chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrific rash on both legs; Itched so bad, still itch; Scratched all night, reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced rash (Verbatim: Terrific rash on both legs), pruritus (Verbatim: Itched so bad, still itch) and scratch (Verbatim: Scratched all night, reaction). The outcome of the rash and scratch were not reported and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the rash, pruritus and scratch to be related to Shingles vaccine.     It was unknown if the company considered the rash, pruritus and scratch to be related to Shingles vaccine.   Additional Information: GSK Receipt date- 06-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the first of the two shingles vaccine and within two days she had a terrific rash on both legs from the knees down that itched so bad that she scratched all night. The patient stated that so intense that it woke her husband. A few days later was in his (patient's husband's) office with her husband and told him about the reaction.  The patient's husband replied that the patient would not be getting the second vaccine. The months later the patient's legs still itch but not as much.  There needs to be more research done on the vaccine. The follow-up could not be possible as no contact details were available. As per the reported verbatim,'So intense that it woke my husband,' patient's gender was coded as female.
High-grade fever of 103F, 1 hours, post vax, and crying a lot.
17 days post vaccination as the first step in prep for a colonoscopy I experienced a reaction to the laxative Miralax, a 17 gram dose. First sneezing, the a flushed feeling accompanied by tingling and itching in hands and feet, the swelling of the lips, nose and tongue. The flushed feeling turned into a cold sweat and shaking.  These symptoms started within 20-25 minutes from ingesting the Miralax and lasted for about an hour and 30 minutes before they began to subside. The puffiness and some pain continued in my face until after midnight, the Miralax was taken approximately 5:45pm I cannot say for certain whether I have ever taken Miralax before, I think so as prep for another colonoscopy over 10 years ago but not certain on that. I am reporting this per my doctor's request.
Attendee voiced his reaction to his vaccine. There were complaints of lightheadedness and tingling sensation in lower extremities.
Inability to move L arm due to pain.  Experiencing SOB - pt reports this is due to pain.  Vaccine  administered through public health event at vaccination site.  Seen in office on 4/27 - no edema, erythema, warmth at vaccine site.  EDC mid June
95.4 body temp, grogginess, confusion, fatigue, headaches, confusion, irritation, lack of appetite, lethargic
Patient presented to ED twice and was then admitted within 6 weeks of receiving COVID vaccination. Patient presented to the ED on 3/4/21, 3/30/21 and admitted 3/30/21.
Sore throat; Cough; Fever; Nausea; Migraine headache; Can't turn eyes left or right; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache), EYE MOVEMENT DISORDER (Can't turn eyes left or right), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough) and PYREXIA (Fever) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced MIGRAINE (Migraine headache), EYE MOVEMENT DISORDER (Can't turn eyes left or right), PYREXIA (Fever) and NAUSEA (Nausea). On 30-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing since an unknown date at an unspecified dose and frequency. On 27-Mar-2021, PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, MIGRAINE (Migraine headache) and EYE MOVEMENT DISORDER (Can't turn eyes left or right) had not resolved and OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Currently 25 weeks pregnant. COVID positive on Jan 5th after exposure to asymptomatic contact. Developed COVID symptoms on January 4th with light dry cough and progressed on the 5th to fevers/chills etc. Jan 8th noticed wheals and itchiness at injection site.  Persistent until today - mild in severity but continuous. Taking benadryl PO and topical cortisone.
Fatigue,  arm swelling and pain at injection site, fever, chills, body pain, headache, neck pain, rash on arm of injection
Tinnitus in both ears; Feeling of fullness in head; ears aching; mild vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Feb2021 13:00 (Lot number: EL9264) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EL1283 at 13:00 in right arm as dose 1, single), administration date: 14Jan2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Tinnitus in both ears", "brain fog", "mild nausea". The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "Tinnitus in both ears"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "Feeling of fullness in head"; EAR PAIN (non-serious) with onset 2021, outcome "not recovered", described as "ears aching"; VERTIGO (non-serious) with onset 2021, outcome "not recovered", described as "mild vertigo". The events "tinnitus in both ears", "feeling of fullness in head", "ears aching" and "mild vertigo" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, head discomfort, ear pain, vertigo.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. The patient received treatment to the events which included flonase (FLUTICASONE) nasal spray.  No follow-up attempts are possible. No further information is expected.
MMR was given 12JAN95, report from mom of t101 on 21JAN95;rash appeared on 22JAN95 described (by mom) as little red dots on trunk, faded & almost gone by 25JAN95;
Spoke with Patient and he was in on Monday and received Prevnar 20 and Shingrix (#1). He felt puny as expected on Monday and Tuesday, but today he felt horrible--emesis x 3, hands swollen (still swollen and not able to make a fist), red spotted rash all over his body, and feeling of throat swelling. His co-workers took him to Hospital and he was given the following medications:  Benadryl Pepcid Prednisolone Epi-Pen--he was advised that if this happens again it could be much worse
Fever for 3 - 4days. Headache  Crying...not eating.  Angry all the time. Screamimg. Very very angry
Had local reaction to PREVNAR 13 consisting of pain, redness and induration that lasted 6 days. No systemic symptoms such as fever and chills.
Mom reports fever of 103F for 24 hours. Mom reports pain at site of injection. Tylenol was given around the clock with no help noted.
Contact-like rash 11cmx5cm surrounding vaccine injection site - erythematous papules, no tenderness, slight edema.
Initial reports were received on 01 December 2009 from the patient's parent and a physician. A 4-year-old female patient, who has "OCD" (obsessive-compulsive disorder) received a dose of FLUZONE SV (lot number not reported) on 20 October 2009; and a month later received a dose of H1N1 (lot number UP031AA) on 20 November 2009. The patient has history of questionable seasonal allergy, but no drug allergy. Illness at the time of vaccination was not reported. The patient has not experienced any adverse events with vaccinations in the past. Approximately 2-3 days after receiving the H1N1, the patient's mother called to report the patient had increased OCD symptoms and she took her to a psychologist and talked to a pediatrician several times. No diagnostic tests or laboratory data were performed. At the time of this report, it was unknown if the patient had returned to baseline. List of Documents held by Sender: none.
16 year old patient received FLUBLOK with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via agency (Reference number- 00817382) and transmitted to Sanofi on 18-Oct-2021.  This case involves a 16-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [Product administered to patient of inappropriate age].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 18-Oct-2021, the patient received a 0.5 mL first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QSAA2136, expiry: 30-Jun-2022, formulation: Solution for injection in pre-filled syringe) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported "Certified Medical Assistant (CMA) calling in regards to FLUBLOK. Caller would like safety information for FLUBLOK given to patients under 18 years of age. Caller would like to know if there are any adverse reactions/safety issues."  No other adverse event was reported.  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.
Within 10 min of vaccine, was nursing quietly when began having arm shaking. This progressed to total body shaking, lasting < 30 sec. Sleepy for about 5-10 min afterwards, then back to normal self. No further adverse events.
Fully vaccinated patient with incidental COVID detected test.  Provider d/c note:   "77 YO ambidextrous female who presented 7/20/2022  2:40 PM to HCF after primary admission to the local Hospital after a fall at the train station on 7/14.  She says she is unsure why she fell, but that she may have gotten tripped in the escalator, and that she fell down the escalator hitting her head and suffering an LOC.   She was found to have a Left frontal IPH within a subdural hematoma.  MRI showed an incidental small right cerebellar cva.     She noted fluctuating speech ability (word fining and aphasia both). She had intermittent HAs which are improving.     She was found to have asymptomatic, incidental COVID 19 infection. She continued to have no symptoms and was removed from isolation at 10 days.    She was noted to have vertigo secondary to her TBI, she will follow with outpatient PT for vestibular therapy.    She was continued on Keppra for seizure like symptoms that occurred while she was hospitalized.    On 7/24 she had a repeat CT head for R hand and R facial numbness and temporary confusion. Her symptoms quickly resolved. CT Head re demonstrated ""a 19 mm hyperdense hemorrhage with rim of low attenuation edema in the left frontal lobe just anterior to the sylvian fissure. There is mild mass effect on the adjacent parenchyma. No additional areas of hemorrhage or acute ischemic infarct. No extra-axial fluid collection. No hydrocephalus."" This imaging re demonstrates her known L frontal IPH, Most recent CT head from HCF, ""A focus of acute hemorrhage within the posterior aspect of the left frontal lobe currently measures 3.8 x 1.0 x 1.8 cm. There is a rim of surrounding parenchymal edema as well as mild localized mass effect.""    She will need to follow up with Neurology in 3 weeks for her small R cerebellar CVA, traumatic L frontal IPH, and post traumatic seizures. "
3-4 DAYS AFTER INFLUENZA VACCINATION IN LEFT ARM, PATIENT DEVELOPED STIFFNESS IN ELBOW THAT SHE RELATED TO THE SAME AREA OF A BLOOD DRAW AT THAT LOCATION 2 WEEKS BEFORE FLU SHOT. SHE SAID THAT SHE COULD NOT BEND ELBOW IN THE MORNING FOR SEVERAL DAYS UPON WAKENING UNLESS SHE PUSHED HER FINGER HARD INTO THE INSIDE OF ELBOW. BY TODAY, SHE SAID THAT IT IS GETTING BETTER, BUT STILL STIFF. NO REDNESS, SWELLING OR OTHER SIGN OF REACTION. SHE HAS NOT CONSULTED WITH HER DOCTORS. SHE DENIES THAT IT IS RELATED TO HER NEUROLOGICAL PROBLEM.
No additional adverse effects reported; One improperly stored dose of VAQTA was administered to the patient; This spontaneous report was received from a medical assistant referring to an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On 23-APR-2020, the patient was vaccinated with in improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date of 17-OCT-2020 (dose, route, and anatomical location were not provided), for prophylaxis. No adverse effects were reported.  The reporter stated that the vaccine experienced a temperature excursion of 68.58 F during 9 hours and 41 minutes. A previous excursion occurred with a temperature of 46.1 F during 7 minutes. No digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S025993; expirationdate: 17-OCT-2020; 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
Headache; Hurting left arm at injection; Tired feeling; 2nd dose taken after 90 days as recommended; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose taken after 90 days as recommended), HEADACHE (Headache), VACCINATION SITE PAIN (Hurting left arm at injection) and FATIGUE (Tired feeling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007A21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose taken after 90 days as recommended). On an unknown date, the patient experienced HEADACHE (Headache), VACCINATION SITE PAIN (Hurting left arm at injection) and FATIGUE (Tired feeling). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose taken after 90 days as recommended) had resolved. At the time of the report, HEADACHE (Headache), VACCINATION SITE PAIN (Hurting left arm at injection) and FATIGUE (Tired feeling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: (Positive) tested positive.         Concomitant product use was not provided by the reporter. Treatment information was not provided. .   This case was linked to MOD-2021-026867 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Patient demographics updated, 2nd dose information updated  and  events updated.
Our nurse accidentally gave the patient a proquad and a varicella not realizing the proquad was a combo vaccine.  the patient received an extra dose of varicella.  patient had no reactions that were reported
reoccurring shingles affecting his right eye; postherpetic neuralgia; diagnosed with recurrent shingles; This spontaneous report was received from a lawyer, referring to a patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In or around 01-JAN-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, shortly after receiving the vaccine, the patient suffered reoccurring shingles affecting his right eye and the right side of the face and head (ophthalmic herpes zoster). Plaintiff was diagnosed with recurrent shingles at various times and postherpetic neuralgia.   As a direct and proximate result the patient experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition, severe, incurable and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury.  The events were assessed as disabling and ophthalmic herpes zoster was considered as medically significant.
Extreme fatigue, Chest pain (daily for two weeks after first shot, not when breathing), sore arm, extreme chills 3 days after first dose, foggy train of thoughts.
Pt has severe headache and was admitted to hospital several occasions at ER after not sure if related to vaccination.  5/26/09 medical records received - multiple ED visits DOS 11/5/08 to 11/28/08. FINAL DIAGNOSIS: Headache, dyspnea Post vaccination presented with headache, myalgia, weakness, fever, chills, nausea, photophobia. Neck pain, Kernig's sign. Odd flat aspect. Elevated intracranial pressure.  Transferred to another ER and diagnosed with a 'viral' illness. Several days later fell at home c/o headache, neck pain, abdominal pain, chest pain, and making choking noises. Body aches and muscle crampiing. Nasal congestion. Mumbling. Admitted to hospital. Subsequent ED visit presenting with headache and dyspnea. Neurology referral pending.
Vertigo; This is a spontaneous report from a contactable consumer for himself.   A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The lot number was illegible and looked like EN6207 and did not clarify which COVID vaccine the lot number was for.  Medical history included tinnitus, where he heard his heartbeat pulse in his ear and hadn't been any improvement in the tinnitus during the check up in last week as of the report. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at age of 44 years old for covid-19 immunisation. The patient's concomitant medications were not reported.  The patient experienced vertigo on 14Apr2021 like he hasn't had before. He did not know if it could be a coincidence that he was experiencing the vertigo after the vaccine on Tuesday(unknown date) or if it was a symptom of the tinnitus he sometimes experiences, his primary care doctor said that vertigo was a symptom of the vaccine.  Vertigo was worse today(15Apr2021) than it was yesterday 14Apr2021, yesterday he had the vertigo for about 5-10 minutes then was fine after the morning. He was sleeping last night and woke up with symptoms of vertigo in the middle of the night. The symptoms are worse today 15Apr2021. Outcome of event was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Got shot about 1:30 pm.  Approximately 12 hours later was awaken because I was freezing (chills), and exploding pain in left arm pit, and a fever of 103.  All glands swollen and painful, where they were  all visible.  All Tuesday, I was flat on my back unable to function physically or mentally.  Was sick until Wednesday when fever broke from taking medication for fever, DayQuil.  Wednesday night I had to put towels under and  above my because I was sweating profusely all night with soaked bedding.  Thursday, I was very tired and felt weak.   My glands are still swollen.  When I went to get second shot today, Pharmacy said I needed to go see a doctor and they would not give me the second shot.  I did have Covid at the end of February 2021, but it never went into my lungs where I had respiratory problems.  Should I not have second shot?  Now what?
Very weak; Trouble breathing; Fever; Very nauseous; Shaky; Kind of dizzy; Bad headache; Muscle ache/ full on body ache; Fatigue (couldn't do anything but sit on the couch)/ very tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), TREMOR (Shaky), ASTHENIA (Very weak), DIZZINESS (Kind of dizzy) and HEADACHE (Bad headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced TREMOR (Shaky), HEADACHE (Bad headache), MYALGIA (Muscle ache/ full on body ache) and FATIGUE (Fatigue (couldn't do anything but sit on the couch)/ very tired). 09-Mar-2021, the patient experienced DIZZINESS (Kind of dizzy). On 14-Mar-2021, the patient experienced DYSPNOEA (Trouble breathing), ASTHENIA (Very weak), PYREXIA (Fever) and NAUSEA (Very nauseous). At the time of the report, DYSPNOEA (Trouble breathing), TREMOR (Shaky), ASTHENIA (Very weak), DIZZINESS (Kind of dizzy), HEADACHE (Bad headache), MYALGIA (Muscle ache/ full on body ache), FATIGUE (Fatigue (couldn't do anything but sit on the couch)/ very tired), PYREXIA (Fever) and NAUSEA (Very nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  On 09-Mar-2021, the patient had muscle aches and on 14-Mar-2021, the patient felt full on body ache. She did not take any medication for her symptoms. All symptoms were still present at the time of reporting. No other treatment information was provided.