chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received a half dose due to the provider only pulling .25mL and thinking it was .5mL.
renal failure; The patient was given another Prevnar 13/ instead of receiving pneumovax 23; This is a spontaneous report from a contactable physician.   An adult female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose in Aug2018 for immunisation.   The patient medical history included renal transplant. The concomitant medications were not reported.  The patient received the 1st dose of PREVNAR 13 at single dose on 26Jul2018 for immunisation.   The patient experienced renal failure on an unspecified date.  The patient received 2 PREVNAR 13 injections by accident 2 yrs before this report. Since she was a renal transplant patient, the schedule for the pneumovax is different. The patient was to receive a Prevnar 13 and then Pneumovax 23. The patient was seen two years ago. The patient was seen 26Jul2018. The immunization with Prevnar 13 was administered with instructions to come back after 4 weeks for the Pneumovax 23. She was scheduled the following month in Aug2018. The patient was given instead another Prevnar 13. The physician wanted to know if the Pneumovax 23 can be given on next Monday (23Mar2020) when the patient will be seen. The outcome of events was unknown.    Information on the lot/ batch number has been requested.; Sender's Comments: There is no reasonable possibility that the event renal failure was related to pneumococcal 13-valent conjugate vaccine. This is more likely associated with the underlying history of renal transplant.
ON 25 JULY 06, PT RECEIVED TDAP, TYPHOID, AND PPD VACCINES ALL IN THE LEFT ARM. SHE EXPERIENCED NO PROBLEMS AT THAT TIME. SHE ARRIVED TODAY C/O 4 - 5 PAIN LEVEL UNDER HER LEFT ARM. I MEASURED A "50x50mm" lump located within her armpit. She also c/o a headache and nausea for 2 days. She was referred for futher evaulation by a physician.
The patient reported some soreness at the site of injection; he accidentally administered a first dose of the Moderna COVID-19 vaccine to a 17 year old patient after misreading the paperwork; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (The patient reported some soreness at the site of injection) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he accidentally administered a first dose of the Moderna COVID-19 vaccine to a 17 year old patient after misreading the paperwork) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he accidentally administered a first dose of the Moderna COVID-19 vaccine to a 17 year old patient after misreading the paperwork). On an unknown date, the patient experienced VACCINATION SITE PAIN (The patient reported some soreness at the site of injection). On 29-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he accidentally administered a first dose of the Moderna COVID-19 vaccine to a 17 year old patient after misreading the paperwork) had resolved. At the time of the report, VACCINATION SITE PAIN (The patient reported some soreness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
sleeping on and off; pulse is rapid; chills; nausea; headache; fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (sleeping on and off), HEART RATE INCREASED (pulse is rapid), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and PRAVASTATIN for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced SLEEP DISORDER (sleeping on and off), HEART RATE INCREASED (pulse is rapid), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever of 102). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (sleeping on and off), HEART RATE INCREASED (pulse is rapid), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 102 (Inconclusive) fever of 102.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
woke up with strong chills/shivering just after midnight on 23 Mar, after getting out of bed felt lightheaded briefly before quickly passing out while standing.
chills; malaise; Pain at injection site; bump at the injection site; Swollen pain; Discomfort under the armpit where the injection was given- Left arm; Laryngitis; Swollen pain; laryngitis-Mild case but voice is compromised; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program database.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, about a week and a half ago after vaccination, the patient experienced chills, malaise, pain where injection site, bump at the injection site, swollen pain, and discomfort under the armpit where the injection was given- left arm. It was reported that, 3 days ago patient developed laryngitis, mild case but voice was compromised. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Dec2020, (Caller had Covid on Dec 18 th). The outcome of the events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unspecified dates, improperly stored doses of GARDASIL 9 (dose, route and site of administration, lot # and expiration date were not reported) were administered to the patients. The vaccine was stored in the temperature between 46 and 77 degrees Fahrenheit for 15 minutes and between 32 and 36 degrees Fahrenheit for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for contact with the reporter was given. Sender's Comments: US-009507513-1702USA006676: US-009507513-1702USA006711: US-009507513-1702USA006713: US-009507513-1702USA006714.
Fatigue; arm pain; general malaise; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 12Feb2021 at 16:45 (at the age of 43-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, asthma, high blood pressure and allergy to ACE inhibitors. Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 13Feb2021 at 12:00 AM, the patient experienced fatigue, arm pain and general malaise. No treatment was provided for the events fatigue, arm pain and general malaise. The outcome of the events fatigue, arm pain and general malaise was recovering. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021277048 same patient, different shot/event
Ringing in ears; Heat; Itching at injection site; Tenderness; Redness grew from size of dime to size of a cup opening; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears), VACCINATION SITE WARMTH (Heat), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Tenderness) and VACCINATION SITE ERYTHEMA (Redness grew from size of dime to size of a cup opening) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 031L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced TINNITUS (Ringing in ears), VACCINATION SITE WARMTH (Heat), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Tenderness), VACCINATION SITE ERYTHEMA (Redness grew from size of dime to size of a cup opening) and VACCINATION SITE SWELLING (Swelling). At the time of the report, TINNITUS (Ringing in ears), VACCINATION SITE WARMTH (Heat), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Tenderness), VACCINATION SITE ERYTHEMA (Redness grew from size of dime to size of a cup opening) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.            The patient called MD, prescribed Benadryl but she didn't take it. Wanted to know if she could take the Benadryl.  No concomitant medication details were provided.   This case was linked to MOD21-057881, MOD-2021-051948 (Patient Link).
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in an 86-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In June 2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of COVID-19 was not reported for Humira. No treatment drug details was reported. Company comment: This spontaneous case concerns a 86 year old female with no reported medical history who experienced the unexpected non-serious adverse event of special interest COVID-19 which occurred at an unknown interval after receiving a dose of mRNA1273. Further details regarding the clinical course, hospital admission, other diagnostic or imaging test done, concomitant medications and treatment were not provided. Information regarding other COVID-19 vaccines were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 86 year old female with no reported medical history who experienced the unexpected non-serious adverse event of special interest COVID-19 which occurred at an unknown interval after receiving a dose of mRNA1273. Further details regarding the clinical course, hospital admission, other diagnostic or imaging test done, concomitant medications and treatment were not provided. Information regarding other COVID-19 vaccines were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
A 6 month old patient was vaccinated with Fluzone High dose quadrivalent, with no AE; A 6 month old patient was vaccinated with Fluzone High dose quadrivalent, with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via consumer/non-health care professional via Medical Information (Reference number- 00772888) and transmitted to Sanofi on 16-Sep-2021.  This case involves a 6-month-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and Accidental overdose).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 16-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ733AB, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and Overdose accidental (latency same day).  It was reported "Caller reported by accident, a FLUZONE HIGH-DOSE VACCINE was given to a 6 month old child. Caller wanted to know what she should do from here. Caller states that FLUZONE HIGH DOSE QUADRIVALENT 21-22was given to a six month old at a different location. "What should we watch for safety and side effects?"   No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Rash on right arm appeared one week after receiving vaccine. (1-13-2021).  Got bigger and was there for about 3 days.
Pulmonary embolism. SOB; Left upper extremity dialysis graft occlusion necessitating balloon and stent; This is a spontaneous report from a contactable physician.  A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in arm right on 25Feb2021 at single dose for COVID-19 immunisation. Medical history included end stage renal disease (ESRD) on HD due to hypertension (HTN), and morbid obesity. The patient was allergic to Levaquin, NSAIDs. Concomitant medications included acetylsalicylic acid (ASPIRIN), atorvastatin, clonazepam, dutasteride, escitalopram, metoprolol, nifedipine, sevelamer, torsemide, cetirizine hydrochloride (ZINE). On 25Feb2021, the patient had left upper extremity dialysis graft occlusion necessitating balloon and stent on the day of the vaccine administration. Pulmonary embolism developed 3 weeks after the first vaccine dose (Mar2021). No leg swelling, no long-distance travel, no immobilization or other cause of pulmonary embolism identified. No cough or fever. Shortness of breath (SOB) developed the day before the Pulmonary embolism (PE) was diagnosed (Mar2021). AEs resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 2 days, received Heparin drip followed by Xarelto as treatment. Events outcome was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided the company cannot completely exclude a contributory role of BNT162b2 administration in the development of the reported 'complication associated with device and pulmonary embolism', with SOB as initial sign and symptom associated with pulmonary embolism. The impacts 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
R/arm itchy, redness, swelling, warm to touch, fever, L/pain, diarrhea, slight nausea. Tx:Keflex 250mg & Naproxen 500mg.
MODERNA INJECTION GIVEN TO PATIENT IN DRIVERS SIDE OF PATIENT CAR. INITIALLY BLED AND THEN BECAME SWOLLEN WITH A KNOT THE SIZE OF A DIME. AFTER 5 MINUTES SWELLING HAD INCREASED TO A SIZE SLIGHTLY LARGER THAN A HALF DOLLAR. AT 15 MINUTES SWELLING HAD NOT INCREASED AND PATIENT DENIED ANY OTHER SYMPTOMS. ICE OFFERED AND PT STATED HE WOULD PUT ICE ON IT WHEN HE WENT BACK TO THE OFFICE. INSTRUCTED PT TO GO TO ER IF THINGS WORSENED. PT RELEASED.
received an expired vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a adult female patient who received HAV (Havrix 1440) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th December 2022, the patient received the 1st dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 27th December 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's comments: The nurse who was also the patient, had stated that, she had received the first dose of Havrix and was informed that the vaccine was expired.  The reporter had consented to follow-up via email. Additional supportive information: The patient had received an expired dose of Havrix vaccine, which had led to expired vaccine used.
On 10/23, patient had DTAP, MMR & Flu vaccine.  Mom called 10/24/2003 stating that left thigh was hard, red, and warm to touch.  Appointment made and seen by NP.  Left thigh 15 inch circumference area with edema, erythematous, firmness and warm to touch.  Right thigh 11.5 inch circumference same reaction.  Started on Zyrtec 1/1 2.5 mL per mouth every day.  Cephalexin 250/5 4mL.
Gave Hib too early didn't need yet.  Pt had Hib on 5-5-08 and was given another on 5-20-08.
VACCINE WAS ADMINISTERED  MORE THAN 6 HOURS FROM VIAL  PUNCTURE IN THE FRIDGE; This spontaneous report received from a pharmacist concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 09:45 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced vaccine was administered more than 6 hours from puncture in the fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administered more than 6 hours from puncture in the fridge was not reported. This report was non-serious. This case, from the same reporter is linked to 20210547709.
On  3/9 - sore arm On 3/10 - fever, body aches, sore arm On 3/12 - woke up dizzy, sweating, pale., very low BP, severe drop in hemoglobin count. Admitted into hospital.    ER dr name unknown so provided family dr nane
p/recv vax pt exp dermatitis on entire body. knee pain & edema & refused to gear wt.
pain at the injection site; sore arm; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 46-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Jun2021 10:30 (Batch/Lot Number: EW0121) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastric bypass 2019, hospitalisation, Flu Vaccine and Pneumonia vaccine; states she was hospitalized after receiving the vaccines , metabolic surgery in 2019. The patient's concomitant medications were not reported. Family Medical History Relevant to AE were none, no one she knows of had a reaction. The patient experienced sore arm on Jun2021, pain at the injection site on 01Jun2021. There was no relevant test performed and no investigation assessment. The patient stated after her first dose of the Pfizer COVID-19 vaccine and no issues other than a sore arm that went away in 2 days. States caller said that she also get the flu and Pneumonia after receiving those vaccines. Caller states after her first dose, she had pain at the injection site and so did her entire family, but they had that pain for 2 days and then it went away. Caller states if they could educate her daughter at home, she wouldn't have taken the shot, but they decided to take it as a family. Caller states she doesn't do well with vaccines but she couldn't stomach giving her daughter a vaccine that she wouldn't take. Caller states now she feels she shouldn't have taken it and just kept taking her natural immune boosters and vitamins because she did fine. Caller states she was around people that had Covid 19 and she has been around lots of people and travelled and was fine. She would not have taken that vaccine. She just went on the 10Jun2021, so after the first vaccine, she had herself checked because she did have bariatric surgery in 2019 and she has to do a checkup. Caller states her vitals and blood work and everything were tested, and the only thing she needs more of is Iron and Vitamin D. Caller states the only tests that came back that she needed to be aware of and do something about, outside of that nothing. States she is going to the doctor to get an iron infusion. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not require emergency room and physician office visit. Prior Vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were flu Vaccine and Pneumonia vaccine; states she was hospitalized after receiving the vaccines. NDC, Lot, Expiration: Unknown. Caller states she doesn't get sick with the flu unless she takes a flu vaccine and she doesn't get pneumonia unless she gets a pneumonia vaccine. Caller states she got this vaccine and now she is sick, she won't do a vaccine ever again. The outcome of the event arm was recovered on Jun2021 and the outcome of the event pain at the injection site was recovered on 03Jun2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021788760 same reporter/drug, different patient.