chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11-year-old female patient Outside Of The Recommended Age Range, was inadvertently administered intramuscularly the DT vaccine rather than the Td vaccine with no reported adverse event; Initial information received on 05-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 11 years old female patient who had reported that patient outside of the recommended age range, was inadvertently administered intramuscularly the dt vaccine rather than the td vaccine with no reported adverse event while receiving vaccine diphtheria-25/tetanus-5 adsorbed toxoids no preservative. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 05-Apr-2022, the patient received a 0.5 ml dose of suspect diphtheria-25/tetanus-5 adsorbed toxoids no preservative (strength, frequency, batch lot number, expiry number and formulation: unknown) via intramuscular route in unknown administration site for immunization. Batch lot number is requested.  On 05-APR-2022, the patient developed a non-serious event 11-year-old female patient outside of the recommended age range, was inadvertently administered intramuscularly the dt vaccine rather than the td vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of diphtheria-25/tetanus-5 adsorbed toxoids no preservative.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (product administered to patient of inappropriate age).  At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.  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 guidelines. 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.
Wasn?t feeling well bad headache since Friday and I?m not one to get headaches  Left arm was swollen hard to pick rise Allergic reaction light rash around area of the shot
urticaria/hives; both arms heavy and numb; large swollen bump at elbow, smaller bumps surrounding the bump at elbow; burning sensation on left ear/burning on back of neck; left ear is swollen; rash throughout her body; itchy; sleepy/drowsy; Tired; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (sleepy/drowsy), PRURITUS (itchy), URTICARIA (urticaria/hives), LIMB DISCOMFORT (both arms heavy and numb) and JOINT SWELLING (large swollen bump at elbow, smaller bumps surrounding the bump at elbow) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced SOMNOLENCE (sleepy/drowsy), FATIGUE (Tired) and HEADACHE (headache). On 29-Apr-2021, the patient experienced PRURITUS (itchy). On 30-Apr-2021, the patient experienced URTICARIA (urticaria/hives), LIMB DISCOMFORT (both arms heavy and numb), JOINT SWELLING (large swollen bump at elbow, smaller bumps surrounding the bump at elbow) and EAR SWELLING (left ear is swollen). 30-Apr-2021, the patient experienced BURNING SENSATION (burning sensation on left ear/burning on back of neck) and RASH (rash throughout her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 29-Apr-2021 at an unspecified dose and frequency; HYDROCORTISONE on 29-Apr-2021 at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (CALADRYL [DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) on 30-Apr-2021 at an unspecified dose and frequency and LORATADINE on 30-Apr-2021 at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleepy/drowsy), PRURITUS (itchy), URTICARIA (urticaria/hives), LIMB DISCOMFORT (both arms heavy and numb), JOINT SWELLING (large swollen bump at elbow, smaller bumps surrounding the bump at elbow), BURNING SENSATION (burning sensation on left ear/burning on back of neck), EAR SWELLING (left ear is swollen), RASH (rash throughout her body), FATIGUE (Tired) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Non Significant FU- Obtained correct email id
This study case was received from the investigator on 02 March 2011. A 27-year-old male subject with a medical history significant for psychiatric illness was vaccinated with ACAM2000 on 24 June 2010 (lot number not reported). Concomitant vaccines consisted of TYPHIM Vi and ANTHRAX on 22 June 2010 (lot numbers not reported). On 04 July 2010, ten days post vaccination, the subject had an abnormal troponin I level of 00.14. An ECG and echocardiogram performed on 04 July 2010 were normal. The subject was diagnosed with Non-specific myocarditis on 04 July 2010, and Other on 05 July 2010, and Unspecified disease of pericardium on 09 July 2010. No other information was provided. The outcome of the subject was not reported. List of documents held by sender: None.  Note: Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Mom says she broke out with a quarter size rash, approx. 8 spots on back, 3 on abdomen, and one on the top of her foot.The spots were red and dry. After the next set of vaccines she had the same rash only the spots were dthe size of a mosquito bite.The 3rd visit she only had a Dtap and her 4th visit she had only a Prenar shot. Her pediatrician feels it is eczema and not the vaccines, but mother wants it reported because sshe feels there is a connection. She does want the vaccines, but does not want to persue them at this time until she can get more information.
Symptoms are mild nausea, mild fatigue, mild headache, and mild dizziness.  Treatment includes tylenol and rest.
Moderna COVID-19 Vaccine  Patient reports to provider that she is experiencing redness and tenderness to her left breast 2 days after vaccination. Denies any drainage from the spot, no fever or chills, no body aches. Skin erythematous to area, 3 cm in diameter to left lower breast area resembling cellulitis.
This spontaneous report was received from a Licensed Practical Nurse (LPN) referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history drug reactions, allergies and concomitant medications were not reported. It was reported that on 09-DEC-2016, the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 (lot # M022086, expiration date 09-OCT-2017) (strength, dose and route of administration were not reported) for prophylaxis. It was reported that the temperature excursion was for 30 minutes at 8.4 degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA005657.
neurological problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: Nov2020 (unspecified if ongoing), notes: Positive. The patient's concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological problems".  Additional information: It was reported the patient was submitting for research, patient was post COVID 19 positive Nov2020, got 2 series of pfizer vaccines on 2021. Reporter was hoping via research will be able find out what was causing of neurological problems.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hives all over face , neck, arms both and thigh both & ear lobes left side more than right ear lobe
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 12-Feb-2012. On 13-Feb-2012, the patient received FLUMIST that was 12 hours expired. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
left shoulder slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (left shoulder slightly sore) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (sulfa - suspected), Cancer (SLL cancer, bladder cancer) since 2013, Arrhythmia (heart rhythm problems) since 2013, Hypertension (blood pressure hypertension) since 2013 and Arthritis (old age arthritis) since 2006. Concomitant products included DIGOXIN from 14-Dec-2016 to an unknown date, APIXABAN (ELIQUIS) from 02-Dec-2016 to an unknown date and METOPROLOL from 03-Dec-2016 to an unknown date for Arrhythmia, ATORVASTATIN from 20-Aug-2014 to an unknown date for Cholesterol, LATANOPROST from 09-Sep-2011 to an unknown date for Glaucoma, AMLODIPINE from 03-Jul-2013 to an unknown date, CHLORTHALIDONE from 24-Jun-2014 to an unknown date and LOSARTAN from 30-May-2013 to an unknown date for Hypertension, METHENAMINE from 10-Aug-2018 to an unknown date and TAMSULOSIN from 19-Aug-2018 to an unknown date for UTI, BPH and Urinary retention, MULTIVITAMINS;MINERALS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ARTHRALGIA (left shoulder slightly sore). At the time of the report, ARTHRALGIA (left shoulder slightly sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided   This case was linked to MOD-2021-101196, MOD-2021-101196 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: The Significant follow up received in which patient demographic details were added. Medical history information is added. Concomitant drugs were added. On 13-Jul-2021: Follow up received does not contain any new information.
Headache, Myalgia, Fever & CoughWheeze  Narrative:
welts on arm; round bumps on arm; itching over entire body; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching over entire body), URTICARIA (welts on arm), VACCINATION SITE MASS (round bumps on arm) and VACCINATION SITE PRURITUS (itching at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). On 22-Mar-2021, the patient experienced PRURITUS (itching over entire body). On 25-Mar-2021, the patient experienced URTICARIA (welts on arm) and VACCINATION SITE MASS (round bumps on arm). At the time of the report, PRURITUS (itching over entire body), URTICARIA (welts on arm), VACCINATION SITE MASS (round bumps on arm) and VACCINATION SITE PRURITUS (itching at the injection site) had resolved.            The action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.  Treatment details included, acetaminophen and some cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: AE outcome was updated.
No problems until the next morning.  Very dizzy and passed out twice when I got up .  Slept most of the day  Chills and sweat and never had a fever  .  The second full day I started out feeling poorly and then felt much better later.  The 3rd day I felt normal and the 4th day symptoms returned.  I was dizzy and lethargic for part of the day.  The 5th day (today) I have a foggy brain and low energy and a slight headache in the front of my head.  I had no side effects after the first two shots and this one hit me like a train.  I am reporting to help others decide if the 3rd shot is worth it.
Constant pain at injection site, pain with movement of arm, wakes up at night with arm pain, no relief with Tylenol, Aleve or Bengay.
EARACHE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced earache, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the earache and headache was not reported. This report was non-serious.
Case number PHEH2017US002900 is an initial spontaneous report received from pharmacist on 24 Jan 2017. This report refers to unknown demographics patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number not reported) at a dose of 0.5 ml intramuscular on an unknown date. A temperature excursion was reported with FLUVIRIN multi dose vial (MDVs). Some may had been opened and some may had been unopened. The minimum temperature reached was 32 degrees Fahrenheit (F). The maximum length of excursion was 12 hours. Pharmacist did not know if patients had received the vaccine after the temperature excursion. No adverse event was reported following this medication error.
Red, warm, tender, and painful left deltoid at vaccine site. Rx: Augmentin ES 600mg PO bid per order. Warm compress.
A report has been received from a Health Professional concerning a, Male subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal). FLUMIST Quadrivalent (Intranasal) started on an unknown date. The patient experienced peripheral paresthesia. The outcome of the event of peripheral paresthesia is unknown. The report was considered to be non-serious. The reporter and company physician concerned that there was no causal relationship between peripheral paresthesia and FLUMIST Quadrivalent.
PT GOT IMMUNIZATION 2 DAYS AGO AND STARTED HAVING SWELLING OF DELTOID AND ARM AREAS THE SAME DAY WITH ALSO REDNESS, HOT AND MILD PRURITUS.  HE WAS SEEN IN OFFICE TODAY 10/03/07 AND GIVEN BENADRYL.
Pain and discomfort in right arm pit with a noticeable  large swollen lymph nodes. Currently still slightly swollen but not painful as of today 03/28/21. Second dose is scheduled for 04/10/21.
Pt states that within a couple of hours of receiving 1st hep b she had the following symptoms: high fever, hives, nausea, hoarseness, headache and stiff neck. She states all symptoms have resolved except headache. Pt to go to doctor if symptoms get worse.
Fever, aches accompanied by blurred vision that turned into double vision over the first 24 hours after shot. Diplopia and ptosis were severe and I visited the urgent care who sent me to emergency eye hospital May 14th, eye exam performed confirming diplopia and ptosis, and did bloodwork. Ordered CT scan that I completed June 4th,. Visited neuro opthamologist again June 10th, ordered emergency brain MRI and EMG. MRI completed June 11, EMG scheduled tomorrow June 16,  diplopia and ptosis still present for the last 5+ weeks, everyday- all the time. Now, I have to wear an eye patch at all times to even kind of see.
6-5-21 8.20pm Pain in  heart, shortness of breath, needing to breathe through mouth, not nose. Held on to counter&walls for balance. Earlier  had joint pain and pain in back. 8:45pm arrive at Urgent Care. Turned away. told to go to ER. 9:15 in ER, Temp 102 pain in heart continues. Given inflammatory at 11pmPain stops shortly after. EKG and Blood work taken. "Small abnormality" s on EKG.Pain ilntermitt through Wed.Motrin given as needed. Energy level low, &tired. Pain constant Wed afternoon. 6/1021 Followup w/family practitioner. Advised to start motrin every 6 hours. 6/11/21 Hospital for EKG,ultrasound , Cardiologist consult. Irregular intermittent p curve. Continue motrin, limit exercise.
Day one- fatique, nausea, chills, low grade fever (100); day 2 continuation of previous, fever 100-101, chills, nausea; Day three temp 99-100 rash on face, neck , chest, and arms, fatuque itching  Rx zyrtec 10 mg 1 tab daily
FATIGUE, HA, CHILLS, JOINT PAIN, TENDER LOCAL LYMPH NODE TO SIDE OF INJ, PAIN INJ SITE, COUGH, SOB, SORETHROAT, LOSS OF TASTE/SMELL,
patient reported her psoriasis flared up after receiving 1st dose, she did not receive the 2nd dose
Patient started to have a large round red area form of right arm where Varicella vaccine given; symptoms started 7/20/08 vaccine given 7/18/08 area 7.5cm x 7.5cm in size.
first it was a prickly burning spot on my right shoulder blade that I thought must be an insect bite. It was hot and swollen and itched.  I took an ott Zyrtec capsule.  Next morning it was much worse and very painful, and had expanded the area affected.  My sister took a cell photo and we looked at the internet and the appearance matched shingles.  I had both shots of the anti-shingles virus two years previously.  Then that area on the right lessened in intensity but then I developed the same thing on the left side.  I went to my primary care physician and he agreed it was shingles but did not think it was related to the Covid-19 vax, but I do think it might be and that's why I'm reporting directly to you now
Localized swelling.  Localized pain.  Localized restriction of motion.  Localized reaction: left upper arm.  Fever, apex 101.0F.  Treated self with acetaminophen and sought treatment in hospital environment on 8/27/2016.  Patient experienced mild tapering of symptoms 8/28/2016 and symptoms largely resolved by 8/29/2016.  Patient still experiencing mild aching pain with full range of motion in upper left arm as of 8/30/2016.
Patient developed tenderness, redness, and swelling two days after receiving the vaccines. Area was also warm to the touch on exam in the office.
after the shot i felt dizzy and blur on my visoin shared with Dr on site she told me these symptoms will go away in three to four days waited for three to four days but symptom got worse i start coughing, runny nose, and chills got negative covid test result and still have the symptoms runny nose, cough and little shortness of breat also pain on my right shoulder and lower back also headach.
07/01/02 102 degrees fever, macular rash to face, trunk, arms, pain with eye movement, fatigue, joint pain in hands and knees. All symptoms resolved by 07/06/02. Fever until 07/02/02. Rash until 07/05/02.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 25-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced COVID-19 (Patient went to Europe and upon return Contracted COVID). At the time of the report, COVID-19 (Patient went to Europe and upon return Contracted COVID) was resolving. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication information provided.  No treatment medication information provided. The reporter causality for the event of patient upon return contracted COVID with HUMIRA was no reasonable possibility.  Company comment- This spontaneous case concerns a 71-year-old female patient treated with Adalimumab (reported as co-suspect) for an unknown indication, who experienced the unexpected non-serious AESI COVID-19. A dose of mRNA-1273 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Onset date of the event was not provided; hence, latency cannot be assessed. Details of symptoms, clinical course, investigation reports and treatment were not provided. Patient´s elderly age and treatment with Adalimumab remain as possible risk factors. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old female patient treated with Adalimumab (reported as co-suspect) for an unknown indication, who experienced the unexpected non-serious AESI COVID-19. A dose of mRNA-1273 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Onset date of the event was not provided; hence, latency cannot be assessed. Details of symptoms, clinical course, investigation reports and treatment were not provided. Patient´s elderly age and treatment with Adalimumab remain as possible risk factors. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
headache, dizziness, nausea, diarrhea, numbness in her left leg ( ?heaviness?).
I couldn't breathe or swallow. This started about 2 months after vaccination. I went to the ED and they admitted me for 2 days. I went to hospital. They finally came up with laryngeal spasmatic pneumonia.
itchy back of neck; rash looks like heat rash (whelps); swollen node on neck (small); congestion;