chrisvoncsefalvay/vaers-outcomes huggingface dataset:
two bouts of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (two bouts of diarrhea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021, the patient experienced DIARRHOEA (two bouts of diarrhea). At the time of the report, DIARRHOEA (two bouts of diarrhea) outcome was unknown. Not Provided          no concomitant medications reported. no treatment details reported.
Severe hives on face and chest lasting longer than 4 hours; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 12:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history include sulfonamide allergy(sulpha based antibiotics). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included birth control taken from unknown date. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 12:45, the patient experienced severe hives on face and chest lasting longer than 4 hours. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe hives was not resolved at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-AUG-2015 the patient was vaccinated with two improperly stored doses of RECOMBIVAX HB 5 microgram/0.5 mL(lot # J009051, expiration date 26-MAR-2016, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion twice. The total cumulative excursion time was 24 hours and 32 hours. The lowest recorded temperature was 34 Celsius degree. The highest recorded temperature was 48 Celsius degree. The storage criteria of the vaccine and the type of excursion were refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
The day after receiving the vaccination, I was very uncoordinated. I had trouble walking a straight line. Very dizzy. It was hard to form words to make sense. I was very tired, thirsty and nauseated. It comes and goes but still persists. Worse in the mornings. Very uncomfortable feeling.  My sentences are coming out clearer, but I cannot hold a coffee cup without it jerking out of my hand. My muscles just do as they please. This has been going on for a week. I cannot text or type because the muscles in my fingers just go wherever they please.
No additional AE/no PQC.; HCP calling to report AE for MMRII being given after its expiration date.; This spontaneous report was received from a medical assistant and referred to a 49-year-old female patient. The patient's concurrent conditions, pertinent medical history and drug reactions/allergies were not reported. Concomitant medications included sterile diluent.   On 06-JUL-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (therapy type: Albumin status rHA (recombinant Human albumin)), 0.5 milliliter, lot #U011149, expiration date: 08-APR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). Product has had no previous temperature excursions. Patient had no side effects reported. No additional adverse event (AE) (No adverse event).
Positive for COVID-19 infection - fever, myalgias, chills, cough and SOA. Received monoclonal antibody infusion
Narrative: 59yo homeless patient in mental health care died of unknown causes on 10/27/2021 in his home found by family. Patient had received covid vaccines on 2/6/21 & 3/9/21. Unable to assess if vaccines related to this death, however given long length in between death and vaccine admin date, likely this death is not related to the covid vaccines.
Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient herself).  This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201), via intramuscular on the left arm, on 18Feb2021 (at 11:00) as single dose for COVID-19 immunisation, administered at hospital. She was planned to receive the second dose of vaccine on 11Mar2021. Relevant medical history included blood pressure problems and type 2 diabetes. Historical vaccine included pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13) administered many years ago for pneumonia and developed swollen arm for about 2 weeks. No relevant concomitant medications were provided. On 04Mar2021, the patient started getting chills, cough, feeling goose bumpy, cold and aches and pains like the flu but she had no fever. On 04Mar2021, rapid COVID 19 test was negative and COVID-19 PCR test was positive. The patient had not recovered from the events.
Patient presented in this office for regular Chiropractic care.  Patient stated she experienced ?excessive fatigue? on Tuesday 1/26/21 and it ?really hit? Thursday 1/28/21. Reported she slept 15 hrs from 6:30pm to 9:30 am on the 29th. Excessive fatigue continued on the 29th and the 30th averaging 12-14 hours of sleep per night.  Patient reported she felt pressure in the head with brain fog to the point that she didn?t trust herself to safely prepare meals.  No appetite due to fatigue and mild nausea. Report O2 was ?a little low? but didn?t quantify. Woke Sunday am 1/31/21 and felt ?more normal?.  During Chiropractic treatment patient stated it felt like her brain had went through a trauma.
Around March 30 I started getting oral ulcers. I didn't think about it possibly being related to the COVID-19 Moderna Vaccine until I continued to get oral ulcers. They would come and go and as of today's date I have been having oral ulcers again for several days.  I also noticed that I was due to start my menstrual cycle on May 10th - I have always been quite consistent in the time frame of the start of my cycle and as of today, May 16th I have yet to begin my cycle. Having read that this has been experienced by a number of other women (post vaccine) I believe it to also be related.
Pt got flu shot had trouble breathing hours later which got worse within 5 hours. Went to ER for treatment. Attached ER report.
Per pt.,  "I woke up on Wednesday morning with a very ?scratchy? or funny feeling in my throat. I felt fine otherwise. I woke up on Wednesday night with a very sore throat and had a low grade temp of 99.6, muscle aches. I did a Covid test that was negative and came to work as I suspected this was from the flu vaccine. We were too short staffed to call off sick. I continued with achiness all day and by the time my shift ended, I had chills, muscle aches and fever 101.7 by the time I got home.  I continued to wake up at night with a severe sore throat and was difficult to swallow. My temp on Friday was 99.6 and improved by evening.   I went to Urgent care as I was concerned that maybe I had strep. I had a total of 3 negative Covid tests at this point. My strep was negative.  At urgent care, he said my throat was swollen and gave me viscous lidocaine as I could not swallow. At Urgent care, I was told this was most likely from the vaccine and recommended that I speak to my usual specialists.  Urgent care did give me an antibiotic if this did not improve, which I did start ( this was started after my temp was already better).  My temp has improved since Friday evening, and sore throat improved on Saturday, but I continue with some hoarseness and dry cough even today.
On the evening I got the shot, I felt extreme fatigue, had a bad headache, and started experiencing debilitating joint pain. At the injection site, I had only a small red area. The next day, I continued with these same symptoms and needed help caring for my child. The area on my arm doubled every 12 hours and has continued to increase in size. 3 days post vaccine, it is currently 2-3 inches in diameter and continuing to grow. It is red, inflamed, itchy, and painful.
Myocarditis heart murmur congestion inflammation Blue lips trouble breathing trouble swallowing fever on and off fatigue
Extreme fatigue and tiredness, sleeping fine but waking up and feeling like you had no sleep, drinking plenty of caffeine but cannot stay awake, lethargy, more tired than ever - this happened as well with the first dose 6 months prior.
blood pressure sky high; blood pressure sky high; couldn't walk; almost having a stroke; little dizzy; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Medical history included atrial fibrillation, blood pressure high, asthma. There were no concomitant medications. No other products. They have not had any other recent vaccinations or started any new medications. Caller said she had her first dose of the Pfizer COVID-19 vaccine shot 25Feb2021, then two weeks later her blood pressure was sky high and she couldn't walk and she went to the emergency room and they said that she was almost having a stroke. She said she was admitted 11Mar2021 and stayed until this past Sunday which was 14Mar2021. She hadn't seen her primary care provider (PCP) yet she only saw the doctor at the hospital. She was supposed to go back on 18Mar to get her second shot, so she wanted to know if it was gonna be safe. Caller said that she has recovered, and when she came home, she was a little dizzy, but they gave her a medication for vertigo and right now she was ok. Outcome of the events was recovered in Mar2021.
difficulty sleeping and needing to take a sleeping medication; she reports symptoms of numbness in her body, that started on her right side and spread to the left side including her fingers and her tongue.; numbness/she reports symptoms of numbness in her body; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left in Apr2021 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation. Medical history included systemic lupus (2011 or 2012). The patient concomitant medications were not reported. Caller stated the first dose of the Pfizer Covid Vaccine was on 12Apr2021 or 13Apr2021, and 18 days later, starting approximately 30Apr2021, she reported symptoms of numbness in her body, that started on her right side and spread to the left side including her fingers and her tongue. Caller received her second dose 02May2021 or 03May2021 and after that she developed the numbness again in her body. Caller stated a few days after the second dose, she reported dizziness and blurred vision. Caller stated she went to the Emergency department, and they did a CT scan, but they did not find anything. Caller stated she was prescribed Meclizine. After she took the medication, the dizziness and blurred vision resolved. Caller stated she still has ongoing numbness in her body, and it has spread to her back. Caller stated on 13Jul2021, she saw a neurologist and she was given Vitamins B2, Magnesium, and Q10. Caller stated on 16Jul2021, she had another MRI test, and the results are unknown at this point. Caller reported the numbness has been ongoing now for 2 months and 20 days and it was giving her a lot of pain and it was getting worse. Caller stated she cannot drive or work and has to take breaks if she goes for a walk. Caller stated she also has difficulty sleeping and she needs to take a sleeping medication since taking the vaccine. Patient was asking for the reason she was having numbness (i.e., was it related to vaccine) and was also asking for treatment advice. The patient underwent lab tests and procedures which included computerised tomogram scan: normal on an unspecified date, magnetic resonance imaging: unknown results on 16Jul2021. Therapeutic measures were taken as a result of adverse events. The outcome of insomnia was recovered on 21Jun2021 and the outcome of other events was not recovered.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024L20A and 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported. Patient reports that he tested negative for antibodies after testing for antibodies 2 weeks. Patient wanted to know if it expected to test negative for antibodies
Fever, Fatigue, Pain, Swelling, Redness around the site of injection.
pt recv vax 12NOV97 & came in office on 21NOV97;reported fever of 103.9 last noc & rash maculopapular confluent 23NOV97 430AM c/o pruritus;still has rash;
Information has been received from a medical assistant concerning a 19 year old female patient with allergy to latex and sulfonamides and no medical history who on 01-FEB-2010 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot #662304/1013Y). Concomitant therapy included YASMIN. On 03-FEB-2010, the patient developed shortness of breath, numbness on the left side of body, and a rash on her chest. The patient was admitted to a medical center on 03-FEB-2010 for initial evaluation and then transferred to another hospital. A magnetic resonance imaging of the brain was performed which revealed a "mini-stroke". The medical assistant added that the physicians at that hospital did not feel the adverse events were related to GARDASIL. At the time of reporting, the patient was recovering from the adverse events. Follow up information received on 09-FEB-2010 from the medical assistant reported that the patient received no other vaccines at the time of the GARDASIL vaccination. The events were not disabling nor life threatening. It was planned that the GARDASIL series would continue. Additional information has been requested.
Patient was supposed to receive TDaP and MA gave Men B according to Lot# documented. NO adverse events from Men B
Patient presented to ER on Aug 14 2005 with right side facial weakness. Also history of tongue tingling and watering eyes for 2-3 days. treated with acyclovir and Prednisone.
rapid heartbeat; high fever; felt horrible; my muscles hurting so bad; couldn't sleep last night due to my muscles hurting so bad / Last night I couldn't sleep because my muscles were hurting really bad /; I am feeling extremely tired; This case was reported by a consumer via interactive digital media and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2020, the patient received the 1st dose of Shingrix. On 10th March 2020, less than a day after receiving Shingrix, the patient experienced myalgia, insomnia and fatigue. On an unknown date, the patient experienced heartbeats increased, fever and feels awful. On an unknown date, the outcome of the myalgia, insomnia, fatigue, heartbeats increased, fever and feels awful were unknown.   It was unknown if the reporter considered the myalgia, insomnia, fatigue, heartbeats increased, fever and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received dose late on the day, before reporting, and experienced myalgia, insomnia and fatigue. The reporter asked, should get 2nd dose dose of Shingrix, if experienced rapid heartbeat, high fever, and felt horrible after the 1st dose.
Dyspnea and pleuritic chest pain onset 4/22-23, prompting presentation to ED. Found in ED on 4/24 to have central R pulmonary embolus extending into interlobar, segmental, subsegmental branches of RUL & RLL, mild R heart enlargement without evidence to suggest RH strain, and mild pneumomediastinum most notable at the thoracic inlet. Tolerating RA. Started on AC with heparin drip, transitioned to xarelto at discharge.
hearing loss; muffled hearing; echoing in ear; it got worse; This is a spontaneous report from a contactable consumer. This 26-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 14:45 (Batch/Lot Number: EIM0162) as SINGLE DOSE for covid-19 immunisation.  Medical history included covid-19 from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 (lot number= ER8727) on 22Mar2021 at 02:45PM on right arm and experienced ringing and pulsing in left ear. The patient's concomitant medications were not reported.  After second shot on 13Apr2021, the patient reported "it got worse, hearing loss, muffled hearing and echoing in ear"  with outcome of not recovered.  Therapeutic measures were taken as a result of reported events included over the counter medications. The patient was not tested positive for COVID post vaccination.
After injection had chills, lightheaded, pruritus, and rash.  Continues to have problems with numbness in hands and feet. Has tested positive for Epstein Barr Virus.
Patient was given a dose of Fluzone MDV from a vial that was at 18.6 degrees Celsius for 6.5 hours; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143997, 2019SA144003, 2019SA144004, 2019SA144008, 2019SA144007 and 2019SA144006 (same reporter).  This case involves a 17 years old male patient who received a 0.5ml first dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] multi dose vial that was at 18.6 degrees Celsius for 6.5 hours (lot UJ005AE, expiration date: 30-Jun-2019) via intramuscular route in the right deltoid on 17-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE), MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) (MCV 4) and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA).  It was an actual medication error due to incorrect product storage.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
Mother specifies "pain, redness, warm to touch in the area of the left deltoid. The doctor prescribed cephalexin 500mg every 8 hrs x 7 days.
on 27MAY93 cardiac arrest pt had group B strep @ 2 wks almost fatal, has many physical problems, on phenobarb, body temp low;
Patient experienced a "reflex response" when shot was given. Pain up and down her arm continued. She visited the Dr. on 11/13/2018 and was prescribed Gabapentin 600 mg at bedtime, but has not had any pain relief from the Gabapentin. She called today to report the incident.
Night of the vaccine, I wake up with both my hands swollen, cramping and hurt really bad. My thighs, calves and feet cramp off and on all night randomly. Tops of feet feel like they are on fire. Feels like charley horses and weird electrical impulses in my legs. Have to get up and walk around. Try to relax and sleep through it. Next day 4-27-21 and for 5 days the top of my stomach hurts like I have an ulcer, nothing will calm it down. Also a headache starts for 5 days. Same night time symptoms for 2 weeks but not as extreme but enough to wake me up multiple times. One month later I go out of town and still have symptoms but not starting to ease. Seems to have settled in my big toes frequently during the day and random in my feet. But tops of feet feel like they are on fire. Try to get an appt at my Doctor. 6-24-21 Dr finally orders bloodwork. 7-23-21 See the owner of the practice. He orders more bloodwork and puts me on Prednisone for 5 days. 2 days in hand cramping has stopped. 7/29 Leg cramping has stopped. 2 days off the medication everything is back. 10/9/21 Left hand still hurts and wakes me up at night. Still can't close my hand in the morning or hold a coffee cup. Still have random leg cramping and odd feeling in feet with occasional burning.
left arm is sore; invalid dose; felt fluid drip down the outside of his arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left arm is sore), UNDERDOSE (invalid dose) and DEVICE CONNECTION ISSUE (felt fluid drip down the outside of his arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced UNDERDOSE (invalid dose) and DEVICE CONNECTION ISSUE (felt fluid drip down the outside of his arm). On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm is sore). On 29-Mar-2021, UNDERDOSE (invalid dose) and DEVICE CONNECTION ISSUE (felt fluid drip down the outside of his arm) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Awoke on Sat June 10, 2006 with rash and itching generalized over entire body. Mother instructed child to take Benadryl (OCT). Rash and itching were gone by Sunday June 11, AM.