chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nurse administered it, it leaked down her arm; A spontaneous report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced nurse administered it, it leaked down her arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The reporter stated that the nurse had issues withdrawing the medication from the vial. She also stated that when the nurse administered the vaccine, it leaked down her arm. After that she was made to wait two hours while it was determined whether or not she could receive the second dose of vaccine.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.    The event, nurse administered it, it leaked down her arm, was considered resolved.   The reporter did not provide a causality assessment of the event nurse administered it, it leaked down her arm.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
LEFT ARM SORENESS; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced left arm soreness. The action taken with covid-19 vaccine was not applicable. The outcome of left arm soreness was not reported. This report was non-serious. This case involving the same patient is linked to 20201252495.
Extreme pain at injection site; severe headache; severe chills and shivering or tremors; all over aching/pain; extreme fatigue; interfered with daily activities and sleep. Took 2 over-the-counter ALEVE pills around 8AM the day after the injection. Relief experienced within a few hours and normal activities resumed early afternoon. 2 more ALEVE pills taken around 9PM the day after injection and side affects no longer experienced.
Not enough diluent used (0.8 ml instead of 1.8 ml) for vial. Patient and parent notified of error. Patient observed for 30 min with no signs or symptoms of adverse reaction.
This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot#, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (Merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that 3 patients had already been back to the clinic and vaccinated with ZOSTAVAX. And this is one of the 3 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
On 7-3, 2022 I started having fatigue. The following morning I began having a runny nose, head congestion and watery eyes. I took a home Covid19 test and it was positive. Four hours later I took another home Covid19 test and it was positive as well. On 7-5, I started having a headache, sore throat and productive cough. I called to get a doctors appointment but could not get in to be seen. On 7-6, I went to a minute clinic and they tested me for Covid19 at the clinic. It came back positive as well. I was prescribed Molnupiravir. I am doing better today with still light fatigue and productive cough remaining. I am reporting my breakthru case of Covid.
Arm was sore for 48 hours post injection.   Ibuprofen was used for treatment
Shaking, weakness, tiredness, diarrhea, nausea  Dr said no work for 7 days. Prescribed Prednisone 20mg for 10 days. Bloodwork done and c reactive protein was  23.3 Was better until off prednisone for 3 days then weakness, tiredness and shakiness returned Dr prescribed  Modafinil 200 mg once a day. Still tired but not as bad.
Soreness at injunction site, elevated temperature (100.1), nausea, headache, chills, body aches, occasional dizziness, occasional fogginess, fatigue
Patients daughter explained her father had a Prevnar 13 vaccine in June, then a blood transfusion that he had a reaction to in July, then possible reaction in October to Fluvirin lot 1413101 exp Jun 15 -that lead him to have severe attack of RA.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Parametics response was very fast and took all vitals. Patient walked out of store after 15-20 more minutes. By the way, the pharmacist that gave the vaccine did not sign in after his lunch break, so all afternoon doses had the wrong pharmacists name attached!
Information has been received from a nurse concerning a female nurse with a history of shingles in the past and herpes simplex who after giving multiple vaccinations of ZOSTAVAX on 14-FEB-2008 developed shingles.  There was no concomitant medication.  It was reported that the nurse noticed a rash on 18-FEB-2008 and also had a cold sore on her lips.  The nurse wore gloves when administering the vaccinations but not when it was being reconstituted.  The nurse is taking acyclovir.  Subsequently, the patient recovered from shingles and cold sore on lips.  Additional information has been requested.
Systemic: Blood Disorder  (diagnosed by MD)-Severe, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Other- Acute Kidney Injury, Hypoxia; lasted 10 days
Patient had swelling, fever, body aches, pain and nausea (unable to eat). She said she was unable to get out of bed the first day after.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8737), in left arm and on 26Apr2021 as dose 2, single (Lot number: EW0169) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had not received any other medication in 2 weeks of vaccination. Patient had no Known allergies. Patient received Anti-viral Paxlovid treatment for COVID-19 starting from 23May2022 to 27May2022.
He was transferred to local Hospital 10/6 with plans for vancomycin, cefepime, and metronidazole through 10/15, ventilator weaning, and rehabilitation.  His course here has been notable for cancer related pain requiring high-dose opioid medications, liberation from mechanical ventilation 10/25, completion of prescribed antibiotics followed by suppressive Bactrim therapy, then recurrent fever 10/31 for which broad-spectrum antibiotics were resumed.  Neck imaging revealed right neck abscesses. Dr. spoke with Dr. (Specialist) 11/1 and he recommended neck drain by IR (done 11/2) with sample to be sent for cultures (negative) and cytology (atypical squamous cells). Course also notable for altered mental status 10/20, neurology consult, CTA and EEG unrevealing, suspected metabolic and/or medication related, hypercalcemia treated with Zometa 10/22, and anxiety. Out of c-collar and TLSO.   On 11/2 I assumed care. 11/9 IR R neck drain removed (wasn't draining much). 11/11 mucus plug/RRT but remained off vent.  11/14 VUMC ENT f/u, biopsy/FNA done, per Dr. this confirms cancer. No surgical options. Not a candidate for chemo or any other therapy due to poor functional status.  Pt and his wife were very clear with me that they would like to go to local hospice care. Before this could be accomplished he developed, on 11/17, worsened mental status then bleeding from prior R neck drain site. It was clear he was dying and we transitioned to comfort care. He died comfortably with his family at the bedside at 1845 today.
Initially just soreness around the injection site. On 3/21 around 5pm EST. Severe pain began around left side collarbone, Pain "catches" when I inhale. Chills, fatigue, brainfog (I forget little things I just did and it takes me longer than usual to recall)
After approximately 48 hours, I experienced fever, nausea, body aches, chills, fatigue, and skin irritation for 24 hours.
Fever 100.1; fatigue; muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 27Mar2021 at 14:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, obesity, high blood pressure and allergy to Sulphate drugs. . The patient received unspecified medications with in 2 weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, the patient experienced fever, fatigue and muscle aches. The patient did not receive any treatment for the reported events. On 30Mar2021, the patient had a  body temperature of 100.1 (Unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, fatigue and muscle aches was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
PAIN IN SHOULDER THAT RADIATES DOWN ARM. PAIN IS CONSTANT. STEROID TREATMENT REDUCED PAIN, BUT ONCE TREATMENT DONE, PAIN HAS RETURNED.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Crying >4hrs, high pitched cry; Redness & swelling soles of feet & toes; Resolved quickly; some dec appetite 1 day only;
Systemic: Flushed / Sweating-Mild, Additional Details: just gave pt water and she was fine after 5 minutes. Asked her to stay a little bit longer. She was good
This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Information about their medical history, concurrent condition and concomitant medication were unspecified. On unknown dates, the patients were vaccinated with two of the improperly stored doses VARIVAX (Merck) (which had a lot # of L002871 and an expiration date of 27-JAN-2017; dose, dosage number, anatomical location and route of administration were unknown. The temperature excursion for the vaccine was 33 F for a time frame of 2 hours. It was also reported that there had been a previous excursion of 12 F for a time frame of 1 hour and the excursions were reported due to a data logger. However, no adverse effects were reported. Additional information has been requested.
Nausea, severe headache, chills followed by chest pain, extreme nausea and continued headache, vomiting, shortness of breath. Began 1/12 with chest pains beginning 1/15 going on thru out weekend. Went to Immediate Care who sent me to ER 1/19/10.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were not known. On 26-FEB-2019 the patient was vaccinated with an improperly stored dose of VARIVAX lot # R002509 and expiration date 25-JAN-2020, for prophylaxis (strength, dose, frequency and route of administration were unknown). Sterile diluent used was properly stored. The patient experienced no adverse events. It was reported that the vaccine used had been at 6°F to 14°F (12.9 F) for 30 minutes. No previous excursions were reported. Data logger was involved. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1903USA009416: US-009507513-1903USA009466.
Experienced confirmed COVID infection; Experienced confirmed COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 at 11:00 as dose 1, single (Lot number: EL3248), in right arm, on 11Mar2021 at 09:00 as dose 2, single (Lot number: EL3248), in right arm and on 22Nov2021 at 13:00 as dose 3 (booster), single (Lot number: EW0176) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), VACCINATION FAILURE (medically significant) all with onset 30May2022, outcome "recovering" and all described as "Experienced confirmed COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: Lab Notes:Nasal Swab; (01Jun2022) Positive, notes: Lab Notes: Nasal Swab. Therapeutic measures were not taken as a result of sars-cov-2 test positive, vaccination failure.
The only side affects I had after receiving the injection was a chill the night of injection, which ibuprofen took care of. About 2 weeks after receiving the vaccination, my arm started hurting at the vaccination site. There is no redness, no swelling, nothing visible, just a pain inside; however, pain has increased. . I texted the CDC about this issue and received a fairly generic response.
Tingling in chest. Chest tight.  VSS. Observed and symptoms resolved within 20 minutes. Released home
Information has been received from a physician concerning a 5 month old female who on 16-NOV-2007 and in approximately January 2008, was vaccinated PO with her first and second 2.0 ml doses of ROTATEQ.  Concomitant vaccinations administered in approximately January 2008, with the second dose included a dose of PEDIARIX, a dose of PEDVAXHIB and a dose of PREVNAR.  On 24-JAN-2008 the patient experienced intussusception and was hospitalized.  A barium enema was administered as an intervention and subsequently the patient underwent a "surgical correction."  After the event on that same day, the physician decided to discontinue therapy with ROTATEQ.  The outcome was unknown at the time of this report.  It was noted that the patient had no adverse event with the first dose of ROTATEQ.  There was no product quality complaint.  Intussusception was also considered to be an other important medical event (surgery) by the physician.  Additional information has been requested.
pt had inc liver function test; reporter indicated pt just happened to receive Engerix-B 4 days prior to yearly physical & had been on clinoril several years w/no inc liver function tests;
patient described shortness of breath, was taken to ER my mother. per mother, she was treated with albuterol Inhaler, steroid and benedryl and released after a few hours. told to follow up with asthma dr on Monday 8/2/21.
I woke up with stabbing pains in my feet, repeated very frequently from 30 seconds to 2 minute intervals.  This got better slowly over the day.  I also felt feverish, hot and cold
Got positive for Corona virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported about herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 06Apr2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 15Apr2021 the patient experienced got positive for corona virus. Consumer reported that "I called because I asked the question, I have my 1st vaccine Pfizer April 6, I got positive for Corona virus on 15Apr, 'just to a second vaccine 27Apr' (not clarified further, if had the second vaccine or it was the due date) and I want to know how long I have to wait for that, for my vaccine after you had the virus". The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Apr2021. The outcome of event was unknown.   Further probing could not be done as consumer hung up the call abruptly. Hence, limited information available over the call.
On Wednesday 4/8/20, patient noticed erythematous papules on his right deltoid, his right abdomen, and behind his right ear. They are mildly itchy.
Lymphadenopathy on left clavicle; Chills/rigors; Fever; Headache; Nausea; Muscle aches; Extreme fatigue; Pain in collar bone on left side; This is a spontaneous report from a contactable other health care professional (HCP) (patient). A 38-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Jun2021 18:00 (Lot Number: EW0182) as dose 2, single for covid-19 immunization at the age of 38-year-old. The patient medical history and concomitant medications were none. The patient did not have any known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19May2021 17:00 (Lot Number: EW0182) as dose 1, single for covid-19 immunization at the age of 38-year-old. On 10Jun2021, the patient woke up to pain in collar bone on left side, she felt a small jelly like bump. On 11Jun2021, the jelly like bump doubled in size and pain. The patient went to Urgent Care and was diagnosed with Lymphadenopathy on left clavicle. The patient would follow-up with family physician if swelling doesn't go down for further testing. It was reported that patient also had symptoms of chills, fever, headache, rigors, nausea, muscle aches, and extreme fatigue on the day after receiving 2nd dose. The outcome of the events was not recovered. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination.
No additional adverse events reported.; the administration of expired dose of GARDASIL 9; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant medication and drug reactions or allergies were not provided.   On 09-JUL-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 ml, lot# R029515, expiration date 08-JUL-2021; route unknown) for prophylaxis (Expired product administered). No additional adverse events reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029515; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Injection site redness, swelling, warm to touch - lasted from 19 Jul-24 Jul 18. Fever, chills, muscle/joint aching; could hardly lift right arm for 2 days. Interfered with normal activity; 3 days with bed rest and acetaminophen.
Patient describes receipt of LAIV (lot #50110 7P Nov 3, 2011; dose #15) and onset of  double vision changes in December. Progressive symptoms were loss of speech enunciation, difficulty clearing throat, and burning sensation and numbness of upper back and  arms. He was diagnosed GBS Miller-Fisher variant in later January and treated with inpatient IVIG.  He would like to receive flu vaccine if can be done safely.  He does recall significant GI illness with severe diarrhea prior to GBS diagnosis. He also reports episodes of frequent pneumonia, and believes has had at least 5, confirmed by CXR (we found documentation of two, f/u immune function eval results normal) Per event note:  Per notes 02 FEB 12: Admitted to Neurology with acute onset of pseudobulbar palsy (dysphagia, dysphonia), diplopia, unsteady gait, and rapidly developing dysarthria, associated with paresthesias and pain in the extremities, and then leading to areflexia, all with a normal sensorium.  Symptoms started on 19 JAN.  He had negative brain / C-spine MRI, negative EEG, negative myasthenia testing, and NCV/EMG testing suspicious for Guillain-Barre syndrome.  Plus, he had positive antibodies to ganglioside GQ1b, pathognomonic of Miller-Fisher syndrome.  He was treated with 5 days of IVIG, and rapidly improved, with normalization of all bulbar symptoms.  He had persistent back pain and limb paresthesias, as well as feeling "juiced up" and very agitated.  Admission dates: 22 JAN - 02 FEB 2012.
J&J vaccine expired on 9/21/2021 at midnight. Patient was vaccinated with expired J&J  12 hours past expiration date on 9/22/2021. J&J was contacted and patients were notified or attempted to be notified of the situation.
Documents reviewed. Vaccine administered, patienttolerated well. She reported L eye "heaviness" about   5 minutes after observation. Symptom resolved within two minutes. She also reported L arm soreness after   infection. She was monitored for 15 minutes without any new or worsening symptoms. She remained well  appearing throughout 15 minute observation period.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 16-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-Dec-2010. There was no adverse event associated with his medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
patient passed out for 30 seconds and came back , he was  sweating , pale and said he felt cold. his pulse was 52/min. gave patient sugary drink and  he felt better in about 2-3 minutes
This spontaneous report as received from a nurse refers to unspecified number of patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse provided that in May 2016, she had a temperature excursion (to 34.4F for 8 hours and 24 minutes) with ROTATEQ (lot# K022990 with expiration date 26-JUN-2016). On unknown dates in 2016, the patients were administered the improperly stored doses of ROTATEQ (orally; dose was not reported). On an unknown date in 2016, the vaccines had a second excursion to 28.9F for 8 hours cycling every 20 minutes. No vaccines were administered since the second excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Complain of slight headache on the scale of 1/10 post vaccination - pt sateted he didn't eat lunch, electrolytes and nutrition given, vital signs BP 122/82 P 82 R 15, T 98.2 O2 sat 99% RA. Pt said problem resolved after prolonged monitoring