chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE; full dose was not administered; This spontaneous report was received from a nurse referring to a 1-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 02-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA) lot # W029538 with expiration date 15-SEP-2024, for prophylaxis (strength, dose, route of administration and anatomical locations were not reported). It was reported that the patient moved while attempting to administer a dose of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine. Reporter stated the full dose was not administered (incorrect dose administered) and some of the dose leaked out and was unsure of how much of the dose was received. No other adverse event (AE) was reported.
Patient complains that his bottom two fingers in his right hand are experiencing numbness/tingling ever since the vaccination.
woke up and right arm felt like it was on fire, went to the ER and blood pressure was 68/40 she went into shock in IUC
Moderna Vaccine was administered after the beyond use date of 30 days at refrigerated  tempature. BUD 10/01/2021
I have had worsening reactions after each COVID vaccine dose I had received/Adverse effect.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I have had worsening reactions after each COVID vaccine dose I had received/Adverse effect.) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I have had worsening reactions after each COVID vaccine dose I had received/Adverse effect.). At the time of the report, IMMUNISATION REACTION (I have had worsening reactions after each COVID vaccine dose I had received/Adverse effect.) outcome was unknown.            Patient date of birth was reported  Concomitant medications details were not reported by the reporter.  The patient had reported had worsening reactions after each COVID vaccine dose that patient had received. Patient reported that patient was not confident in medical opinion of the lack of side effects from vaccines prefer to build natural immunity.   Treatment details were not reported by the reporter.
a friends sister was so freaked out, got the vaccine, and stroked out; This is a spontaneous report from a non-contactable consumer (friend).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  A friends sister was so freaked out, got the vaccine, and stroked out (medically significant) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
muscle soreness at the injection site; This is a spontaneous report from a contactable physician reported for self. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in Dec2020 for COVID-19 immunization. Medical history and concomitant medication were not reported. She reported muscle soreness at the injection site after use of product in Dec2020. The outcome of event was unknown.   Information about lot/batch number are requested.
TWITCHING; LITTLE BIT SHORTNESS OF BREATH; COULD NOT SLEEP AS IF HAD NERVOUS CONDITION; RIGHT LEG KICKING OUT; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included: stroke, and concurrent conditions included: disabled, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and was receiving lot of medications including blood thinners. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-SEP-2021, the patient experienced twitching. On 19-SEP-2021, the patient experienced little bit shortness of breath. On 19-SEP-2021, the patient experienced could not sleep as if had nervous condition. On 19-SEP-2021, the patient experienced right leg kicking out. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from twitching, little bit shortness of breath, could not sleep as if had nervous condition, and right leg kicking out. This report was non-serious.
Error in dosage - diluent was not mixed in with the pfizer vial.   No adverse reaction - wanted to document - facility administered not us as provider.
STICKY AND OOZY EYES; HER EYES BECAME BLOOD SHOT; HER EYES BECAME RED; WHITE PATCHES IN MOUTH; VERY SENSITIVE TONGUE/TONGUE WAS VERY SENSITIVE; RUNNING NOSE WITH A CONSTANT NASAL DRIP; FATIGUE; HER EYES BECAME OOZY; SLEPT ALL DAY; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Sjogren's disease, rheumatoid arthritis, odours,environmental allergies, and had problems with eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, the subject experienced her eyes became oozy. On 27-MAR-2021, the subject experienced slept all day. On 27-MAR-2021, the subject experienced fatigue. On 27-MAR-2021 17:30, the subject experienced running nose with a constant nasal drip. On 29-MAR-2021, the subject experienced very sensitive tongue/tongue was very sensitive. On 30-MAR-2021, the subject experienced white patches in mouth. On an unspecified date, the subject experienced her eyes became blood shot, her eyes became red, and sticky and oozy eyes. Treatment medications (dates unspecified) included: allergy medication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from her eyes became blood shot, sticky and oozy eyes, her eyes became oozy, and her eyes became red, had not recovered from running nose with a constant nasal drip, fatigue, and white patches in mouth, and the outcome of very sensitive tongue/tongue was very sensitive and slept all day was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
One week later the patient started to feel itchy on both arms and the injected arm started to feel really itchy and painful. She went to the doctor and she got a prescription for XRays (she has not gotten the xrays) and got a prescription for cortisone for the itching. She is getting antoibiotics IV for the rash to prevent because she is diabetic. She is not sure of she is getting IV steroids too for the rash and topical allergy.
Lingering pain and soreness at injection site 33 days post vaccination. Patient has range of motion, but site is still sore to movement. Patient states this pain occurs "sometimes". Also complains of pain to the lateral aspect of left breast near armpit and upper clavicle region.
fever; joint pain; injections site pain; injection site redness; injection site swelling; nausea; shivers; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced nausea and shivers. On 22nd June 2019, the patient experienced injection site pain, injection site erythema and injection site swelling. On 23rd June 2019, the patient experienced fever and joint pain. The patient was treated with non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On 23rd June 2019, the outcome of the fever was recovered/resolved. On 24th June 2019, the outcome of the nausea was recovered/resolved. On 25th June 2019, the outcome of the shivers was recovered/resolved. On 26th June 2019, the outcome of the injection site pain, injection site swelling and joint pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, nausea, shivers, fever and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. Less than a day after receiving his 1st dose, the patient developed injection site pain, swelling and redness. On 22nd June 2019, the patient applied an ice bag at night.  The patient also developed nausea, shivers, fever and joint pain.  All symptoms had resolved except for the site redness, which persisted but had improved daily. The patient did not have vaccine information for this adverse event and did not consent to follow up. There is a discrepancy with respect to the onset date of the events nausea and shivers. In source document, the onset date is reported as 27th June 2019 (future date)and outcome date as 25th and 26 June 2019 respectively. The onset date for nausea and shivers was kept as unknown June 2019 conservatively. Also, the outcome of the events injection site pain, injection site swelling, joint pain, nausea and shivers was reported as recovered/ resolved with sequel but in narrative it was recovered/ resolved. Outcome of all these events is retained as per narrative.
The patient made a claim for his 1st dose Moderna shot. He checked in with the pharmacy technician to confirm his first dose. He confirm it is the first Moderna dose with the pharmacist. He received the 3rd doses of Moderna without being moderately to severely immunocompromised. The pharmacist, realized it is his 3rd Moderna dose because he tried to get a vaccination card for his dose but he showed her a card with 2 other Moderna doses elsewhere.
Seizure lasting approx. 1 and 1/2 minutes. EMT called: pt appeared to be not breathing; non responsive for 20min.  11/23, 11/25 and 11/30 Medical records received for DOS 11/19/09 - Final DX: Seizure disorder C/O seizure activity, vomiting. Horizontal nystagmus. Last seizure 9 yrs prior. WBC increased.  D/C to home w/ABX therapy.
THE NURSE ACCIDENTALLY GAVE 1ST DOSE OF PFIZER VACCINE TO 11 YEAR OLD KID.  PFIZER IS INDICATED FOR 12 YEARS AND UP.  SO FAR, THE PATIENT DOESN'T HAVE ANY SIDE EFFECTS YET.  WE NOTIFIED THE PATIENT'S MOM ABOUT THE INCIDENT AND NOT TO GET 2ND DOSE UNTIL THE PATIENT TURNS 12.
Cellulitis (Rt) upper arm - discharge summary included. Vaccine administered at pharmacy.
Patient received the vaccine and while waiting at the post vaccine observation lobby, fainted. He stated he was not diabetic, did not have breakfast that morning and was nervous about the vaccine. Fainting episode lasted less than 1 minute, and afterwards patient was alert to person time and place. He was taken by ambulance by paramedics for further evaluation because his fiance stated that she saw him have a small seizure. I did not witness the seizure.
I went to the ER on 12/1/2021 with sore neck, lump on head & neck, joint aches the day before. On examination they found a shingles rash on the back of my neck, head & ear. I was given acyclovir 1000mg for 7 days. Over the next few days the rash spread to the front of my neck.
Site: Pain at Injection Site-Mild, Systemic: chest pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient states after shot she had pain in her chest and pain
bilateral swelling and pain in knees beginning Feb. heat, ice, elevation, rest did not improve. pain and swelling in second toe in left foot.   PCP office visit x3, ortho office visit x2. rheumatologist office visit x1. diagnosed with spondylarthritis by rheumatologist.
Lightheadedness (maybe) Feeling of Intracranial pressure  Blood pressure or 140+/95+ Trouble breathing Lower VO2 max despite normal exercise regimen  Dissociation (physical, not mental)
Pediatric dose was given to a child who should have received an adult dose.  No ill effect.
A little bit of chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (A little bit of chills) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (A little bit of chills). At the time of the report, CHILLS (A little bit of chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
husband's Zostavax vaccination record with this letter as proof of patient's infection and vaccination with the Zostavax virus through secondary transmission; This spontaneous report was received from a nurse practitioner, referring to a currently 82-year-old patient, via a immunization record from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 1801USA001762). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 29-DEC-2006, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported).  On an unknown date, the patient experienced shingles (herpes zoster). It was reported, the patient's wife infection and vaccination with zoster vaccine live (ZOSTAVAX) virus through secondary transmission (captured on Marrs# 1801USA001762).       The outcome of herpes zoster and the causality assessment between zoster vaccine live (ZOSTAVAX) and the aforementioned event was not reported.        This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-1801USA001762: US-009507513-2107USA007312:
Measles like rash on body that lasted about 10 days. One month after MMR vaccination was diagnosed with GianottiCrosti syndrome.
FAINT HEART PALPITATIONS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested  No concomitant medications were reported. On 14-MAR-2021, the subject experienced faint heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from faint heart palpitations. This report was non-serious.
Information has been received from a nurse concerning a 23 week old patient who on 22-Jun-2009 was vaccinated orally with a dose of ROTAVIRUS (Lot # 663679/1765X) that was improperly stored as low as 31 degrees F on one occasion in the month of June 2009. No adverse effects were reported. Follow-up information was received from the licensed practical nurse concerning the 6 months female who on 22-Jun-2009 was vaccinated with the second dose of ROTAVIRUS (Lot # 663679/1765X thimersol free) at the private doctor's office / hospital. Secondary suspect therapy included the second dose of RECOMBIVAX (Lot # 662113/0293Y). Concomitant therapy included the second dose of PREVNAR (Lot # 034438), the second dose of PENTACEL (Lot # C3282AA). This is one of tow reports from the same source. No further information is available.
Client reports that the following morning after getting his COVID 19 Pfizer vaccoine that we woke up with facial numbness above the nose and that is lasted 2 days, but Tylenol assisted with it.
Redness, swelling, itching, pain after 24 hours of administration, warm to touch. 20 mm round appx 7/26/10.
Increased lacrimation, shortness of breath, urticarial rash. 25mg of po Benadryl given (+) 12mg of IM Decadron given. No wheezing.
Pt recvd 3 doses of Engerix-B 27APR90, 28MAY90, & 13NOV90 & 18AUG91 it was determined by titer result that pt did not respond to the vax series;
(R) upper arm swelling, pain, redness Treatment with cold, Tylenol, elevation
psoriatic arthritis flare up; puffy hands; Swelling of hands; Had pfizer vaccines and headaches; Had pfizer vaccines and sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4411554-00.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 04Aug2020 (ongoing) (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Had pfizer vaccines and headaches"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Had pfizer vaccines and sore arm"; PSORIATIC ARTHROPATHY (non-serious), outcome "not recovered", described as "psoriatic arthritis flare up"; OEDEMA PERIPHERAL (non-serious), outcome "not recovered", described as "puffy hands"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "Swelling of hands". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "psoriatic arthritis flare up", "puffy hands" and "swelling of hands" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "had pfizer vaccines and sore arm" and "had pfizer vaccines and headaches" related to BNT162b2.  Had Pfizer Vaccines and Headaches and Sore Arm, Psoriatic Arthritis Flare Up and Puffy Hands with Humira (Adalimumab). On unknown dates, the patient experienced Psoriatic Arthritis Flare Up and Puffy Hands. In 2021, the patient experienced Had Pfizer Vaccines and Headaches and Sore Arm. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Had Pfizer Vaccines And Headaches And Sore Arm onset in 2021 and Had Pfizer Vaccines And Headaches And Sore Arm onset in 2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Psoriatic Arthritis Flare Up and Puffy Hands with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided,  the causal association between the events   psoriatic arthropathy, vaccination site pain, oedema peripheral, peripheral swelling,headache  and the suspect product  BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
Nurse reported that on 7/5/00 the patient developed a red, raised abscess at the site of Acel-Imune administration. She was treated with cefadroxil.
Splotchy, raised, firm, red spots; once swelling subsided they itch. Currently still itchy on day 5 after shot.
C/O redness, swelling and warmth at site of his varicella injection. C/O achy at site and itchy. Denies tenderness. Denies difficulty breathing or swallowing. Start hydrocortisone for itching BID and warm compresses TID. Assured local reaction that should resolve on own. Advised to return to clinic if site increases in size, warmth, redness, drainage, pain or develops fever.
sore at injection site; This is a spontaneous report from a contactable Other HCP. This 67-year-old female nurse (patient) received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported) on 30Dec2020 09:00 (at the age of 67-years) as single dose, unspecified route into left arm for immunization. Medical history included hypertension, depression, and hyperlipidemia.  Known allergies: crestor, ANSAIDS, red dye, lavendar. Concomitant medications include hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), amlodipine (AMLODIPINE), bupropion hydrochloride (WELLBUTRIN), and atorvastatin calcium (ATORVASTATIN CALCIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to BNT162B2.  On 31Dec2020 at 6 AM the patient experienced 'sore at injection site'.  No treatment was received as a result of the event.  The outcome of event 'sore at injection site' was recovered on an unspecified date.
Information has been received from a mother concerning an 18 year old daughter who in December 2010, was vaccinated with the first dose of GARDASIL. The patient fainted after receiving the dose. The patient also had been experienced headaches after receiving the dose. The patient received unspecified medical attention. The outcome was unknown. No further information is available.