chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. was in a sitting position approximately 10-15 min after MENACTRA vaccine administered when pt reported she didn't feel well. Pt appeared pale, pt then escorted by 2 nurses to exam table, when pt completely passed out, eased to the floor in a sitting position. Ammonia Inhalent used and pt came around within about 10-15 sec. Pt followed commands and advised to take slow deep breaths and made appropriate eye contact. Pt assisted to exam table and reclined with legs elevated. Cool cloth applied to forehead. BP 102/60 P=5-, pt denied any nausea/vomiting feeling. Pt continued to recline for approx 30 min, then assisted with ambulation without any apparent difficulty. Pt had reported after episode that she had not eaten this morning. Pt's color much improved after 30 min and reported feeling better. Pt left health department with mother without any further concerns. No other vaccines were placed ppd test placed to (L) forearm.
Symptoms = cough, dizziness, nausea, tested positive for COVID, lives in extended living facility, s/p hospital stay 5 days earlier, discharged back to facility. Now back to Emer. dept. hospital for Covid-19. Tested positive on 7/24. May have been tested on 6/30 at the facility.
Tinnitus. Loud ringing in right ear. It is constant, started just after the vaccine. I am having trouble sleeping and concentrating. Will be making a dr appt but unsure if they can help?
Have symptoms of stomach; Headache; Her daughter isn't 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 parent.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Have symptoms of stomach"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MALAISE (non-serious), outcome "unknown", described as "Her daughter isn't feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller daughter received vaccine 3 week ago and she is scheduled to receive her vaccine today 07May However, her daughter isn't feeling well and have symptoms of stomach and headache. The mother stated that she has gotten tested for covid-19, however, it came out negative. Read ISI. Mother wants to know of it will be safe to give her vaccine in a later date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ADACEL given 9/22/14. Patient developed 7 cm wheal - edema and pain at injection site within 48 hours of administration.
Administered expired vaccine. No reaction by patient Administered 7/6/2023 expired 4/8/2023
Patient reported Extreme fatigue, chills, body aches, extreme headache, low grade fever 100.6
red arm; itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red arm) and PRURITUS (itchy arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red arm) and PRURITUS (itchy arm). At the time of the report, ERYTHEMA (red arm) and PRURITUS (itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.   This case was linked to MOD21-052042 (Patient Link).   Reporter did not allow further contact
Headache, body aches, arm pain and rash about 4 uncles away from injection site
Patient stated that at 12:40 PM she began to fell itchy. Red 2 inch rash was present on the left wrist to hand area. 5 mm rash also appeared on the right forearm as well as small macular papules located on left and right antecubital areas. Vaccine site was warm to touch. No redness or rash noted in that area. Patient continued to be monitored. At 12:53 patient stated still feeling itchy. Given 10 mg tab of Zyrtec PO. As well as given ice pack to help with itching. Vitals at 12:55 PM were as follows T: 97.3, BP: 159/96, P: 86, RR:18. Patient monitored for an additional 15 minutes.  At 13:10 vitals were as follows: T: 97.9, BP: 148/94, P: 76, RR: 18. No s/s of SOB or wheezing present. Patient instructed to follow up with primary care, ER, or urgent care regarding elevated BP as soon as possible and also in regards to hives and s/s of reaction to vaccine given if symptoms worsen. Patient alert and verbalized understanding and agreed to follow instruction
Pt was given Daptacel injection instead of Adacel. I spoke with the patient 8/31/07 and she reported that her arm had been sore for 2-3 days after the injection with a pain that shot down her arm to her hand. She no longer has the pain and she had no other symptoms or illness.
This spontaneous report was received from a certified medical assistant, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored ROTATEQ (lot # M033338 expiration date: 15-APR-2018) orally, for prophylaxis. The vaccines were exposed to 32 degrees F to 35 degrees F (0 degrees C to 1 degrees C) and the cumulative time was 32 hours. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA007407: US-009507513-1703USA007408: US-009507513-1703USA007409.
received vaccine at 1007, complaint of dizziness and nausea at 1010, BP 147/74 HR 80 100% on room air. continued to monitor. at 1050 BP 161/82 HR 88 100% on room air. continues to complain of dizziness and nausea and starting to have tremors. Patient was placed in a wheelchair vs at 1036 152/74 HR 139 100% on room air, at 1040 patient was taken to the ER via wheelchair.  Given tylenol in ED. Discharged.
Pt received first HPV (Gardasil) vaccine, MCV4 (Menactra) booster and Influenza injectable vaccine.  Injections administered per office protocol and well tolerated.  Within 3 minutes pt became pale, declared that he had a frontal headache and felt off, and then proceeded to lay down on exam table.  He displayed brief seizure-like behaviors.  He then opened his eyes, was momentarily confused, and then gradually returned to his normal baseline with good color and resolved HA.
Intense Back pain; headaches; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0172), via an unspecified route of administration, in left arm on 06May2021 17:30 (at the age of 36-years-old) at first dose, single for COVID-19 immunization. Medical history included COVID-19. The patient had no known allergies. Prior to vaccination, the patient was not pregnant, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced intense back pain and headaches on 06May2021 20:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the events. Outcome of the events was not resolved.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was reported. The case was reported by the patient for themselves. The patient experienced bad muscle pain after receiving SHINGRIX vaccine. The patient inquired whether how long this side effect would last.
Fever, body aches, significant fatigue, lack of appetite, and a headache.    Headache persist 3 days after the shot.
Muscle Aches, Stomach Pain, Fever of 101.5 to 102.7
Tdap and MENACTRA administered IM in (R) deltoid. Area swollen/red with induration. Length of swelling 18 cm x 17 cm. Instructed by provider to use Ibuprofen for pain w/ cold compresses.
covid arm; warm; itchy; red circle about 4-5 inches in diameter; not very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and VACCINATION SITE PAIN (not very sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, ENALAPRIL, GABAPENTIN, HYDROCHLOROTHIAZIDE, PROPRANOLOL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and VACCINATION SITE PAIN (not very sore). On 23-Apr-2021, VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and VACCINATION SITE PAIN (not very sore) had resolved.        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.   No treatment information was provided.   This case was linked to MOD-2022-451927, MOD-2022-451928 (Patient Link).
VERY HIGH FEVER.  105.6. Child got very hot around 9 pm.  Treated her and by next day it was a low-grade fever.  One more day and fever was gone.  This high of a fever is UNACCEPTABLE.  This SHOULD NOT have happened. Scared the hell out of us, as it should have. Vaccine was only .25 mls (child dose) and I made sure by checking it as it was administered.
March 4, 2021 received 1st Moderna Vaccine; April 1, 2021 received 2nd Moderna vaccine. Approximately April 28, 2021 began having air hunger. Began feeling heart palpitations. Symptoms continued to worsened. June went to PCP multiple tests ordered: pulmonary function, stress test 7 day patch monitor. Monitor showed irregular heart rhythm with runs of SVT. Saw cardiologist due to irregular heart rhythm. He indicated other tests were with in normal limits. And that arrhythmias were not life threatening. He would continue to monitor me. Over the next few months arrhythmias worsened. Medication started and arrhythmias again. 14 day monitor completed - multiple runs of SVT daily as well as some PVCs. Medication changed. Symptoms persist on the medication, but not as sever as before. Will need medication the rest of my life. Prior to the Moderna vaccine I had absolutely no heart issue, no palpitations, no shortness of breathe, etc.
Starting at 12:30am on Sunday, I started experiencing severe chills and headaches.  I normally sleep through the night with no issues whatsoever (I'm a healthy 6'1" 170lb 24-year-old guy with no co-morbidities) but had a restless night where my fever eventually rose to 101 degrees Fahrenheit.  This continued throughout the next 48 hours with my fever fluctuating between 99.5 and 101.  I woke up 5-6 times both nights completely drenched in sweat.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EN5328), in left arm, on 02Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Known allergy sulfa drug" (unspecified if ongoing), notes: sulfa drugs allergy. Concomitant medication(s) included: FAMOTIDINE, start date: 08Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Slight redness at site with swelling from deltoid down to the elbow.....warm to touch.  It was not tight but was uncomfortable to patient.  It started out more swollen at the injection site the night of the vaccination, then swelling slightly increased down the arm and stopped shy of the elbow. She says it is slowly getting better.  She is going to ice it and take IBU for pain/swelling.
Got vaccine on the 23rd, on 25th got fever, chills, headache, and this happened for four days. Had shingles at the same time.
Headache and minor cognitive impairment (10 weeks); eczema on legs (severe; treated with cortisone; lasted 4 weeks)
Rash on left arm, slight itchiness, slight discomfort. Onset approximately one week after vaccine administered, lasted 2-3 days.
Rash on right thigh - started on Day 2 S/P DTAP-IPV. Suspect cellulitis vs inflammatory reaction to vaccine.
After receiving the COVID vaccine  at 12:43 patient stated that she couldn't breath and her arms & legs were numb at 1:10 pm.  Patient received an Epinephrine pen at 1:12 pm and the paramedics were contacted.
Itchy feeling on skin. When I scratch bumps appear all over my body. More bumps greater on left than right
positive COVID-19 test; This is a spontaneous report from a Pfizer COVAX  from a contactable consumer (husband of the patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on 31Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, the patient was diagnosed with COVID-19 on 01Apr2021, but then she was tested negative of the virus. The patient was scheduled for the 2nd shot on 23Apr2021. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recvd a series of 3 doses of Engerix-B 15NOV90, 17DEC90 & 11JUN91; 9AUG91 tested for Anti-HBS & found to be non-reactive; pt recvd 4th dose of Engerix-B 19AUG91; APR91 devel viral chronic fatigue synd and/or poss mono;
I have Shingles, It is on my head and in my eye/ suspected Vaccination failure; I have Shingles, It is on my head and in my eye; Shingles on my head and in my eye/I have a breakthrough case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUN-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient was vaccinated a few years before the date of reporting. The patient was having bad breakthrough case of shingles on head and in eye. The patient found it to be creepy and invasive. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient developed a left upper extremity brachial plexopathy with onset of symptoms 9 days after receiving Moderna COVID19 vaccine.
Tiredness; Muscle and joint pain; Muscle and joint pain; Hardness; This is a spontaneous report from a contactable consumer (patient self-reported. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not provided), via an unspecified route of administration, on 05Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she spoke with an RN at Pfizer earlier today to report her side effects. On an unknown date, since vaccination, she experienced tiredness, hardness, and muscle and Joint pain and wanted to know if these were reported side effects of the vaccine. The patient expressed concern about getting the second dose because she didn't want to have the same or worse side effects. The patient got response like that Pfizer was unable to make treatment recommendations. The patient was scheduled for her second dose on 26Mar2021. The patient declined to filing a safety report, no further information or details were captured. Outcome of the events was unknown.  Follow up needed, follow up questionnaire attached for further information.
20 minutes after dose pain in left hip area when walking, 2 hours extreme pain in left hip when walking or sitting, 4 hours pain in left hip and knee walking, sitting, or lying down. 24 hours Tizanidine 4mg as needed (not effective). 57 hours pain suddenly disappears- numbness in left leg from knee to ankle, left leg weak from hip to ankle, walking difficult with left leg failing randomly causing falls. 7 Days numbness confined to kneecap, left leg weak but improving, leg failure improving but must walk with a cane.
Case was given Moderna and not Pfizer booster according to our consent form.  The correct label was put on vaccination card.  RN states she is certain she gave Pfizer and not Moderna.
CHEST PAIN; DIFFICULTY BREATHING; BODY PAIN WHEN DO AN ACTIVITY; FEELING SLEEPY; LITTLE DIZZY; ACHINESS; WHEEZING; TIGHTNESS; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gluten allergy, and sulfa allergy, and other pre-existing medical conditions included the patient had no medication allergy. The patient was previously treated with iron pills and birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced body pain when do an activity. On APR-2021, the subject experienced feeling sleepy. On APR-2021, the subject experienced little dizzy. On APR-2021, the subject experienced achiness. On APR-2021, the subject experienced wheezing. On APR-2021, the subject experienced tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, difficulty breathing, body pain when do an activity, feeling sleepy, little dizzy, achiness, wheezing and tightness was not reported. This report was non-serious.
Rash on neck; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 20Apr2021 at 16:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included rash (Also usually get the same type of rash when she has a common cold). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medications within two weeks of the COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 30Mar2021 at 16:15 as a single dose for COVID-19 immunisation. On 22Apr2021, the patient experienced rash on neck. Patient also stated that she also usually gets the same type of rash when she has a common cold. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on neck was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient had racing heart and chest pain following vaccination. Pain resolved within 30 minutes. Patient wanted to note this as  he has a history of heart disease.
She developed involuntary movement of head and tongue.  No previous hx of Tourette?s syndrome.
Headache in left and right side temples, dizziness, sharp pain in the head from time to time; Tylenol, continuing... has not stopped
A report has been received from a pharmacist concerning a 14 year old female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received nasal FLUMIST on an unknown date. It was reported that inadvertently sprayed both halves of LUMISTS in a single nostril. The outcome of the event of full vaccine sprayed in one nostril was unknown. The reporter considered the event to be non-serious. Corrected report 14-DEC-2012. Coding of full vaccine sprayed in one nostril was changed from inappropriate dose of vaccine to drug administration error. Corrected report: 11-APR-2014. The cas has been updated with full data due to KUR term additions for FLUMIST/Q/Laiv.
Pt seen in office 3-9-07 with c/o L arm shoulder pain and fever. Symptoms started after vaccination L deltoid 3-7-07. Pt c/o fever at home of 103 deg. 8x8cm demarcated area of erythema L upper deltoid. Started on Keflex.
I experienced itchiness, rashes, toe nail fungus, discoloration in skin, redness under my knees and armpits.
Started with fever irritability within 30 min. Fever 103 degrees. Fussy and slept most of the day. Parents gave alternating TYLENOL and MOTRIN and afebrile in AM but stilkl fussy.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender (reported as over 12 years). On an unknown date the patient was vaccinated with PROQUAD for an unspecified indication (anatomical locations, route, dose number, lot number and expiration date unknown). Concomitant medications were not reported. The pharmacist stated that on an unknown date an unspecified patient, over 12 years of age received PROQUAD, and no adverse effects reported. Additional information has been requested.