chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner via a company representative refers to a 85-year-old female patient. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On an unknown date, when the patient was 78 years old, she was vaccinated with unspecified pneumococcal vaccine (reported as "product administered might have been PNEUMOVAX 23") (exact dose, dose number, lot #, expiration date and route of administration were not reported) for prophylaxis. On an unknown date at 85 years of age, the patient was diagnosed with cancer. The outcome of the event and the causality assessment between the event and PNEUMOVAX 23 were not provided. Upon internal review, the event of cancer was considered to be medically significant.
Left axilla lymph nodes swelled during the night after vaccine on Monday morning and were very painful. Pt reports using a heating pad even though was advised to only use ice for inflammatory response if occurred. Took ibuprofen for continued discomfort. Reports swollen lymph nodes did go away after Saturday morning so lasted 4 days with Wednesday being the worst and then slowly getting better.
Swollen lymph nodes in armpit in the same arm the injection was given. Quite a bit of pain and will be going back to the doctor.
12MAR pt recv vax & 13MAR arm very sore;14MAR can't lift arm;21MAR arm still sore, can't life, aching;25MAR MD visit recommends Ibuprofen;14MAR arm aches @ noc wakes pt up, feel tired & grouchy everyday;arm aches deep in bone;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 07-Aug-2012, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-Nov-2015, the patient was treated at a medical office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Tenderness, redness, swelling at administration site, rash on body - appeared & lasted 2/23/11 to 2/27/11. Pt did not report to ED & symptoms resolved by 2/28/11. She used one dose of Ibuprofen 250mg.
Mom states that he pt was crabby on 11/4/00 with chills, refused to eat, had a large red hard spot on arm at the Prevnar site. Mom states took to pediatrician on 11/6/00. Red spot measured 2 1/2 x 3 inches, red, raised and hard.
PATIENT STATES THAT SHE HAS A RASH ON THE ARM THAT SHE RECEIVED THE IMMUNIZATION. THE RASH EXTENDS UPWARDS TO HER NECK. THE RASH IS NOT ITCHY OR PAINFUL. NO SWELLING REPORTED
This is a spontaneous report obtained from a contactable consumer (patient). A 71 year old female patient received, on 08May2017, PREVNAR 13 in the left deltoid, single dose, for immunization. Relevant medical history included depression. No illness at time of vaccination were noted. Concomitant medications included citalopram hydrobromide 20 mg, once daily, for depression (ongoing), bupropion Hcl 300 mg, once daily, for depression (ongoing), ASPIRIN once daily (ongoing), B12 from May2017 (ongoing) and hepatitis C vaccine (within 4 weeks) in the left arm, for immunization. On 08May2017, the patient's left upper arm was sore. On 09May2017, the patient's large area was red and was very, very hot and on 10May2017 was probably covering one fourth if not one third of her arm. The patient was recovering from the events at time of this report.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse regarding a female physician who inadvertently experienced Prevnar squirted into her eye. Relevant medical history was not provided. Inadvertent exposure to Prevnar being squirted into her eye. Concomitant medications were not reported. The physician inadvertently experienced Prevnar being squirted into her eye on 7/11/2005. The physician noted that it was due to a faulty needle. The reported noted that the physician rinsed her eyes with water and stated that the physician experienced very mild irritation, Accidental exposure. No additional information was available at the time of this report.
Unable to wake up for more than two minutes. Pale and couldn't tell if she was breathing or not. Was rushed in the ER upon visit they said everything came back normal. And they didn't want to keep her because they thought it would only stress her out. She also got a rash, high fever, diarrhea and cold a flu symptoms that lasted for 4-5 days after the vaccines. She still has a "rash" that comes and goes on her face. She was also seen by Local urgent care and her pediatrician.
1 hr after HBV #1 patient experienced a migraine HIA stabbing pain radiating from back of head through to the front.  With chest pains and SOB
Information has been received from a registered nurse concerning an elementary school aged child who was vaccinated with a dose of varicella virus vaccine live. On approximately 23-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/12/2006 Information has been received from a registered nurse concerning an elementary school-aged child who on 17-SEP-2001 was vaccinated with a dose of VARIVAX (Merck). On 02-MAR-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Patient was administered a flu vaccine and had no issues at the time. Before administration I verified patient had no previous vaccine reactions or known allergies. Patient left after administration and came back a few minutes later for a new bandaid because he noticed he was bleeding a little. As I was changing the bandaid I noticed he had some swelling localized to the injection site. I gave the patient a new bandaid and had them sit in the immunization room while I got an ice pack. When I inspected the site a few minutes later the swelling appeared to have minimized but I still gave the patient an ice pack. I had patient sit for about 25 minutes and talked with them. Patient said they had no pain at the injection site and felt normal. They were unaware of any swelling at the time. After sitting for about 25 minutes I let the patient leave with an ice pack because they did not feel they needed to stay any longer.
body aches, chills that lasted about 12 hours took Ibuprofen, not sure if it helped or not
Pt complain of a swelling arm, with hot to the touch and overall pain at the injection site that radiate down close to her elbow. Pt was told to put a cold compress on the affected area, TYLENOL for pain and BENADRYL for the swelling.
About five weeks after the vaccine I had an afib which woke me up around 04:00 AM. By 09:30 AM I went to the emergency room. My heart rate was up to 161BPM. They diagnosed me with hyperthyroidism. I saw the cardiologist the following day. He did an EKG and bloodwork. He prescribed me blood thinners. He advised I should visit an endocrinologist.  02/16/2022 I did see an endocrinologist and he advised that I have graves disease.  He prescribed Tapazole.
Large red, raised rash that was approximately 8 inches in diameter and spreading across patient's arm.
her period will not stop; breast tenderness; breast retraining water and bloated.; arm soreness; increased heart rate when trying to go to bed; sleep disturbance; mood was affected; very depressed/felt awful; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased heart rate when trying to go to bed), SLEEP DISORDER (sleep disturbance), MOOD ALTERED (mood was affected), DEPRESSED MOOD (very depressed/felt awful) and FATIGUE (exhausted) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HEART RATE INCREASED (increased heart rate when trying to go to bed), SLEEP DISORDER (sleep disturbance), MOOD ALTERED (mood was affected), DEPRESSED MOOD (very depressed/felt awful) and FATIGUE (exhausted). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On an unknown date, the patient experienced OLIGOMENORRHOEA (her period will not stop), BREAST TENDERNESS (breast tenderness) and BREAST OEDEMA (breast retraining water and bloated.). On 21-Mar-2021, HEART RATE INCREASED (increased heart rate when trying to go to bed) had resolved. On 22-Mar-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 24-Mar-2021, FATIGUE (exhausted) had resolved. At the time of the report, SLEEP DISORDER (sleep disturbance), MOOD ALTERED (mood was affected), DEPRESSED MOOD (very depressed/felt awful), OLIGOMENORRHOEA (her period will not stop), BREAST TENDERNESS (breast tenderness) and BREAST OEDEMA (breast retraining water and bloated.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
t104 started 4 hr p/vax given APAP q 4 hr;temp stayed 104 for 9 hr would not drink x 48 hr-vomited 72hr-pedialyte;seen in ER by MD thought problems were caused by pertussis vax-lethargic
This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with doses of improperly stored (temperature -9.8 C for 15 hours and 42 minutes total cumulative, because of data logger) (Merck) VARIVAX, lot # K002921, expiry date 26-FEB-2016; lot # L013827, expiry date 27-APR-2017 (dose, frequency and route of administration not reported). Previous temperature excursion was reported. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
got COVID twice; got COVID twice; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he caught COVID disease twice.  Clinical Course: 10-17 years. Reports he caught COVID disease twice, has received COVID vaccine, And he don't have a booster, cause he got two shots and got COVID twice. Causality was Not reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Client was monitored for 15 min post vaccination. While walking to her vehicle, she reported to her family members that she was dizzy and was escoted to a chair nearby in the parking lot. The client began to vomit. The client was assessed by staff and it was noted that her HR was elvated in the 140s. The Ambulance was then called  due to the client continuing to vomit and report of tightness in her chest. The Paramedics arrived and the client was taken to a nearby hospital for further evaluation and care.
9/27/23- Woke up with a swollen face, rash all over body, itching. Saw dermatologist and next day, 9/28/23 went to clinic. Given prescriptions: Prednisone and hydroxyzine HCL. 10/5/23 - woke up and could not walk and my right foot was ice cold. Daughter took me to the emergency room at Hospital and was admitted and had surgery to remove blood clots.  A fasciotomy was done.  I was in the hospital for 5 days.  Had difficulty with my left arm and not able to lift it and had constant pain.  After discharge, I saw a neurologist who ordered an MRI of my neck and spine to find a solution.  Referred me to a rheumatologist who ordered blood work and an MRI of the left shoulder.  Still under doctors care and unable to work at this time.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  09/20/2021 Is this your first or second dose- 1st Date of symptom onset - ? 09/20/2021 Symptoms - ? metallic taste in mouth 20 to 30 minutes after receiving vaccine, fever of 101, heavy headed Last day of work and shift - ? NA Home remedies- employee took tylenol for fever at 1730 Any improvement- No improvement as of yet Recommendation- Advised employee to continue taking tylenol per package instructions as needed, monitor symptoms and if they worsen to follow up with doctor or urgent care.  Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
Moderna COVID shot 1 given 3/13/21 and shot 2 given 4/11/21. Patient developed some vague back pain for last 2 days starting 6/19/21 intermittently between the shoulder blades.  Patient states in last 24 hours he noticed increasing shortness of breath and shoulder pain worsened with exertion.  Patient was found to have suspected myocarditis induced NSTEMI + Heart Failure with Reduced Ejection Fraction to 40%. Patient now requires several medications including ASA, carvedilol, lisinopril, KCl, and ivabradine. Patient only other past medical is obesity (BMI ~45), and family hx of elderly onset CAD of a maternal grandfather who smoked.
Information has been received from a consumer's mother concerning her 2 year old daughter with no prior medical history and no known allergies who in February 2000, was vaccinated with a dose of MMR (second generation). Concomitant vaccination included a dose of diphtheria toxoid/pertussis vaccine/tetanus and a dose of poliovirus vaccine, as well as two other normal childhood vaccines. Following vaccination, the patient developed a fever of 102F and had a staring seizure. Unspecified medical attention was sought. Upon internal review, staring seizure was determined to be an other important medical event (OMIC). Additional information has been requested.
Pt. called office to report pain and swelling at injection site.  Denies redness, heat, or drainage.  Also denies having SOB or chest pain.  Pt. unable to lift arm past shoulder and swelling is from elbow to shoulder.
Information has been received from a father concerning his son who on 06/24/00 was vaccinated with one dose of varicella vaccine. On 07/01/00 the pt developed a rash all over his body "like a blanket" and a fever of 101 F. The father noted that the pt was also rubbing his eyes. On an unspecified date the fever resolved, however, the rash continues. the pt did not seek medical attention.
Went to bed at 11:00 pm on June 23, 2022 was awakened at 1:00 am with extreme diarrhea and vomiting.
No adverse event. Patient was inadvertently given 2017-2018 formula of AFLURIA. Upon discovery of the error patient was notified immediately and was then revaccinated with current formula. 2017-2018 AFLURIA was transferred to our store recently from another pharmacy along with current 2018-2019 formula and was not noticed until after vaccination had been given. Last years vaccine immediately taken out of inventory upon discovery.
This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second dose were longer than recommended) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine)    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second dose were longer than recommended) and NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second dose were longer than recommended) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second dose were longer than recommended).    No concomitant medications were reported. Patient's age was reported as 2.7 years.  No treatment details were reported.
Vial was in the refrigerator for about 12 hours, 2 patients were injected with the same vaccine vial for their first dose; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vial was in the refrigerator for about 12 hours and 2 patients were injected with the same vaccine vial for their first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, the patient received their first of two planned doses of mRNA-intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, eight doses were used from a vaccine vial and the vial was stored on an ice cooler between patients. When finished for the day, the punctured vial was kept in the refrigerator under the recommended temperature range.   On 24 Dec 2020, after the vial that was initially punctured at an unknown time on 23 Dec 2020, was in the refrigerator for about 12 hours, two patients were injected with same vaccine vial for their first dose. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event, vial was in the refrigerator for about 12 hours and 2 patients were injected with the same vaccine vial for their first dose, was considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2020-001778:Same reporter, same source, different patient
Expired vaccine was stored on 18-Oct-2021 and was administered on 26-Oct-2021; 601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored on 18-Oct-2021 and was administered on 26-Oct-2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored on 18-Oct-2021 and was administered on 26-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored on 18-Oct-2021 and was administered on 26-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Date the vial was placed in refrigerator was on 18-Oct-2021. Temperature excursion was not reported. The patient did not experience any adverse event. The reporter stated that initially there were 606 doses from expired lot and they found out later that some patients that were impacted had received the Janssen COVID-19 vaccine. Treatment information was not provided