chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; Flublok given to 7 yr; Initial information was received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves 7 years old female patient who experienced sore throat while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Sep-2022, the patient received suspect influenza quadrivalent recombinant vaccine (lot UJ887AA) (strength, form, dose, frequency, expiry date: unknown) via intramuscular route in unknown administration site for influenza and experienced sore throat (oropharyngeal pain) and (product use issue) (latency: same day).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered on 21-Sep-2022 for the event sore throat and was Unknown for the event flublok given to 7 yr.  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.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 18-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt presented to clinic on 10/11/2022 for Twinrix #2.  At this visit, pt reported feeling a "searing pain" in R shoulder during vaccine administration on 09/ 08/2022.  Pt received four vaccines at visit on 09/08/2022 (Twinrix, flu, COVID-19 booster, and Typhoid).  Twinrix and annual flu administered in pt's R deltoid.  Pt unsure whether Twinrix or annual flu caused pain during administration; reports that he thinks it was Twinrix due to the volume injected.  Pt reported feeling "normal soreness" for "about a week" after vaccination, then states feeling increased pain and decreased ROM in R shoulder.  Pt reported following-up with PCMP.  Per pt, PCMP advised pt to take ibuprofen PRN and apply warm compresses to affected site; pt denies improvement or resolution of sx with these interventions.  Per pt, pain and decreased ROM in R shoulder have neither improved nor worsened since sx onsent.
1st A-Fib Event:    Tue 9/27/22 8:30am after 90 min of morning errands and a quick bite to eat, up and down 2 flights of stairs, turned around to close a door and felt dizzy.  Got water and sat down. Checked heart with watch. While resting, after 2 failed attempts for ECG (due to high heart rate) watch advised I was in Atrial Fibrillation BPM 120-140+.  Went to Urgent Care. They hooked me up to heart monitor, confirmed AFIB and immediately ordered ambulance for transport to ED.  Started fluids before ride. Transferred to ED, had blood taken and brief consult with Cardio  who advised going to try get me in for Echocardiogram before a cardioversion ay 4:30 (8 hours after I last ate).
Began feeling cold later in the afternoon and could not get warm.  By 7 PM went to bed with chills, fever which when taken later in the night was 100.8 degrees.  Fever broke in morning but followed with sore throat, coughing, hoarse voice which continues at this writing 10/25/2014 at approximately 8 AM.  I have not sought medical care at this point but felt as though this was extreme enough to report.  If I do need to seek medical assistance within the next few days, I will send a follow up report.
This spontaneous report was received from a medical assistant regarding 3 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL (confirmed not GARDASIL 9). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
the second dose given early on 29Aug2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 56-year-old female patient who received HAV (Havrix) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 29-AUG-2023, the patient received the 2nd dose of Havrix. On 29-AUG-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: the second dose given early on 29Aug2023).  The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-AUG-2023 The reporter was a practice manager. The patient was given her second dose yesterday (day before reporting). The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received the 2nd dose of Havrix before recommended schedule, which led to shortening of vaccination schedule.
pt recvd vaax 4OCT94 & the next day exp facial flushing, temp elevation to 99.6, chills, weakness & swelling in the rt axilla & in both groins;
Severe chills, starting at 7:08 PM lasting well into the night.  Fever lasting a couple days.  General fatigue
Employee became diaphoretic, complained of SOB and tingling from the feet up to her head. She was hypertensive at 159/105, and tachycardic at 115.
All over body stiffness including jaw.  Painful musclature  Hands swollen and unable function  All over body pain
I had nasal congestion, sneezing, coughing and this is all minor. The worst thing was seeing the positive result. I ended up doing a video health meeting and received a prescription of Paxlovid.
Pt was given H1N1 Im @ 8:50am - she cares for infant - no adverse reaction - observed for 15 min. Then she said as she held her neck " I don't feel well" she asked for water. BENADRYL given. She was alert, pale. BP 134/100 P. 68. Ambulance called. She said she has anxiety she did not need hospitalization. BP 140/80 - color returned. After 30 min she was able to leave on her own.
PATIENT WAS ADMINISTERED A SECOND DOSE OF ROTOTEQ AT 11 MONTHS OF AGE
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 65 years old female patient with high cholesterol, osteopenia, gastrooesophageal reflux disease (GERD), arthritis, asthma, anemia, postherpetic neuralgia and allergy to codeine. On 24-AUG-2012 the patient was vaccinated IM with a dose of PNEUMOVAX23 (lot # reported as 0653AE, exp. date: 10-FEB-2014). Concomitant medications included aspirin, vitamin D (unspecified), ALLEGRA, NITROSTAT, PRILOSEC, NEURONTIN, omega-3 marine triglycerides, PRAVACHOL and EFFEXOR. On 25-AUG-2012 the patient developed redness, swelling and rash at the site of injection. Also, she developed lymph node pain in the underarm area of the arm that received the injection. No treatment was given for the adverse event. No lab diagnostics studies performed. The patient did not seek medical attention. The patient recovered completely on 28-AUG-2012. Additional information has been requested.
Vaccine expiration date was June 6, 2022. It was not pulled from stock and mistakenly given to patient on 11/14/22. No adverse events observed. Provider was notified and patient will be rescheduled to repeat dose.
nerve pain that travels to the left elbow; hot left bicep muscle that improved somewhat, but worsened when they got their second dose; leftover marble-sized knot on the injection site; noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve pain that travels to the left elbow), VACCINATION SITE WARMTH (hot left bicep muscle that improved somewhat, but worsened when they got their second dose), VACCINATION SITE MASS (leftover marble-sized knot on the injection site) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (nerve pain that travels to the left elbow), VACCINATION SITE WARMTH (hot left bicep muscle that improved somewhat, but worsened when they got their second dose), VACCINATION SITE MASS (leftover marble-sized knot on the injection site) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose). At the time of the report, NEURALGIA (nerve pain that travels to the left elbow) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose) had not resolved and VACCINATION SITE WARMTH (hot left bicep muscle that improved somewhat, but worsened when they got their second dose) and VACCINATION SITE MASS (leftover marble-sized knot on the injection site) outcome was unknown.            Treatment information not provided   This case was linked to MOD-2021-098836 (Patient Link).   Reporter did not allow further contact
fever; Sore arm; body aches; headache; chills; Administration date=09Jan2021/Administration date=21Dec2020; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received second dose of BNT162B2 (Pfizer, lot number: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (lot number: E51685) in left arm on 21Dec2020 13:45 for COVID-19 immunization. On 10Jan2021 07:00, patient experienced sore arm, body aches, headache, chills, and fever. Treatment was not received for these events. Patient was not recovered from these events.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated intramuscularly with the first and second 0.5 ml dose of GARDASIL respectively on 18-AUG-2011 and 23-AUG-2012 (Lot# not reported). No adverse effects reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Pain at injection site lasted 24 hrs; MAJOR INSOMNIA NIGHT AFTER VACCINE COULD NOT FALL ASLEEP; Mild headache; Chills; Lack of appetite; Fatigue; This spontaneous report received from a physician concerned a patient of unspecified age and sex. 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: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced pain at injection site lasted 24 hrs, major insomnia night after vaccine could not fall asleep, mild headache, chills, lack of appetite, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at injection site lasted 24 hrs, major insomnia night after vaccine could not fall asleep, mild headache, chills, lack of appetite and fatigue was not reported. This report was non-serious.
Delayed onset reaction at injection site. Started with erythema, swelling, extremely hot skin. Area increased in size for several days and covered most of upper arm. Was painful...woke me up during sleep when I rolled over on it. I applied cold compresses. I have a in nursing. I know a reaction when I see one!
Headache that evening; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache that evening) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy (Allergic to oysters and gets hives when eating oysters.). Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced HEADACHE (Headache that evening). On 25-Apr-2021, HEADACHE (Headache that evening) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported by reporter.
sore, warm, redness, soreness, tenderness, itchiness Keep skin cool and dry.  May do cool compresses Aveeno oatmeal bath/lotion Start medrol today, follow instructions Benadryl/zyrtec as needed for breakthrough itching Topical hydrocortisone as needed Follow up if symptoms worsen or persist Advised to not take second vaccine
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had acute illnesses and chronic and long standing health conditions.     On 06-Feb-2022 at 1:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 1:14 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine went into 2 to 8 degree Celsius in thaw state on or about 24 Dec 2021.This vaccine was administered up until its Mfg Exp date of 04-Apr-2022. Vaccine administration time was reported as 13:14:48. The patient received the additional dose.  No concomitant product reported by reporter.  No treatment medication reported by reporter.   This case was linked to MOD-2022-542869 (Patient Link).
They have got a little worse; sore throat; watery eyes; being congested; runny nose; tired / fatigue; back hurt; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (They have got a little worse), BACK PAIN (back hurt), OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes) and NASAL CONGESTION (being congested) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088DZ1A and 0910Z1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, VITAMINS NOS and PROBIOTICS NOS for an unknown indication.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced BACK PAIN (back hurt) and FATIGUE (tired / fatigue). On 10-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes), NASAL CONGESTION (being congested) and RHINORRHOEA (runny nose). On an unknown date, the patient experienced CONDITION AGGRAVATED (They have got a little worse). The patient was treated with PARACETAMOL (TYLENOL) on 11-Aug-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (They have got a little worse) outcome was unknown and BACK PAIN (back hurt), OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes), NASAL CONGESTION (being congested), RHINORRHOEA (runny nose) and FATIGUE (tired / fatigue) had not resolved.            Patient enquired if the symptoms she was experiencing were normal and were there any recommendations for treatment.
This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerning a 63-year-old, adult male patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported). The patient received the expired dose of the product, which was considered as expired vaccine used. The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 4/13/2023 BLURRED VISION ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/12/2023 BLURRED VISION ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 4/13/2023 WEAKNESS ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/12/2023 WEAKNESS
only ones that ended up with dementia; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had only ones that ended up with dementia while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious only ones that ended up with dementia (dementia) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (only ones that ended up with dementia).  At time of reporting, the outcome was Unknown for the event only ones that ended up with dementia.; Sender's Comments: Sanofi company comment dated 17-Jan-2022: This case involves an unknown age female patient who had only ones that ended up with dementia while receiving vaccine INFLUENZA VACCINE. lack of information regarding event details, medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
MUSCLE SPASM; BURNING SENSATION STARTS LIKE BEING ON FIRE; TINGLING; TENDERNESS MOVED DOWN TO ELBOW AND BELOW IT; LITTLE WARM TO TOUCH; FEELS LIKE SOMETHING IS IN IT LIKE A BB-GUN; INJECTED ARM TENDER TO TOUCH /INJECTION SITE SORENESS; BUMPS; NAUSEA; HEADACHE; FATIGUE; ARM SORENESS; BODY ACHE /HURTS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included seizure, and migraine, and concurrent conditions included allergic to bees, non-alcohol user, non-smoker, allergic to wasps, penicillin allergy, and allergic to sulfa drugs, and other pre-existing medical conditions included no drug abuse or illicit drug usage. patient is allergic to seizure and pain medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced body ache /hurts. On 11-MAY-2021, the subject experienced arm soreness. On 11-MAY-2021, the subject experienced nausea. On 11-MAY-2021, the subject experienced headache. On 11-MAY-2021, the subject experienced fatigue. On 16-MAY-2021, the subject experienced little warm to touch. On 16-MAY-2021, the subject experienced feels like something is in it like a bb-gun. On 16-MAY-2021, the subject experienced bumps. On 16-MAY-2021, the subject experienced injected arm tender to touch /injection site soreness. On 17-MAY-2021, the subject experienced tenderness moved down to elbow and below it. On 17-MAY-2021, the subject experienced muscle spasm. On 17-MAY-2021, the subject experienced burning sensation starts like being on fire. On 17-MAY-2021, the subject experienced tingling. Treatment medications (dates unspecified) included: ibuprofen, menthol, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache /hurts, nausea, headache, and fatigue on 15-MAY-2021, and had not recovered from injected arm tender to touch /injection site soreness, little warm to touch, feels like something is in it like a bb-gun, muscle spasm, burning sensation starts like being on fire, bumps, arm soreness, tingling, and tenderness moved down to elbow and below it. This report was non-serious.
Loss of hearing on left ear completely to the point of vertigo symptoms; only 80 percent of hearing has returned despite going to doctor and using ear drops; development of Tinnitus since 80 percent of hearing returned.
Vaccinator injected the needle in the upper area of the Deltoid muscle, not in the mid muscle. I am unable to have any ROM in the right arm with pain on the top area of my shoulder radiating into the neck, as wells radiating down the right arm
SADDLE PE IN BOTH LUNGS  ELIQUIS-HEPARIN-TPA SURGERY TO BUST UP CLOTS
This spontaneous report as received from a registered nurse refers to herself a 55 years old female patient with no drug reaction or allergies, and no pertinent medical history. The patient was vaccinated intramuscularly with a dose of ZOSTAVAX (Lot # and dose not reported) on 18-OCT-2012. There were no concomitant medications. The next day on 19-OCT-2012 the patient experienced a little tenderness which lasted about 2-3 days. The patient did not seek for medical attention. No treatment information was given. No lab diagnostic studies were performed. On approximately 22-OCT-2012 patient recovered. This is one of several reports received from a same reporter. Additional information has been requested.