chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sometimes feels like she's having a mental episode like she would space out like she was in a whole other world; migraines, describes the migraines in December not at a 10, but at a 20,; dizziness; nausea; fatigue; body aches; she couldn't drive; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (she couldn't drive), MENTAL FATIGUE (sometimes feels like she's having a mental episode like she would space out like she was in a whole other world), MIGRAINE (migraines, describes the migraines in December not at a 10, but at a 20,), DIZZINESS (dizziness) and NAUSEA (nausea) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 004C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced IMPAIRED DRIVING ABILITY (she couldn't drive), MIGRAINE (migraines, describes the migraines in December not at a 10, but at a 20,), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches). On an unknown date, the patient experienced MENTAL FATIGUE (sometimes feels like she's having a mental episode like she would space out like she was in a whole other world). The patient was treated with BUTALBITAL;CAFFEINE;PARACETAMOL for Migraine, at an unspecified dose and frequency. In December 2021, FATIGUE (fatigue) and MYALGIA (body aches) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (she couldn't drive), MENTAL FATIGUE (sometimes feels like she's having a mental episode like she would space out like she was in a whole other world), DIZZINESS (dizziness) and NAUSEA (nausea) outcome was unknown and MIGRAINE (migraines, describes the migraines in December not at a 10, but at a 20,) was resolving.            It was reported that the patient had migraines were bad to the point where she had to lay down.  She described the migraines in Dec not at a 10, but at a 20.  In Jan she was on unspecified medication from her primary care physician that brought the migraine level down to 5 to 7.  She had seen a new doctor who prescribed a new medicine called Butalbital-Acetaminophen-Caffeine that kept the migraines down at a 1 or 2.   No concomitant medications were reported.
Heart disease, high Fever, convulsions,  paralysis, blurred vision, body aches, nausea, brain fog, memory loss
Moderna 3/3/21, 3/31/21, 12/20/21. Positive on 1/22/23
Chills, no fever, lasted 2 days. Not severe. Severe inflammation at injection site with soreness, very red skin shoulder to elbow and all around upper arm, Turgid, painful, and itchy.  Still spreading, ongoing at 6 days. Beginning to "fade" a little at injection site area, but still spreading downward.
Sore arm from 1/10 till 1/11 1/11 afternoon achy, fatigue, headache, chest congestion
Patient given flu vaccine at 1:10pm on 9/12/2015. 1:15pm Signs of nausea and dizziness. 1:25pm Signs of headache and gland swelling. 1:30pm Tongue and throat slight swelling. 1:30pm EMT called. 1:33pm EpiPen 0.3mg injection administered in left thigh. 1:35pm Patient stated improvement in symptoms and breathing. 1:45pm Fire and Rescue arrived and began assessing patient. 1:50pm EMT arrive and take over pt care. 2:15pm Patient transported to ER.
it started bleeding a lot; She is not sure if the vaccine made it all the way to the muscle; not sure if she received a full dose; a lot of the vaccine was dripping down her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (it started bleeding a lot), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She is not sure if the vaccine made it all the way to the muscle), UNDERDOSE (not sure if she received a full dose) and DEVICE CONNECTION ISSUE (a lot of the vaccine was dripping down her arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (it started bleeding a lot), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She is not sure if the vaccine made it all the way to the muscle), UNDERDOSE (not sure if she received a full dose) and DEVICE CONNECTION ISSUE (a lot of the vaccine was dripping down her arm). On 07-Apr-2021, VACCINATION SITE HAEMORRHAGE (it started bleeding a lot), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She is not sure if the vaccine made it all the way to the muscle), UNDERDOSE (not sure if she received a full dose) and DEVICE CONNECTION ISSUE (a lot of the vaccine was dripping down her arm) had resolved. Not Provided          Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-223820 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Patient clarified this case concerns 2nd dose not 1st, information given for another case concerning third vaccination
Pt presented in our office 6/4/04: complained of blanching macular rash to trunk and face, plus around half dollar size area of erythema to injection site-left thigh. Also complained of fever (100 degrees), irritability and decreased appetite.
I felt nothing at the time of injection, but I thought the position of the vaccine was strange (too superior and posterior to be in the belly of my deltoid).  When my arm started to ache a few hours later, it was not the same kind of discomfort I've experienced with the last 20+ seasonal flu vaccines I've received. Instead of getting better, within a few days, I had severe pain in my shoulder joint and profound loss of range of motion, particularly forward elevation and adduction/external rotation. By 10/28, taking 600 mg ibuprofen multiple times/day and in the worst pain of my life (including appendicitis and C-section).  I progressed to 800 mg dosage before beginning acupuncture treatments on 11/8.  With acupuncture, I am recovering my motion enough to put on my own bra and drive and perform daily activities and I am managing my pain, but I still am uncomfortable and unable to do many of the things I could (such as lifting my toddler over my head) prior to the vaccination.  I experienced no injury or other events that lead me to believe that this could be related to something other than the flu vaccination.
Vomiting-12 hours Headache-48 hours Neck Pain- 48 hours Upset stomach-7 hours
Vaccine information unavailable. s/p flu vaccine with pcp on Fri in pcp office. Sat am awoke with local redness.
Moderna COVID-19 Vaccine  Developed rash at injection site that lasted ~2 days post-IM.  Size about 2inch long x 1in wide. Warm to touch, not itchy, not raised, no other sites. Went away for several days but re-appeared ~5-7 days post-IM and lasted for ~3 days. Same size and quality.  Used hydrocortisone 1% topical on 2nd occurrence which seemed to alleviate.
sore arm with her first and second vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm with her first and second vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vesicular rash with crusted lesions over face, trunk, and extremities. Febrile x 3 days.
Approximately 28 hours after injected with Shingles Vaccine, red swollen area 2"x2" noticed at injection site. Area tender and warm to touch. In next 24 hours, area grew to 7"x6" with more swelling, redness, hot to touch, requiring ice packs, antihistamines and antibiotics.
pt recv vax 2JUN95 & 1-2 days post vax pt presented w/sterile abscess-5cm in diameter @ the inj site;area was also red & tender;pt also had a low grade fever;cool compresses prescribed;as of 8JUN95 inj site abscess persists;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 25-OCT-2015 09:04, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.3 and -5.5 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient got sore, red and swelling at injection site after 1 week  She said she was sore for 1 day after  getting vaccine and got better. Week later her injection site is swollen. red and painful. she took  ibuprofen around 7am advised patient to take ibuprofen and use cold compress if swollen if symptoms gets worse see doctor.
Felt tingling in left arm and shoulder and leg, general malaise. NO SOB, no weakness, no egg allergies, no treatments given.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin) and Allergy to intravenous contrast media (IVP dye).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore arm). At the time of the report, ARTHRALGIA (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-060659 (Patient Link).
Large red welt increasing from inj. site to entire arm. "All veins collapsed". Pt now on ZYVOX & cephalexin.
Patient is stating that he felt nauseated the next day with elevated blood pressure and starry and blurry vision in his left eye after getting the Moderna (Spikevax) vaccine. Today, 2 days later, his blood pressure is still abnormally high. In the past, he did not have any reactions to Pfizer Covid vaccine.
Night of administration and info next day approx 1/2 to 1 inch below injection site got hard. Redness, burning, tingling, "unbearable" itching, and extreme swelling. Swelling around 3x normal. This reaction spreading down to elbow. Symptoms lasting around 4 days. Treatment with ice and promethazine.
Migratory urticaria over most of body for period of about 10-14 days. No signs of anaphylaxis or systemic symptoms
A few hives-neck down to bottom of buttocks-itch occasionally. They are fading away as of 1/31/02. Joints hurt very bad. Taking an antahistamines.
Today patient noticed right arm is red, hot, and puffy. States has red blood blisters like blisters on arm as well. States has had headache and felt tired since getting vaccinated with Moderna. Encouraged follow up with PCP, states will follow up with.
dizzy & unsteady; 28DEC93 No response to f/u request;
Shingles on my left upper abdomen; Red Rash with bumbs that are consistent with Shingles; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL0015E) via an unspecified route of administration in the left arm on 24Apr2021 at 14:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included bee stings. Concomitant medications included protein power and herbal tea. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ELO151) via an unspecified route of administration in the left arm on 03Apr2021 at 10:15(at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 26Apr2021 at 12:00, the patient experienced red rash with bumps that are consistent with shingles. The patient reported that his dermatologist believes that he had shingles on left upper abdomen. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient received treatment for the reported events which included valtrex. The clinical outcome of the event shingles and red rash with bumbs was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of VAQTA lot # J016216 expiration date 18-AUG-2016, Lot # K026529 expiration date 02-JUN-2017, Lot # K005958 expiration date 02-MAR-2017 (dose and route were not reported). No co-suspect and concomitant therapies were reported. The nurse reported that Department of Health requested glycol thermometer readings that showed improper storage of the vaccine. Doses of vaccine may have been administered to an unspecified number of patients on unspecified dates. Nurse also stated according to the Sensitronic thermometer there had not been a temperature excursion in this refrigerator. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Anaphylaxis  sharp pain left side by chest swelling in nape of neck by thyroid extreme sinus pressure between eyes tongue swelled glands under ears swelled throat swelled. Epi pen given by HCP in pharmacy
Light fever; Sore joints; Headache; Fatigue; High blood pressure; Severe rash; Severe rash or hives; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04May2021 at 07:30 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 04May2021 at 15:45, the patient experienced fever, sore joints, headache, fatigue, high blood pressure and severe rash or hives. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events light fever, sore joints, headache, fatigue, high blood pressure and severe rash or hives were resolving at the time of reporting.   Information on lot/batch number has been requested
Patient and brother were brought to the mass vaccination clinic by their father, for his initial dose of Pfizer vaccine on 5/12/21. Father went to the medical website and rescheduled the boys' second dose appointment due to location convenience. The boys presented on 5/27/21 for a second Pfizer vaccination, dose spacing was only 15 days apart instead of the minimum recommended of 18 days separation between doses. RN called and spoke with father, discussed the concern. Father reports neither child has experienced any adverse reaction and is aware that VAERS is being completed.
Client experienced syncopal episode immediately after receiving 3rd shot. Client slumped on exam table. He was lowered on exam table with feet elevated and fanned with file. Client appeared pale and non-responsive for approximately 4 to 5 seconds. 2 to 3 muscle twitches noted during time client was unresponsive. Client became responsive to voice and touch and remained in supine position on exam table for 15 to 20 minutes and then left the clinic unaided. Client was accompanied by girlfriend. Client states started feeling lightheaded during 1st shot, Hep A, and then immediately after 3rd shot, Tdap client was slumping and unresponsive. Client stated had fainted when receiving previous shots on 11-21-16.
This retrospective pregnancy case was reported in a literature article and described the occurrence of webbed penis in a male infant. The mother received Flu Seasonal TIV Dresden. The pregnancy resulted in a live neonate with a congenital anomaly. On an unknown date, at unknown gestation weeks, the infant was born via unknown delivery method. The infant was diagnosed with webbed penis. Serious criteria included GSK medically significant and congenital anomaly. Additional event(s) included maternal vaccine exposure. The outcome of webbed penis was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown). It was unknown if the investigator considered the webbed penis to be related to Flu seasonal TIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described penile webbing in a male infant who was exposed to unspecified inactivated trivalent influenza vaccine (IIV) in utero (manufacturer unknown). The patient was a part of the prospective observational study conducted during the 2013-2014 influenza season at a family planning clinic and three obstetrics and gynaecology practices which assessed the feasibility of recruiting pregnant women less than 20 weeks gestational age (GA) to participate in a text messaging based vaccine adverse event monitoring program after receipt of inactivated influenza vaccine (IIV) and utility of text messaging to monitor health events, including fever frequency on vaccination and next 2 days (Days 0-2), health events during pregnancy, pregnancy outcomes, and neonatal outcomes. All four sites were affiliated with hospital. The patient's mother was a pregnant woman with gestational age less than 20 weeks by last menstrual period and/or ultrasound at the time of enrollment. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date during the 2013-2014 influenza season, the patient's mother received unspecified IIV (administration route and site unspecified; dosages unknown; batch number not provided) during the gestational age less than 20 weeks. Age at vaccination was unknown. (In this study, 70.5% had documented receipt of tetanus-diphtheria-pertussis vaccine during the same pregnancy). The infant was exposed to unspecified IIV in utero. On an unspecified date, an unknown period after vaccination, the patient had penile webbing (major birth defect). The patient's mother had stopped reporting 168 days before delivery. The birth defect was identified on electronic medical records (EMR). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on relationship between penile webbing and IIV. The authors concluded, "This study demonstrated the feasibility of text messaging for influenza vaccine safety surveillance throughout pregnancy. In addition, in these women receiving IIV during pregnancy, post-vaccination fever was infrequent and a typical pattern of maternal and neonatal health outcomes for pregnancies was observed." This is 1 of the 16 valid cases in the same literature article.
Dizziness and loss of balance about 20 min after getting the vaccine, and it lasted about 2 hours. Headache for a day after getting the vaccine.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Shingles vaccine given 3-30-14. Two days later the patient broke out in shingles rash on the side of his stomach. (left side)
Severe abdominal cramps, vomiting,  chills, muscke aches and fatigue lasting 3 days
Severe swelling, hives, itchiness, redness, and heat to the area surrounding injection site (appeared almost like cellulitis).. Lymph nodes swelling/tenderness to L arm/clavicle/neck. Began topical hydrocortisone as well as oral 50 mg benedryl at night and daily antihistamine (zyrtec 10 mg).
ABOUT 10 MINUTES AFTER THE INJECTION THE PATIENT COMPLAINED OF ITCHINESS AND SWELLING IN THROAT. PATIENT WAS GIVEN ABOUT 60-70 MG OF LIQUID DIPHENHYDRAMINE AND WATCHED AT THE PHARMACY. AFTER ANOTHER 20-30 MINUTES, THE ITCHINESS AND SWELLING WENT AWAY PATIENT WAS RELEASED. PATIENT WAS SPOKEN TO VIA PHONE CALL ABOUT 60-90 LATER AND IS DOING WELL.
Full body rash start at 0400 on 5/21 - initially started as a headache, rash is pruitic - took PO Benadryl at 1305 and then came to ER - in ER received PO dexamethasone
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, patients were vaccinated with an improperly stored dose of GARDASIL 9, lot # L017407, expiry date 15-AUG-2017; lot # L007560, expiry date 15-JUN-2017; lot # L011846, expiry date 16-JUN-2017, (dose, frequency and route of administration not reported). No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further details provided. This is one of five reports received from the same reporter. Additional information has been requested.