chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a license practice nurse and the patient's mother refers to a now 16 year old female patient. The patient's concurrent condition included learning disability. The patient had no other drug reactions/allergies. On 10-OCT-2009 the patient was vaccinated with the first dose of GARDASIL injection (dose, route and lot# not reported). Then the patient had a delay in receiving her second dose and therefore the physician's office determined that they should restart the GARDASIL series since there was a gap in years from 2009. The patient received another "first" dose of GARDASIL on 27-NOV-2012, her second dose on 27-DEC-2012 and the completion of the GARDASIL series on 05-JUN-2013. The patient's mother reported that the patient had suffered first with constant headaches and "now" continuous seizures. The patient also experiences severe back pain. The patient had been hospitalized many times (dates and length of stay was unspecified). The patient had taken many different medications approximate (12) including a blood pressure medication in effort to prescribe treatment (brand, dose and manufacturer unspecified) for the patient's condition. The patient was still experiencing these symptoms and these adverse events had been occurring over the last two years. The nurse also reported that after the patient received the full series of GARDASIL the patient started to experience intense headaches on an unspecified date. The intensity and pain of the headaches caused the patient to visit an unspecified neurologist on an unspecified date in December 2013. The patient performed spinal tap, magnetic resonance imaging (MRI), X-rays and blood work (result unspecified). At the time of reporting, the patient was not recovered from the event. Upon internal review, the event of continuous seizures was considered to be medically significant event. Additional information has been requested.
severe redness &s welling @ site of administration 8cm x 15cm; generalized myalgias; onset 4-5 days p/administration;
Following administration of Pfizer Covid vaccine, dose #1, pt. experienced hive-like rash with significant shaking. Symptoms began within 5 min of admin. Breath sounds clear and equal bialt. B/P-170/92, P-124, R-18, SaO2-99%. c/o tingling and numbness on lips, progressing to tongue and back of throat. Patient transported to ED, where she was noted to have twitching of her right leg, perioral numbness, and a change in sensation of her face, as well as a urticarial rash to bilateral upper back and shoulders. Patient received 50mg PO benadryl and 20mg PO famotidine. She was observed for ~90 minutes and discharged with a prescription for an epi-pen and a referral to an allergist. She was instructed not to get the 2nd dose of vaccine until approved by her PCP or allergist.
The next day pt. woke up with fever, chills, lymph node swelling inj. site inflamed, headache.
Unconsolable crying, emesis x 1, flat blanchable macule rash, hives, wheezing. Gave 1/2 tsp of Benadryl, nebulizer treatment of Xopenex 0.32mg and applied ice pack to injection site.
Approximately one week after the Moderna 2nd booster I woke up with extreme muscle tightness in my jaw, elbow area, quads, hips and glutes.
lips started swelling up; eyes started swelling up; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips started swelling up) and EYE SWELLING (eyes started swelling up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (she fell and broke her ankle. Six days later she needed surgery and was itching all over from the medication they gave her.) in January 2021. Concomitant products included LOSARTAN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced LIP SWELLING (lips started swelling up) and EYE SWELLING (eyes started swelling up). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 08-Feb-2021, LIP SWELLING (lips started swelling up) and EYE SWELLING (eyes started swelling up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's primary care physician who took her off of Losartan just incase the reaction was induced from this medication.
"Had QUADRACEL in L thigh and MMRV in R thigh. Developed mild pink rash around injection sites within 24 hrs. Yesterday developed deeper red area around injection on R thigh which mother marked. The deeper redness has decreased in size but milder redness has spread. Pt acting and feeling fine, no fever". "Area of deep erythema and induration circled, if this spreads, mom should call back. Expect blotchy erythema around injection site of varicella vaccine and then maculopapular rash more widespread due to measles".
Extreme itching and dermatographic hives, angioedema of hands/feet/scalp. Anaphylactic reaction in throat/chest, prescribed prednisone on 12/4 due to this. After prednisone, angioedema and anaphylaxis gone but hives still present 24/7. On multiple doses of OTC antihistamines around the clock ever since. Keeps hives/itching at bay for the most part but still having dermatographic swelling of skin. If I miss a dose, the hives reappear. Many blood tests including allergy tests came back negative, no discernable cause for this.
adult recv vax & child who receives care from adult also devel a rash & swollen knee/hands;sx have resolved;child has been immunized;
I have had debilitating menstrual cramping and an exceedingly heavy flow for the first several days of my period. This began in September, the month after my second Pfizer covid 19 shot.  I have never experienced these symptoms before getting the vaccine. I am unable to attend school or work during these days, as the pain is so great and  over the counter pain relievers do not alleviate the  pain.
I had a sore throat in the evening and the next day it continued. I didn't have any fever but I did an at home test kit and it was positive. I called my doctor my doctor who told me to quarantine for 10 days. I did not treat it with medication, I stayed home, drank a lot of water and rested. I have completely recovered from my symptoms. I took another test to return to work after 10 days and it was negative.
Constant ringing in ears (tinnitus), especially left ear began one week after 2nd shot.
This spontaneous report as received from a Licensed Practical Nurse refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, frequency and route not reported). The Lot number of VARIVAX (Merck) was reported as L011084, expiry 01-APR-2017 and L013395, expiry 16-APR-2016. No adverse event was reported at the time of this report. This case is one of the several reports from the same reporter. Additional information has been requested.
PATIENT WAS GIVEN VACCINE AT APPROX 1030AM. PATIENT'S VAR DID NOT INDICATE ANY TROUBLE WITH PREVIOUS VACCINES. PATIENT WAS TOLD TO SIT IN WAITING ROOM FOR 15 MIN.  APPROXIMATELY 10 MIN LATER PATIENT HAD FALLEN AT FRONT OF STORE AFTER FEELING LIGHT HEADED. PATIENT'S FRIEND HELPED HER LAY DOWN.  WHEN PATIENT GOT UP SHE FELL FORWARD WITH HER GLASSES ON AND HIT HER FOREHEAD. PATIENT WAS BLEEDING EXCESSIVELY . 911 WAS CALLED AND PATIENT WAS TRANSPORTED BY EMS TO HOSPITAL FOR STITCHES.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # reported as L019994, expiration date 02-DEC-2016. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information has been requested.
Patient started to experience pain in his feet at the end of his tennis game. Subsequently the burning sensation in  his feet became more prominent and and started occurring at night and during the daytime. The lower extremity burning progressed to become constant, and progressed from his feet up to the midcalf. Around mid June, patient started experiencing similar sensation in his left hand subsequently moved to the right hand. The symptoms are limited to the wrist bilaterally and predominantly in the median sensory nerve distribution.
my cousin took the Pfizer booster; The first two shots were Moderna; Off-Label use; sick; The lymph node under her armpit were like swollen for like couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) as dose unknown number (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure. The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (1st dose, lot#036A21A), for COVID-19 Immunization; Moderna vaccine (2nd dose, lot#019B21A), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021, outcome "unknown", described as "my cousin took the Pfizer booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 28Dec2021, outcome "unknown", described as "The first two shots were Moderna"; OFF LABEL USE (non-serious) with onset 28Dec2021, outcome "unknown", described as "Off-Label use"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "sick"; LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "The lymph node under her armpit were like swollen for like couple of days". Therapeutic measures were not taken as a result of illness, lymphadenopathy.  Additional information: It was reported that my cousin took the Pfizer booster and she had Moderna but then she took the booster and then you know she kind of got sick and her lymph I guess the lymph node under her armpit were like swollen for like couple days.   The lot number for bnt162b2 was not provided and will be requested during follow up.
lot of pain; bad headache; nauseated; muscle pain; This is a spontaneous report received from contactable reporter(s) (Physician).  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing); "Headache" (ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: TYMLOS taken for osteoporosis. The following information was reported: MYALGIA (non-serious) with onset 02Feb2021, outcome "not recovered", described as "muscle pain"; PAIN (non-serious) with onset 03Feb2021, outcome "not recovered", described as "lot of pain"; HEADACHE (non-serious) with onset 03Feb2021, outcome "not recovered", described as "bad headache"; NAUSEA (non-serious) with onset 03Feb2021, outcome "not recovered", described as "nauseated". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to clinic to receive second full dose of Moderna vaccine (0.5mL). Patient was given Moderna booster dose (0.25mL). Vaccine was administered by RN.
; This is a spontaneous report received from a non-contactable reporter  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "I am not happy about it"; RASH ERYTHEMATOUS (non-serious) with onset 2022, outcome "unknown", described as "I got a rash that was from my thigh line to my knee cap with total red flared up with bumpy and itchy and skin coming off of that"; SKIN REACTION (non-serious) with onset 2022, outcome "unknown"; SCAB (non-serious) with onset 2022, outcome "unknown", described as "even though my flared up went away I have these scabs on my skin"; BURNING SENSATION (non-serious) with onset 2022, outcome "unknown", described as "inside my elbow and a patch in my armpit and it was itching very, and burning and hot, very hot"; SCAR (non-serious) with onset 2022, outcome "unknown", described as "left pigmentation of a scar of burnt of scabby flat scar skin and off and on burning"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "skin was itching very badly/inside my elbow and a patch in my armpit and it was itching very, and burning and hot, very hot"; SKIN HYPERPIGMENTATION (non-serious) with onset 2022, outcome "unknown", described as "thigh patches to my knee patches of scabby, scaly, burn kind of looking skin not burnt but what you call it hyperpigmentation skin; it is white like a ghost and then there is some dots".    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever; Headache; vomiting or puking; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number was not reported), via an unspecified route of administration on 15Mar2021 09:30(at the age of 76-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Blood pressure high. The patient's concomitant medications were not reported. The patient experienced fever headache and vomiting or puking on 15Mar2021. The events were assessed as non-serious. The patient received one Tylenol every four hours, unknown strength, for treatment of fever, headache, and vomiting. The events outcome was reported as unknown.   Additional Context: Consumer says his mom had her first dose of the Pfizer COVID-19 vaccine shot yesterday at 09:30 and when she come home she was fine, then later had fever, headache, and vomiting or puking until now. Caller says he would like to know should he take her to hospital. Consumer says that he does not have his mom's vaccine card to provide NDC/LOT/EXP from it for the Pfizer COVID-19 vaccine. He says that she took one Tylenol every four hours, unknown strength, for treatment of fever, headache, and vomiting. No further details provided about patient's Tylenol. Concomitant Medications/Other Medical Conditions: Caller says his mom takes high blood pressure medication that is it, unable to confirm if this medication is new or not, caller just kept repeating high blood pressure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
get so sick after he received his first flu shot; Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious social media case from patient's wife.  The case was related to 2020SA297232, 2020SA297338, 2020SA297344, 2020SA297203, 2020SA297183, 2020SA297189, 2020SA297215, 2020SA297267, 2020SA297198, 2020SA297259, 2020SA297264, 2020SA297224, 2020SA297197, 2020SA297275, 2020SA297193, 2020SA297278, 2020SA297301, 2020SA295993, 2020SA290234, 2020SA273251, 2020SA285105, 2020SA289150 and 2020SA297164  This case involves a patient of unknown demographics who got sick after he received his first flu shot (illness), while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, it was reported that the patient who got sick after he received his first flu shot (illness), (unknown latency) following the administration of INFLUENZA VACCINE. The reporter had raised a concern that the product was not of help but of hindrance and had had named the product a poison.   Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
sore arm for 2 days, nausea,fatigue, chills/aches for 2 days
Heart rate increased 20-30 beats per minute for 24 hours. Fever, chills, lack of appetite, general malaise.
Sore arm, fever for 24 hours, reached 103. Passed out, nausea, head ache, loss of appetite
Information has been received from a pharmacist referring to a patient of unknown age and gender on 03-MAR-2015. The patient had no drug reactions/allergies and had "issues with left arm (Unspecified). On 01-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K010648, expiration date October 2015, 0.65 ml, once) subcutaneously in right arm. Concomitant therapies included tizanidine hydrochloride (muscle relaxer), unspecified patch for muscle pain, levothyroxine sodium and sertraline hydrochloride. In March 2015 the patient developed itching, redness, swelling at injection site. The patient used hydrocortisone cream (manufacturer unspecified) on site as self care. The patient had not had many vaccinations and sought medical attention via contacting the pharmacist. The outcome of these events was reported as not recovered/not resolved. The relationship between these events and ZOSTAVAX was not reported. No PQC was involved. Additional information has been requested.
Swelling, large bruise on arm, redness down shoulder- all more than you would expect from a typical flu shot
Hospitalized (11.14.21 - 11.19.21);  COVID-19 positive (11.13.21);  Fully Vaccinated  Admission Date: 11/14/2021 Discharge Date: Nov 19, 2021 Brief history and medical decision making:  53-year-old female with shortness of breath admitted for COVID-19 pneumonia She is fully vaccinated Received 5 days of remdesivir She is to complete 10 days of Decadron outpatient Sent home on 3 liters/minute nasal cannula of oxygen. Potassium replaced prior to discharge DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Non-intractable vomiting with nausea, unspecified vomiting type [R11.2] COVID-19 virus infection [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: This is a 53 yo woman with a history of hypertension who presented from home with worsening shortness of breath and was found to have bilateral lung infiltrates and was positive for COVID-19. She was treated for COVID-19 pneumonia with improvement and stabilization in oxygen demands. She completed a course of remdesivir and was discharged home to complete 10 days of decadron. Patient received Decadron for DVT prophylaxis. She experienced hypokalemia and replacement was provided. She required 2L of O2 at rest and 2L of O2 with ambulation. She will follow up with her primary care physician next week. She agrees to the medication recommendations and follow up plan. Discharged in stable condition.
Hot and cold at the same time, stomach ache, head ache for a few days after onset, wide awake during night followed by very tired for the next few days.
Initial report was received from a consumer on 22 Dec 2010: This patient was vaccinated with S-OIV FLUVIRIN (Novartis) (unknown batch no.) on 21 Nov 2009. On 01 Dec 2009 patient started to experienced rash on hands, thighs, legs, chest and feet. Patient reported that the rash disappears periodically since then but it had not completely gone away. Patient also had swollen lips since the onset of symptoms. It was reported that this symptoms had never appeared before receiving the vaccine. The outcome of the event was not reported.
Ischemic Stroke and vertigo with no risk factors. I was a 38 year old healthy male beforehand. Only change in my life was this vaccine! About 1.5 months after second dose.
Change in condition: Resident was observed leaning forward in his W/C after supper (1830). Resident was unresponsive to staff and could not hold himself in an upright sitting position. Resident's pupils PERRLA, resident unable to grasp hands, talk, smile etc. Resident's vital signs: BP: 101/69 mmHg; O2: 96% RA; P: 107/min; R: 26/min (shallow); T: 96.5 deg. F. Upon auscultation of the lungs, no adventitious lung sounds noted. Hospitalist at medical facility notified via telephone and telephone order received to send resident non-urgently to ER for evaluation per Dr.  Sent to ER and admitted under observation status.
Patient received Menomune 8/12/03. On 8/18/03 about 6pm, he developed headache and about 1AM on 8/19/03, he developed back pain, neck pain, nausea, vomiting. Reports couldn't get up; lacked strength. He went to hospital where he reports lab tests showed elevated WBC. He reports CAT scan, urine, spinal tap done and ruled out West Nile Virus and meningitis. 60-day follow up on 12/03/2003: "Vaccine recipient has recovered from the adverse events that were reported for this vaccination." Medicl record states weakness, dizziness, dehydration. msv
Received two doses of Fluad Quadrivalent on the same day; This spontaneous case was received on 12-Oct-2023 from other healthcare professional (pharmacist) via digital communications (reference number SEQW23-03323) and concerned a 74-year-old, male patient.  The patient's concurrent conditions included high blood pressure and chronic obstructive pulmonary disease (COPD). The patient's concomitant medications included metoprolol tartrate, venlafaxine, losartan, omeprazole, diclofenac, Crestor (rosuvastatin calcium), trazodone, Norvasc (amlodipine besilate), Lovaza (omega-3-acid ethyl ester), Singulair (montelukast sodium), clonidine and azathioprine, all used for unreported indication.   On 12-Oct-2023, the patient received two doses of Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration and anatomical location: not reported) at two different locations, as reported, for immunisation against influenza disease (explicitly coded as 'Extra dose administered'). The batch number reported was 371630 and the expiry date was 30-Jun-2024.  At the time of initial reporting, the patient did not experience any adverse events after the administration of Fluad Quadrivalent.  The case was assessed as non-serious.  Company comment: A 74-year-old male patient received two doses of Fluad Quadrivalent at two different locations, as reported (explicitly coded as: 'Extra dose administered'). Reportedly, patient did not experience any adverse events following vaccination. Extra dose administered is assessed as not related as per company specific conventions.; Sender's Comments: A 74-year-old male patient received two doses of Fluad Quadrivalent at two different locations, as reported (explicitly coded as: 'Extra dose administered'). Reportedly, patient did not experience any adverse events following vaccination. Extra dose administered is assessed as not related as per company specific conventions.
The patient was to receive Flucelvax and instead received Fluad 65+. Information was looked up and evidence by research and manufacturers the patient experimented stronger local side effects due to the vaccine. This patient also received his first dose of COVID-19 vaccine (Pfizer pediatric).
Death on 2-28-21.  Not felt by this provider to be likely related to vaccination.
p/vax pt devel pain & swelling @ inj site;applied ice;progressed w/swelling & redness to elbow, resolving this AM 10/18/99;still red w/some swelling;