chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Failed to get 2nd dose, 1st in 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (first dose received in 2018).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-Feb-2023  Reporter's Comments: The patient received the first dose of Havrix in 2018. The patient failed to receive the booster or 2nd dose of Havrix. The patient was asking do we need to restart or just give the 2nd dose. The reporter requested Medical Information including product excursions/stability. The patient was asking could Twinrix be given instead. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Reported to Employee Health - had 2 grand mal epileptic seizures & was treated in ED. Had had TD in past without incident & unsure if related to Tdap. Seizures about 40 min after injection.
I started having flushing within a minute of receiving vaccine  next I noticed I had heart palpitations I was told my skin was clammy then  I had another episode I was taken to ER and decardron  was given. I was observed in ER for few hours . Since that day I have heart palpitations every day along with chest pain sometimes I am not  able to wean off steroids I also had diarrhea on 1/3 that lasted few days . These side effects are very scary every day heart palpitations I feel my heart would stop
Case number# PHEH2015US023424, is a report initially received from a consumer (patient's mother) via a Patient Oriented Program on 09 Nov 2015. This report refers to a child female patient. Historical condition was not reported. Current condition included tuberous sclerosis. Concomitant medications included levocarnitine, DEPAKOTE and Vitamin D. The patient received AFINITOR for the treatment for brain and spinal cord frontal ganglioglioma from 19 Jul 2014 at a dose of 5 mg, QD (route: oral). On an unknown date, the patient received Influenza Virus Vaccine Unknown Inn from an unknown date and dose (route: unknown). It was stated that, the patient's treatment with AFINITOR discontinued for the 2 weeks prior and 2 weeks after the flu shot. On an unknown date, the patient developed local reaction. It was stated that, it was not as severe as she had after previous year's flu shot. The patient restarted her AFINITOR (2 weeks after the flu shot) and not missed any doses since then. The AFINITOR stopped on 05 Jul 2015. Patient's mother reported that on 10 Feb 2016, the patient had rash on patient's face, around her lip area that caused her lips to crack and chafe (chapped lips). The local doctor gave her some Mupirocin cream and the patient used this for about 3 days and it cleared up and had not returned. The patient's AFINITOR was held on 02 Oct (year unknown) and 02 Nov (year unknown). She resumed therapy on 02 Dec (year unknown) with no reappearance of the rash. Last month, patient had an EEG that showed no seizure activity so the doctor did not believed that the DEPAKOTE being increased was a help to the patient. So he decreased it back to her regular dose. Treatment with AFINITOR was temporarily interrupted. On an unknown date, the patient was completely recovered from the events. The seriousness and causality of the events was not reported. Follow up report received from a consumer (patient's mother) via a Patient Oriented Program on 11 Mar 2016: Added new events (rash) (chapped lips), treatment medication, and action taken of suspect AFINITOR and updated narrative accordingly.
12/2021 Had a history of Shortness of breath, palpitations and lack of energy. Went to my doctor. He put you on a 3 day Holter monitor, a stress EKG, chest x-ray and Echo cardiogram. Holter monitor showed I had AFIB and with medicine, this has gone away. This all became worse after the vaccine. The doctor is trying to figure out what is going on and is wondering if it is post COVID. I will be wearing a Holter monitor for 3 weeks in a few days.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 27-MAY-2015, the patient was vaccinated with improperly stored MMR II (route of administration and dose were not reported) (lot number reported as: K016152, expiry date: 24-SEP-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Hospitalization: 10/22/22 - 10/25/22 Presentation to the ED: Pt came to the ER w C/o after sustaining a fall from standing height from his bed on his hip without any head injury. He had nonspecific complaints of weakness and some slurred speech.    COVID + date: 10/22/22.  Treatment: REMDESIVIR.  Discharge to: SNF.
Body aches, hot flashes, headache, weakness, body sensitivity to touch, fever, chills
Pneumonia; This is a spontaneous report from a contactable consumer(patient). A female patient of 64 year of age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 15Mar2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced pneumonia. Therapeutic measures were taken because of pneumonia, patient was prescribed prednisone and also stated that she could not get the second dose while taking prednisone. It was reported that patient wanted to know if she needs to start the vaccination series over. The outcome of events remains unknown.  Information about the Lot/batch number has been requested.
This spontaneous report was received from a registered nurse and refers to a currently 29 year old non-pregnant female patient. There were no concurrent conditions, no pertinent medical history and no drug reactions or allergies. On 01-MAY-1998, the patient was vaccinated with the first dose of VARIVAX Subcutaneous injection, for prophylaxis (reported as "prevent chicken pox") (strength, dose, route, anatomical location, lot # and expiration date not reported). Other suspect products included sterile diluent (MERCK STERILE DILUENT) (strength, dose, frequency, route, lot, expiration date, and indication were not reported). There were no concomitant drugs or vaccines. The registered nurse reported that on an unknown date, the patient had a varicella titre completed which showed a "very low titre" (antibody test negative). Subsequently, the patient received on an unknown date a booster dose of VARIVAX (strength, dose, route, anatomical location, lot # and expiration date not reported), which the patient tolerated. No Product Quality Complaint was involved. The outcome of the event and the causality assessment between the event of very low titre and the suspect products were not provided.
Fatigue, soreness and fever and rash arm from 4 days on the top of the left arm. Rash and hives, redness and pain on 4/15-4/23/2021. Shingles diagnosed on August 28, 2021. I was so swollen. Nerves were dark, purple and swollen. Recent shingles August 28-September 15, 2021 on right side on my face, cheek and ear only.
Itching, rash, burning, large whelp, high fever, hurting all over, headache.
Evening after vaccines, patient had 3 brief tonic clonic seizures.  EMS came and gave versed, patient was transported to local ED (hospital).  No report of fever at home, but was starting to have fever at ED (37.8) so they have acetaminophen.  No additional meds given in ED, thought to be complex febrile seizure.  There is a family history of febrile seizures.
On 10/13/2011, patient received Hepatitis B and FLUZONE. Immediately, patient cried, held breath, stopped breathing, turned pale, became limp, bradycardia. Blown air into mouth, called EMS, transported to hospital.
After receiving the vaccine the morning of 8/29/22, the patient awoke on 8/30/22 and noticed a large bump at the injection site; the patient presented to the clinic in the afternoon as a walk-in. Upon inspection, the injection site had swollen into a round, uniform lesion measuring approximately 6-7 cm in diameter and raised approximately 0.5-1 cm above the patient's normal skin level. The lesion is firm, round, and uniform with distinct boundaries, mildly erythematous, and warm to touch. The patient reports that the lesion is nontender, nonpainful, and mildly pruritic. The patient denies all other symptoms, including shortness of breath, chest pain/tightness, rash, fever, headache, nausea, vomiting, diarrhea, and other local and systemic signs/symptoms.  The patient was assessed by MD. Dr. recommended that the patient continue to monitor the symptoms and apply a cold compress to the site twice a day for 15 minutes at a time until the lesion begins to dissipate. The nurse discussed other signs and symptoms that the patient should monitor for, and when the patient should get back in contact with the clinic and/or seek emergency medical attention. The patient verbalized understanding the plan and had no further questions or concerns.
Information has been received from a nurse practitioner concerning a 22 year old female patient with a history of syncope vasovagal who "about 2 months ago" in approximately August 2009, was vaccinated with a dose of GARDASIL (route and lot # unknown).  The nurse practitioner reported that "about 2 months ago" a patient fainted after her first dose of GARDASIL and also had a seizure like episode after tonic clonic movements.  The patient sought medical attention at the nurse's office.  At the time of this report the patient was recovered.  Additional information has been requested.  Follow up information has been received from a nurse practitioner who reported that the patient received diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) on the same day as GARDASIL.  The nurse practitioner stated that the diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid was given first in one arm and then GARDASIL was given in the opposite arm, within seconds of receiving the second shot, the patient fell back "jerked" and lost consciousness for a few seconds.  The patient immediately woke up and asked what had happened.  The patient's vital signs were assessed and remained in the office for about 15 minutes before she was able to leave.  When the patient left she seemed to have fully recovered with no lasting effects.  The nurse practitioner further noted that the patient had experienced a vaso-vagal response from a blood draw previously (date not reported).  Upon internal review patient's "tonic - clonic movement and had a seizure like episode" was considered as an other important event (OME).
Inflammatory reaction (left deltoid) a site of smallpox vaccination (inflammation, induration, lymphadenopathy).
brain hemorrhage; Can not  Walk; Can not speak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (brain hemorrhage), WALKING DISABILITY (Can not  Walk) and SPEECH DISORDER (Can not speak) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced CEREBRAL HAEMORRHAGE (brain hemorrhage) (seriousness criterion hospitalization). On 30-Apr-2021, the patient experienced WALKING DISABILITY (Can not  Walk) (seriousness criterion intervention required) and SPEECH DISORDER (Can not speak) (seriousness criterion intervention required). The patient was hospitalized on sometime in April 2021 due to CEREBRAL HAEMORRHAGE. At the time of the report, CEREBRAL HAEMORRHAGE (brain hemorrhage), WALKING DISABILITY (Can not  Walk) and SPEECH DISORDER (Can not speak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient ended up going to Hospital by ambulance and underwent t emergency surgery. She stayed in ICU and in at the time of report, she was still hospitalized.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Issues with severe cramping, heavy periods and clotting.  I have never suffered from any of this before.
I had a metallic taste in my mouth and slight tingling of the tongue blade with onset 10 mins following vaccination. This lasted about 3 hours.
Patient came to the emergency room with worsening abdominal pain affiliated with bloody diarrhea that has been going on for approximately 1 month. Ischemic sigmoid colon and proximal rectum. End descending colostomy created in LUQ. Transected at mid rectum. Stumped marked with suture. Very low, narrow pelvis -indicated that he had ischemic colitis  -Wound ostomy team following for new colostomy.  - Started having bowel function on 12/13 His diet was advanced.  Patient was treated for pain; and replaced back on Xarelto as the patient was on Xarelto prior to admission due to paroxysmal atrial fibrillation. ED visit and hospital admission was within 6 weeks of receiving the COVID vaccine.
Thrombocytopenia resulting in undetectable platelets that improved with 4 days of dexamethasone and IVIG with improvement in gum bleeding and petechial rash of bilateral lower extremities
headache/ nausea/diarehha/vomiting/swollen lymph nodes above collar bone
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. ON 16-AUG-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # L042266, expiration date 27-OCT-2017, exact dose and route of administration were not reported). The administered dose experienced a temperature excursion of 11.5 degree Fahrenheit for 3 hours and 54 minutes. Previous temperature excursions was reported. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
The baby developed a slight rash to chest area and back area. The doctor was notified and Benadryl 1/2 Tsp given po as per doctor's orders. His temperature was 98; pulse was 132 and respirations were 28.
Fever, chills, muscle aches, joint pain, bones hurt, migraine, tired, nausea.
pt recvd vax & started trembling; turned blue; cold skin; eyes rolled back; to hosp T 105; episode lasted approx 2 mins w/mild blue coloring & limpness; mom was told infant has virus;
Injection site : redness, swelling, warm to the touch. Flu-like symptoms, muscle aches, nausea, vomiting, headache, dizziness, itching, weakness. Contacted pharmacy when symptoms continued for 2 1/2 days,  they recommended plenty of fluids, Tylenol, rest. If symptoms did not improve return or go to ER to be hydrated. On 4th day symptoms began to subside and some improvement occurred. Took until day 6 to feel somewhat normal. Visited nurse at clinic and was advised to file report.
Exanthema - Information has been received from a registered nurse concerning a 28 year old caucasian male diabetic patient who on 16 May was vaccinated sc in the left arm with a first dose of varicella virus vaccine live (lot 634839/10643J).  On 02 Jun 2000 the patient developed 10-12 lesions that looked like varicella.  The patient was seen by a physician and on an unspecified date recovered.  It was noted that on 15 Jun 2000 the patient was vaccinated in the left arm with a second dose of varicella virus vaccine live (lot 634839/1874J)
Head to toe joint pain and body aches, Raging headache. Localized hot red "egg" with a tingling sensation. Had a smaller similar reaction to the first shot and thought it may be an infection from shot but now know it was a milder overall reaction to the immunization.
Both legs severe ache from hips to ankles.  Rest and Acetaminophen 500 mg (2).  Legs returned to normal the afternoon of 31 March 2021.
No notable immediate adverse effects noted.  16 year old received Moderna instead of Pfizer.
Vertigo, hot flashes, extreme lethargy, depression, lost appetite, insomnia, headache, nausea,  no menstrual cycle for 3 months, memory loss
Erythematous papules appeared on the right buttock and over the next 3 days red down the right leg following the dermatome.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to 2018SA302863 (same reporter). This case involves a patient (age and gender unknown) who received expired dose of vaccine, MENACTRA. The patient's past medical history and concomitant medication were not provided. On 09-Jul-2018, the patient received a single dose of suspect MENACTRA lot U5462AB via (Expiry date: 19-Jan-2018) via unknown route in unknown administration site. It was a case of actual medication error due to issue with how the imprint of the expiration date on the vials was written (two-digit year) which was different than previous vaccinations that they had received (Product label confusion) which eventually led to administration of the expired vaccine (expired vaccine used). It was unknown whether the patient experienced any 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 Directive and Module VI of the 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.
Neck pain Collarbone pain Joint pain and inflammation Hair loss Fatigue Psoriasis flare
Got Fever; Body ache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:45 (at the age of 42 years old) as dose 2, single for COVID-19 immunisation. Medical history reported as none. No allergies to medications, food, or other products. There were no concomitant medications patient received within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Mar2021 (at the age of 42 years old) as single for COVID-19 immunisation. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced got fever, body ache on 25Mar2021 22:00. No treatment received for the adverse event. Since the vaccination, the patient did not tested for COVID-19. The case was reported as non serious. Outcome of all the events were recovering.  No follow-up attempts are needed. No further information is expected.
Arm sore; Joint pain all over my body; Bad headache; Nauseated; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Concomitant was not reported. On an unspecified date, the patient reported that she had Pfizer shot yesterday at 9:00 o'clock and she did not felt that day and later in the evening at 8:00 o'clock, her arm was really sore and she continued to have joint pain all over the body and had a bad headache and nauseated. She wanted to know that she can take Anacin or Tylenol or Dramamine because she got a bad headache and nauseated. When probed for vaccine details, consumer stated, "The one we got yesterday. I am 86 and I don't know why I am feeling like this (headache and nauseated). My husband was trying to help me here. We both got this one but he has a joint pain but now I have (incomplete sentence). They gave 2 little card and they said come back the 26th of this month. All I see on this just little card. (name) , I don't know what else is here, it says CBC in the corner. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient reports redness and swelling around the injection site. A temp of 101. Nausea, diarrhea, headache and muscle weakness also. On 8-5-18 patient reports redness to be clear.
On Saturday evening on 08/21/2021,I had a really bad cough, dry cough, fever, my pulse was not low but I was having difficulty breathing. I was wheezing a lot. I received COVID-19 test on 08/23/2021- positive. I was taken to the hospital, via ambulance a couple of hour after my results came back. I went to the ER, I was given IV fluids and 10 different breathing treatment. I received oxygen in the ambulance. And they gave me steroids, prednisone 40 mg od, I was on steroids for a total of 1 week. They also gave me iron via IV fluids. From blood test  my iron was really low. I was discharged late Thursday, 08/26/2021. Nobody else in my house hold tested positive for COVID-19. I have a 6 yo and 7 yo. and nobody tested positive. I still have lingering shortness of breath and fatigue. I have resumed to a normal lifestyle. Before I had COVID-19, I would use my inhaler once a month. Now I have to use it several times a day.
Pt devel inc temp w/episode of cont screaming, Hosp x 3 days 14MAY to 16MAY;
chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 616M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and NAUSEA (nausea). At the time of the report, CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  No treatment information was provided
Pain in entire left shoulder joint. Could not sleep. Cannot lift my arm. Next morning severe pain cannot lift arm .
One week after my vaccine, on Saturday morning 4/10th I woke up and saw red in the outer white part of my left eye . I looked closer and it looked like blood, a burst/popped blood vessel. I felt no pain or irritation in my eye. My eye and surrounding eye area were not swollen or inflamed. There was no fluid or substance leaking from my eye or tear ducts. My eyes were not watery.
Scattered rash first noted on ankle area, right shin, right shoulder, neck, slightly around nose.  Generalized itching throughout the body.
At 10pm 09/01/10 pt began screaming and hard to console off and on for 4 hours. Better at 2:00AM today and now sl rash on face and neck. No fever or other sx now.