chrisvoncsefalvay/vaers-outcomes huggingface dataset:
is now sick.; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he received the vaccine on unspecified date and is now sick. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.
Pt developed a rash on left side, face, neck, body and thigh. Left thigh developed reddened indurated area almost as round as a tennis ball. Pt became irritable and experienced a decrease in sleep and had temperature of 101F. On 6/5/00, requested that child be brought in for assessment purposes. Pt found to have 8mm to 10mm induration on left thigh. A few papules on thigh only.
10 hours after: body aches 11 hours after: nausea 12 hours after: chills, fever 101-102 Woke up twice in next 10 hours, dehydrated, had to urinate, chills gone, fever 100.8 24 hours after: still dehydrated, fever 99.8, symptoms otherwise resolved
states that a male patient age 86, was injected with with Fluzone High Dose on two different occasions this year because the patient forgot that he already had a flu shot, with no ae; Initial information received on 23-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 86 years old male patient for whom it was reported that a male patient age 86, was injected with fluzone high dose on two different occasions this year because the patient forgot that he already had a flu shot (overdose), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patients medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date of 2020, the patient was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Lot UJ505AA; expiration date: unknown) via unknown route in the left deltoid as prophylactic vaccination.   On an unknown date of 2020, (unknown latency) after the patient was injected with fluzone high dose second time this year because the patient forgot that he already had a flu shot (overdose).  No adverse event reported at the time of reporting.  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 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.
Information has been received from a nurse practitioner regarding a 2 year old male with asthma, frequent episodes of otitis media, allergy to SUPRAX, and history of pneumonia, respiratory syncytial virus infection, and colic who received PNEUMOVAX 23 (lot# 0491AE; expiration date 01-SEP-13) intramuscularly on 14-SEP-2012, for recurrent asthma. Concomitant medication included ALVESCO, montelukast sodium (MSD), XOPENEX, AXID, and FLOVENT. On 15-SEP-2012, the patient developed cellulitis at the injection site in his left thigh. Treatment included clindamycin and SEPTRA. No further information provided. Additional information is not expected.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.  No Medical History information was reported.   On 10-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).  It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient received empower health and wellness center.  It was reported that 113 Bivalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.  Treatment information was not provided.
Moderna vaccine #2 given 3/5/2021. Within 24 hours severe fatigue, myalgia, abnormal taste in mouth, dizziness.   For weeks similar severe fatigue (not able drive, walking 100 feet only with shortness of breath). Ongoing lightheadedness both seated and standing and worse with going up 1 flight stairs.  Holter identified nonsustained ventricular tachycardia and eventually with  episodes of sustained ventricular tachycardia x 5 and ongoing nonsustained ventricular tachycardia patient was admitted to hospital for third time and underwent cardiac radioablation 4/26/21.
A RED RASH DEVELOPED AT THE INJECTION SITE WHERE THE PREVNAR 13 WAS ADMINISTERED.
No additional AEs; HBP with responsibility for vaccine storage calling to report a temperature excursion. Product administered. No additional AEs. No PQCs.     ?    Names of vaccines involved (including lot/exp) VARIVAX W025273 08/10/2024        ?    Temperature: -; This spontaneous report was received from a healthcare business professional (HBP), referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme, anatomical site of vaccinations and route of administration were not reported; lot number W025273, expiration date reported and validated as 10-AUG-2024) as prophylaxis, that experienced a temperature excursion (product storage error). No additional adverse events.  The vaccine experienced a temperature excursion of minus (-) 10 degrees Celsius (C) for 59 minutes. There was no previous temperature excursion.  This is one of several reports received from the same reporter.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
after both vaccine they notices that they were very tired and low blood pressure; After both vaccine they notices that they were very tired and low blood pressure; felt tightness of the chest, at moment of the vaccine  but didn't linger.; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (felt tightness of the chest, at moment of the vaccine  but didn't linger.), BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (After both vaccine they notices that they were very tired and low blood pressure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010a21a and 029l20a) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Blood pressure high and Coronary disease. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), AMINOPHYLLINE, LOSARTAN, METOPROLOL, MULTIVITAMIN [VITAMINS NOS] and AMLODIPINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST DISCOMFORT (felt tightness of the chest, at moment of the vaccine  but didn't linger.). On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (After both vaccine they notices that they were very tired and low blood pressure). On 12-Mar-2021, CHEST DISCOMFORT (felt tightness of the chest, at moment of the vaccine  but didn't linger.) had resolved. At the time of the report, BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (After both vaccine they notices that they were very tired and low blood pressure) outcome was unknown.            No treatment medication was provided   This case was linked to MOD-2021-330698, MOD-2021-330881 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up received. concomitant product amlodipine added. concomitant product frequency added.
developed extensive blood clotting left leg within 3 weeks after JJ vaccine. no underlying known malignancy or coagulopathy or prolonged travel. placed on eliquis and will be following with vascular
Light headed, swollen glands on left side of throat, hurts to swallow, thick tongue, chills, not feeling well, fast heart beat and face is tingly .
Nerves numbness and tingling,  from the top neck and shoulders to the tip of my fingers..
Adjuvant was administered inadvertently without the antigen component. Patient was instructed to return in 4 weeks to receive the full vaccine. Patient agreed to return.
Headache, SORE ARM INJECTION SITE STARTED ON 2ND DAY. RADIATING PAIN FROM INJECTION SITE TO HAND FIRST DAY .BOTH RESOLVED
This case was reported by a nurse via sales rep and described the occurrence of localized erythema in a 56-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced localized erythema, local swelling and tenderness. On an unknown date, the outcome of the localized erythema, local swelling and tenderness were recovered/resolved. It was unknown if the reporter considered the localized erythema, local swelling and tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid and by next day had redness and swelling near the elbow only with tenderness that was lasted for 3-5 days. This case has been linked with case US2018GSK064276 and US2018GSK064280, reported by same reporter.
2 days after vaccination had fever of 101.5, sore throat, and felt achy
Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). At the time of the report, PAIN IN EXTREMITY (Sore left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-356211 (Patient Link).
Right leg numbness; Right leg twitch; left side facial twitch; Chills; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), HYPOAESTHESIA (Right leg numbness), MUSCLE TWITCHING (Right leg twitch), MUSCLE TWITCHING (left side facial twitch) and CHILLS (Chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and CHILLS (Chills). On 30-Apr-2021, the patient experienced MUSCLE TWITCHING (left side facial twitch). On 08-May-2021, the patient experienced HYPOAESTHESIA (Right leg numbness) and MUSCLE TWITCHING (Right leg twitch). On 23-Mar-2021, PAIN IN EXTREMITY (Arm soreness) and CHILLS (Chills) had resolved. On 08-May-2021, HYPOAESTHESIA (Right leg numbness) had resolved. At the time of the report, MUSCLE TWITCHING (Right leg twitch) and MUSCLE TWITCHING (left side facial twitch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided by Reporter.
Headache, Arthralgia & Diarrhea Narrative: Employee received 1st dose of Moderna vaccine on 07/28/2021 at 09:30 and by that evening (~18:30) began experiencing symptoms of injection site pain/discomfort, chills, headache, joint pain, body aches, fatigue, one episode of diarrhea, and swollen axillary glands. Reports did not use any medications to relieve symptoms. As of 08/02/21, reports all symptoms had resolved and had returned to work.
pt became listless Tuesday noc t101.2 slept 4-10PM & vomited breast milk & blood clots;pedialyte given pt still vomiting;called MD mom told to watch pt;
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. No information regarding medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL lot # K005881 and expiry date of 14-JAN-2017 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Patient developed right eye pain and blurred vision.  Symptoms improved with dexamethasone 10 mg IV x1.  Current working diagnosis is optic neuritis.  Follow up with ophthalmologist is planned.
Narrative:  Patient received second COVID vaccine 4/13/2021. Patient admitted to inpatient setting secondary to Positive COVID Pneumonia on 12/15/21 Patient remain in hospital setting until 1/6/21
Patient experienced  dizziness and giddiness onsite EMS was called vitals BP 109/69  HR 68 100% O2 Patient refused evaluation or care and released against medical advice.
BRUISE GOT WORSE; KNOT; SORE SPOT ON HER ARM; This spontaneous report received from a patient concerned a 61 year old. The patient's weight was 164 pounds, and height was 65 inches. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. There was no drug abuse or illicit drug usage. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered on 22-MAR-2021 at right arm for covid-19 prophylaxis. On 22-MAR-2021, the patient had a sore spot on her arm and her arm stayed a little bruised but she did not pay much attention to it. (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, 1 total administered on 12-NOV-2021 at right arm for covid-19 prophylaxis. Age at time of vaccination 61 years old. No concomitant medications were reported.  On 12-NOV-2021 she got the booster shot on the same arm and the spot did not get better, it had progressively gotten worse. After the booster shot, it just got worse and felt even more bruised. It was swollen for quite a while and it had progressively gotten worse. It was like there was a knot under there. It hurts to rub finger across it. She states that it was the size of an egg on her right arm. It was extremely painful to touch and it hurts when she was laying on it while sleeping. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore spot on her arm, bruise got worse, and knot. This report was non-serious. This case, involving the same patient is linked to 20230644295 (Dose number in series 1).
Mom stated that pt had diarrhea the next day. Dad said he also had diarrhea, but didn't get the flu vaccine.
Vaccination 5/6 5/7 generalized myalgias 5/8 felt improved / able to golf 5/9 admitted to local hospital /  hospital transferred to another hospital acute pericarditis
pt recv vax 445PM; 2 hr later exp blurry vision & mental status changes; adm to hosp ped ICU w/inc intracranial pressure/bleeding; CT scan of head revealed an intracranial mass lesion in the brain; sx may not be related to vax
8.5 by 6cm of erythema and slight induration left anterior tigh (large local reaction)
Headache.  Moderate Aches in joints.  Mild muscle aches.  Lethargic.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.   It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Patient recived Moderna vaccination and was sitting while being monitored for 15 minutes when he began having seizures.  Patient was then taken with paramedics.
p/vax pt devel joint pain & stiffness; joint stiffness prevents pat from lying down; sleeps in chair; symptoms lessen when pt moves about
3 hours after Covid vaccine pt experienced itchy skin, chest tightness, trouble breathing and swelling of the arms, nasal congestion. The next day, developed a rash on the neck area. Pt took loratidine, hydroxyzine, benadryl and used hydrocortisone cream and had improvement after 4 days.
Myalgia, Fever, Chills and myalgias x 36 hrs Narrative: developed redness/itching (no hives) well demarcated ~2" away from injection site, not cellulititic,? delayed COVID "arm"
Fever up to 101, body aches primarily targeted at 6 chronic pain sites but substantially more significant than usual, headache, injection site pain, thumb muscle twitches, "electrical" momentary pains in a variety of places, including head and arms
pt recv vax 10JUL96 & JUL96 pt exp subcutaneous warmth, swelling, tenderness & inflammation @ the inj site which MD described as being almost like a cellulitis or a granuloma;reporter unsure if the pt exp was r/t vax;
she also stated her mother has an autoimmune disease.; This is a spontaneous report. A non-contactable consumer (Patient's daughter) reported for a female patient. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date as a dose 1, single for COVID-19 immunization. Patient medical history and concomitant medication were not reported. On an unspecified date the reporter stated that her mother who had 1st dose and wants to know about the approval of the vaccine because reporter was worried and stated that her mother had an autoimmune disease. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
pt recvd vax on 1MAY92 & on approx 3MAY92 exp an aching sensation involving hands, arms, lower back; sx felt flu-like in nature;