chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she developed a rash; her throat was itching; her face was bright red all over her face and chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Mar2021 (Lot number: ER8730) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Dose:1st, lot number EN6205.), administration date: 02Mar2021, when the patient was 66 years old, for COVID-19 immunization and did not have any side effects.  The following information was reported: RASH (medically significant) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "she developed a rash"; THROAT IRRITATION (medically significant) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "her throat was itching"; ERYTHEMA (medically significant) with onset 22Mar2021, outcome "recovering", described as "her face was bright red all over her face and chest". The events "she developed a rash", "her throat was itching" and "her face was bright red all over her face and chest" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash, throat irritation, erythema which included Benadryl injection, Solumedrol, Pepcid and Famotidine injection.  Clinical course: She had both of the Pfizer covid 19 vaccines in Mar2021. The patient stated she did not have any side effects after the first dose but 30 minutes after the second dose she had a reaction. She developed a rash and her throat was itching and her face was bright red all over. The patient reported she was sent to the hospital and got a couple of injections and it got better. They gave her a Benadryl injection. She is wondering if she is okay to get the COVID booster. She was doing fine. They made her sit there for 30 minutes. She left, and got to her car. Then she developed an immense heath scratching in throat. She looked in the rear view mirror and her face was bright red all over her face and chest. So she went back in. They wouldn't let her leave. She had a scratching in her throat. They sent her to the emergency room. In the ambulance they gave her Benadryl and Solumedrol. When she got to the Emergency room they gave her Pepcid on arrival. She saw improvement and everything. Everything started resolving right after. They gave her one more injection of Famotidine. She was only there a half of and hour and went home.  Follow-up attempts are completed. No further information is expected.
It began several days later with heart palpitations ans out of Breath.  Then my Peripheral vision on the R eye disappears dor several seconds.  Within 3 weeks red blotches on the face. Now Is the neck and chest.   I now have HBP high cholesterol and I?m pre diabetic.  I test positive for autoimmune disorder
Adverse effect of vaccine, initial encounter (Primary). Word finding difficulty. Decreased sensation. Comments: left side of face, Neuro exam today reassuring however it would be difficult to fully "rule out" any more serious adverse reactions without intracranial imaging. Offered head CT but patient declined. Anxiety, To help mitigate anxiety when due for second vaccine. Lorazepam (ATIVAN) 1 mg tablet; Take 0.5-1 tablets by mouth every 8 hours as needed for Anxiety.  Dispense: 1 tablet; Refill: 0. Patient given the following instructions and/or handouts: If your symptoms continue and you change your mind about wanting to proceed with a brain scan to rule out blood clots. Return if symptoms worsen or fail to improve. Total time spent on patient's care today including pre-visit work, face to face time, education or counseling, documentation etc. was 30 minutes.
Muscle pain (back, legs, top of feet), headache, fever lasting 3 days, shortness of breath and fatigue lasting 10 days (as of today).
Adacel vaccine was injected in left arm along with ShingRX vaccine (due to extensive scarring on right arm) Wed. afternoon 7/5. Pt experienced some pain at the site of injection (& took Tylenol) and by 7/7/2023 the area was a red and itchy (greater than 4 inch radius) so she informed the pharmacy. 7/7/2023. She was going to take Benadryl as soon as she went home. She didn't not request us to contact her prescriber or her again.
7 minutes after receiving 1st dose of Pfizer vaccine, flushing, itching and throat tightness occurred requiring epinephrine and bendryl, and ER transfer for further medications and monitoring over a 4 hour period. In the ER, methylprednisolone and famotidine given, and an additional dose of benadryl. Discharged on 3 days of steroids, Pepcid and around the clock Benadryl to decrease risk for flare-ups.
During my earlier years working in an industrial area I had inhaled asbestos which caused me to have plural thickening in my lungs. Every year since that diagnosis I have been required to annual Pulmanary (lung and heart) testing. On February 11th I had my 30th annual Pulmonary exam consisting of EKG, Stress Test, and Chest X-ray. As in the past, results were all good. On March 3rd I had my 1st Pfizer vaccination. Five days later on March 8th I collapsed, was taken to the hospital by ambulance having suffered a massive Pulmonary Embolism affecting my heart and right lung. During my 2 hour operation, Surgeons used a flexible suction tube inserted thru my groan to remove a large blood clot (embolectomy). Pieces totaling about 14cm long, 2cm wide and 1/2 cm thick. I was discharged 3 days later and instructed to take blood thinning medication probably for the rest of my life. I am now 78 years old.
Diagnosed with shingles; This is a spontaneous report from a contactable other health professional. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 10Feb2021 at 08:30 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took vancomycin and experienced allergies, and first dose of bnt162b2 on 21Jan2021 at 09:30(lot number: unknown) for COVID-19 immunization. 20Feb2021 (reported as 10 days after second Pfizer COVID vaccination), the patient was diagnosed with shingles. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the event with valacyclovir. The outcome of the event was not recovered. The patient has no COVID prior to vaccination and was not tested post vaccination.  Information on the lot/batch number has been requested.
LABORED BREATHING; redness; swelling; wheezing; coughing; fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling), WHEEZING (wheezing), COUGH (coughing) and HEART RATE INCREASED (fast heart beat) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insulin dependent diabetic and Obesity.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ERYTHEMA (redness), SWELLING (swelling), WHEEZING (wheezing), COUGH (coughing) and HEART RATE INCREASED (fast heart beat). On an unknown date, the patient experienced DYSPNOEA (LABORED BREATHING). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Wheezing and Labored breathing, at a dose of 1 dosage form. At the time of the report, ERYTHEMA (redness), SWELLING (swelling), COUGH (coughing) and HEART RATE INCREASED (fast heart beat) outcome was unknown and WHEEZING (wheezing) and DYSPNOEA (LABORED BREATHING) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she took pocket mouth mas and an emergency use bag with the help of her husband for breathing difficulty patient stated that due to fear she did not went hospital. Patient had obesity with body mass index30 to 33 No Concomitant medication reported by the reporter Patient experienced COVID-19 March to April   This case was linked to MOD-2021-234141 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30-APR-2021:Contains  significant information: second dose date, relevant history -obesity, insulin dependent diabetes, treatment medication-Benadryl, event - labored breathing
Information has been received from a healthcare professional referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates since 30-MAR-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (oral, lot # K024700 with expiration date: 30-JUL-2016; lot# L013192 with expiration date: 19-JAN-2017, dose was unknown (50 Fahrenheit (F) for 45 minutes and 32F for 72 hours). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter didn't like to be contacted.
2 wks post vax, exp severe nausea, fatigue, wt loss, nerologic symptoms, breathing difficulty lasting 1.5 yrs. Have numerous med records. Has been diagnosed with seizures.
body ache; discomfort; swelling on their left arm; got the third dose  without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING, PAIN, DISCOMFORT, and OFF LABEL USE in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 039K20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Diabetes.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced OFF LABEL USE. On 05-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING. On an unknown date, the patient experienced PAIN, and DISCOMFORT. On 04-Sep-2021, OFF LABEL USE (got the third dose  without being immunocompromised) had resolved. At the time of the report, PERIPHERAL SWELLING, PAIN, and DISCOMFORT outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-318414, MOD-2021-318331 (Patient Link).
Extreme irritability, refused to walk for over 1 wk & had been walking prior to vax. Pt was lethargic, fussy, only wanted to be held. Slept more than usual. PT was seen 1/21, very irritable & fussy. Mom says, back to nml 1/28/00.
Vertigo symptoms experienced morning of 10/13/2020. Periodic light-headedness throughout the day, but patient recognized a pattern of harsh dizziness (vertigo) at night while first laying down in bed, when turning side-to-side, and getting up out of bed. Patient describes the sensation as feeling like he is "falling out of the sky" and must hold onto something for approximately 10 seconds before returning to normal. Vertigo symptoms persisted, and patient went to his doctor on 10/21/2020. Nurse practitioner diagnosed the symptoms as benign paroxysmal positional vertigo (BPPV) and prescribed 40 Meclizine 25 mg tablets. Nurse practitioner also instructed the patient to undergo BPPV exercises twice daily for two weeks. On 10/24/2020, patient noticed BPPV symptoms subsiding, but not completed resolved.
PT MOTHER CALLED STATING THE PATIENT IS EXPERIENCING HIGH FEVER AND CHEST PAIN /TIGHTNESS/BREATHING TROUBLES, RECOMMENDED TO SEE A PHYSCIAN ASAP.
Pt reports soreness at injection site lasting about 24 hours. 5/29/06 hives noted on front of neck and chest, denies fever GI sxs, 5/30/2006 hives spread to include back no itching associated with hives. Seen by PMD today who recommended stopping vaccine series. Will assess job at med center VS risk of disease.
Upper abdominal pain,bloating starting in mid afternoon, lasting into evening.  Unable to eat much after morning meal.  Nausea and severe pain, much stomach gas.  Unable to sleep.  Lost 5 pounds in 1 week.  Felt like trouble with digestion and accompanied with inflammation in my abdomen.   Started eating very digestable foods - eggs, sweet potato, rice, toast, applesauce and nothing after 1 PM.  I felt better in the morning and then relapsed later in the day.  Started aspirin for pain, simethicone for gas and Bactrim for UTI.  Took probiotics thinking vaccine destroyed good gut bacteria.  Started Pepcid and Sucralfate 10/22/2021.  Nausea - stopped Sucralfate 5 days later.   Pepcid as needed.Started feeling better early November.  Able to eat full meal and most usual foods without much evening bloating, pain or nausea.  I am feeling close to my old self.  Take antacid or Pepcid occasionally. Went to Hospital ER and waited 6 hours to see a physician and finally left after a CBC which showed unremarkable. ER doctor at Hospital  remarked how great my medical tests were but was unable to treat my condition.  He decided my bladder was too full and I had slight constipation and discharged me.   My new family doctor didn't know how to treat me either and essentially gave up.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX, "1 vial given intramuscularly", which had lot # M005973, expiry date: 02-FEB-2018, dose: unknown. The vaccine had temperature excursion ranging from 5 degree Fahrenheit to 7 degree Fahrenheit through 08-JUN-2016 to 29-JUL-2016 on various random unspecified times. The vaccine had no previous temperature excursion. The call was because of data logger. No adverse effects and no product quality complaint (PQC) reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Pt started developed vesicular rash on the back on 6/22/08. The rash has spread to his scalp and extremities.
Client reports that with second dose Pfizer COVID vaccine, she developed tingling in both lower extremities from knees down.  Tingling started 48 hours after vaccination and lasted 2 days, resolving without intervention.
skin rashes; itchiness; my skin has become very sensitive and remains very red; my skin has become very sensitive and remains very red; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 44-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 administered in Arm Left on 30Jan2021 10:45 (Batch/Lot number and Expiry date was not reported) and dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 10:15 (Batch/Lot Number: EN6200) (at the age of 44-years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included none. There were no known allergies reported. The patient concomitant medications were not reported. The patient did not have covid prior vaccination and has not been tested for covid post vaccination. On 01Feb2021, the patient experienced skin rashes and itchiness. Since the first dose of the vaccine, the patient had skin rashes and itchiness throughout the body. Also, he reported that my skin has become very sensitive and remains very red for a few minutes when I scratch it, even if lightly. Even just drying off with a towel after a shower makes my skin very red. Side effects continued after the second dose. There was no treatment received. The clinical outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Case number PHEH2015US000680, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 59 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 25 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
Fever a couple of hours after vaccinations. Redness around injection site right thigh. Next day, right thigh swollen, hot and red. Thigh continued to swell over next couple of days. Redness and swelling eventually went down approximately 7 days later.
On the 9th day, woke up with edema/redness/burning/heat at the injection site. It tripled in size in one day. Took Benadryl the first night, after going to the ER. Perscribed Keflex in case there was cellulitus. Second day, applied hydrocortizan cream, took 1000 mg of Keflex, took 10 mg claritin,  10mg zyrtec and 20mg of Pepcid AC. 3rd day the redness had gotten better, still some edema, no heat, still some burning but much better. Saw dermatologist, they ruled out cellulitus and recommended continuing with anti-histamine regimen and hydrocortizone. Will continue till three weeks after 2nd dose.
was not able to get the 2nd dose on time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (was not able to get the 2nd dose on time) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (was not able to get the 2nd dose on time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (was not able to get the 2nd dose on time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
my friend just died after taking your shot; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported a patient (friend) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. His/her friend just died after taking your shot (And he/she know of more.) He/she will just keep his/her immune system high. They didn't need a vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: my friend just died after taking your shot
after giving the vaccine, told pt to have a seat in front of the pharmacy for at least 15 minutes. pt stated she had children with her and wants to walk around in the store but will be close the to pharmacy. told pt to report any sx right away to the pharmacist if any sx are present. pt came back to the pharmacy reporting sx of excessive sweating. asked pt if any other sx and she said it was only the generalized sweating. pharmacist told pt to have a seat and to be observed for at least 15 minutes for the sx to resolve. checked pt blood pressure: 125/82 (which is based on the pt previous readings is usual per pt). after 15 minutes, pt wanted to leave stating that she had to leave. checked pt blood pressure again with reading 181/85. explained to pt if she experienced any sx's of a reaction including generalized itching, excessive thirst, any redness, hives, swelling of lips, face, throat, wheezing, shortness of breath, stomach cramping, or fainting to contact (or have someone contact) 911 right away
Gave Tdap BOOSTRIX as ordered on encounter form; Should have been ADACEL
Pt seen 1/23/2006 for well visit and immunizations. On evening of 1/24/06 pt had fever all day and at about 16:00 on 1/24/06 dad noted pt breathing funny. Went into room noted her seizing. Seizure lasted about 2 minutes and temp 105.6 3/13/06 Received medical records from ER which revealed patient experienced fever, febrile seizures, cyanosis.  She was teething at the time & also was dx w/bilateral otitis media
approx 1 mo p/vax pt exp pain on lt side, shoulder, chest under breast; sx progressed to pain & swelling of knees & ankles to Er 25NOV r/o cardiac concerns; saw MD 26NOV for tests; mild discomfort joints, UTI;
J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/16/2022 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC
myocarditis; Information has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. In or around August 2015, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information, lot number and expiration date were not provided) for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, on unknown date, the patient suffered myocarditis.  As a result of the receipt of the vaccination, the patient experienced sustained severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event of myocarditis to be related to suspect therapy. At the time of the report, the patient's outcome was not recovered.  Upon internal review, myocarditis was considered to be a medically significant and disabling event.
HARD TO BREATHE; INCREASE HEART RATE; WHEEZING; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to sulfa antibiotics, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced hard to breathe. On 01-APR-2021, the subject experienced increase heart rate. On 01-APR-2021, the subject experienced wheezing. Laboratory data included: Heart rate (NR: not provided) 104-114, Potassium (NR: not provided) Low, and SARS-CoV-2 test (NR: not provided) unknown. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hard to breathe, increase heart rate, and wheezing. This report was non-serious.