chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Tingling in fingers and foot-Medium, Systemic: Nausea-Medium, Additional Details: Paramedics were called to assess patient and because she didn't have difficulty breathing she decided not to go with them. her husband came and she said he would take her to urgent care.
Patient was given initial dose of ROTARIX @ 28 weeks.  Then follow up dose 4 weeks later was given.  However ROTATEQ was given at that point.
Mom c/o spots and itching around site and upper arm post injection. No pustuals or drainage. Second Hep B was deferred by dr.
Fever, body chills, muscle spasm, headache Treatment was rest, naproxen, cold pack on neck for fever.  Most symptoms subsided by 8 am 3/8/21 except joint pain and flu like muscle ache.
FLUZONE administered to a 60 year old when it is approved for 65 years and older.
sore at injection site; This is a spontaneous report from a non-contactable consumer reporting for a patient. This 53-year-old male received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on an unknown date (at the age of 53-years) as single dose, at unspecified route of administration for immunization. Medical history was unknown.  Allergies were unknown. Concomitant drugs were unknown. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19.  It was unknown if the patient received any other vaccines within 4 weeks prior to BNT162B2.  On an unspecified date, the patient experienced 'sore at injection site'.  It was unknown if the patient received treatment as a result of the event.  The outcome of event 'sore at injection site' was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large bruise on mid-lower left arm. Burns and tingles. Painful. Warm to touch.
No additional adverse event reported; Caller reports an expired dose of PROQUAD was administered to a patient yesterday; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 01-SEP-2021, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported) lot number T007395 (rHA) and expiration date 29-AUG-2021, administered as prophylaxis.  No additional adverse events were reported.
SEVERE LYMPH NODE SWELLING AND PAIN UNDER LEFT ARM. INTERMITTENT NUMBNESS AND TINGLING OF LEFT HAND.  PAIN IS WORSE ON MOVEMENT AND PALPATION. PAIN IS RELIEVED WITH OVER THE COUNTER PAIN MEDICATIONS.
Bell's palsy; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a clinic for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician at a clinic for Bell's palsy. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of Bell's palsy to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was determined to be medically significant.
Pt received 2 month vaccines. Came in the following day with a rash all over his body. -Called mother on July 26th, Mother stated baby is better and no longer has a rash.
Patient was inadvertently given second covid vaccine 20 days after first dose instead of manufacturer recommended 21 days separation.
Arterial fibrillation; Blood in stool for one time event after the 1st dose; Very very rapid heart beat after the 1st dose/ Increased heart rate that she can hear her heart beat sound after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool for one time event after the 1st dose) and ATRIAL FIBRILLATION (Arterial fibrillation) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HYDROCHLOROTHIAZIDE) and ROSUVASTATIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEART RATE INCREASED (Very very rapid heart beat after the 1st dose/ Increased heart rate that she can hear her heart beat sound after the 1st dose). On 31-Mar-2021, the patient experienced HAEMATOCHEZIA (Blood in stool for one time event after the 1st dose) (seriousness criterion medically significant). On an unknown date, the patient experienced ATRIAL FIBRILLATION (Arterial fibrillation) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) (oral) on 28-May-2021 at a dose of UNK UNK, bid. On 31-Mar-2021, HAEMATOCHEZIA (Blood in stool for one time event after the 1st dose) had resolved. On 21-Apr-2021, HEART RATE INCREASED (Very very rapid heart beat after the 1st dose/ Increased heart rate that she can hear her heart beat sound after the 1st dose) had resolved. At the time of the report, ATRIAL FIBRILLATION (Arterial fibrillation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had never experienced any heart trouble before. The patient was referred to a cardiologist. The patient was scheduled for an echocardiogram (ECHO) and a positron emission tomography (PETSCAN).  Company Comment   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.   This case was linked to MOD-2021-216160 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received: updated information since patient was scheduled for ECHO and PET scan by cardiologist.; Sender'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.
Seizure and loss of consciousness 30-45 minutes after Tdap & MCV 4 pt. was taken by ambulance to medical center. CT scan of brain negative.
Extreme pain at injection site beginning 2-3 hours after injection. Significant discomfort for 3+ weeks at injection site.  Unhealed lesion at injection site two months later
Loss of appetite; Severe headache; Fever of 103.8; Left underarm lymph node swollen to the size of an egg; Joint pain; Injection site swell up to the sizeof my hand; Very fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 53-years-old) as a single dose, for COVID-19 immunisation. Medical history included asthma, high blood pressure, osteoarthritis and overweight. Concomitant medications included tiotropium bromide monohydrate (SPIRIVA RESPIMAT), budesonide, formoterol fumarate (SYMBICORT), meloxicam (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN); all for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 02Mar2021 at 15:00 (at the age of 53-year-old) as a single dose, for COVID-19 immunisation. The patient had a history of allergy to tree nuts. The patient did not receive any other vaccine in four weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 04:15, within 24 hours the patient had fever of 103.8 (unspecified units), left underarm lymph node swollen to the size of an egg, severe headache, joint pain, injection site swollen up to the size of hand, loss of appetite and had very fatigue. The patient reported that after 48 hours, body temperature went down to 101.6 (unspecified units) everything else the same. It was reported that on day 3, the body temperature of the patient had reduced to 100.5, appetite came back, still had some fatigue, joint pain reduced, lymph node still swollen and very painful, injection site still size of hand. The patient did not receive any treatment for reported events. The clinical outcome of the event loss of appetite was resolved on 25Mar2021 while the clinical outcome of the events fever of 103.8, left underarm lymph node swollen to the size of an egg, severe headache, joint pain, injection site swollen up to the size of hand and very fatigue was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recv vax 13MAR96 & describes episode of crying w/onset 3hr p/vax;4hr high pitched cont unconsolable crying followed by 3 more hr cnt cry still high pitched but not as high;jerking motions 2-4hr p/crying started;t103ax & 2hr given APAP
Fever; chills; headache; muscle aches; joint pain; nausea; unable to sleep; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 22Mar2021 at 08:45 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid, hypertension and hypercholesterolemia. The patient had a history of allergy to doxycycline, fragrance, pollen and grasses. Concomitant medication included levothyroxine sodium (SYNTHROID), simvastatin (UNKNOWN MANUFACTURER), metoprolol (UNKNOWN MANUFACTURER) and cetirizine hydrochloride (ZYRETEC) and iron (UNKNOWN MANUFACTURER) all for unknown indication received within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration on 01Mar2021 at 09:00 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 18:00, the patient experienced fever (101.5) (unspecified units), chills, headache, muscle aches, joint pain, nausea and unable to sleep. The patient did not receive treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever (101.5), chills, headache, muscle aches, joint pain, nausea and unable to sleep was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient reported flu-like symptoms of chills, fever, cough.  All symptoms resolved on Saturday 3/12/16 except for the cough which patient reports still having on 3/15/16.
4/1/06; was the date mother states child started "breaking out in hives". States she took him to ER and ER physician gave her prescription for EPI PEN  Foux at home.
Severe chills/rigors, fevers up to 102.8, extreme weakness during the night.  Unable to stand or walk the next day.  via ambulance to ER on afternoon of 9/9/2021.  Four days in hospital.
Patient was administered influenza vaccine.  Immediately following, patient had facial swelling, especially around her eyes and right area of neck.  Patient was administered 20mg IV dexamethasone.
Mom called @12:30 am 5/22/2009 stating child have fever of 101 and body aches. Advised to go to ER.
Patient returned to office w/trouble breathing, itchy ears, feeling like her lungs/throat were closing. No hives. Labored talking. Slightly swollen lips. Audible wheezing. Returned approx 20 mins after vaccines given. BENADRYL 50 mg given immediately. After exam .3mL epinephrine given SQ.
Itching, hives all over body.  While at clinic was treated with 50 mg BENADRYL.  Took 2 more BENADRYL doses 50 mg at home on same date, 10-20-09.
Pt is 17 yrs old and Moderna vaccines are currently only approved 18 yrs and older.
I have been experiencing vertigo prior to the first booster and it worsened after the second booster.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were possibly vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # M009766, expiration date 23-FEB-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 6 degrees Fahrenheit for 48 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
The vial was initially stored in the refrigerator on 05-Jan-2023 and administered on 27-FEB-2023; No adverse event; Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date 04-Feb-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date 04-Feb-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Jan-2023 and administered on 27-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date 04-Feb-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Jan-2023 and administered on 27-FEB-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date 04-Feb-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Jan-2023 and administered on 27-FEB-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date 04-Feb-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Jan-2023 and administered on 27-FEB-2023).    No concomitant medications were reported. It was unknown if patient received any other vaccine 4 weeks prior to COVID-19 vaccine. Health nurse stating that she was inquiring on a medication error with the Moderna Bivalent 6 months to 5 yrs. Dose was administered after 30-day Use by Date of 04-Feb-2023. Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date or after manufacturer date of expiry It was reported that individual vials were used. The vial was initially stored in the refrigerator on 05-Jan-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 04-AUG-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 0.65 ml injection, subcutaneously (lot # K000995, expiry date: 16-MAR-2015 (reported as 06-MAR-2015); indication unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Noted with soreness at injection site; abdominal pain; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-089030), for BNT162B2. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 02Mar2021 (Batch/Lot number was not reported) to an unspecified date for endometrial carcinoma; macrogol 3350 (MIRALAX), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to 02Mar2021, for constipation.  Medical history included endometrial carcinoma. The patient's concomitant medications were not reported.  The patient previously received first dose of bnt162b2 for covid-19 immunisation, Keytruda infusions.  The patient noted with soreness at injection site on 03Mar2021. Noted with abdominal pain on evening of 03Mar2021. Stated she believes abdominal pain related to stopping MIRALAX on 02Mar2021 when she began LENVIMA. Prior to start of LENVIMA, patient took MIRALAX daily for constipation. Noted with "fairly loose stools" since 02Mar2021. The action taken in response to the events for lenvatinib mesilate was unknown , for macrogol 3350 was permanently withdrawn on 02Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccine administered after use by date. Efficacy study done by Moderna and vaccine dose deemed effective, no re-vaccination needed. Moderna Case ID.
Raging headache, achy, stuffed nose, fever 100.1 for about 10 hours
Altered mental status, CVA vs Sepsis.  Patient reports  "clot was seen" put records are not forthcoming at this time.  Symptoms started about 2 weeks after vaccination.
Patient fully vaccinated (Moderna), but not boosted, admitted to the hospital on 1/29/22 with COVID-19 and associated hypoxia. Patient was discharged on 2/3/22.
Vitreous rupture. Floaters, flashes of light, blood in left eye.
Bad abdominal pain starting roughly 24 hours after the injection and lasting about 2 days. The pain would settle down if I lay in one position for a while, but would start up again if I moved into a different position.   There were no GI symptoms with it--no gas or diarrhea. I didn't notice any other symptoms except the pain. Pain went from just under the breastbone down to the groin. It felt very much like I'd gone through a crushing ab workout and was sore.  Walking, changing position, or pressing anywhere on the abdomen caused pain.  The first day I could barely walk with the pain, and spent most of it in bed. The second day it was more of an annoyance. It seemed to improve with rest.  I've previously had mild flu-like symptoms after the vaccine, but never this particular symptom, and not for over 48 hours.
Extreme pain in joint, difficulty waking, and full body aches for 24 hours.  Exhaustion and difficulty waking, going on day four.  It does seem to be improving each day, though day 3 had dizziness also.
left arm soreness that started 2 days after injection, went away then returned accompanied by swelling and itching
Chills and fever up to 103 degrees for 4 days. Swelling, redness and pain at injection site. Skin peeling two weeks later.
This patient was admitted thru the ER on 11/04/01 with progressive SOB, chest pain in the mid-chest associated only with cough, and deep breath. According to the family the patient there were no new problems until one day after the patient received the influenza vaccine when he ran a fever and became progressively following that injection. The  influenza vaccine was given about 1 week PTA. On the day of admission, he developed severe, SOB, and developed pleuritic chest pain. RR 28, o2 Sat 50%, O2 by mask was 90% on admit. Also 1-2 + pitting pedal edema present the day of admission. Chest x-ray revealed pneumonia. Initial cardiac enzymes were negative. On admit the patient had scattered rhonchi.
Numbness in pinky finger started as I was leaving. It varies in intensity and I fully expect it to go away completely.
pt recv vax approx 10am, mom called back @ 2PM stating the lt thigh was hard, swollen & hot to touch; pt was irritable but afebrile; mom returned call 430PM the swelling had abated, the pt was feeling fine;
developed a diffuse body rash that worsened over time. Includes the face.  Covers her chest, stomach, back, arms, legs. Not itchy. Not painful. No other symptoms. Looks similar to other rashes reported after vaccination.
Red swollen bump at site of inj (1 inch diameter) then gradually spread to 5 inch area with smaller lesions.
Pt recv vax on 3/15/99; on 3/23/99 pt exp fine, maculopapular rash on trunk & neck, fever (103.3), swollen neck glands
"Golf-ball" size swelling at site where KINRIX was given. TYLENOL given. Following morning, swelling down to elbow. TYLENOL given. Worse that night. BENADRYL given. Friday morning at its worst - red, hot swelling 2 inches past elbow. Slowly better over weekend. Today 10/17/11 - golf-ball size swelling.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: After administration of her first COVID vaccination from Pfizer, patient was instructed to take a seat for 15 minutes for monitoring. Patient fell forward on her chair and hit her head on the shelf. Patient was immediately being cared for by the pharmacist who administered the vaccine. Patient was kept laid down on her side to prevent further complications, was given water. She was responsive, but felt nauseous and stomach ache. Blood pressure was taken 92/62 and 86/64 and was okay after 30 mins