chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable other HCP via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A patient of unspecified age and gender started to receive BNT162B2, via an unspecified route of administration from 23Dec2020 to 23Dec2020 at first single dose for COIVD-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Pharmacy student on the line who had patient who received the first dose of the COVID vaccine shot on 23Dec2020. Then the patient went home on Christmas break and later tested positive for COVID on 29Dec2020. She was calling to see how to proceed with the second dosage. Outcome of the event was unknown.  information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for corona virus infection based on the known safety profile. However given the short duration of 6 days since the vaccine first dose, it is unlikely patient would have fully developed immunity.
Pericarditis - acute left sided chest pain, pleuritic, worse with lying down (couldn't lay down to sleep without significant pain).  Started on high dose ibuprofen and colchicine.   Weened Ibuprofen over 4-6 weeks as symptoms decreased.  took colchicine for 3 months.  evaluated by cardiologist after completion of colchicine with normal echo/ekg/labs.  minimal residual discomfort has waxed and waned since.
Developed PMR (Polymyalgia rheumatica)  This was the most ill i ahev been in my entire life. The pain of the PMR was almost unbearable. The pain was releived by taking prednisone but then i had the adverse effects of sleep loss and weight gain.
Patient was administered an injection from a vial that had expired a week ago; 1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an injection from a vial that had expired a week ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an injection from a vial that had expired a week ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an injection from a vial that had expired a week ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported. Concomitant product use was not provided.
Patient is a 92 y.o. male with a history of dementia who recently left ED AMA on 7/29/23 s/p fall and found to have Right rib fractures who presented to hospital 8/9/2023 after fhe was found with confusion and weakness. On admit, COVID-19 positive with hypoxia.    1. Acute Toxic Metabolic Encephalopathy: possibly due to infection/COVID with baseline of dementia and hard of hearing. Improved with supportive care. 2. Acute Hypoxic Respiratory Failure: Secondary to viral pneumonia. Requiring 2-3 liters L O2 on admit; weaned off O2 8/11/23.  3. COVID-19 Pneumonia: Vaccinated. PCR positive on 8/9/23. CXR non-acute. Sepsis was ruled out. Continued on decadron and remdesivir through 8/14/23; no furhter decadron needed since he is not requiring oxygen. Isolation per protocol. 4. Diarrhea: 1 day prior to admit; resolved on 8/11/23.  5. Chronic Anemia: Baseline Hgb ~11. Stable on admit. 6. Dementia: really with age related memory loss; continued home meds  7. BPH: Continued home meds 8. Code status: DNR-CCA,DNI, confirmed with both POA, daughters
I got the shot and got it/Suspected Vaccination Failure; then I got it anyway; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shot and got it/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: then I got it anyway).The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he/she always got the shingles shot then he/she got shingles anyway. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
The first injection I received was from an empty syringe, the healthcare worker told me she didn?t notice it was empty until after she gave it to me and said she would need to inject me again, which she did immediately after noticing the empty syringe. I immediately felt a burning sensation going down my arm but did not have any immediate pain. Approx. 3 1/2 - 4 hrs later, my muscle where I received the injection began feeling very sore. After several days, I used a lidocaine patch on my arm which eased the pain so it was tolerable. However, today is the 11th day of my pain and I have not been able to sleep through the night for the past 3 nights due to excruciating pain that wakes me up and I am unable to raise my arm. The pain and my range of motion for my arm has progressively gotten worse by the day with today being close to unbearable.
extreme fatigue light headed, headaches, migraine, half of arm swollen, followed by lump, arm painful with rash
Known AE's in literature, however I wanted to report- Intercostal pain- severe. My entire rib cage, inside and out were on a complete flare that I have never felt before. It was hard to breath, not shallow or during extent of deep breath, but in between the two. I was getting false chest pains as the intercostal pain over the chest would flare. This was constant pain that started within 12 hours of the dose. It resolved to about 90% by day 20, however I still have lingering intercostal pain. This may be a flare of my lyme reacting to the vaccine. It is still worth it to get dose 2, but I am not looking forward to the AE's.
stuffy sinuses; sore throat; mucous in the throat; dizziness; nausea; fatigue; pain at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (stuffy sinuses), OROPHARYNGEAL PAIN (sore throat), SECRETION DISCHARGE (mucous in the throat), DIZZINESS (dizziness) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis, Thyroid disorder, Gastro-intestinal disorder NOS, Hair loss and Bipolar disorder. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), LAMOTRIGINE (LAMICTAL) and ARIPIPRAZOLE (ABILIFY) for Bipolar disorder, DEXLANSOPRAZOLE (DEXILANT) for Gastro-intestinal disorder NOS, FINASTERIDE (PROPECIA) for Hair loss.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced SINUSITIS (stuffy sinuses), OROPHARYNGEAL PAIN (sore throat), SECRETION DISCHARGE (mucous in the throat), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection arm). At the time of the report, SINUSITIS (stuffy sinuses), OROPHARYNGEAL PAIN (sore throat), SECRETION DISCHARGE (mucous in the throat), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included thyroid medication. No treatment was received by the patient for the symptoms developed.
fully vaccinated (Pfizer, 3/17/21, 4/8/21); symptom onset 8/3/21
Felt feverish, noticed several red raised bumps on back and over the next two days red itchy bumps appeared on face, head, torso, arms, legs. Approx 20.
About 5 hours after receiving this vaccine, this patient developed headache, chills, nausea, and fever of 102.9. She continued to have fever the next day. By day 3 her fever had resolved but she continued to have severe headache and fatigue until 5 days after the vaccine on 12/20.
There is a possibility patient may have received 0.25 ml of vaccine rather than the recommended 0.2 ml of the Moderna Bivalent presentation for 6 months to 5 years. A staff member was not aware of the correct dosing of the bivalent vaccine. The system in place for drawing up vaccine and administering vaccine may have allowed for staff member to have drawn up 0.25 ml and another staff member to give the vaccine. It cannot be determined fi the correct or incorrect amount was drawn up or given. There has been no reported adverse reaction from the parents to date.
20 yo female had first Pfizer off which is reflected in database. A minute after she began have heart palpitations. Then she began fighting for air. Immediately felt her hands and arms were like foot falls asleep numb, tingling. Nurse had her wait and she stayed about 45 minutes due to 130s heart rate. Eventually did improve and cleared to work but thought she might pass out so sent home. On the 9th awoke but didn't feel good and felt like she ran a mile, out of breath. Nurse advice line sent her to the ER. Sense that heart was twitching even in her leg beating through her skin 'weirdest thing.'   Reports no prior anxiety toward the vaccination.  Her heart rate was 180 in the ER. Multiple ER visits since then.  First vaccine was at another clinic.
Severe arm pain. Feels pain in upper arm and shoulder x 6 weeks. Feels arm is very "heavy". Arm hurts when tries to lift it above his head.
administration of Kinrix to a patient after his 7th birthday; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 11-SEP-2023, the patient received Kinrix. On 11-SEP-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a patient after his 7th birthday).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2023 The Healthcare professional called and reported administration of Kinrix to a patient after his 7th birthday which led to inappropriate age at vaccine administration. The Healthcare professional asked if this dose was considered valid. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023126111:same reporter
Patient is presenting with redness at the injection site. She is 2 days post injection. Site is firm, red, and tender. Patient does not have fever.
Temp 100.1,  diarrhea, body aches, treated with Tylenol
"Covid arm"- red rash developed the next morning at the injection site. Slightly sore, not itchy yet.
Pt received vaccine Sat 3/30. She began to feel local reaction on Sunday. It was at its worst on Tuesday and better today (Wednesday 4/3/19). Today it was about a 3 inch circle, red, warm, and itching.
Rash at injection site.  Approximately 3 inches in diameter. Warm, swollen, itchy.
12 YEARS OLD PATIENT RECIEVED  PFIZER PEDIATRIC COVID 19 VACCINE
COVID arm - large hot bumps on my arm at injection site as well as under arm in arm pit and breast area accompanied by significant pain.
stiffness and pain lower back left hip  achiness  trouble sleeping, tired   intermittent bloating
Had TD vaccine given then patient was getting blood drawn.  Patient passed out in chair - called 911, stabilized and went to hospital via ambulance.
seizures x 3 months, 20-30 a week memory issues ringing in ears brain fog rapid eye movement
Dizziness,Swirly Headaches, temp 100.5, fatigue, body aches.  Tylenol & rest.
patient in the ER received an expired dose of Imovax vaccine, no AE; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received an expired dose (third dose in series, 1mg) of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date not reported) via an unknown route in an unknown administration site on an unknown date as post exposure immunization.   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, 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.
'73 -year-old male presents to the emergency department with shortness of breath, patient was diagnosed with Covid recently, he was started on dexamethasone on 2/1 , patient was admitted to this hospital on 1/22 and was discharged on 1/26 to health and rehab. Patient has had increasing 02 requirement since being diagnosed with Covid, currently on 6 L nasal cannula with shortness of breath, patient reports cough and fever as well, on arrival patient's respiratory rate is elevated and he is salting 87% on 6 L nasal cannula, was quickly transitioned to BiPAP. Prior to arrival given IV fluids by nursing home staff and have his 02 increased to 9 L nasal cannula. Patient was continued on 6 L nasal cannula by EMS and transported to the emergency department on arrival patient denies abdominal pain but per EMS report staff tt1ought his abdomen looked more swollen than normal.   Patient was treated with Remdesivir for 5 days, Decadron 10 days and baricitinib 14 days along with therapeutic Lovenox per Vanderbilt treatment guideline. Hospital course was complicated by worsening respiratory status and elevated C-reactive protein requiring patient to be restarted back on steroid. Patient was also treated with vancomycin and cefepime for 5 days for Klebsiella pneumonia. Repeat inflammatory marker started trending downwards. Patient's oxygen requirement stabilized. Patient had prolonged hospital course and was accepted to select subspecialty for longterm acute care. Patient and his wife were in agreement patient finished a course of cefepime prior to discharge and cefepime was stopped.
pt recv vax & devel itchy, macular-type rash on face & chest wall, erythema, fever of 99.4 & hives on lt wrist & neck; pt was placed on therapy w/DPH;
Myalgia, Fever, chills, injection site pain swelling Narrative: #2 dose within 24 hrs on 2/27/21 experienced pain at injection site, 2 cm area swelling, chills body aches fatigue for 2 d
Moderna as first dose, Pfizer as second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 IMMUNISATION (Moderna as first dose, Pfizer as second dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced COVID-19 IMMUNISATION (Moderna as first dose, Pfizer as second dose). On 21-May-2021, COVID-19 IMMUNISATION (Moderna as first dose, Pfizer as second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Added contact information (address, institution) and patient initials.
She feels weak; Lethargic; Went down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: history of migraines and woke up with a migraine; "Asthma" (unspecified if ongoing), notes: Caller stated his wife has asthma. The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "She feels weak"; LETHARGY (non-serious), outcome "unknown", described as "Lethargic"; MALAISE (non-serious), outcome "unknown", described as "Went down".  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (08Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Dry cough, cold chills, rapid heart beat, high temp. Flu vaccine given 12-1-10.
As previously stated IPT diagnosis was given shortly after original two-part vaccination. It was unknown if vaccine was cause of ITP because many things can cause ITP and I also had a bacterial infection at the time of original vaccination. However, two days after the booster received on 2/22/2022 my platelet levels were tested at 10,000, the lowest they have ever been even with my being on my medicine that had been keeping platelet levels stable in the normal range.
Patient was given incorrect vaccine for age, no adverse reactions noted.  Patient was closely followed by PCP.
Tenderness and lump, redness at site of left arm.  Patient seen and given Etodolac 400 twice a day.
I began to have symptoms at 9pm- tiredness and headache. Then. In the middle of the night I had body aches and fever. My temperature was 100.8, then 99.8 then 101.7. Ive also been having chills and headache
LD. site of TDAP with erythema & swelling, warmth - swelled the day after administration, then erythema - localized reaction - was sore for several days.
Narrative:  COVID infections following completion of COVID vaccine series 01/27/21 COVID vaccine dose #1 02/18/21 COVID vaccine dose #2, seen and treated in the ED for UTI with doxycycline 03/10/21 Pt fell down from 10 ft ladder and reports dizziness, mild headache, and back pain and chest pain after fall 05/20/21 Pt states is having issues with his memory and weakness in legs, continues to have back pain after recent accident 06/08/21 Patient states that he has been increasingly dizzy and seems to lose his breath at times, reports B/P at home very low (70-80s/50-60s) 07/19/21 Pt reports fatigue, muscle weakness, chronic runny nose (Rhinorrhea), dry throat; reports close exposure to someone with known case of COVID-19 (wife); COVID swab performed - COVID positive 07/20/21 Pt reports chills, cough, fever, loss of taste or smell, runny nose 07/21/21 Pt reports feeling much better with mild symptoms of loss of taste or smell and runny nose; reports low BP readings with no s/sx of hypotension; denies fever, chills, cough 07/23/21 Pt reports improving daily but still has low BP readings with no s/sx 07/25/21 Pt reports improvement 07/29/21 Quarantine end
Muscle weakness in arms and legs within hours of the shot (from shot to present, ongoing) Slightly impaired cognitive functioning, "brain fog" (from shot to present, ongoing) Tingling/pins and needles in lower legs (began 8/9/2021 and ongoing). Periodic at first, now nearly constant Tingling/pins and needles in fingers (began 8/12/2021 and ongoing)
This spontaneous report as received from a registered nurse refers to mulitple unspecified patients of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. On unknown dates, multiple unspecified patients were vaccinated with ROTATEQ, lot # K005397, expiration date: 29-FEB-2016 or lot # K001198, expiration date: 25-OCT-2015, route default to oral, (dose and frequency were not reported) after it was exposed to a supported temperature excursions of 32.9F for 2 hours and 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Started experiencing pain in L knee day after vaccine (Thursday). By Friday AM could not hardly bend my L knee due to swelling and pain. (I have had no prior injuries or arthritis in my L knee.) Treated it with ibuprofen, ice and heat. Saturday AM my R knee felt just like my L knee did. Treated it the same way. The pain moved down into my calves on or about the 7th day. It has gotten better very slowly over the last 12 days, but still now back to normal.
This initial spontaneous report was received from a medical assistant referring to multiple patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions described. The reporter stated that from 29-SEP-2015 through 30-SEP-2015, the patients received improperly stored doses of M-M-R II injection (lot # L000458 with expiration date 06-JAN-2017 and lot # L009212 with expiration date 17-MAR-2017 and lot # L012481 with expiration date 10-APR-2017; dose and route were not provided. There was no concomitant medication. Product quality complaint was not involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.