chrisvoncsefalvay/vaers-outcomes huggingface dataset:
By error the nurse administered Jynneos vaccine beyond use date; Case reference number US-BN-2022-004311 is a spontaneous case report initially received on 24-Oct-22 from health care professional via Communications (reference: USBAV22-1762) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On 21-Oct-2022, six patients were vaccinated with an unknown dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00013, Expiration date: Sept,2024) at an unknown dose, through unknown route of administration, at unknown anatomical location, for monkeypox prophylaxis.  On the same day, as reported by error, the nurse took the box that had a beyond use date of October 18, 2022, and administrated six doses to patients, (explicitly coded as 'Expired product administered'). Vials were not punctured prior to administration.  As reported, the patients have not reported any adverse events.  The Reporter did not assess the event per seriousness criteria and assessed causality between the event and Jynneos as possible related.  This case is linked with the case US-BN-2022-004306, US-BN-2022-004307, US-BN-2022-004308, US-BN-2022-004309 and US-BN-2022-004310 (same reporter).  Additional information received from on 31-Oct-2022 included local case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.
Tingling/loss of feeling in legs, fever of 105 and chills, bad headache.  Gave 1 Tylenol and 2 Motrin, fluids and popsicles to lower temp.  In Dr office during this time.
Pregnancy; This spontaneous pregnancy case was reported by an other and describes the occurrence of PREGNANCY (Pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (Pregnancy). At the time of the report, PREGNANCY (Pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
A. 2-4 hours post dose: tiredness (may have been unrelated and due to lack of sleep and activity that day) B. Some buzzing in ears, and increased tinnitus (pre-existing) off and on up to ~ 24 hours post C. 4 hours post dose to current (24 hours post): Soreness in arm, at/around injection site, typical of other vaccinations (minimized bruising and soreness by rubbing arm during 15 min wait time to disperse serum and reduce bruising/ soreness); soreness increasing overnight ? feels much like exercise muscle soreness, still tender to touch at site at 30 hours post inoculation.
tired; headache; fell tired muscle tired; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced tiredness, headache and muscle fatigue. On an unknown date, the outcome of the tiredness, headache and muscle fatigue were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, headache and muscle fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and fell muscle, tired and headache.  The reporter asked how long would this last.
Mother stated pt had red raised approximately 2 1/2 cm lesion top of head x 1 wk, was seen by MD. He stated that it looked like a fungus rash kept expanding to a confluent rash on right side of head with a linear line across right cheek bone. Dx as shingles.
Patient experienced her first multiple seizures on May 9, 2021?16 days following her second Pfizer vaccine. She was nearly five years seizure free, and she only ever had one isolated seizure episode at a time, previously.  Treatment is ongoing as her seizures are more frequent and harder to regulate. Treatment is open ended.
Intense pain during injection and post injection, still to this day. Still sore at injection site. Diagnosis of frozen shoulder from Dr.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: about 5-10 minutes after shot pt was already seated, then fainted. i laid her on the floor with her feet elevated on the chair then she came back and was alert and oriented to person place and time. i checked her BP systolic was approximately140/80 with a62 pulse. EMS was called and patient was checked out by them. She was offered transport but declined
Severe chills, body aches, and fever during the night.  Subsided during the night.  No fever the next morning but very weak the next day, (May 3).  Because it happened during the night I cannot state how long it lasted or what my temperature was during that time.  On May 4,  I experienced mild nausea and sore throat.
Narrative: Headache, Fever, Constipation, Diarrhea, NauseaVomiting, GastricBleeding, CHILLS, ABD PAIN 8/10
Impaired emotional state, the abdomen began to inflate, 8/2/2021 is taken by ambulance to the hospital where corresponding studies were carried out. He was having complications from cirrhosis. Then you are discharged on the same day 8/2/2021. On 2/18/2021 he was complaining of generalized pain, they call hospice to be evaluated, caregivers when they proceed to take vitals he was without vital signs.
Pt complained of pain-stiffness left side neck 1-2 days after immunization.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
I?ve had an IUD - Mirena for 3.5 years which has caused my menstrual cycles to stop completely. I no longer get periods. 2 days after the shot I started a heavy period and am still on it. I didn?t think it had anything to do with the vaccine but I was worried something was wrong and needed to see a doctor until someone told me it could be from the shot. After some research I was told by the pharmacist that it?s an adverse reaction and suggested I report it.
Patient was administered the new Moderna Bivalent booster on 9/19/22 and then accidentally administered the same Moderna Bivalent vaccine again on 10/14/22
Pt had involuntary twitches of body, due to receiving vaccine. Pt received BENADRYL 50mg 1mL to buttock. Twitches more in Rt leg and Lt arm. Vitals 136/93 P 83 O2 99% vitals were rechecked after 15 min BP 125/80.
STIFF NECK; DRY MOUTH; HEADACHE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 09:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021 11:00, the subject experienced stiff neck. On 18-MAR-2021 11:00, the subject experienced dry mouth. On 18-MAR-2021 11:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiff neck, headache, and dry mouth. This report was non-serious.
I am a healthy, very active (bicycle ride 1 hour daily) adult male.  I have no serious health conditions.  However, for the past few weeks I've been more fatigued than usual and have had lowered muscle strength and cramps in my arms and leg muscles.
On the afternoon of May 11, 2021 I noticed blood in my urine; later I saw blood in my stool & my gums bled when I brushed my teeth.  My husband took me to a nearby ER, where I  spent 6 hours.  They did a CT; Covid test; and urine culture which showed I had a UTI.  Finally at midnight an ambulance arrived to take me to a hospital.  As I'm being wheeled out of the ER I notice my right hand is becoming purple splotched. I was told that's petechia & it continued to spread over my body.  The EMT with me in the ambulance told me I had low platelets; he said I had "6", which I have learned meant 6,000.   I was put in the "Progressive Care Unit" at the hospital.   Blood  tests were taken & I was hooked up to an IV which delivered steroids; later more IVs were added, so that I had 3 at once delivering steroids, whatever they give for "nutrition" and insulin (they would not let me take my regular insulin (U500) thereby letting my blood sugar get all the way up to 578 at one point!  At some point early on I was told I had ZERO platelets!  A hematologist/oncologist was called in and he ordered a bone marrow biopsy on Thursday morning.  I have never heard a definitive answer on what they found, but they have not contacted me again.  My blood sugar was checked every hour for days making some very sore fingers!  Everything they did with needles resulted in purple/ red bruises all over my upper body, including one huge hematoma on my right forearm.  I have pictures to show my "bruising" if you need to see them.  I was finally released on Sunday morning.  I have struggled since then with constant backache; & sore tailbone, I assume from the biopsy.
Fluzone Quadrivalent was administered to a patient which was was unstable, plus it took a long time before delivery, no AE; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with 2019SA274480 (same reporter).  This case involves a 15 years old male patient who received 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UT6654KA, expiry date: 13-Jun-2020) via intramuscular route in the left deltoid on 06-Sep-2019, which was incorrectly stored.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual mediation error due to incorrect product storage. It was reported that vaccine was unstable, plus it took a long time before delivery. Shipment come and it took 3-4 days to be delivered. Vaccine was out of range and unstable.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
RASH AT SITE ON RIGHT ARM LATER SPREAD DOWN ARM, SOME SWELLING OF/AROUND THE EAR/NECK, CALLED MD, PATIENT TAKING ZYRTEC AND ZANTAC AS WELL AS RX TRIAMCINOLONE 0.025% CREAM.
feel this is some sort of allergic reaction; began to develop itchy, sore welts; began to develop itchy, sore welts; I developed a persistent itch on both of my hands on the skin between my thumb and fore finger.; Within 9 days of the 2nd dose I began to develop itching lumps on the back of my head approximately 1 inch above my hair line.; Within 9 days of the 2nd dose I began to develop itching lumps on the back of my head approximately 1 inch above my hair line.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3248), second dose via an unspecified route of administration, administered in right arm on an unspecified date in Feb2021 at 14:00 as dose 2, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing Sufla related drugs. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982), first dose via an unspecified route of administration, administered in right arm on an unspecified date in 04Feb2021 at 08:30 as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced within 9 days of the 2nd dose I began to develop itching lumps on the back of my head approximately 1 inch above my hair line on 08Mar2021 at 20:00, I developed a persistent itch on both of my hands on the skin between my thumb and fore finger on 12Mar2021, began to develop itchy, sore welts on 17Mar2021. It was reported that, within 9 days of the 2nd dose, I began to develop itching lumps on the back of my head approximately 1 inch above my hair line. On 12Mar2021 I developed a persistent itch on both of my hands on the skin between my thumb and fore finger. On 17Mar2021 I began to develop itchy, sore welts on about 45% of my body. On an unspecified date, the Doctors, ER and others feel this is some sort of allergic reaction. Prior to receiving the vaccine my only allergy was to Sulfa type drugs. Adverse events resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care. Adverse events treatment included IV therapy and ongoing Prednisone. The outcome of all the events was reported as not resolved and outcome of the event feel this is some sort of allergic reaction was unknown.  Follow-up attempts are completed. No further information is expected.
Fever and tiredness next day.  Temperature 2 1/2 degrees above my normal (99.9 vs. 97.4)  Redness at site, red spots below that, merged into pinkish patch.  Day after grew redder and larger (3"x4").  Kept growing larger and redder over next days.  A bit itchy, more of a burny sensation.  Some mottling, with white spots.   Eventually, became 6x7" reddish area, towards elbow.  8 days after vaccine: faded but still obvious, and reddish, especially after shower.  Fainter next week, but still large.  19 days (!) still there and a few spots itchy again.    Note:  This was similar to my reaction to 2nd COVID vaccination, but that began 5 days after vaccine and lasted only 16 days before vanishing.
ALLERGIC REACTION; This spontaneous report received from a consumer concerned a 48 year old white Hispanic female. This report was received from news/social media. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. Vaccination site had outdoor temperatures around 78-80 degrees. No concomitant medications were reported.  On an unspecified date in  APR-2021, the patient experienced allergic reaction (rash), after vaccination and was hospitalized (date unspecified). Treatment medications given on an unspecified date in /APR/2021 included: epinephrine, methylprednisolone sodium succinate, diphenhydramine hydrochloride and fluid. The patient was hospitalized overnight and was discharged with good health. The duration of hospitalization was 1 day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction on APR-2021. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to. Sender's Comments: V0: -JANSSEN COVID-19 VACCINE Ad26.COV2.S- ALLERGIC REACTION. This event is labeled and is therefore considered potentially related.
About 11  minutes after patient received Moderna vaccine patient started complaining of having a shooting pain from his neck down to his shoulder. Took patient' s blood pressure and reading in left arm was 155/104. Reading in right arm 147/102. Called 911.  Patient also claimed his tongue started feeling "fat". Paramedics arrived to check him out in ambulance.
Mild pain in his arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included short memory loss.   On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 8th December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: After receiving the vaccine the patient experienced mild pain in his arm at the injection site that was still ongoing at the time of reporting. The reporter does not have vaccine information for this adverse event, he stated short term memory issues prior to vaccine dose. The reporter did not consent to follow up.
This individual got her second Pfizer vaccine in March 2021. A month later, she developed Bell's palsy and significant arthritis pain. She can not bend over or raise her arm up comfortably. She has no control over the right side of her face and cannot close her right eye.
Last Thursday June 10, associate  received  2nd dose of the pfizer covid 19 vaccine and at first  symptoms were mild with nausea but last night  6/14, started getting chills, body aches, fever, nausea, and headaches that couldn't be relieved by Tylenol or ibuprofen.  Currently 6/15. still getting fevers, chills, headaches come and go.  Still taking Tylenol and Ibuprofen every 6 hours.
Reports itching "all over".  Patient reports Pepcid & diphenhydramine 25mg at 0930.  Patient began to clear throat during monitoring. Administered additional 25 mg diphenhydramine at 1117.  1/24/21 patient reports that she went to ED for treatment. As given "shot of prednisone" and discharged.
Patient walked himself out of clinic; while entering car in clinic parking lot patient fainted and hit head on gravel. Patient was of consciousness when clinic staff arrived on scene. Patient was pale. BP was taken and 5 liters of oxygen was administered while patient lied on bed with elevated legs. Ice pack was given for head trauma.
received the first dose on 24Sep2019 and has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th Septemer 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Vaccine data was not available. The reporter consented to follow up.
5 patients received a vaccine dose that was refrozen/one patient received it 9 days ago and the other 4 received it 7 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (5 patients received a vaccine dose that was refrozen/one patient received it 9 days ago and the other 4 received it 7 days ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (5 patients received a vaccine dose that was refrozen/one patient received it 9 days ago and the other 4 received it 7 days ago). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (5 patients received a vaccine dose that was refrozen/one patient received it 9 days ago and the other 4 received it 7 days ago) had resolved.        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.   The action taken with mRNA-1273 in response to the event was not applicable.
17 year old patient. 16 minutes after immunized refers feeling dizzy, looks pale, sweating and scared. V/S are taken Pulse 60, o2-100, R-18, DXT- 93mg/dl. Patient is lying down and legs are elevated, comfort and privacy are provided. Mother is aware of procedure and treatment.