chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother reports that patient slept longer than ml on 11/26-11/27/18 but main concern is that patient became lethargic at 10/10:30 am on 11/27/18 w/facial pallor and "faint heart sounds" - pt. had to be slapped and splashed w/water and disrobed to awaken and even then only slowly woke up. Parents did not check temperature at that time so unknown if fine. Mom called office once pt. was alert and wanted to speak w/a phone nurse who was not available at the time so advised to bring pt to office. Pt was stable then (approximately 12/1 pm) so mom decided to not come to office.
Information has been received from a licensed practical nurse concerning a female (age not reported) who on approximately 24-OCT-2006 was vaccinated with Pneumovax 23, 0.5 ml, IM.  This was the patient's second Pneumovax 23 injection because the first vaccination was stored improperly and given.  The physician's office contacted the patient to come in and gave the second Pneumovax 23 injection.  The date of administration of the improperly stored vaccination was reported as unknown.  On 30-OCT-2006 (yesterday), the patient was contacted and she was fine.  Follow-up information has been received from a licensed practical nurse who reported that the patient developed a local reaction of redness which resolved in two days.  Additional information is not expected.
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were inadvertently vaccinated with GARDASIL (dose, route and lot# were not reported) (confirmed not GARDASIL 9) that had been improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
pt states had a positive COVID test on 12/27/21; sx have progressively worsened with SOB/DOE, non-productive cough, fever, aches, chills, malaise; pt found to still have a positive COVID test on 1/3/22; AHRF; COVID pneumonia; given Decadron, O2 supplement, ABX; transferred to ICU and placed on BiPAP; given Baricitinib and then stopped due to acute renal failure requiring hemodialysis; pt was intubated; septic shock; seizure during dialysis; bilateral pneumothoraces; chest tube placed; pt was transitioned to comfort care, extubated and vasopressors dc'd; given medications for comfort; pt passed away in the hospital
C/o chest pain, almost passed out this am when she awoke. Some tingling in arms & legs. No fever.
The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer. At HCF, I served as a Cold Chain Operator (CCO), who is responsible for transporting COVID-19 and flu vaccines to encampment sites. Standards for transporting these vaccines include keeping said products between 2C-8C. In order to maintain such cold temperatures requires the use of: cooler bag, 3 fridge plates, 1 frozen plate, and 2 sheets of bubble wrap. The bubble wrap serves to protect the vaccines from having direct contact with any of the cold plates. Somewhere during the transportation process, one of the sides of the bubble wrap got pushed down, causing potential exposure of the vaccines to the cold plates, which are most likely below 2C. Due to insufficient data to support the idea that the vaccines were considered active, we must assume that the 4 Moderna vaccines provided during our shift on 3/7/2022 are possibly invalid.  We arrived to their encampment around 9:00 AM on 3/7/2022. We provided our vaccination services to our patient, and followed standard procedure. After observing the patient for over 15 minutes, having the patient report no adverse symptoms, we allowed them to go back to their encampment.
Difficulty breathing, sharp chest pain when breathing that radiates to my back. Chills and extreme fatigue. Diagnosed and receiving treatment for Pleurisy or inflammation of the lungs at the ER two days after receiving the vaccine.
States she had chest pain, heavy chest, SOB, joint pain, and vertigo. She did not report this to us (her PCP) she reported this to her Intergrative medicine Doctor after the fact, a few  months later, and he told her to have us report this to VAERS.
Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccinating Child had no ill effects thus far
Terrible arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Terrible arm pain) in a female patient of an unknown age 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 PAIN IN EXTREMITY (Terrible arm pain). At the time of the report, PAIN IN EXTREMITY (Terrible arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.The reporter contacted Moderna today 8Apr2021 and during the call mentioned that she had spoken with someone recently and that this someone's mom had terrible arm pain that lasted a week after receiving a Covid-19 vaccine dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-071208 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071208:crosslinked
Pain in her arm; Soreness in her breast; pain in her nipple; Lymph node; This is spontaneous report received from a contactable consumer reported for her daughter. A 37-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 06Mar2021 (age at vaccination was 37 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first Pfizer COVID vaccine on 06Mar2021 and immediately came home with pain in her arm on the side where she got the shot, pain in her nipple on the side that she got the shot and soreness in her breast on the same side as vaccine administration on an unspecified date, but the symptoms resolved. She stated that it went away after couple of days. She took some Tylenol and was fine. She stated that she knew there were lymph nodes in the area, but wanted to know if that was normal and how to treat it. She wanted to know if possible if it could be a lymph node. She wanted to see if there were other cases where not the lymph node but in the actual breast itself. She received the response which stated that lymphadenopathy is a commonly reported AE from the clinical trials but does not specify location of the lymph nodes in question. No information for timing of onset or duration. The patients in the trial were allowed to treat symptoms with acetaminophen or NSAIDs, if medically appropriate. The caller was referred back to HCP for evaluation and treatment. The outcome of the events pain in her arm, soreness in her breast and pain in her nipple was resolved on an unspecified date in 2021. The outcome of the event lymph node was unknown.  Follow-up attempts completed. No further information expected.
heart palpitations; severe chills; This is a spontaneous report from a contactable consumer (patient's husband) via medical information team. A 63-year-old female patient received BNT162B2 (COMIRNATY, solution for injection; lot number: er2613 and expiry date was not reported), via an unspecified route of administration, on 16Apr2021 (at the age of 63-year-old), as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection; lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for covid-19 immunization. On 16Apr2021, the patient experienced severe chills and heart palpitations that lasted for 3 hours. The reporter stated that, it was a 1-time event that lasted about 2-3 hours and the patient was fine afterwards. The outcome of the events was recovered on 16Apr2021.  No follow-up attempts are needed. No further information is expected.
Pain and redness at injection site the day following injection. Red, itchy rash on chest, back of neck, bottom of face, earlobe 1 week after injection. Self treated w/ BENADRYL (2 tabs) and some left over triamcinolone cream from previous unrelated script. Week 2 is substantially improved.
There area was raised, like a pimple; Arm was sore; Hair started falling out/unusual loss of hair; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair started falling out/unusual loss of hair), VACCINATION SITE MASS (There area was raised, like a pimple) and VACCINATION SITE PAIN (Arm was sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (since child), Cold (Sinus causes on set 3 pets), Penicillin allergy, Drug allergy (Amoxicillin), Drug allergy (Atorvastatin) and Drug allergy (Ditropan). Concomitant products included ROSUVASTATIN and LISINOPRIL for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ALOPECIA (Hair started falling out/unusual loss of hair). On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MASS (There area was raised, like a pimple) and VACCINATION SITE PAIN (Arm was sore). At the time of the report, ALOPECIA (Hair started falling out/unusual loss of hair) and VACCINATION SITE MASS (There area was raised, like a pimple) had not resolved and VACCINATION SITE PAIN (Arm was sore) outcome was unknown.            No treatment medication was provided.  Concomitant medication included Multivitamins.  No reaction to Moderna 1, 2 and Booster dose. Notified as unusual loss of hair about 3 months after the last shot.    This case was linked to MOD-2021-395763, MOD-2021-395777, MOD-2021-395825 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Significant FU: Patient demographic details added, allergic condition added, medical history added, Drug start date time updated,concomitants added, event outcome updated for hair loss.
At 11 pm the same evening of the 2nd shot (7/27/2021), patient experienced fever, nausea, severe headache, backache, chills.  The chills were severe and kept patient up for 5 hours.  All symptoms reduced in severity the next day.  Patient took ibuprofen to reduce headache and  backache.
April 2022 I noticed I was getting fatigued much sooner than ever before. By August 2022, I was short of breath after minimal exertion and fatigued after not much physical activity. In September of 2022, I had my annual exam with Medical Center. During my exam, the Dr told me he wanted an EKG after spending a lot of time listening to my heart. The EKG confirmed what he had suspected, there was Arterial Fibrillation. I was given a consult with a Cardiologist and to get an Echocardiogram (ECG) and started on Eliquis. The results of the ECG  were not readable do to poor image quality. The diagnosis of A-Fib was confirmed by the Cardiologist on 10/5/2022 and I was advised to continue on Eliquis. advised to follow up with the  Medical Center . I made appointments and my Cardiologist appointment is 12/1/2022.
Within 1 hour of receiving her first ever flu vaccine she became ill. -forceful vomiting, nausea, chills , sleepiness -last approx 20-24 hours -residual nausea & lack of appetite -reporting diarrhea but it is unclear if this is related to other Sx as she was reporting diarrhea on the day of her vaccination.
Initial report received on 18 May 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 12-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; received on 08 July 2011, 12 September 2011 and 02 December 2011 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 27 April 2012, approximately 5 months after the last dose. On 29 April 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 02 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 02 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
all kind of disease because my immune system not working after the vaccines; Psoriasis; 1st dose date 5Feb2021, 2nd dose date 13Mar2021; Headache; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (all kind of disease because my immune system not working after the vaccines), PSORIASIS (Psoriasis), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose date 5Feb2021, 2nd dose date 13Mar2021) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 052B21A and 037C21A) for COVID-19 vaccination.     Concomitant products included GLIBENCLAMIDE (GLYBURIDE) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (all kind of disease because my immune system not working after the vaccines), PSORIASIS (Psoriasis), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose date 5Feb2021, 2nd dose date 13Mar2021) and HEADACHE (Headache). The patient was treated with METHOTREXATE for Psoriasis, at an unspecified dose and frequency; FOLIC ACID for Psoriasis, at an unspecified dose and frequency; TRIAMCINOLONE for Psoriasis, at an unspecified dose and frequency and HYDROXYZINE for Psoriasis, at an unspecified dose and frequency. At the time of the report, IMMUNE SYSTEM DISORDER (all kind of disease because my immune system not working after the vaccines), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose date 5Feb2021, 2nd dose date 13Mar2021) and HEADACHE (Headache) outcome was unknown and PSORIASIS (Psoriasis) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient height mentioned as 5.5 feet.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Significant Follow Up- Corrective treatment added
Diarrhea; Chills; Soreness at the site of injection; Case reference number MOD-2021-008777 is a spontaneous case report sent by a Non-Health Professional on 17-JAN-2021 00:00:00 , which refers to a Male aged 64 Years .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  2 days later,  the patient developed Diarrhea. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed Chills,Soreness at the site of injection. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Diarrhoea . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Non-Health Professional did not declare any relatedness between Diarrhea and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .    Brief 3 line summary of above for  listing: Report Source- Non-Health Professional,  Age- 64 Years,  Sex- Male,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Diarrhea - Unknown,Soreness at the site of injection - Unknown,Chills - Unknown.
Patient given a Moderna booster per parent request, even though they received Pfizer for their primary series. No complaints of any reactions.
7 month Well child appointment. The patient was given KINRIX with DTaP and IPV; instead of PEDIARIX. It is recommended for children between 4 and 6 yrs. of age. They also received Hepatitis B vaccine and a PCV13 the same day of the event.
6 hrs after vaccine: low grade fever; 9 hrs after vaccine: fever, severe chills, moderate to severe body aches, inability to sleep; 15 hrs after vaccine: symptoms continued, fainted while walking back to bed after urinating, unconscious for about 1 minute; 21 hrs after vaccine: fever broke, no remaining symptoms whatsoever
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were reported. On 09-MAR-2016, the reporter vaccinated the patient with GARDASIL, 0.5 ml dosage, administered intramuscularly (dosage number, lot # and expiration date were not reported), even though the product in the vial did not appear as cloudy as it should be following agitation of the product. This was considered to be a product quality issue. However, no adverse effects were reported at the time of the report. Additional information is not expected since no consent for contact was provided.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-MAR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 632 hours, with the lowest recorded temperature of 34 degrees and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 9/25/2022 at 5PM I had sniffles and it felt like an asthma attack. On 9/26/2022 morning, I started to feel really bad. I had full blown aches, mucous, cough, shortness of breath, tearing of eyes, massive headache, and brain fog. I tried to call my doctor and did not get in touch. That came back 9/28/ positive COVID-19 test. On Thursday I got in touch with my doctor. They prescribed PAXLOVID, doxycycline and prednisone. I am basically taking 2 a day of each, and that seem to have done the trick because I had 2 COVID-19, negative tests. I still have a lot of mucous, a lot of brain fog, not able to concentrate, I am starting to get some of my taste buds back. It is really triggering my asthma. I have to use my nebulizer with albuterol twice a day. It is even doing something to my eyes, I am seeing blurry, raised blood pressure.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 4 (booster), single (Lot number: GJ6796) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "Known allergies: Bacitracin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Experienced a rebound of COVID symptoms approximately 3 days after finishing Paxlovid course.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300261669 same patient, different drug/event;
A patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Number of doses or vials reported as 1 dose but there may be more. Date the vial was initially stored in the refrigerator was unknown by the hcp. Vial did not undergoes any temperature excursions. No Treatment medications were reported.