chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 03/04/2021 and 03/25/2021. The individual was on hospice care at home for dementia at the time of the adverse event. The individual tested positive for COVID-19 on 10/07/2021 after being admitted to hospital after a fall that fractured their hip. The individual was a poor historian due to dementia, but caregiver stated symptom onset was 10/07/2021 with cough, shortness of breath, fatigue, and respiratory distress. The individual could not be safely discharged to home to continue hospice care due to being immobile after hip fracture, so hospice care was continued in the hospital until the individual died on 10/12/2021.
Product was stored beyond 30 days use; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Product was stored beyond 30 days use) and EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was stored beyond 30 days use). At the time of the report, PRODUCT STORAGE ERROR (Product was stored beyond 30 days use) and EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications was reported. No temperature excursion and adverse event was reported. Vials were placed in refrigerator on 29 Oct 2021.
headache, cold, congestion, body aches x 2 days starting 11/7/21
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 13-JAN-2016, the patient was vaccinated with an improperly stored dose of MMR II (dose and route of administration were not provided) lot # L012479, expiry date 10-APR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested
Irritation in left armpit, has progressed to become a large bruise across entire armpit.
Patient received vaccines and discovered after that patient had received same vaccines 5/2012. No adverse events.
Information has been received from a physician concerning a 29 year old male who was vaccinated with a first 1x dose of varicella virus vaccine live. Subsequently the pt developed a fever, a headache and approximately 15 lesions. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Patient received vaccine 10 days after the beyond  use date. Beyond use date was on 11/20/2021. re vaccinate scheduled.
0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21  at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal
3 hours after receiving my Pfizer vaccine my arm broke out in rashes and some started to bleed.
Fatigue, muscle aches, exhaustion, heart palpitations, irregular heart beat, irregular period, heavy clotting during menstrual cycle, headaches, joint pain, difficulty breathing, dizzy, light headed, racing heart, eye twitching, forgetfulness, memory loss, difficulty concentrating
11:30 am nausea, then weakness, shaky, chills, sinus headache, body aches, dizziness, felt like fainting, joint and muscle pain, that evening had nightmares.
I received the 2nd shot out of the Covid 19 series on Wednesday March 10th. I had severe left arm pain where I received the shot, could not even sleep on it and/or lift it.  The following morning I woke up to go to work and throughout the day the symptoms progressed.it began with slight dizziness, headache, fatigue, nausea, chills and fever for the 24hrs following -- I ended up taking Tylenol Extra Strength for relief of the headache/fever.   Exactly 6 days later I felt an itching on my wrist that later progressed to "Covid Arm" swelling at the site of injection, onto an upper body allergic reaction with hives then later to lower body as well.  it has been relieved with Benadryl nightly.
The patient was under the authorized and recommended age and received the first dose of the Moderna COVID-19 vaccine. Patient was registered for her appointment with an incorrect date of birth. The patient was counseled and given time to ask any questions to the vaccinating pharmacist and counseling pharmacist. After she received her vaccine she was told to wait in a room for 15 minutes to be observed for any adverse effects. The patient left the facility reporting no adverse signs or symptoms.
Fever or Chills  Cough  Shortness of Breath  Muscle or body aches  Congestion or running nose
PATIENT WAS GIVEN AN ADULT PFIZER BIVALENT VACCINE BY ACCIDENT.  PATIENT HAD NO ADVERSE REACTIONS NOTED.
Extreme case of hives, subsided some after taking Benadryl. Today feels much better, not itching much, greatly improved.
Varicella disease DX: 04/25/2005- rash x 4 days itchy. Immunized 02/22/2001- possible vaccine failure.
During administration syringe broke and unknown amount of the vaccine was administered. Full dose was readmininstered without incident. Provider explained situation to patient. No adverse reaction noted.
1) Tingling in lips for maybe hour after jab. 2) Pressure in left side of chest after jab for a couple of hours 3) Difficulty breathing for an hour or less. Chest felt tight, like it felt more difficult to get a normal sized breath. I do have some asthma, and did my inhalers, which did seem to help somewhat. 4) Woozy head and slightly blurry eyes for hours afterwards.  5) Woke up in the middle of the night (from pleasant dreams) with heart pounding ... felt like it was going to ?pound out of my chest?. Pounding lasted for many hours (and still somewhat through noon). 6) Pain in left should area injection site worse than previous 2 jabs.  (no complaints; just adding for sake of throroughness)
This case was reported by a healthcare professional and described the occurrence of elevated aspartate aminotransferase in a 41-year-old female subject who was vaccinated with Havrix (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy and sulfa allergy. There were no concurrent medications. The subject had no adverse events following receipt of previous immunizations. The subject received no other vaccinations on 5 June 2007. On 5 June 2007 the subject received 1st dose of Havrix (1440 elisa unit, unknown, left arm). The healthcare professional reported that in late June 2007, less than one month after vaccination with Havrix, the subject had blood work performed that showed elevated aspartate aminotransferase by double the normal amount. The subject was retested approximately two weeks prior to 05 November 2007, on an unspecified date in October 2007, and aspartate aminotransferase remained elevated at double the normal range but not higher than the first test performed in late June 2007. At the time of reporting the even was unresolved. Comment: Elevated aspartate aminotransferase was assessed as medically serious by GSK.
This case was reported by a consumer via call center representative and described the occurrence of device use error in a 76-year-old female patient who received ADVAIR Diskus unknown (batch number 5ZP1526, expiry date February 2017) for drug use for unknown indication. On 19th November 2015, the patient started ADVAIR Diskus (unknown) 100/50 ug at an unknown dose at unknown dosing. On 20th November 2015, 1 day after starting ADVAIR Diskus, the patient experienced device use error. The action taken with ADVAIR Diskus was unknown. On an unknown date, the outcome of the device use error was unknown. Additional details included that the patient reported that she used ADVAIR for the first time "yesterday". It went well and she reported that she felt it really helped her. On the morning of reporting, when she tried to use the device, she could not get it open. She was trying to flip the light purple section up to expose the mouthpiece. She had forgotten that the inhaler needed to be twisted to expose the mouthpiece. She was attempting to use the product incorrectly. Follow up received by a consumer on 4th December 2015 and 17th December 2015: The reporter stated that, the patient started the course with ADVAIR Diskus on 18th November 2015, and she might have received a dose of Flu vaccine on the same day. On 1st December 2015, 13 days after receiving the Flu vaccine and ADVAIR Diskus, the patient experienced cold symptoms, sniffles and cough. The patient thought that, she had flu. The patient visited back the doctor, who confirmed that she did not have the flu, but sinusitis instead. She was prescribed an antibiotic. In November 2015, less than a month after vaccination and after receiving ADVAIR Diskus, the patient never felt good (malaise), at some point felt nauseated, wheezing and trouble breathing while walking. On 17th December 2015, the patient was still wheezing. It was unknown if the events were related to Flu vaccination. The patient would talk to her doctor about taking ADVAIR twice per day instead of once per day, which has let to an underdose. The patient denied permission to contact her physician.
Redness, swelling and pain at injection site. Also c/o fever and chills, Temp today 101.3.
Nausea, vomiting, severe fatigue, fever, chills, weakness ongoing for over 2 weeks.   Have not reported to doctor because I felt ok before I got the vaccine and I can?t miss work.  The first dose didn?t make me feel sick.
Erythematous, maculopapular rash with vesicles appeared on 12/12/2014. Rash covered entire body except feet and head. Treated with prednisone on 01/01/2015.  Rash began to improve at this time.  Laryngitis began 01/14/2015.  Aphasia began 01/16/2015.  He was hospitalized and diagnosed with CVA.  He has shown some improvement at this time.
Patient presented to the clinic on 3/22/2022 for a dose of the Moderna COVID-19 vaccine. She stated that this vaccination would be her booster dose and presented a photo of her vaccine cards showing her completed 2-dose primary series. This writer overheard her discussing immunocompromised dosing/4th doses with her vaccinator. She stated that, in her view, she should qualify for a 4th dose because she is currently pregnant and therefore is an immunocompromised person, but she also acknowledged during the conversation that the immunocompromised COVID-19 vaccination schedule hasn't been extended to pregnant persons as of yet. She received a booster dose consisting of 0.25ml/50mcg of Moderna (LOT 069H21A-F) to the LD, waited for her observation period, and exited the facility without incident. However, while verifying which lot number the client had received, this writer noted that she has a record of having received a booster dose (0.25ml/50mcg) of Moderna (Lot 039F21A) on 11-05-2021 from the pharmacy to her LD.  This writer called the provider, who reported that receiving 2 booster doses was unlikely to be harmful. This writer then called the client to make her aware of the situation and relay the provider's response. She denied having received the vaccine that was recorded for 11-05-2021, stating that she received her first booster dose at our clinic. She stated that she had made an appointment with the pharmacy, but had not actually gone to it. She speculated that there may have been an error and that pharmacy might have accidentally recorded a completed vaccination instead of cancelling her appointment. This writer replied that this writer couldn't speak to the conditions/practices of another clinic, but provided the pharmacy and advised her to call their clinic for more information. In addition to the current practice of carefully reviewing a client's vaccination cards, the clinic will now perform checks of a client's vaccination history in Database before vaccination. Written and verbal education to this effect was delivered on 3/22/2022. Staff have verbalized understanding and demonstrated proficiency with this practice.
Dizziness; achiness, headache, fever, chills, cough coming from lungs.
Redness and swelling at injection site; Redness and swelling at injection site; Red bump at the injection site; This is a spontaneous report from a contactable pharmacist. A 71-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL3302), first dose administered intramuscularly in the left arm on 27Jan2021 at 09:00am (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and coronary artery disease (CAD). The patient has no allergies to medications, food, or other products. Concomitant medications were not reported. The COVID-19 vaccine was administered at the pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, the patient got redness and swelling at the injection site, and also a red bump at the injection site. It has decreased some but still visible 4 weeks later. The red bump is in the middle of the deltoid, but there was no shoulder involvement. The outcome of events redness, swelling and red bump at the injection site was reported as not recovered.
Blotchy red itchy rash on face x 24hrs getting worse seen by nurse told could be rxn to MMR;
skin rash. Red, raised, hard to touch, and itchy Narrative:  Rash appeared 5 days (2/7/2021) post 1st  vaccination dose (2/2/2021). As of 2/10/2021 the rash is still present.  Other Relevant History:
Allergic reaction - ? flu shot. Broke out in itchy rash right leg and to lesser extent a few spots on right arm. Began last night and has spread. Rec loratadine 10 mg bid for 5-7 days. Advise if develops any other symptoms. Noted allergy to flu vaccine. Rec not get vaccine in the future. VAERs completed.
Patient received a TDAP rt deltoid and ZOSTAVAX in right posterior upper arm 12/14/13. Then noticed mild erythema on 12/19 and 12/20 was seen by myself for cellulitis extending 10.5 X 5.5cm.
Pt presented with 6 day history of redness, itchiness and tenderness to right upper arm. Presented to clinic 5/12/03 today. Given Benadryl by mouth with relief.
Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
have a bad neck; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "have a bad neck".  Additional Information: The patient asked if they could take a steroid after taking the vaccine. The patient had the vaccine on Wednesday (Apr2021) and also had a bad neck.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
FLUZONE HD administered (3rd year in a row) on 9/24/17. Pt woke up w/rash on 1 side of body around trunk. Possible allergic (uncommon since she's gotten the vaccine every year) reaction. Pt is calling MD incase it's a shingles flair or allergic reaction. Needsto be treated.
Pain in upper left arm and shoulder; no swelling or redness at site of injection.  Vaccine received on 5-23-03 in the afternoon.  Morning of 5-24-03, I couldn't move my left arm; used my right arm to raise the left.  My left hand trembled and I made myself cry.  Decided to continue to push myself and made myself feel faint.  By 5-26-03, I was beginning to be able to use my left arm again - to put on my lap seat belt for example.  Morning of 5-28-03, seemed to be much worse again - very difficult to lift my left arm again, but by afternoon, better.  This morning, 5-29-03, much worse again - difficult to shower so I decided to send this report. Problem is with left upper arm. The medical record received on 3/22/04 states shoulder pain.
Pt received Varicella vaccine on 3/7/2000. Was seen in office on 3/9/2000, for varicella rash on face, about 10 maculae.
diarrhea; upset stomach; shortness of breath; racing heart; Change in taste; nausea; headache; Tingling of Her lips; Cheeks felt fat; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling of Her lips), SWELLING FACE (Cheeks felt fat), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and DYSPNOEA (shortness of breath) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PARAESTHESIA ORAL (Tingling of Her lips) and SWELLING FACE (Cheeks felt fat). On 17-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (shortness of breath), PALPITATIONS (racing heart), TASTE DISORDER (Change in taste), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Tingling of Her lips), SWELLING FACE (Cheeks felt fat), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (shortness of breath), PALPITATIONS (racing heart), TASTE DISORDER (Change in taste), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications reported.
Bottle of vaccine was not thrown out from Tuesday's clinic. Nurse was conversing with other staff and did not confirm date on bottle and administered Moderna COVID-19 vaccine, that had been opened Tuesday (06/15/2021) morning at 9:00am, and was approximately 36 hours expired, it had been at room temp since Tuesday morning at 9:00am.
received the second dose of the COVID-19 vaccine/He had tested his patient's antibodies in his commercial laboratory and the result was negative; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient had his first dose of BNT162B2 on unspecified date for covid-19 immunization. It was reported by the physician that he had a patient who received the second dose of the COVID-19 vaccine and had tested his patient's antibodies in his commercial laboratory and the result was negative. The physician was asking if that was an expected result or should it be positive.  The outcome of the event was unknown.   Information on the Batch/Lot number has been requested.
New onset Tinnitus beginning approximately 1 week following the first vaccine, worsening with each vaccination becoming unbearable following the booster dosage in October 2021.  Unable to hear cell phone over ringing in ears, difficulty sleeping due to constant, loud, high pitch ringing.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age (also reported as about 45 years old). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported). On an unknown date, the patient experienced cold sores after administering with ZOSTAVAX. It was reported that the patient was not sought any medical attention. It was also reported that the patient had not received any treatment. The pharmacist also reported that developing of cold sores happens frequently. The outcome of the event cold sores was unknown. The case is linked to case 1401USA014439 and 1401USA014550 (same reporter link). Additional information has been requested.
I experienced itching around tight clothing area, whelps developed, my lips began to swell, my throat began to swell shut, and I had to take Benadryl for that reaction. After I recovered from the reaction my asthma has been flaring up more than normal. When I went to the doctors office for the reaction I was prescribed a steroid pack. It took 2 weeks to recover and return to normalcy.
After HPV vaccine, patient left clinic and was setting in waiting room while dad went to the restroom. After 5 minutes after vaccine administration, patient stated she felt lightheaded, started to have trouble seeing, and felt nausea. Father states that patient was very sweaty and pale. Father had her lay down and make staff aware of this change. Vital signs were obtained that were within normal limits (BP, SpO2, and HR). Patient was laid down with legs elevated. After 10 minutes, patient started to feel better with improved color. She then slow sat up and was given water to drink. 15 minutes in patient was then transferred by wheelchair to our clinics treatment room. Patient was sitting up, feeling better, vitals were normal and stable on 3 consecutive checks about 5 minutes apart.  Patient no longer had any symptoms. After physical exam with no concerns, patient was discharged from our clinic and walked home with father.
Description of the event per the emergency room note from 3/23/22. Patient had his COVID vaccination on 3/23/22 and he then went grocery shopping where he began having a seizure. He had full body convulsions which lasted for a few minutes followed by postictal state. His wife did CPR for approximately 1 minute. He did miss a dose of his Depakote within the past day or 2. This is only the 2nd seizure has has had in the past 10 years.  He had some GI symptoms last week but these have resolved.  Upon arrival to the ER patient had returned to his baseline. His valproic acid level was low in the ER.