chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A medical assistant reported a patient's titers for the Mumps was low, less then 9. The medical assistant states the measles and rubella titers were good. The caller states it was unknown if the patient previously received the MMR vaccine since the; This spontaneous report was received from a medical assistant referring to a 65-year-old female patient. The patient's medical history included  mastectomy. The patient's concurrent conditions, drug and allergy history or concomitant therapies were not provided.  On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Manufacturer unknown) (strength, dose description, route of administration, lot # and expiry date, were not provided).  On 16-MAR-2022, the Medical assistant reported that the patient's titers for the Mumps was low, less then 9 (Antibody test abnormal). The reporter stated the measles and rubella titers were good (Normal). Additionally, it was reported that it was unknown if the patient previously received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Manufacturer unknown) vaccine since the patient was born outside country and they do not have her immunization record.  At the reporting time, the outcome for Antibody test abnormal  was not provided. The causal relationship between Antibody test abnormal  and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Manufacturer unknown) was unknown.
Patient hospitalized within 60 days of receiving a COVID vaccine for a right Ureteropelvic junction (UPJ) obstruction
Approximately 18 hours after injection experienced fever of 101.5, extreme muscle aches, extreme fatigue, joint aches. It lasted approximately 20 hours
pain in her arm that comes and goes (both shots); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm that comes and goes (both shots)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm that comes and goes (both shots)). At the time of the report, PAIN IN EXTREMITY (pain in her arm that comes and goes (both shots)) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported. Patient said no to follow up for safety.   This case was linked to MOD-2021-098263 (Patient Link).
Received DTaP and HIB in right thigh on 4/21/05. Swelling noted on 5/14/05; increased irritability. Began with fever to 100.6; not consolable. Information frommedical records states abcess, cellulitis. msv
Pfizer / BioNTech: Batch/Lot No: Unknown; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Batch/Lot No: Unknown; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications, also reported as other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech: Batch/Lot No: Unknown; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (May2022) Positive; (May2022) Negative, notes: Day 9 and Day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Anti viral Paxlovid, started on 21May2022 and stopped on 26May2022. Clinical course was reported as, on Day 11 on 31May2022 at 13:00, patient had cold like symptoms and tested positive again after testing negative on Day 9. Patient had no symptoms during the first round of Covid. However starting on day 11, she had a bad cold and a low-grade cough and very tired. She lost sense of smell but retained taste. While the cold symptoms subsided she continue to have a low-grade cough. It's now day 11 of round two. Patient tested negative on day 10. She was extremely lethargic and was very active and exercised regularly but have no energy to do anything. Very concerned. Patient received no treatment for symptoms and not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Employee is 17 years old and received Moderna.  Should have received Pfizer.  No adverse reactions noted 16 hours later.
02/10/22 presents to ED for " Leg Pain". PMHx of "breast cancer s/p mastectomy/ XRT/ currently on chemo, IDDM"
The patient came in 2 days after receiving the vaccine and stated she was having a reaction. The injection site was hot to the touch and swollen, approximately 6 inches in diameter. I asked how she was feeling and she stated her joints hurt...not only her shoulder joint of the arm receiving the vaccine but all over. She also stated she started running a fever one day (approximately 24 hours) after the vaccine was given and that was also when the swelling around injection site started. She also stated her throat was feeling scratchy about the same time but that she was not having difficulty breathing. When she came to me it had been almost 48 hours since she had been given the vaccine. The swelling had doubled in diameter in the past 24 hours. She told me she has had allergic reactions in the past to oral generic medications because of the fillers that are in them but was unaware of what specific fillers she was allergic to. She said in the past she took BENADRYL and it helped her reaction. I TOLD HER TO TRY A DOSE OF BENADRYL BUT IF she saw no improvement she needed to go to the ER to see a Dr.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore arm in injection site), injection site hemorrhage (bleeding from injection site) and vaccination site discharge (thinks vaccine leaked out with blood) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013L20A) for COVID-19 immunization. No medical history reported. On Jan 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 19, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On Jan 20, 2021, patient experienced vaccination site pain (sore arm in injection site). On Feb 19, 2021, patient experienced injection site hemorrhage (bleeding from injection site) and vaccination site discharge (thinks vaccine leaked out with blood). On Jan 23, 2021, vaccination site pain (sore arm in injection site) outcome: unknown. On Feb 19, 2021, injection site hemorrhage (bleeding from injection site) and vaccination site discharge (thinks vaccine leaked out with blood) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular and mRNA-1273 (Moderna COVID-19 vaccine), unknown route: unknown. Concomitant medications not reported. The patient's treatment unknown.
temperature excursion; No additional adverse effect; This spontaneous non-valid report was received from a health care professional and refers to unknown patients. No information regarding the patients pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 06-MAY-2021, vaccines experienced the temperature excursion of above 9 degrees Celsius (C) (16.3 C) for 5 minutes for Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and hepatitis A vaccine, inactivated (VAQTA); from -14 C to -10 C (-14.2 C) for 30 minutes for measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX). The event was reported due to digital data logger. There were no previous temperature excursions.  On unknown dates, patients were vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1691302; expiration date: 23-JAN-2022); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T008151; expiration date: 21-JUN-2022); hepatitis A vaccine, inactivated (VAQTA) (lot # T008698; expiration date: 04-JUN-2021; lot # T033519, expiration date: 11-DEC-2021); haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T005737; expiration date reported as unknown, but upon internal validation confirmed as 10-JUN-2022); measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T012418; expiration date: 10-JUN-2021; lot # T029100; expiration date: 23-FEB-2022; lot # T007395; expiration date: 29-AUG-2021;lot # reported as T012537; expiration date reported as: 17-OCT-2021); Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T024557; expiration date: 15-MAR-2022 (reported as 15-MAR-2021)) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot #T021826; expiration date: 25-JUN-2022; lot # T002843; expiration date: 23-JAN-2022; lot # T025942; expiration date: 30-JUL-2022; lot # T000344; expiration date: 01-MAY-2022; lot # T028309; expiration date: 20-AUG-2022) (doses and route of administration were not provided); all for prophylaxis. There were no additional adverse events reported.
Information has been received from a physician's assistant concerning her 13-month-old Caucasian, birth twin son with no pre-existing allergies, birth defects or medical conditions, who, on 17-Jul-2006 was vaccinated with a first dose of PROQUAD (lot #652234/0951R).  Concomitant vaccination given on the same day included a first dose of HAVRIX (lot #AHAVB105CA).  There was no illness at the time of vaccination.  On 25-Jul-2006, the patient developed a fever of 101-103 degrees Fahrenheit.  The patient also experienced fussiness and a scattered rash described as macular-papular rash that appeared on 28-Jul-2006 at 7:00 am.  No medical attention was sought.  The patient was treated with diphenhydramine hydrochloride (BENADRYL) for the rash and acetaminophen (TYLENOL) for the fever.  Subsequently, the patient recovered on 01-Aug-2006.  The patient's vaccination history included: PEDIARIX given in the right thigh on 30-Aug-2005 (lot #AC21BC15DA), 02-Nov-2005 (lot #AC21B022BA) and 21-Dec-2005 (lot #AC21B053AA); PEDVAXHIB given in the left thigh on 30-Aug-2005 (lot #651250/0186R), 02-Nov-2005 (lot #651897/0529R) and 21-Dec-2005 (lot #652026/0541R); and PNU-IMUNE 23 given in the left thigh on 30-Aug-2005 (lot #A85856F), 02-Nov-2005 (lot #B10637E), and 21-Dec-2005 (lot #B08686).  The patient's sister had the same symptoms, however, the lesions were more severe (WAES #0608USA00904).  Additional information has been requested.
Ringing in ears; heart pounding; sharp spikes in chest; headaches; numbness in legs, toes and hands; Vision problems; sore muscles; not sleeping
Patient reports child woke the day following vaccines with extremely painful and stiff neck. She reports that child was drooling, spitting and screaming out in pain. Able to take and move all limbs. No apparent seizure activity. Resolved completed by the following day and has not reoccurred.
On 4/13/2021 at 11:00 AM pt. began experiencing left leg pain with swelling noted around left knee and extended above knee. By 11:00 PM pt. felt faint and nauseated and left leg was swollen and discolored. Rescue squad was called and took pt. to Hosp where she was told it was sciaticia. After showing the medical professionals her leg and insisting upon an ultrasound of her leg she was told the "machine" was not available and she would be called the next day to be scheduled. Per pt's daughter, she was never called and daughter called hospital to have U/S scheduled. Pt. went back to hospital on 4/14 at 3:15 PM for U/S and she was diagnosed with multi DVT's in left leg which at that time had swelling all the way down to her foot. Pt. was put on Coumadin.
Pt received vaccines on 02/16/15, developed fever of 101.7 max on 02/08/15 with diarrhea but no URI symptoms which resolved spont. On 2/11/15 developed generalized maculo-papular rash, no fever/URI symptoms.
Pain under and around the left breast; especially when  I lie down.  Dry cough.  After getting up and walking around, the pain lets up a little, coughing up phlegm.
pt. reports feeling tightness/itching of the throat.  pt. denies any difficulty swallowing / breathing &/or other s/s.  Hx of asthma.  Medics present.  pt. denied EMS transport to ER.  Pt. also declined Benadryl.  Advised pt. to wait an additional 30 mins to be monitored (1hr total) & pt. agreeable.  After 15 mins (1530) pt. reports feeling better.  pt. still waiting the remaining 15 mins.  Post 30mins. - pt. reports some improvement - still feeling a tightness in throat.  patient declined EMS transport & benadryl (again).  pt. decided to go home.  Advised to pull over & call 911 if anything changes / symptoms worsen.
Left knee Osgood Schlatter's disease sharp pain for 3 days, especially at night.  Rec'd shot Saturday morning, pain started Sunday evening and ended Wednesday morning.  Pain was enough that it woke me up Sunday, Monday and Tuesday nights.  I treated the pain with ice and ibuprofen, but still very painful to move and to touch.  Wednesday it got better about as quickly as it started on Sunday.  I did not do any physical activity that would have triggered such sever pain.  The only thing that was different is that I received the Moderna  vaccine.  By Thursday my knee was back to normal.
Pfizer vaccine - tongue swelled impeding speech, face swollen, tingling in the face, hives on face and neck.  This passed within 24 hours Tingling in hands and feet - started within five hours of shot has not improved.
Narrative: Patient received 1st dose of Moderna COVID-19 vaccine at non-Facility pharmacy on 3/5/2021. Within 15 minutes, patient felt lip numbness, had a metallic taste in her mouth, and got lightheaded/disoriented. She presented to non-Facility emergency room for evaluation (records unavailable).
High fever, cough, rapid heartbeat, arm is red/swollen at injection site and is difficult to use this arm. Using BACTRIM DS 800-160 + BENADRYL + NSAIDS.
Arm red, hot to touch, swollen - started afternoon of imm.  Progressed to emcompass shoulder to elbow by Wednesday afternoon.  Fluid filled blisters by evening of 10/17/07; on antibiotic (Keflex)
total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C, 30 minutes with a...; Initial information received on 29-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 57 years old and unknown gender patient who was administered Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv] after the vaccine was exposed to a temperature excursion with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine (lot QFAA2125, expiry date: 30-Jun-2022) (formulation, strength, dose and route not reported) for immunization.  On an unknown date, the patient was administered Influenza Quadrivalent Recombinant Vaccine  after the vaccine was exposed to a temperature excursion total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C reported, total time out of range is 30 minutes with a minimum of 12.3C and maximum of 15.6C reported. total time out of range is 1 hour with a minimum of negative 1.8C and maximum of 1.8C reported (product storage error) (unknown latency).  Action taken was not applicable.  Outcome: Unknown   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.
Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; This is a spontaneous report from a contactable physician.   A 66-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EH9899) intramuscular at single dose on28Dec2020 18:00 for Covid-19 immunisation, administered at hospital.  Medical history included Covid-19: he tested positive for COVID and received the monoclonal antibody, bamlanivimab on 13Dec2020; other unspecified health conditions which might make him high risk. The patient previously received monoclonal antibody 17-1a, bamlanivimab on 13Dec2020. For Covid-19. The patient received other unspecified medications in two weeks. On 28Dec2020 21:00, 3 hours after vaccination, he was feeling bad with flu-like symptoms, nausea, headache, dizziness, fatigue and diarrhea. No treatment received. Covid was not tested post vaccination. The outcome of events was not recovered.  His colleague now knows he should have waited 90 days after the antibody but reporter was wondering if there was information. Since there probably is no information, this is a unique situation and reporter wondered if Pfizer wants him to run any particular tests or send in some blood to Pfizer for testing to further medical knowledge on giving the vaccine within 90 days of the antibodies.
large red area lt thigh w/small bumps & residual knot lt thigh 1-2cm diameter-non tender;
Narrative:  Patient received covid vaccines on 1/21/2021 & 2/23/2021. Pt only received hearing aids and optometry services from the agency. No info available on pt's medical history. Pt is 83yo male who died on 10/20/2021. No info on pt's death provided. Likely vaccines not related to pt's death given pt's age and length of time between date of vaccines given & date of pt's death.
Patient has a history of seizures and informed us he tends to pass out when getting a shot. I administered the first shot, he passed out for 2 minutes, then came to, I talked to him when he became conscious, asked if he was ok and if he wanted to proceed with the second shot, he said yes. I administered the second shot and he passed out again and then started to seize for 20minutes until the ambulance arrived.
Pt. reports very small dark brown spots on the tips of her middle three fingers. They're transient (there in am when awakens, disappears after a few hours.) No pain, swelling, itching. May have slight tingling in this hand.
This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported.
11/13/22 presents to ED for "shortness of breath". PMHx of "COPD"
KINNRIX and Hep A given in (L) deltoid on 6/13/17. That evening. (L) arm noted to be red, swollen, warm to touch, and painful. Seen in clinic on 6/15/17 and started on clindamycin for cellulitis.
11/9/05 at 0845 - patient called advised us of redness and swelling in left deltoid where vaccine given. 11/10/05 - evaluated at  office - red, swollen and warm to touch.
broke out in many tiny red bumps over arm neck & stomach, area, will last for about 30 mins comes & goes; happens about twice a week now; did see MD @ hosp-given Hydroxyzine for 1 wk; pills did nothing;
injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of appetite; joint pain; feeling unwell; received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the left arm on 22Jan2021 13:15 (lot number: EL3302; expiration date: unknown) at a single dose for covid-19 immunization. Medical history included mental disease, seasonal allergy in spring and allergies to sulfa antibiotics. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included aripiprazole (ABILIFY). The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the right arm on 05Jan2021 13: 45 (lot number: EJ1685) at a single dose for covid-19 immunization. The patient received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021. On 23Jan2021 02:00 AM, she had chills, fever with temperature of 99.7 F, headache, tiredness, loss of appetite, joint pain and feeling unwell for 2 days post vaccination. She also mentioned that the injection site was painful on 25Jan2021 for 4 days post vaccination. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was unknown.
2/26/21 afternoon.  Could not keep balance and fell if I tried to walk.  Was okey next day without treatment.
This spontaneous report was received from an other professional (office manager) regarding a pediatric patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 10-JAN-2018 and 12-MAR-2018, an unspecified dose of M-M-R II and VARIVAX went out of range. It was unknown if any of those vaccine was administered to unspecified pediatric patients. An adverse event report was taken as a precaution.
First:  Vaccine was not given at Center.  It was a drive-up at  Drive Thru.    Adverse general side effects that lasted from 3:00 a.m. 02/27/2021 through 03/01/2021:  fatigue, headache, muscle pain, joint pain, chills, nausea, heart palpitations, loss of appetite.  Considerably more pain than with Fibromyalgia, shaking chills even though wrapped in a quilt, more heart palpitations than usual.