chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received that of a total number of people immunized with RabAvert as either a booster or pre-exposure prophylaxis, a large percentage of theses individuals did not have protective rabies antibody titer levels at tow years after immunization. We received additional information. Of a total 58 patients, 27 had initial DIA (dot immunobinding assay) test indication inadequate titers for antirabies protection in 2004 after primary series or booster vaccination in 2002 for pre exposure prophylaxis. An additional 13 patients had border line values. As the tests were performed with an unrecommended system, retesting was preformed using RFFIT ( rapid fluorescent focus inhibition test), as recommended. Upon retesting of all 58 patients, all but two had adequate antibody titers. One of these had received the primary series in the Philippines in the 1970's and had received on booster in 2002. He will be revaccinated. The other person had received the primary series in 2002 and showed neutralizing antibody level of ,1:5. This person will be boostered. Assessment: unchanged. OMIC
The patient complained of pain in his left arm. The mother saw swelling and redness. The arm is painful to touch and hard. One half of the left upper arm is involved. The patient was treated with Motrin and started to improve.
Persistent right eyelid muscle spasms. After 2 weeks, both eyes spasm. Alternating, severity increases in bright environments or while standing.; This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 31Mar2021 at 16:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 16:00, the patient experienced persistent right eyelid muscle spasms. After 2 weeks, the patient experienced both eyes spasm, alternating, severity increased in bright environments or while standing. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event persistent right eyelid muscle spasms, after 2 weeks, both eyes spasm, alternating, severity increased in bright environments or while standing was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This was my second shingles shot, not sure of manufacturer or dosage above.  I woke up the next day with flu like symptoms- fatigue, body aches, and diarrhea.  This has lasted for 5 days.  The diarrhea has been the worst as I have had bad stomach cramps also.  I am hoping this will get better soon.
Hardened area of lt lateral thigh 3 wks post injection. Was seen by MD yesterday but still wanted to report
Case previously recorded as MA2009-4401.  Initial case report received from a nurse via agency on 16 NOV 2009.  A 3 year-old female patient was vaccinated with 0.5 mL of FLUVIRIN 2009/2010 (batch no. 102045P1) i.m. on 14 NOV 2009.  No adverse events were reported.  Wrong age is unexpected after vaccination with FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures are necessary.  Agency reference no.: NA09-008317.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles and tingling. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles and tingling were unknown. It was unknown if the reporter considered the shingles and tingling to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX on the left arm. The patient was recently diagnosed with shingles. The patient had no lesions or itching. She only reported tingling under her right rib. The patient visited emergency room. The pharmacist did not know when the tingling had begun, but thought it to be within the past few days before the reporting date, as the patient saw her doctor and received a prescription of Valacyclovir on the date of reporting.
flu; Initial information received on 16-Oct-2021,there was no any adverse event in the case process as non-case.  Follow-up information received on 16-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involved adult female patient who experienced flu (influenza) after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient past medical treatment, vaccination, family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via intramuscular route in hand for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My ex-wife got the flu shot twice in her life. Both times she got the flu. My co worker got the flu shot twice. Both times she got the flu. My daughter got the flu shot, and she got the flu. I hadn't had a vaccine in over 50 years, not going to start taking one now. Haven't had the flu in over 20 years until a vaccinated family member gave it to me"  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event flu.  At time of reporting, the outcome was unknown for the event flu.  There would be no information available on the batch number for this case.
Information has been received from a physician concerning a 9-year-old white female with no known allergies who on 16-OCT-2000 was vaccinated with a  dose of Varivax. On 27-APR-2006 the patient developed chickenpox. She was seen and diagnosed on 28-APR-2006. No additional information is expected.
Minor reaction to the first vaccine included cold sweats, body aches, fatigue, and sore arm, which lasted approximately 3 days. Following the vaccine, I had a very light menstrual cycle which lasted only 2 days.  Reactions after the second vaccine were similar but longer lasting and more intense. These reactions included a fever >100.0 for 5 days, body aches, extreme fatigue, and sore arm. After the second vaccine, I also experienced  weakness in my legs, tingling or numbness in my legs that would come and go,  and an inability to stand for more than a few minutes - which progressively got better, but lasted for about two weeks. In regards to my menstrual cycle, I skipped a cycle, had a light cycle, and had abdominal swelling until the end of the next full cycle. Since the second vaccine I have had two menstrual cycles, both of which were light, but each one becoming more typical of pre-vaccine menstrual cycles.
Pt recv vax on 11/3/98; on same day pt exp red, swelling, sore, warm vax site; pt imp 11/7/98
Developed generalized hives 6-7 hours after the influenza vaccine. Had to see nurse practitioner; given Kenalog shot and Prednisone and Benedryl. Studies done by nurse practitioner.
COVID Positive post vaccine >14 days Narrative:  COVID Positive post vaccine >14 days
INFLAMED LYMPH NODES; CHILLS; BAD HEADACHE; This spontaneous report received from a patient concerned a 62 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: 26-MAY-2021) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced bad headache. On an unspecified date, the subject experienced inflamed lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflamed lymph nodes, and chills, and bad headache on 12-MAR-2021. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Death Narrative: Patient had Pfizer COVID vaccine dose #1 on 3/20/21. He called his provider on 3/30 to report known exposure to COVID that occurred on 3/27 and 3/28. On 4/1 he tested positive for COVID swabbed at the facility and sent to the main facility for processing. He was notified of positive result on 4/1 at 4pm. He was advised to quarantine and to call facility call center/triage should he develop any fever, shortness of breath, and other Covid-related symptoms. Provider received a phone call from PD on 4/8 notifying of patient unattended death. According to EMS report neighbors were aware of patients COVID positive status. No one had seen or heard from the patient in 3 days so they contacted PD for wellness check. Entry was forced into apartment and patient was found deceased, sitting on the couch. Not breathing ashen color. Pt has ringer and no Pulse. PMH: Quit tobacco 5-15 yrs ago Hyperlipidemia Hyperglycemia Obesity Allergic rhinitis, stable Hx AAA and Right ICA aneurysm, S/P Open repair in 2013 Patient had no prior history of COVID before 4/1 diagnosis. He was not having any symptoms between 4/1 when he tested positive and he did not call to report any symptoms between 4/1 diagnosis and death. There was no communication after 4/1 positive covid test. Patient was scheduled for a phone call with RN on 4/8 the date he was found deceased. Cause of death is not mentioned, but suspected to be due to COVID infection. There were no reported side effects to COVID Vaccine administration.
had a little of a sore arm; a little lump on the arm; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 20Jan2021 as a single dose for COVID-19 immunisation. The patient also reported that the shot was a "breeze". The patient's medical history and concomitant medications were not reported. On 21Jan2021, the next day (as reported), the patient experienced little of a sore arm and a little lump on the arm. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
This case was reported by a nurse via sales rep and described the occurrence of local reaction in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of local reaction (1st dose received on an unknown date. For tolerance, refer case US2018GSK198473). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local reaction. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced local reaction, which was much milder than the reaction experienced with the 1st dose of SHINGRIX. The reporter did not agree to be followed up.
no adverse reactions noted at visit; This non-serious case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2342230-1. The original narrative from the sender is as below:  No adverse reactions noted at visit.  Current illness was reported as none.
swollen shoulder; Painfull shoulder; uncomfortable lower gut; This case was reported by a consumer and described the occurrence of swollen joints in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced swollen joints, injection site pain and abdominal discomfort. On an unknown date, the outcome of the swollen joints, injection site pain and abdominal discomfort were not recovered/not resolved.   It was unknown if the reporter considered the swollen joints, injection site pain and abdominal discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received first shot 5 days ago, from the date of reporting. On the date of reporting, the patient was still experiencing swollen on shoulder and the site was painful if touched.  My His lower gut was uncomfortable
Pt experienced excessive sweats, fevers (102.0), lightheadedness, nausea, dizziness, redness, edema for 5 hours.
Moderna Booster Dose (0.25ML) inadvertently given to 11 year old.
Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old male patient who experienced pneumococcal meningitis, pneumococcal sepsis, upper respiratory infection and stroke. The patient received the fourth dose on 30-May-2009. The patient also received the first dose of VAQTA (Merck) on 30-May-2009. During the winter of 2008-2009 the patient experienced wheezing, treatment unknown. On 09-Jun-2009 the patient was seen in the office with wheezing treated with ORAPRED in addition to PULMICORT and Albuterol inhalation therapy. On 13-Jun-2009 follow-up showed the wheezing resolved. On 20-Jun-2009 the patient presented to the physician with a two day history of fever, fussiness and being uncomfortable per the parents. In the office the child engaged with the staff and was playful. He was afebrile with no cough noted and was diagnosed with an upper respiratory infection, treatment unknown. On 21-Jun-2009 the parents telephoned the office and "seemed nervous which was not normal for them". The physician examined the child and noticed a drooping eye, side unknown, and was diagnosed with stroke. This event was considered medically important. The child was admitted to the local hospital and on an unknown date was transported to another hospital. On 23-Jun-2009 the child died. The cause of death was reported as meningitis pneumococcal and pneumococcal sepsis. Serotype testing was not performed at the time of this report but is being requested by the child's physician. No additional information was available at this time of this report.  8/24/09 Hospital records received DOS 6/21/09 to 6/23/09. Assessment: Fever. meningitis. Patient earlier this day presented at ED with fever. Seen later for drooping and swelling of right eyelid and vomiting after Advil. Moderate distressed, photophobia, fussiness. Not alert, moaning, hypotonic. 9/1/09-records received for 6/23/09-COD-Pneumococcal meningitis, septic shock, acute respiratory distress syndrome, multiorgan failure, left hemispheric infarct. Transferred from another facility after presenting with febrile illness, progressive lethargy and poor feeding and worsening respiratory distress. Developed respiratory failure intubation and ventilator support, developed shock, multiorgan failure.
Headache; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches".  Additional information: the events occurred 16 hours after second dose of Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE reported; Nurse calls to report that GARDASIL 9 was stored improperly and administered; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 29-JUL-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis, lot number 1637651 with expiration date in 09-JUN-2022 (dose, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a temperature range of 50 degrees Fahrenheit (°F) for the time frame of 1 hour and 46 minutes. There was no previous temperature excursion and the call was because of a data logger.  No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA000266:
Patient came to clinic yesterday (L) deltoid was red, swollen and hot. He received Flu vaccine on 11/14/16 in that arm.
Rash on left arm below the injection site. Itching and little swelling.  Came on day after vaccine and lasted lasted five days.   Used ice for the swelling and Cortizone 10 ointment for the itching.
Nausea, Vomiting and diarrhea starting 18 hours after shot.
Patient received the shot which apparently hit a nerve because he immediately jumped when shot was administered. Called to report that he still had shooting pains and headache 2 weeks post shot. Went to MD & received pain Rx.
Flu like symptoms; Sweats; CAN'T KEEP ANYTHING DOWN; Cold chills; Headache; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-MAR-2021 around 08:30 am for prophylactic vaccination. No concomitant medications were reported.  In the middle of the night, (captured as MAR-2021), the patient experienced flu like symptoms, sweats, cold chills, headache, can't keep anything down (PT of abdominal discomfort). The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The outcome of the flu like symptoms, sweats, cold chills, headache and can't keep anything down was not reported. This report was non-serious.
IMMEDIATELY AFTER RECEIVING FLU IZ WHILE SITTING, COMPLAINED OF DIZZINESS, AND DIAPHORESIS AND WAS LOWERED TO FLAT ON A FLOOR MAT. CLIENT REMAINED THROUGHOUT ALERT AND ORIENTED, WITH EASY RESPIRATIONS, PINK LIPS, PAIN FREE AND ABLE TO MOVE SYMETRICALLY. WITHIN 10 MINUTES CLIENT FELT ABLE TO STAND AND WALK. 02 SAT 99, BP 120/80 AND HR 72. CLIENT STATED SHE HAD NOT DRANK ENOUGH THAT DAY, SO WAS GIVEN 8 OZ OF WATER BEFORE LEAVING.
side effects/it 5,8 or 12 hours after injection that I may have side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects/it 5,8 or 12 hours after injection that I may have side effects) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects/it 5,8 or 12 hours after injection that I may have side effects). At the time of the report, VACCINATION COMPLICATION (side effects/it 5,8 or 12 hours after injection that I may have side effects) 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.   No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2021-398608 (Patient Link).
feeling like i have the flu with a full grade fever; feeling like i have the flu with a full grade fever; every time she receives the shot, the symptoms worsen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: FH8028) for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "each time, the symptoms or reaction was worst", "soreness". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "feeling like i have the flu with a full grade fever"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "every time she receives the shot, the symptoms worsen".  Additional information: As per agent (Name withheld), the patient experienced side effects from the COVID vaccine and wants to know if should proceed with the booster. Caller stated that she was solely vaccinated with the Pfizer COVID vaccine and each time, the symptoms or reaction was worst. Caller mentioned that first time 04 April, the second time it was a full blown feeling like i have the flu with a full grade fever, then the third time I had my ears swell up to the point you cannot hear in any ears now. Caller mentioned that seek urgent care and she was told never saw anything like that and to ER. Caller stated that ER said the same that they never saw anything like that. Caller added that after consultations was prescribed with a steroid drops and actually got hearing for about the week. Caller mentioned that now it is time for the second booster, is it advised to the second booster or switch to other vaccine. After providing response, caller stated that she thinks she fall under the category of those who shouldn't take the vaccine. Caller also mentioned that every time she receives the shot, the symptoms worsen. Caller also added that seek medical advise from her doctor and they didn't know what to do as well and referred to Pfizer. There were no relevant lab tests.