chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines administered beyound 30-day use by date; Vaccines administered after being in stored in fridge past 30 days; Patient received first dose of primary series from Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 72-year-old 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.
Had temperature of 103-105 F that did not come down with fever reducing medications for approximately 48 hrs.
Pt recvd vax on 1JUN92 & exp giant hives & pruritus, generalized rash, angioneurotic edema w/throat discomfort; Lab eval on 2JUN92 revealed WBC 13,800, LDH 191;
Additional information received on 5/12/03 from the reporting physician provided medical history. A physician reported via a company representative that a 7 month old male received his second dose of Prevnar on 1/14/03. Medical history included hypospadias. The reporter indicated that the child was not ill at the time of vaccination. On 3/17/03, at the age of 10 months, he developed pneumococcal sepsis and was subsequently hospitalized. A blood culture was performed; the results of the subtype is pending. He was treated with Rocephin and Clindamyacin. He recovered. The reporter considered this event to be life threatening.
heart attack; Clotting; heart attack with 100% blockage; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack), THROMBOSIS (Clotting) and ATRIOVENTRICULAR BLOCK (heart attack with 100% blockage) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus (controlled with other medicines; A1c was 6.8 on 11-Mar-2021).    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria hospitalization and medically significant) and ATRIOVENTRICULAR BLOCK (heart attack with 100% blockage) (seriousness criterion hospitalization). At the time of the report, MYOCARDIAL INFARCTION (heart attack) and ATRIOVENTRICULAR BLOCK (heart attack with 100% blockage) outcome was unknown and THROMBOSIS (Clotting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood cholesterol: good blood work (normal) good blood work related to cholesterol. On an unknown date, Blood cholesterol: more than doubled in a month (abnormal) more than doubled in a month.         It was also reported that patient had good blood work related to cholesterol on 11-Mar-2021, however it was more than doubled in a month following administration of suspect drug.   No treatment medications provided.  Patient was concomitantly taking medications for type 2 diabetes.  Company comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2022 15:00 (Batch/Lot number: unknown) at the age of 14 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE., Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 03Jun2021, when the patient was 13 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE., Location of injection: Left Leg , Vaccine Administration Time: 03:00 PM), administration date: 14May2021, when the patient was 13 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Mar2022 12:00, outcome "not recovered", described as "Swollen lymph nodes". Therapeutic measures were not taken as a result of lymphadenopathy.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Extra dose administered/elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered/elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster) and NO ADVERSE EVENT (No Adverse event) in an elderly 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. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.   In October 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 16-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered/elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered/elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster) 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 did not provide any causality assessments.   No concomitant medications were reported. Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.  No treatment drugs were reported. This case is regarding 4th out of 13 patients.   This case was linked to MOD-2022-688372 (E2B Linked Report).; Sender's Comments:  MOD-2022-688372:master case 1 of 13
Patient receiving both flu and pfizer booster vaccines. After administer flu shot on right arm administered pfizer vaccine on left arm. Briefly after administration of the pfizer vaccine patient fainted. After coming to patient was very flushed, sweaty, and tired. Called 911 and the local EMT arrived shortly after. They took her vitals and sugars. Her sugar was normal but blood pressure was very low. They observed her as she lay flat to increase blood circulation. With her blood pressure increasing the EMT offered to bring her to the hospital, the mother opted out. Patient was brought to car with her mother and would continue to rest at home.
Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.; Fluid behind ears - had sense of hearing loss; I am depressed and furious; physical blockage in both nostrils; Fluid in sinuses and nasal cavity; Fluid behind ears - had sense of hearing loss; Fluid in nasal cavity; I am depressed and furious; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASAL TURBINATE HYPERTROPHY (Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.), EFFUSION (Fluid behind ears - had sense of hearing loss), DEPRESSION (I am depressed and furious), NASAL CONGESTION (physical blockage in both nostrils) and SINUSITIS (Fluid in sinuses and nasal cavity) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 ("recovered within 2-3 days") in January 2021 and Loss of smell ("took 7 weeks to recover from") in January 2021. Concomitant products included ALFUZOSIN and DOXYCYCLINE for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL TURBINATE HYPERTROPHY (Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.), EFFUSION (Fluid behind ears - had sense of hearing loss), DEPRESSION (I am depressed and furious), NASAL CONGESTION (physical blockage in both nostrils), SINUSITIS (Fluid in sinuses and nasal cavity), DEAFNESS (Fluid behind ears - had sense of hearing loss), RHINORRHOEA (Fluid in nasal cavity) and ANGER (I am depressed and furious). The patient was treated with FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, NASAL TURBINATE HYPERTROPHY (Within 36 hours, have had first time in my life, turbinate hypertrophy in my nose.), EFFUSION (Fluid behind ears - had sense of hearing loss), DEPRESSION (I am depressed and furious), NASAL CONGESTION (physical blockage in both nostrils), SINUSITIS (Fluid in sinuses and nasal cavity), DEAFNESS (Fluid behind ears - had sense of hearing loss), RHINORRHOEA (Fluid in nasal cavity) and ANGER (I am depressed and furious) outcome was unknown.            Consent was given for safety follow up.  Patient reported that the was going to the hospital and would talk later.   This case was linked to MOD-2021-132479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Narrative updated.
Had first vaccine 12/28/2020 only sore arm. 2nd vaccine 1/25/2021. She developed fever of 101.5 for 2 days, body aches, cough, dizziness, high BS, pale, tachycardia.
This spontaneous report was received from a healthcare worker refers to a 3 years old patient of unknown gender. On 18-DEC-2014, patient was vaccinated with an improperly stored dose of MMR II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Extreme nausea and diarrhea. Took some pepto bismo.  This has been going on for about 4 hours
Patient called on 10/11/07 to ask why she had received Gardasil a friend told her asthmatics should not get Gardasil. She has had worsening of hives since - She had none at the time of her vaccination but has had them in the past.
approx 1hr p/vax pt devel h/a followed by fever 101 & myalgias, arthralgia, diarrhea began 16hr post vax;currently breast feeding;
Tinnitus after 2nd Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Manufacturer unknown, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; J&j vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus after 2nd Pfizer vaccine".  Additional Information: It was reported that batch/lot was Unknown as it was Not available/provided to reporter at the time of report completion. The Awareness was reported as 13Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Exposed to father with chickenpox.  Approximately 40 lesions, trunk, arms, legs.  Above lip and hair line.  No fever.
after 5days she had a hard time breathing and her heartbeat is rising for 1hour and then the 6th day same case, difficulty breathing and heartbeat rising for 3hours; after 5days she had a hard time breathing and her heartbeat is rising for 1hour and then the 6th day same case, difficulty breathing and heartbeat rising for 3hours; This is a spontaneous report received from a Pfizer Sponsored Program Support. A contactable consumer (patient) reported this female patient of unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 16Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 21Feb2021, 5 days after the vaccine, she had a hard time breathing and her heartbeat was rising for one hour. The 6th day she had difficulty breathing and heartbeat was rising for 3 hours. The patient was worried about taking the second dose of BNT162B2. The outcome of difficulty breathing and heartbeat was rising was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
First day and first night extreme Sore arm- no sleep Second day - fatigue,  foggy head,  nausea , moodiness, extreme finger joint pain Third  day (today)  - Headache , ears ringing, low fever, joint pain,  sensitive skin, exhaustion,
Pt developed clinical signs of intussuseption (vomiting, colicky abd pain, diarrhea with currant jelly stools (gelatinous blood)) on 10/27/08. She received what appears to be her first dose of RotaTeq 10/20/08 at her PCP's office. Pt was admitted to Medical Center after transfer from ED. A rotaviral antigen test was positive both at the ED and at Medical Center. Pt had an air contrast enema + for a sectosigmoid intussuseption- it reduced well without surgical intervention.  11/03/2008 MR received for DOS 10/28-29/2008 with D/C DX: Intussusception.  Pt presented with 2 day hx of  emesis, decreased po intake, flexing legs in pain and diarrhea which turned bloody. IS sucessfully reduced by Air Enema. D/C next day.
fever, vomiting began 1AM on OCT93 & cont throughout the day total of 11 times;
Terrible rash/ very painful rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Terrible rash/ very painful rash) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NORTRIPTYLINE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced RASH (Terrible rash/ very painful rash). The patient was treated with CLOBETASOL for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Terrible rash/ very painful rash) outcome was unknown.            The patients symptoms remained for approximately 3 weeks.   This case was linked to MOD-2021-228443 (Patient Link).
12 year old who developed parotid gland swelling and enlarged cervical lymph nodes within hours of FLUMIST. Improving 24 hours later.
gave #2 shot before the 28 day time frame,  got #1 shot on 3/25/21
Pt. has redness and warmth around injection site, and painful arm. 10 cm area of erythema, tenderness and increased warmth to surrounding injection site.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), PYREXIA (SLIGHT FEVER) and CHILLS (CHILLS) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (Light headedness), PYREXIA (SLIGHT FEVER) and CHILLS (CHILLS). At the time of the report, DIZZINESS (Light headedness), PYREXIA (SLIGHT FEVER) and CHILLS (CHILLS) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included blood pressure medication. Treatment details included were reported as none.
Client received DTaP, MMR, IPV on 9/15/04. Client's left leg is twice the size of other thigh. It is hot to touch and rash. Mother is giving Children's Motrin, cold compress and put in tub.
patient reports that arm was sore the next day. We were closed on Sunday, patient reported it was still sore after a few days after event and that it did not dissipate.
Vaccine Administration Error. Vaccine reconstituted  with sterile water not provide diluent.
Client received Varicella vaccine on 6-18-2001. Developed s/s chickenpox 12/17/07
Inflammation at the injection site; Pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix (right arm). In APR-2023, less than a day after receiving Shingrix, the patient experienced injection site inflammation (Verbatim: Inflammation at the injection site) and injection site pain (Verbatim: Pain at the injection site). The outcome of the injection site inflammation and injection site pain were not resolved.   It was unknown if the reporter considered the injection site inflammation and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site inflammation and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date:23-MAY-2023 The reporter reported that she received first dose of Shingrix vaccine a month ago (date not provided) in her right arm and since that day she had been experiencing pain at the injection site and something she describe as inflammation at the injection site. Symptoms persist until the day of reporting.  Adverse Event had been filed. The reporter consented to follow up.
I had low hemoglobin for a few visits in a row and the DR decided to do an occult blood test and an colonoscopy endoscopy. On May 28th 2021, I met with a specialist and I stated chemotherapy on June 15, 2021 and that is ongoing and will end mid December.
TWO VACCINE ADMINISTERED FOR COVID-19 (MEDICATION ERROR); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included heart transplant. The patient was previously treated with Pfizer's covid-19 vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced two vaccine administered for covid-19 (Medication error).  Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Antibodies went up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two vaccine administered for covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20210611952.
One hour after administration, patient experienced a nose bleed. Approximately 2 hours after administration she noticed her heart rate fluttering which turned in to a strong throbbing feeling at the base of her sternum. This was regular rate, but very strong, intense feeling. This lasted until the next day when it decreased frequency and ended by afternoon. Also she experienced a mild headache the day after receiving the immunization. She states that she has a hx of seasonal allergies. Also states that she was very anxious about receiving the immunization prior to admin. She states that she was also a little dehydrated.
Slight swelling at injection site; Itching and a red ring at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (Slight swelling at injection site) and VACCINATION SITE PRURITUS (Itching and a red ring at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Slight swelling at injection site) and VACCINATION SITE PRURITUS (Itching and a red ring at injection site). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Slight swelling at injection site) and VACCINATION SITE PRURITUS (Itching and a red ring at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient called to report her reaction today to the county vaccination effort and ask for a copy of her consent. Patient stated that 4 hours after vaccine administration, she experienced headache, fever, chills, rapid heart rate, and shortness of breath. After 30 minutes of symptom onset, she presented at local emergency room and was admitted with sinus tachycardia. Patient was discharged the following morning. She states she followed up yesterday with her PCP, states she has some lingering hip and back pain, but original symptoms have resolved.