chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ILLNESS (has been sick) and HEAD DISCOMFORT (head congestion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 02-Jun-2021, the patient experienced ILLNESS (has been sick) and HEAD DISCOMFORT (head congestion). On 11-Jun-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved and ILLNESS (has been sick) and HEAD DISCOMFORT (head congestion) was resolving.            Concomitant medication information was not provided.  Treatment information was not provided.
Chills and fever, highest was 103. Painful leg cramps and body aches. Stomach sensitivity for 2 days+ arm has a large bump at the injection site. Bicep is twice as big as my left bicep. The bump is very hard, but very little pain. Took Advil with the fever.
LOCAL INJECTION REACTION INCLUDING: SWELLING ON THE AREA, REDNESS, HOT TO TOUCH, AND PAIN. REACTION STARTED THE NEXT DAY AFTER RECEIVING VACCINE. VACCINE WAS ADMINISTERED 10/3 AND PT CAME IN TO CLINIC TO INFORM OF REACTION ON 10/7/19. PATIENT DID NOT WANT TO BE TREATED OR SEEN BY A DR SINCE SYMPTOMS WERE IMPROVING.
2 days after administration of FLUZONE, noted to have quarter sized, red area below injection site.
Initial and follow-up information has been received from a physician for the Pregnancy Registry for GARDASIL concerning a 25 year old female with maternal obesity (270 pounds) and a history of atypical squamous cells of undetermined significance (ASCUS) pap smear, no previous pregnancies, and anorexia at age 14 who on 26-FEB-2007 was vaccinated with her first dose of GARDASIL (Lot # 654540/1162F). On 17-APR-2007, the patient was vaccinated with second dose of hepatitis B vaccine, recomb (RECOMBIVAX HB). Concomitant therapy during the pregnancy included promethazine hydrochloride (PHENERGAN). The physician reported that the patient was in her early pregnancy and is going to see an OB/GYN physician, but has not done so yet. Her last-menstrual period was 01-MAR-2007 with estimated conception in mid March, but the patient's period was light so they are not sure until they get an ultrasound. Estimated date of delivery 06-DEC-2007. Follow-up information was received from the physician via telephone. The physician reported the OB/GYN physician's name. The patient had her first appointment on 26-APR-2007 and was scheduled for ultrasound on 22-MAY-2007. Follow-up information was received from the physician. On 01-AUG-2007 the patient had an ultrasound which was normal. She declined a maternal serum alpha-fetoprotein (MSAFP) test. The patient was prescribed promethazine hydrochloride (PHENERGAN) for nausea and vomiting. During labor/delivery, the baby had "non-reassuring" fetal heart tones. On 17-DEc-2007, at 40 weeks from LMP, the mother delivered a normal female baby via C-section. There were no congenital anomalies. Birth weight was 8 pounds 4 ounce, length 20 inches, apgar score was 8/10. Maternal obesity of 270 pounds was reported informed the outcome of the pregnancy. Upon internal review, the non-reassuring fetal heart tones was considered to be an Other Important Medial Event. No additional information is expected.
This was my Booster dose, I wasn't sure if that counted as a full "dose', so I chose "3" as the dose above.  On Oct 30th I had intense hand itching that night at a concert. Then things were fairly normal for a few days. On November 6th I experienced severe itching on my legs, arms, feet and hands that night. On November 8th, I went to work and noticed some red welts appearing on my arms and they stayed for hours. I dismissed my class early and drove home, incredibly uncomfortable from the itching sensation in my hands. Later that night, the welts got bigger across my breasts, legs, hips and anywhere I touched or scratched my skin. My husband noticed I had a watery looking welt show up underneath my left eye. I booked an appointment with my doctor the next morning because the red welts, itching hands and eye blister were still very much there. ( I have had a similar reaction to this when I previously took the antibiotic Bactrim and experienced full body hives from it. ) My doctor prescribed me Prednisone, 10 mg and Levocettizine 5mg as well as gave me a topical cream Triamcinolone  0.1% for the welts. In her office, I didn't even THINK to tell her that I had received my Moderna booster dose back on 10/28 as a possible reason for this, so it didn't even come up as a possibility as I tried to find my cause for this allergic reaction. I have now been on the medication for three days and still am experiencing the migrating, red welts and hand itching at night.
Patient was given 0.25mcg Moderna Bivalent Booster not 0.5mcg, wrong dose was given to patient.
mom reports child had a rash on stomach & back on the morning of 23APR99 when pt out of bed;pt reported some spots resembled hives & that the rash was in streaks;rash had disappeared by that same afternoon;
Red circle a several inches in diameter appeared around my injection site a full week after my first Moderna dose. Yes he itching came first then woke up next day with same muscle soreness as day 1, and noticing the red circle. No red circle immediately after shot.
Developed erythema multiforme, dehydration, fever. 05/14/2007 MR received for 3 night admit (5/3-6/07) for petechial rash and fever x 5 days. Dehydration noted.  Vomiting began on day 3 and was intermittant.  No diarrhea.   PE: Mildly ill appearing.  TMs bulging and erythematous with cloudy yellow fluid posteriorly. Ulcers on buccal mucosa.  Inguinal lymphadenopathy. Erythematous cheeks in a scattered morbilliform rash. Central violaceous coloring. Does blanch. Child is actively scratching.  Petechiae on arms, erythematous confluent macules on extremities.  Perivaginal erythema. Developed watery diarrhea and thrush during admission.  Petechiae and rash resolving during admission.  Discharge DX: Viral syndrome, Fever-resolved, Viral exanthem-resolving, Diarrhea-resolving.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients. This is the second of the two reports.  A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. This patient was vaccinated and has tested positive for Covid-19 on an unspecified date, not sure when she tested positive for the Covid-19. She was asymptomatic. It was also reported that she got sick on 03Jan2021. The second dose is due 21Jan2021, is it ok for her to receive it? How long can she wait if she does not get the vaccine at 21 days? The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021051642 same reporter/product, similar events and different patient
The night of my second Pfizer shot I developed very bad paresthesia.  Very intense "electrical shocks" in my shins.  Strong enough to wake me from sleep.  These seemed to pass away for a few weeks but then returned about 3 weeks later and have continued as of this date (7/22/2021).  I feel shocks and pin pricks globally all over my body several times a minute.  Sometimes more than once within ten seconds.  This has been my daily experience since early June 2021.  The intensity of the sensation is less, but the frequency is extreme.
Information has been received from a nurse concerning a female who was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL on 17-MAR-2009. On 17-MAR-2009 the patient experienced pain at the injection site immediately after the second dose of vaccine. The patient was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL "3 months ago" At the time of reporting (17-MAR-2009) the patient was not recovered. The patient sought medical attention by visiting the physician's office. No further information is available.
Patient received MMR/HIB 07/22/2002- seen in office 07/29/2002.  Patient appeared off balance-appeared improved 07/30.  Patient saw Pediatric Neurologist 08/05/2003.  Seen again 08/29/2003- resolved.  patient noted bet 18/21 months to have speech delay.  Patient is currently being evaluated for intermittent ataxia which cannot be explained immediately after recovered and was considered to have normal exam.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported that doses of ROTATEQ were stored improperly and were administered to an unspecified number of patients (doses and lot numbers not provided), orally on unspecified dates. No adverse effects reported. This case is linked to cases MARRS#1408USA000288 and MARRS#1408USA000499 (same reporter link). Additional information has been requested.
Pt c/o 3-21-12 of "bubble" on bus to school at site of injection. Reaction appears bigger on 3-22-12 and seems red and slightly swollen at site of injection. Pt seen & assessed & monitored by nurse practitioner and prescribed AUGMENTIN 875 mg PO Q12 hours & BENADRYL 25 mg PO q 6 hours prn on 3-22-12 & ice/warm compresses. F/U 3-26-12 sx resolved.
got the shingles shot and soon after got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:01-MAR-2023 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter knew people (patients) who got the shingles shot and soon after got the shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.
Pain and discomfort at vaccination site Fever (99.6 axillary) Chills Nausea Malaise
Patient recieved NDC 59267-1055-01, for 5 to 11-year-old. Patient is 12. Patient is not suffering any adverse effects
Left upper arm area of induration, redness, and warmth to the touch, approximately 4 cm in diameter. Center is indurated and very tender to the touch. No drainage.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild
tired so slept; chills (freezing); chills (freezing); aches; fever 100 degree F; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A 55-year-old female patient received second single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL1284, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 12Jan2021 07:30 for Covid-19 immunisation. Facility type vaccine: Hospital. Patient previously took first single dose of BNT162B2 (Pfizer, lot number: EJ1685) on 22Dec2020 06:15 (at 54-years-old), vaccine location: Left arm for Covid-19 immunisation. Facility type vaccine: Hospital. The patient was not pregnant. The patient had no known allergies. Patient had no other relevant history. There was no other vaccine given within four weeks. There were no concomitant medications. The patient did not have Covid prior vaccination. On 12Jan2021 22:00, also reported as 12 hours post second dose injection, the patient experienced chills (freezing), aches, and fever at 100 degrees F. The patient took paracetamol (TYLENOL). On 13Jan2021, also reported as in the middle of 1st night, she had 101.1 degrees F. On the same date, in the morning, the chills were gone, and fever was down to 99.9 F. On the second day (14Jan2021), she still had aches with temperature at 99.9 F and was tired, so she slept. The patient took paracetamol again. On the third day (15Jan2021) she had slight aches and no fever. On the Fourth day (16Jan2021) she was normal. No other treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from chills on 13Jan2021, fever recovered on 15Jan2021, while the other events recovered on 16Jan2021.
A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning an 11-year-old male. Neither relevant medical history nor concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 01-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
This case was reported by a other health professional via call center representative and described the occurrence of joint range of motion decreased in a patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number Y279A, expiry date 30th June 2019) and (batch number 92XR5, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced joint range of motion decreased. On an unknown date, the outcome of the joint range of motion decreased was unknown. It was unknown if the reporter considered the joint range of motion decreased to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The physician reported that they had 8 patients who experienced limited range of motion in their arm after receiving the FLUARIX vaccine. The could not identify the patients who received the FLUARIX. They stated that 8 patients out of 1400 patients developed limited range of motion after receiving the FLUARIX vaccine. The reporter did not have specific patient information. The reporter stated that the patients required follow up treatment. The healthcare professional (HCP) did not give specifics on what that treatment involved. The reporter consented to follow up. This is 1 of 8 cases reported by the same reporter. There are 2 batch numbers provided for FLUARIX QUADRIVALENT 2018-2019 season, but it is not sure which is the correct batch number.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Vaccine administered past its 30-days Expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 11:04 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 5:18 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   vaccines went into 2-8 degree Celsius thaw state on or about 20-Dec-2021  No concomitant medication information provided. No treatment medication information provided.
chills, fever, muscle aches/pains, nausea over the course of 2+ days
12/17/2021 Patient sought care with a local gynecologist for a small mass in her groin area, the doctor thought it may be a hernia and said Patient's ovaries felt fine.  /12/19/2021 Patient got her first moderna covid shot.    12/20/2022 Abnormal menstrual bleeding/12/27/2021 started bloating and sought care at urgent care.  The physician said she should get a ct scan.  01/03/2022.  Patient recieved a ct scan that showed multiple abdominal masses possibly ovarian in origin  the largest mass was around 10cm.These masses grew very rapidly after the covid shot or possibly caused by  the shot. She also had aceites and pleural effusion.   Patient wound up having surgery on Feb 8 multiple masses were removed,  the largest being 25 cm .  This all happened very rapidly after the covid shot
Patient states that he found a 2 to 3 inch lump in his left armpit.  He found it when showering.  It was not tender and not red
Fever, fatigue, headache, vomiting, chills, muscle aches, arm soreness
Very tight chest, short of breath the morning after getting the second dose. Four days after the shot, tingling in my left arm that shoots down to my hand and tingling and numbness in my left leg down to my foot. The left leg also has pain in the calf
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a licensed practical nurse concerning a 12-year-old male. The product expired on 19-Jan-2010. On 20-Jan-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Same reporter
The 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (The 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1-340321) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (The 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (The 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medications were reported. No treatment medications were provided.  On 15-Apr-2021, the patient received first dose  (Sputnik COVID-19 Vaccine) (Batch No:- 1-340321) (unknown route) 1 dosage form.
Dose 2. Lot # 027B21A.  Extreme fatigue within a couple hours of arriving at home. All over body aches and muscle pain started on Wednesday night. Got worse during Thursday. Developed a rash on right arm at injection site about 8" x 4". Area  slightly swollen and hot to the touch. Friday woke up with a low grade fever and fatigue. Arm still had rash. Additionally an itchy red rash also developed on my lower back and thighs.   Saturday ? still have rash on arm though it is now about half the size. Still fatigued but not as bad as before. Rash on lower back and thighs still there.  Used Tylenol, Alkaseltzer Night and Alkaseltzer Day for aches, pain and fever.
Patient received Pfizer vaccine today after  initially receiving the Moderna vaccine at another site on 29 January 2021.  Event possibly due to patient knowledge deficit/lack of awareness and staff  member error in the screening process.  No adverse reactions noted. Event reported to Agency.  Patient follow up as warranted.
Shivers, fever, flu-like feeling, migraine, body-ache, severe left arm soreness and redness  within hours after vaccine, sustained 24 hours after vaccine, severe tiredness, 3rd day eyes did not focus, persistent headache and left arm soreness.
1.5 hours after receiving FLUARIX vaccine pt. reported onset of visual disturbance of blurry vision so that she could not see husband or daughter clearly, had difficulty focusing. She also had perceptual/visual distortion/ - 'hallucination' - off to her left side a circle, disk - like a wavy mirror. About 1/2 hour later she had pain behind her right eye which lasted 1/2 hour. Symptoms gradually disappeared after 1-1.5 hours. For eye pain took 2 tabs ALEVE.
3 hours after immunization, developed hives on right arm, progressed across chest and abdomin. Examined at ER at 8:30pm. Given Zantac and Benadryl. No lab work done. Hives resolved by 2am 7/31/02.
pt recv vax 16APR96;denies rxn to 1st or 2nd vax;devel welt hot hive-like spot @ inj site;seen by MD felt had rxn;took APAP sinus that evening;no evidence of allerg rxn the next day