chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This is a spontaneous report from a contactable other health care professional (registered nurse). A contactable Registered Nurse reported similar events for 3 patients. This is 2 of 3 reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection ,batch/Lot number was not reported, expiry date: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller was listening to the radio, and they said people are reporting an uptick of shingles after getting the COVID 19 vaccine. She had shingles after the vaccine as well as 3 other people she knows. It was out of the blue. On an unspecified date, One of the people she works with was going through shingles now after the vaccine. His happened within 6 months of the shot. The person was going to be terminated if he didn't get the vaccine. She doesn't have his information to do a report. The outcome of event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101084524 Same reporter/drug/AE, different patient
felt dizzy; felt weird; soreness in groin; rash on neck that is expanding under arm pit going towards breast, abdomen, groin and pelvis; headache; achy all over especially her left knee where she had a knee replacement; achy all over especially her left knee where she had a knee replacement; swelling in hands and feet; neck sore; felt cold right away; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), HEADACHE (headache), PERIPHERAL SWELLING (swelling in hands and feet), NECK PAIN (neck sore) and FEELING COLD (felt cold right away) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HEADACHE (headache), PERIPHERAL SWELLING (swelling in hands and feet), NECK PAIN (neck sore), FEELING COLD (felt cold right away), MYALGIA (achy all over especially her left knee where she had a knee replacement), ARTHRALGIA (achy all over especially her left knee where she had a knee replacement), GROIN PAIN (soreness in groin) and RASH (rash on neck that is expanding under arm pit going towards breast, abdomen, groin and pelvis). On 11-Apr-2021, the patient experienced DIZZINESS (felt dizzy) and FEELING ABNORMAL (felt weird). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 10-Apr-2021, PERIPHERAL SWELLING (swelling in hands and feet), NECK PAIN (neck sore), FEELING COLD (felt cold right away), MYALGIA (achy all over especially her left knee where she had a knee replacement), ARTHRALGIA (achy all over especially her left knee where she had a knee replacement) and GROIN PAIN (soreness in groin) had resolved. On 11-Apr-2021, DIZZINESS (felt dizzy), HEADACHE (headache) and FEELING ABNORMAL (felt weird) had resolved. At the time of the report, RASH (rash on neck that is expanding under arm pit going towards breast, abdomen, groin and pelvis) had not resolved.      No concomitant medications provided.
After getting shots, noted tender lymph nodes under right arm and "red streaks" approximately 2x1.5inch under right arm and on front side of arm.  States this morning "going away".  Instructed to call her physician.
Patient presented to our pharmacy today requesting a Tdap vaccine. Patient was given a Pfizer Covid-19 vaccine instead and then a Boostrix once the error was detected. Pharmacy followed up with patient. He was concerned of adverse effects. Counseled on potential for sore arm, injection site reaction and generalized symptoms such as fatigue, fever and body aches.
Hot flashes. Started suddenly, having zero before to having about one every hour or so, both day and night. Each one would last about 10-15 minutes. My temperature increased 2-3 degrees (from 96 to 99). As suddenly as the they started, they stopped on June 9, roughly. Also period went from regular to nothing during this time and it hasn?t returned even though hot flashes have subsided.
Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL vaccine (yeast) injection, Lot # not provided. Subsequently the patient became pale and slumped over for about 10 seconds. The patient did not lose consciousness. No further information was provided. At the time of the report, the patient recovered. The patient sought medical attention. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of RETINAL MIGRAINE (Macular Migraine, usual ocular migraine in the opposite eye), VISUAL IMPAIRMENT (Jazzed Sphere in right eye/Jazzed Sphere in left eye), VACCINATION SITE PAIN (Arm soreness), FATIGUE (Very Fatigued,tired,) and HEADACHE (slight headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Retinal migraine (for over 30 years). Concurrent medical conditions included Blood pressure high (Higher blood pressure than normal). Concomitant products included LANSOPRAZOLE for Hiatal hernia, HYDROCHLOROTHIAZIDE for Hypertension. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced RETINAL MIGRAINE (Macular Migraine,usual ocular migraine in the opposite eye), FATIGUE (Very Fatigued,tired,) and HEADACHE (slight headache). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Jazzed Sphere in right eye/Jazzed Sphere in left eye) and VACCINATION SITE PAIN (Arm soreness). On 27-Jan-2021, RETINAL MIGRAINE (Macular Migraine,usual ocular migraine in the opposite eye) had resolved. On 28-Jan-2021, FATIGUE (Very Fatigued,tired,) and HEADACHE (slight headache) had resolved. At the time of the report, VISUAL IMPAIRMENT (Jazzed Sphere in right eye/Jazzed Sphere in left eye) and VACCINATION SITE PAIN (Arm soreness) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reported that although she had ocular migraine for over 30 years, the vaccination triggered the symptoms and also affected the opposite eye, which was different from the eye which usually got affected. No treatment medications were reported. This case was linked to MOD-2021-224742, MOD-2021-224742. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up was received on 14-JUN-2021. Second dose details were added; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.
Extreme tingling and numbness in head, legs, arm and hands started hours after receiving and lasted 3 days. Fever/body chills lasted two days after receiving. Extreme dizziness hours after receiving and lasting about 3 days. Abnormal period began one week later (2.5 weeks early) with terrible period cramps, abnormal increase in blood loss, nausea and headache.  About a week and a half after receiving first vaccine I felt real congested, stuffy, and like I had a cold. Abnormal for a generally healthy person without history of chronic or really any sicknesses. Chronic ?cold? feeling every couple weeks since receiving (today?s date is june 26).  The tingling and numb sensation happens every day to this day in my left forearm, palm and fingers, and on the left side of my skull.  It starts gradually and lasts for about 20-40 minutes, about 2-5 times a day. No amount of movement or massage for blood flow helps. Still experiencing irregular and abnormal cycles, and extreme heavy flow almost at once that has never been normal. New direct stabbing and cramping pain has began to occur since my first cycle after the shot. It?s a sharp stabbing and cramping pain in my reproductive organs area. Worsening hormonal acne with no changes to previous routine/no new medications, etc.
She got a fever about 10 hours after the shot and had a 99-101.5 fever for 7 days straight and after that 7 days, she had a rash all over her body from her head to her private area. Did not show on her legs. She did not want to eat very much, was super fussy and clingy. I gave her an epsom salt bath for the past few days and it went away after a day 1/2. The entirety of the course has been about 12 days so far. She seems to be getting back to normal now, but I am still keeping a close eye out on her.
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 13 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced drug administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Shortness of breath, chills and body aches. Multiple headaches that go on and off. Had to call off work.
MUSCLE SPASMS; TIGHTNESS IN BOTH LEGS; NUMBNESS IN BOTH LEGS AND LIPS WERE NUMB; LIPS WERE TINGLING AND RIGHT SIDE TINGLING ON FACE; CHEST DISCOMFORT; BURPING A LOT; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included hashimito's disease, fibromyalgia, auto immune disorder, retinal detachment, epstein-barr, sciatica, and migraines, and concurrent conditions included alcoholic, non smoker, steroids allergy, and adrenaline allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with paracetamol, epinephrine, and cortisone acetate for drug used for unknown indication. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced muscle spasms. On 24-MAY-2021, the subject experienced tightness in both legs. On 24-MAY-2021, the subject experienced numbness in both legs and lips were numb. On 24-MAY-2021, the subject experienced lips were tingling and right side tingling on face. On 24-MAY-2021, the subject experienced chest discomfort. On 24-MAY-2021, the subject experienced burping a lot. On 24-MAY-2021, the subject experienced chills. On 24-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from lips were tingling and right side tingling on face on MAY-2021, and chills on 25-MAY-2021, was recovering from muscle spasms, and had not recovered from headache, tightness in both legs, burping a lot, chest discomfort, and numbness in both legs and lips were numb. This report was non-serious.
After both booster shots, I started getting a bounding heartbeat that was fast that happened randomly that happened everyday. I also had trouble getting a full breath and had to use my husbands asthma inhaler. It was scary. I did not go to the doctor or ER due to worrying about COVID. I received my 4th booster on 2/19/2022, Pfizer lot number FJ6369 and the same symptoms happened. This went on for about 5 weeks. I have an annual exam coming up in May that I am going to ask about.
Slight fever/  I felt like I had a little fever and then I felt okay after about two days and now on day six, I am having a fever; Little fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received BNT162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 15:30 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing), notes: Verbatim: Gout. Concomitant medication(s) included: COLCHICINE taken for gout; ALLOPURINOL taken for gout. The following information was reported: PYREXIA (non-serious) with onset 10Jan2022, outcome "unknown", described as "Slight fever/  I felt like I had a little fever and then I felt okay after about two days and now on day six, I am having a fever "; FATIGUE (non-serious) with onset 10Jan2022, outcome "unknown", described as "Little fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, fatigue.  Additional Information: The patient received his first dose on Monday and this morning he woke up with a fever. When he first had the shot, that day he had little fatigue and he felt like he ha a litter fever and then he felt okay after about two days and now on day six, he is having a fever again. The consumer had taken some Tylenol this morning (16Jan2022) and Dicam as treatment. The patient did not have any prior vaccination within 4 weeks.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Eyelids swollen, rash all over face, arms and chest. Also wheezing.
Patient was to receive Fluzone Quad and received Flublok, intended for father. Alerted mother, patient is fine, no adverse reaction reported.
pt devel fever of 103 about 11PM on 24JUL95; mom advised to use APAP, tepid baths; pt had febrile sx @ about 4PM on 25JUL; pt transported via ambulance to ER; had 2 more sz during transport; pt released home w/mom & had f/u this AM w/MD;
not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (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: MALAISE (non-serious) with onset 25Mar2021, outcome "unknown", described as "not feeling well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Powder component /without liquid component. Not sure if product was given incorrectly; Powder component /without liquid component. Not sure if product was given incorrectly; Powder component /without liquid component./if this is a QA issue.; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter mentioned that, there was a powder component in box without liquid component and it was not sure if product was given incorrectly or not, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered. The reporter was not sure if it was a QA issue. The reporter consented to follow-up.
THE PATIENT CALLED THE OFFICE STATING THE VACCINE INJECTION WAS ITCHY, RED, SWOLLEN.  SHE ARRIVED AT 3:15 PM.  VITAL SIGNS STABLE, NO RESPIRATORY DISTRESS/SYMPTOMS.  THE AREA WAS RAISED/SWOLLEN  APPROX. ONE HALF INCH HIGH BY TWO INCHES IN DIAMETER.  THE PATIENT STATES SHE NEVER HAD A REACTION TO ANY VACCINE IN HER PAST.  DR. EVALUATED THE PATIENT.  ICE PACK APPLIED, DISCHARGED TO HOME IN STABLE CONDITION.
Rash, dizziness, lightheaded, tired. Patient currently using topical hydrocortisone cream (otc) for rash.
Almost immediately pain, bright pink red/raised bumps on right arm from shoulder to elbow. Itching comes & goes. No treatment seeked. Reported event on 10/26/2010.
Abnormal soreness of upper extremity, chills, body aches.  T 37.7, erythema 10cm x 6.5 cm with induration 5 cm x 6 cm at injection site. Right anterior cervical lymph nodes full with supraclavicular lymphadenopathy.  Treated with Bactrim DS 1 by mouth twice a day for ten days.
AFTER HAVING A BOWEL MOVEMENT THIS MORNING, THE COLOR ON THE TISSUE WAS BLUE/TEAL IN COLOR.. THE STOOL ITSELF WAS THE SAME BUT VERY DARK.  I 'M NOT SURE IF THIS MEANS ANYTHING BUT I THOUGHT I WOULD REPORT IT BECAUSE I'VE NEVER HAD THIS HAPPEN UNTIL AFTER TAKING THE MODERNA BOOSTER SHOT ON 11/01/21.
3 1/2" x 3 1/2" redness of (R) upper thigh.
Felt very ill for days before rash broke out. Rash on several locations on body. Very itchy and red. No LARGE blisters. Still have some rash. Dr. gave cream for itchy rash.
Patient described breaking out with hives all over her body. She also reports having headache, fever, flushing. She reports all symptoms have persisted for around 5 days
Patient presented back to pharmacy around 5 hours after receiving immunization with itching, erythema and urticaria around the neck and shoulders; no angioedema; no bronchospasm or shortness of breath. Patient reported self-administration of Diphenhydramine 50mg around 10 minutes prior to presenting to pharmacy with reaction. She reports having food allergies, but not to eggs, and she always carries an EpiPen with her at all times for that reason and is trained on how to use it. She reports getting the flu shot yearly since age 10 and has never experienced an adverse event. Two hours prior to reporting to pharmacy with reaction, the patient had some watermelon and other things to eat so we are not completely sure of what caused the reaction. Around 30 minutes after reporting to the pharmacy with reaction, patients hives were gradually subsiding and improvement noticed.
This spontaneous report as received from a consumer refers to an approximately 11 years old female patient, the reporter's daughter. Patient's current condition included hypothyroidism. No drug reactions or allergies were reported. In January, March and July 2012 the patient was vaccinated with doses of GARDASIL injection (location and exact route were not specified); dose 1, dose 2 and dose 3 (lot number 672652/0022AE, expiration date 28-SEP-2014), as recommended by physician. Lot numbers 08408A, expiration date 14-OCT-2013, and 12618A, expiration date 11-NOV-2013, are invalid for GARDASIL. Concomitant medications included SINGULAIR. In December 2012 (also reported as by December 2012), the patient was feeling yucky all the time, had passed out, experienced migraines almost every day, her cheeks were scalding red and was tired all the time. After passing out the patient was taken to an Emergency Room at a Medical Centre (date unspecified), but was not admitted. The patient was later seen by a neurologist (date unspecified), who prescribed gabapentin for headaches. The patient had blood tests performed (dates and results not specified). The outcome of the events was reported as not recovered, the patient's condition did not improve (it was also reported that therapy was not reintroduced). The relatedness between the events and GARDASIL was not reported. Upon internal review the event of had passed out was considered medically significant. Additional information has been requested.
there is a female patient in her 60's at their office that the vaccine is being considered for due to "very stubborn" hand warts.; there is a female patient in her 60's at their office that the vaccine is being considered for due to "very stubborn" hand warts.; there is a female patient in her 60's at their office that the vaccine is being considered for due to "very stubborn" hand warts.; This spontaneous report as received from a physician via medical assistant refers to female patient who would be "in her 60's" at the time of report. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was considered to start therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, expiration date and lot number unknown) (Circumstance or information capable of leading to medication error, inappropriate age at vaccine administration) of "very stubborn" warts on the hands (off-label use on unapproved indication), as the physician has read a few articles about the off label use of GARDASIL 9 in the treatment of warts on the hands.   The reporter confirmed that at the time of this report, the vaccine has not been administered to the patient.  This is one of two reports received from the same reporter.; Sender's Comments:  US-09507513-2202USA004993:
With injection #1 patient said he had severe right arm pain to the point he had to wear an arm sling. With injection #2 per PCP patient has right bicep fracture
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K201A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Jan-2021. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 06-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This is a case of product exposure during pregnancy with no associated adverse events for this 28-year-old female. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy. No concomitant medications were provided by the reporter.  No treatments were provided by the reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 28-year-old female. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
My son once again woke up with a rash from head to toe, the day after his vaccination. Rash last two weeks. See attached pictures.