chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; expired PROQUAD with an expiration date of 1/23/2022 was administered to a patient on 3/11/2022; This spontaneous report was received from a consumer, referring to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-MAR-2022, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T025508, expiration date was reported and validated as 23-JAN-2022) as prophylaxis (expired product administered). No additional adverse event reported.
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). No concomitant medication was reported. On an unknown date, the patient developed shingles. The patient received unspecified antiviral medication and gabapentin as a treatment of the adverse event (also reported as "(1) patient was given antiviral treatment only and the 2nd patient received the antiviral medication and gabapentin"). The patient sought medical attention, he visited the physician's office. The outcome of shingles was reported as recovering/resolving. The relatedness between the event and the ZOSTAVAX was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Patient reports headache, body aches and also right arm numbness. Reports that all but the numbness has subsided. Continues to have numbness and tingling in arm where injection was given.
Friday- Dizzy, too dizzy to walk,  erratic heartbeat, nauseous, fatigued, chills, exhausted , foggy., heavy feeling.Thursday- exhausted, heartbeat off pounding, couldn?t walk from one room to another, foggy , chills, heavy feeling. Saturday -fog lifting, tired but not as much, heart beat erratic. Sunday -fog gone, more energy, 5:15-5:45 heartbeat very erratic, exhausted after episode.
Date and time of vaccination: (list both if they received both shots): First- 01/08/2021 Second- 02/05/2021 Patient complaining of decrease in appetite for the past 3 days. Patient states that she has no desire to eat anything and wanted to know if this could be related to her covid-19 vaccine. She denies any nausea or vomiting. She states that she had diarrhea all day yesterday and had no incident today.
Right after the injection started having heart palpitations and some difficulty breathing. Face felt flushed after about 10 minutes but then flush went away. Went home. Heart palpitations continued for 6 hours after the injection. Became harder and harder to breathe. Took some aspirin and atenolol, didn?t work much. Took antihistamine medication (claritin), it became easier to breathe. Realized it was an allergy. Also took a different antihistamine to sleep (doxylamine). Had fever 99.5 all day next day (despite taking dayquil). Went to urgent care because heart still did not feel right (although much better than on the 6th) they did an EKG test and confirmed there was no abnormality. Went home, took Claritin every day for 4 days and NyQuil and DayQuil for fever. Fever resolved on Sunday, May 8. Still have heart palpitations or sensations related to increased heart beat from time to time when trying to work out or move around quickly as of may 10th. No difficulty breathing since Saturday.
21 hrs after administration of PEDIARIX, Hib, PREVNAR13 and ROTATEQ Pt experienced fever of 103.7. Tylenol improved temp to 100.7.
Pt had 5yr vaccines 10/26/17 in office at F-up. Mom C'ld phone triage nurse 10/28/17 to report (Lt) arm site with 2x3" area erythema and edema. Afebrile-(+) C/O LT arm pain. Tx=Mom to monitor; Give TYLENOL or IB w/BENADRYL. Mom to C/back if S/S worsen.
Pain at injection site within a hew hours with general muscle aches. Aches continued next day, especially pain in left hip (possibly unrelated); Pain at injection site within a hew hours with general muscle aches. Aches continued next day, especially pain in left hip (possibly unrelated); Pain at injection site within a hew hours with general muscle aches. Aches continued next day, especially pain in left hip (possibly unrelated); Pain at injection site within a hew hours with general muscle aches. Aches continued next day, especially pain in left hip (possibly unrelated); This is a spontaneous report from a contactable consumer (patient).  A 55-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration, in Left arm on 23Feb2021 10:50 AM (at the age 55-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included high blood pressure from an unknown date and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration, in Left arm on an unspecified date 10:30 AM as dose 1, single for COVID-19 immunization. The patient concomitant medications included sertraline hcl (ZOLOFT), losartan, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), multivitamin, Tumeric (received within two weeks of vaccination). The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 23Feb2021 1:00 PM, the patient had experienced pain at injection site within hew hours with general muscle aches, aches continued next day, especially pain in left hip (possibly unrelated). Patient had not received any treatment for the events reported. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Pain began migrating away from injection site about 24 hours after injection.  Went up shoulder and into my shoulder blade, causing enough pain I couldn't left my arm nor lay down on that side.  After 48 hours, the pain was further migrating down the left side of my back, up the left side of my neck, around my shoulder into my armpit, and under my left breast.  After 72 hours, the pain had further migrated into the center of my back and chest - basically the entire upper left quadrant of my chest cavity was in severe pain.   Urgent Care clinic noted that all lymph nodes on my left side were severely swollen/inflamed.  Prescribed a high dose of steroid- Prednisone- and recommended taking ibuprofen to help reduce the swelling, and heating pad to also help alleviate the pain.  Some of the pain began to subside within about 8 hours of first dose of prescription.  Today is the third day of taking the steroid and my pain, while still present, I would consider mild now.
RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 71-year-old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to right arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose) (dose number in series 1). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210610, 20211209775, 20211210159, 20211210409, 20211210733, 20211210408, 20211210555, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209912, 20211210141, 20211210585 and 20211210107.
Pt reports swelling, redness, itchiness at sight of injection. There was noticeable swelling
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL, start date: 25Jul2022; DESVENLAFAXINE, start date: 01Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (15Aug2022) Positive, notes: Tested positive again on 15Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a nurse regarding a 2 month old female patient. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On 24-APR-2017, the patient was vaccinated with a properly-stored dose of VAQTA injection (dose and route of administration were not reported) lot number M039202; expiration date 11-MAR-2018 for prophylaxis. No adverse effects were reported. Additional information is not expected as the reporter refused additional contact.
Parasthesia starting in right hand radiating up through arm to right side of neck and face. SX developed after vaccination into right, deltoid. Resolved in 24 hrs. No TXT req'r. Currently patient had mild soreness at injection site.
Triamcinolone crm 0.1% rub into affected area bid prn. ZOFRAN 4mg tab q8 hrs for nausea #15 f/u prn.
I've developed a tic on my left eye that makes my eye keep closing about twenty times in a minute. A few days later it spread to my righ eye and now sometimes I cannot see because my eyes want to close at almost all points in time. This started about a week to ten days after I received the vaccine. Currently did no treatment, and it is ongoing.
About 3:00  p.m. of day of injection, head felt "fuzzy" and I felt somewhat  unsteady upon standing and walking.  Today, next day, I feel a little better.
Booster dose received on the morning of Nov 13. Blood pressure and pulse were normal at approximately 112/70 the week before the vaccination and the day following vaccination. High pulse rate 101bpm, high blood pressure 188/89, dizziness on the afternoon of Nov 15. On the afternoon of the 15th, the lymph node at the right base of the skull was swollen and hard. Symptoms recurred to a lesser extent on the 16th and 18th with exercise/stress. bp and pulse return to slightly elevated after 1 hour rest period.
Developed rash. Started as 3 spots on lower abdomen, then over the course of the week developed more spots on abdomen, under left arm, under right breast, and on back.; They itch when touch; Patient developed rash/They are raised, erythematous spots with scaling in the middle; They are raised, erythematous spots with scaling in the middle; This is a spontaneous report from a contactable Other HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. EL3302, expiry date not reported), via an unspecified route of administration on left arm on 10Jan2021 at a single dose for covid-19 immunization.  Medical history included pollen allergy.  The patient was not pregnant. Concomitant medication included fluoxetine (FLUOXETINE), ethinylestradiol, ferrous fumarate, norethisterone acetate (HAILEY 24 FE); both on unspecified dates for unspecified indications.  The patient had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot no. EJ1685, expiry date not reported) on 20Dec2020 on left arm for Covid-19 immunization. On 12Jan2021, the patient developed rash. Started as 3 spots on lower abdomen, then over the course of the week developed more spots on abdomen, under left arm, under right breast, and on back. They are raised, erythematous spots with scaling in the middle. They itch when touched. No ulceration, no oozing. The spots are larger and more red now than when it first began. The patient had nasal swab on 17Jan2021, and it was negative. Outcome of the events was not recovered. The vaccine was given on school or student health clinic. No other vaccines were given in four weeks.   No follow-up attempts are possible. No further information is expected.
Patient called today, complaining of itchiness & redness at the site of injection, which started last night.  It then spread out, she noticed this morning.  Per Patient, it now seems to be improving.
*On 2-22-2021, the day after my first COVID-19 vaccine dose, I started feeling a sense of pressure and heaviness in my head, general fatigue/weakness, & eye fatigue at varying intensity throughout the day.  *I thought these were normal side effects, over in a few days, but symptoms persist almost daily, at varying levels, to the present (5-7-2022). They did not respond to ibuprofen or acetaminophen.  Resting with feet up, and lying down for one (or two) naps a day helps for a while.  No head pressure & heaviness when asleep at night.  I received 2nd dose of Pfizer BioN Tech Covid-19 vaccine (lot EN6204) on 3-15-2021; booster (3rd dose) lot 30145BA on 9-27-2021.  *Vertigo/ER/hospital/PT: SEE 19 Below:
I woke up one morning will getting out of bed. I stepped on my left foot and noticed a lot of pain in my left foot. I went to an apple urgent care center. They did blood work.  I also had pain in my left arm as if someone was pressing on my nerve.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 08-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Moderate to severe lymphadenopathy in the neck/under chin and affecting throat. Swelling caused moderate pain and mild difficulty swallowing with mild breathing obstruction/discomfort. Onset of symptoms was roughly 10-12 hours post Moderna injection #1. Symptoms abated somewhat with Benadryl and NSAIDs. Raspy voice, pain in neck/chin jaw from swelling, visible swelling of lymph nodes and discomfort (somewhat positional) when breathing, swallowing, speaking. Night #1 was severe. I may have gone to the ER if I was not so immunocompromised. Day 2 was uncomfortable/painful but better with NSAID use. Night 2 had increased swelling and pain that improved after taking Benadryl and Singulair and nightly dose of Celebrex. Day 3, I am a bit uncomfortable with mild pain and visible swelling, but improved from Day 2.
Patient received vaccination and had local reaction at site of injection. Patient complained of lightheadedness and passed out. Called 911 and she was sent to ER for observation.
I noticed a bruise the next day after the vaccine at the injection site. It was the size of a lemon. Approximately 2 weeks post vaccine, the shoulder and the arm are sore. And now the shoulder is to the point where I cannot move my arm far back or raise it up like I used to because it really hurts. I did not see a doctor because I thought the pain was going to go away. In February, the pain did not go away, the doctor did an x-ray and called it tendinitis. The doctor told me to take Aleve 4 times a day. 2 in the morning and 2 at night, but I am kind of scared to take that much. And to do some exercises. And gave me a prescription to do physical therapy, but not until the pain goes away. I have not recovered from the adverse event. I still have issues with the left arm. It still hurts.
At 11:35 the child stated she felt dizzy and was starting to have a mild headache. Public Health Nurse was called over to assess the child. The child was asked to lay down on the floor and head propped up. PHN assessed the child and gave water. The child was escorted to the nurse's office to continue to lay down 11:54AM. The child felt better and was able to return to class.
Severe leg pain, left leg, inside leg from ankle up 19 inches, lasting a couple of hours.
Patient admitted to the hospital with COVID-19 symptoms on 7/24/2022- 7/27/2022.  Medications given included cholecalciferol 25mcg PO daily, remdesivir daily x 2  days, ascorbic acid 1000mg PO daily, zinc sulfate 50mg PO daily, dexamethasone 6mg IV daily,
Pt received the vaccination in May and informed us today that he had a reaction. States the arm was swollen and red, and he went to urgent care.
Muscle oreness, redening and swelling of upper right arm around the area of injection.  The affected area also felt "hot" to the touch and muscle felt "hard" .    Treatment: Avelox 400mg.  Once a day for ten days.
Pt. developed skin rash (typical rash of herpes zoster) on the lt. side of her neck in a dermatomal distribution for 5 days prior to her presentation to the clinic on 04/24/13. Just started her on Valcyclovir 1gx2x7 days.
Patient reported pruritis, nausea/vomiting, uricaria, vertigo, shivering, diarrhea. She has been treated with Tagamet, Prednisone, MEclizine, Zofran, and Clobetasol lotion.
mild soreness in upper left arm,near injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 53-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: EP6955) at the age of 53 years as unk unk, single for covid-19 immunisation. Relevant medical history included: "glaucoma" (unspecified if ongoing); "IBD" (unspecified if ongoing). Concomitant medication(s) included: TUMS CHEWIES; IBUPROFEN; COMBIGAN; ROCKLATAN; AMITRIPTYLINE. Vaccination history included: Bnt162b2 (Dose:1), when the patient was 53 years old. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Apr2021, outcome "recovering", described as "mild soreness in upper left arm, near injection site".  Additional Information: The patient had no allergies to medications, food, or other products. He did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Other medications he received within 2 weeks of vaccination were MULTIVITAMIN, Probiotic, TUMS chewable (PRN), Ibuprofen (PRN), COMBIGAN eye drops BID, ROCKLATAN eye drops QD, amitriptyline QD. Other medical history: Glaucoma, IBD. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not diagnosed with COVID-19. No treatment was received for the adverse event.  No follow-up attempts are possible. No further information is expected.
I had a scary thing happen with my heart; subsequently the rest of my body; My heart suddenly started pounding and racing; face was tingling and  hands were tingling; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (I had a scary thing happen with my heart), DISCOMFORT (subsequently the rest of my body), PALPITATIONS (My heart suddenly started pounding and racing) and PARAESTHESIA (face was tingling and  hands were tingling) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 22-May-2021, the patient experienced CARDIAC DISCOMFORT (I had a scary thing happen with my heart), DISCOMFORT (subsequently the rest of my body), PALPITATIONS (My heart suddenly started pounding and racing) and PARAESTHESIA (face was tingling and  hands were tingling). At the time of the report, CARDIAC DISCOMFORT (I had a scary thing happen with my heart), DISCOMFORT (subsequently the rest of my body), PALPITATIONS (My heart suddenly started pounding and racing) and PARAESTHESIA (face was tingling and  hands were tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Developed headache after injection. No prior headaches in years before this shot. Now daily headaches, and randomly spiking blood pressure
an 87 y/o female with PMH significant for right MCA CVA s/p thrombectomy 12/27/2020 with left sided residual, left ophthalmic CVA, type 2 DM, HTN, HLD, obesity who complains of twitching.   History is obtained from pt's sister at bedside. She states over the past 3 days the pt has had twitching of her left face and arm which she says is basically constant. Unknown if there have been any recent medication changes. Pt had a telephone appointment with NES today who referred her to stroke neurology. Today pt's sister asked her neighbor who is an RN to come take a look at her, who advised that she bring the pt to the ER.
Initial report received from a health care professional on 25 September 2009. A 21-year-old male with a concurrent illness of sinus congestion, had received an intramuscular left deltoid injection of FLUZONE No preservative 2009-2010, lot number U3171AA on 24 September 2009 and one day later, he developed shortness of breath, sweating and a feeling of heaviness in his left arm and leg. The patient had been sick in bed fro two days with sinus congestion prior to vaccination. The patient denied any pre-existing medical conditions and he had not been taking any concomitant medications. At the time of the report, the patient's recovery status was unknown. Documents held by sender: None.
Diarrhea x 5 days, blood in 1 stool on 12/9/15.
Swelling of tongue and face with heat. Waited 30 min it started to subside went home took Benzedrine got better. Good so far
whooping type cough on 31Aug92.Had been seen several times since 11Aug90 /w cough.Pt adm to hosp for pertussis type illness.Had 4 DPT vax.
Shiver, Nausea, high fever, muscle ache in my arm at the spot of injection.