chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received dose from expired vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided. Date the vial was initially stored in the refrigerator: Unknown   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Significant Follow-up received on 17-Nov-21  includes reporter information, patient information and batch number updated.
Swelling, redness, warm spot at the place of the vaccine, itchiness amore than a week after the vaccine.
My arm started hurting about a week and a half after shot and has not stopped. It is not quite as excruciating as it first was but , it still hurts and I have limited movement without pain . Has been like this for 2 weeks now.
Child came in for a follow up and needed a booster I gave the moderna half dose instead of the pfizer by accident he stayed the 15 mins had no reaction
My husband and I went out to eat with his aunt and uncle. A couple of days later I started to feel a little off but thought I was just getting a cold. A few days later my husband's aunt called to let us know they had tested positive for COVID-19. I took a home COVID-19 test that came back positive immediately. I called my doctor, we discussed that with many medications and sensitivities to many different antibiotics that I would not take the PAXLOVID. I was advised to use over the counter medications. It took me three weeks to get over COVID-19.
Immediately following 3rd immunization patient fainted back and hit her head on the wall. By the time provider entered the room, extremities with tonic clonic posturing. She immediately sat up and started crying, cold came back. Ice applied to head. Had apple juice. Felt shaky but better. Monitored for 30 min. Pt says this happened in the past when in foster care.
Left arm injected 11:15 AM (12-01-11), fever 101 degrees 8PM; severe swelling inflammation; pain; 1 inch below inj site to above elbow; called RPh; took BENADRYL for allergy; called personal doctor; advised to E.R.; Z-PAK, ZYRTEC & ADVIL; compresses 4x day - 4-7 days.
Sore arm, rash that?s made up of a bunch of purple dots all over my left arm around my injection shot.
9:30 AM - Recipient sent to observation area post administration- tolerated well. In observation area 5 min. later recipient began stating she feels dizzy, screaming she does not feel well, began shaking upper torso and extremities, eyes shut - placed on ground floor with elevated legs, applied 10L/min oxygen via mask,  v/s taken (HR/PR/ Pupil reaction), EPIPEN 0.3mg administered @ 9:38 am, with good response as recipient seemed to calm down, no screaming, no shaking. At 9:52am EMS arrived and took over.
Patient was administered the vaccine on 8/27 and by the end of the day experinced soreness. She was awaken at night with sweats and then later developed chills, fever, and the arm is swollen and red about 4 finger lengths. The red area appears to be at the lower end of the left deltoid.
Lt. upper arm with 5cm x 8cm oval - red, raised, and warm - tender to touch.
Woke up the morning of 1/28 unable to hear any sound out of left ear, gradually possibly gaining hearing back however there's a constant ringing in left ear still concurrent as of today's date 3/23 (almost 2 months of on-set symptoms)
8mins post vaccination pt had a syncopal event.  Pt then c/o respiratory distress, sweating, dizziness, HA, Severe Abdominal pain. Vitals: BP 105/71, HR 85, RR 18. Pt assiested to w/c.  EMS Called 17:48.  EMS arrived and assessed the patient.  Pt was cleared.  Pt was d/c to home under the care of her husband.
Patient describes hives beginning 1/27/2010 AM when she awakened. Hives started on her  neck and have progressed to her face, arms, and back. Has 2 on her legs and one started on palm of her hand today. Initially used BENADRYL gel, switched to cortisone cream at advice of her MD. MD also recommended BENADRYL orally but she has not obtained this - she plans to purchase today. Is to see MD of no relief w/in next few days.
Swollen lip and cheek, chin right side(3/24) Welts on both thighs 3/25,  3/25 Dr. prescribed prednisone 10 day pack
Developed golf ball size swelling at site, tenderness X8 days. Evaluated 7/31/09 unremarkable, no pain, no redness, no swelling.
3JUN93 raised knot @ size of fifty cents piece, bruised mid section @ 3cm x 3cm, area hot to touch @ inject site; 2 reddened areas (knots) around @" below inject site on lt arm;
Mom reported "dime" size swelling- redness at inj. site - "nickle" size swelling/redness itchy under injection site on 4-14- Child to ER R/T swelling/redness 4-14-09. ER dx "Cellulitis"- Prescribe antibiotics.
Patient came to pharmacy and claimed she got a swelling and redness at site injection. Site of swelling was big like an orange and solid hard. Patient was advised to contact MD and call pharmacy if things gets worse.
Client received a seasonal flu vaccine today but had already received one for the year on 12/7/09. No adverse reaction noted.
Received Pneumo on 10/16 at 2:30.  8:00 pm swelling edema from elbow to shoulder.  Instructed to go to PMD in Woodville, tx with benedryl and Ibuprofphen, sweeling has decreased.
pt recv vax & devel a fever, chills, & inj site rxn, characterized by edema, erythema, & pain
Had Tdap in right arm 9/17/09.  Approx. 1-1/2 hours later in car on ride home, noted stiffness and pain in LEFT shoulder beginning. Woke up next AM in tears c/o LEFT shoulder hurting. No shot was given in left arm. No fever, warmth, redness, etc. in left shoulder area; just a lot of pain and limited ROM.  Had soccer practice night before injection given, but no specific injury known/received although was "horsing around with friends".
Painful inflamed wrist, hands, neck and top of feet. Elevate C-reactive protein.
Client reported receiving first dose of Pfizer vaccine on February 13, 2021 but did not have vaccination card for proof. Staff was unable to verify vaccination due to the vaccination being administered in a different state and not being on. Client was unable to access a clinic offering Pfizer vaccine. Client consented to receiving Moderna vaccine for second dose, being another mRNA vaccine after being informed of potential risk. Client had no adverse reaction to vaccine administered.
Weird neurological sensations throughout my body. Pressure of my eyes, weakness, malaise.
This spontaneous report as received from a physician via company representative refers to a 66 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (route, lot # and expiry date were not specified). The patient came the next day to the physician's office complaining of pain in her arm where the vaccine shot had been administered. The outcome of the event was unknown. The causality of the event was not reported. Additional information has been requested.
Starting about 48 hours after the Shingrix shot my arm hurt really bad, like someone had punched it, and the redness around the injection site began to spread and began to get really warm to the touch . It's slightly itchy but not uncomfortably so. The redness now covers most of the front of my upper arm and is still warm to the touch. Anywhere I touch that is red feels like it is bruised. I had an instance last night where I got the chills, out of nowhere, and could not warm myself up for about 2 hours. The same thing happened this morning but not for as long, maybe 30 minutes.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing). Concomitant medication(s) included: TRI-SPRINTEC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Indication: No known allergies. Treatment of COVID-19 with Brand Paxlovid. Treatment started date from 31May2022 to 05Jun2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SPIKEVAX (COVID-19 Vaccine, mRNA)  Sporadic full body rash/hives. Flare ups come at inconsistent intervals and to varying degrees of itchiness. Started on/around Dec. 17th and continued since then.
A week later had some itching and an area of redness around injection site.. Had soreness after injection. No redness. Some ticking on and off after injection.
no adverse event; vaccine administrated afte a temperature excursion; This spontaneous report was received from a nurse referred to a patient of unknown age. No information regarding the patient's pertinent medical history, concomitant therapies and drug reactions or allergies was provided.  On 01-JUL-2020, the patient was vaccinated with improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot# S005878 with expiration date :25-NOV-2020.   The dose of vaccine was stored above 9 Celsius degree: 8.9 Celsius degree for 15 minutes. Previous temperature was above 9 Celsius degree: 14.2 Celsius degree for2 hours. Digital data logger was involved. No adverse effects were reported.
red swollen area 5x8cm lt deltoid region;c/o of SOB;tx epi;
Hot to the touch; Red patch the size of her hand under the injection site; Swollen; Chills; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hot to the touch), INJECTION SITE ERYTHEMA (Red patch the size of her hand under the injection site), INJECTION SITE SWELLING (Swollen), CHILLS (Chills) and HEADACHE (Slight headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cancer and Thyroid disorder.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE WARMTH (Hot to the touch), INJECTION SITE ERYTHEMA (Red patch the size of her hand under the injection site), INJECTION SITE SWELLING (Swollen), CHILLS (Chills) and HEADACHE (Slight headache). At the time of the report, INJECTION SITE WARMTH (Hot to the touch), INJECTION SITE ERYTHEMA (Red patch the size of her hand under the injection site), INJECTION SITE SWELLING (Swollen), CHILLS (Chills) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified medicines for blood pressure, thyroid and cancer.   No treatment information was provided by the reporter.
Mild headache, lethargy, mild temperature (99.1 degrees Fahrenheit)
patient received 3 vaccines then had blood drawn, immediately after blood draw patient lost consciousness for approximately 20-30 seconds. Patient had cold pack placed to back of neck, cold cloth to forehead. Upon awakening patient was given apple juice and a granola bar. Patient's vital signs were stable and she was escorted to the front of clinic and driven home by a friend.
Swelling and redness at injection site. Treated with oral steroids and Tylenol. Family questioning if vaccine contained latex, to which the patient had a known allergy.
Lips numb, throat tightened, high fever, chills, felt faint ?.  Took Benadryl  ?.  Affects started about 20 minutes after each vaccine
Patient came into clinic to receive, J&J vaccine. No contraindication to getting the J&J  vaccine. Vaccine was given to patient in Left Deltoid at 1121am on 11/04/2021. At approximately 1136am patient reports numbness and tingling in left hand. Vitals were taken at 1140am HR: 61, BP: 150/90, Oxygen: 90%, RR: 14. Patient reports known health history of hypertension, no respiratory distress, no difficulty breathing, no vision changes, no loss of consciousness. Had patient stay for observation, vitals were retaken at 1215pm, and were WNL.  Patient reports tingling/numbness in hand is improving and referred to health care provider ASAP for further observations.
Did not receive 2nd dose on due date; Felt like throat was closed; This spontaneous case was reported by a nurse and describes the occurrence of THROAT TIGHTNESS (Felt like throat was closed) and INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose on due date) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROAT TIGHTNESS (Felt like throat was closed). On 11-May-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose on due date). On 11-May-2021, INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose on due date) had resolved. At the time of the report, THROAT TIGHTNESS (Felt like throat was closed) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications and treatment information was not provided.  The patient felt like his throat was closed when he was on his way home, 30 minutes after the 1st dose. He was due for his second dose on day of this report but they declined to give the patient due his side effects after the first dose.
rash on face, arms, legs, diaper area multiple, small papules, bright red w/o vesicles or pustules; somewhat clustered on heels & thighs; seem non tender-spares trunk; pt dx w/probable viral exanthem;
A non-serious spontaneous report of strep and positive influenza test has been received from a non health professional concerning a male child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Neither the patient's medical history nor the concomitant medications were reported. The patient received FLUMIST in Aug-2011. On 27-Dec-2011, the patient experienced strep and positive influenza test. The outcome of the events strep and positive influenza test was unknown.
Progressive: Chills, rigors, temp not to exceed 102 first 36 hours. Rash, lightly cyanotic at injection site which continues to progress now with appearance of "blood pressure" cuff nearly circumferential around the upper arm.  Good capillary refill, increasing pruritus rather than lessening.  Pepcid 20mg BID, Benadryl 25mg q6 hrs and topical steroids not alleviating or lessening the spread of the atypical colored rash.
I went into anaphylactic shock about 20 minutes after I received the shot. I was immediately admitted to the hospital and stayed for 10 days. I was unable to recall many things up until the day I was released.
pt recv vax & exp pain the arm, swelling & redness; No further details were provided;
This spontaneous case report was received from a nurse (PVX2018-169) on 18-Jan-2018. The report describes male consumer (older than 64 years) who "ate 15 minutes after taking VAXCHORA". The consumer was receiving oral VAXCHROA for cholera protection. Also the consumer was above the approved age for VAXCHORA. It was reported that the consumer ate 15 minutes after taking VAXCHORA. VAXCHORA is indicated for patients up to 64 years old, but the consumer was above this age group as indicated his date of birth. The action taken with VIVOTIF with respect to the events "ate 15 minutes after taking VAXCHORA" and consumer was above the approved age for VAXCHORA was not applicable. The clinical outcome of the events "ate 15 minutes after taking VAXCHORA" and consumer was above the approved age for VAXCHORA was unknown. Sender's Comments: Company's comment: The causality of the events "ate 15 minutes after taking VAXCHORA" and "consumer was above the approved age for VAXCHORA" was considered as not applicable.
sore arm next day for a few days - then stopped then restarted about 5-7 days later with additional sharp pain in arm neck back, wrist and hand ongoing still happening. still hard to use arm. had dr appt at urgent care and will be getting an MRI
The patient was treat for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 07-NOV-2007, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the patient's vaccination with zoster vaccine live(ZOSTAVAX), the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, the patient had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Do not know lot number.  Had 2 doses.   Hands in pain all the time and still unable to open soda bottles.
The patient called the clinic on 10/12/2001 stating she had an onset of chest pain the same day of the vaccine. The patient stated the chest pain felt like a heart attack. The patient denied SOB, a cough or rash. The patient felt flu-like symptoms. During the phone contact with the patient on 10/12/2001, the patient did not have labored breathing and did not sound distressed. The patient was instructed to follow-up with the ER as soon as possible with the severe reported chest pain.
Information has been received from a nurse practitioner concerning a 6 year old female who on 03/01/96 was vaccinated with a dose of varicella virus vaccine live (site unknown) On 10/20/01, it was reported that the pt "now" has chicken pox. The pt sought unspecified medical attention. Additional information has been requested
Swollen Lymphnode in Right Breast - Axillary Lymph Group.  Pain, Swelling
Face/Neck red/hot to touch, itchy, slightly inflammation Took zyrtec @ bedtime 1/8/21 awoke, symptoms worse, face /neck burning - spoke with cvs pharmacist, recommended benadryl, took 2 pills 10:30am 1:30 pm Tele Health visit w/PA , benadryl not helping, prescribed steroids 1/8/21 5pm took 2 tablets prednisone
Right arm was severely swollen. Also had chills and a rash on my groin. It lasted for 3 days. Fever, fatigued and anorexia. Happened with both doses, > with 2nd.
Moderna 1st dose given on 3/15/21 and patient subsequently admitted to the hospital on 4/1/21
The patient experienced sharp pains and described it as neuropathic pain in the left arm for about 3 weeks. The patient states that he does not consider it a problem and continues to want the second dose. He does not want MD consultation.
5 days post vaccination, patient developed rash on central abdomen. 6 days post vaccination, rash on abdomen resolved and rash appeared on bilateral forearms. Patient took Benadryl and rash subsided by day 8 post vaccination.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 16-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/12/2021. PATIENT FULLY VACCINATED ON 02/12/2021.
The patient did not report this until 5/19/19 when inquiring about her getting the second dose of this series. She stated that her right hand was very red and swollen for several days after the shot. She did not change anything else during this time and the vaccine was the only thing different she had done. She stated that she did not take anything for it and did not inform the pharmacy of it until now. The doctor did not seem concerned about the reaction.
11/29/21 Was brushing teeth, felt really sweaty and lightheaded, saw blackness with stars and had ringing in the ears. Then fell forward and passed out, hit head, had bruise on left shoulder. No treatment done. On November 30th woke up and found hives all over my face, neck, arms, chest and back. Saw PCP and was rxed steriods and allergy medicine. Slowly resolved in four days. Still experiencing skin issues, skin is more irritable and turns red and raised easily from itching. Gets random outbreaks on legs, hands, back, face. Pt on Syzal, long-term allergy medicine. Echo done mobile heart activity tracking done. Bloodwork and urine done. WBC count high, IGe high.