chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headaches; Chills; Feverish; Weak; Light was bothering her; Sound was bothering her; No appetite; Started feeling bad next day; This case was reported by a other health professional via sales rep and described the occurrence of headache in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a day after receiving Shingrix, the patient experienced headache, chills, fever, weakness, photophobia, sound sensitivity increased, appetite absent and feeling bad. The patient was treated with hydrocodone. On an unknown date, the outcome of the headache, chills, fever, weakness, photophobia, sound sensitivity increased, appetite absent and feeling bad were recovering/resolving.   It was unknown if the reporter considered the headache, chills, fever, weakness, photophobia, sound sensitivity increased, appetite absent and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix in the pharmacy and experienced headaches, chills, felt feverish, weak, light and sound was bothering her and had no appetite. The patient started feeling bad the next day, less than 24 hours after vaccination. The patient took a hydrocodone to make herself feel better. The symptoms lasted through next day after vaccination, but patient felt better 2 days later. The reporter consented to follow-up.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to vaccine underdose. It was also a case of syringe issue since the vaccine leak out of the end of the needle. It was unknown whether the patient experienced any adverse events. 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 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt. given ROTATEQ on 7/11/2012. Developed intussusception on 8/12/2012 that was reduced with an air enema.
12 hours after dose (8 pm), very mild muscle pain and fatigue started. By 10-11, increased whole body muscle pain, some joint pain, fatigue, and chills began. Chills were pretty bad (for me at least). Almost like increased cold sensitivity. Headache began this morning (24 hours after vaccine). Temp 99.5.
DTaP & PCV 13 3rd in series given IM. Baby was well. Started to run a fever of 103 degrees at 1600. Fussy, fever all night, continues to be fussy. MOTRIN for comfort.
Hearing loss in right ear for two days, feeling was like like water in ear (which there was not). Also had pain all over body for several hours, plus and major tingling in left arm and hand.
Patient was given either Vaxelis or Vaxnevance orally along with Rotavirus by mistake. After mistake was made aware, went through sharps container to identify that Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake, but wanted to report for both as possible outcomes. No adverse reaction as of 6/19/2023
Chills; Fever; Fatigue; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date the patient experienced chills, fever and fatigue for 48 hours. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever and fatigue was resolved on an unknown date after 48 hours.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client exhibited signs and symptoms of an anxiety attack 2 minutes after receiving first dose of Pfizer vaccine. Client was restless and stated that his heart "was racing". Client did not lose consciousness and vital signs were stable.
PATIENT COMPLAINED OF SHOULDER AND MUSCLE PAIN 1 DAY AFTER GETTING THE VACCINE. HE SAW HIS PCP AND A SHOULDER DOCTOR AND THEY BOTH SUSPECTED OF SHOULDER INJURY RELATED TO THE VACCINE. PATIENT SAID HIS MOTION HAD BEEN SIGNIFICNATLY REDUCED SINCE THEN, BUTTHE SYMPTOMS ARE IMPROVING AND HIS RANGE OF MOTION IS IMPROVING. PATIENT WILL UPDATE ON PROGRESS.
Info has been received from an RN concerning a 5 year old female who in 2001 was vaccinated with a dose of varicella virus vaccine live. The RN reported that on 11/21/05, the pt developed "lots" of varicella lesions. The pt was noted to be afebrile. Unspecified medical attention was sought, but no lab/diagnostic tests or treatments was required. At the time of this report, the pt was recovering. Additional info has been requested.
CHEST CONGESTION; SHORTNESS OF BREATH; CHILLS; FEVER; HEADACHE ON THE RIGHT SIDE OF THE HEAD; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry:14-DEC-2021) dose was not reported, administered on 14-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-DEC-2021, the patient experienced chest congestion. On 14-DEC-2021, the patient experienced shortness of breath. On 14-DEC-2021, the patient experienced chills. On 14-DEC-2021, the patient experienced fever. On 14-DEC-2021, the patient experienced headache on the right side of the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, chest congestion, shortness of breath, and headache on the right side of the head. This report was non-serious.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route unknown, lot#L048236, expiration date:31-MAR-2018). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
She said after receiving she became weak and shaky unable to walk. ED visit. Today feeling much better still has some weakness, but back to normal activities.
Patient start hypo ventilating prior to shot.  Stated she felt ok after shot.  Left to go to car and fainted 5 minutes after shot.  Gait unstable required staff to carry her back inside of building out of car.
Information has been received from a pharmacy student concerning a female with no drug allergies who in December 2009, was vaccinated with the third dose of GARDASIL (lot# not reported). After receiving GARDASIL (unspecified which dose), on an unspecified date the patient experienced hair loss. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Mild itching; Redness at the injection site; Slightly mild sore muscle; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Mild itching), INJECTION SITE ERYTHEMA (Redness at the injection site) and MYALGIA (Slightly mild sore muscle) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition provided.). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced MYALGIA (Slightly mild sore muscle). On 03-Feb-2021, the patient experienced PRURITUS (Mild itching) and INJECTION SITE ERYTHEMA (Redness at the injection site). On 04-Feb-2021, INJECTION SITE ERYTHEMA (Redness at the injection site) had resolved. At the time of the report, PRURITUS (Mild itching) had not resolved and MYALGIA (Slightly mild sore muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Suspected vaccination failure/Having both shots you can still get the shingles; Got it in her left eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter reported that even after having both shots anyone can still get the shingles. The reporter's friend was living proof and got shingles in her left eye and still not over them. This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pt recvd 3 Hepatitis-B vax on 26JUL89, 29AUG89, 25JAN90 following these titer=99; one yr later titer=4;
11/28 - pt. agitated, mental changes. 11/30 - wheezing noted in lungs, anxious, shortness of breath. 12/2 - patient moved to Critical Care unit. 12/28/07 Reviewed partial hospital medical records which reveal patient experienced lower abdominal pain x 1 mo & rectal bleed x 2 wks. Admitted 11/26- Developed cough, wheezing & SOB & dx w/hospital acquired bronchopneumonia.  Tx w/IV antibiotics.  Developed (+) c. difficele.  Later in hospitalization dx w/GBS & intubated.  Developed mild acute pancreatitis & ileus. FINAL DX: Guillain Barre syndrome. 2/11/08 Reviewed hospital medical records.  No D/C summary available. Admitted 11/26/2007-2/2/2008 when transferred to inpatient rehab.  Originally admitted for lower abdominal pain & GI bleed & was to have hemicolectomy.  Received flu shot while hospitalized then developed generalized weakness & respiratory distress. Intubated & transferred to ICU.  LE reflexes absent.  Tx w/IVIG x 2 w/some improvement.  Trach done & weaned from vent. FINAL DX: no d/c summary available but transfer H&P states: debility & Guillian Barre syndrome, recovering; hypertensive cardiovascular disese; recent acute respiratory failure s/p trach & ventilation treatment; c. diff, resolved; hypothyroidism; COPD; & generalized anxiety disorder. Patient admitted in Acute Rehab at medical center for physical and occupational therapy. Patient is still very weak. She needs assistance/supervision with walking, grooming, using bedside commode. 1/20/2010 Left with chronic disability. She needs 24 hour care/assistance. She can walk with walker but is very weak. She needs assitance bathing, cleaning, and grooming. She is on PRN Oxygen.  02/03/2010 Patient admitted in rehab for physical and occupationa therapy.
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and genders. On unspecified dates in 2014, doses of RECOMBIVAX HB (Lot# and expired date unspecified) and other vaccines (captured in MARRS 1409USA008659, 1409USA008512, 1409USA006676, 1409USA008510, 1409USA008511, 1409USA008514) were administered to unspecified patients (dose, frequency and route unspecified) after exposed to temperatures of 10 C degree for 37.5 hours/ temperature excursions on 08-AUG-2014, 13-AUG-2014 and 28-AUG-2014. No adverse effect has been reported. This is of the several reports from the same source. Additional information has been requested.
lt deltoid region w/erythema & edema;area measured 7cm x 4cm occurred 2 days p/vax;
It hurts for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: It hurts for 2 days). The outcome of the pain was recovered/resolved (duration 2 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had his/her shingles vaccine before end of December.  It hurted for 2 days, but he/she did not think it was more painful than shingles as described to him/her by a friend. The follow up would not be possible as no contact details were provided.
Inconsolable crying started within 30 minutes of vaccine injections, brief episodes of console. TYLENOL given about 3 - 4 hrs after injections. Crying much improved within 2 hours of TYLENOL. Swaddling helpful.
tiredness; headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in the right arm on 05Mar2021, at 16:30 (at the age of 72 years old) as dose 1, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), failed back surgery, arthritis, and atherosclerotic cardiovascular disease (ASCVD). The patient has no known allergies. He did not receive other vaccines in four weeks before vaccination. The patient received other medications in two weeks prior to vaccination and he reported that they are too many to name. On 07Mar2021, at 18:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. The patient has not recovered from the events.  No follow-up attempts are possible. No further information is expected.
getting a second influenza vaccine this season as it was being offered, despite having gotten an influenza vaccine approximately one month ago, with no reported adverse event; Initial information received  on 18-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age male patient who was getting a second INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] vaccine this season as it was being offered, despite having gotten an influenza vaccine approximately one month ago, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Oct-2022, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation, dose; unknown) (lot number and expiry date: not reported) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, a non-serious event reported, patient was getting a second influenza vaccine this season as it was being offered, despite having gotten an influenza vaccine approximately one month ago, with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain in right arm at injection site.  Symptoms have persisted and worsened.  Aches all night and range of motion is limited.  Taking Advil to see if it will help.  Has not gotten better.
Patient recieved 12+ dose of Pfizer instead 5-11 dose. Parent was notified and not adverse reaction was reported.
has experienced hypertension; This is a spontaneous report from a contactable pharmacist via medical information team. An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Since receiving the Pfizer COVID vaccine on an unspecified date, the patient experienced hypertension. The cardiologist ruled out other possible causes and wanted to know if the vaccine was the cause. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial case was received from a health care professional on 03 October 2013. A 72 year male patient had no medical history reported, received a dose of FLUZONE HD vaccine intramuscularly on 30 September 2013 (batch number not reported). Patient had not reported concomitant medication. It was reported that on 30 September 2013 patient experienced red like sunburn on arms, trunk, groin and back pain. No corrective treatment was reported. At the time of report the outcome was recovered.
Woke up with severe rash, hives.  Extreme itching with welts appearing as she was scratching them.  Tried over the counter itch relief cream, no relief. Took her to ER at app 9:30 pm.  Benadryl prescribed. Got relief in the early hours of Sun 5/29/2011.
sharp stomach pain/really sharp stomach pains; back pain/back pains intermittently; sweating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 01Mar2021 14:30 (Batch/Lot number: unknown) at the age of 29 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION taken for depression, start date: Dec2020 (ongoing); VIENVA taken for contraception, start date: 2019 (ongoing). Vaccination history included: Bnt162b2 (Dose 1; Dose: 0.3mL injection to the left arm at 14:30), administration date: 10Feb2021, when the patient was 29 years old, for covid-19 immunisation. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "not recovered", described as "sharp stomach pain/really sharp stomach pains"; BACK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "back pain/back pains intermittently"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "unknown", described as "sweating". Additional information: The reporter was the patient's husband. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on the same day of vaccination. The events come and go but usually occur early in the mornings at around 04:00. The events did not result in an emergency room/physician office visit or hospitalization. No relevant tests were performed. The reporter would like to know if there are any recommendations on what to do to lessen the symptoms (remedies or anything to make her feel better).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day of vaccine 3 -4 hours after receiving the vaccine, I began feeling tingling in my right arm, progressed to numbness and extreme pain in the shoulder. I have been having weakness and it hurts to use it. Headaches on the right side of head, around ear.  Facial drooping began , I was then taken to the hospital and was placed on stroke watch. I was then cleared of a stroke and sent home. I followed up with Dr.,  who has diagnosed me with having bells palsy. It has been over a week and I am still having trouble with my speech which is pretty noticeable.  I am having short term memory.
Dizziness 6:00 pm two hrs after administration 3:45 AM- 100.3 fever, muscle aches, chills, fatigue  Symptoms came and went through out the day. Toward the end of the day: muscle cramping in hands/fingers; tingling in left hand/fingers
Jaw pain in my lower left jaw that feels like I had a tooth extracted. My teeth are fine. It hurts to open my mouth fully. The pain started about 3 hours after receiving the vaccine
Pain went away several days after injection on the 20th, but pain has returned and with swelling of my upper arm.
Information has been received from a registered pharmacist concerning a female patient in her "70s" who in approximately February 2012, was vaccinated with a dose of 0.65 mL ZOSTAVAX (Merck) (Lot# not reported) subcutaneously. In approximately February 2012, the patient experienced dizziness and chest-tightening after being vaccinated with ZOSTAVAX (Merck) and was hospitalized in an unspecified  hospital (duration and location unspecified). The patient was anxious before getting the vaccination. The AE was improved on therapy. Subsequently, the patient recovered from dizziness and chest-tightening on an unspecified date. Additional information has been requested.
Pt recvd 3 doses of Engerix-B on 9APR90, 7MAY90, & 29OCT90 & was found to be a non-responder;