chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered with expired vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-314570, MOD-2021-314573, MOD-2021-314793, MOD-2021-314805, MOD-2021-314810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: follow up received contain No New Information
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. . A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Other medical history: Breast Cancer. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication was taken in 2 weeks. No any vaccine was received previously. No known allergies. Paxloid treatment : Treatment start date: 11Nov2022, Treatment stop date: 15Nov022,  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I can?t be certain of the exact date but for at least 2 weeks I?ve had recurring symptoms of Bell?s Palsey which I had January 19, 2019.  I feel weakness in the right side of my face and my right eye is oozing.   I notice my speech is a bit slurred because of lack of full control of my mouth.  Nothing is drooping just the nerves.  I had not thought about it may being an adverse affect until today.
I began getting nauseous and had a headache around 6pm and then the chills around 8 pm At 8:30 pm I decided to take my temperature and it was 101.3 this continued all throughout the night with me waking up with aches pains chills or hot flashes every hour. My temperature reached 103.9 around 2 am. the fever finally broke around 4 pm on 01/31/21
10JUL pt recv vax 14JUL98 c/o h/a followed by sz hosp-paralysis lt side 2mo later;MRI showed spot on brain;c/o seeing spots-optical neuritis;
5ml syringes that had been provided by the Health Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
severe ringing in his ear on Sunday June 6; he couldnt hear/he has significant hearing loss; This is a spontaneous report from a contactable consumer (patient's parent).  A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: unknown) via unspecified route of administration in left arm on 29May2021 at 14:00 (at the age of 16-year-old) as a dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient was not reported. Patient had no known allergies. Patient did not receive any other medications (concomitant) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 06Jun2021 (Sunday) at 08:00, patient started having severe ringing in his ear and could not hear. His parent took him to urgent care on June 9 and patient was prescribed a steroid, nothing changed after a week. Appointment was Scheduled with ENT where they did hearing test and said patient has significant hearing loss. Patient was getting an MRI tomorrow and going back to ENT to get a steroid shot in his ear to see if they can restore hearing loss. They mentioned they did have other patients that received COVID vaccine and now have hearing loss but are not 16 and were much older than patient (reporter son). They told us not to get second vaccine shot. The event resulted in doctor or other healthcare professional office/clinic visit along with visit to Emergency room/department or urgent care. The event as serious [Seriousness criteria-Disabling/Incapacitating]. Device date was 17Jun2021. Patient received steroid as a corrective treatment. Outcome of the events were not resolved on an unspecified date.
After a minute of receiving the Pfizer Covid-19 vaccine, the patient felt lightheaded and proceeded to stand up and walk back to open the door to the pharmacy clinical room.  The patient passed out and fell hitting his head on the counter and then landed on the floor.  The patient lost consciousness for only a few seconds not remember or noticed hitting his head.  The patient's skin then became cold and clammy and he began sweating.  one 16 ounce water bottle was administered.  The patients feet were elevated and a pillow was placed under his head.  After 3-4 minutes he was helped up and sat down in a nearby chair.  Within a minute, the patient's face appeared pale and white.  He alerted us that he wasn't "feeling well" and wanted to lie back down.  He was then helped back down elevating his feet and placing a pillow under his head.  Vitals were administered by the Emergency team that had just arrived.  Blood sugar was normal and heart rhythms and blood pressure measured normal.   After about 10 minutes that patient felt normal and was able to stand and walk on his own.
Patient reported developing a "butterfly rash" across the bridge of nose and cheeks approximately 24 hours after COVID-19 vaccine.  Rash resolved without treatment within 10 days.  Also experienced some fatigue.
Day after immunization developed fatigue, diffuse myalgia, headache, sweating, chills, nasal congestion, vomiting x1; ongoing
pt recv vax; about 10 mins later, lt leg became red w/ hives; dph given;
An hour after getting the vaccine I started to get chills. As the chills set in, a deep itch started jumping to different parts of my body, head to toe. My eyes also started watering profusely. I got very tired and went to lay down.  At 1:30/2:00p ( 1.5-2 hrs post vaccine) my throat started to tickle/itch. It felt like I needed to clear my throat. Then it started to feel thick in my throat. Almost as if I had mucous or something in my throat, but could not cough it up. I also felt the constant need to swallow. This lasted about 6 hrs, with the eye watering and itchiness starting to wane around hour 4, and the rest dropping off slowly after. 12 hrs after the shot, the symptoms I was experiencing were gone. My left shoulder has felt like it was bruised ever since the morning after the vaccine (4/3/2021). Today, 4 wks later,  it still hurts to the touch.
Fever of 102, body aches, dizziness, chills starting 12 hours after injection
Sudden onset of sore throat, headache, sinus congestion and pain, dry painful cough, chest congestion, body ache, sore muscles, fever 99.8.
This spontaneous report as received from a health care worker concerning to unspecified number of patients of unknown ager and gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse symptoms were reported. No adverse symptoms were reported. The temperature excursions that were reported for PNEUMOVAX 23 was supported excursion with in-house stability data. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
11/29/21 presents to ED for "shortness of breath" "respiratory distress". PMHx of "CAD s/p multiple stents " "ischemic cardiomyopathy (EF 35%), HTN, obesity, DM, DLD, CVA and GIB"
My son has been running a fever between 101.1-102.2 F the day after we gave him infant Tylenol each time and the fever subside. Fever is high between 12pm-6pm.
Dizziness upon standing; tightness to throat with swallowing; dizziness; tingling to chest and neck; mild itching; BP 148/96; This is a spontaneous report from a contactable Pharmacist. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via intramuscular route of administration in the left arm on 27Feb2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown if the patient had been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 at 10:15, the patient complained of tingling to chest and neck, mild itching, tightness to throat with swallowing and sips of water, and dizziness. The BP was 148/96. The patient was given dexamethasone 4mg (MANUFACTURER UNKNOWN) by mouth at 10:21. The patient reported dizziness upon standing at 10:24. At 10:53, the patient was ambulating in hallway with no dizziness and left symptom free. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events tingling of chest and neck, mild itching, tightness to throat with swallowing, dizziness, BP 148/96 and dizziness upon standing were recovered on 27Feb2021.   No follow-up attempts are needed. No further information is expected.
Patient complains of pain in all joints the day after first SHINGRIX dose, but pain has continued in both shoulders since then.
Patient presents with complaints of rash and whole body itching. He states he recently got the 2nd COVID vaccine this past week. He states he noticed increased itching and his wife also noticed it. He states today when he was working outside and sweating the itching and redness became worse. He also then started to feel very hot all over. He has not taken anything for the symptoms. He did apply over the counter spray type calamine lotion to help with itching.
severe upper back pain with increase in pain with movement of my neck radiating between shoulders pain in the upper thoracic with walkiing and  raising arms tingling in the upper back bl
This spontaneous report was received from a nurse and refers to a 21 year old non pregnant female patient with exercise induced asthma. The patient did not have any drug reactions or allergies. On 09-NOV-1994, the patient was vaccinated with the first dose  RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). On 06-DEC-1994 and on 07-AUG-1995, the patient was vaccinated with the second and the third dose of RECOMBIVAX HB, respectively (dose, route of administration, lot # and expiration date were not reported). The patient was not taking any concomitant medications. On 22-DEC-2015, the patient's Hepatitis B titers were drawn and the results showed a less than therapeutic level (units not provided). The outcome of the event was not reported. The relatedness between the event and RECOMBIVAX HB was not provided. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a 6 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a 21 year old female who on 30-NOV-2007 was vaccinated IM with a 0.5 ml second dose of Gardasil (lot# 659439/1267U). On 16-DEC-2007 the patient developed golf ball sized lump at the injection site. Medical attention was sought.  The patient was treated with unspecified antibiotics.  At the time of reporting the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 1/15/2008. Information has been received from a licensed practical nurse concerning a 21 year old female patient with no medical history or allergies who on 30-NOV-2007 was vaccinated IM with a 0.5 ml second dose of GARDASIL (lot# 659439/1267U). There was no concomitant medications. On 17-DEC-2007, the patient went to the physician's office to have her arm checked. It was reported that her left arm was swollen and painful where she got the vaccine. The day before yesterday the patient started having tenderness in her upper left deltoid. It was noted that it had been nearly two weeks since she received the vaccine. The are was minimally swollen, slightly tender to pressure, no redness, no identifiable, visual abnormality. Assuming that it might have been due to the vaccine and possibly bacterial in origin, the physician gave the patient CIPRO 250 mg three times a day for 5 days, but asked her to return in 48 hours to re-evaluate. On 19-DEC-2007, the patient went back to the physician's office for a re-evaluation. The patient's left upper arm was still slightly tender, but she felt it was less so. Her arm also felt less full. There was no redness, minimal swelling and minimal tenderness on direct palpation. The patient was given instructions to call in a couple of weeks if the pain was still present and to call any time sooner if there was an increase in pain, redness, fever, etc. At the time of reporting the patient was recovering. Additional information is not expected.
Aching joints and muscles, fever, sore throat, nausea two days after injection of Tdap.  No treatment.
Nausea; fatigue; chills; 99.6 temperature; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EM9809; Expiration Date: unknown) via an unspecified route of administration, in right arm on 09Feb2021 13:45 at single dose for COVID-19 immunisation.  Medical history included complex regional pain syndrome, CRPS (non-active), fibromyalgia, multiple non-life-threatening allergies to medications and environmental. The patient not-receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient not received within 2 weeks of vaccination; Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 11Feb2021 11:00, the patient experienced nausea, fatigue, chills, 99.6 temperature. On 11Feb2021, the patient underwent lab tests and procedures which included body temperature: 99.6 The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient with no known allergies. About one week ago (approximately 23-OCT-2014) the patient was vaccinated with ZOSTAVAX (lot # was not provided), 0.65 ml, subcutaneous in the left arm. On the same day, the patient also vaccinated with Influenza virus vaccine (manufacturer unknown) (strength, dose, frequency, route, lot # and indication were not provided). Pharmacist stated patient's husband called the pharmacy on behalf of his wife (patient), and reported the patient experienced swelling, redness, itching at the injection site and no rash in October 2014. Pharmacist stated the swelling had decreased somewhat. Pharmacist stated the client contacted their health care provider and was told to keep monitoring the event. The treatment was not given. The outcome of events was reported as not recovered/not resolved. No further details provided. Additional information has been requested.
I did visit an ER due to having an issue with left arm tilting and right neck tiling and right jaw tilting to the side. I was kept overnight in the ER and did have some brain fog that developed again as well as slurred speech however in the morning it was improved greatly and I did pass the neuro test given to me. I did lose the ability to cry and also the ability to feel the sensation of heat from spices. I am still experience fatigue, eye pressure, however many of my other symptoms have improved. I was taken off many medications and have improved with my asthma. I am still experiencing pain in between my shoulders. One day my left knee was painful on the outside and numb on the inside.
pt brought to hospital on 2/1/22 with AMS and septic shock secondary to left upper and lower extremity wounds; ABX; during hospital course, mental status worsened with increase in fatigue, cough developed and pt was tachypneic; O2 requirements increased; pt intubated; found to be positive for COVID on 2/14/22; ICU; steroids; status eventually changed to DNR; palliative extubation and pt passed away in the hospital
Imm. Thurs 9/19/02 given. Rash on arms and chest with itch. Began raised bumps progressed to whelps as described by pt. This occurred Friday 9/20/02. 12N took Benadryl, Friday 2 pills q 6h x 24 hrs. Use Moisturizer on areas. Areas improved Sunday.
itchy; red circle the size of a golf ball; Pain in right arm from hand up to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), ERYTHEMA (red circle the size of a golf ball) and PAIN IN EXTREMITY (Pain in right arm from hand up to shoulder) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in right arm from hand up to shoulder). On 03-Mar-2021, the patient experienced PRURITUS (itchy) and ERYTHEMA (red circle the size of a golf ball). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOCAINE HYDROCHLORIDE (NEOSPORIN + BURN RELIEF) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy) and ERYTHEMA (red circle the size of a golf ball) outcome was unknown and PAIN IN EXTREMITY (Pain in right arm from hand up to shoulder) had not resolved. Not Provided          The patient reported, still has pain in her right arm from her hand up to her shoulder. She reports an 8 out of a 1-10 pain scale when she moves it.  Concomitant product use was not provided by the reporter. Treatment medication included Neosporin to treat the itchiness.  Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-039742 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Reporter address updated, new event added.
Pt had an episode of syncope and associated flushing/sweating.  Pt also reported nausea and right temporal H/A 6/10, and chills.  Pt was found to be hypertensive Vitals: 157/99, 94-99, 14, O2 sat 99%, Temp 97.3F Emgergency called and pt transported to ED via EMS.  zofran 4 mg odt given@ 1801 per EMS. Prior to transport, pt reported same experience after previous dose. In ED: HPI: Patient is a 32 y.o.female. Patient and/or patient's caregiver states: 32 yo healthy female PMHx stress incontinence, H pylori, anxiety EMS vasovagal syncope s/p 5 min after 2nd Pfizer shot today given 1800,  zofran 4 mg odt given@ 1801 per EMS. Feeling headache, fatigue, nauseous without syncope, lightheaded. Denies focal weakness, able to ambulate and tolerate PO. +cigarette smoker. Anxious and crying.. Vitals: 141/91, 84, 16, spo2 99% Pt given tylenol for headache and hydroxyzine 25 mg x 1 dose for anxiety. Able to tolerate PO fluids, neuro exam intact. No fall or head strike reported, doubt ICH or other emergent traumatic or neurologic emergency. Patient is hemodynamically stable. Patient without chest pain or SOB, doubt ACS as possible cause of syncope. Patient eloped prior to reassessment.
arm aches, painful, weakness,     no treatment other than massaging the area, taking Aleve.   Awakens me in the night.  Comes and goes, more uncomfortable at times
Death apparent heart attack 1/16/10. Pt. w/ CAD/ angioplasty 7/09 w/ stent placement. On multiple meds, smoker, denied symptoms 1/14/10.
one week after the 2nd shot of Pfizer vaccine, I developed stiff neck such that I cannot turn my head beyond my shoulder and have difficulty to turn my head when driving and changing lanes.  two days later, my lower back pain re-occured after being pain free for more than a few years.   I let the both pain to recover by itsself but the recovering process of the back pain is quite different from my past experience; the back pain last for more than 3-4 weeks until I feel freely to move around.