chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles vaccine was given on 5/23/14. Per pt. on the next day the injection site got itching and swelling. Pt tried oral BENADRYL and topical BENADRYL for 3 days. On 5/27/14, she reported it got better.
Started developing diffuse urticaria and new-onset dermatographism 11 days after the vaccine. Treated with antihistamine Zyrtec up to 30 mg daily and as needed Benadryl for about 3 weeks and then as needed. Improved significantly after 3 weeks but has not yet fully resolved nearly 6 weeks later
After receiving TD vaccination on 08/10/2004 patient came back with a complain of a hardening tissue at the site of the vaccination 3-4 days after the injection.  The nurse said the patient did not experience any pain or redness at the injection site, just the hardening of the tissue.  Follow up on 09/14/2004:  Patient recovered.
Patient received first dose of Pfizer-BioNTech on 1/8/2021.  Patient was given Moderna on 2/1/2021.  No adverse event was reported by the patient
PT SAYS HIS ARM IS "PARALYZED" AND IS UNABLE TO MOVE IT.  VERY PAINFUL
Child developed hives on her face and extremities; she also had brief period of unresponsiveness (apnea).  She received 02 by mask, oral benadryl (25MG) and oral prednisone (21MG).  She was monitored for about 45 minutes.  Her hives improved and her 02 sat remined at 100% in room air, so she was discharged home.  She had another outbreak of hive about 12 hours later (at home) and was given another dose of benadryl.  She has continued to take oral prednisone (21MG) to complete a 5 days course
PATIENT RECEIVED BOOSTRIX ON 5/25/22.  ABOUT 36 HOURS LATER HE DEVELOPED HIVES AND ITCHING OVER HIS WHOLE BODY.  HE CONTACTED PHARMACY ON 5/28/22 TO SEE WHAT HE COULD TAKE.  SYMTOMS ARE NOT GETTING WORSE,  BUT SLIGHTLY BETTER TODAY. HE DID START A NEW SPECIALTY ANTIBIOTIC THAT IS MAILED TO HIM AND IS ON HIS 2ND 2 WEEK BOUT. HE DOESNT KNOW WHICH HE IS REACTING TO. BUT HE HAS NOT HAD ALLERGY TO TETANUS IN THE PAST.  I RECOMMENDED BENADRYL TO SEE IF THAT WOULD HELP, WHICH HE WILL TRY.
Injection site pain, Pain from left shoulder to forearm  from day of injection to 2 days post injection;  slight headache Day day after injection.  IS pain/Arm pain treatment- Tylenol and cold compress HA- Tylenol
This spontaneous report as received from a pharmacist refers to a 50's plus years old female patient. The patient was vaccinated with PROQUAD (lot #, dose and route were unknown) instead of ZOSTAVAX today (on 11-OCT-2012). No other co-suspects were reported. No concomitant medications were reported. Pharmacist states error only, when occurred at the local clinic. No adverse effects reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Patient felt achy in her extremities. She had afib and was taken to the hospital the following night for heart rate above 160 that could not be controlled.
5/15/2022- Presents to ED, c/o of SOB and sore throat, tested Covid + at home. Had fever of 100 at home. VSS in ED afebrile. WBC-15.7 , creatnine 1.91 and covid + test. Ordered Decadron , azithromycin and Bebtelovimab. Admit Covid 19.  5/16/2022- AKI s/t to dehydration d/t sore throat. Follow up with Nephro outpatient. Creatnine stable 1.6. WBC-12.6 Complete Zithromax and d/c home.
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant drug was reported.  On 27-Jun-2023, the vial was initially thawed.  No treatment drug was reported.   The case corresponds to 30th out of 30 patients who had received expired vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up received: Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Mater Case (Patient 1)
I received a flu vaccine and immediately had itching on the arm i was injected. This spread down my arm and up my face on the side of injection. Area felts hot and itchy. The next morning I woke up with a cold sore, possible caused by the disruption to my immune system.  I only get a cold sore once every 8-10 years so it is not common for me. This was my first time receiving this vaccine.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that, on unspecified dates, multiple number of patients were vaccinated with doses of improperly stored ZOSTAVAX 19400 PFU, for prophylaxis, dose, route, anatomical location were not reported (with Lot # reported as M011665, expiration date 17-MAY-2017). No adverse effects reported. The temperature registered was of more than 5° Fahrenheit (F) but less than 14°F with a time frame of 337 hours. No previous temperature excursion was reported. No digital data logger, nor Product Quality Complaint (PQC) were involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005962:
Caller reported that patient received 1st dose one year ago, 2nd dose 7 months ago, and has not yet received 3rd dose of GARDASIL 9 due to rescheduling vaccination. 'AE; No adverse event; This spontaneous report as received from a Registered nurse refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  In September 2022, reported as one year ago, patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in March 2023 (conflicting information reported as 7 months ago), dose 0.5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported) for prophylaxis.  It was reported that the patient had not yet received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Inappropriate schedule of product administration) due to due to rescheduling vaccination. No symptoms reported.
Began with headache.  Turned to nausea roughly 8 hours after shot.  Nausea turned to sever vomiting and for several hours.  Tremors. Sweating. Fatigue.  More headache. Loss of appetite. Joint and muscle aches. Continued joint pain, appetite loss and fatigue.
pt recvd vax 15MAR93 & c/o t102 off/on since Monday; APAP given; c/o abdo cramping last noc; This AM woke w/red round wheals to bilateral upper/lower extremities, chest abdo, buttocks, back; c/o itching;
Sore arm; This is a spontaneous report received from a contactable consumer from medical information team.  A 55-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional Information: The patient also had a sore arm after the first dose of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021304566 Same reporter, product, and event; different patient
About 2 to 5 min after vaccine administered became hot, red, dizzy, unable to focus, EMT's and RN came to aid and BP was escalated.
Pounding headaches and pounding heart could not move leg arm, nausea, dizzy, could not sleep. 2nd week, dr put me on a med pak for 6 days - +3 ADVIL - 4's a day. Symptoms slowed - but today, it is 4 wks and still hurt.
Both legs were very sore and would not support his weight.  His fever rose to 102 and remained there for 36 hours.  He had a head ache and said he couldnt see.  He followed me when I talked so I think it was a migraine and not actual lack of vision.  He had unquenchable thirst.  The symptoms lasted for 36-48 hours except for the legs swolleness and inability to hold him.  That lasted 3 days.  After 36 hours his fever bounced between 100 and 102 for another 36 then broke.  He also got a rash on the leg that had 2 vaccines and a large welt where the DTaP was given.
Patient states all muscle tone lost, could barely get out of chair, couldn't lift legs. This happened in the pm after the flu shot.  The patient was fine the next day.  Patient also had arexvy and Pfizer vaccine day prior.
This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL DOSE OMISSION (The 2nd dose is out for me I will not be getting it), TINNITUS (7 days ago patient reports tinnitus or ringing in ears began, and this has been ongoing constantly since then) and FATIGUE (first 3-4 days patient reports experiencing fatigue) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005021A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced FATIGUE (first 3-4 days patient reports experiencing fatigue). On 03-Aug-2021, the patient experienced TINNITUS (7 days ago patient reports tinnitus or ringing in ears began, and this has been ongoing constantly since then). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (The 2nd dose is out for me I will not be getting it). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 03-Aug-2021, FATIGUE (first 3-4 days patient reports experiencing fatigue) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (The 2nd dose is out for me I will not be getting it) outcome was unknown and TINNITUS (7 days ago patient reports tinnitus or ringing in ears began, and this has been ongoing constantly since then) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Concomitant product information was not provided. Patient stated that "The 2nd dose is out for me I will not be getting it". Reporter did not allow further contact.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age 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 an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment medication was reported
pt recvd vax 18SEP95 9:00 & post vax 17:00 pt exp local rxn & devel diff breathing;devel wheezing, stridor, angioedema, & hives;19SEP95 had inc coughing, diff swallowing;seen in ER 19SEP95;dx acute allergy rxn-persistent anaphylactic rxn
May be coincidence, but after 3rd vaccine for Lyme (Lymerix), the pt experienced leg pain, particularly in the ankle and thigh. (Had mild Lyme infection in 6/99).
Problems regulating temperature; Hot sweats; Headaches; Sick; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced illness, problems regulating temperature, hot sweats/hyperhidrosis, headache.  The patient's medical history was not provided. Concomitant product use was unknown by the reporter.  On an unspecified date the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route and site for prophylaxis of COVID-19 infection. On 5 Feb 2021, approximately 8 prior to the onset of the events, the patient received their second dose of mRNA-1273 (Lot number: unknown) via unknown route and site for prophylaxis of COVID-19 infection.   On 5 Feb 2021, the patient experienced illness. On an unspecified date the patient experienced problems regulating temperature, hot sweats/hyperhidrosis, headache. Treatment information was unknown.    Action taken with mRNA-1273 in response to the events is not applicable.   The event illness were considered resolved on 6 Feb 2021. The events problems regulating temperature, hot sweats/hyperhidrosis, headache were considered not resolved during the time of this report.
pt w/knot in arm; arm was cleaned w/Betadix and 1 1/2 inch needle used; pt devel cellulitis; local cellulitis MD reports pt w/allergy to Hep B vax;
Tiredness; Pain injection site; Headache; muscle pain; Joint pain; Nausea; just isn't feeling good; feels like face and around eyes are swollen; feels like face and around eyes are swollen; This is a spontaneous report from a contactable consumer reported for self. This 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 in her right arm at single dose for required to at work. None medical history and concomitant medications. She is at work right now. She doesn't have a prescribing doctor. She works at the ER, and they were provided to employees. There is pain at the injection site, which she expected. She has had tiredness, headache, muscle, and joint pain. No chills.  She has had nausea. She just wasn't feeling good. She feels like her face is swollen. Like around her eye lids is swollen, but she asked her kids, and they said it doesn't look swollen. She can feel it, but not see it. She got the vaccine on 17Dec2020. She started having all the side effects on the 18Dec2020. They have just persisted. She took something for nausea. She took Ibuprofen for pain, Headache, muscle pain, Joint pain. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
ED MD note: The patient is a 7 year old who presents with syncope that occurred right after he had immunizations in clinic today. No palpitations, chest pain. No abnormal movements to suggest seizure. No fever.  On my physical exam, the patient is quite well appearing, interactive and appropriate for age, and developmentally normal. The patient is well hydrated, and has no pallor or conjunctival paleness. The HEENT exam reveals moist mucous membranes and no oropharyngeal pathology. The neck is rangeable. The lungs sound clear without focal findings, and the patient is breathing comfortably. The heart has a regular rate and rhythm. Distal perfusion is good, with 2+ cap refill in the feet and 2+ DP pulses. The abdomen is soft, nontender, and nondistended. The musculoskeletal exam reveals no bony tenderness or joint swelling/tenderness. Neurologic exam is unremarkable.  EKG revealed normal sinus rhythm with sinus arrhythmia, no delta wave, no Brugada pattern, no strain/hypertrophy, and no block or abnormal intervals.  My assessment is that the patient's differential includes vasovagal syncope, cardiac, and neuro causes. Based on the history and physical, cardiac causes are quite unlikely. Additionally, the history and physical do not support a neurologic cause. I think that vasovagal syncope is most likely, because of the occurrence right after immunizations, normal EKG, and epidemiology of syncope. We observed the patient for an hour without any events or abnormal rhythm. I reviewed the last set of vital signs and I am comfortable with the discharge heart rate, respiratory rate, and blood pressure. We gave instructions for home care. We gave strict followup guidance with PCP and reasons to return here.
soreness at the site of the injection in left arm; headache; chills; muscle pains,; joint pain; feverish; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (soreness at the site of the injection in left arm), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle pains,) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of the injection in left arm), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle pains,), ARTHRALGIA (joint pain) and PYREXIA (feverish). The patient was treated with ACETAMINOPHEN for Fever, Chills and Headache, at an unspecified dose and frequency and IBUPROFEN for Headache, Muscle pain and Joint pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at the site of the injection in left arm), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle pains,), ARTHRALGIA (joint pain) and PYREXIA (feverish) outcome was unknown.            There were no concomitant medications provided in source document. The patient has taken acetaminophen and ibuprofen as needed for her symptoms.
patient got a red swollen arm at site of injection she noticed 4 days. Painful and swollen, hot to the touch. was advised to see primary care to determine if it was cellulitis or allergic reaction. Primary care doctor diagnosed allergic reaction and prescribed prednisone 5mg daily for 5 day, then every other day for 5 more doses
Headache, Sedation, Myalgia, Arthralgia, Pain/Rash @ injection site Narrative:
entire left armpit and triceps are tender; swollen; not feeling too well; fatigued; fever of 100.5 degrees F; arm soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.5 degrees F), VACCINATION SITE PAIN (arm soreness on the injection site), TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen) and FATIGUE (fatigued) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney cancer. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (fever of 100.5 degrees F) and VACCINATION SITE PAIN (arm soreness on the injection site). On 04-Mar-2021, the patient experienced TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen), FATIGUE (fatigued) and MALAISE (not feeling too well). On 04-Mar-2021, PYREXIA (fever of 100.5 degrees F) had resolved. At the time of the report, VACCINATION SITE PAIN (arm soreness on the injection site), TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen), FATIGUE (fatigued) and MALAISE (not feeling too well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: fever of 100.5 F.
sore throat, itchy eyes, GI distress (diarrhea) chills were the onset. Today 10/20 I have fever (100.8) chills, body aches, sore throat, headache. taking tylenol flu medication
5NOV watery eyes-1 wk a/ER; 11NOV paralysis to rt side face-dx bell's palsey to ER;
Prolonged dizziness/vertigo for 1 week from later day of vaccine to when seen 10/29/19 in office. Required Meclizine, improved on Meclizine but still mildly symptomatic.
received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported
The patient reported a lump in her throat to a nurse approximately 5 minutes after receiving VARIVAX. The nurse walked the student to Dr. where she was assessed and diagnosed with an anaphylactic allergic reaction. Dr. stated she heard a possible wheeze in the right upper lung to accompany the difficulty breathing. The patient was given epinephrine 0.3 mg intramuscularly and hydroxyzine hydrochloride 50 mg orally. Paramedics were contacted and arrived to transport the patient to the local hospital for follow-up care. The patient was conscious and alert at the time of transport.
fever (104 F), irritable, loss of appetite started w/in 24 hrs of vax;
Pt states she started itching Friday on the buttocks and itching has now spread to abdomen and thighs. Pt took Benadryl and was instructed to continue with Benadryl today and call me tomorrow unless it becomes worse and was then told to seek medical attention after discussing this with Dr.