chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash that is itchy and injection site is scaly 3 months later.  I've been dizzy and memory issues, but not sure those last two items are related - they are new however.
Pt vaccinated with DTP/OPV developed high fever up to 104 x 10-14 hrs. Resolved in 24 - 48 hrs.
This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain and feeling unwell. On an unknown date, the outcome of the pain and feeling unwell were recovering/resolving. It was unknown if the reporter considered the pain and feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter was a patient's mother called in for information regarding whether or not SHINGRIX was a live vaccine. The patient was not feeling well for a day or so after receiving SHINGRIX vaccine. The patient described the feeling as achy. No other information was available through the caller regarding this adverse event. The call center representative failed to obtain the physician's information.
On 4/9/2021, pt states she has a NSTEMI MI, was hospitalized for approximately 3 days and had to be treated in the cath lab.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves Adult female patient of unknown age who experienced facial numbness, epstein-barr type symptoms, lethargy, fibromyalgia type symptoms and memory problems, while she received vaccines IMOGRAM RABIES AND IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect IMOGAM RABIES not produced by Sanofi Pasteur lot number not reported. On an unknown date, The patient developed a non-serious facial numbness (hypoesthesia) following the administration of RABIES (HDC) VACCINE and following the administration of IMOGAM RABIES. On an unknown date, the patient developed a non-serious epstein-barr type symptoms (epstein-barr virus infection) following the administration of RABIES (HDC) VACCINE and following the administration of IMOGAM RABIES. On an unknown date, the patient developed a non-serious lethargy following the administration of RABIES (HDC) VACCINE and  following the administration of IMOGAM RABIES. On an unknown date , the patient developed a non-serious fibromyalgia type symptoms (fibromyalgia) following the administration of RABIES (HDC) VACCINE and following the administration of IMOGAM RABIES. On an unknown date , the patient developed a non-serious memory problems (memory impairment) following the administration of RABIES (HDC) VACCINE and following the administration of IMOGAM RABIES. (Other relevant tests included No lab data.) Final diagnosis was memory problems, fibromyalgia type symptoms, lethargy, epstein-barr type symptoms and facial numbness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for facial numbness, as Unknown for epstein-barr type symptoms, as Unknown for lethargy, as Unknown for fibromyalgia type symptoms and as Unknown for memory problems. Documents held by sender: none.
Shivering, high fever, nausea, weakness, dizziness, body aches and pain, pain at injection site
15mm X 16mm whelp with surrounding left arm area of redness 20 X 20 observed 15mg increased only slights to stated size. Advised to use liquid Benadryl as directed and hydrocortisone cream. Called on 7/19/01 and no answer. Mother phoned and said all resolved and child is fine.
Soreness and redness at the injection site; Soreness and redness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Soreness and redness at the injection site) and VACCINATION SITE ERYTHEMA (Soreness and redness at the injection site) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness and redness at the injection site) and VACCINATION SITE ERYTHEMA (Soreness and redness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness and redness at the injection site) and VACCINATION SITE ERYTHEMA (Soreness and redness at the injection site) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 21-Jan-2021, the patient received 1st dose of Moderna COVID-19 vaccine (Lot number 030L20AH; expiration date: not known; left arm). On 18-Feb-2021, the patient received 2nd dose of Moderna COVID-19 vaccine (Lot number: 015M20A; expiration date: not known; left arm). On 09-Nov-2021, the patient received 1st booster dose of Moderna COVID-19 vaccine (Lot number: 939904; expiration date: not known; left arm). On 18-Apr-2022, the patient received 2nd booster dose of Moderna COVID-19 vaccine (Lot number: 066K21A; expiration date: not known; right arm). On an unknown date, patient received the booster dose of Moderna COVID-19 vaccine, Bivalent. No treatment medications were reported.   This case was linked to MOD-2022-660549, MOD-2022-660555, MOD-2022-660557, MOD-2022-660560 (Patient Link).
The night before I felt like I had gas in my chest. I drove myself to the emergency room early the next morning because I could not breath. They did an x-ray that did not show anything, they also did CT scan that showed I had Multifocal pneumonia. I was given the first dose of amoxicillin at the hospital and sent home a prescription. On Friday I went to see my primary care physician who discontinued that medication and switched me to a broad-spectrum antibiotic.
During 15 min waiting period patient developed lightheadedness and dizziness with heart racing.  No chest pain or chest tightness.  She felt weak and unable to walk.  At first was thought to be a vasovagal reaction and she was given po fluids and monitored.  Vitals were stable.  HR was in the 70s with a baseline of 50s.  She began to feel somewhat better in terms of the lightheadedness and dizziness and was able to walk to "clinic" area at the vaccination event.  Her heart rate was fluctuating between 50 and 107 and otherwise vitals remained normal.  Blood pressure up a bit more than likely due to anxiety.  BP 132/90;  HR 50 - 107;  Rep 20; P.O. 98%; denied pain.  She was given 25mg diphenhydramine IM.  No complaint of throat closing, no anaphylaxis.  She continued to feels waves of tachycardia.  Rescue squad dispatched for further management and observation to make sure no delayed anaphylactic reaction.  Her course at the ED was benign.  No further management other than fluids.  Urine pregnancy test was negative.  No bloodwork completed.  Patient observed four hours with no adverse event and left ED feeling her normal self.  At no time had anaphylactic reaction.
vomited; muscle pain.; severe flu symptoms for about 4 hours; This is a spontaneous report from a contactable healthcare professional, the patient. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot# EL1284), via an unspecified route of administration in the right arm on 23Dec2020 at 10:45 (at the age of 58-years-old) as a single dose for Covid-19 vaccination. Medical history was not reported. The patient did not have any allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were unspecified (had received other medications in two weeks). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 00:00, the patient experienced severe flu symptoms for about 4 hours, vomited and had muscle pain. Therapeutic measures were not taken for the severe flu symptoms for about 4 hours, vomited and had muscle pain. The clinical outcome of the events severe flu symptoms for about 4 hours, vomited and had muscle pain was recovered.
2/20/03 mother stated baby had shaking and "bubbles" from the mouth during night one time. Now bubbles from mouth second time. Child responsive, no shaking second time. Referred to ER, left ER without being seen. Mother felt baby sick from shots. 2/21/03 mother states baby ok now. No tremors or fussiness.
Lost my taste during my hospitalization; I have a UTI; Lost my smell during my hospitalization; I had spinal edema; Bladder distension; I had increased paralysis from my right upper leg down, It later went from my left upper leg down; I couldn't get out of bed, I can't lift my legs. I'm unable to do; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MONOPLEGIA (I had increased paralysis from my right upper leg down, It later went from my left upper leg down) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MONOPLEGIA (I had increased paralysis from my right upper leg down, It later went from my left upper leg down) (seriousness criterion medically significant) and HYPOKINESIA (I couldn't get out of bed, I can't lift my legs. I'm unable to do). On 15-Mar-2021, the patient experienced OEDEMA (I had spinal edema) and BLADDER DILATATION (Bladder distension). On 12-May-2021, the patient experienced AGEUSIA (Lost my taste during my hospitalization), URINARY TRACT INFECTION (I have a UTI) and ANOSMIA (Lost my smell during my hospitalization). At the time of the report, MONOPLEGIA (I had increased paralysis from my right upper leg down, It later went from my left upper leg down), HYPOKINESIA (I couldn't get out of bed, I can't lift my legs. I'm unable to do), OEDEMA (I had spinal edema), BLADDER DILATATION (Bladder distension), AGEUSIA (Lost my taste during my hospitalization), URINARY TRACT INFECTION (I have a UTI) and ANOSMIA (Lost my smell during my hospitalization) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment included were Tylenol, steroids, Gabapentin, plasmapheresis, and urinary catheter.  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment:  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Nausea/vomiting, hot/red/swelling around injection site noted approx. 14 hours after administration. Given ZOFRAN ODT and cefadroxil antibiotic.
Ipol that had undergone temperature excursion on 16MAY2021, and was recommended that it not be used, had been given to patient with no adverse event; Initial information was received on 20-May-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 20 months old female patient who was administered 0.5 ml third dose of suspect IPV (VERO) [IPOL] (lot R1D972M, expiry date: 17-JUL-2021) via intramuscular route in the left thigh for prophylactic vaccination on 19-May-2021 (Product storage error)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); HEPATITIS A VACCINE and PNEUMOCOCCAL VACCINE 13V for prophylactic vaccination.  It was a case of an actual medication error due to Incorrect product storage.  At the time of report, no adverse event was reported.  Caller stated that she called to get stability for IPOL because it was puncture and she was advised to discard. Caller stated before she could take it out of the fridge it was administered to a child. She would like to know what should be done from here. Ipol that had undergone temperature excursion on 16MAY2021, and was recommended not be used  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.
Sever swelling at injection site; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This nurse reported similar events for 3 patients. This is 3rd of 3 reports.   A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration on an unspecified date at unknown dose: both vaccines were administered on the same arm for immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced sever swelling at injection site (non-serious) on an unspecified date after use of the product with outcome of unknown.  No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019351994 same reporter/ drug/ AE, different patient.;US-PFIZER INC-2019352012 same reporter/ drug/ AE, different patient.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medcial history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PEDVAXHIB lot # L004740, expiration date 16-NOV-2017 (dose and route were not reported). The vaccine underwent supported temperature excursions. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Rec'd shot in arm, by the afternoon had flu-like symptoms - very severe according to wife. Fever, chills, aches, and sore arm. Lasted about 2 days. Full recovery.
a lot of muscle spasms in the leg and making it hard to walk, and sometimes they are very sharp; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE SPASMS (a lot of muscle spasms in the leg and making it hard to walk, and sometimes they are very sharp) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (a lot of muscle spasms in the leg and making it hard to walk, and sometimes they are very sharp). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (a lot of muscle spasms in the leg and making it hard to walk, and sometimes they are very sharp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   the concomitant medication includes high blood pressure medication and vitamins
Headache, Myalgia, Fever, Injection site pain, Chills Narrative:
Information has been received from a consumer concerning her 12-month old daughter who on 09-Jan-2002 was vaccinated with a dose of varicella virus vaccine live (lot #638244/0466L). Suspect vaccination on the same day included a third dose of HIB conj. vaccine (lot #639437/0929L) and a third dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 641449/1230L). The patient's vaccination history was noted to include a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (IPOL), and an "RV shot" on 27-Feb-2001, a first and second dose of HIB conj vaccine on 27-Feb-2001 (lot #638138/1548K (also reported as 1548K0")) and 01-May-2001 (lot #639437/0929L) respectively, a first and second dose of hepatitis B virus vaccine rHBsAg (yeast) on 14-Aug-2001 (lot #640323/0753L) and 19-Nov-2001 (lot #640323?0753L) respectively, and a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live  on 01-Apr-2002 (lot #638706/0745L (also reported as "0745L0"). The mother reported that each time the patient "had a shot (any shot)" she experienced a rash around the diaper area and a fever (Hib conj vaccine (WAES #0401USA01373), hepatitis B virus vaccine rHBsAg (yeast) (WAES #0401USA01516) and measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (WAES #0401USA01517). The mother was told to "just wait through the fevers." A product quality complaint was not involved. Additional information was received from a physician which indicated that there was no administration of varicella virus vaccine live to the patient at his facility. No further information is expected. The mother reported that the patient developed a severe urinary infection after therapy with Hib conj vaccine (WAES #0401USA01373).
49 y.o.   Admit Date:  7/2/2022   Discharge Date: 7/6/22   Principal Dx/ Final Dx: Chronic obstructive pulmonary disease with acute exacerbation   Relevant Inpt Dx: Principal Problem:   Chronic obstructive pulmonary disease with acute exacerbation Active Problems:   History of peripheral stem cell transplant   COVID-19 virus infection   Chronic systolic congestive heart failure   Tobacco abuse       HPI:   Hospital Course:   This 49 year old man with copd and cardiomyopathy was admitted with sob.  He had copd exacerbation and covid and chf.   He was treated for copd with nebs and inhalers and steroids.  He did get empiric antibiotics.  He is improved and will taper steroids.  He was treated for covid with remdesivir and is doing well.  Course is complete   He had chf with  acute on chronic systolic chf.  He was given iv lasix.  He did improve but had aki from overdiuresis.  He is now on oral lasix and aldactone has been held.  He will go home wearing life vest and will follow up with cardiology after quarantine ends.             Consults:   IP CONSULT TO SEPSIS NURSE NAVIGATOR IP CONSULT TO CARDIOLOGY       Disposition:  home   Discharge Condition:  fair
The Pt experienced non stop crying since the vaccine was given in the thigh and the site was red and swollen. The pt was seen in the MD's office for evaluation. Tylenol given.
On one week follow-up visit to both urgent care and the emergency room, my primary care doctor noticed that my symptoms occurred less than 48 hours from my vaccine.  I received the vaccine approximately 3:00 pm on Saturday February 13. At 11 am on Monday February 15 started feeling pain and tenderness on lower left side which was intermittent and worsend by nightfall. The next day on Tuesday February 16 I went to the urgent care and then they sent me to the ER in which epiploic appendigitis was determined to be the cause. Sent home to a course of ibuprofen and rest because the condition self-corrects.
This spontaneous report as received from a registered Nurse refers to a 23 year old female patient, with kidney stones and a rash due to BACTRIM. On 02-DEC-2013 the patient was vaccinated with VARIVAX (Merck) (lot J006359, expiration date 23-May-2013), subcutaneous in the left arm. Concomitant therapies included drospirenone, YASMIN. On 02-DEC-2013, within 1 hour after patient was vaccinated with she developed a 50 cent piece size hard, red swelling at the injection site. Over the last two days the area has increased to 7 inches by 12 inches. She also has a fever of 100 F, with itching and pain at the injection site, body aches and malaise. Patient was diagnosed with an infection and cellulitis. At the time of the report the patient has not recovered from the events. The patient went to the emergency room and was treated with Clindamycin (manufacturer unknown). A urine lab diagnostic was performed on an unknown date and the results were not provided. The nurse is requesting a lot check on VARIVAX (Merck) (lot J006359, expiration date 23-May-2015), due to this adverse experience. Additional information has been requested.
Developed rash on 11-19-12. Temperature low grade since after vaccinations until 11-20-12. Temperature up to 103 degrees F. Taken to Urgent Care. Given antibiotic. Amoxicillin.