chrisvoncsefalvay/vaers-outcomes huggingface dataset:
use past expiration date with no reported adverse event; Initial information received on 27-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call canter.  This case involves a 4 years old female patient who was administered with vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] which was past expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Apr-2022, the patient received a 2nd dose 0.5 ml of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (strength and formulation unknown) lot C5732AA, expiry date: 22-Apr-2022, frequency: once, via intramuscular route in the left deltoid for immunization.  On 26-APR-2022, the patient developed a non-serious event use past expiration date with no reported adverse event (expired product administered) (latency same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.  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 guidelines. 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.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021 at 8:00 AM, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    No concomitant medications were provided. No treatment medication were provided.   This case was linked to MOD-2021-370221 (Patient Link).
whole body muscle aches, chills, fever over 101, light headed/dizzy (fainted), fatique, some nausea. all disapated within 48 hours of getting shot
Awoke on the morning of 6/26/2021 with partial blindness in left eye, complete medical examination on 6/26 and follow up MRI on 7/8/2021 show no abnormalities and no explanation for the loss of vision.  Patient had thorough yearly physical the week prior to 6/26/2021.   Eyesight has returned but patient now experiences regular "flashes of light" with no explanation from doctor.    9/01/2021 patient showed signs of white patches on skin on both arms.  White patches have continued to grow and spread through upper torso and back.    10/01/2021 patient began noticing red patches on the face, across the nose and cheeks.    01/01/2022 patient notices white bump growing on lower lid of the left eye Patient was examined and diagnosed with Vitiligo and Rosacea in April 2022 by dermatologist. Growth on left eye has not been diagnosed but was examined by doctor on May 10, 2022.      Patient has received the additional COVID boosters: Pfizer - EL9263 - 2/10/21- intramuscular - left arm Pfizer - 330308D -12/6/2021- intramuscular - left arm
approximately 1/2 of the dose leaking at the site of administration at needle; a dose of MENQUADFI leaked at the injection site during administration; Initial information was received on 25-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 18 years old male patient who reported that a dose of menquadfi leaked at the injection site during administration and approximately 1/2 of the dose leaking at the site of administration at needle after receiving meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of 0.5 ml of suspect meningococcal a-c-y-w135 (t conj) vaccine (Solution for injection) lot U7632BB (strength, expiry date unknown) via unknown route in unknown administration site for Immunization.  On 25-Jul-2023 the patient developed a non-serious event of a dose of menquadfi leaked at the injection site during administration (vaccination site extravasation) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine. On an unknown date the patient developed a non-serious event of approximately 1/2 of the dose leaking at the site of administration at needle (incorrect dose administered) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  It was not reported if the patient received a corrective treatment for the events (a dose of Menquadfi leaked at the injection site during administration).  At time of reporting, the outcome was Unknown for the event a dose of menquadfi leaked at the injection site during administration and was Unknown for the event approximately 1/2 of the dose leaking at the site of administration at needle.  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.
Patient developed headache, body aches 1-2 hours after vaccination. The next day he developed dyspnea on exertion, fever and chills. There were wheezings heard over LLL. Radiograph of the chest demonstrated. Patient was treated with Zithromycin PO.
arm is tight; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is tight) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is tight). At the time of the report, PERIPHERAL SWELLING (arm is tight) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-369375, MOD-2021-369392 (Patient Link).
When I received my first dose of the Pfizer COVID shot I had no issues. When I received the second dose I had the vaccine injected and then I got up and walked to the monitoring room where we sit for 15 minutes. Immediately upon sitting down in that room I felt very woozy, lightheaded, and my heart was beating out of my chest. I checked my pulse on my smart watch and it was in the 80s but my resting HR is normally in the 60s or 70s. I got nervous at that point so I took some deep breaths and tried to relax and my symptoms improved within a minute. I sat for the remainder of the monitoring period and right at my 15 minute mark all of my symptoms returned. HR in the 100s, lightheaded like I was going to pass out, chest heaviness, and shortness of breath. I alerted the nurse in the monitoring room and she took my BP and HR and they have me a bottle of water. My throat felt a little weird too and I was worried that it was starting to close up, but I was able to swallow  water normally. I remained in the monitoring room for about 15 more minutes and at that point my symptoms mostly resolved and I felt well enough to leave. For the next approx 48 hours I have had some mild- moderate chest heaviness. More worse in the initial 24-36 hours after the vaccination.
Difficult breathing, headache, fatigue, tiredness, dizziness, pain inside the chest, palpitations
Pt developed seizures 3 days after vaccine and this is the 3rd patient that I was assigned to that developed seizures days after being vaccinated with the pneumococal vaccine. The 1st two episodes were with patients that had the vaccine only one year before but were given again since the hospital was not aware that they were already given the vaccine at the nursing homes where they were residents.
Initial report received on 21 November 2008 from an other manufacturer, who had received the original report from a consumer.  A male patient (demographics not provided) had received an influenza vaccine (trade name, manufacturer name, lot number, route and site of administration not provided) years ago on an unspecified date.  Per the reporter, at an unspecified amount of time later, the patient experienced Guillain Barre syndrome.  Treatments received, and diagnostic test performed were not provided.  Recovery status of the patient was not provided.  No contact information for follow-up was provided.  No further information is expected.  Documents held by sender: None
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced cried for three hours. The patient received a dose on an unspecified date. Additional suspect medication included PENTACEL and ROTATEQ. On an unspecified date after receiving vaccine, the patient experienced cried for three hours. The patient recovered. No additional information was available at the time of this report.
I received the Flu Mist at 4:00 PM on 2 Deck 2006, after leaving and arriving home at 7:30pm i felt nausea and a headache.  By 8:30PM I was vomiting which continued until approx 4:am on 3 Dec 2006.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar event for 3 patients. This is 3rd of 3 reports. A patient of an unspecified age, gender and ethnicity received PREVENAR 13, via an unspecified route of administration on an unspecified date at single dose, for immunization. The patient medical history and the patient's concomitant medications were not reported. The patient experienced pain redness and swelling at the site of injection. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017006205 Same reporter/drug/AE, different patients.;US-PFIZER INC-2017006187 Same reporter/drug/AE, different patients.
Swelling of lower limbs began on/around 4/16/2021.  Progressively increased to bilateral leg edema with pitting, low back pain, groin/abdominal distension, fatigue, and foamy urine.  On 7/9/2021 my PCP referred me to a Nephrologist who diagnosed Nephrotic syndrome/Minimal-change disease.  I am currently under nephrologists care.  Current medications for treatment:  tacrolimus 1 mg capsule; lisinopriL 5 mg tablet, atorvastatin 10 mg tablet,  torsemide 20mg tablet.
used the diluent from the Acthib and put it into the powder of the Pentacel and vaccinated the patient with no AE; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was vaccinated with powder of the Diptheria / Tetanus / 5 Hybrid AC Pertussis / IPV (MRC) / HB (PRP/T) (Pentacel VERO) powder diluted with ACT HIB and experienced no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC 5)/HIB(PRP/T) vaccine (with an unknown expiry date, lot number) powder form diluted with ACT HIB (product preparation error) via unknown route in unknown administration site for prophylaxis.  No lab data was reported.  Action Taken: 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 guidelines. 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.
Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Hypertension-Severe, Systemic: Weakness-Severe
Flu like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms". Additional information: The event occurred 5 days after receiving the second dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that he was aware of a male patient that received Shingrix and experienced muscle pain. No further information was reported. This is 1 of the 4 linked cases reported by same reporter.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 01-Apr-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 01-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 01-Apr-2022) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022 at 4:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Apr-2022 at 4:13 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 01-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   ethnicity was reported as (Privacy) Concomitant product use was not reported. Patient took second booster dose.  The patient's ethnicity was provided as (Privacy).  A Series of patients approx. 540 patients received lot number 066H71A past its 30 days expired date. Vaccines went into 2-8 degree Celsius thaw state on or above 24-Dec-2021. This vaccine was administered up until its Mfg Exp date of 04-Apr-2022.   Treatment information was not provided.
Information has been received from a physician concerning an 18 year old female with asthma who on 10-JUN-2008 was vaccinated with the first dose of GARDASIL and the second dose of GARDASIL on 12-AUG-2008, lot # 660557/0072X, intramuscularly in right deltoid.  It was reported that the patient experienced nausea, abdominal pain, headache, sore throat and fever "several " hours after receiving her second dose of HPV
Back in June I had to get hand surgery, I hadn't worked much since then. Recently in the last 2 months, my right arm has been having more trouble. I couldn't pick anything up without discomfort and pain. Ever since I got the vaccine, I couldn't go to sleep with my arm above my head. I can't do that without discomfort. The pain down the arm has recently started in the last month or so. The pain in my right arm has radiated down to my elbow. You can feel the heat coming from my arm like it's inflamed where the shot was. That's with both arms.
provider at the clinic gave a Moderna vaccine to a 17 year old. Indications are for 18 and over at that clinic. MD on call was notified. No reports of reactions or side effects noted per provider
pt recv vax in late OCT96 & devel an inj site rxn w/a quarter-sized welt w/redness & induration;pt recovered;this is 1 of 5 pt;
few days, 4 patient received Boostrix expired dose by error; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The pharmacist had reported that a dose of Boostrix was given by error on the past few days to the patient which was already expired on 30th September 2022. Lot number data was not available. No other information was available at the moment. The reporter did not consent to follow up.  Additional supportive information: The patient had received an expired dose of Boostrix, which led to expired vaccine used. This case was one of four cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022146819:same reporter US-GSK-US2022AMR147249:same reporter US-GSK-US2022AMR147251:same reporter
Within one week of receiving second dose I began to experience a high pitched tone in both ears. The ringing has been incessant for approximately 10 days. My left feels "full" and has reduced hearing.  The high pitched tone varies from soft to loud and worsens after taking Benadryl.  When I talk it feels like I have a tin can on my head. Noises are very tinny.  I was not warned that I could get tinnitus from the vaccine. I never would have gotten it had I been warned.
no additional AE; 66 year old Patient was inadvertently co-administered MENACTRA and GARDASIL/the intended TDAP Vaccine was co-administered on 14-JUN-2021; This spontaneous report was received from a medical assistant, concerning a 66-year-old female patient. The patient was known as a healthy individual with no chronic conditions or issues. No information was provided regarding previous drug reactions, concomitant therapies or allergies.   On 14-JUN-2021, the patient was inadvertently co-administered HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly for prophylaxis (dose, dose number, frequency scheme, anatomical injection site, lot number and expiration date not reported) with meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) on the same day and time that diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) was co-administered (doses, dose number, frequency scheme, route of administrations, anatomical injection sites, indications, lot numbers and expiration dates not reported for both suspect therapies)(wrong product administered). No additional adverse event (AE).
Patient noticed that she had bruising on both of her lower legs. From knee down to her ankles.  Made Dr appointment with cadiologist.
Administration of an expired dose of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) (batch number K7TF9, expiry date 24th May 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th May 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 26th May 2021, unknown after receiving Pediarix and Pediarix 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 details were provided as follows: Age at vaccination was not reported. The reporter informed that, Pediarix dose was given on 26th May 2021 which was expired on 24th May 2021, which led to expired vaccine used. The reporter did not consented to follow up.
Injection given Friday morning. On Saturday she was very tired all day. Sunday she was very tired and became light-headed around noon. By Sunday evening she was lethargic. Monday morning, still lethargic and light-headedness has increased. Feeling somewhat disoriented. No fever, blood oxygen at 93.
January 30th: Severe chills,  muscle aches, fatigue,  headache, and fever lasting about 12 hours. Max temperature was 102.6F which was treated with 325mg of acetaminophen to prevent it from going higher. Fever was above 101 continuously until the morning of February 1st when it came down.  January 31st: Febrile all day (max 101.6F), extreme fatigue, mild headache, mild muscle aches, mild chills. February 1st: Afebrile, moderate headache in the morning, then no symptoms