chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a field representative refers to a 4 year old male patient. No information about medical history, drug reactions and allergies was specified. The field representative reported that on 28-AUG-2014 the patient went for a routine check up, received one shot of (Oka-Merck) PROQUAD (lot#, dose not reported), injection in each arm, subcutaneously for routine vaccination. Concomitant therapies included QVAR. On 29-AUG-2014 the right arm was sore. The next day it continued to swell from "his shoulder to his elbow". It looked like he had a purple sleeve and arm was also hot (also reported as 28-AUG-2014). The field representative called the doctor and the doctor said it was "normal". The doctor did not say that she needed to report the AE. There was no product quality complaint. The outcome was reported as recovered on 31-AUG-2014. The causality of the events was not specified. Additional information has been requested.
arm soreness at site of injection; patient inadvertently received VARIVAX vaccine; This spontaneous report was received from a licensed practical nurse referring to an 18-year-old non-pregnant female patient. Information of concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications was unknown.   In 2005, the patient was vaccinated with 1st dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection intramuscularly for prophylaxis, and in 2009, the patient received 2nd dose of varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly (both strength, dose, lot#, expiration date and anatomical location were unknown). On 21-APR-2023, the patient inadvertently received varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly (0.5 milliliter (mL), lot# W031811, expiration date 05-OCT-2024, strength and anatomical location were unknown) (extra dose administered).  At the reporting time, the patient complained of arm soreness at site of injection of most recent dose (vaccination site pain) (onset date reported as 21-APR-2023). It was unknown if any lab diagnostics or studies were performed. The patient did not seek for any medical attention or receive treatment. The outcome of the event vaccination site pain was reported as recovered.   The causality assessment between the suspect vaccine and event vaccination site pain was not provided.
Pfizer Orange cap 5-11 covid19 vaccine wasn't diluted with 1.3.ml of saline and 0.2ml dose was administered from the original stock vial.
Developed shingles 12/19/2022; took antiviral medication started to improve.
Today I had tachycardia which has remained at 95-120 BPM since it happened (8:30 am); Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 13:00 (Lot number: FJ8762) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 23Mar2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 02Mar2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021 13:00, outcome "unknown", described as "Booster"; TACHYCARDIA (non-serious) with onset 20Dec2021 08:30, outcome "not recovered", described as "Today I had tachycardia which has remained at 95-120 BPM since it happened (8:30 am)". Therapeutic measures were not taken as a result of tachycardia.  Additional Information: Prior vaccination within 4 weeks was reported as none. The patient had no known allergies. Prior to vaccination, patient was diagnosed with COVID-19 and since vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Pt. states that after receiving the 3rd dose of Moderna 12/09/2021, started experiencing symptoms 12/11/2021 chills, fever (103.0), and headache. Resulting in Fever Blisters surrounding the nostrils. Primary communications recommendation Observation and reporting. Symptoms have subsided with lingering fatigue and dehydration,
Vertigo, disequalibrium that is ongoing more than three months later. Daily at first with severe symptoms on November 24, 2011. By January 2012, had three- and then five-day stretch with no symptoms, but they continue.
Patient felt light headed. Sat down. Eyes rolled back. Patient slid off chair to the ground. Was unconscious for a minute and woke up on the floor. He was breathing fine and was alert and oriented on the ground when he woke up.
Few hrs later arm sore, muscle sore/stiff, hard to lift arm injection given in, neck on that side stiff. Slight headache. Couldn't sleep on that side of body.
The pt experienced hives, was cranky, had fever, experienced redness and swelling of left deltoid at the injection site and heat at site.
Mother presents with child to get opinion about rash - sudden onset of flat, diffuse, layered rash on cheeks, thighs and trunk - denies fever (says 98.5 R). No change in child's normal behavior - mom says has had 2 days of diarrhea. Recommended doctor visit.
Pfizer-BioNTech COVID-19 Vaccine EUA. This last night I experienced chills and a low grade fever, along with weakness. It doesn?t feel like I have a fever currently but weakness is still apparent.
myalgias; slight fever; difficult to sleep; sweating profusely; injection site pain; This case was reported by a other health professional via call center representative and described the occurrence of myalgia in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On 19th September 2019, the patient experienced myalgia, fever, difficulty sleeping and excess sweating. The patient was treated with paracetamol (Acetaminophen). On 21st September 2019, the outcome of the myalgia was recovered/resolved. On an unknown date, the outcome of the fever, difficulty sleeping and excess sweating were unknown and the outcome of the injection site pain was not recovered/not resolved.   The reporter considered the myalgia, fever, difficulty sleeping, excess sweating and injection site pain to be related to Shingrix.  Additional details were provided as follows: This report concerns to patient himself. The patient did not receive any other vaccine at the same time. Approximately 8 hours after receiving a dose of Shingrix, the patient began experiencing myalgias and slight fever (101 degrees F). The patient took acetaminophen which helped, and during the evening, it was difficult to sleep for him and he was sweating profusely. The myalgias continued into 20th September 2019 during which the patient continued taking acetaminophen. The patient also experienced some injection site pain which was continuing at the time of reporting.  The myalgias fully resolved by A.M. of 21st September 2019 and the patient had ceased acetaminophen. The patient stated, the injection site pain was minor. There were no other local reactions. The suspect vaccines course was not discontinued. The report did not include any product complaint. The reporter agreed to be followed up.
Heart palpitations caused by Myocarditis which resulted in premature ventricular contraction (PVC)
9 yr old male received vaccine from Purple vial, essentially. No adverse reactions noted during time in clinic.
Elevated blood pressure, heart palpitations, heart flutter, racing and increased pulse rate,  syncope, pvc,  cold extremity (feet and toes), all starting in March 2021, and continuing to present.  PCP office visits with ekg, , referral to and cardiologist visit, heart monitor x2 weeks, paramedics, inpatient hospital treatment with nitro glycerin/ ekg x3/ heart stress test  Myocardial perfusion rest stress exercises spect cvis, Tc99 Sestamibi x2), X-ray chest PA and lateral,
Red, swollen, warm, tender to touch welt below injection site roughly 3 inches in diameter lasting about 72 hours.
Initial report was received 04 September 2008 from a health care professional.  A five-year-old patient received an injection of DAPTACEL (lot number, date, route/site of vaccination not reported) and an unspecified amount of time later, they developed 2-3 cm swelling, with no redness, that had been sore to touch.  Five days post immunization, a red band developed below the injection site that was hot to touch, itchy and bumpy.  Over time (amount of time not specified), the band continued around the arm, almost to 360 degrees.  The patient was evaluated by a physician.  It was not reported if the patient had recovered.  No further information was provided.  17 September 2008: Corrective version created with the same latest date as the prior version to amend the received ate to 04 September 2008 in the source for the health care professional.  Follow-up information received on 14 November 2008 from a physician.  The patient received on 22 August 2008, the fifth dose of DAPTACEL (lot number C2950AA, expiration date 28 February 2010) in the left arm, and an additional second injection of "MMR" (manufacturer Merck, Lot number not provided) in the right arm.  The patient recovered.  Per the reporter, they have no further information to provide.  No further information is expected.  17 November 2008:  A corrective version was created with the same latest received date as the previous version (17 November 2008) in order to amend the expiration date of the DAPTACEL in the above narrative from 17 March 2008 to 28 February 2010 for lot number C2950AA.  The adverse event of medication error was also removed from the case as the product was given appropriately.  It was also noted that the patient had been evaluated by a physician and this information was added to the first narrative dated 04 September 2008 as reported by the health care professional at that time.  No other relevant medically significant information was added to the case.  Documents held by sender:  None
This spontaneous report as received from a Registered Nurse via a company representative refers to a 12 month old patient. On 18-JUL-2017, the patient was vaccinated with VARIVAX for prophylaxis. Other suspect therapies included sterile diluent. On 20-JUL-2017, 2 days after onset of therapy the patient experienced varicella. The outcome of varicella was unknown.
Continuously headaches - something like poking inside my head; This is a spontaneous report from a contactable 45-year-old male Other health professional reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK9231, and Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 12Jan2021 (at the age of 45-year-old) as single dose for COVID-19 immunization. The patient medical history included raw shrimp allergy. No other medical history was reported. The concomitant medications for patient were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1685, and Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 23Dec2020 at 03:30 PM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. On 12Jan2021 at 14:00, the patient had an event described as "continuously headaches - something like poking inside my head". The patient had emergency room visit and physician office visit. The patient received unspecified pain medications as treatment. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
short of breath, cough, nausea, weakness, diarrhea, fatigure
Date vial was initially stored in the fridge 14Dec2022 and administered on the 14Jan2023; No adverse event; 9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (Date vial was initially stored in the fridge 14Dec2022 and administered on the 14Jan2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vial was initially stored in the fridge 14Dec2022 and administered on the 14Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (Date vial was initially stored in the fridge 14Dec2022 and administered on the 14Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and PRODUCT STORAGE ERROR (Date vial was initially stored in the fridge 14Dec2022 and administered on the 14Jan2023).    No concomitant medication was reported.  It was unknown if any other vaccines in the 4 weeks prior to COVID-19 vaccine was received.  9 patients received doses of the Moderna COVID-19 vaccine bivalent after its beyond use date lot AS7168B.  On 14-Dec-2022, the vial was initially stored in the fridge.  Pharmacist would like to be advised about the stability information, validity of the doses and if the patients should be revaccinated.  Vials was of size 2.5ml which did not undergo any temperature excursions.  This case contains information for the 2nd of 9 patients described by the reporter.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704964 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704964:Master case - 1st adult patient (vaccine start date: 13-Jan-2023)
This spontaneous report was received from a pharmacist, via a company representative, concerning a male patient of unknown age. Medical history and concurrent conditions were not reported. In 2013 (reported as received the vaccine about one year ago) the patient was vaccinated with a dose of ZOSTAVAX (dose reported a single shot)(strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The pharmacist reported that, "an anonymous patient (demographics unknown) received the ZOSTAVAX vaccine about 1 year ago (specific date unknown)(approximately in 2013) and got shingles 2 weeks after receiving the ZOSTAVAX vaccine. At the time of the report the outcome was unknown. Additional information has been requested.
Deceased 11/19/2021; Hospitalized 11/11/2021; COVID-19 positive 11/13/2021; fully vaccinated  BRIEF OVERVIEW: Admission Date: 11/11/2021 Discharge Date: Nov 19, 2021   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Generalized weakness AKI (acute kidney injury) Altered mental status, unspecified altered mental status type Venous stasis ulcer of other part of left lower leg with fat layer exposed with varicose veins Venous stasis ulcer of other part of right lower leg with fat layer exposed with varicose veins Pneumonia due to COVID-19 virus COVID-19 AMS (altered mental status)   HOSPITAL COURSE: 90 y.o. male who presents today from assisted living with one week of progressive generalized weakness and AMS. PMHx of venous stasis ulcers on legs chronic, unhealable, CAD, HTN, pacemaker, PAF, CKD3, h/o PE and DVT on Eliquis. Patient was actually enrolled in hospice recently to try to achieve better pain control for leg ulcers, despite life expectancy being >6 months. He had been started on neurontin and hydromorphine, then the narcotic was changed to moprhine.  Patient has CKD. In the ED he was noted to be COVID+ but on RA.  He was admitted for further care.     Neurontin and narcotics were held and patient's mental status improved. Palliative care was consulted and began oxycodone for pain control. This was titrated up.  Initially patient remained on RA and was symptoms free with the covid19 infection. Repeat CXR was consistent with multifocal PNA and PCR confirmed covid +. Was offered monoclonal AB treatment but declined. On 11/14 patient began declining again with AKI and hypotension and worsening AMS. Lactic acid was normal, WBC 11.  CXR 11/14 showed new medial rt lung base opacities concerning for aspiration/PNA.  Unchanged lt opacities.  Blood cultures sent and zosyn given while ruling out superimposed bacterial infection. Given worsening renal function, despite patient not having had received narcotics in the past 12 hours, narcan was given with good response.  Narcotics held.  Patient was placed on IVFs and bolused. Starting on 11/14 patient began to have an O2 requirement and was started on Decadron. After initial narcan patient then had recurrent hypotension and sedation.  2nd narcan given with some response.  At this point discussion was had with daughter regarding goals of care. As patient was at the beginning of his covid course, which was likely to continue to worsen, having AKI, AMS, and then bleeding and severe pain from his chronic LE venous ulcers, We made the decision to pursue comfort care.  All aggressive interventions were discontinued and patient was started on comfort medications.  Hospice were consulted.      The patient was discharged home with hospice on 11/19/21.
1st dose 5 months ago, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received the first dose of Engerix B 5 months ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-FEB-2023  Reporter's Comments: The pharmacist reported that the patient never got the second dose of Engerix B.  The reporter asked how to proceed with this patient. The reporter did not have data about the first dose given to the patient like lot number or expiry date. The administration date of the first dose of Engerix B was not provided.  The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Engerix B, which led to incomplete course of vaccination.
Information has been received from a 74 year old female with high cholesterol, allergic  to sulfur medication, penicillin and erythromycin who on 04-JUL-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included SYNTHROID, DETROL LA, NEURONTIN, PLAVIX, baby aspirin, simvastatin (manufacturer unknown), metoprolol, calcium (unspecified) and vitamins (unspecified). Two days after getting the vaccine, on 06-JUL-2008, the patient developed redness, soreness and warmth (the size of a coffee cup) at the injection site. As of the day of reporting, the patient was recovering. The patient sought unspecified medical attention. No further information is available.
Rash - localized papules. No bullae or blisters around site of injection (left upper thigh) Possible folliculitis but possible local varicella from vaccine.
trouble thinking; trouble concentrating/ forget how to play piano; felt that everything; Muscle pain; visual disturbances; flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty thinking in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th October 2019, less than a day after receiving Shingrix, the patient experienced muscle pain, visual disturbance and flu like symptoms. On 30th October 2019, the patient experienced difficulty thinking (serious criteria GSK medically significant), concentration impaired and feeling abnormal. On 1st November 2019, the outcome of the muscle pain, visual disturbance and flu like symptoms were recovered/resolved. On an unknown date, the outcome of the difficulty thinking, concentration impaired and feeling abnormal were recovering/resolving.   It was unknown if the reporter considered the difficulty thinking, muscle pain, visual disturbance, flu like symptoms, concentration impaired and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The reporter called on behalf of his mother.  The patient received the Shingrix in her left arm. On the same day, the patient developed muscle pain, flu like symptoms and visual disturbances. She took over the counter medications to treat these symptoms and these symptoms had resolved by that Saturday. The day after receiving the vaccine, patient had trouble thinking and concentrating. She felt that everything was moving slowly and she forgot how to play the piano. The patient's mental status started to improve on Saturday, however, she did not feel 100 percent back to normal till the time of reporting. The reporter did not consent to follow-up. This case has been linked to US2019203777, reported by the same reporter.