chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; rash/hives on her neck; injection site very swollen; injection site red; fatigue; headache; muscle pain; joint pain; chills; hives on her neck; ITCHY; Hypersensitivity reaction; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever) and RASH (rash/hives on her neck) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 1:00 AM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills). At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERSENSITIVITY (Hypersensitivity reaction) to be related. No further causality assessments were provided for URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills).     No  concomitant medications were provided. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received and contains patient demographics,AE not yet resolved On 01-Jul-2021: follow up received and contains patient demographics ,product details and event outcome as unknown
Shortness of breathe; wheezing; 2-year-old male patient received BNT162B2 in the right leg; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 2-year-old male patient received BNT162b2 (BNT162B2), on 05Aug2022 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 2 years, in right leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 05Aug2022 at 15:00, outcome "unknown", described as "2-year-old male patient received BNT162B2 in the right leg"; DYSPNOEA (medically significant) with onset 05Aug2022 at 20:15, outcome "recovering", described as "Shortness of breathe"; WHEEZING (medically significant) with onset 05Aug2022 at 20:15, outcome "recovering". The events "shortness of breathe" and "wheezing" required physician office visit.   Therapeutic measures were taken as a result of dyspnoea, wheezing that included Steroids.  Additional information: The patient had no covid prior to vaccination and no covid tested post vaccination. No known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got vax at son's pediatricians office; 2.5 wks later, feet asleep, then feet, hands, and tongue, eventually no feeling, fell, went to neurosurgery then to neurologist, dx post-viral neuropathy and GBS.  Couldn't walk, drive, write.
Swelling & pain 30mins after vaccine. Patient is using ice and ibunprofen.
rash itch; reoccuring palpitations; reoccuring tachycardia/ tachycardia; palpitations; fatigue; pressure in head; fever; hot; chills; pain at injection site (left); This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), PALPITATIONS (reoccuring palpitations), TACHYCARDIA (reoccuring tachycardia/ tachycardia), RASH (rash itch) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site (left)). On 04-Feb-2021, the patient experienced PYREXIA (fever), FEELING HOT (hot), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (pressure in head). On 05-Feb-2021, the patient experienced PALPITATIONS (palpitations) and TACHYCARDIA (reoccuring tachycardia/ tachycardia). On 09-Feb-2021, the patient experienced PALPITATIONS (reoccuring palpitations). On 11-Feb-2021, the patient experienced RASH (rash itch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 07-Jan-2021, VACCINATION SITE PAIN (pain at injection site (left)) had resolved. On 08-Feb-2021, PALPITATIONS (palpitations), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved. On 09-Feb-2021, TACHYCARDIA (reoccuring tachycardia/ tachycardia) had resolved. On 13-Feb-2021, PALPITATIONS (reoccuring palpitations) had resolved. On 25-Feb-2021, RASH (rash itch) had resolved. At the time of the report, FEELING HOT (hot) and HEADACHE (pressure in head) outcome was unknown.        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.
Instead of putting it in the deltoid it went to the back of her arm  lower than where it should go /  not intramuscularly; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and it was observed that instead of putting it in the deltoid, it went to the back of her arm and lower than where it should go and she doesn't think she got it intramuscularly i.e. incorrect route of product administration occurred.   The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient received their planned dose of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. The dose number were not reported.  On an unknown date while vaccine administration it was observed that instead of putting it in the deltoid it went to the back of her arm and lower than where it should go, and she doesn't think she got it intramuscularly. The event was a medication error.  Treatment information were not provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of event was considered as resolved on an unknown date.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, with no associated AEs.
nausea; fever; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 1st dose of Shingrix. On 22nd January 2020, 2 days after receiving Shingrix, the patient experienced nausea and fever. On an unknown date, the outcome of the nausea and fever were recovered/resolved.   It was unknown if the reporter considered the nausea and fever to be related to Shingrix.  Additional details were provided as follows: The patient 2 days after receiving dose of Shingrix experienced nausea and fever which had resolved. The reporter consented to follow up.
p/vax pt exp inj site lt arm itching, redness, pain w/small varicella like rash around inj site
Patient called on Tuesday 10-1-13 that she experienced a rash on her arm at first, then spread to her legs and trunk with itching. Told to try BENADRYL.
Driving her to school this morning, she had a grand mal seizure for a little more than a minute...a couple hours until back to communicating. She's recovering perfectly as usual.  She has them occasionally (every few months) but normallly driven by her menstrual cycle which is not coming up and made this uncommon. I just wanted to report it so you have the information.   It could be in the birth defect category below, but I'm not a doctor so not sure and selected none of the above.
approx 8hr post vax exp high temp, fainting, vomit, diarrhea, muscle aches, joint pain;
Information has been received from a registered nurse concerning a 5 year old male with no known drug allergies, a recent shingles exposure and a history of having received first dose of MMR on 04/28/1997 and second dose on 01/31/2001 who on 01/29/1997 was vaccinated with varicella vaccine not reported. There was no concomitant medication. On 04/19/2001, the pt was seen at the physician's office. The pt had vesicles on his trunk, head, nose, chin and face, some open, some filled and itchy. The pt was noted to be afebrile. Treatment ordered was Benadryl and Aveeno Bath. The physician prescribed Zithromax 30 mg for 1 day and then 150 mg day 2 through 5 for an upper respiratory infection (bronchitis) which the pt also had. On approximately 04/27/2001, the pt recovered. No additional info is exptedte.d
Initial night difficulty sleeping due soreness at injection site, headache, and sore joints. Following Day: Flu-like symptoms: weakness, lethargy, headache, sore joints, sore muscles. Two days after: Symptoms eased up. Three days after: 8/10 back spasms, momentarily incapacitating. Reduced with NSAIDs and heat. *Patient had similar reaction to anti-malarial medication over a decade prior.
Pt's mother was with him and also received her first dose of Moderna.  His mother also co-signed his pink COVID vaccination sheet. the nurse explained the scenario to the mother and son regarding age requirements and stated that we will schedule to return for a second Moderna vaccine to complete the series.    He received the same Moderna fact sheet/EAU and received the same screening information such as potential side effects as other pts. Tylenol availability if needed for discomfort and his return appointment.    Reported for pt being underage only.
Redness of (L) arm x 1 day & today. Arm is sore x 7 days. No fevers. No treatment.
Suspected vaccination failure; I just got my second shot I had a full blown case of the shingles; it was the worst pain I ever had; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an adult patient who received Herpes zoster (Shingle's vaccine).    Co-suspect products included Herpes zoster (Shingle's vaccine).   On an unknown date, the patient received the 1st dose of Shingle's vaccine and the 2nd dose of Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine and Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine and Shingle's vaccine. It was unknown if the reporter considered the pain to be related to Shingle's vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient reported that, he or she got his or her 2nd shot and had a full-blown case of shingles, and it was the worst pain he or she ever had. This case was considered as suspected vaccination failure as details regarding time to onset for target disease (shingles) and laboratory confirmation were unknown at the time of reporting.
Intermittent, mild non-resting discomfort in pt's back and inside of L knee x 1 week
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 57 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included gout. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802070 expiry: 23-AUG-2021) dose was not reported,1 total, administered on 11-MAR-2021 10:03 vaccinated at left arm as prophylactic vaccination. Concomitant medications included prednisone 20 mg a day for gout.   On 29-JUL-2021, the patient had confirmed immunological vaccine failure.  Laboratory data included: IgG (NR: not provided) test that showed no antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210800851-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
PATIENT REPORTED TO US TODAY THAT SHE HAD SHARP SHOOTING PAIN IN RIGHT SHOULDER RADIATING UP THE RIGHT SIDE OF HER NECK AND DOWN THE RIGHT ARM UNTIL THE ELBOW, STARTING SOON AFTER THE VACCINE ADMINISTRATION, AND LASTING ALL WEEKEND. THERE DID NOT APPEAR TO BE ANY REDNESS OR SWELLING AT THE INJECTION SITE.  SHE DESCRIBED PAIN AS MODERATE TO SEVERE.  SHE STATES SHE ATTEMPTED TO VISIT URGENT CARE CLINIC,, BUT WAS NOT ABLE TO SEE A DOCTOR (LONG WAIT).   SO SHE SELF TREATED WITH OTC IBUPROFEN, WHICH SEEMED TO HELP WITH GIVING HER REFLIEF FROM THE PAIN.  SHE CALLED HER PCP ON MONDAY WHO TREATED HER FOR PAIN SYMPTOMS.  SHE STATES THE INJECTION SITE WAS HIGHER UP IN THE RIGHT SHOULDER SO SHE THINKS THAT MIGHT BE A POSSIBLE CAUSE FOR THE PAIN.
I received my second Pfizer booster for COVID-19 on 4/28/2022. On 7/22/2022, I developed a cough. I also felt fatigued, but I thought it was possibly on account of the heat and because we had just gone hiking. We were abroad at the time, and we flew home on 7/27/2022. I took a home COVID-19 test that evening and got a positive result. I called my doctor, and he prescribed me a 5-day course of Paxlovid. We picked up the prescription on 7/28/2022, but I haven't taken it, since I didn't really feel sick and I haven't ever had a fever during the illness. My doctor told me about the side effects of the Paxlovid; since they sounded worse than the symptoms I was experiencing, that was another reason why I decided against taking it. At the time of this writing, I'm just a little bit congested, but other than that, I don't really feel ill. My wife also has COVID-19. She took a home test today and got a positive result. I haven't taken a test today, since I figure that I would probably also get a positive result, since we likely were exposed the virus at the same time.
I received the SpikeVax on Tuesday, and after I exercised on Wednesday morning, I was really short of breath.  I continued getting ready for school and started to feel achy all over.  I thought it was too late to call in a sub, took Advil, and left for work.  At work, I had to climb three flights of stairs with my bag and a gallon jug of water.  I couldn't catch my breathe even after 20 minutes.  My peer called our in-school health clinic because she told me later that I was very confused.  Staff came to my room.  By that time I was shaking and couldn't stand on my own without holding onto something.  I was also having difficulty swallowing.  An ambulance was called.  I don't remember too much of what I said, but I do remember being confused enough that I truly thought if I closed my eyes, no one could see me.  On the way to the hospital, my breathing calmed, and I no longer had difficulty swallowing.  Then I became overly tired and had difficulty staying awake even when people were talking to me.  By the time the ER doctor saw me, he said my vitals were great, and he thought it was an immune response to the vaccination.  (Spike Vax - given at Pharmacy). He allowed me to go home without tests.  I have no idea how long I was there.  I really don't remember much until 3:30 when I woke up in bed.  I slept heavily for the next day and a half.
Information has been received from a physician concerning a 17 year old male patient (also reported as 19 year old at onset date) who on 16-NOV-1993 was vaccinated with a first dose of MMR II HSA (route, site and lot number not reported). On 14-OCT-1994, the patient was vaccinated with a second dose of MMR II HSA (route, site and lot number not reported). On 29-NOV-2009, the patient experienced mumps (date diagnosed reported as 29-NOV-2009). The patient was afebrile and had left parotitis. The outcome for mumps was not reported. No further information is available.
Patient is 17 years old, received dose of Moderna vaccine inadvertently. Pt monitored for 15min post administration, no signs or symptoms of adverse reaction.
6 days post vax pt devel high fever for 2 days (101-105) sl rash & diarrhea persisting for 4 days which may have been d/t antipyretics (diarrhea);
The patient  was admitted on 2/19/2022 because of complaints of right-sided weakness.  Patient was normal when he went to bed but woke up with weakness and paresthesias.  No speech changes.  Patient had PFO closure in 2020 after his previous CVAs.Patient was admitted, MRI and 2D echo were ordered.  N  MRI showed small area of acute/subacute ischemic infarct in the internal capsule area.  Patient was continued on aspirin, Plavix and statin.  During his hospital stay, patient became incidentally positive for COVID-19.  He was asymptomatic.  Arrangements were made for patient to go to inpatient rehab at local facility. Patient is currently on insulin sliding scale, his metformin and Trulicity are on hold here, can be resumed at local facility as per rehab physician's discretion.
shortness of breath, heart issues, severe headache, severe blood clots in leg and lungs
Injection site redness, swelling, itching, and hot to the touch, extending from elbow to mid-arm (almost shoulder), approximately 6 inches wide.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 08-FEB-2017 (also reported as 09-FEB-2917), the patient was vaccinated with an improperly stored dose of ROTATEQ per oral, lot # M031650 with expiration date 16-MAR-2018, for prophylaxis (dose was not reported). The vaccine was exposed to a temperature between 5 and 25 Celsius degrees in 4 cycles. The cumulative time was 1.5 hours. A data logger was used to log temperatures. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005482:
I woke up at 2am freezing. I had severe chills and could not get warm for a few hrs. I was able to get back to sleep and woke up sweating. I proceeded to have ?chills? and ?hot flashes? until around 3pm the day after vaccine. My temperature reached 101 at its highest. I noticed yesterday, 2 days after the vaccine, that I was getting a large red mark on my left arm. It?s in a circular shape and about 3-4 inches in diameter. It is slightly tender and itchy. Today, 3 days after the vaccine, my left arm still has the large red circle and it does still itch. Luckily the fever and chills have gone away. I have been sweating in my sleep the past 2 nights, which I never do. Not sure if that?s related, but it seems like it is more than coincidence.
One month after receiving second Pfizer dose for COVID-19 vaccination, I started experiencing A-FIB out of the blue.  The A-FIB was continuous until I received cardioversion/TEE procedure (3/10/21); followed by cryoablation on 6/2/21.
Information has been received from a physician via a company representative concerning three patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with GARDASIL (strength, dose, route, lot# and expiration date unknown). It was reported that three patients fainted in the office after receipt of GARDASIL. The physician noted that these patients (names unspecified) recovered shortly after fainting. Additional information has been requested.
10 mins post injection, SVT with heart rate at 166, sweating, tingling in hands. Subsided in a few mins. 50mg of Benadryl taken. At about 40 mins post injection, heart rate was 170, tightness in throat, numbness and tingling in arms, hands and face. Lasted about 10 mins. Discharged from ED to home. Symptoms of tingling sensation in arms and lump in throat until next morning.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Since 23-MAY-2014 (approximately in 2014, exact date was not reported) unspecified number of patients were vaccinated with unspecified number of doses of VARIVAX (Merck) (lot#J012378, expiration date: 03-OCT-2015) (dose not reported) that were exposed to temperatures outside of range on 23-MAY-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Injection site pain; Fever of 101.3; Tired; Headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date: unknown), via an unspecified route of administration on 18Jan2021 20:00 (at the age of 56 years old), at a single dose in the left arm for covid-19 immunisation. Medical history included allergies: dust, mold, trees & grass; and diagnosed with covid-19 on unspecified date. Concomitant medications included escitalopram oxalate (LEXAPRO) and fexofenadine hydrochloride (ALLEGRA 24 HOUR). The patient previously took augmentin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient has not been tested for covid-19 since the vaccination. On 19Jan2021 20:00, the patient experienced injection site pain for seven days and fever of 101.3 which lasted for 12 hours; tired and had a headache for two days. The patient did not receive any treatment for all the events. Outcome of all the events was recovered on unspecified date. The events were reported as non-serious.
Pt received 15 m shots (hep a, flu, PENTACEL) on 11/10/2011, then on 11/11 developed rash - erythematous, blotchy, itchy, maculopapular (period) with few vesicles spread all over body - face, neck, perineum, back, chest, thighs, arms, seen by derm -> hypersensitivity reaction.
Within 24 hours of her first Pfizer vaccine, she developed angioedema of lower lip only. Took Claritin w/o any improvement. Seems to be spontaneously resolving. Of note, she is also on lisinopril and has been for years. Denies any dyspnea, dysphagia, facial swelling, tongue swelling.