chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been experiencing intense upper arm pain from my shoulder to my elbow.  I am not able to lift my arm.  My blood work shows inflammation markers and low levels of ANA and IFA markers.  I did not have any of these symptoms or markers before taking the vaccine.  I am not able to go to work.  I have seen a primary care physician and a neurologist.  When taking the steroid Prednisone, the pain does subside, but I am not allowed to take a steroid for more than one week.   I stopped taking my second dose of Prednisone 4 days ago, and now all the pain has returned and I cannot lift my arm.  This situation is frustrating and scary.  The doctors do not have a diagnosis or treatment plan.  Pain relievers do not help at all.
received second dose 37 days after first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 37 days after first) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 37 days after first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 37 days after first) had resolved. Not Provided          No concomitant and treatment drugs are provided.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Headache, Nausea and vomiting, Body aches, chills. Tylenol. resolved by following day. Continued sore throat , jaw  and external ear pain on left side only
Vaccine administered 12 hours after expiration date. Expiration 5/25/2021. Administered 1209PM on 5/26/2021
pt recv vax 9JUN95 & approx 1wk prior to 20OCT97 pt devel chickenpox w/greater than 100 lesions;
First several months I had night sweats, diareah, dizziness, and heart racing.  I began to have high blood pressure for the first time in my life.  A year later and I still have heart racing and higher blood pressure than normal.
Patient recieved dose on 2/16/21. Diagnosed with febrile hemolytic anemia in the setting of hereditary spherocytosis in remission after 1st dose of Pfizer COVID-19 mRNA
Pt received doe #2 to left deltoid at 1300. Immediately he began profusely sweating. he was observed for ~ 1 hour and continued to be diaphoretic. No CP, SOB, lightheadedness or syncope. Vital signs normal. Brought to employee health clinic. Remained slightly diaphoretic but normal exam/ vital signs stable
Pt received immunization HPV #3 on 08/31/15. On 09/02/15, pt called Health Dept stating (L) arm very sore, so sore to raise or lay on it. Pt states she feels very weak, not herself.
Started with c/o bilat arm pain, shooting up about 2 wks after injection. Couldn't lift arms due to pain.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of VARIVAX (Merck), (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that the VARIVAX (Merck) lot # was J003705 with expiration date: 27-MAR-2015 (also reported as 12-OCT-2015) and indicated that the VARIVAX (Merck) lot # was J003706 with expiration date: 27-MAR-2015 (also reported as 12-OCT-2015) and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of VARIVAX (Merck) vaccinations. The office was in the process of contacting the patients for revaccination. The correspondence process was review and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Platelets dropped 20 points after first week and then another 20 points, second week afterwards and actually 20 points within 5 days; This is a spontaneous report from a contactable consumer (patient wife) or other non hcp. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that her husband had his first Pfizer shot and his platelets dropped 20 points after first week and then another 20 points, second week afterwards and actually 20 points within 5 days and platelet count was low anyways. She wanted to know, what would happen when he gets his second shot." The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sore left arm; Chills; fatigue; 99.1 temp briefly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 10:30 as dose 4 (booster), single (Lot number: FG9694) at the age of 37 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 10Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. 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 (Booster), Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 10Sep2022 at 14:00, outcome "recovering", described as "99.1 temp briefly"; CHILLS (non-serious) with onset 10Sep2022 at 14:00, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2022 at 14:00, outcome "recovering", described as "Sore left arm"; FATIGUE (non-serious) with onset 10Sep2022 at 14:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, chills, fatigue, pyrexia. Additional information: Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. AE treatment: Ibuprofen.
Case number PHEH2013US015052 is an initial spontaneous report received from a nurse on 12 Jul 2013. This report refers to an adult patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient's vaccination history included administration of MENACTRA (other manufacturer, batch number: not reported) on 29 Aug 2008. The patient received an intramuscular dose of 0.5 ml MENVEO (batch number: 12013) on 13 Mar 2013. It was reported that the patient possibly received MenA lyophilized conjugate of MENVEO diluted with sterile water instead of being reconstituted with MenCYW-135 liquid conjugate. It was reported that a box of MENVEO was found with one full dose and one vial of powder, but without diluent. The patient would be re-vaccinated. No adverse event was reported following maladministration.
Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced NASAL CONGESTION (Nasal congestion). At the time of the report, NASAL CONGESTION (Nasal congestion) outcome was unknown. Relevant concomitant medications were not reported.  In Dec-2021, the patient had nasal congestion for the last three days. She had got her booster dose of Moderna COVID-19 Vaccine on Saturday and woke up Sunday with nasal congestion. Treatment information was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
Headache, arthralgia, metallic taste Narrative:  Patient previous covid dx: 3/19/2020; antibodies at least as of 10/22/2020 vaccine: 12/31/2020, the next day awaoke with sore arm and mild headache sx progressed over next 4 hours to severe headache and neck/bilat shoulder pain and profound malaise. Some migratory arthralgias, transient lower extremity pains, and a metallic taste. Reminiscent of covid for about 6 hours. Some relief with nsaids and apap. By 30 hours later, just tired and soreness at injection site
On February 16, 2021 I suffered a seizure in my sleep my husband witnessed this. I didn't know I had it the next day I had chills, headache and slept more (I never take naps) I felt like I had a virus. Saw my Doctor on 2/24/21. Referred to Neurologist. Saw Neurologist on 3/5/21. Started Vimpat EEG on 03/09/21.
Breakthrough case admission after 3 vaccines Pfizer 3/3/21 Lot# EN6206;  Pfizer 3/24/21 Lot# ER2613;  Pfizer 10/18/21 Lot# Ew0186
2 days I suffer severe body aches, bone and spinal ache hence most of time slept. Somewhat fever condition. Hence just tested and sleep most of time. Observed reddish swelling at injection site with somewhat still painful.
Bumpy hives (some reddish, some whitish) on thighs, buttocks and backs of arms, mildly itchy (woke me up before 5 a.m.).  A 1% hydrocortisone cream alleviated the itchiness, and the treated hives subsided in ~ an hour.  I seem OK now but thought I'd report this side effect as it is not listed in the literature I received.  Also sometimes hives has come back so I'm not sure yet whether they have been resolved.  The sore/achy arm was expected and doesn't bother me.  I noticed that my paperwork has the right arm checked as the injection site but this it an error: the injection was in my left arm.
TESTED  + FOR COVID 7-30-22 WITH SHORTNESS OF BREATH AND WAS ADMITTED TO HOSPITAL SAME DATE.  DECEASED 9-3-22.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 years old child patient and unknown gender. On 21-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reproted. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
1:22 AM:  chest pain, abdominal cramps, chills, difficulty breathing, hyperpnea, bilateral upper extremity trembling VS: pulse 112, respirations 22, temperature 37.0 Celsius, BP 156/103, O2 sat 99% on room air has history of deep vein thrombosis, pulmonary embolism 1:30 AM sent to emergency room via ambulance  4:00 AM report from emergency room: patient is stable and reported feeling better and breathing easier shortly after arriving to ER.  Patient received 500cc NS bolus IV. Labs findings unremarkable.  INR 2.0, PT 21.3, PTT 31. Last taken VS -BP 127/71, P109, R20, O2 93%RA. Patient will be discharging  with Dx: reaction to COVID vaccine.
UPON PHONE CALL WE MADE TO CHECK PATIENT STATUS ON 10/18/2005 PATIENT MOTHER STATED THAT THE PATIENT WAS DOING FINE, THE CHILD DID HAVE A FEVER OF 101.00 F. BUT NO LOCALIZED REACTION TO INJECTION. WE MADE ANOTHER FOLLOW UP CALL ON 10/20/2005 TO CHECK PATIENT STATUS AND MOTHER STATED CHILD WAS FINE, DOING WELL STILL HAD FEVER OF 101.00 F. AND EYES WERE "PINK AND CRUSTY". DR. INFORMED MOTHER TO MAKE FOLLOW UP APPOINTMENT TO LOOK AT EYES AND EVALUATE THE FEVER. MOTHER MADE APPOINTMENT FOR 10/21/2005 AND THEN CANCELLED APPOINTMENT AND DID NOT COME FOR ANOTHER APPOINTMENT UNTIL 10/09/2007. THE 10/09/2007 APPOINTMENT WAS FOR A WELL CHILD EXAM.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 63 years old patient who received vaccine FLUZONE HIGH DOSE lot UJ024AA, expiry date: 29-APR-2019 via intramuscular route in the left deltoid on 29-APR-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Inappropriate age at vaccine administration, overdose and wrong vaccine administered. It was reported that she administered a FLUZONE HIGH-DOSE to a 63-year-old by mistake and mistakenly given the high dose instead of the lower dose quadrivalent. It was reported that No adverse symptoms. 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 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. Documents held by sender: none.
Information has been received from a physician, via a company representative, concerning a patient who, on unspecified date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# not reported).  On an unspecified date, ("not recently") the patient developed arm swelling around the injection site.  The patient sought unspecified medical attention.  Outcome was not reported.  There was no product quality complaint involved.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested.
Pt recv vax on 5/4/99; on 5/9/99 pt exp erythema multiforme & mucous diarrhea
Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022; Dose administered after 30-day Use By Date/vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypocalcemia. Concomitant products included IBUPROFEN, FLUCONAZOLE, FLUTICASONE PROPIONATE and OMEPRAZOLE for an unknown indication.    On 13-Apr-2022 at 1:46 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 1:46 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any known allergies. On 25-Feb-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Patient did not experience any side effects yet. No treatment information was reported.
patient noticed round 'rash' in left armpit on Friday 1/15/2021, it's just an outline of a circle patient's arm was sore locally for a couple days but nothing else presented, including itching, dryness, muscle aches, fever, or any other body symptoms.
This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Hives to torso and legs. EPI PEN and BENADRYL given.
Will not take second dose due to side effects; Backaches; Headaches; Nausea; Bad upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Bad upset stomach), INTENTIONAL DOSE OMISSION (Will not take second dose due to side effects), BACK PAIN (Backaches), HEADACHE (Headaches) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Bad upset stomach), BACK PAIN (Backaches), HEADACHE (Headaches) and NAUSEA (Nausea). On 03-Mar-2021, the patient experienced INTENTIONAL DOSE OMISSION (Will not take second dose due to side effects). On 03-Mar-2021, ABDOMINAL DISCOMFORT (Bad upset stomach), INTENTIONAL DOSE OMISSION (Will not take second dose due to side effects), BACK PAIN (Backaches), HEADACHE (Headaches) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Rash at site of injection; Redness at site of injection; itching at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at site of injection), INJECTION SITE ERYTHEMA (Redness at site of injection) and INJECTION SITE PRURITUS (itching at site of injection) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at site of injection), INJECTION SITE ERYTHEMA (Redness at site of injection) and INJECTION SITE PRURITUS (itching at site of injection). The patient was treated with CORTISONE ongoing since an unknown date for Skin reaction, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE RASH (Rash at site of injection), INJECTION SITE ERYTHEMA (Redness at site of injection) and INJECTION SITE PRURITUS (itching at site of injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
pt recv vax & 3wk later exp maculopapular & vesicular rash w/<25 lesions;titer was extremely low & was classified as negative;
Patient presented to hospital emergency department with complaints of generalized weakness, fatigue, mylagias, chest tightness, diaphoresis, and uncontrollable drooling one day after receipt of COVID-19 vaccine dose #4.  Found to be hypertensive, with initial blood pressures in in the ED of 148/116 and 173/110 mmHg.  Patient claimed to have run out of supplies and had not received maintenance blood pressure medicines for approximately one month.  Clinic records show documentation of chronic nonadherence.  Also present was concern for approximately daily illicit use of methamphetamine.  Accordingly, antihypertensive treatment was urgently provided as well as a comprehensive diagnostic workup for other possible cardiovascular disorders.  Following counseling on the expected course of events following vaccination and the importance of compliance with all prescribed therapy, he was discharged with stable vital signs, improving symptoms and a temporary supply of antihypertensive medications, along with scheduled follow-up plans with his primary care provider.
This spontaneous report was received from a  medical assistant via a field representative, referring to two separate unspecified female patient (both medical assistant's daughters) of unknown age. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were unknown. On unknown dates, the patients were vaccinated three doses of with GARDASIL (lot#, expiration date, concentration, dose, route and frequency were unknown) for prophylaxis. On unknown dates, the patients both developed ovarian cysts. The patients both received some sort of medical treatment for the ovarian cysts. The outcome of ovarian cyst was unknown. The causality between event and GARDASIL was not provided.