chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 year old patient received an extra dose of Pediarix in the same visit; This non-serious case was reported by a consumer via sales rep and described the occurrence of extra dose administered in a 4-year-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: 4 year old patient received an extra dose of Pediarix in the same visit). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUN-2023 The healthcare professional reported that the patient received an extra dose of Pediarix in the same visit, which led to extra dose administered.  No other information known or provided. The reporter did not consent to follow-up.
Severe back pain, left leg pain, and left leg weakness that started 1 day after the vaccine and progressively increased.
patient received the YF-VAX but the diluent that was used to reconstitute it was a sterile diluent which was taken from an MMR vaccine, with no adverse event;Initial information received on 07-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional and physician via Media Information (under reference 00803170).  This case involves a 1 years old female patient who received YELLOW FEVER VACCINE (YF-VAX) but the diluent that was used to reconstitute it was a sterile diluent which was taken from an MMR vaccine (product preparation error).  Patient received no other vaccines as concomitant medication(s).  The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided.  On 05-Oct-2021, the patient received a 0.5 mL first dose of suspect YF-VAX (Total, lot UJ386AA and expiration date: 22-AUG-2022) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to Wrong diluent used (same day latency).  It was reported "Caller states that a patient received the YF-VAX in her office on 05OCT2021 but the diluent that was used to reconstitute it was a sterile diluent which was taken from an MMR vaccine and not the diluent supplied with the YF-VAX. Caller wanted to know if that dose counted and how to proceed."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Heart disease; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC DISORDER (Heart disease) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Known allergy was reported.  Concurrent medical conditions included Hypertension since 09-Nov-2017, Type 2 diabetes mellitus since 09-Nov-2017, Hyperlipidemia since 14-Nov-2018, Neuropathy since 04-Feb-2019 and Heart disease, unspecified since 17-Jun-2022. Concomitant products included SEMAGLUTIDE from 27-Jun-2022 to an unknown date for Diabetes, ATORVASTATIN from 30-Sep-2021 to an unknown date for Hyperlipidemia, LOSARTAN from 09-Mar-2022 to an unknown date for Hypertension, PREGABALIN from 08-Dec-2021 to an unknown date for Neuropathy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2022, the patient experienced CARDIAC DISORDER (Heart disease). The patient was treated with CLOPIDOGREL (oral) ongoing from 13-Apr-2022 for Heart disease, unspecified, at a dose of daily. At the time of the report, CARDIAC DISORDER (Heart disease) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist was called to report that about 15 adult patients received expired booster Moderna COVID-19 vaccine on 05-Jul-2022 through 07-Jul-2022. The Lot number reported as 059M21A and manufacturing expiry date 15-OCT-2022. The Number of doses were 15 and Vials were 3 Red Cap. On 02JUN2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-607837 (Patient Link).
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 14-AUG-2015, the patient was vaccinated with 0.5 ml dose of improperly stored GARDASIL, intramuscularly, lot # K005881, expiry date 14-JAN-2017 (site of administration was not reported). No adverse effects were reported. Additional information has been requested.
3 days of extremely sore arm at site of injection; last night I developed a fatty lump in my arm pit area. Very painful. Can move it around.
Developed bilateral hand and finger pains that comes and goes.  Has started to increase more and has a burning sensation.
Received Pfizer vaccines on  2/28, 3/21/21 COVID-19 positive by PCR on  2/3/22 admitted to hospital on 2/3/22 d/t worsening cerebellar ataxia in the setting of COVID-19 infection  underlying cerebellar ataxia, HTN, DM2
flu like symptoms; This case was reported by a consumer and described the occurrence of flu like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced flu like symptoms. On an unknown date, the outcome of the flu like symptoms was unknown.   It was unknown if the reporter considered the flu like symptoms to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The pharmacist reported that some patients got mild flu like symptoms after receiving Shingrix. This case has been linked with US2019AMR184960, reported by same reporter.
vomiting, pojectile-like, pale & was lethargic;unresponsiveness, like absence-like sz lasting for short periods ;would cry w/stimulation;when mom returned from work found pt not looking right & vomiting & fussy;dx lethargy r/o sepsis;
Case number PHEH2012US008173, is an initial spontaneous report received from nurse on 09 Apr 2012. This case refers to a 19-year-old female patient. The patient was received only Men A liquid conjugate component of MENVEO vaccine (batch number: M10053) intramuscularly, reconstituted with a sterile diluent instead of MenCYW-135 liquid conjugate vaccine component of MENVEO on 06 Apr 2012. No adverse reaction had occurred following this administration error.
About 15min after the vaccine my arm started feeling heavy, I started getting a headache it felt like the headache I got when I got covid in July. The next day in the morning I started feeling fatigue, body aches, & congestion. Everything lasted till Sunday evening except the heaviness on my arm this symptom lasted till Wednesday. I took Tylenol for this symptoms.
ADMINISTRATION OF AN EXPIRED  VACCINE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958423 and 20210958321. This case, from the Others is linked to 20210958425.
This spontaneous report as received from a nurse refers to a 67 years old patient. The patient did not have any drug reactions/allergies. The patient was vaccinated with the first dose of PNEUMOVAX 23 (0.5 ml, Intramuscular, lot # were unknown) in 2009 and the second dose of PNEUMOVAX 23 (0.5 ml, Intramuscular, lot # 671555/1314AA, expiration date was 05-MAY-2013) on 14-NOV-2012. No other co-suspects were reported. Concomitant medications included omeprazole and FLONASE. On 14-NOV-2012 the patient experienced swelling at the injection site after receiving PNEUMOVAX 23 and swelling was moving down toward her right armpit and down to elbow along with pain and redness. Ibuprofen and BENADYRL were given for adverse event. The outcome of event was unknown. The patient had sought unspecified medical attention. Additional information has been requested.
HCP has no further AE information; HCP called to report a TE for  ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for GARDASIL 9, ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to an approximately 2-month-old (also reported as 3-month-old) male patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours. On this date, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event).     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA003147: US-009507513-2311USA002927: US-009507513-2311USA002928: US-009507513-2311USA002932: US-009507513-2311USA002931: US-009507513-2311USA002930:
8 days after vaccination, developed itchy area on left arm, about 1 inch below vaccination site.  9th day (today), more itchiness, slightly swollen, some redness.  Read online about "vaccine arm", applying cortisone-10 to area for itchiness relief
Still admitted (8) days. Patient is a 82 y.o. male with severe O2 dependent chronic obstructive pulmonary disease, who was hospitalized about 6 weeks ago for chronic obstructive pulmonary disease exacerbation with bronchitis.  He was doing well until yesterday when he developed cough productive of dark colored mucus, and fever.  During the night he woke up and was in respiratory distress and had severe weakness, and his wife called an ambulance and had him brought to the emergency room.  In the emergency department he was found to be hypoxemic at 84%.  He had tachycardia and increased respiratory rate, but normal blood pressure.  Labs revealed leukocytosis and bandemia, as well as lactic acidosis at 2.3.  D-dimer was elevated at 2000.  COVID PCR was positive.  Procalcitonin was significantly elevated at 6. Chest x-ray showed bilateral pulmonary infiltrates left greater than right.  CT angiogram of the chest excluded pulmonary embolism, and confirmed bilateral left greater than right pulmonary infiltrates.  ASSESSMENT / PLAN: * Bilateral pneumonia Assessment & Plan Community-acquired pneumonia with high risk for Gram-negative infection.  Recent MRSA screen was negative.  Treat with cefepime and doxycycline.  Mucinex and Acapella to help clear prominent pulmonary secretions.  Sputum culture requested   Severe sepsis  Assessment & Plan Severe sepsis criteria with sepsis parameters of tachycardia increased respiratory rate leukocytosis and bandemia, and severe sepsis criteria of lactic acidosis.  2 L saline bolus (30 mL/kg) and maintenance IV fluids.  Antibiotics for pneumonia   Acute on chronic respiratory failure with hypoxia  Assessment & Plan Patient is normally on 2 L of oxygen mainly at night, needing 2 L continuous now   COVID-19 virus infection Assessment & Plan COVID positive.  Checking inflammatory markers, but I believe this is not contributing to a lot of his symptoms.  Patient will receive IV Solu-Medrol for chronic obstructive pulmonary disease and COVID.  Also treat with remdesivir   COPD (chronic obstructive pulmonary disease)  Assessment & Plan Severe chronic obstructive pulmonary disease.  Do not appreciate wheezing on admission exam.  Treat with Solu-Medrol.  Treat with long and short-acting inhalers.   Coronary artery disease involving native coronary artery of native heart without angina pectoris Assessment & Plan Maintain aspirin and statin therapy     Essential hypertension Assessment & Plan On Hyzaar.  This will be held temporarily due to severe sepsis     Protein-calorie malnutrition, severe  Assessment & Plan Body mass index less than 20. To be followed by nutrition    Elevated d-dimer Assessment & Plan D-dimer 2000 on admission.  CTA of chest excluded pulmonary embolism.  Will add upper and lower extremity venous ultrasounds to screen for DVT.  DVT prophylaxis with Lovenox.
I have lost my sense of taste and smell.  I also had deep rashes with both vaccines that lasted for several days.
SEVERE PAIN IN THE ARM ON WHICH THE SHOT WAS ADMINISTERED. CANNOT MOVE THE ARM A BIT AND ITS BEEN 3 DAYS AND THE PAIN IS STILL THERE AND HAS NOT SHOWN ANY IMPROVEMENT. DON'T KNOW HOW LONG IT WILL TAKE TO HEAL.
Shortness of breath (left lung inflammation; side closest to injection site); Shortness of breath (left lung inflammation; side closest to injection site); This is a spontaneous report from a non-contactable other hcp (Patient).  A 31-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTEH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 02Jul2021 10:00 as single dose for covid-19 immunization. (Vaccination facility: Hospital). Medical history included allergies to sulfa from an unknown date and unknown if ongoing, patient had Never smoked. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (Lot number= ER8735) in left arm on 11Jun2021 09:00 for covid-19 immunization. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient was not diagnosed with Covid prior vaccination. It was reported that on 04Jul2021 Shortness of breath (left lung inflammation: side closest to injection site), no previous medical concerns with her lungs. Highly physically active individual (especially cardiovascular) consuming a healthy diet. Patient did not receive any treatment for the events. Patient was not tested for covid post vaccination. The outcome for the events was reported as resolving at the time of this report.   No follow-up attempts are possible. No further information is expected
Patient cannot lift his arm since he got the first dose of shingrix. he gets pain when lifting arm and cannot raise arm fully. pain and tightness is present at the injection site.
Headache; Chest pain; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program,t. A female patient of unspecified age (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported the patient experienced headache and chest pain in Mar2021, and took acetaminophen (TYLENOL). The clinical outcomes of headache and chest pain were not recovered at the time of reporting (14Mar2021).  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. Concurrent conditions, medical history, historical and concomitant drugs were not reported. The registered nurse reported that on 09-JAN-2018, the patient was inadvertently vaccinated with a dose of PROQUAD subcutaneously in the left arm, lot # N010865, expiration date 01-OCT-2018, for prophylaxis (strength, dose and albumin status not reported), instead of the intended dose of M-M-R II (albumin status, lot # and expiration date not reported). The registered nurse also reported that on the same date (09-JAN-2018), the patient received her second dose of VARIVAX subcutaneously in the right arm, lot # M010480, expiration date 01-MAR-2018, also for prophylaxis. All vaccines were reconstituted with sterile diluent (MERCK). No adverse effects reported.
Patient has some kind of nodule/growth just above the collar bone. It feels like a small pebble and is sensitive to touch.
Dizziness, fatigue, vomiting,  THIS WAS THE J+J VACCINE
A female patient had a breakthrough infection after vaccination but it is unknown if she received Moderna vaccines; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BREAKTHROUGH COVID-19 (A female patient had a breakthrough infection after vaccination but it is unknown if she received Moderna vaccines) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAKTHROUGH COVID-19 (A female patient had a breakthrough infection after vaccination but it is unknown if she received Moderna vaccines). At the time of the report, BREAKTHROUGH COVID-19 (A female patient had a breakthrough infection after vaccination but it is unknown if she received Moderna vaccines) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
No adverse event Covid 19 vaccine expired 10/27/2022 Given 10/28/2022
Fever, chills, body aches, flu like symptoms on day 2 thru 4. Extreme pain at injection site.
This is in follow-up to report(s) previously submitted on 5/14/2008. Information has been received from a medical assistant concerning a female in her teens with no pertinent medical history who in March 2008, was vaccinated with a first dose of GARDASIL from her OB/GYN. There was no concomitant medication. Subsequently, "soon after administration" the patient developed persistent nausea for the last 2 weeks. The patient has an appointment to see the office (her primary physician). At the time of reporting the patient had not recovered. Additional information has been requested. Follow-up information was received from a health care professional. The office did not administer the GARDASIL however the patient was presented to the office on 02-APR-2008 and stated she might have had a reaction to the GARDASIL. Her symptoms were nausea. The patient also had recently began taking a new birth control pill (unspecified). The physician had seen the patient and explained that he could not determine if the nausea was due to the vaccine. The physician felt like it was more possible that it was due to the change in her OCP. The patient was prescribed medication for nausea. At the time of reporting it was unknown if the patient had recovered. Additional information is not expected.
I had a violent reaction; lesion on my brain and found everything once I was in hospital; I am upset; Dizziness; Vomiting; the "rungs" (not clarified) and the stomach after giving me something it stopped. I went from both ends when I had to throw up I just went out from both ends, (it was) bad; This is a spontaneous report from a contactable consumer (patient).  An 88-year-old female patient received first dose of bnt162b2 (BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunization. Medical history included diabetes, blood pressure high, thyroid. Concomitant medication included amlodipine, valsartan (DIOVAN), metformin, levothyroxine sodium (LEVOXYL) for thyroid, atorvastatin (LIPITOR). The patient had the shot on Saturday and Sunday, she had a violent reaction and she just want to report it. It was first shot she had the first on Saturday and it happened (incomplete sentence). Her follow up was that she found other problems. She found lesion on her brain, she found everything else once she was in the hospital. So actually this reaction was (incomplete sentence). She known never she was little upset today. She was not right why not follow up latter she was little upset today, so she just want to let you know she had a problem. When probed for the vaccination date, consumer stated, the date was 23Jan2021. When probed for start date of the events, consumer stated, it was 24Jan. When probed for the side effects, consumer stated, she had extreme dizziness, she had extreme vomiting and "run" (not clarified) and that was about it Dizziness she went to 12 o'clock noon she started with the dizziness and it was over in about 5 in the afternoon and the "rungs" (not clarified) and the stomach after giving her something it stopped. She went from both ends when she had to throw up she just went out from both ends, (it was) bad. They did not give her anything for that. They did all sorts of test and found out that she had other problems. When probed for any Laboratory test, consumer stated, "Yes, she did it and she was fine." When probed for laboratory results, consumer stated, "No, she did not have the results. Her doctor just gave them to her over the phone and said that she was good. Her A1C was 5.9." The event lesion on her brain was reported as serious per hospitalization. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 5.9 on an unspecified date. The outcome of events was unknown.
Swollen left testicle, visible blood in urine.  Urine culture negative.  Ultrasound scheduled for 20 APR.
Sore Left Shoulder for several months.  Shortness of Breath and Chest Pain