chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Float staff unfamiliar with workflow in clinic, pulled Pfizer vial and didn't dilute, gave too concentrated dose to patient.  Per guidance on administration errors, dose does not need to be repeated.
Pt. received FLUZONE HD on 11/06/2018. The following day the patient experienced typical injection site reaction in addition to fever. She then developed a blotchy rash on her back and legs.
This is a spontaneous report obtained from a contactable nurse who reported for herself. A 67 year-old patient received, on 23Dec2014, PREVNAR 13 single dose. Relevant medical history was unknown. Concomitant medications included SYNTHROID and acetazolamide for Meniere's disease. On an unspecified date, the patient had a breakout in her mouth like a horse shoe red (in the middle of the back of her mouth, it was not on one side, it was all the way round other side just like the exact figure of the horse shoe and it was hurting). The patient's joints were not acting (her joints were little worse) and she had also pain in joints. The patient received ADVIL. The patient was recovering from pain mouth, while clinical outcome of the other events was unknown. Follow-up (04Mar2015): Follow-up attempts completed. No further information expected.
headache; dizziness; a patient received who received the Moderna Covid vaccine as her 1st dose on 01AUG2021 and received the Comirnaty as her 2nd dose today.; a patient received who received the Moderna Covid vaccine as her 1st dose on 01AUG2021 and received the Comirnaty as her 2nd dose today.; This is a spontaneous report from a contactable other hcp(nurse). A 35-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/lot number: EW0191, Expiry date: Sep2025) via intramuscular route in left deltoid, on 08Sep2021 08:40 (age at vaccination: 35-years) as dose 2, single for COVID-19 immunisation. The patient medical history included chronic Lumbar pain from 14Nov2014, Tension Headache from 14Nov2014, Latent TB infection from 03Jan2015, Over weight from 02Mar2015, H. Pylori infection from 10Aug2017. Concomitant medications were not reported. The patient previously received the MODERNA COVID (Lot No. 038B21A, Expiration date: 30Sep2021) via intramuscular route, administered in left deltoid vaccine as her 1st dose on 01Aug2021 03:26 (age at vaccination: 35-years) for covid-19 immunisation and received the COMIRNATY as her 2nd dose today on 08Sep2021. There was no emergency room or physician's office visit due to the adverse events. She does not think it is life threatening but could not decide if it was medically significant or not stating that is why she was calling. The patient experienced a patient received who received the Moderna covid vaccine as her 1st dose on 01Aug2021 and received the Comirnaty as her 2nd dose today on 08Sep2021, headache, dizziness on 14Sep2021. The clinical outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.  Follow-up (08Sep2021): New information received in a follow-up spontaneous report from contactable Nurse. This Nurse reported for a 33-year-old female patient that: details about first and second vaccines (batch/lot number, expiration date, route of administration, anatomical location, time of vaccination)  Follow-up attempts are completed. No further information is expected.  Follow up (20Sep2021): New information received from a contactable Nurse. This nurse reported for a patient in response HCP letter sent which included that: Event verbatim headache' and dizziness' coded as such, start date and stop date time updated, Event onset date was added as 14Sep2021 as per case context, and medical history added.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
pt developed covid arm, red round 3 inch diameter rash near/around injection site-non itchy. patient will monitor
Severe axonal acute sensorimotor polyneuropathy (guillain-barre syndrome) with complete quadriplegia and acute respiratory failure requiring mechanical ventilation.  Developed tingling in fingers and face on 10/6/22 then rapidly progressive symmetric weakness and hospitalized at Sturdy Hospital on 10/7/22 and intubated on 10/8/22.  She was transferred to Medical Center on 10/16/22.  Diagnosis is confirmed by areflexia, symmetric weakness, lumbar puncture with elevated protein on 10/17, EMG/NCS on 10/20/22  confirming severe axonal sensorimotor polyneuropathy.
SHORTNESS OF BREATH      pt diagnosed with COVID Thursday 9/23, reports progressive SOB, tonight states that he was coughing and couldn't catch his breath also noted low spo2 when ambulating. per EMS pt spo2 drops to 70's when ambulating
pt recv vax & devel nausea & a h/a the same day; That evening devel a migraine & was administered Demerol; The following day pt devel vomiting; No further details were provided;
pt recv vax & devel diarrhea;pt recovered p/4 to 5 days;
pt recv vax 15SEP95 & pt exp t102.5 R;23SEP95 the pt devel a red rash on trunk, arms & the moist areas of body;rash resolved w/in 1wk & pt recovered on 20SEP95;
9/7/15 Evening-itching at vaccine site. 9/8/15 Rash at vaccine site-office visit. Palm size 6-7 cm area of erythema with edema. 9/8/15 PM-after visit to office, temp 103 degrees F. 9/9/15 Severe, diffuse arthralgias and low grade fever. Erythema increasing ? 15 cm. 9/10/15 Decreasing arthralgias. 9/14/15 Erythema resolving. Skin still pruritic.
2hr p/vax pt c/o stiff neck, pain in the tongue;h/a;pt taken to ER & given DPH;
Significant chills, fast heartbeat, and occasional dizziness. Got the shot about 6pm on Friday. Arm was very sore, took ibuprofen but unable to sleep well Friday night. By Saturday morning had flu like symptoms (muscle aches and pains, loss of appetite, nausea and fatigue, etc.) as well as significant chills, fast heartbeat, and occasional dizziness. Symptoms lasted all day and into the evening. Took an effervescent antacid before bed for nausea/pain and eventually slept somewhat better by early Sunday morning. Began to feel better Sunday as the day progressed. Symptoms, including fast heartbeat, chills, etc. started to subside. Other than sore arm, seemed pretty much back to normal by Sunday night. Consulted with doctor office about reaction during visit on 3/4/19. Recommendation that I don't get the second shot.
Information has been received from a health professional concerning a 20 year old female who was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The healthcare worker is reporting that a patient had received 2 doses of MMR when she was a child, but the recent titer results came out negative for rubella. The patient does not have symptoms. Additional information has been requested.
"Started to feel faint in the observation area. Told his wife that he feels lightheaded and pre-syncopal. He had no recollection of what happened, but came to after a sternal rub.  He denies hx of syncope, epilepsy or other medical problems.  He does not take any medications  Endorses he ate and drank before getting the shot.  Pt with a witnessed momentary LOC, was lowered gently to the floor by providers.,States he felt better after laying down and having something to drink.  Admit to some nausea, but denies vomiting, Next dose recommended: Yes   "
severe hair loss, numbness in legs/muscle/ joint pains, constant chest pains; severe headaches, "knots" on head; eye sensitivity; sores in mouth, sick with "flu" more often than usual; blood in stool; itchy skins, rashes, difficulty concentrating, memory loss; chronic fatigue; severe mood swings arthritis in fingers, fungal growth on neck.
Pt eyes rolled back in head, head fell back on dad's lap, body became stiff and had urine incontinence. Did not response verbally for approx. 1-2 mins, breathing normal throughout episode. Episode lasted 1-2 mins. Paramedics called and transferred to ER.
Hard to get up; Numbness of lower extremities; Sneezing; Fever 99.9F; Fatigue; Pain and tenderness on the injection site; swelling (hardness) injection site; Redness on the injection site; swelling (hardness) injection site; A spontaneous report was received from a consumer concerning a 65-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hard to get up, numbness of lower extremities, sneezing, fatigue, pain and tenderness on injection site, vaccination site swelling, redness on the injection site and fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16-Feb -2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of Covid-19 infection.   The patient reported that she had pain, tenderness, swelling (hardness), redness on the injection site, severe fatigue, hard to get up, sneezing, fever 99.9F, and her lower extremities were numb. No further information was provided. Treatment information was unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, hard to get up, numbness of lower extremities, sneezing, fatigue, pain and tenderness on injection site, swelling injection site, redness on the injection site, and pyrexia were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 41-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Psoriatic arthritis.    Concurrent medical conditions included Rheumatoid arthritis and Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced COVID-19 (COVID-19). In March 2022, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  In 2022, patient was positive for COVID. In MAR2022, it resolved.  Reporters causality of events with Humira was no reasonable possibility.  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
Client came in for COVID Vaccine -Pfizer, He received vaccine, upon entering client info into system, it was discovered that his first COVID Pfizer dose was given on 5/16/21. Mother with patient at time of vaccination and during monitoring. Pt. Was stable and had no effects after 25 minutes of monitoring.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. The patient experienced flu-like syndrome and persistent upper respiratory infection symptoms. The outcome of the event of flu-like syndrome and persistent upper respiratory infection symptoms is unknown. The report was considered to be non-serious.
bleeding; Vaginal spotting and some discomfort (cramping); Vaginal spotting and some discomfort (cramping); Vaginal spotting and some discomfort (cramping); This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient (not pregnant) received bnt162b2, dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization at the age of 26 years old. The patient received bnt162b2, dose 2 via an unspecified route of administration on 19Apr2021 13:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization The patient medical history was not reported. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced bleeding, vaginal spotting and some discomfort (cramping) on 05Apr2021. Reported as: Vaginal spotting and some discomfort (cramping). Its has been occurring since the fist dose in March. I am on the birth control Yaz but I am regular with taking it and it has been the same birth control for over a year. I have not had regular spotting before and I went to an OBGYN on 5/12 and there were no abnormalities that would indicate another cause of the bleeding. It's not serious but I'm reporting in the hope that your studies begin including effects on things like menstrual cycle because it sounds like there are effects like this happening.The adverse event result Doctor or other healthcare professional office/clinic visit. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain and Headache. Concomitant products included IBUPROFEN for Pain and Headache, MULTIVITAMINS [VITAMINS NOS] and CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for an unknown indication.    On 04-May-2021 at 10:27 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced FATIGUE (Extreme fatigue). At the time of the report, FATIGUE (Extreme fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was reported.   This case was linked to MOD-2021-209131 (Patient Link).
4 hr p/vax in lt arm pt noticed a black & blue area about 1 1/2-2" long & 1/2" wide; the greatest bruising was around the puncture site itself; the area was warm & tender to touch;
Received H1N1 nasal ~ AM 12/29/09. Taken to ER later that evening with hives and wheezing. No hx RAD no probs with seasonal flu mist & mom discussed this w/ me at her physical on 2/5/10.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-APR-2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Last night 9/12 1 1/2 hours after dinner started with hives, tongue and mouth swollen, throat tightens, went to ER was given Solumedrol IV, Prednisone 50mg, x 5 days, tsp PCN.
It started on the June 19th in the afternoon I was very tired, I was hot, I was cold, I thought I was in the sun too much. But I didn't know I had a low-grade fever at the time. I had a dry throat and headache. I don't get headaches so when I got home I checked my temperature it was 100.5 which is low grade but it's enough to cause my other thing to happen which is stroke like symptoms. I took a COVID-19 test because why would I have a fever. The line was very faint. I went to bed I had a bad nights sleep, I did take TYLENOL. My headache got really bad I woke in the middle of the night and took an ADVIL PM to try and sleep better. I woke up the next day and took another test it was positive. I went to urgent care they did another test it was positive. I started to get a mirage, one eye got really big and one got really small and I was having double vision. I called my neuro. On Tuesday my voice changed really bad. Sometime my vocal cords are paralyzed and it is hard to speak. My temp stayed normal because I was taking TYLENOL. The neuro called back and told me to go to the ER but I didn't think my throat would get that bad to the point where I wouldn't be able to breathe. Wednesday my symptoms peaked. And yesterday there was a cough also and I was very tired but I kept taking the TYLENOL. In the morning I went to sleep and as the day went on I started to feel some improvement. Sometimes it takes a week sometimes it takes up to 3 weeks if it's really bad. So I am dealing with COVID-19 symptoms and symptoms of a stroke.
trouble sleeping; almost falling over; Light headedness; fogginess; mother drive her home; injection site itchiness; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping), FALL (almost falling over), DIZZINESS (Light headedness), FEELING ABNORMAL (fogginess) and IMPAIRED DRIVING ABILITY (mother drive her home) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017521A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced INSOMNIA (trouble sleeping), VACCINATION SITE PRURITUS (injection site itchiness) and VACCINATION SITE ERYTHEMA (injection site redness). 26-Apr-2021, the patient experienced FALL (almost falling over), DIZZINESS (Light headedness), FEELING ABNORMAL (fogginess) and IMPAIRED DRIVING ABILITY (mother drive her home). At the time of the report, INSOMNIA (trouble sleeping), FALL (almost falling over), DIZZINESS (Light headedness), FEELING ABNORMAL (fogginess), IMPAIRED DRIVING ABILITY (mother drive her home), VACCINATION SITE PRURITUS (injection site itchiness) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.
Patient reports tingling in fingers and toes beginning the day after vaccination, off and on, mostly at night, and sore/achy feeling under chin in area of lymph nodes starting 8/16.  Patient says lymph nodes are not swollen and are not painful when palpitated.  No fever accompanies other symptoms.  Recommended alerting PCP as to adverse events and to notify dr immediately  if any nausea, vomiting, irregular heartbeat, dizziness or fainting occurs.
developed raised itchy erythematous papular rash on hands/face/back/abdomen/arms about 24 hours after received second vaccine. of note, had similar event after measles vaccine (in retrospect; at time reaction was thought a contact dermatitis from something environmentally). no mucosal involvement; not requiring admission. treated with zyrtec.
Could this be a diminished outbreak of chickenpox/Has anyone else reported breakthrough chickenpox; small itchy bumps on my torso /  had noticed several of these these small itchy bumps; small itchy bumps on my torso / had noticed several of these these small itchy bumps; This case was reported by a consumer and described the occurrence of chickenpox in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix. On 23rd March 2020, 19 days after receiving Shingrix, the patient experienced chickenpox, itchy rash and papular rash. On an unknown date, the outcome of the chickenpox, itchy rash and papular rash were unknown.   It was unknown if the reporter considered the chickenpox, itchy rash and papular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On about 23rd March 2020 (specific date not recalled), the patient noticed small itchy bumps on torso.  Since 23rd March 2020, the patient had noticed several more of these small itchy bumps. The itching was well-controlled by anti-itch cream. There were less than 50 of those spots.  The patient asked if this could be a diminished outbreak of chickenpox. The patient also asked if anyone else had reported breakthrough chickenpox.
Wet her pants; Couldn't get up; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Wet her pants) and DYSSTASIA (Couldn't get up) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced URINARY INCONTINENCE (Wet her pants). 12-Mar-2021, the patient experienced DYSSTASIA (Couldn't get up). At the time of the report, URINARY INCONTINENCE (Wet her pants) and DYSSTASIA (Couldn't get up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
Vaccines were kept frozen after expiry and then administered; Vaccine administered beyond use date or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen after expiry and then administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen after expiry and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen after expiry and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported as vial would be in freezer about 1-3 days No concomitant and treatment medications were reported by the reporter.
The caller reports that approximately one week after her second COVID19 Pfizer vaccine, she experienced swelling of her left axillary lymph node with related discomfort and pain. She reports the symptoms resolved in about 1-1.5 weeks without further complication.