chrisvoncsefalvay/vaers-outcomes huggingface dataset:
short of breath; losing weight; very ill; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to 5 antibiotics) and Disability NOS.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill). At the time of the report, DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. The patient reported receiving the vaccine 16 months ago. No treatment details were reported.   This case was linked to MOD-2021-264021 (Patient Link). This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to 5 antibiotics) and Disability NOS.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill). At the time of the report, DYSPNOEA (short of breath), WEIGHT DECREASED (losing weight) and ILLNESS (very ill) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. The patient reported receiving the vaccine 16 months ago. No treatment details were reported.   This case was linked to MOD-2021-264021 (Patient Link).
The pain started at the same time she got the shot and got progressively worse. She can barely use her arm. There is no swelling however she cannot even raise her arm. My other daughters had no side affects. But patient is in serious pain and has significant mobility issues.
My dad had the covid vaccine on Thursday & Friday morning we couldn't wake him up.  He had a significant change in mental status.  An ambulance needed to be called & he was hospitalized for a week.  He is currently in a rehabilitation hospital.
Headache; Fever; Chills; Body Aches; Fatigue; Coughing; Tested positive for COVID; Tested positive for COVID; Runny nose; This is a spontaneous report from a non-contactable consumer or other non hcp. A 37-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: EL3247; Expiration Date: 31May2021) via an unspecified route of administration, administered on 18Mar2021 10:37 (at the age of 37-years-old) as dose 2,single for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: EL3247; Expiration Date: 31May2021) via an unspecified route of administration, administered on 25Feb2021 as a dose 1,single for covid-19 immunisation. The patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She has an a 11 month old baby, so she must have had a newborn. It was reported that on 02Aug2021 the patient experienced runny nose and on 04Aug2021 08:44 the patient tested positive for covid 19 who had both doses of the Pfizer COVID vaccine. Reporter further stated that on an unspecified date patient experienced headache, fever, chills, body aches, fatigue and reporter know patient was coughing because reporter heard patient was coughing. patient has no loss of taste or smell. On 04Aug2021 the patient underwent lab tests and procedures PCR SARS COVID 2 RNA which resulted positive and underwent QLNAAT, RT, PCR/TMA (COVID 19) which resulted positive. The patient was recovering from the events.  For Lack of Efficacy, request the following information: Description of complaint: Received call from HCP to report a patient at the site she works at tested positive for COVID 19 virus after receiving both doses of the Pfizer COVID 19 vaccine. She did not wish to provide patient name and only gave initials as she did not tell patient that she was reporting on her behalf.   Follow-up attempts are completed. No further information is expected.
A nine year old girl received Flublok Quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Global Medical Information (GMI) (Reference number- 00440411) and transmitted to Sanofi on 21-Jan-2021.  This case involves a 9 years old female patient who received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA, expiry date: 17-Mar-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 11-Oct-2020 (Product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other concomitant vaccines.   It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  On 11-Oct-2020, both the 9-year-old patient and her mother came into the clinic for their flu shot. It is possible that the Flublok was inadvertently given to the 9-year-old instead of to the mother, but that is not certain. It could have been a mix-up in the paperwork. Reporting nurse stated that she always double-checks for this, just before administering the flu vaccine, which is why she thinks it could just have been recorded incorrectly.   At the time of report, 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 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.
PATIENT RECEIVED A DOSE OF PFIZER BIVALENT BOOSTER DOSE WAS PAST BUD, SPOKE TO DAD AND HE STATED THAT PATIENT HAS NOT EXPERIENCING ANY ADVERSE EVENTS. WHOLE FAMILY WILL SCHEDULE TO BE RE-VACCINATED.
Nurse 1 drew up vaccines for nurse 2. Nurse 2 administered vaccines and while documenting vaccine information noted that two DTAPs had been administered. Poison control was contacted who stated that no side effects should occur besides the ones that can occur normally with vaccines. Patient was held in office for 15 minutes and there were no adverse reactions noted. Mother was also informed of error and what to watch for.
Approximately 10 minutes after injection patient started to complain of an itchy throat and a metallic taste in her mouth. No acute distress noted. No oral, facial or throat swelling noted. Lungs clear bilaterally and patient moving air without difficulty. Skin warm and dry. Patient speaking clearly and in full sentences. Patient continued to be monitored.   Patient complained of slight chest "tightness" and increased mucus production approximately 20 minutes after initial vaccination. Upon exam no acute distress noted. Lungs clear bilaterally. Skin warm and dry. Patient speaking clearly and in full sentences. Patient able to manage oral secretions, no drooling noted. No oral, facial or throat swelling noted. No notable redness or rash observed. EMS called and arrived without incident.    Patient discharged by EMS and was advised by them to go home and take a Benadryl. Discussed EMS recommendation with patient and she verbalized understanding and stated that she would call 911 or go to ER if symptoms change or worsen.
the right side of my face was numb starting at 20 min post injection and lasted 6 hours.
Pregnant: due June 9th. Found out at 20 week ultrasound- succenturiate placenta with velamentous cord insertion. My first dose of vaccine was only at 18 weeks though.   After first dose of vaccine only sore arm and a knot in the arm that was visible but pain free for 1.5-2 weeks.  After second dose of vaccine: next am started with nausea, progressed to stomach cramps, body aches, headache, then fever 100.1. this lasted the whole day into the PM. Went to sleep. Woke up the next morning perfectly fine. All symptoms had resolved.
Donor came to center to report that after immunization on 1/30/15, donor got a fever on 1/31/15 which continues until 2/1/15 together with "chest heaviness". Donor went to doctor, dx with bronchitis and tx with oral amoxicillin.
Body ache, head-ache, runny eyes/nose. Excess salivation and flu-like symptoms. Sore neck, possible swollen lymph nodes, started Fri 11/22 night. Worsened sx from Sat-Sun.
Fever 2 days Chills 2 days Nausea 3 days Migraine Headache 3 days Fatigue 3 days
Case number PHEH2013US021620, is an initial spontaneous report received from a pharmacist on 15 OCT 2013. This case refers to a multiple patients. Past medical history and concomitant medications were not reported. These patients were vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on an unspecified date, reporter believes FLUCELVAX causes more local adverse reactions than FLUVIRIN. These patients were complained of pain at injection site. No adverse event was reported following this administration error.
This spontaneous report as received from a healthcare worker (a billing department employee) via company representative, refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose and lot number were not reported), intramuscular. Concomitant medications were not reported. On an unknown date, patient had a seizure in the car on the way home from the pediatric office after receiving an unspecified shot in the GARDASIL series. The patient was taken to an unspecified emergency room where he received unspecified treatment. On an unspecified date, the patient was fully recovered. The relationship between GARDASIL and seizure was not reported. Upon internal review the seizure was considered to be medically significant. This case is linked to case 1306USA003568 and case # 1306USA004931 via same reporter link. Additional information has been requested.
Started with some itchiness around 7 PM. When arrived home and took clothes off, noticed red blotchy areas on arms, torso, legs, and stomach. Took some BENADRYL with some relief, but after the BENADRYL wears off, symptoms return. Also had a headache that was relieved with GOODY'S powder and rest. Still with complaints of itchiness and hives that comes and goes on 2/20/18.
This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (On 26 Apr I started with fever so I took the test the next day and it was positive), PRODUCT DOSE OMISSION ISSUE (More than 35 days since first shot) and PYREXIA (Fever after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (Fever after first dose). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (On 26Apr I started with fever so I took the test the next day and it was positive) and PRODUCT DOSE OMISSION ISSUE (More than 35 days since first shot). At the time of the report, SARS-COV-2 TEST POSITIVE (On 26 Apr I started with fever so I took the test the next day and it was positive), PRODUCT DOSE OMISSION ISSUE (More than 35 days since first shot) and PYREXIA (Fever after first dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, COVID-19: positive (Positive) patient stated she started with fever so took the test next day and it was positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not provided. Treatment information not provided. The second dose was scheduled for 18-May-2021, but the patient was out of the country.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 10:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported. Age of patient was reported as 51.76 for dose administered on 14-Feb-2021. Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 32 degrees Fahrenheit from 9:00 AM to 10:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.   This case was linked to MOD-2022-566976 (Patient Link).
fever, chills, abdominal pain, swelling at sight and very sore, fatigue, headache, muscle pain, joint pain, nausea, unable to sleep
Pt starting getting a rash on the arm they received the vaccine. Rash spread to other arm, chest and back. She is complaining of some small tight chest. Pt was given PO benadryl
Patient it was hot and har - 8X11 cm.  ID physician stated it was a local reaction to the R deltoid with erythema, warmth and tenderness.  No evidence of cellulitis.
vertigo; arm hurt; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Mar2021, outcome "unknown", described as "arm hurt"; VERTIGO (non-serious) with onset 16Mar2021, outcome "not recovered", described as "vertigo". The event "vertigo" was evaluated at the physician office visit.  Additional information: The patient was concerned in taking the second dose of the vaccine since 8 days (also reported as 8-9 days) after she got the first dose of the vaccine, she had some vertigo and it has been on and off since. Her doctor told her to consult a neurologist and her neurologist has said that it is ok to take the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Raised bump day of vaccine, itchy, red still has raised bump itchy, red as of 3/5/13.
did not get full dose as vaccine split on her arm; A spontaneous report was received from a consumer concerning her daughter, a 26-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced didn't get the full dose and the vaccine split on their arm during administration (accidental underdose).  The patient's medical history was not provided by the reporter. Concomitant medication was not provided by the reporter.  On 02-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the patient didn't get the full dose and the vaccine split on her arm during administration.  No laboratory details were provided.  Treatment information for the event was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was unknown.   On 02-Mar-2021, the outcome of the event, didn't get the full dose and the vaccine split on their arm during administration, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of 26-year-old female with Accidental underdose for the first dose of mRNA-1273 (lot #: Unknown) with no associated adverse events. Event considered resolved.
nausea, fatigue, sore muscles, headache, joint pain, chills, sore throat, sore arm, migraine
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY  11/17/2021 &  12/5/2021  --  RECURRENCE OF SAME SYMPTOMS
Received Tdap vaccine on 9-27-13. Awakened AM at 9-30-13 complaining of migraine, nausea, and "possibly a fever". Mom does not have thermometer to check actual temperature. Headache went away around 5 PM but continued to have upset stomach until 10/1/13 evening. Mother did not contact Doctor's office. States gave her something for headache.
Pt recvd 3 doses of Engerix-B & had a borderline response;
Red rash chest and back, and 10 am welt at injection site. fever 101 24 hour post injection required BENADRYL and TYLENOL
Numb arms when sleeping.  Bad short-term memory, aches in hips and lower back.  Fatigue, depression.
The following day after my second Pfizer dose (10/12/21- 6pm) I had some tenderness and swelling in left arm pit. Soreness worse the  next day (10/13/21).. Also noticed a lot of soreness/achiness in right and left shoulder joints and pain down right and left arms the day after the second vaccine. All symptoms are still noticeable today (10/13/21)
SLEEPY; TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced sleepy. On 30-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleepy and tired was not reported. This report was non-serious. This report was associated with product quality complaint :90000174832.
Approximately 30 min after administration, the doctor was finishing up patients well child check up and he was standing up and passed out, fell forward onto his face.
he developed a rash from his chest to his arms and legs, and now it is on all of his face; he started to develop a rash and had a telehealth appointment with a doctor and they said it looked like chicken pox; and the doctor said in their opinion that the rash looks like Chicken Pox; This is a spontaneous report from a contactable pharmacist. A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: not reported) (age at the time of vaccination was 21 years), via unspecified route on 08May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: not reported), via unspecified route on an unspecified date, as dose 1, single for COVID-19 immunization. On 10May2021, the patient had developed rash from his chest to his arms and legs, had a telehealth appointment with a doctor and they said it looked like chicken pox. The outcome of the event was unknown.  No follow-up attempts were possible; information about lot/batch number cannot be obtained.
administered a fluzone quadrivalent injection to a patient who has already had a influenza shot this season on 22dec2022 with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 49 years old and unknown gender patient to whom administered a INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] injection who has already had a influenza shot this season on 22dec2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 07-Feb-2023, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE(strength, formulation was unknown, lot UT7680NA via intramuscular route in the right deltoid for Immunization.  On 07-Feb-2023 the patient developed a non-serious event of administered a fluzone quadrivalent injection to a patient who has already had a influenza shot this season on 22dec2022 with no reported adverse event (inappropriate schedule of product administration, Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  Outcome: Unknown  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.
3RD DOSE PFIZER COVID VACCINE GIVEN 7/22/22, LOT # UNKNOWN; pt resides at unknown residence; brought to ED via EMS with low O2 saturation; O2 supplementation; found to be positive for COVID and UTI; sepsis; DNR; pt declined definitive and supportive tx; pt passed away in the hospital.