chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shot made be sick for about 12 hours; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had Shingles 3 times, every time was worse than the time before).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   The reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-May-2022 Reporter's comment: The case was received by the patient via interactive digital media. The patient stated that the Shingles shot made him/her sick for about 12 hours, but it was much better than getting shingles. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
The patient went to the emergency room due to the following: high blood pressure, dizziness, bilateral leg numbness and throat swelling. She was given steroids and Benadryl and was released after a few hours. She received a prescription for steroids and was off work for one week.
she has excruciating body pain, in her all body since yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (she has excruciating body pain, in her all body since yesterday) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced PAIN (she has excruciating body pain, in her all body since yesterday). At the time of the report, PAIN (she has excruciating body pain, in her all body since yesterday) outcome was unknown.            Other medications were not provided. Treatment information was not provided.
Initial report received on 22/Sep/2006 from the patient. A 68 year old female patient had received an intramuscular, right arm, fourth dose injection of Imovax Rabies,lot number unknown, on 24/Aug/2006. At an unspecified time post-vaccination, the patient experienced pain and weakness in her right arm. Recovery status for this event was not reported. This patient had a separate event of pain in the shoulder and arm following the fifth dose of Imovax that is recorded in case 2006-02504.
Swelling, redness, vomiting, fever, pain at injection site, redness/swelled in multiple places on upper right arm, headache, body aches, neck pain
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 30-MAY-018, the patient was vaccinated with a improperly stored GARDASIL 9 (which had a lot # of N022952 and an expiration date of 14-JUN-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions on an unknown date: 47 degrees F to 77 degrees F for 24 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507512-1807USA013144.
temperature has been dropping today over the last 30 minutes and is now at 91.2 degrees; Diarrhea; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temperature dropping and diarrhea.   The patient's medical history was not provided. Concomitant medications known to have been used by the patient included amlodipine, losartan, apixaban, and docusate sodium.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029K20A) for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient temperature had been dropping over the last 30 minutes and was at 91.2 degrees and she experienced diarrhea.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the events were resolved on 12 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
flu-like symptoms; Chills; fatigue; headache; dose received: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 09:30 (Lot number: FG3527) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 16Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM, Route of Administration: Intramuscular), administration date: 19Jan2021, when the patient was 32 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM, Route of Administration: Intramuscular), administration date: 09Feb2021, when the patient was 33 years old, for COVID-19 Immunization, reaction(s): "flu like symptoms (chills, headache and tiredness) ", "flu like symptoms (chills, headache and tiredness) ", "flu like symptoms (chills, headache and tiredness) ", "flu like symptoms (chills, headache and tiredness) ". The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 09:30, outcome "unknown", described as "dose received: 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset 07Dec2021 21:30, outcome "recovering", described as "flu-like symptoms"; CHILLS (non-serious) with onset 07Dec2021 21:30, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 07Dec2021 21:30, outcome "recovering", described as "fatigue"; HEADACHE (non-serious) with onset 07Dec2021 21:30, outcome "recovering", described as "headache". Therapeutic measures were taken as a result of influenza like illness, chills, fatigue, headache. Additional information: The patient had no list of any other medications received within 2 weeks of vaccination.  Acetaminophen received as treatment for the adverse event.  The patient was not diagnosed with COVID-19 prior to vaccination.  The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021147534 same patient/drug, different dose/,similar vent
A report was received from a consumer on 12Nov02 concerning a 20 year old male vaccinee who experienced hives and flu-like symptoms including fever and aches after receiving Fluvirin on 07Nov02. On 08Nov02, the vaccinee experienced hives and flu-like symptoms after receiving Fluvirin on 07Nov02. On 09Nov02 the vaccinee sought medical attention at an infirmary. The vaccinee was injected with diphenhydramine and released. Symptoms continued at the time of the report. The vaccinee was reported to be allergic to the sulfa drugs.
Based on additional information received on 24 April 2014, this case initially considered as non-serious was upgraded to serious: confirmed influenza virus infection. Initial report received from healthcare professional on 14 February 2014. A '07-month-old female patient whose medical history and concomitant medication were not reported. The patient had received dose of FLUZONE and the patient had unevaluable event and was tested for type A after administration of vaccine on an unknown date. The laboratory details and corrective treatment were not reported. The outcome of the event was unknown and required emergency room/ doctor visit at the time of report. Follow-up information was received from the healthcare professional on 24 April 2014. The patient received the following vaccines on 28 January 2014: a first intramuscular right thigh injection of FLUZONE (lot number UH906AD); a third intramuscular left thigh injection of PENTACEL (lot number C4560AA); a third intramuscular right thigh injection of ENGERIX (GlaxoSmithKline, lot number AHBVC190BA); a third intramuscular right thigh injection of PREVNAR (Wyeth, lot number G95397); and a third oral dose of Rotavirus vaccine (Merck, lot number J008385). Per the office note, the patient needed an influenza booster vaccine, to be scheduled in one month. On 13 February 2014, i.e. 13 days post-vaccination, the patient presented to the emergency room with complaints of fever, cough, sneezing, fussiness, and poor appetite for several days prior to the visit.  Symptoms were worse at night.  Parents denied vomiting, diarrhea, rash, or pulling at ears; the patient had no known sick contacts. Physical exam revealed the following: temperature 101.3, heart rate 165, respiratory rate 32, pulse oximetry 98%.  Left tympanic membrane was erythematous and bulging. No rales, wheezes, or rhonchi were noted on auscultation, and mucous membranes were moist. Laboratory testing showed  influenza virus type A (H1N1 and PCR) to be positive.  Respiratory Syncytial Virus antibodies were negative, Influenza Virus type B (PCR) was negative, and chest x-ray was within normal limits. The patient was diagnosed with influenza and prescribed Tamiflu for 5 days. The event subsequently resolved on an unspecified date. Of note, the patient had a history of seborrhea, with no illness at time of vaccination and no concomitant medications. At the time of her office visit on 28 January 2014 she weighed 16.72 pounds and was 26 inches long. Birth weight was 7 pounds. List of documents held by sender: Office note, ER note.
about 2 hours after receiving vaccine  projectile vomiting fever that went  from 99.0 to 104, developed rigors went to Emergency Room
Vomiting (excessive, projectile) x 3, fever to 101 approx 12 hours post-vaccination. malaise lasted approx 24 hours
Observations Covid19 vaccine: On 1/8/21 the first of the 2-stage Moderna vaccine was injected at the facility.  The injection was barely felt and the symptoms were mild over the next few days. On January 17th - 9 days later - the area around the injection felt itchy upon waking.  Swelling, redness and heat were observed at the injection site in an area about 2 1/2 inches in diameter. Soap and water was applied for the itchiness and Tylenol was taken. The itchiness mostly subsided.  Above the affected area a few scattered raised splotches are present. I had read about this set of reactions to the vaccine but had not read that this might occur as many as 9 days after the initial shot, so I thought I'd share that with my doctor via My Chart and with you in case it was useful. Thanks. This is the first day of the reaction and I expect it to go away on its own over the next few days. It's not sore just slightly itchy.
Vaccine received 12/18/20.  Experienced fatigue, chills, body aches, fever on 12/19/20 ~3pm. Temperature ranged 101.3-102.6 deg F.  Reduced with Tylonel.  Temperature 12/20/20 ranged 100.5 deg F down to 99.5 deg F by end of day with no antipyretic medication taken on 12/20/20.
sick; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer reported for herself. A female patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 25Mar2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient was scheduled to receive the 2nd dose on 15Apr2021. Unfortunately she became sick and tested for Covid-19 virus but no results yet. Lab data included SARS-CoV-2 antibody test on an unknown date (reported as "last Friday" as of 05Apr2021) with an unknown results. Outcome of the event was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient requested Shingrix vaccine. Pharmacist thought patient requested for Flu vaccine. Flu vaccine was given instead
rash that has spread from shoulder to lower extremities including buttocks, top of feet and ankles and legs.; This is a spontaneous report from a contactable pharmacist. An 88-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via intramuscular route of administration in the right arm on 05Apr2021 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had no known drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via intramuscular route of administration in the right arm on 13Mar2021 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced rash that had spread from shoulder to lower extremities including buttocks, top of feet, ankles and legs. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event rash that spread from shoulder to lower extremities including buttocks, top of feet, ankles and legs was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
1. Body rash 24 hours after fever 2. High fever (102 F to 104 F) 3 days after immunization.  (first 2 days was 99 F to 100 F and then gone on the 3rd day until the 4th day when he spiked 103 F) for 2 days and 101.5 F for 2 days 3. Restlessness and hyperactivity and easily frustrated with extreme emotional upset 4. Vomiting 5. Lethargic, Sleeping for 18 to 20 hours for 3 days 6. Head banging on floor, walls and people holding him and the onset of repetitive movements (flaps arms, rubbing hands on textures continuously, screams frequently, walks in circles when aggravated or tired or pats his hands on his head) 7. Loss of Appetite 8. Blisters in back of throat 9. Flu symptoms without the flu. 10. Trips to Doctor's Office and ER
pt recv vax 28NOV96 & 27FEB96 a VZV IgG ELISA showed a neg titer;
SWOLLEN LYMPH NODES IN GROIN, UNDER CHIN, BEHIND EAR, UNDER ARM, AT BASE OF NECK
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On 30-JUL-2018, the patient was vaccinated with improperly stored VARIVAX lot # N035941, expiration date 18-DEC-2019 (dose and route were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of 6°F to 14°F during 1 hour 25 minutes. It was reported that previous temperature excursion occurred at 6°F to 14°F for 3 hours, multiple excursions. It was reported that the call was because of a data logger. The reporter also stated that the sterile diluent was stored appropriately. No adverse effect was reported.
ran fever x 3 days; starting approx 3 hrs p/inject; fever was 102 till 31JUL92 when it reached 104.6 & rash developed;
Adverse events reported the day after vaccination where fever (101 degrees), vomiting, hard nodules at injection sites. Too painful to move entire arm. Onset the evening of vaccinations.
Caller is a nurse calling in to request information regarding revaccination recommendations for an infant to received ROTATEQ and regurgitated part of the dose(see request case 02215583 for details). Caller was a transfer; Caller is a nurse calling in to request information regarding revaccination recommendations for an infant to received ROTATEQ and regurgitated part of the dose(see request case 02215583 for details). Caller was a transfer from agent but; This spontaneous report was received from a registered nurse and refers to an infant patient of unknown gender. The exact age of the patient was not provided. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-JUL-2022, the patient was administered their first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot # 1879860, expiration date: 13-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The reporter stated that part of the dose was regurgitated (accidental underdose). The patient did not have any other adverse events after receiving their dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The outcome of the event of regurgitation was unknown.  The causal relationship between regurgitation and the suspect vaccine was not reported.
This case was reported by a nurse via call center representative and described the occurrence of throat swelling in a patient who received FLUARIX QUADRIVALENT (batch number 9JX2N, expiry date unknown). In 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, 5 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced throat swelling, eye swelling, lip swelling, chest tightness and headache. On an unknown date, the outcome of the throat swelling, eye swelling, lip swelling, chest tightness and headache were unknown. It was unknown if the reporter considered the throat swelling, eye swelling, lip swelling, chest tightness and headache to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: The patient experienced eye or throat or lip swelling, chest tightness and headache. The healthcare professional wanted to know if prior, similar reports have been reported for the reported lot number.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L033707 with expiry date of 18=MAY-2015. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
little arm soreness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 24Feb2021 09:30 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient who received the first dose of the Pfizer COVID-19 vaccine experienced a little arm soreness on an unspecified date. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Patient refused to eat for 12 hours after vaccines. Localized reaction at the site of the PENTACEL vaccine in the lower extremity. Patient was improved within 24 hours.
I developed a staph infection in my nose. I've had one before so I self-diagnosed and treated, using over the counter antibiotic. It lasted four days when I called the doctor to get a different antibiotic since it was taking longer than usual to start going away .
Covid vaccine was accidently stored in the freezer instead of the fridge.  No adverse symptoms noted.
Case number PHEH2013US021671 is an initial spontaneous report from nurse received on 16 OCT 2013 and a follow up report from the nurse received on 11 NOV 2013. This case refers to an adult female patient. She received FLUVIRIN 2013/2014 (batch number: 13395P), 0.5 ml intramuscularly in the left deltoid on 15 OCT 2013. The nurse stated that patient received FLUVIRIN from pre filled syringes that had temperature excursion of 54 F for 8 hours. No adverse event reported following this medication error.  Follow up report from the nurse received on 11 NOV 2013. Site of vaccination and batch number of FLUVIRIN vaccine were updated.
arm swelled from shoulder to finger tips lasted 2 days and was not able to use arm;
This spontaneous report as received from a physician refers to 84 patients of unknown age and gender. The patients' medical history and drug reactions or allergies were not reported. On unknown dates since January 2015, the patients were inadvertently vaccinated with improperly stored doses of ZOSTAVAX (dose, route, lot# and expiry date were not reported). Concomitant medications were not reported. No adverse experiences were reported. Additional information has been requested.
Day 1: Headache, mild fever, chills, severe body aches,  tired, sweats,  and nausea. Fevered welt at the sight of injection.  Symptoms were present the following day after injection.  Day 2 after injection most symptoms have resolved mild episodes of sweats, stiffness, and continued fevered welt by injection sight. Day 3 same symptoms as Day 2 but less body stiffness and more energy.
During the hospitalization , patient was treated for following diagnosis 1. Acute hypoxic respiratory failure with ARDS secondary to COVID-19 bilateral pneumonia (POA): Patient was intubated on 09/12/2021  Patient was extubated on 09/18/2021 and within few minutes of extubation patient passed away comfortably with family members bedside  Patient was pronounced dead at 12:31 p.m. on 09/18/2021
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on FEB-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced suspected immunological vaccine failure. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210340782-COVID-19 VACCINE AD26.COV2.S - Suspected Immunological Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
January 21, 2015 optic neuritis left eye begins. By Fri vision loss in left eye. Patient went to ER, ophthalmologist and back to ER for MRI. Find lesions in brain. Treated with 5 days of IV infusion steroids. Diagnosed with M.S. Feb. 3, 2015. Withdrew from school Feb 11, 2015.