chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. Te registered nurse reported that on 02-NOV-2015, the patient was vaccinated inadvertently with a dose of both MMR II and a dose of PROQUAD (route, dose, lot # and expiry date were not provided). No adverse effects were reported. Additional information has been requested.
fever 103 11SEP92 5PM; hives main buttocks thighs legs fever until 13SEP92; APAP & DPH;
Low grade fever; nausea; vomiting; headache; sweating; chills; couldn't sleep; This is a spontaneous report from a contactable consumer (patient). A 28-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810, Expiry date: unknown) via an unspecified route of administration in arm left on 10Feb2021 08:00 AM as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication of patient included gabapentin (GABA) (other medications the patient received within 2 weeks of vaccination). Patient had historical vaccine at 28-year-old, first dose of BNT162B2 (Lot number: EL3249) in left arm on 21Jan2021 at 12:45 PM for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021 11:45pm, patient experienced low grade fever, nausea, vomiting, headache, sweating, chills and couldn't sleep. Patient reported no for serious, seriousness criteria-results in death, seriousness criteria-Life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-Disabling/incapacitating, seriousness criteria-congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The patient underwent lab tests and procedures which included body temperature was low grade fever on 10Feb2021. Patient did not receive any treatment for adverse event. The outcome of the events was recovering.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EN5318), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN5318), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "chronic migraines" (unspecified if ongoing); "depression" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Doxycycline, reaction(s): "Drug Allergy".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022 at 16:30, outcome "not recovered" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Negative, notes: Nasal Swab; (25Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient tested positive for Covid-19 after being fully vaccinated and boosted. The treatment included Prednisone. COVID tested post vaccination and Covid tested prior to vaccination. No other vaccine in 4 weeks.
Nauseous (sick to stomach); Night sweats; Bad headache; This is a spontaneous report from a non-contactable consumer.   A 62-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 19Apr2021 at her 62-year-old female (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization.  Patients past medical history included: thyroid issue, tumor on the pituitary, declined in walking, walker use. Patients concurrent condition included: relapsing remitting multiple sclerosis(ongoing). Patient's concomitant medication included: was not reported. On 19Apr2021, patient started therapy with Pfizer covid-19 vaccine for unknown indication, it was reported that patient experienced: nauseous (sick to stomach), night sweats, and "bad" headache on unknown date.  The outcome of the reported events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was positive for COVID-19 on 16FEB2023, I had feeling that I wasn't well. I had a fever, short of breath but not too compromised. Before I tested I had an earache, I am not sure if there related.
Approximately 3 hours after injection, client developed bright red, "cherry red" toes on left foot. No reported changes in sensation or circulation. Toes remained bright red for about half an hour and then returned to normal. Episodes of this are ongoing, reoccurring approximately daily. If leg is elevated for more than 5-10 minutes, symptoms resolve.
Information has been received from a physician concerning a female patient that had not started her menstrual cycle who on an unspecified date was vaccinated with a dose of GARDASIL (Lot #, expire date and route not reported). Physician stated that on an unspecified date, the patient experienced abdominal and vaginal pain. It is unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
having hot flashes; patient passed out; Initial information was received on 09-Nov-2020 regarding an unsolicited valid serious case received from a nurse.  This case involves a 72 year-old female patient who experienced hot flashes (hot flush) and passed out after having another hot flash (loss of consciousness), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given.   On 02-Nov-2020, the patient received (once) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ511AA and expiry date 30-Jun-2021) via intramuscular route in the right arm (it was assumed that it was the patient's deltoid) for prophylactic vaccination.  On 02-Nov-2020, the patient had serious hot flashes (hot flush) two hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On an unknown date in Nov-2020, the patient passed out after having another hot flash (loss of consciousness) more than 24 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   These events were assessed as medically significant.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were unknown.; Sender's Comments: This case involves a 72 year-old female patient who experienced hot flush and loss of consciousness after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset was compatible. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
So it started like, I got the shot on Saturday so either Sunday or Monday my neck was really sore and my neck had a lump about the size of a pecan on my neck. I ended up calling the VA and they told me to go to urgent care. The DR at urgent care gave me antibiotics and I was on them about two weeks. I went into my DRs office and they didn't really know what it was. It took about a month and a half for the lump to go down. It was really sore, but once it started going down it was as sore.
received 8 doses in the past 4.5 months and was told there was a concern for error in her prep series with no reported adverse event; received 8 doses in the past 4.5 months and was told there was a concern for error in her prep series with no reported adverse event; Initial information received on 30-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who received 8 doses in the past 4.5 months and was told there was a concern for error in her prep series with no reported adverse event. (Rabies (HDC) vaccine) [imovax rabies].  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 Rabies (HDC) vaccine (form, strength, dose, frequency, lot number, expiry date: unknown) via intramuscular route in unknown administration site for Immunization    On an unknown date the patient received 8 doses in the past 4.5 months and was told there was a concern for error in her prep series with no reported adverse event (extra dose administered) and (product preparation error) (unknown latency).  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.
patient experienced nausea and felt she may vomit after vaccination .  She hadn't had anything to eat or drink in at least past few hours.  once she had some apple juice and goldfish crackers she felt better .
Localized swelling and induration w/ multiple vesicles, and large bulla, fever and myalgias w/ nausea.
Developed a headache, fatigue, and a fairly large, red itchy patch around injection site 8 days after vaccination
Red blotches on left arm; Blurry left eye; Stomach pain; Lethargic; Feels very tired; This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (Red blotches on left arm), VISION BLURRED (Blurry left eye), ABDOMINAL PAIN UPPER (Stomach pain), LETHARGY (Lethargic) and FATIGUE (Feels very tired) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 017E21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, ATORVASTATIN, CLOPIDOGREL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and POTASSIUM for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced RASH MACULAR (Red blotches on left arm), VISION BLURRED (Blurry left eye), ABDOMINAL PAIN UPPER (Stomach pain), LETHARGY (Lethargic) and FATIGUE (Feels very tired). At the time of the report, RASH MACULAR (Red blotches on left arm), VISION BLURRED (Blurry left eye), ABDOMINAL PAIN UPPER (Stomach pain), LETHARGY (Lethargic) and FATIGUE (Feels very tired) outcome was unknown.            Treatment information not provided. Action taken with mRNA-1273 in response to the events was  not applicable.
pt recv vax 19APR96 & 13MAY96 pt was exposed to a sibling w/chicken pox;23MAY96 pt exp ten lesions & sl fever;
Swollen sores and inflamed tastebudsall over my tongue; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 26Mar2021 at 15:15 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced swollen sores and inflamed taste buds all over tongue. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if patient received treatment for the adverse event. The clinical outcome of the event swollen sores and inflamed taste buds all over tongue was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4/7/2021 at 1:30 PM - muscle soreness; couldn't raise arm to shoulder height. Right arm at injection site was raised/swollen and felt warm to the touch; 4/8/2021 at 4:00 AM - woke up with chills; hands and feet were cold and I couldn't get warm. Right arm still raised/swollen and felt warm to the touch; 4/8/2021 at 1:50 PM - low grade fever of 100.1 developed and lasted until approximately 7:30 PM. Right arm still raised/swollen and felt warm to the touch; 4/9/2021 at 4:00 AM - woke up to a red rash about 2x4 inches around the injection site. Right arm still raised/swollen and felt warm to the touch; 4/10/2021, 4/11/2021 and 4/12/2021 - same symptoms as 4/9/2021; 4/13/2021 - rash and swelling have disappeared, but injection area is still sore to touch.
Patient was given Spikevax and Fluzone Quad on the same arm. On the area of injection, patient's arm swelled and bruised immediately. I asked the patient to wait for 15 minutes and I placed an ice pack on her arm while she waited. An associated stayed with her just in case any further adverse reaction happens. Patient waited at least 10 minutes and the area seemed to reduce. She said she was fine and wanted to leave.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE ).   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medication information was reported. No treatment medication information was reported. Formulation of Humira was reported as Solution for injection in pre-filled pen. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns adult female patient of unspecified age, with medical history of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was resolving. The medical history of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA) could be the risk factor for the event. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns adult female patient of unspecified age, with medical history of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was resolving. The medical history of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA) could be the risk factor for the event. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Infant received her 3 month shots at 3:15PM. She was given 3 shots and one oral vaccination. Infant started to get fussy around 9PM. By 1130Pm infant was screaming everytime she was moved. Infant woke to nurse at 1AM and at that time temperature was taken under her armpit using a digital termometer. Her temp at 1:15AM was 103.3. Infant was then rushed to the ER. She was would go from screaming to lethargic during the drive to the hospital. Once at the hospital her fever was taken once again under the arm. Temp at that time was 38.9. She was given Tylenol to bring the fever down. Doctors drew blood, blood cultures, urine, spinal and a chest x ray. Infant was stuck over twelve times in order to get an IV line. She was given two antibiotics IM because they were unable to start a line. Infant was also given a MRI to rule out stroke. During this whole time she would scream and cry. Very stressful for her. She was admitted onto the general medical ped unit. She was treated with antibiotics and fluids.
pt's mom called c/o fever-adverse ? rnx to shots-watch;APAP for fever;23OCT call cont w/fever-rsh if persist come in-24OCT seen in ofc
no additional AE; improperly stored administered vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose: 0.5 milliliter, lot# S003446, expiry date: 04-FEB-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -10.8 degrees Celsius for 1 hour 30 minutes. There were previous excursions related: -12.3 degrees Celsius for 1 hour and -10.3 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA003543:
Within 45 mins. of receiving vaccination, symtoms occurred including: Head felt heavy, felt faint, hives on chest (remains today, fever of 101-102, lethargic, muscle aches, upset stomach and diarrhea.
waited 90 days to get his 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 90 days to get his 2nd dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Heart disease gonococcal NOS and Stent insertion NOS. Concurrent medical conditions included Injury NOS. Concomitant products included PRASUGREL HYDROCHLORIDE (EFFIENT), LISINOPRIL, METOPROLOL TARTRATE (METOPROLOL XL), PANTOPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 90 days to get his 2nd dose). On 18-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 90 days to get his 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Electrocardiogram: negative (Negative) Negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that he does not smoke, is under weight, had no blood pressure or cholesterol problem.  No treatment information was provided.  Patient had 5 stents put in every 3 months periodically. During his 5th procedure on 22-Feb-2021, he had last stent put in and he felt fine after the surgery.   This case was linked to MOD-2021-306596 (Patient Link).
a patient received a dose of PEDV AX HIB following a temperature excursion; No other adverse effects were reported in the patient; This spontaneous report was received from a medical assistant, referring to an unknown patient of age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) at a dose of 0.5 milliliter (ml) (vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T000886 which has been verified to be valid, expiration date reported and validated as 29-MAY-2022) as prophylaxis, following a temperature excursion (product storage error). On an unknown date, the vaccine experienced a highest temperature of above 47 degrees Fahrenheit (F)/ 9 degrees Celsius (C) (8.8 C) for a time frame of 31 minutes, as recorded by data logger. No previous temperature excursion was reported. No other adverse effects were reported.
Case PHEH2016US023367 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 36 year old patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.