chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was ordered to give Pentacel, PCV13, and Rotavirus. On the encounter form, I put Pentacel, PCV13, and Rotavirus. Before grabbing the vaccines, I reverified what I needed to give and got the vaccines from the refrigerator and their respective VIS. I forgot to recheck if I had the correct vaccine and put the lot numbers of the vaccines that I had prepared. Once I sent the encounter form to Immunization Clinic, they called me the following day on 6/1/23 at around 10AM and informed me that the PCV13 I put on the form matched the lot number of HPV. Instead of giving the aforementioned vaccines, I gave Rotavirus #2, Pentacel #1, and HPV#1 instead of PCV13#2 on 5/31/23 @ 10AM. After realizing I probably gave the wrong vaccine, I called the patient's mother to see how she was doing. The mother informed me that the baby is fine and denied any adverse reactions. I also advised them to come back to the clinic to have the the correct vaccine administered, which is PCV13 #2. To prevent another error, I will reinforce the use of the 10 rights of medication administration and verify with another nurse before preparing and administering the vaccine.
Pt developed 7mm area of erythema and 5mm induration as well as injection site pain
Nausea, shortness of breath, lightheaded, itching LUA by injection site. BP 168/87 (pulse 69), 97% O2 sat. Final BP 146/74 (pulse 63), 97% O2 sat.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot# N002915 and expiration date 24-JUL-2018 (dose, frequency and route of administration were not reported) reconstituted with properly stored sterile diluent. There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion from 6 to 14 degrees Fahrenheit for 1 hour. Data logger was not involved. There were no previous excursions reported.
Soreness and stiffness within 4 hours of injection, swollen and redness from a 2"-6" band around circumference of arm. A lot of stiffness, pain and general malaise. Patient called on 2/2/2017 to say swollen arm has cleared up.
no adverse event reported by parent- client was given "booster" dose in shorter time frame and age group not currently authorized for "booster" dose
Patient passed out around 5 minutes past dose. He did not have a complete loss of consciousness. Lowered him to floor, elevated legs, and slowly lowered head to ground. complained of being cold, had shivers, and complained of ringing in the ears and nausea.  once resolved, sat him up and observed again. around 30 minutes past vaccine  had a second fainting spell, to which called 911 for observation. Patient completely resolved and left with mom and EMS walked him to her car.
Initial case received on 28 January 2010 from a healthcare professional and also from a non-healthcare professional. A healthcare professional reported a 64 year old female patient received an 0.5 ml intramuscular injection (site not reported) of H1N1 (lot number UP062AA) on 14 January 2010. The patient experienced an unspecified fever and hives (site not specified) on 15 January 2010 and non-specified stomach problems on 27 January 2010. Her medical history included neurological problems of hands . A non-healthcare professional reported the patient's medical history included reflex sympathetic dystrophy and an unspecified allergy to morphine. Since 14 January 2010 (date of vaccination), the patient experienced "increased hand pain" and her grip not being as good in both hands. The reporters both stated that the patient had no illness at  the time of vaccination. She had contacted, but was not seen by her physician. It was unknown if the patient recovered from the adverse events. Documents held by sender: None.
Information has been received from a non healthcare professional, who was informed by a nurse from the physician's office, concerning a patient who on 02-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 662905/1162X) injection, and on 03-SEP-2009 experienced fever, hard knot under the injection site, cellulitis, chills and severe pain. The patient's outcome was not reported. The patient sought unspecified medical attention. This is one of two reports received from the same source. Additional information has been requested.
Received Hep A and Tdap at health department 11/6/06. 1-2 hours later developed sharp, intense, localized headache about 7-8 on a 1-10 pain scale. Lasted 5-10 minutes before subsiding. Dizziness and nausea with headache. Similar headache 11/7/06 with dizziness and nausea. No history of severe headaches.
1125- c/o "my tongue feels funny". No obvious swelling noted. BP 154/72, resp 20  Pulse ox 100% Takes pepcid AC daily for "stomach problems". States "my friend made me anxious before my shot" 1130 - Benadryl 25mg po given per standing order. 1140  BP 127/71 pulse 60 resp 18 pulse ox 100% 1145 - denies further c/o tongue feeling funny. 1155 - BP 120/80  Pulse 58 resp 18 pulse 100% 1200  Denies further feeling in tongue.  Escorted ambulatory with steady gait to car. Instructed friend to drive.
low grade fever on 29JUn-throughout 20JUN inc to 105 R late PM; eyes rolling around per mom; called paramedics who examined pt told mom could take to ER; in ER t40.3 R & febrile seizure on 30JUn about 245AM;
Redness, warmth, and swelling at injection site in 4x4 inch size.
After First Injection, the next day I was fine The 2nd Day I had Diarrhea  for 24 hours.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # N025568, expiration date 08-DEC-2018, dose and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (MERCK) (lot# N021583, expiration date 18-NOV-2019). The vaccine was exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (8 degrees Fahrenheit) for 30 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported.
Welts on legs, swelling of welts on legs, redness, warmth of welts, fever
Case number PHEH2014US019507 is an initial spontaneous report received from a physician on 29 Sep 2014 with a follow up report received from the reporter on 29 Sep 2014. This report refers to a 66 year old female patient (reporter's wife). her past medical history and concomitant medications were not reported. Her vaccination history included five doses of seasonal influenza vaccine in the past five year prior to this report. On 21 Sep 2014, she was vaccinated with FLUCELVAX (batch number: not reported). On 22 Sep 2014, she experienced loss of sweet and salty taste sensations due to which she had no appetite and lost seven pounds of weight in seven days. It was reported that everything tasted bland or could taste nothing at all but it was also reported that she could taste spicy foods like wasabi. It was reported that the patient cries as she loves to eat but now cannot eat anything and at this rate she would die of starvation. She has not lost her sense of smell. It was reported that nothing made her better and it had gotten worse sine the date of vaccination. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported. Follow up report was received from the reporter on 29 Sep 2014: The vaccination history and the events (weight loss and had no appetite) were updated.
This spontaneous report was received from a healthcare worker, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # L013204, with expiry date on 28-JAN-2017, (strength, dose and frequency were not reported). No adverse effect was reported and no product quality complaint was reported. Temperature: 9 Celsius degrees 40 hours, administered (AE), yes, no previous temperature excursion and no data logger involved. Temperature: 9 Celsius degrees. Time frame: 40 hours. Was it administered (AE) ? Yes. Previous temperature excursion? No. Was call because of a "data logger"? No. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 21JUL95 & 22JUL rt thigh tender, 27JUL rt thigh tender, swollen, warm, 28JUL MD noted likely source of persistent fever; 7AUG MD noted sterile abscess fr DTP;
Vaccinated 1/20/2012. Developed localized erythema, swelling, pain associated with HA, fever, nausea the day after vaccination 1/21. Fever, HA, nausea resolved by 1/22. Erythema, swelling with induration and pain persist to 1/26 - day of office visit. Today's date is 1/27/2012.
Sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2021 as dose 2, single (Lot number: EW0167), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "brain aneurysm" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: sensitive to aspirin for Drug allergy; Known allergies: sensitive to ibuprofen for Drug allergy. Vaccination history included: BNT162b2 (lot No: EW0153, Dose 1, on Left arm), administration date: 14Apr2021, for Covid-19 immunization, reaction(s): "Sore arm", "fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: For the Pfizer Covid shots and boosters: Sore arm and fatigue.vaccine was received, yes, other medication in 2weeks  No follow-up attempts are possible. No further information is expected.
Patient reports onset of pain and burning in vaginal/genital area the week following vaccination with Zostavax (April 10-17, 2007). Pre fever blister discomfort on lips. Redness and discomfort in eyes. Treatment: steroid creams, antifungal and Cipro x 2 courses all with no relief. Patient reports extreme nervousness since onset. Further treatment planned.
Gastrointestinal issues such as nausea, abdominal pain, and cramps lasting more than 24 hours.
Pt. states that she developed a "muscle" in her arm. She states it feels like a knot. Pt. states the knot feels it is about 2 inches. Pt. states it feels sore but not painful. Pt. denies redness or it being hot to the touch.
Patient was given this vaccine roughly 25 minutes after the expiration date for the diluted vial.  Because Pfizer cannot give guidance on sterility of the vaccine after 6 hours, we are reporting.  We have told patient he does not need revaccinating for the first dose, due to Pfizer stability information given to us, however they cannot verify sterility.  We have told patient to watch for infection and to call at first sign of one.   At this time, almost 48 hours post vaccination, patient only has symptom of arm soreness at injection site.  He has not had fever, chills, muscle aches, headache, etc associated with this vaccine.
One of five pt (B/W JUL-AUG 1990) experienced inject site rxn which included erythema & swelling. tx included ice pack @ site of injection & Tylenol PRN. Pt afebrile.
Initial report received from a healthcare professional on 09 October 2013. A 52-year-old female patient had received a dose of FLUZONE ID, (batch number- UT4721BA) intradermally in left deltoid on 07 October 2013. The patient denied any illness at the time of vaccination and had no pre-existing physician diagnosed allergies, birth defects, medical conditions. On 08 October 2013, 1 day after vaccination, the patient presented with 6 cm redness, 10 cm swelling and left deltoid pain. The patient stated that she felt feverish and was afebrile at evaluation. Laboratory details were not reported. The patient was treated with injection site cleansing, cold compresses, topical application of hydrocortisone and bacitracin ointment. At the time of this report, the outcome was unknown. Documents held by sender: none.
Difficulty Swallowing BOTH Food & Water..Approximately 2-HOURS AFTER Injection.
2-year-old who accidently received quadracel and they were supposed to receive daptacel with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves 2-year-old male patient who accidently received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [quadracel (VERO)] and they were supposed to receive diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported 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 0.5 ml total dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine, Solution for injection (strength, expiry date: unknown) (lot: U78388A) via intramuscular route in the left vastus lateralis for Immunization and 2-year-old who accidently received quadracel and they were supposed to receive daptacel with no reported adverse event (wrong product administered) (latency: same day)   Reportedly, medical assistant calling on behalf of a 2-year-old who accidently received Quadracel and they were supposed to receive Daptacel. She would like to know if it counted for the patient's DTaP. She would also like to know what they should look out for in terms of potential side effects. She states that the patient previously received two Pentacel injections and one Vaxelis injection.   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.
lot of dizziness; Body aches; Very sleepy; Chills; A hurting arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lot of dizziness), MYALGIA (Body aches), SOMNOLENCE (Very sleepy), CHILLS (Chills) and PAIN IN EXTREMITY (A hurting arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DIZZINESS (lot of dizziness), MYALGIA (Body aches), SOMNOLENCE (Very sleepy), CHILLS (Chills) and PAIN IN EXTREMITY (A hurting arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (lot of dizziness), MYALGIA (Body aches), SOMNOLENCE (Very sleepy), CHILLS (Chills) and PAIN IN EXTREMITY (A hurting arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications were reported as blood thinners
Pt vaccinated with DTP developed urticarial rash one day after DTP#3 given. Pt given tylenol & Benadryl.
Two weeks after vaccination I had severe constipation. It developed over several days and I had to seek treatment. No reoccurrence since that time.
had the Menactra 2 years ago and was given Menquadfi yesterday with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who experienced had the menactra 2 years ago and was given menquadfi yesterday with no reported adverse event while receiving vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and 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 02-Aug-2022, the patient received a  o.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE once (lot U7294AC; expiry date: 23-May-2024)  via intramuscular route in the left arm and On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, dose, formulation, route,lot number: not reported) both for prophylactic vaccination.  On 02-AUG-2022 the patient reported had the menactra 2 years ago and was given menquadfi yesterday with no reported adverse event (wrong product administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken:not applicable.   At time of reporting, the outcome was Unknown for the event wrong 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 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.
For the first month, disrupted my period that I was fixing to have that week by a week. More intense bleeding than usual. Every month after that my period has been irregular.
Information has been received from a licensed visiting nurse concerning her female coworker with penicillin allergy and no pertinent medical history who on 06-AUG-2009, was vaccinated with a RECOMBIVAX HB (lot # 6664769/0652Y, thimerosal free),  1 mL, intramuscular route. Concomitant therapy included CELEXA. It was reported that on 06-AUG-2009, the patient complained of muscle aches, weakness, and fever of 101 degrees F after receiving RECOMBIVAX HB. On 07-AUG-2009, the patient recovered. The patient did not seek medical attention. Additional information has been requested.
chattering teeth/Chills; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHILLS (chattering teeth/Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced CHILLS (chattering teeth/Chills). At the time of the report, CHILLS (chattering teeth/Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Extreme soreness at injection site (unable to lift arm) about an hour after receiving vaccine. Upon standing up after laying down experienced dizziness and extreme nausea both the day of vaccination and 24 hours later.
Headache, Myalgia, NauseaVomiting, somnolence Narrative:  She called a hotline within our system for vaccine reactions
Initial information received on 25-Mar-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 16 years old male patient who was vaccinated with a 0.5 ml dose of expired vaccine MENACTRA (lot U5835AB and Exp. Date 27-FEB-2019) via unknown route in the left arm on 22-Mar-2019. The patient's medical history was not reported and No concomitant vaccines were given. It was a case of actual medication error case due to expired vaccine used. No side effects were 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. List of documents held by sender: none.
From initial information received on 20Aug04 from a physician regarding an adverse event occurring, it was reported that a six month old male pt received a second dose of ActHib, lot number UE119AA, administered in the right anterior lateral thigh; a third dose of Tripedia, lot U1272BA, route and site of admin not reported; and a dose of Prevnar, lot 495930, route and site of admin not reported, on 20Aug04. Immediately following the admin of ActHib, the pt began crying. The crying was persistent and got worse within the first ten minutes. Acthib was the second vaccine administered of three. The persistent crying improved after one hour. It was not reported whether the pt recovered from this event. From additional information received on 21/Mar/2005 from the responsible physician, it was reported that the patient has recovered from these events. No further information is anticipated. This case is considered closed.
PAINFUL, SWOLLEN, WARM TO TOUCH RIGHT DELTOID. MYALGIAS, STIFF, PAINFUL NECK AND SHOULDERS. HEADACHE, FATIGUE AND FEVER LESS THAN 102. TREATMENT: IBUPROFEN 200MG 2 TABS Q4-5 HRS, DARVOCET N100 650MG-100MG 1 TAB Q4 HRS PRN.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL lot # K007828, expiration date- 02-MAR-2017, (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 1.0 C, Time frame was 20 minutes. There was a previous temperature excursion - 1.2 C for 20 minutes and call was because of data logger. M-M-R II was in the product tab but did not experience a temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a healthcare worker, for VARIVAX (Merck), a pregnancy registry product, concerning an approximately 20 year old female patient with sulfonamide allergy, drug hypersensitivity to AUGMENTIN and SEPTRA, and a history of abnormal uterine bleeding who on 11-AUG-2011 was vaccinated with the first dose of VARIVAX (Merck) (lot number: 669650/0413AA, expiry 26-MAR-2013), 0.5ml, via subcutaneous route. Concomitant therapy included CAMILA. On 30-AUG-2011, the patient went to the reporter's office and she reported that she was pregnant. According to the healthcare worker, an urine pregnancy test was performed prior vaccination and was negative. No treatment was given to the patient. The patient did not seek medical attention. Follow up information received from the healthcare worker who reported that she did not have any information regarding the outcome of pregnancy. Case was lost to follow up. Additional information is not expected.