant ringing in my ears that never seemed to subside. It was (and still is) quite loud and virtually impossible to ignore. At first I wasn't sure if the ringing in my ears wasn't just a matter of listening to the TV too loudly (my friend tends to make a habit of this but the amount of time spent at her home is not a regular thing) but after several weeks I concluded that this was not the case. I don't use earbuds - ever - or anything else that would expose me to excessive, loud noise. It has never gone away and it is now going on 7 months.
Rash (raised red areas) under arm pits then spread to trunk and then legs. Child has runny nose and low grade fever. 7/21/10 spoke with mother. Plans to take child in to MD. Child still playing no lethargic. Rash not itchy. Other 2 children in household not vaccinated with Varicella as refused on 7/13 visit.
About 8 hours later after the vaccine,  I started to have rapid heart rate.  I record my heart rate as high as 107 bpm, as a resting heart rate. My heart rate stayed up there. I consulted my doctor and my thyroid was elevated.  I also went my cardiologist and she said my PCV was elevated.  I also saw my endocrinologist they also determined my thyroid was elevated.  I wasn't able to sleep due my heart rate being so high.  I had bloodwork and I haven't heard back from it.