chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received Tdap, MCV, & Varicella 7/30/09. Developed Temp 101.7 the evening of vaccines. Also c/o skin feeling sensitive at injection site. Mom report to PCP who directed her to call ACHD TC from Mom 7/31/09. Will F/U with parent Monday am. Encouraged parent to administer TYLENOL or MOTRIN for fever & go to ER for persistent fever changes in neuro status. Discussed cold compresses to injection site. 8/3 - TC with parent - son sustained a fever over 24 hours - high Temp 102.7. Controlled with MOTRIN - developed vomiting 24 hours. Mom feels son had a GI virus. By Sunday 8/2/09 child back to normal.
Case  number PHEH2014US020756 an initial spontaneous report received from a pharmacist on 14 OCT 2014. This report refers to a 24 year old female patient. Her medical  history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413501) intramuscularly on 13 OCT 2014, which was stored approximately 30 minutes before administration (syringe was pre-drawn from multi-dose vial). No adverse event was reported following this administration error (incorrect storage of drug).
Dizzy, sweating, seizing, passing out.  Administered Epi Pen and called 911.  Patient later taken to Hospital by a friend.
Extreme joint pain. Lower back pain. Fatigue in January 2022 and current.  Intermittent Shortness of breath noticed around January 2022.
Angioedema, difficulty swallowing, swelling of tongue and mouth and throat, onset 35min after vaccine, no hx of similar events in the past
Patient fully vaccinated (Moderna) but not boosted, admitted to the hospital on 1/14/22 with COVID-19 and associated hypoxia. Patient was discharged on 1/17/22.
as he was rubbing, blood came out; This is a spontaneous report from a non-contactable consumer (patient friend). A male patient of an unspecified age received BNT162B2 (lot/batch number and expiration date were unknown) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was rubbing his arm vigorously after getting BNT162B2 and as he was rubbing, blood came out. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
04/28/21 - 5:00 a.m  102.2 Fever -  1000mg Acetaminophen taken - Fever subsided within  approximately 4 hours. 04/28/21- 11:00 a.m 102 Fever -  1000 mg Acetaminophen taken  - Fever subsided within approximately  2 hours. 04/28/21 - 6:00 p.m. 101.4 Fever - 600mg Naproxen taken - Fever subsided  within approximately 2 hours; First  and second fevers accompanied by chills, strong headache, lightheadedness, nausea and diarrhea. 4/28/21 -Above symptons begans to improve by 11:00 p.m.  with the exception of strong headache. 4/29/21 - Headache began to dull and subsided by the end of the day.
09/08/22 presents to ED for "abdominal pain". PMHx of "multiple abdominal surgeries secondary to hernia with mesh 2019, hypertension, hyperlipidemia, diabetes, COPD, asthma, GERD, renal cell cancer, gastric sleeve surgery 2016, and hemicolectomy"
Warm to the touch; Tender; Swollen; Red spot; A little off from deltoid muscle; A spontaneous report received from a consumer concerning, 90-year-old, female patient who received Moderna's COVID-19 vaccine a little off from the deltoid muscle and experienced redness, swelling, warm to the touch, and tenderness. PT: [Product administered at inappropriate site, injection site erythema, injection site swelling, injection site warmth, and tenderness].   The patient's medical history was not included. Patient's concomitant included calcium, vitamin D, levothyroxine sodium, atorvastatin, citalopram hydrochloride, amitriptyline, triamterene/hydrochlorothiazide, acetylsalicylic acid, and lorazepam.   On 02 FEB 2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in left arm (Batch #: 007M20A) for prophylaxis of COVID-19 infection.   On 02 Feb 2021, the patient received the vaccine 'a little off from the deltoid muscle' as described by the patient's daughter (nurse). Approximately 9 days later, the patient developed a red spot on her arm and it was swollen and warm to the touch. At the time of the report, the patient's arm was still swollen. The redness was fading and her arm was tender. Treatment for this event included paracetamol.   Action taken with mRNA-1273 in response to the event was not provided/unknown.   The event, vaccine administered at inappropriate site, was considered recovered/resolved on 02 Feb 2021  The event, redness was considered recovering/resolving.   The events, swelling and tenderness, was considered not recovered/not resolved.  The outcome of the event, tenderness, was unknown/ not reported.; Reporter's Comments: This report refers to a case of product administered at inappropriate site for mRNA-1273, (lot # 007M20A) with associated injection site erythema, swelling, warmth, and tenderness. Based on the current available information and temporal association between the use of the product and the start date of the injection site events, a causal relationship cannot be excluded.
TIA or complex migraine; Trip to ER with many tests. Left side numbness from face to toes. Resolved itself mostly. Still left side face tingling and numb teeth left side
patient had redness and swelling in upper arm that had vaccine administered.  Also arm was warm to the touch.  Occurred the night of vaccine and has progressively got worse.  Doctor put patient on keflex and told her to use over the counter hydrocortisone cream and benadryl tablets to help with reaction, also ice the affected area.
Starting in September 2021, Mild to Moderate Tinnitus (Subjective type). Starting on September 24th 2021, Moderate to Severe Tinnitus (Subjective type). Tinnitus reported to physician on October 1st, 2021.
mom states pt had t102; chills, vomiting, diarrhea immed p/shot; sx lasted 2 days;
I developed a 4? welt at the injection site within 6-12 hours after vaccine. It was red, swollen, hot, hard, and painful. My skin over my entire body felt hot, prickly, rashy, like a heat rash. Skin appeared flushed but not like a rash. These symptoms persisted for 6 days, let up, welt became a bruise. Then on day 10 the welt flared up again, to its original size and whole body rash reappeared. Skin appears flushed but feels like a heat rash, is hot, burning, stings, scratchy and is uncomfortable and distracting. Clothing is scratchy and uncomfortable. This is now going on for 16 days. I don?t feel this is normal.  Saw a nurse on 2/23 and was told to wait it out. Take Benadryl if needed. Benadryl doesn?t really seem to help much. Makes me tired cannot take during day.
Pt complained of dizziness & lightheadedness after 1st pfizer injecction, brief period of syncope today. Skin warm & dry, mom says her daughter has passed out previously after lab work injection. BP 94/63  P68 RR16 O2 sat 100%. Symptoms quickly resolved after a few minutes of laying down. alert/oriented, left with her mom ambulatory/ stated she was feeling better, skin warm & dry, no cyanosis noted per nurse.
1st shot fatigue for 7 days 2nd shot , left arm. Severe pain for 2 days couldn?t lift arm above shoulders. Couldn?t sleep. Lingering shoulder soreness and carpal tunnel symptoms. Lot # 048A21A  3/11/21 Booster shot @ pharmacy. Right arm  10/25/21. Symptoms continue to get worse. Intermittent shoulder pain and carpal tunnel symptoms at night. These symptoms are causing me lost sleep. I have an overall unwell feeling all the time.
This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to an 8 week old infant, gender unknown.  There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 19-SEP-2016, the 8 week old infant received vaccination with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. The administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported.  The licensed practical nurse stated they did not know why the temperature excursions occurred but there were no further excursions.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004952: US-009507513-1705USA004967: US-009507513-1705USA004960: US-009507513-1705USA004965: US-009507513-1705USA004973: US-009507513-1608USA012794: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004946: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004966: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004974: US-009507513-1705USA004975: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA005004: VAQTA US-009507513-1705USA005005: VAQTA US-009507513-1705USA005006: VAQTA US-009507513-1705USA005007: VAQTA US-009507513-1705USA004887: RECOMBIVAX HB US-009507513-1705USA004888: RECOMBIVAX HB US-009507513-1705USA004889: RECOMBIVAX HB US-009507513-1705USA004890: RECOMBIVAX HB US-009507513-1705USA004891: RECOMBIVAX HB US-009507513-1705USA004892: RECOMBIVAX HB US-009507513-1705USA004893: RECOMBIVAX HB US-009507513-1705USA004894: RECOMBIVAX HB US-009507513-1705USA004895: RECOMBIVAX HB US-009507513-1705USA004896: RECOMBIVAX HB US-009507513-1705USA004897: RECOMBIVAX HB US-009507513-1705USA004898: RECOMBIVAX HB US-009507513-1705USA004899: RECOMBIVAX HB US-00950751.
Had mild reaction to the shot, flu like symptons for a couple of hours Tested positive for COVID 19 on Feb 2, 2022 - had runny nose and slight fever for 3 days, heavy fatigue for about 2 days, mild fatigue for another 3 days
5 days p/vax devel fever, went outside to play, fainted, was lethargic very hot-thristy; tooke to MD, fever 103.8; next morning still fevering, high pitched cry, lasted for 10 days straight;
Pain in left arm (entire arm), wrist fatigue, stabbing pain in left hand, tremors in left hand - pain since date of injection, tremors noticed 10/30/17.
received Pfizer COVID vaccines 2/10/2021 and 3/3/2021. Positive COVID test 8/31/2021. Admission to ICU 8/31/2021, on BiPAP
Information has been received from a consumer concerning her daughter, a 9 year old girl with no known  allergies or pertinent medical history who was vaccinated in the arm with the first dose VARIVAX (Merck) (Lot # not provided) when she was 12 month old.  On 25-APR-2008 the patient was vaccinated in the arm with second dose of VARIVAX (Merck) (Lot # not provided).  There was no concomitant medication.  The very next day the patient was diagnosed with strep throat and was put on therapy with AUGMENTIN which was completed on 04-MAY-2008.  That is when the patient's spots began.  The reporter stated "the spots looked like mosquito bit bumps, with raised read heads that are now turning a yellowish color.  These bumps were very red, painful, and stung.  On the 4th day the bumps or rash were spreading to the child's sides around to her back."  The patient sought medical attention.  She was seen at the doctor office on 07-MAY-2008 for follow up.  Diagnosis was "virus" and one nurse told the reporter it "looks like chicken pox".  The patien'ts treatment was "HYPOXYX" which the reporter said "is not working".  As the time of report, the patient didn't recover from the spots.  The reporter questioned if the patient should be seen by a dermatologist and stated she would call the doctor office again.  No further information is available.
Was given DTaP (Infanrix) vaccine instead of TD by a certified medical assistant . No adverse reaction noted Contacted the CDC. No further  immunization needed at this time. Next TD will be in 10 years due to already having the Tdap in the past.  Patient notified of the error by other staff member.
This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0172) via an unspecified route of administration in the left arm on 05May2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. 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. Concomitant medications included montelukast sodium (MANUFACTURER UNKNOWN) and CVS multivitamins (MANUFACTURER UNKNOWN) all from unknown date for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8729) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 00:00, within 12 hours of second dose the patient experienced chills, severe headache, fever of 101 and fatigue. On 06May2021 at 00:00, the patient underwent body temperature and the result was 101 (unspecified units). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, severe headache, fever of 101 and fatigue were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and INFLUENZA LIKE ILLNESS (flu-like symptoms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator. Patient took Benadryl and Zyrtec for some days and she got better.
A 35-year-old female patient reports having an allergy to the Janssen booster dose. Swelling on the left side of the face and redness. By administering the second dose of modern the next day, he created facial edema on the left side of his face and he felt SOB. He is considered alert, does not present edema in the respiratory tract, strong peripheral pulses and presents facial edema.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sporanox, reaction(s): "Known allergies: Sporanox". Vaccination history included: Covid-19 vaccine (Primary immunization complete;, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (FIRST BOOSTER DOSE;, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 13Jun2022, outcome "not recovered", described as "in pain for 9 week"; DEPRESSED MOOD (non-serious) with onset 13Jun2022, outcome "not recovered", described as "scared/depressed"; LYMPHADENOPATHY (non-serious) with onset 13Jun2022, outcome "not recovered", described as "swollen lymph nodes under both of my arms and in my neck and on my subclaviclular areas on both sides". The events "swollen lymph nodes under both of my arms and in my neck and on my subclaviclular areas on both sides", "in pain for 9 week" and "scared/depressed" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient stated that on 13Jun she got swollen lymph nodes under both of her arms and in her neck and on her subclaviclular areas on both sides. She stated that she had been in pain for 9 weeks now. She stated that she had many blood tests, MRI, ultrasounds, CT scans, x-rays to rule out ultrasounds, CT scans, x-rays to rule out cancer. She stated that she had been very scared and depressed thinking that she had something awful. No follow-up attempts are possible. No further information expected.
patient stated got a sensation in his right jaw soon after the immunization and they it went across to the left jaw and then disappeared after a 1/2 hour.
driving home and it was about 25 to 30 minutes after the shot that the upper lip was tingling and puffy; the upper lip was tingling and puffy; cheek was puffy and hot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (driving home and it was about 25 to 30 minutes after the shot that the upper lip was tingling and puffy), LIP SWELLING (the upper lip was tingling and puffy) and SWELLING FACE (cheek was puffy and hot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PARAESTHESIA ORAL (driving home and it was about 25 to 30 minutes after the shot that the upper lip was tingling and puffy), LIP SWELLING (the upper lip was tingling and puffy) and SWELLING FACE (cheek was puffy and hot). At the time of the report, PARAESTHESIA ORAL (driving home and it was about 25 to 30 minutes after the shot that the upper lip was tingling and puffy), LIP SWELLING (the upper lip was tingling and puffy) and SWELLING FACE (cheek was puffy and hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: pt threw up and was very nausious after 5 min of injectoins
No additional AE; a 14 month old was administered a vaccine that had been expired for 2 weeks; This spontaneous report was received from a medical assistant and referred to a 14-month-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 26-APR-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (0.5 milliliter, lot #T034828, expiration date: 11-APR-2022 (it was reported that the vaccine had expired for 2 weeks)) for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
NAUSEA, CHEST PRESSURE/BURNING, DYSPHAGIA, DYSPNEA Narrative:  Per code triage note: "pt sitting in a chair c/o substernal pressure/burning sensation which radiates upward from his stomach into esophagus which started last night. Reports nausea but no vomiting. Reports when he takes his pills or eats oatmeal it is not going down into his stomach, takes 1 hour for him to eat even with water. He reports h/o GERD and PUD; denies chest pain. He states he has chronic SOB from COPD & asthma for many years which has been unchanged. EKG WNL. VS stable except elevated BP 162/71. Had COVID-19 vaccine [on 1/8/21] and is wondering whether these symptoms are due to the vaccine." Patient sent to hospital for evaluation, refused admission.
dehydrated; my electrolytes were messed up; dizziness; could hardly walk; my BP was high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (non-serious) with onset 06Oct2023, outcome "unknown", described as "could hardly walk"; DEHYDRATION (medically significant) with onset 06Oct2023, outcome "unknown", described as "dehydrated"; DIZZINESS (non-serious) with onset 06Oct2023, outcome "not recovered"; BLOOD PRESSURE INCREASED (non-serious) with onset 06Oct2023, outcome "unknown", described as "my BP was high"; ELECTROLYTE IMBALANCE (medically significant) with onset 06Oct2023, outcome "unknown", described as "my electrolytes were messed up". The events "dehydrated", "my electrolytes were messed up", "dizziness", "could hardly walk" and "my bp was high" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (06Oct2023) high. Therapeutic measures were taken as a result of dehydration, electrolyte imbalance. Clinical course: patient went into dizziness 4 hours after receiving dose that patient could hardly walk. Patient had been done well with the other doses. Patient spent 4 hours in the ER, BP (blood pressure) was high and electrolytes were messed up. Patient was dehydrated. Paitent had an IV, magnesium and potassium in the ER. Patient have had dizziness ever since. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Red, blotchy areas noted on scalp, face and trunk of body.  Eye lids puffy.
Started sweating at 10:30 pm 3/3/2021, fever started 3/4/2021 around 2 pm  400 mg taken at that time.  At 5:00 pm 3/4/2021 fever seemed to be rising., 400 mg ibuprofen taken. At 5:30 pm fever was 105.7, additional 500 mg extra strength Tylenol, and 25 mg Benadryl.  At 6:09 pm temperature was 104.
Chills, chest pain, stomach pain, weakness, site pain, nausea, loss of appetite, numbness of the tounge, throwing up blood