chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large lymph node on left neck; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient. A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 12:00 (Batch/Lot number: unknown) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 03Jun2021 12:00, outcome "not recovered", described as "Large lymph node on left neck".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reaction/event as reported: large lymph node on left neck. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3cm x 4cm raised tender eryth around injection site, temperature of 99.8
High Fever over 105 degrees, dizziness, headache, body aches, and rash in shot area (left shoulder) and lymph node area in armpit (left side only) and under breast (left side only). Left lymph node area in armpit area severely swollen and tender but minor swelling in lymph node area under left breast.
hair has been falling out one week after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair has been falling out one week after the second dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Patient on multiple concomitant medications did not report medical history). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), VITAMIN D NOS, LOSARTAN, METOPROLOL, CETIRIZINE, OMEPRAZOLE and PROBIOTICS NOS.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ALOPECIA (hair has been falling out one week after the second dose). At the time of the report, ALOPECIA (hair has been falling out one week after the second dose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
patient received vaccine and then started walking down the hall and felt dizzy so we laid him on the ground and got ice packs and gave him a juice box
Swelling on left sid of neck area, above ? area, approximately the size of a dime. Painful to touch. No pain or tenderness on axilla. Temp 98.8. Amoxicillin 250mg po q x 7 day.
pt recv vax 12MAY97 9-10AM;13MAY97 awake w/rash on face & in PM temp 101 oral;APAP not given;seen in ER 10PM-1AM dx adverse rxn to vax;
11 hours after injection: Pain and swelling at injection site. Blister at injection site. Itching of arm of injection site. 13 hour after injection: Chills and muscle aches 20 hour after injection: Fever (101.4 - 101.7), Nausea, Vomiting, Muscle cramping, diarrhea. Symptoms persisted 48 hours, until about 72 hours after injection
Within a few hours of the flu shot, she had a mild fever (101.3) through the night. Treated fever at home with rest, childrens ADVIL, and a gentle warm bath. The next morning she still had a fever, but still considered to be mild. This was a Friday morning. Throughout the day we alternated TYLENOL and ADVIL and were able to manage the fever symptoms. Late into the night, Friday night (24 hours after her flu shot) she started coughing, which became progressively worse through the night and into Saturday morning. Her fever went up to 103.1 at the highest, with alternating TYLENOL and ibuprofen medications. The cough sounded very croupy. She was having difficulty breathing. She had a reaction very similar in the past after another shot, and they had suggested using BENADRYL to help ease the symptoms. We began giving her BENADRYL around 1am Saturday morning when the cough was getting worse. Gave another dose early Saturday AM around 7am and then took her to the urgent care. At urgent care she was given a dose of DECADRON. The cough improved but the fever has remained. It is now 4 days later and she still has a mild fever and occasional cough. We will take her back to the doctor tomorrow AM if symptoms do not improve again.
I was having trouble breathing for several weeks but thought it was due to my asthma. I went to My allergist who said my breathing problem was not due to my asthma after having a breathing test. I went to my internist office that afternoon. I explained I was having trouble breathing and had pain in my left calf. I had an ultrasound of my left leg which showed s blood clot. I then had a ct Scan which showed pulmonary embolisms. I was put on Eliquis and sent home to rest.
Dose 1 given 3/11/2021 Pfizer Lot # EN6207 Pt was hospitalized with Covid 19 at a local medical center (LOCATION).
Constant vomiting since he woke up at 6:30AM, every 15 minutes or right after feeding him liquid. Tired and sleeping all the time, very fatigued. Tried Pedialyte and Emerol for nausea, still was getting dehydrated. Had to take him to emergency room at 4:30PM. Blood test was taken, and IV administered for 2 hours. On April 22, he has diarrhea, is sleepy and drinking only liquids since he vomited in the morning.
Vaccine CDC handout was handed to patient and read through. Patient received vaccine with no complications.  Patient returned to clinic on 05/05/2022 with reduced movement and pain in right arm. No redness, swelling, or pain noted at the site of injection.  Patient was given medication which mildly helped. Patient returned back to clinic on 05/12/2022. Site still with no redness, swelling, or tenderness.  Patient still with limited ROM and pain. Patient was given prednisone taper.
Pt recvd 3 doses of Engerix-B 28SEP91 & it was determined that pt did not respond to the vax series;
Forty-five following vaccination reported that he was driving home and started feeling "flushed". He reported that he looked in his rear view mirror and stated that his face was "very red". He also reports that he had a foul taste in his mouth "like he was chewing on an onion. He denied seeing any rash, shortness of breath, sweating, palpitations or racing heart. He stated that symptoms lasted for a half hour. He denied taking anything to alleviate the symptoms.  Afterwards he reports that he felt good.
ag test 10Feb2023; ag test 10Feb2023; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 43-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Feb2023, outcome "recovering" and all described as "ag test 10Feb2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Feb2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded. This case will be reassessed should additional information become available.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 02-JAN-2018, 22-MAR-2018 and 24-MAY-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# M022173 and expiration date 15-MAR-2019; lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Initially at the 30 min mark post vaccination patient complained of itchiness all over body, mild redness noted on upper extremities and upper back. About 45 minutes post vaccination patient complained of throat discomfort. Treatment provided was adult dose Epi pen of 0.3mg , solumedrol 125mg and Benadryl 50mg. Patient taken by ambulance at 6:00pm
Swelling of throat and tongue about a half hour after vaccination. Patient took benadryl and symptoms resolved.
Information has been received from a physician, via a company representative, concerning a 4 year old male, with no known drug reaction allergies, who on 06-JUN-2001 was vaccinated (route unknown) with a 0.5 mL dose of Varivax (Lot # 635453/0756K). On 05-MAY-2006 the patient developed a mild case of chickenpox. Unspecified medical attention was sought. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of arm paralysis in a patient who received BOOSTRIX. On 1st October 2014, the patient received BOOSTRIX. On 2nd October 2014, 1 days after receiving BOOSTRIX, the patient experienced arm paralysis (serious criteria GSK medically significant) and paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the arm paralysis were not recovered/not resolved. It was not reported if the reporter considered the arm paralysis and paralysis to be related to BOOSTRIX. Additional information was provided: The patient could not move half of their digits in their left arm and it progressed to the entire left arm. This AE has not resolved no medical interventions have been provided to the patient yet the MD will be getting an MRI for the patient. RN refused to report the AE at the time of the call due to uncertain causality and stated they would call back.
Information has been received from a registered nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M024702, expiration date: 18-MAY-2018; lot # L028278, expiration date: 28-JUL-2017; lot # L042264, expiration date: 26-OCT-2017; dose and route were unknown) for prophylaxis. No adverse effects were reported. The temperature for the vaccine stored was 10 Fahrenheit degree with 35 minutes time frame. Previous temperature excursion was reported as exposure to 35.6 Fahrenheit for 8 hours and 53 minutes, 13.3 Fahrenheit for 3 hours and 22 minutes, 32.9 Fahrenheit for 24 hours and 34.5 Fahrenheit for 24 hours (cumulative 60 hours and 15 minutes). Data logger was involved.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA001053:
Pain with redness at injection site, followed hours later by erythematic macular papular rash to LE and UE.
11Apr91 pt vax; week later exp h/a, fatigue, & nausea, sometimes bothered w/ sinus & allergy problems.
None.  FYI as I was previously told to report when 2 doses of MENACTRA accidentally given to different patient.  Patient was given MENACTRA on 6/29/07.  Patient had already received MENACTRA on 6/21/05.
About 1 hour after vaccination the individuals left side of face went numb and left tongue became numb.  He also felt very flushed.  About two hours after vaccination the symptoms slowly resolved and the next day symptoms were 90% resolved.  Numbness involved only the left scalp and face and left side of tongue.
DAPTACEL experienced a temperature excursion which was not covered by the extended stability data, and DAPTACEL was administered after the excursion occurred with no reported adverse event; DAPTACEL experienced a temperature excursion which was not covered by the extended stability data, and DAPTACEL was administered after the excursion occurred with no reported adverse event; Initial information received on 31-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] experienced a temperature excursion which was not covered by the extended stability data, and daptacel was administered after the excursion occurred 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 unknown dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection (strength, lot number and expiry date: not reported) via unknown route in unknown administration site for immunization experienced a temperature excursion which was not covered by the extended stability data, and  was administered after the excursion occurred with no reported adverse event (product storage error) (latency: unknown) (poor quality product administered) (latency: same day).  It was reported as Suspected power glitch Max/low temperature reached: Max temperature was 6.8C; low temperature was negative 0.1C Human error? No Does extended stability data cover the excursion? No If negative advice, was the product administered to a patient? Yes.  No lab data was reported.  Action taken was not applicable.  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.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. In February 2016 reported as "1 year ago", the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscularly, dose and frequency reported as "single dose" (strength, anatomical location, lot number and expiration date were not provided) for prophylaxis. Subsequently, on 21-FEB-2017, the patient was vaccinated with a second dose of RECOMBIVAX HB intramuscularly, dose and frequency reported as "single dose" (strength, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Chills initially, fever, treated with Tylenol and blankets and rest. 2nd dose of Tylenol 650 given 4hrs after onset.
Within 1 hour of receiving Hepatitis A vaccine and HPV vaccine, mother reported that patient experiencing nausea, vomiting, and fever.
patient delevoped hives within 20 minutes of vaccine administration. went to pcp for follow up.pt also received immune globulin hep a at the same time.
Having intermittent hives on both hands, arms, face, leg & foot; This is a spontaneous report received from contactable consumer, the patient. A 55-year-old adult [non-pregnant] female received the first dose of BNT162B2 (solution for injection; Lot reported as unknown and expiry information not provided) as a single dose via an unspecified route in the left arm on 03Mar2021 at 15:15 (at 55-years-old), for COVID-19 immunization.  Relevant medical history included a leg amputation in Sep1975 due to bone cancer (osteosarcoma) and allergies to milk, wheat (gluten), bug bites, penicillin and prochlorperazine (COMPAZINE). Concomitant medications sans indication, posology and therapy dates included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), and bupropion hydrochloride (WELLBUTRIN). The patient was diagnosed with COVID prior to the vaccine and was not pregnant at the time of vaccination, Additionally, the patient denied receiving any other vaccines within four weeks prior to this vaccine. On 08Mar2021 at 12:00, eight days after receiving the vaccine (as reported) the patient experienced hives on both hands, arms, face, leg and foot.  The patient denied any visit to a doctor, other healthcare professional, clinic, emergency room or hospital as a result of the event. The patient has not been tested for COVID since receiving the vaccine. There was no treatment received for the events. The outcome of the events hives on both hands, arms, face, leg and foot was unknown.   The lot number for the vaccine, BNT162b2, was provided as unknown though will be requested during follow up.
didn't feel great afterwards; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel great afterwards) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel great afterwards). At the time of the report, FEELING ABNORMAL (didn't feel great afterwards) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported .  Treatment medication were not reported .
The NP ordered TDAP in the written orders.  Staff member went to NP and clarified if she wanted TDAP or TD.  She said she wanted tetanus-diptheria.  Staff member gave the TD with no adverse reaction.  Staff member explained to the patient he was only getting tetanus and diptheria, staff also gave him a letter explaining TD and what to expect.  Staff then tried charting it and it would not accept the NDC number.  Staff went to the charge nurse  and asked her why it wasn't accepting the NDC number.  Staff then went to the provider and explained what happened. NP thought we only had DPT so she then tried to cancel her original order but was unable to delete it
pt recv vax 9MAR98 & 20MAR98 pt had swollen neck glands & joint aches;23MAR98 pt devel full body rash which started on chest & stomach progressing to arms, legs & face;MD was instructed to call hlth dept;neck swelling maybe d/t hep C
Pt is fainting after receiving imz shot.  Pt remained sitted after vaccination. Caregiver tried to give water to patient. Patient fainted.  Caregiver agreed to call 911 for help. After a few minutes, patient regained consciousness.  Caregiver cancelled 911 call.  Caregiver and patient go home after patient regained full consciousness.
Red, warmth, swelling, pain. TYLENOL/ice Cephalexin started.
Headache, Myalgia, UrticariaPruritus, Site pain, redness, fatigue, chills Narrative:
initially local reaction with erythema and edema, developed into itching and whole body uriticaria. Improved with q4-6 hour dosing of benedryl x 3 days
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild
Sever headache beginning about 10 hours after vaccination, with nausea, and passed blood clots through nose about 16 hours following vaccine with small further amounts on May 15. All accompanied by extreme fatigue. It was the passing of blood through my nose that was unexpected and seemed worth reporting.
Patient states she has 3 red quarter size circles below the vaccination site. She could not say if it was ever  swollen or not but at this time it was not. She also stated a line that was going down her arm from said spots but it was starting to fade and not going down very far. She did not indicate any pain from site. She was going to visit the walk-in after speaking with me. She had her vaccine on 12/29/21 and just decided to call us on 1/2/22. Unclear exactly when this started after immunization.
Information has been received via a company representative from a nurse who was the mother of the male patient (age not reported). On an unknown dates the patient was vaccinated with dose 1, and 2 of GARDASIL 9. On an unknown date the patient was vaccinated with dose 3 of GARDASIL 9, intramuscular (site not reported) for prophylaxis. On an unknown date, after dose 1 and 2 the patient was tired. On an unknown date, after dose 3 the patient had an allergic reaction that caused swelling of the face, unspecified inflammation and experienced difficulty breathing. The patient was taken to the hospital when the adverse event occurred but the primary reporter did not known what treatment was given. The patient did not die. On an unknown date the patient recovered from hypersensitivity. The outcome of tiredness was not reported.  No product quality complaint involved. The reporter considered the event serious due to hospitalization. Upon internal review the event was also considered serious as medically significant. The relationship between hypersensitivity, tiredness and therapy with GARDASIL 9 was not reported. Additional information has been requested.
difficulty breathing; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program.   A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Mar2021, the patient's oxygen came out of her mouth and she experienced difficulty breathing. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.