chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did not get the full dose of vaccine after the syringe malfunctioned and was provided half of a dose from a different syringe; The syringe malfunctioned; Slightly sore arm; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a slightly sore arm/vaccination site pain, did not get the full dose of vaccine after the syringe malfunctioned and was provided half of a dose from a different syringe/accidental overdose and device connection issue.  The patient's medical history was not  provided. Concomitant medication history was not provided.  On 19 Feb 2021, the patient received their second dose  of two planned doses of mRNA-1273 (Lot number: 022M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The syringe malfunctioned and the states that she did not get the full dose of vaccine and was provided half of a dose from a different syringe.  On same day she had slightly sore arm.  Treatment of these events were not provided.  The outcome for sore arm was unknown and recovered for accidental overdose and device connection issue .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site pain, a causal relationship cannot be excluded.  The causality for the event of vaccine underdose and syringe connection issue is assessed to be Not Applicable.
Hotness in right arm; Itchiness on right arm; Burning in right arm; Swelling in the right armpit; Swelling in right arm; Rash on right arm; Soreness in the right armpit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Hotness in right arm), VACCINATION SITE PRURITUS (Itchiness on right arm), VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE RASH (Rash on right arm) and AXILLARY PAIN (Soreness in the right armpit) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE RASH (Rash on right arm), AXILLARY PAIN (Soreness in the right armpit) and VACCINATION SITE LYMPHADENOPATHY (Swelling in the right armpit). On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hotness in right arm), VACCINATION SITE PRURITUS (Itchiness on right arm) and VACCINATION SITE PAIN (Burning in right arm). At the time of the report, VACCINATION SITE WARMTH (Hotness in right arm), VACCINATION SITE PRURITUS (Itchiness on right arm), VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE RASH (Rash on right arm), AXILLARY PAIN (Soreness in the right armpit), VACCINATION SITE PAIN (Burning in right arm) and VACCINATION SITE LYMPHADENOPATHY (Swelling in the right armpit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medications included fluocinonide 0.05% cream, tylenol and Claritin.
pt recv vax 7 12 to 15hr later pt devel flu sx including fever, chills, diarrhea, h/a & sore throat;pt was unable to get out of bed for 2 days;
it was rpt pt 2nd dose of vax & subsequently pt VZV IgG test revealed lack of seroconversion. MD felt lack of response was not related to therapy w/varicella
Patient received the Moderna COVID19 booster vaccination (3rd dose) as opposed to the Pfizer (the vaccination the patient initially received for the first 2 doses early 2021.)   Patient showed no signs or symptoms of any adverse event.
One week after getting vaccine I developed the Shingles even though I had Shingles vaccine; More than nine months after vaccination I am still experiencing the neurologic symptoms.; This is a spontaneous report from a Contactable Consumer (patient). A 91-Year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262), via an unspecified route of administration, administered in right arm on 20Jan2021 at 14:00 (at the age of 91 years old) as a single dose for COVID-19 immunisation. The patient's medical history included arthritis, kidney disease, edema from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient having known allergies with Iodine, Sulfa, Morphine, Demerol, Ultram. The patient did not receive other vaccine in four weeks. The patient's concomitant medication included Synthroid (LEVOTHYROXINE SODIUM), Predisone (PREDNISONE), Lyrica (PREGABALIN), Xeljanz (TOFACITINIB CITRATE), Amlodipine (AMLODIPINE) for unknown indication start dates and stop dates were not reported. One week after getting vaccine on 04Feb2021 the patient experienced the shingles even though the patient had Shingles vaccine and more than nine months after vaccination the patient was still experiencing the neurologic symptoms. The patient got admitted to hospital for 3 days. The patient received bandages, valacyclovir as treatment. On 18Jul2021 the patient underwent lab tests and procedures which included SARS-CoV-2 antibody test (Nasal Swab) and the report was negative. The outcome of the events was recovered with lasting effects on unspecified date.
Fever. Weakness. Hallucinations.Severe headache. Unable to get out of bed for 24 hours.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.
101.5 degree temperature for 18 hours  5"x4" welt/bright red throbbing itchy injection site reaction, temperature at injection site with infared thermometer was 102.9 degrees
Flu like symptoms for 2 days post injection.  In the weeks since, mild alcohol consumption results in two days of severe vertigo
no adverse event; a dose of VARIVAX was administered after a temperature excursion; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-SEP-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot #W002601, expiration date: 24-JAN-2024 (strength, anatomical location, and route of administration were not provided) as prophylaxis, after experienced a temperature excursion of 5.7 Fahrenheit degree during 30 minutes with a previous temperature excursion of 6 to 14 Fahrenheit degree for 1 hour and 6 minutes. No adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2209USA003958:MSD
had 3 shots and I still get them just not as bad/suspected Vaccination failure; had 3 shots and I still get them just not as bad; had 3 shots; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient was the reporter itself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 3 doses of Shingles vaccine and experienced shingles. The patient received 3rd dose of Shingles vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
leukemia advancing or progressing; leukemia advancing or progressing; white blood cells have quite taken a jumped up to 20,000; This is a spontaneous report from a Pfizer-sponsored program , received from a contactable Other-HCP via medical information team. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 2, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said that when she went to her doctor in May2021 after having received two doses of the vaccine, her white blood cells have quite taken a jumped up to 20,000 and heard that after getting the vaccine the white blood cells can go up. Her physician told her that it might be her leukaemia advancing or progressing, but he said some people are getting their elevated white blood cell count from the Pfizer COVID vaccine. Caller was going to see her doctor again next week and wants to know if Pfizer have seen increase in white blood cells as a side effect after receiving the vaccine. Adverse events resulted into physician's office visit. The patient underwent lab test which included White Blood Cell count: white blood cells jumped up to 20,000 on an unspecified date in 2021. The outcome of events was unknown.  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 have been completed and no further information is expe; Sender's Comments: Based on the limited information provided the role of the vaccine BNT162B2 in contributing/triggering the event advancement or progression of leukemia cannot be meaningfully assessed nor excluded. The case will reassessed once information regarding patients medical history and concomitant medications are available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Shortly after the vaccine I felt heart palpitations, shortness of breath at times, and  slight fatigue. It usually occurs when I?m not doing any physical activity and I started to try to record heart rhythm  on my smart Watch.
Day after vx given developed redness, swelling that extends from vx site to just below elbow. Nl ROM of arm, 2+ radial pulse positive TTP at site o/w no TTP.
Pfizer on 12/30/20 and 1/20. Positive on 10/26
numbness around lips and mouth; tingling around lips and mouth; This case was reported by a physician via sales rep and described the occurrence of hypoesthesia oral in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hypoesthesia oral and paresthesia oral. On an unknown date, the outcome of the hypoesthesia oral and paresthesia oral were unknown.   It was unknown if the reporter considered the hypoesthesia oral and paresthesia oral to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comments: The physician reported that the patient received first dose of Shingrix at a local pharmacy and after the shot, the patient reported feeling numbness and tingling around the lips and mouth. The patient was not sure if she should take the second dose.  The doctor did research and felt the patient should not take the second dose. This was all the information available. The reporter did not consent to follow up.
pt recv vax 1AUG96 & 7MAY97 pt devel approx 15 lesions;
I had Tingling on my left hand, in my pinky, had of my finger #4. This started October 1st, 2022. On Feb 9th, 2023, I saw tour doctor and he referred me to have an EMG, I had it and the diagnose was that I had Ulnar Neuropathy at the elbow. It is a mild to moderate case.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 11/23/2022 ATRIAL FIBRILLATION, UNSPECIFIED  SHOCK, UNSPECIFIED 11/23/2022 ATRIAL FIBRILLATION, UNSPECIFIED
Patient came into Pharmacy on 7/10 stating having pain and redness in injection site. Stated injection site feels a little warm to touch but not hardening. Told patient expected soreness and redness for about 2 to 3 days after injection. Told patient to contact PCP if gets worse after three days and if not resolved by 7 days.
Started feeling a fever, headache, cough, aches and chills. Took a home COVID-19 test and it was positive. Had a telehealth appointment with my Dr. and was prescribed PAXLOVID. Took full course of PAXLOVID. Took another home COVID-19 test and it was negative.
This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered 0.5mls of Moderna of 6m-5 year vaccine to an 8 year old patient.) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Administered 0.5mls of Moderna of 6m-5 year vaccine to an 8 year old patient.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered 0.5mls of Moderna of 6m-5 year vaccine to an 8 year old patient.) 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 WRONG PRODUCT ADMINISTERED (Administered 0.5mls of Moderna of 6m-5 year vaccine to an 8 year old patient.).    No concomitant medications were reported. It was reported that the  patient was given 0.5mls of Moderna of 6m-5 year vaccine to an 8 year old in error and asking if it was equivalent.  No treatment information was reported.
10 month old patient  given 6-11 year dose  of 0.2mL Pfizer.  Post vaccine symptoms included productive cough, runny nose, diarrhea, malaise
Migrating pain from below armpit through shoulder through upper arm and lower arm to wrist on left side. Injection was given in upper left arm.  Pain has lasted 10 days and shows no sign of improving.  Pain is similar to that received by blunt force trauma.  Saw doctor today on the 10th day and received an EKG to rule out heart issues.  EKG was normal.  Doctor recommended continued use of Ibuprofen.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: en6200), on 22Mar2021 as dose 2, single (Lot number: er8727), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: ff2589) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to Iodine" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Negative, notes: Negative test after completing 5 day course of Paxlovid; (01Jun2022) Positive, notes: positive antigen test 7 days after the negative test; (05Jun2022) Positive, notes: a positive antigen test 11 days after the negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Negative test was performed after completing 5 day course of nirmatrelvir; ritonavir (PAXLOVID) followed by a positive antigen test 7 days after the negative test. and a positive antigen test 11 days after the negative test. Initial symptoms were mild while taking Paxlovid. There were no COVID symptoms when testing positive 7 through 11 days after the negative test and completion of the course of nirmatrelvir; ritonavir.
Had first vaccine 07Jan2021-within a couple of hours noticed an odd smell and color to my urine that lasted for about 48 hours.  Had second vaccine 04Feb2021-the same thing occurred within a couple of hours and also lasted 48 hours
Pt. woke up in the morning feeling hot, redness to arm and some swelling.
patient who received an undiluted dose of the Pfizer Covid vaccine; patient who received an undiluted dose of the Pfizer Covid vaccine; Light-headed; This is a spontaneous report from a contactable pharmacist. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Batch/Lot Number: ER8727; Expiration Date: Jul2021), Via an unspecified route of administration, administered on 26Apr2021 09:30 as single dose for COVID-19 immunization. NDC number of Pfizer Covid vaccine was 59267-1000-01. The patient medical history and concomitant medications were not reported. on 26Apr2021, The reporter was a clinical pharmacist coordinator for a hospital system in Mississippi. Was notified by one of the clinics administering the Covid vaccine that a patient had got the vaccine without it being diluted. They had gotten 0.3ml undiluted vaccine from the vial (undiluted dose of the pfizer covid vaccine) and the patient was little lightheaded from 26Apr2021. The outcome of events was unknown.  Follow-up (28Apr2021): New information received from the mail trail sent includes: Patient is 69 years old, (ethnicity withheld) female, DOB: (withheld) Amendment: This follow up is being submitted to amend previously reported information: The event recoded to patient who received an undiluted dose of the Pfizer Covid vaccine to Product concentrate not diluted and overdose and to delete the event wrong diluent used.  No follow-up attempts are possible; No further information expected.
On or around January 25, 2021, a lymph node along the left side of my neck/clavicle became swollen. As of the date of this report, the lymph node remains swollen, the size has not changed, it is discomforting, and at times restricts my neck movement. I went to Urgent Care on January 27, 2021 and they advised they were not sure the cause. I have taken an X-Ray (the results showed everything was normal); I took a blood test (results pending) and I have a follow-up appointment with my PCP for February 2, 2021.
encephalitis; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around December 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered encephalitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he  suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of encephalitis was considered to be not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of encephalitis was determined to be medically significant and disabling.
NAUSEA, FEVER/CHILLS, SHAKES/TREMORS. PT HAS NOT TRIED ANY RX OR OTC TREATMENTS
NauseaVomiting, Tachycardia, Shortness of breath, chest tightness Narrative: Onset of tachycardia within 15 minutes. Within one hour this worsened, and developed associated chest tightness and nausea.
Cellulitis of Left thigh Cephalexin prescribed on 12-9-16.