chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 hrs p/vax high pitched screaming-9 o'clock TC to MD cont to scream; MN to Er t101, swelling @ inject site;
hives through out trunk, face , neck , arms. Slight s.o.b. only. (R) ear ache , sore throat,flushed . OBset abouyt 20 min. per shot . Benadryl 50 mg. po through out day for recurring hives. Shortness of breath only at 1st. hour. no treatment for breathing needed. ( I anaphylact for bee stings, so can differenciate. have at this point had recurrence of hives through out  last 20 hours.
Chest Pain beginning 1/1/22 Consistent Pressure in middle of chest, occasional sharp pain in upper left portion of chest.  Fatigue  Shortness of Breath
fever 105 ax, hallucinations 48 hrs p/shot; pt states will see own MD;
dry throat; a swollen red hard patch in the arm; whole body itchiness (mostly back and arm) at night; lost strength on her body; Dizziness; throat pain; swallowing pain; Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat), PERIPHERAL SWELLING (a swollen red hard patch in the arm), PRURITUS (whole body itchiness (mostly back and arm) at night), ASTHENIA (lost strength on her body) and DIZZINESS (Dizziness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast feeding.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY THROAT (dry throat), PERIPHERAL SWELLING (a swollen red hard patch in the arm), PRURITUS (whole body itchiness (mostly back and arm) at night), ASTHENIA (lost strength on her body), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (throat pain), ODYNOPHAGIA (swallowing pain) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding). At the time of the report, DRY THROAT (dry throat), PERIPHERAL SWELLING (a swollen red hard patch in the arm), PRURITUS (whole body itchiness (mostly back and arm) at night), ASTHENIA (lost strength on her body), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (throat pain), ODYNOPHAGIA (swallowing pain) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078004, US-MODERNATX, INC.-MOD-2021-078363 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078004:Husband Case US-MODERNATX, INC.-MOD-2021-078363:Baby Case
Employee received MMR vaccine 5/18/09. Presented with rash trunk and extremities. Referred for eval and trt positive pruritis. Treated with BENADRY ? other meds?
Hospitalized w/Covid symptoms 5 days. Shortness of breath, fatigue , bad taste in back of throat still exist today 02/23/2021
Loss of taste, smell Achy Fever and shakes Loss of appetite  Irritability Lethargy
Reaction to H1N1 vaccine; Initial information received on 20-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care  professional.  This case involves patient (age and gender unknown) who had reaction to H1N1 vaccine (vaccination complication) , while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past vaccinations included H1N1 vaccine (three vaccine since 1975). The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided. At the time of the event, the patient had ongoing reaction to  sulfa drugs.   On an unknown date, the patient received a dose  of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious reaction to H1N1 vaccine (vaccination complication) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data reported.   It was not reported if the patient received a corrective treatment.  The patient outcome was unknown for the vaccine complication.  There will be no information on the batch number for this case.
Pt should have been given Hepslav but writer gave Energix-B in error.
itchy rash after a week spreading through her body; itchy rash after a week spreading through her body; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (itchy rash after a week spreading through her body) and VACCINATION SITE RASH (itchy rash after a week spreading through her body) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), ATENOLOL, ESTRADIOL, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), FUROSEMIDE SODIUM (FUROSEMIDE ACCORD [FUROSEMIDE SODIUM]), LISINOPRIL, OMEPRAZOLE (OMEPRAZOL 1 A PHARMA), LEVOTHYROXINE SODIUM (SYNTHROID) and MAGNESIUM.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy rash after a week spreading through her body) and VACCINATION SITE RASH (itchy rash after a week spreading through her body). At the time of the report, VACCINATION SITE PRURITUS (itchy rash after a week spreading through her body) and VACCINATION SITE RASH (itchy rash after a week spreading through her body) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Hydrocortisone
Pt's mother called stating pt had a 3 inch in diameter red raised area with purple spots throughout on R thigh were MMR was given on 6/2/14. Pt placed hydrocortisone cream on rash and it appeared to help. Was instructed to use OTC BENADRYL-childrens as directed on box and call if not resolved in 4-5 days. Child eating, drinking normal. No fever noted by parent.
Patient started with left sided weakness and slurring of speech the evening of 1/16.   Symptoms improved after a little while so went to bed.  The next am he woke up with  worsened left arm and leg weakness, difficulty walking and slurred speech with drooling.    He was diagnosed with a right middle cerebral artery stroke.  Patient unable to return home due to dense left hemiparesis; was admitted to a nursing home for stroke rehab and PT/OT/ST.  Thankfully he is very gradually improving
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267228; 2019SA267230; 2019SA267231; 2019SA265193 (same reporter).  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right arm on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  It was a case of actual medication error due to incorrect product storage.  At the time of report, no adverse event was 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.  Documents held by sender: none.
Information has been received from a physician for the Merck pregnancy registry concerning a 23-year-old caucasian female hospital employee with a conception date of 13-DEC-2006 (previously reported as her last menstrual period was 12-DEC-2006) who on approximately 15-NOV-2006 and 27-DEC-2006 was vaccinated with her first and second doses of varicella virus vaccine live (Oka/Merck) (lot# 652630/0247F). She reported to the physician that she had performed two home pregnancy tests on 01-JAN-2007 which were positive (estimated LMP 28-NOV-2006, EDD 05-SEP-2007). Unspecified medical attention was sought. No additional information to report. There was no product quality complaint. Follow-up information indicated the patient underwent an ultrasound on 01-FEB-2007 which showed a viable pregnancy. No maternal adverse events related to the vaccine were noted. Follow-up information has been received from a physician indicating the patient underwent a routine screening for maternal serum alpha fetoprotein (KSAFP) on 22-MAR-2007 which revealed a negative result. It was unknown whether a local reaction at the vaccination site occurred from the previous doses of varicella virus vaccine live (Oka/Merck). No maternal adverse events were noted for varicella or Herpes zoster symptoms. Follow-up information has been received from a completed varicella virus vaccine live (Oka/Merck) questionnaire from an obstetrician and pediatrician indicating that the (full-term 7 lb 11 oz) normal male was born with no congenital anomalies or abnormalities or complications. The mother of the infant experienced mild pre-ecclampsia during pregnancy. There were no complications during labor/delivery, no infections or illness during pregnancy or concurrent medical conditions. Concurrent drug therapy during pregnancy included prenatal vitamins for routine care. The infant did not have any feature of congenital varicella zoster syndrome. Additional information has been requested.
Information has been received from a pharmacist concerning a patient who is a child who on an unspecified date was vaccinated with a dose of MMR II and a dose of VARIVAX (MSD). Subsequently the patient had "an allergic reaction which involved a rash". The pharmacist did not know if this was dose 1 or 2 of MMR II and VARIVAX (MSD). Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of vitreous detachment in a adult female patient who received HAVRIX (batch number 5SR75, expiry date unknown) for prophylaxis. Co-suspect products included ENGERIX B (batch number 7N5M5, expiry date unknown) for prophylaxis. On an unknown date, the patient received HAVRIX and ENGERIX B. On an unknown date, unknown after receiving HAVRIX and less than a year after receiving ENGERIX B, the patient experienced vitreous detachment (serious criteria GSK medically significant) and blurred vision. On an unknown date, the outcome of the vitreous detachment and blurred vision were unknown. It was unknown if the reporter considered the vitreous detachment and blurred vision to be related to HAVRIX and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, the patient experienced blurred vison and vitreous detachment after receiving HAVRIX and ENGERIX B. The reported batch number 55r75 for HAVRIX was updated to 5SR75 as per sales data sheet The reported batch number 7ngm5 for ENGERIX B was updated to 7N5M5 as per sales data sheet.
had lip trembling about 4 hrs /p imm. was blue in color & shivering but felt hot.Called MD went to ER.Had sz & had T 106.8, was hospitalized over noc. mom called 29Jun92 & states pt is fine now.
This spontaneous prospective pregnancy report was received from a pharmacist refers to a female patient of unknown age. Information on patient's medical history and concurrent conditions were not reported. The patient's concomitant therapy included sterile diluent. On 30-AUG-2018, the patient was vaccinated with VARIVAX (strength, dose, frequency, route, lot # and expiry date was not reported) for prophylaxis (exposure during pregnancy). The patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. The pregnancy outcome was outcome pending. No product quality complaint (PQC) was involved.
Pt presented to the Pharmacy on 9/29/18 to report an adverse rxn to the PREVNAR vaccine she had received on 9/28/18. Her arm at injection site was red, inflamed and developing hives. She was also experiencing some red cheeks and hotness. She indicated the symptoms started the evening before.  She has not sought medical treatment. I indicated to see a doctor if any of the sxs got worse.
No adverse effects were noted to date.  This was an extra dose of the Kinrix given 1 year after the first dose in error
Patient presented to the ED for 15 episodes of emesis in the morning of 16 Sep. The patient tested positive for COVID on August 30th.  He was seen in the ED on 1 Sept and had a CT PE that was negative for clots at that time. He states that his main symptom of COVID was loss of appetite and he had lost approximately 15 lb in the past 3 weeks due to loss of appetite. He completed his quarantine and returned to work. On Wednesday 15 Sep 21, he received the first Pfizer vaccine as well as a Fluarix flu shot. He had a Headache and arthralgias after the shot.  On 16 Sep 21 he woke up and vomited numerous times.  He states that he has a mild cough still from Covid, but denies chest pain, shortness of breath dizziness or light headedness. He has been making urine and stooling appropriately though he has felt dehydrated on 16 Sep 21.   In the ED on 16 Sep 21, the patient was found to have an elevated d-dimer of 3.13 and he underwent a new CTPE.  This was positive for multiple pulmonary emboli in the left upper and lower lobar arteries.  His nausea/tachycardia and clinical dehydration resolved with anti-emetics and intravenous fluids.  He was started on heparin and then Xarelto for his pulmonary emboli.  He never had shortness of breath or dyspnea on exertion.  He was discharged home in about 24hrs after ED visit.
I received my Covid-19 vaccine on 10/14/2022. On the morning of 12/04/2022 I woke up with a slight fever and body aches. Tested positive for Covid-19. Over the next few days, I started to feel fatigue sinus congestion.
vaccine given at 0915, pt c/o of chest feeling funny,tight, voice became hoarse and cough started at 0923. 0925 12.5ml Benedryl given , 0930 @ puffs Albuterol given one minute apart 935 c/o hard to get air in and lump in throat, 937 c/o knot in throat feels larger can't take deep breathe, pt requested we give her Epi pen to her.   Epi-Pen 0.3mg given IM right lateral thigh at 0937. 0939 she can take a deep breath, lump in throat feels smaller and she is sitting on the side of the bed. 0940 sitting on side of bed still coughing, 0943 Cough improving talking better no longer hoarse voice.  Squad arrived at 0945 and transported to hospital ER.  Patient has dealt with anaphylaxis for years due to allergies and per her PCP ok to get Moderna vaccine but she needed to be monitored for two hours after injection.
Immediate onset of numbness and tingling in 4th and 5th digits, left hand.  Followed by a burning pain Seen via telehealth 12/30/20 Recommended conservative measures Started on NSAIDs Examined 1/4/21 Script for PT provided
Unusual bruising reported on 11/8/16. Did not seem emotionally affected. Bruise still appeared after 11/8/16. Vaccine administered 10/28/16.
Fingers turned ice cold - toes turned blue and ice cold - 2nd toe on each foot had large purple patch.  Symptoms lasted for over an hour.  Vitals stayed fine.
Headache starting around 5:30pm followed by extreme nausea around 6pm. Took advil and wore nausea bands. Woke up following morning with headache at a 3 level out of 10, took advil and went to work, headache worsened to 6 out of 10 got chills and left work and was home around 9:30am took more advil and slept until 1:30pm woke up with headache at level 6 out of ten and when getting up and moving around headache worsened to level 8/9 out of 10 so continued to lay in bed until 6pm got up and took more advil and an ice pack for my head and laid back down.
The following symptoms started at the 12th hour after I received the second dose (and they lasted for 48 hrs): -High fever (around 102-103 degrees) -Muscle pain (in legs and back) -Fatigue -Sweating -Headache
Pain and swelling at injection site; arm ache; muscle aches, headache, fatigue, lethargy; felt feverish.
Allergies. Such as when I?m exposed to  regular allergic products plus feeling of pin sticks.
Flu like, very ill, fever, chills, sweats, headache (migraine like), weakness, could not get out of bed. Called pharmacy told me to take TYLENOL should subside in 1-2 days if not go to the doctors. Started to subside after 24 hours
Chronic itching and some hives (appeared five days after vaccination) Rosacea flare on face Pain and tingling in fingers and toes
Redness & inflammation in left deltoid region.  Instructed to give Benadryl.  Return to office if worsens.
pt devel sudden breathing difficulty; 8PM was relieved when pt coughed up phlegm as noted by EMS: did not go to ER or pvt MD;
hives on both feet, itching.  Benadryl, alternate vaccinator-mother will do no more IPV
Narrative:  1-2 minutes after patients 2nd covid vaccination, he went into a seizure and lost pulse in the vaccine clinic. CPR was initiated and 911 called. Patient went into cardiac arrest where Epi was given and AED instructed to give 1 shock. CPR was continued and pulse returned and patient awoke throwing up. Ekg revealed ST depression and patient was transferred to Emergency Department. Follow up notes on patient from ED was cardiac arrest was induced by COVID vaccine anaphylaxis
Went to Urgent Care 12/24/11 with rash - Dx. viral and OM - rash proceeded to get blisters and worse - today (12/27/11) looks like final stages of varicella.
24 hours, post vax, the pt had edema beneath left arm with soreness. States she "felt like a baseball was under her arm". It is still swollen and tender but not swollen now.
Migraine and dizziness treated with acetaminophen, arm where the shot was received experiencing no pain the first day, throbbing pain the following days treatable with ibuprofen but intolerable without it
I woke up in the middle of the night to my arm burning and the injection site red and swelled up the size of a softball. The redness continues to spread and my arm burns and itches terribly.
"CC: cold covid shot x2. 2nd shot 2/26, 1st shot 4 weeks prior Moderna HISTORY  Age: 59 Gender:F Symptoms:  Cough:Y thinks form post nasal drip and had some laryngitis Shortness of breath:Y Difficulty breathing:Y wheeze at HS Loss of taste:N Loss of smell:N ------------------------ Fever > 100.4:N Subjective fever:N Chills:N Rigors:N Myalgias:N Headache:Y sinus teeth hurt Sore throat:N Diarrhea:N Nausea/Vomiting:N Nasal congestion/rhinorrhea:Y, yellow mucous constant  Additional symptoms:  Onset and duration: 3/1  Recently in an area with COVID-19 community spread (within past 14 days): If YES, where?N If YES, what were the specific dates of travel (or does the patient live in this area)? Close contact with a suspected or laboratory-confirmed COVID-19 patient: If YES, in what capacity?N Healthcare worker with potential exposure to a person with suspected COVID-19? If YES, in what capacity?Y pharmacy tech If YES, was PPE (personal protective equipment) used?Y  Chronic medical conditions/Immunocompromised? List: Seasonal allergies/allergic rhinitis High blood pressure Arthritis Anxiety If female, currently pregnant:NA Smoking history:N Has the patient had the flu vaccine this year?y If YES, approximate date of flu vaccine?Oct"
Hospitalized 1/3/2022; COVID-19 positive 1/3/2022; fully vaccinated. BRIEF OVERVIEW: Discharge Provider: MD; Primary Care Provider: DO; Admission Date: 1/3/2022; Discharge Date: Jan 7, 2022. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute cystitis with hematuria [N30.01]; Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung [J18.9]; COVID-19 [U07.1]; UTI (urinary tract infection) [N39.0]. HOSPITAL COURSE: Patient is a 78-year-old female with past medical history of polio, hydrocephalus, anemia presented with urinary symptoms admitted altered mental status, and generalized weakness. UA grossly positive. Also noted to be COVID positive, previously vaccinated. Chest x-ray with left mid lung and lower lung infiltrates. CTH with marked lateral and third ventriculomegaly, similar to prior exam; periventricular and subcortical white matter changes that may reflect a combination of interstitial edema/transependymal CSF flow and/or chronic small vessel ischemic disease. The patient was admitted on Rocephin and azithromycin to cover for urinary tract infection and community-acquired pneumonia. Azithromycin was stopped. Urine cultures grew Proteus mirabilis, pansensitive. Rocephin was given x5 days prior to discharge. The patient was not continued on antibiotics after discharge. COVID pneumonia, fully vaccinated no hypoxia remains stable on room air. Decadron and remdesivir not indicated. Mentation improved during hospitalization, back to presumed baseline based on conversations with roommates/caregivers. During hospital stay patient was noted to be asymptomatic bradycardia with intermittent second-degree AV blocks, otherwise hemodynamically stable. Cardiology was consulted, with recommendations for avoidance of rate-controlling medications. No other workup recommended. At time of discharge, the patient was in stable condition with appropriate vital signs (stable, but low heart rate) and labs. She was tolerating oral intake. Home healthcare services were arranged prior to discharge for continued care as an outpatient.
No additional adverse effects reported; one patient was administered a dose of expired but properly stored VAQTA; This spontaneous report was received from a medical assistant referring to a 21 months old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.    On 12-AUG-2020, the patient was administered a dose of expired but properly stored hepatitis a vaccine, inactivated (VAQTA) (strength: 25/0.5 (units not provided), lot # S009562, expiration date was reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019) (exact dose and route of administration were not reported) for prophylaxis (expired vaccine used). No additional adverse effects. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S009562; expirationdate: 05-MAY-2019; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability