chrisvoncsefalvay/vaers-outcomes huggingface dataset:
05/17/21; Patient attended school, orthodontist, baseball training and practice. Mother picked patient up from baseball practice at approximately 07:30pm and both of patients legs were a pale pink color and developed into a deep red over the next hour. Patient started developing hives that were itchy, red, and uncomfortable,  "all over body" per Mother. Mother states hives were mostly on his trunk, both legs down to calf/shin area, thighs, both arms (notably more irritated on the same arm where patient received injection). Mother took patient to the Emergency Room between 9:30-10pm. Patient was seen by ER Physician, who stated rash did not appear to be poison ivy, mother denied any recent changes in laundry detergent, soap, lotion, etc. ER Physician informed mother and patient that he thought the reaction was to the COVID-19 vaccine and advised against receiving the 2nd dose. Patient was prescribed 40mg Prednisone for 8 days, and mother is giving patient Benadryl as needed.
No adverse effects reported.; Inadvertent administration past expiration date; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.   On 11-JUL-2019 the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #: N024717; expiration date: 04-APR-2019; dose details unknown) for prophylaxis (expired product administered) inadvertently by the nurse. No adverse effects reported.        The outcome of expired product administered and no adverse event was unknown.
three hours after vaccination is given, red itchy patches appeared on elbows, knees, hands, and wrists, and scattered on the upper portion of the arm. Skin itched as well as neck and chest itching (no rash on neck or chest). Taken to ER and given IV benadryl. Benadryl solved the problem and I was able to leave the hospital within 2.5 hours.
This case was reported by a physician and described the occurrence of a systemic reaction in a subject of unspecified age and gender who was vaccinated with Flu vaccine, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Flu vaccine (unknown).  At an unspecified time after vaccination with Flu vaccine, the subject experienced a systemic reaction.  At the time of reporting the outcome of the event was unspecified.
Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old patient (gender not reported) who was vaccinated with 0.5 ml fourth dose of ADACEL (batch number U5770AA and expiration date 15-SEP-2019) via intramuscular route in the left deltoid on an unspecified date instead of DAPTACEL. The patients medical history was not reported. Concomitant medications included FLUZONE QUADRIVALENT for Immunization; ACTHIB for Immunization; and Pneumococcal Conjugate Vaccine for Immunization. It was an actual medication error due to wrong vaccine was administered (patient received Tdap instead of DTap) and inappropriate age at vaccine administration (ADACEL administered to 4 years old). It was reported that, on 18 Sep 2018 patient visited to physician. No information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Experienced itching about 4h after injection. She massaged area & used ice & next day experienced pain & difficulty lifting arm. Went to see dr which gave her BACTRIM DS BID x 10 days. That evening swelling got worse went to ER & was given IV ROCEPHIN & BENADRYL (PO). Was released after an hour. Given KEFLEX, q6h. for home use. Patient is feeling better & swelling has gone away. Has recovered.
¨still has severe pain¨; ¨Headache¨; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (¨still has severe pain¨) and HEADACHE (¨Headache¨) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE MODERNA.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced MYALGIA (¨still has severe pain¨) and HEADACHE (¨Headache¨). At the time of the report, MYALGIA (¨still has severe pain¨) and HEADACHE (¨Headache¨) outcome was unknown.            No Concomitant medication were provided by reporter.  No Treatment information was reported.   This case was linked to MOD-2021-207508 (Patient Link).
Vaccine expired 07/12/2022, 3 days earlier.  Pfizer notified and they have stability data for 2 days after expiration date.  Form submitted to Pfizer to determine if suppliers have more data.  Doctor does not recommend revaccination.  Parent notified.
pt had DTP/HIB/OPV 8OCT92 had low grade fever 101 for 1 1/2 days subsequent to vax; 12OCT92 temp up to 102.4 & adm to hosp-aspetic meningitis due to echovirus type 6;
Patient had high dose flu vaccine on 9-10-13, called today because he has had fever since that evening (100-102 degrees F). Has been taking ibuprofen and has sore throat, stuffy, advised him to see his doctor.
Patient is a 82 y.o. female patient of, MD with history of afib, HTN  presented to Hospital with  weakness, diarrhea, headache, cough, nasuea, body aches    Covid-19 Virus Infection Date of onset of symptoms: 7/21/23  Symptoms present on admission: cough weakness, diarrhea, nausea, cough, body aches  Date of covid positive test: 7/24/23  Afebrile, HR 119 max, RR 18-25, BP soft in ER as low as 95/57  Imaging: CXR lungs clear, NAD on admit  LA  2.2, D Dimer <.27, CBC normal, Creatinine 0.97, troponin 7 Oxygen requirements on admission: none Medical therapy: not a candidate Consultants following: none  Baseline fibrinogen 575, ferritin 36 , CRP 85 , LDH 199  Albuterol PRN Guaifenesin Continuous pulse ox PT/CM 07/25/23 At time of exam patient request discharge home. Inquiring about Paxlovid. E-consult to ID Mild dehydration  P/w diarrhea, poor intake, low BP IV fluids x 1 liter to avoid overload 07/25/23 SBP now 110.    Lactic acidosis  Initial 2.2 - repat 2.1  Suspect  dehydration rather then sepsis IV fluids   Afib HTN EKG: afib RVR rate 105 initially  Suspect fast rates from dehydration , improved to 75  Anticoagulated with coumadin Pharmacy consult to dose
11/1/2021 right leg/toes are dark purple no palpable pulse 2+ pitting edema C/o SOB resp 40 to 60sec apnea episodes. B/p 83/56 manually  radial pulse 112 Dr aware and new order to send to ER. for possible right leg arterial clot.
Blister on stomach; It was itchy.; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blister on stomach) and PRURITUS (It was itchy.) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     Concomitant products included INSULIN for an unknown indication.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced BLISTER (Blister on stomach) and PRURITUS (It was itchy.). At the time of the report, BLISTER (Blister on stomach) and PRURITUS (It was itchy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported by patient.
This spontaneous report was received from the office administrator referring to a 14 year old male patient. No information regarding the patient's medical history and concomitant medication were reported. The patient's concurrent conditions included drug reactions and allergies to amoxicillin. On 31-JUL-2018, the patient was vaccinated with his first dose of GARDASIL 9 intramuscular route, lot # N025429 and expiration date 27-JUL-2020 (strength, dose and anatomical location were not reported) indicated for prophylaxis also reported as "recommended for male patients his age ". The office administrator reported that the patient's mother notified on 02-OCT-2018, that her son developed an oval, pink and scaly rash (exfoliative rash) on his torso and upper inner thighs within a day or two after vaccine administration which was evaluated subsequently by an unspecified allergist on an unspecified date, who thought that it looked like pityriasis rosea (pityriasis rosea). On 02-OCT-2018, the patient's mother brought the patient to the physician office for evaluation and the patient still had the oval, pink and scaly rash on his torso and upper inner thighs. It was unknown if the patient sought medical attention or if diagnostic laboratory test were performed. The patient would see an unspecified immunologist on 05-OCT-2018. The outcome of exfoliative rash and pityriasis rosea was reported as not resolved. The causal relationship between exfoliative rash and pityriasis rosea with GARDASIL 9 was not reported.
Initial information received on 26-Feb-2019 regarding an unsolicited valid serious case received from a consumer. This case involves a female patient (age unknown) who experienced symptoms similar to meningitis, while she received vaccine MENACTRA. The patient's past vaccination(s) included a first dose of MENACTRA. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a serious symptoms similar to meningitis, following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient was hospitalized for this event. Other relevant tests were not reported. Final diagnosis was symptoms similar to meningitis. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none. Sender's Comments: This case concerns a female patient who presented with symptoms similar to meningitis after vaccination with MENACTRA. As with any vaccine, vaccination with MENACTRA may not protect 100% of susceptible individuals. The time to onset is unknown. Moreover, information regarding patient's medical condition at the time of vaccination and confirmatory lab tests ruling out alternate predisposing etiologies are required for complete assessment of the case and considering the cases as a vaccine failure. Based upon the reported information, the role of vaccine cannot be assessed.
Pt was given Influenza injectable 0.25 ml dose, pt was 3 years and 2 weeks of age. Dose inappropriate for age. Pt given 0.5 ml dose as per Manufacturer guidelines.
Information has been received from a Nurse Practitioner (N.P) concerning a teenager female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. It was reported that the patient had a seizure after GARDASIL was given. It was reported that the patient went to the emergency room, but it was unknown if the patient was admitted to the hospital. The patient was not given GARDASIL in this nurse practitioner's office but this nurse will be following up with this patient next week. It was also reported that the patient had a first appointment scheduled with the Nurse Practitioner sometime next week (date unknown). The Nurse Practitioner stated that she had spoken to the patient's mother who explained that 30 minutes after receiving the first dose of GARDASIL, the patient had a seizure in the parking lot. The outcome of the patient was unknown at the time of the report. Upon internal review seizure was determined to be an other important medical event. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 17-10-2012 11:41, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Several minutes after vaccine, I began to feel warmth and swelling in the back of my throat and tongue, and heat down the from of my chest, as well as tenderness. I had a little heart racing, and some minor trouble breathing. I emailed my doctor at 12:30 PM. Some pressure in chest. Took a nap, and woke at 3:30 PM with tingling in hands and fingers. Called doctor. Left a message. Call was returned around 4 PM. Was having tingling in face, stiff neck. Sore arm, left shoulder but not red. She told me my doctor had left and to file this report and that I would probably feel better but would never get this "acella"? dosage again.
pt recv vax 12MAR96 840AM & devel fever 3hrs p/vax up to 105 @ 7PM;lt leg swollen from hip to knee;pt taken to MD had blood work done;given APAP w/advil,but fever wouldn't go below 101;called clinic 2PM,t103.4,irritable;allerg to vax
Started 5 days after 1st vaccine with headaches then severe joint pain that lasted for 5 days then the heart and chest pain started and has been going on now for 4 weeks. We went to urgent care the er and pediatrician. He had high levels of inflammatory marker and after a echocardiogram the ER doctor said most likely pericarditis. Pain in chest and lungs worse when laying down. My 9 you cannot walk long distances or at a fast pace cannot play and had been taking ibuprofen on and off for almost 4 weeks now. It is NOT heart burn because antacids do not help his shortness of breath and chest pain.
The next day my daughter started to get a rash on her arms and legs. It has never receded, she seems to have this bumpy rash permanently.
Mom noted small red dot on lt upper thigh on 2/24/08 was also fussy, site progressivly enlarge with redness and slight swelling. Child conntinue with fussy, but no fevers noted and site without warmth to touch. To office on 2/26/08 with 1x3/4 inch red bumpy area to lt upper thigh, although not warm to touch.
Pt complained of pain radiating down arm, neck and back. No redness or heat coming off injection site. A week later the pain came back. First complaint was on 10/19 (day after injection). Then on 10/22 pain disappeared then resurfaced on 10/26.
Injection site swelling (~6 cm across), redness, and tenderness beginning 12/28, resolved when patient took benadryl
Patient reported that approximately 30 minutes after getting her injection she started to feel a "short but sharp" pain in her arm.  She then reported feeling dizzy and having trouble thinking, she stated "it was more than a brain fog".  She did not fall, but felt the need to lie on the floor because she was so dizzy she thought she was going to fall.  She was also very fatigued.  She reported that she did not have any of those problems with the other Pfizer vaccinations she had received.  She stated these symptoms lasted a little over 30 hours, and that she didn't start to feel better until Thursday evening.
Patient states they received Vaccine on Monday, became confused at work on Tuesday and then presented to ED after multiple seizures overnight Wednesday and then was having trouble ambulating. also complains of left elbow pain
shingles.; patch of skin irritation; pain in my right shoulder blade; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 51-years-old via an unspecified route of administration, administered in arm left on 04Feb2021 (Batch/Lot Number: el9265) as 1st dose, single for covid-19 immunisation.  Medical history included dermatomyositis, high blood pressure, depression and premenopausal from an unknown date and unknown if ongoing. Concomitant medications included folic acid; lisinopril; ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); all taken for an unspecified indication, start and stop date were not reported. The patient reported having pain in her right shoulder blade on 19Feb2021 09:30, on 21Feb2021, noticed a patch of skin irritation under her right arm. It started to spread. She went to DR on 28Feb2021 and was told she had shingles. Therapeutic measures were taken as a result of the events which included 3 medicines (unspecified). The patient was recovering from pain in right shoulder blade, did not recover from patch of skin irritation and the outcome of shingles was unknown. The patient received the second dose on 25Feb2021.
This spontaneous report as received from a pharmacist refers to a 16 year old male patient. On 02-SEP-2014 the patient was vaccinated with (Oka/Merck) PROQUAD (lot #, expiration date, dose and route unspecified). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Because of itchiness, on 1/6/2021 I noticed a red, raised area at the injection site. It was approximately the size of a quarter. On 1/8/2021, the area had doubled in size, which prompted me to call my primary care doctor. I spoke to my doctor's nurse on the phone and she spoke to my doctor. I was prescribed prednisone, 40 mg once a day for 5 days. When the prednisone was finished, an outline to the rash was visible but not red, just discolored. Since, the outline also disappeared and the rash is completely gone.
Myalgia, Fever, inj site pain, warm to touch, fever, body aches Narrative:
Sore arm 24 hours; mild head ache; This is a spontaneous report from a contactable nurse.  A 42-year-old female nurse (patient) reported that received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ELO140), at the hospital into the left arm on 24Dec2020 at  06:00 AM as single dose for COVID-19 immunization. The patient did not receive other medications in two weeks. The patient did not report  allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history none. On 24Dec2020 at 07:00 AM the patient started experiencing sore arm 24 hours and mild headache. No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Dec2020.
No adverse event. Pt was given ROTARIX that was expired. Does the pt need to be given another ROTARIX to replace this one? He did not have any reaction to it. Patient was given vaccine on 10/24/18 and it expired on 08/05/18. Please advise.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # N003698 and expiration date: 31-OCT-2019. The LIQUID PEDVAXHIB was reconstituted with sterile diluent (manufacturer unknown) which did not undergo a temperature excursion. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of four reports received from the same reporter.; Sender's Comments: US-009507513-1708USA008059: US-009507513-1708USA010647: US-009507513-1708USA010656:
First day painful arm Second and third day nausea and diarrhea  Fatigue all days 7th day painful swollen left collarbone lymph node 7th day left side of face numbness 8th day tripeled size of lymph node swelling 4x4 inches and left side of face is totally numb
Pt's parents had waited 15mins after vaccination to monitor for any adverse effects, the Pt father came into the immunization clinic after the 15 mins and reported she was pale and unresponsive. The nurse was notified as well as the Nurse Practitioner, and the Doctor on duty, Pt lungs and heart rate were all normal according to the Nurse Practitioner and O2 stats were taken and was at 100%. The ambulances were called and the patient was transported to the ER for further monitoring.
Right upper out arm area swollen around injection site 4x3 reddened and induration, no c/o pain.
Gave H1N1 mist. Child under 2 yrs old. Should have been H1N1 (shot). Called mom and will repeat and give shot then child to come back in 4 wks for 2nd dose.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021 at 2:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Oct-2021 at 2:20 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.68 years for dose administered on 22-Oct-2021.  No concomitant medications were reported.  Vial was moved to fridge on 29-Sep-2021. Product moved to clinic on 22-Oct-2021. Batch number 035C21A underwent temperature excursion on 22-Oct-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 10:00 AM. Beyond use date for the vial was reported as 29-Oct-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).