chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first dose (4/1/2021)  gave me no side effects.   The second dose ( 4/29/2021) gave me  side effects  the next day of fatigue, headache.  I felt better 24 hours later. The booster shot on 11/18/2021 gave similar side effects as second dose the next day, fatigue, headache which resolved in 24 hours.   11 days later I started scratching on my left arm? within 24 hours I had hives all over my body, red skin, hot, swollen, itchy, it started on my arms and then it started moving around to my ears, my scalp, my neck, my torso, my legs, my feet.  I started taking one Claritin per day and using calamine but it wasn?t doing anything.   After 2 days I switched to Zyrtec twice a day and the hives were a little bit better .   By week 3 I was on 1 Zyrtec a day? week 4 1 Zyrtec every 48 hours or so.  I?m on week 6 and I?m taking 1/2 Zyrtec per day?. As soon as it wears off the hives start again.  At times when the Zyrtec is wearing off I have a feeling of my throat getting swollen and at times I feel my chest is tight, and I?m tired.
Scattered macular/papular eruptions - some w/small pustules - over trunk and upper arms. Lesions mildly pruritic. Normal eschar at vax site.
My son developed a hive like rash that I was in contact with the pediatric nurses from the facility where the vaccines were administered. I was initially told the hives were a common and normal side effect of the MMR shot. Over the next few days the hives turned into purple, lesion like bruises. Everywhere he had been touched was a deep purple color and all patches were changing to this bruised color tone. At that time we were advised to take him to the ER as the pediatric office was not currently open. When we arrived at the ER at hospital he had to be given epinephrine along with other drugs to calm his reaction down. Since then, we've dealt with ear infections directly following, mild eczema, but most concerning is the GI issues. He has suffered from chronic constipation symptoms. We were advised to give MIRALAX, which we did, until it caused him to develop rectal prolapse. The first time that happened we went to the ER at hospital. I have since taken him off the MIRALAX and I've not seen rectal prolapse in 6 months, but he still withholds up to 4 days at a time and strains every time he has to have a bowel movement. Most recently, he's also developed blood and mucous in his stools.
Information has been received from a registered nurse concerning a female who was vaccinated with the varicella virus vaccine live. The registered nurse reported that the patient "has a had two doses of varicella virus vaccine live and still has not seroconverted". Unspecified medical attention was sought. Additional information has been requested.
I believe pt was given 0.3 ml of undiluted Pfizer covid 19 vaccine.  there was an opened vial in clinic and 6 doses had been administered.  it appeared that there was an additional dose in the vial the other NP working today placed on the counter. it was in the brown bag marked with stats of previously opened vial and the seal was missing.  It was later discovered that this may have been an undiluted vial.
8 days after vaccine- all of a sudden had itchiness at vaccine spot.  Raised lump, hot, itchy and red. No other symptoms at this time.
Local (L) upper ext. swollen, pain & pain down (L) arm to hand, swelling of hand.
Started with weakness and fatigue progressed to high blood pressue and fainted for the first time on 2/28/2009. Has been diagnosed with Postural Orthostatic Tachycardia Syndrome.
pt recvd vax; devel soreness & swelling at inject site followed by n,v,chills & fever; was tx w/ dph cream & application ice;
Sore arm, headache, nausea, sweats Time: from 7PM (Feb. 17th) until morning of the second day (Feb. 19th).
Sx for 4 days:  Fever (T39.5 ) Nausea Body pain  headache  weakness  Stomache
Fever and crankiness on Dec. 3rd - followed by 2 evenings of uncontrollable high pitched crying for about 7 hours each night - very disoriented and unresponsive to consoling constant contact w physician.
pt recvd vax;had generalized tonic clonic sz,lasting less than 5 min & resolved w/out meds;t of 104.9 & otitis med;later that noc, another sz; past hx of febrile sz 30-sep-94; father also h/o febrile sz;
Discharge Provider: Medical Doctor Primary Care Provider: Medical Doctor Admission Date: 7/6/2022 Discharge Date: Jul 10, 2022  PRESENTING PROBLEM: Weakness; Weakness of right lower extremity   HOSPITAL COURSE: 61-year-old female with a past medical history significant for multiple sclerosis who presents due to complaints of headache and right lower extremity weakness.   Patient was seen by EMS.  She was overall stable and had no hypoglycemia that time.  She was brought into the emergency department where code stroke was called.  Patient was found to have an stroke scale score 5. She went for CT scan of the head which showed no acute bleed.  Neurology was consulted for further evaluation and the patient was thought to warrant admission to the hospital.   Patient did undergo CT angiography of the head and neck as well as CT perfusion scan of the brain.  No acute pathology was seen on CT angiogram number CT perfusion scan.  Neurology recommended MRI for further evaluation.   Patient was admitted to the hospital and did undergo MRI evaluation.  MRI was of limited value but it did rule out acute ischemic event.  All further imaging did not show any acute pathology.   With no interventions, the patient did feel some symptomatic improvement in her right lower extremity weakness.  However, the patient states that her symptoms seemed very reminiscent of her previous episodes of MS flare and she inquired as to the use of steroids.  Discussion was had with Neurology.  Neurology did agree with steroid use.  Patient was prescribed methylprednisolone 1 g IV daily for 3 days.  With methylprednisolone, patient's strength significantly improved in her right lower extremity.   Although patient's strength is improving in her right lower extremity, she was still not back to her baseline state in regards her functional status.  Patient was seen in consultation by PT/OT.  She was thought to benefit from subacute rehab placement.  Patient was discharged to skilled nursing facility on 07/10/2022 in stable condition.
excursions exceeded 72 hours of went below 0 C with no reported adverse event; patient was given a (Fluzone QIV) vaccine that had undergone a temp excursion with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 66 years old male patient who reported excursions exceeded 72 hours of went below 0 c and patient was given a influenza quadrival A-B multidose vaccine preserved [Fluzone Quadrivalent Multidose]  that had undergone a temp excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient reported excursions exceeded 72 hours of went below 0 c with no reported adverse event (product storage error) (unknown latency).  On 11-Sep-2023, the patient received 0.5ml dose of suspect influenza quadrival A-B multidose vaccine preserved, Suspension for injection (lot U8049AA; strength, expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination (Immunization) that had undergone a temp excursion with no reported adverse event (poor quality product administered) (latency: on same day).  The situation occurred due Refrigerator malfunction and Human error not involved.  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
room was spinning; dizziness/ head feels light; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration injected in the left arm on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received her Pfizer vaccine 1st dose on 28Jan2021. The patient stated that on 01Feb2021, she woke up at 7:30 and her room was spinning. She sat on the edge of the bed and stated it lasted 10 min and the dizziness lasted for one hour or so. By noon, she stated she was back to "almost normal." She stated today (02Feb2021) that her head feels light. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
on the second day after vaccine patient had a headache for the day; fatigue; muscle pain; chills; fever of 101.1 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever of 101.1 degrees F) and HEADACHE (on the second day after vaccine patient had a headache for the day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04021A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, DULOXETINE and OLANZAPINE for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 20-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (fever of 101.1 degrees F). On 21-Mar-2021, the patient experienced HEADACHE (on the second day after vaccine patient had a headache for the day). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 21-Mar-2021, FATIGUE (fatigue) and HEADACHE (on the second day after vaccine patient had a headache for the day) had resolved. On 22-Mar-2021, MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (fever of 101.1 degrees F) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Body temperature: elevated (High) 101.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has scheduled 2nd dose of vaccine on17-04-2021.  Patient reports taking an over the counter Migraine Pill (NOS) that contained caffeine.
This spontaneous report as received from a pharmacist via field representative refers to a female patient of unknown age (1 of 2 patients known by pharmacist/several patients). The pharmacist reported that in approximately October 2013 (reported as over past 2-3 weeks), she had several patients vaccinated with PNEUMOVAX23 vial (dosage, lot and expiry date were not reported) who had experienced serious local reactions after vaccination including swelling and redness. Patients sought medical attention-had called pharmacist. The reporter (pharmacist) knew of 2 patients who had these events, including one patient who could not move her arm after the injection (disability). The outcome of events was unknown. The reporter also mentioned that her partner at the pharmacy had seen 3 or 4 patients with injection site reactions. The reporter considered the event could not move her arm after the injection as disability. This is case 2 of 3 reports received from the same reporter. Additional information has been requested.
Pt received TDAP instead of rec. TD. No reactions reported. Pt contacted of error. Rec. ACIP recommendation.
High fever since immunization that were received on 1-16-08. Seen for reaction and high fever on 1-17-08
Fever-101, Chills, Body aches, Left arm so sore, I could not move it. My arm was in constant agonizing pain with no relief from elbow up to shoulder. It felt like I had a broken arm. I was unable to sleep that night and I was too sick to go to work the next day.  24 hrs later, my arm is still in pain, but not as severe. No more fever presently.
NO ADVERSE EVENT.  MODERNA WAS GIVEN TO 17 YEARS OLD INSTEAD OF 18 YEAR OLD
unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     The patient's past medical history included Cyst (cyst between toes on left foot, it disappeared without a trace and never came back) and Cough. Concurrent medical conditions included COPD (COPD symptoms returned after 5 to 7 days after the 1st shot) and Allergy NOS (Allergy issues returned after 5 to 7 days after the 1st shot).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  It was reported that patient had COPD and after the 1st vaccine the COPD symptoms disappeared, Patient could breath better, chronic allergy issues disappeared and patient had a cyst between two toes on left foot it disappeared without a trace and never came back, the coughing was gone but the COPD symptoms and allergy issues returned after 5 to 7 days after the 1st shot. Patient stated that the 1st vaccination was fantastic. Patient spoke with their HCPs and she was told that no patients reported the unattended benefits. Patient stated she didn't took any drugs. It was reported that patients condition of COPD symptoms and allergy issues disappeared initially after receiving 1st vaccine, However after 5 to 7 days of 1st vaccine it got reappeared. No treatment information was reported.   This case was linked to MOD-2022-613577, MOD-2022-613593 (Patient Link).
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported. Company comment-This spontaneous case concerns an adult female patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 on unknown date after a dose (dose number not specified)of mRNA-1273 vaccination.  Latency cannot be assessed since vaccination date nor event onset date were provided. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments: This spontaneous case concerns an adult female patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 on unknown date after a dose (dose number not specified)of mRNA-1273 vaccination.  Latency cannot be assessed since vaccination date nor event onset date were provided. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Stye on right eye; Left ankle pain; Right foot bruising; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 11Mar2021 at 14:00(at the age of 24-years-old) as a single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 08Apr2021 as a single dose for COVID-19 immunisation. Medical history included prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient had no known allergies. On 31Mar2021 at 09:00 the patient experienced, stye on right eye, left ankle pain and right foot bruising. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 29Mar2021, the patient underwent nasal swab and the test result was negative and on 29Mar2021, the patient underwent COVID-19 virus test and test result was negative. The clinical outcome of the event stye on right eye, left ankle pain and right foot bruising was not recovered at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained. No further information is expected.
CHILDS DOB REPORTED AS DATE ON CONSENT BUT DOB IN SYSTEM IS ANOTHER WHICH WOULD MAKE THE CHILD 11 YEARS OLD AT TIME OF VACCINATION AND DEFINED AS UNDER AGEDS.
red, swollen, hot, itchy and painful at injection site. area of redness grew exponentially over a 24 hour period.
no adverse event moderna confirmed 216K22A was viable until 2/21/23 despite beyond use date of 1/22/23
I had heart palpitation and my blood pressure was high, I was prescribed low dose of BP medication to maintain a decent Blood Pressure.
ELEVATED CREATINE KINASE LEVEL; MUSCLE WEAKNESS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for pain. On 21-MAR-2021, the subject experienced muscle weakness. On 24-MAY-2021, Laboratory data included: Creatine kinase high (NR: not provided) 210. On an unspecified date, the subject experienced elevated creatine kinase level. Laboratory data (dates unspecified) included: Creatine kinase high (NR: not provided) 150 or so, 160. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle weakness, and elevated creatine kinase level. This report was non-serious.
This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications and drugs reactions or allergies were not reported. On unknown dates, an unspecified number of patients received improperly stored doses of VARIVAX injection, lot # N017395, expiration date 07-JUN-2019, for prophylaxis (dose, dose number, route of administration and anatomical location were not reported). It was reported that sterile diluent used for reconstitution of the vaccine was properly stored. No adverse effects were reported. It was reported that the vaccines were stored in temperature of -9 to 8 (also reported as -8.8) degrees Celsius for 52 minutes (date unspecified). There were no previous temperature excursions recorded. A digital data logger was involved in recording the excursion details. This is a non-valid case due to lack of patients' identifiers. Please add to the end of the narrative: As of 27-NOV-2017, all telephone attempts to obtain follow-up information have been unsuccessful.
Clenched muscles in hand and persistent, throbbing pain. Hand pain started after first dose of Pfizer Covid-19 vaccine; symptom dramatically worsened within 24 hours of second vaccine dose.
A 39-year-old female patient had received a left arm, subcutaneous (not recommended route of administration for this product) injection of Menactra, lot number 02207AA, on 16 May 2007. The following day, she experienced redness, itching and swelling at the injection site. The event required medical examination, and the patient was treated with Tylenol and hydrocortisone cream. At the time of this report, the patient has not recovered.