chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PENTACEL was given without the powder to a patient, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional (medical assistant).  This case involves a four-months-old female patient who was vaccinated with a 0.5 mL second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ344AA and expiration date 04-Apr-2021) via an intramuscular route in the left vastus lateralis on 26-Aug-2020 for prophylactic vaccination however only powder portion of pentacel was given to the patient.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient was concomitantly vaccinated with a dose of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  This was an actual medication error case due to active ingredient not added to diluent (latency was same day).  At the time of reporting, the patient had no adverse event.  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.
About 8 hours after vaccine administration on 1/15/21 - woke up in the middle of the night with chills, headache, pain in joints and injection site, nausea. Sat up on the side of the bed - passed out and woke up on the floor.  Tried to readjust slowly, passed out again. Place ice pack on stomach and behind neck to treatment with legs up. 1/16/21 continued to experience chills, headache despite cool compress and Tylenol 1000mg TID and Motrin 600mg x 1 dose at 1900. Fatigue and body aches throughout the day - very limited on any daily activities. Sweats and joint pain and pain around L arm injection site.
soreness at the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number reported as EN5318; Expiration Date reported as May2021) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number reported as EL3248, Expiration Date was not reported). The patient's medical history and concomitant medications were not reported. The reporter stated that, she experienced some dehydration the following day after her first dose. She called to see if that was a side effect. The next day she was fine. The only side effect she experienced was minimal soreness at the injection site after both doses on an unspecified date. If she had serious side effect, she would have completed the questionnaire. The outcome for the event was unknown.  Follow-up attempts completed. No further information expected.
Swollen, itchy bicep where vaccines are given. Pt states it was the worst 11/7/19 and has since gotten a little better. Pt took diphenhydramine and it helped some symptoms.
Flu symptoms. Body aches, fatigue, fever, chills, lasting 48 hours.; Flu symptoms. Body aches, fatigue, fever, chills, lasting 48 hours.; Flu symptoms. Body aches, fatigue, fever, chills, lasting 48 hours.; Flu symptoms. Body aches, fatigue, fever, chills, lasting 48 hours.; Flu symptoms. Body aches, fatigue, fever, chills, lasting 48 hours.;This is a spontaneous report from a non-contactable other Health Care Professional. A 28-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 18:00 as DOSE 2, SINGLE for Covid-19 immunization).Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. Concomitant medication included duloxetine taken for an unspecified indication, start and stop date were not reported.Patient took first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) on an unspecified for covid-19 immunization.The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On 09Feb2021 09:00 the patient experienced flu symptoms. body aches, fatigue, fever, chills, lasting 48 hours. Patient was not received any treatment. On 11-FEB-2021 the outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
11 days following COVID vaccine #2, patient died within 15 hours on February 16, 2021, of sudden, new onset atrial fibrillation leading to bradycardia unresponsive to atropine and oxygen. Patient had been seen by primary care doctor in December 2020 for Medicare annual wellness exam and had a normal EKG and heart exam;  moderate hypertension well controlled. No other history of cardiac disease or arrhythmias, no angina, no dyspnea, no cyanosis. All renal dialysis parameters had been stable since starting on thrice-weekly dialysis in 2017. No history of preceding illness or vaccine reactions. No fever, no rash, no GI symptoms, no change in consciousness (clear mental status), no asymmetry of face/arms/legs. All medications administered by caregiver who is daughter and MD.
pt recvd vax & exp inject site rxn w/ redness, pain & swelling;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-JUN-2016, the patient was vaccinated with improperly stored dose of M-M-R II 0.5 ml injection, lot# L032181, expiry date: 25-AUG-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I had pain, swelling, redness in the arm where I got the shot with severe chills, fever, swelling and tenderness under armpit.
Body aches, malaise at 24 hrs post vaccine Streak down left arm 72 hrs post vaccine Fever 5 days post vaccine with increased redness distal to vaccine injection site Worsening redness 6 days post vaccine, malaise
With 12 hours of HPV, tetanus, and PPD developed low grade fever, vomiting, diarrhea.
Minutes after receipt of vaccines pt had a syncopal episode, striking left side of face on filing cabinet. Immediate attention was rendered - Glucola given. Watched for 20 minutes.
A 17 year old patient was given the COVID Moderna vaccine. The COVID Moderna is licensed for 18 years of age and older.
Pt was in the bathroom in the mall and felt dizzy, lightheaded, and fell. Pt hit his head, no LOC, no pain, no trauma noted. Pt denies not nausea, vomiting or chest pain. Pt got his first COVID vac yesterday per pt. Pt had hx of valve replacement and HTN.
administration of Kinrix (probably instead of Pediarix); Kinrix - Inappropriate age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 03-AUG-2023, the patient received Kinrix. On 03-AUG-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: administration of Kinrix (probably instead of Pediarix)) and inappropriate age at vaccine administration (Verbatim: Kinrix - Inappropriate age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 09-AUG-2023 The healthcare professional asked for guidance on this situation. The reporter did not provide Kinrix lot number and expiration date. The reporter consented to follow up. The reporter reported that the administration of Kinrix to a 2 year old patient (probably instead of Pediarix), which led to wrong vaccine administered and inappropriate age at vaccine administration.
tenivac was inadvertently given to a 6 month old patient with no adverse event; Initial information received on 28-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient and it was reported that tenivac (DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) was inadvertently given to a 6 month old patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and HIB VACCINE CONJ (OMPC) (PEDVAXHIB) for Immunisation.  On 28-Jul-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U7092AA, expiration date: 24-Jun-2023, via intramuscular route in the left thigh as immunization.  On 28-JUL-2022 the tenivac was inadvertently given to a 6 month old patient with no adverse event (accidental exposure to product) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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.
No ADR, timing ERROR, 2nd dose given 56 days after 1st Narrative: Timing ERROR only
This 79   year old   white male received the Covid shot on  2/16/21  and went to the ED on   2/21/21    and was admitted  on  2/21/21 after a fall with rib fractures and traumatic hematoma.  He went to the ED again on 4/27/21 and was admitted with Abdonminal aortic aneurysm  and died on   4/28/21 .  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
This spontaneous report has been received from a pharmacist and a 66 years old female patient referring to the patient. Information about concurrent condition and concomitant medication was unknown. On unknown date in 2016, the patient received PREVNAR 13 and "did fine" after receiving PREVNAR 13. At 5 p.m. on 07-MAR-2017 the patient was vaccinated with PNEUMOVAX 23 (dose and lot number not provided) in a pre-filled syringe intramuscularly for prophylaxis. By 7 p.m., the patient's left arm was extremely sore, had a burning feeling, and a tiny lump, "like a mosquito bite" at the injection site. At around 8:30- 9 p.m., the patient stated that her arm was enormously painful and that she put ice on her arm and took TYLENOL. On 08-MAR-2017 the patient's arm was noticeable swollen, itching, and had a raised red rash at the injection site. She then talked to her physician who recommended to take an anti-inflammatory, an unspecified antihistamine and BENADRYL (dosage and manufacturer unspecified). On 09-MAR-2017, the day after, in the morning the patient stated that the itching had subsided but that it was still swollen and had spread to below her elbow. She then went to her physician who prescribed unspecified oral steroids. On Friday 10-MAR-2017, the pharmacist examined the patient's left arm, and the patient reported that her arm had improved. On 15-MAR-2017, the patient stated that the swelling was down, the redness was gone, and it "doesn't feel swollen," however she had not fully recovered. Upon internal review, the events were determined to be medically significant. Additional information has been requested.
Flu shot killed my mom; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient died after vaccination with flu shot.; Reported Cause(s) of Death: Unknown cause of death
when giving vaccine it leaked out of the syringe; when giving vaccine it leaked out of the syringe; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose number unknown (booster), single (Lot number: GJ3274, Expiration Date: 31Jan2023) at the age of 68 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol takes medication for this. There were no concomitant medications. Vaccination history included: flu shot (had a flu shot 25Sep2022), administration date: 25Sep2022, when the patient was 68-year-old; Pfizer covid-19 vaccine (Dose number unknown), administration date: Oct2021, when the patient was 67 years old, for COVID-19 immunization; Pfizer covid-19 vaccine (Dose number unknown , lot FK9895), administration date: Apr2022, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: UNDERDOSE (non-serious), PRODUCT LEAKAGE (non-serious) all with onset 16Dec2022, outcome "unknown" and all described as "when giving vaccine it leaked out of the syringe".  Additional information: This hasn't happened before, and they have used these needles and syringes before with no issues. It leaked out where the needle meets the syringe at the luer-lock junction.  No follow-up attempts are possible. No further information is expected.
Elevated white blood cells; This case was reported by a pharmacist via call center representative and described the occurrence of white blood cell increased in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   Concurrent medical conditions included cancer and pneumonia.   On 15th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was unknown.   It was unknown if the reporter considered the white blood cell increased to be related to Shingrix.  Additional details were received as follows: The patient is an oncology patient and also had a history of pneumonia within the past 6 months The reporter stated that, the patient had the 2nd dose and had elevated white blood cells. To the knowledge of the reporter the patient had no occurrences after the first dose. The reporter consented to follow up.      Lab Comments: In July 2019 blood test was done
Patient received the vaccine and stated that they felt a tingling down to their wrist at the time of administration. It resolved shortly after and he no longer felt the tingling.
This spontaneous report was received from a consumer and refers to her daughter a 11 year old female patient. The patient's concurrent conditions include attention problem and her concomitant medications include STRATTERA. It was reported that the patient did not have any drug reactions or allergies. On 01-MAR-2018, the patient was vaccinated with GARDASIL 9 injection in the right arm (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in March 2018, the patient developed a dime-sized knot with redness which was not hot at the touch at injection site on the right upper arm, also, it was stated that the patient was afebrile. It was reported that the patient did not seek for medical attention, no treatment was provided for the event and no clinical analysis were performed. The outcome of the events injection site nodule and injection site erythema was not recovered and the reporter did not provided the causality assessment between the aforementioned events and therapy with GARDASIL 9.
1. (L) arm Hep A then Td 2. (L) arm Gardasil Immediate onset of nausea and pre syncopal symptoms, BP 80/60 Improved within 10 min lying down
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L035105, expiration date 14-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 24 hours with the highest recorded temperature of 30.8 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient is 17 y.o. and 12 weeks pregnant, patient received the Moderna vaccine.
Physical fatigue with insomnia, aches, chills, constant headache, dizziness, watery stool.
I was exposed to Covid on 01-01-2021 and I was then tested for it and was negative.  I have a red wheel mark at the injection site which has lasted two weeks.
Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensation all over body, especially breast area. Patient has also blue spots on upper Thigh. Patient also complaining of weakness, body aches, and abdominal pain sometimes. Patient also today is complaining about head ache and feeling confused.
This spontaneous report has been received from a registered nurse and referred to a 24-year-old female patient. The patient did not have any relevant medical history, concurrent conditions or concomitant therapies to be reported. On 24-MAY-2017, the patient was vaccinated with a dose of M-M-R II subcutaneously (strength, dose, and frequency were not reported; lot number M044350 with an expiration date 04-NOV-2018) for immunization that was reconstituted with sterile diluent (DILUENT MRK) (lot number M044350 with an expiration date 04-NOV-2018). Subsequently, 20 minutes later on the same day, while the patient was still at the vaccination site, she developed itching of the entire body without the presence of any visible rash. After medical attention, the patient was treated with oral BENADRYL 25 mg. After this, the patient was sent home with instructions to take additional BENADRYL for itching if needed. There were no laboratory diagnostic tests performed. At the time of this report, the outcome of pruritus generalized was unknown. The causality assessment between pruritus generalized with M-M-R II was not reported. Additional information has been requested.
Cellulitis to left upper arm treated with keflex 500 mg BID x 10 days
Received H1N1-LAIV 10/30/09. Noticed stinging right after. Continues to sting when hangs head down to date 11/20/09.
This spontaneous report as received from a medical assistant refers to a 12 month old infant, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported. Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Fever of 100 for 2 days/nights. Soreness in left arm. Persistent shortness of breath and fatigue after minor exertions since the vaccination. Telehealth visit on 10/22/2021 with HCP. She recommended C/D/Zinc supplement, but this makes my IBS and BPH worse. She also said exercise could help. Symptoms have not gotten worse but have not improved either.
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Rash a couple inches below the injection site that is about 5 inches in length, 2 inches wide, that is raised, red, and warm to the touch. Informed patient to call primary care doctor to get treatment if needed.
Fever to 102 for 72 hrs and loss of smell starting during fever and continues currently
Re-admitted to hospital 1/10/21 for Pneumonia, physical deconditioning; still admitted
I've had tinnitus most of my adult life.  I've been reading about tinnitis and COVID and hearing reports that some people are developing it or, if they already had it, that COVID seems to have made it worse.  I have NOT been diagnosed with COVID and have not contracted it as far as I know.  I only wanted to report that my tinnitus seems have to gotten significantly worse since I got my first dose of vaccine.  It's loud all the time, even with background noise.