chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 05-APR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for the prevention of shingles (herpes zoster.) On an unknown date after receiving ZOSTAVAX, the patient experienced optic migraines, loss of hearing in her left ear, neuropathy, cardiac issues and a cerebral brain bleed. As a result of these symptoms, the patient presented to a medical provider. As a result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitation not present prior to using ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Optic migraines, loss of hearing in her left ear, neuropathy, cardiac issues and a cerebral brain bleed were considered to be disabling. Upon internal review, loss of hearing in her left ear, neuropathy and a cerebral brain bleed were considered to be medically significant. Additional information has been requested.
Hives appeared on the face within a few minutes of receiving is 4 month (second set) of DTaP, IPV< HIV and PCV7. These resolved quickly with administration of epinephrine 1:1000 0.1 ml IM.
Pt recvd 1 dose of Engerix-B & devel rash & itching p/48 hrs; resolved but left marks;
pt recvd 2 doses of Hep B on 9DEC91 & 10JAN92; 24 hrs later devel stomach discomfort, chills, achiness, t100; 48 hrs p/vax devel stiff neck, stiff shoulder, h/a, myalgias & malaise; seen in ER; treated w/ meds;
redness and soreness at site. mild fever. syncope, malaise, headache, aches
2-weeks after dose 1, first lifetime seizure occurred and a spinal tap confirmed oligoclonal bands in CSF. Additional generalized seizures have occurred monthly since and I received a diagnosis of epilepsy and multiple sclerosis
This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored dose of RECOMBIVAX HB lot # M022077 with expiration date on 10-MAR-2019 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 1 hours and 15 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.
General malaise following 1st covid injection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ovarian CA" (unspecified if ongoing); "covid 19 infection" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "General malaise following 1st covid injection".  Additional Information: Event took place after use of product. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccines in clinic, stated he was feeling fine/denied dizziness, walked to mother and left. After a few minutes passed, patient's mother ran back inside the clinic, stating she needed help. This nurse and MA ran to entrance, where mother was assisting patient back inside. Mother stated that they got to the vehicle, but while talking she felt that her son "seemed off". Mother stated that his head tilted back and his eyes rolled back in his head. Mother stated she honked the horn to wake him up, he lifted his head and said "what". Mother stated that she was not leaving and came inside for us. Patient appeared pallor and was laid on a cot and assessed. Pulse was strong and equal. Breath rate was controlled. Patient was able to converse the entire time and stated he did not feel well. Patient was provided with a snack and water. Patient remained on cot for approximately 10 minutes. Patient sat on the edge of the cot and ate his snack and drank his water for approximately another 5 minutes. Patient was able to stand without assistance after and ambulate to the door. Denied any dizziness.
Headache started 30 minutes after injection and has been continuous without relief. This is day 6. Headache is severe enough that wakes me in my sleep. I wake up with the headache every morning. Tylenol and Aleve do not help.
1wk p/vax began quarter size red area w/rash;w/in 1-2 more days area of redness inc 3/4 circumference upper arm, swollen, warm to elbow;t97.6 saw MD;
mom reported 16JUL96 that pt had a rxn following 1st inj ;pt had elevated fever, screamed for hr, slept for a day;pt now developmentally delayed;pt has very little rxn w/next 3 inj given @ MD;
PATIENT DEVELOPED COUGH, FEVER, LOSS OF TASTE OR SMELL, MUSCLE ACHES, HEADACHE, AND RUNNY NOSE ON 07/13  AFTER EXPOSURE TO HER HUSBAND WHO IS ALSO POSITIVE FOR COVID.  PATIENT TESTED POSITIVE FOR COVID ON 07/14
5/5/2021 URI  This is a new problem. Episode onset: x3 days. The problem has been gradually improving. Maximum temperature: 99.9 on sunday. Associated symptoms include congestion, coughing, a plugged ear sensation (right ear has pain), sinus pain (Right side), sneezing and a sore throat (right side). Associated symptoms comments: Fever Chest pressure for 1 night. Treatments tried: Inhaler, cold & flu     Review of Systems  HENT: Positive for congestion, sinus pain (Right side), sneezing and sore throat (right side).   Respiratory: Positive for cough.
Patient received PNEUMOVAX on 10/25/12 - called and complained of sore arm & had difficulty raising arm. Dr said she may need physical therapy on 10/28. She then called her dr. Now getting some physical therapy.
Approximately one day post vax, pt experienced hive on the opposite leg from the injection.  The rash began to spread over the week. The rash got worse and turned into hives and welts.
Hives over upper body parts, redness and swelling of skin and lumps on certain body parts, itching and soreness.
Information has been received from a 60 year old female patient with sulfonamide allergy concerning herself. Concomitant therapies included hydroxyurea and vitamin D (unspecified). On 14-DEC-2016, the patient was vaccinated with PNEUMOVAX23 (single dose of 0.5 ml, lot # M026317, expiration date ??-JAN-2018) intramuscularly for prophylaxis. On the same day, the area below the injection site on the patient's right arm began to turn red and swollen after receiving the PNEUMOVAX23. The patient also stated that her temperature was 100.4 (unit unknown) when she visited her physician about this. The patient received treatment for the events. The outcome of the events was unknown. The causality between PNEUMOVAX23 and the event was unknown. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The nurse reported that four vials of M-M-R II did not show the color as indicated in the prescribing information after reconstitution. Once the product was reconstituted, the color was more clear than light yellow. As a result of this, on an unknown date, the patient missed a dose. No adverse events were reported. Additional information has been requested.
0.5ml was injected instead of 0.3ml.  Attempted to contact patient via telephone and e-mail on 10/18/21 without response.
itchy, painful blisters and was diagnosed with Herpes Zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. On or around 21-FEB-2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered itchy, painful blisters and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), her symptoms resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was considered to be not recovered. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered to be disabling.
top lip was swollen and really sore; lip was burning real bad.; lip was sore and it was hurting; lip was hurting, could not drink well cause the need to use a straw; fever of up to 102°F; fever of up to 102°F and was not talking; This spontaneous case was reported by a consumer and describes the occurrence of MOOD ALTERED (fever of up to 102°F and was not talking), LIP SWELLING (top lip was swollen and really sore), ORAL DISCOMFORT (lip was burning real bad.), CHEILITIS (lip was sore and it was hurting) and DYSPHAGIA (lip was hurting, could not drink well cause the need to use a straw) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BACLOFEN for Muscle stiffness, CITALOPRAM HYDROCHLORIDE (CITALOPRAM [CITALOPRAM HYDROCHLORIDE]), COLECALCIFEROL (VITAMIN D3), MAGNESIUM, ACETYLSALICYLIC ACID (ECOTRIN), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40), AMLODIPINE BESYLATE, SIMVASTATIN, AMITRIPTYLINE and APIXABAN (ELIQUIS) for an unknown indication.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced MOOD ALTERED (fever of up to 102°F and was not talking) and PYREXIA (fever of up to 102°F). On 11-Nov-2021, the patient experienced LIP SWELLING (top lip was swollen and really sore), ORAL DISCOMFORT (lip was burning real bad.), CHEILITIS (lip was sore and it was hurting) and DYSPHAGIA (lip was hurting, could not drink well cause the need to use a straw). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MOOD ALTERED (fever of up to 102°F and was not talking) and PYREXIA (fever of up to 102°F) was resolving and LIP SWELLING (top lip was swollen and really sore), ORAL DISCOMFORT (lip was burning real bad.), CHEILITIS (lip was sore and it was hurting) and DYSPHAGIA (lip was hurting, could not drink well cause the need to use a straw) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: 102 (High) fever of up to 102°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medicine: torax delayed release DR 250mg for headache and isinopril 10mg for unknown indication Patient lip was really hurting and buring so care taker provide vaseline
Started about one week after injection.  Has had imtermittent rash on arms, neck, posterior head, and groin that he describes as small bumps that are not vesicles or pustules.  Occurs about every other day or so lasting hours.  Pruritus.
pt recv vax on 31oct95; 20jan97 pt devel varicella, with more than 40 lesions.pt recovered
Rt upper arm presented large 1-1/2" hard, erythematous tender area.
first day of receiving it, I had a headache and was drowsy four days later I woke up to vomiting and diarrhea, I was shaking. I was freezing but sweating. This lasted 24 hours. a week and a day my injection site had become irritated as well was it felt as though some one was burning me with a hot iron.  this never happened until 1/8/2021.  a week and two days later I had severe diarrhea, headache and was nausea all day. This was on 1/9/2021
Pneumonia Vax was given up in shoulder bone, it caused dark bruising.  5 hours later unable to move because of pain, kind of paralyzed. Doctor advised to take Advil/ Ibuprofen and put heat. Today there is still bruising and pain at site but have movement.
Immediate large lump and swelling in my arm, after about 2-3 hours the pain was so severe and now 2 days later I can't touch my arm and the lump is alot bigger. 24 Hours later my arm is not able to move with out pain. Level a 10+ I'm terrified to get the next dose now.
Information has been received from a registered nurse concerning an 18-year-old 200 lb. 69 in. female with a history of benign neoplasm of the pituitary gland and craniopharyngeal duct with no known drug reactions/allergies who on 19-OCT-2007 was vaccinated SC with a 0.5mL second dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included Gardasil and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified). Concomitant medications included replacement hormones (therapy unspecified) and numerous medications (therapy unspecified). There was no reported illness at the time of the vaccinations. On 19-OCT-2007 at 20:00 hours, (also reported as "two days later"), the reporter indicated that the patient's worse day was 20-OCT-2007. She presented to the physician on 22-OCT-2007, who indicated the area was the "size of 2 inches all around "(also reported as about 3" in diameter). The patient was treated with cold compresses, OTC Benadryl cream and ice. There were no laboratory or diagnostic studies performed. The patient's vaccination history included: 26-JUN-1989, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), and OPV (manufacture unspecified); 25-AUG-1989, a second dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), and a second dose of OPV (manufacture unspecified); 27-OCT-1989, a third dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified) and a third dose of OPV (manufacture unspecified); 13-JAN-1990, a fourth dose of diphtheria toxoid (+) pertussis acellular vaccine  (unspecified) (+) tetanus toxoid (manufacturer unspecified); 09-FEB-1990, rubella virus vaccine (therapy unspecified); 11-AUG-1990, a first dose of measles virus vaccine live(Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), and Hib conj vaccine (OMPC) (manufacturer unspecified) 13-NOV-1990, a fourth dose of OPV; 02-JUN-1993, a first dose of hepatitis B vaccine (recombinant) (manufacturer unspecified); 21-JUL-1993, a second dose of hepatitis B vaccine (recombinant) (manufacturer unspecified); 27-DEC-1993, a third dose of hepatitis B vaccine (recombinant) (manufacturer unspecified); 18-May-1994, a fifth dose of OPV and a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), 06-MAY-1995, a first dose of varicella virus live vaccine; 29-APR-1999, hepatitis A vaccine (manufacturer unspecified, an influenza vaccine (manufacturer unspecified) on 15-NOV-2001, 16-NOV-2002, 08-NOV-2003, 13-NOV-2004, and 15-NOV-2005. A product quality complaint was not reported. Additional information is not expected.  Follow up infromation from the patient's mother provided no addditional information. Current patient status was not reported.  Additional information is not expected.
I have been having irregular heart beats ever since I received the vaccine. Never before have I had heart issues. My entire body also felt like it was on fire at one point.
2 days after receiving dose 2 I developed hives on left and right arm, red, itchy, blotches on my legs below the knee and 4 days later my eyes swelled up
Narrative: COVID infection after COVID vaccine series 02/23 COVID vaccine dose #1 03/16 COVID vaccine dose #3 12/20 pt present w/ c/o cough, fatigue, rhinorrhea, sore throat, red throat; COVID POSITIVE 12/21 pt with continued SOB, reports burning up and sweating like crazy, c/o cough, fever, headache, myalgia, rhinorrhea, dyspnea, wheezing; seen in ED; treated with dexamethasone 6mg IV x 1, duoneb; r/o PE, discharged from ED
nauseau still on 3rd week afte vaccine. Diarahea  week 2. chills the first week.  Also bad headaches. week 2. Lost 7 pounds feel like gagging when think about eating food or after.
Henoch Schonlein Purpura 2 days after vaccine, currently being managed outpatient
four hours after taking shot - temperature, chills, extreme skin sensitivity, nausea, headache, overall flu like symptoms. Lasted 14 hours, and then recurring bouts of general malaise off and on for over a week.
Pt states her hands were turning red at which time RN was called to assess. Bilateral hands were red and blotchy. She states she feels the need to frequently clear throat but is not short of breath. She states her lips feel tingly. No angioedema noted, redness is not spreading from palms of hands. No redness or rashes noted at injection site. Pt was given 50mg of diphenhydramine prior to leaving. She waited in lobby with staff observation for another 15 minutes, Redness in hands was resolved. Educated pt to call emergency services should symptoms persist or worsen. Pt verbalizes understanding. This RN will call later today and tomorrow to follow up with pt.
Information has been received from a doctor of pharmacy concerning a patient of unknown age and sex. The patient's pertinent medical history and drug reactions or allergies were not reported. On 31-AUG-2012, the patient was vaccinated intramuscularly with an expired dose of PNEUMOVAX23 (dose was not reported) (lot #: 669579/0595AA; expiration date; 30-AUG-2012). There were no adverse effects. Additional information has been requested.
Information has been received from a physician concerning a 15 year old female student with no medical history, who on 23-JUL-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot# 656051/0244U) at 11:00. Subsequently, at 11:20 the patient fainted in the lobby as she walked out of the office and she lost consciousness for less than one minute. There were no illnesses at the time of the vaccination. The patient sought unspecified medical attention. On 23-JUL-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
The patient's wife called the pharmacy July 19,2021 to inform of the problem. She reported that her husband was feeling excrutiating generalized pain,weakness,numbness and tingling of arms and legs,speech slurring,weakness of left side of the face causing his left eye to remain opened. She reported that they visited the emergency room and his doctor's office several times but was discharged with no diagnosis.
Complained of shortness of breath and weakness. Also complained of congestion, eyes burning, sore throat and feeling spacey. Medrol dose pack. Mactrim DS BID for 10 days.
My child fell asleep doing homework and was awakened at 6:30 for evening activities.  Complained of a headache.  Returned early from evening activity complaining of nausea and alternating between chills with shaking and sweats. Episodes of vomiting followed. No fever, no rash.  Complained of considerable pain at the time of the injection and immediately following.  This submission is approximately eight hours after the injection.
Patient inadvertently received an undiluted dose of the Pfizer Bivalent 5-11 dose. The incident was discovered shortly after administration. The patent only reported a sore arm at the time. I followed up with the patient in 2 days and mom reported that the arm was still sore and they were having difficulty sleeping. No other adverse effects were reported and I informed them to call us if any new or worsening side effects arose.
Thrombophlebitis, 45 day prescription of Xaralto, outcome not yet applicable.
same day of vaccine she fell; This spontaneous case was reported by a consumer and describes the occurrence of FALL (same day of vaccine she fell) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Patient was allergic to novocaine.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (same day of vaccine she fell). At the time of the report, FALL (same day of vaccine she fell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  As per the case narrative it was unable to obtain information about the type of vaccine administered by the patient.  There was no further information about the adverse event occurred and event was captured as per the statement "He reports the same day of vaccine she fell".  Follow up was requested
No symptoms originally. Within about one month, white blood cells were elevated and red blood cells decreased so that he was passing out, weak, and unable to walk unassisted.
t 1335, patient reported feeling light swelling of her throat. Patient reported no other symptoms. Patient offered diphenhydramine. Patient declined diphenhydramine. Patient advised to wait for further observation. Patient advised to notify EMTs if symptoms progress. EMT assessed patient's vitals: blood pressure 124/64 mmHg, heart rate 64 beats/minute, and 98% SpO2%. Patient reassessed at 1400. Patient stated she felt good. Patient offered vitals. Patient refused vitals. Patient offered diphenhydramine. Patient denied diphenhydramine. Patient educated on getting benadryl, getting an EpiPen, and seeking emergency care if symptoms progress and has difficulty swallowing/breathing. At 1410, patient left facility to self with steady gait and unlabored respirations.
I had Covid in August and the symptoms I experienced are the same except for loss of taste and smell. Symptoms: Severe headache, muscle and joint pain was extreme (pain medication had no effect), tired and no energy. Lasted through next day after shot then was fine. I am very concerned about taking the second shot at this point as it is my understanding the second shot will make a person MORE ill.