chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she got one of the strains of HPV that she was supposed to be protected from; only received two shots but not the third dose; Information has been received from a current 28-year-old female patient reporting on herself (age at the time of the first event was not reported).  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unspecified date, when the patient was younger, she was vaccinated with the first and second doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection (dose, frequency, route, lot number and expiration date were not reported) to prevent Human papillomavirus (HPV).  The patient stated that she received two shots but not a third dose.   On an unspecified date, reported as within last few years, the patient reported she got one of the strains of HPV that she was supposed to be protected from with the Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccine. However, the patient did not specify which strain (vaccination failure).  The outcome of vaccination failure was not reported.  It was also reported that the patient started the series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) on 01-MAR-2021 and 12-APR-2021, first and second doses respectively (reported in MARRS 2108USA004963), and she wanted to know the dosing schedule as she had not received the last dose yet.; Sender's Comments:  US-009507513-2108USA004963:
Low grade fever, chills, arm sore & hot to touch, body aches. Took acetaminophen. Ice on injection area.
Warm flushing feeling, numbness around site, waited 10 minutes, pt. left site.
no adverse event; Patient received first dose of GARDASIL 9 in July 2016. Diid not receive second and third dose; This spontaneous report was received from a physician assistant and refers to a 22-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On unspecified date in July 2016, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, strength, lot # and expiration date were not provided). The patient did not receive second and third dose ( inappropriate schedule of product administration). No other adverse event was reported.
Patient was vaccinated on 10/28/09 and 3 days later developed headache and extreme arthritis (all joints swollen). Physician diagnosed her with serum sickness and prescribed medrol on 11/11/09. Had internal itching that lasted one week.
He passed away 14 days after receiving the 1st dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Mar2021 17:30 (Lot number: EP7534) at the age of 47 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Known allergies: any type of cillins" (unspecified if ongoing). No covid prior vaccination. No other vaccine in four weeks. Other medications in two weeks included blood pressure medications. The patient took concomitant medications. The following information was reported: DEATH (death) with onset 03Apr2021 02:30, outcome "fatal", described as "He passed away 14 days after receiving the 1st dose.". Therapeutic measures were not taken as a result of death. The patient date of death was 03Apr2021. The reported cause of death was "He passed away 14 days after receiving the 1st dose.". No treatment for AE. No covid tested post vaccination. It was also reported that patient did not Recovered. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: He passed away 14 days after receiving the 1st dose.
Developed 4.5mm x 5mm areas + redness, swelling and tenderness at site of injection L upper thigh. No significant systemic reactions due to vaccine.
Starting on the evening of the vaccine injection: I had a slight irritation in my throat and some sluggishness. The following day I developed a cough which got progressively worse during the next couple of days. Also the following day I started to feel bad pain in my lower trunk area, hips, etc. along with minor fatigue. Two days after that I had what I would consider severe pain in that area. By the third day it started to get better, but still was bad. And slowly got better over the next few days until now where I'm just back to my normal pain level in those areas. The fatigue level is back to normal and I still have a slight cough.
pt recvd vax;24 hrs later itchy rash on face,cramping,diarrhea,dizziness,insomnia;low grade T for 36 hrs w/ only minor cold sx afterwards
pt recv vax & devel an intense, burning pain @ the inj site which lasted about 10min;pt also screamed for a good 10min;
Stomach pain underneath base of ribs, slight nausea. June walked around the treatment room holding her stomach. She was classy, said she was hot. Staff had her lay down and wait an additional 15 min on top of the first 15 min wait.
As her husband, and caregiver since 2017, when she was diagnosed with dementia (I believe she had symptoms long before that) I noticed a very observable increase in the severity of her symptoms of confusion, memory loss, not being able to stay focused, disorientation, anxiety, agitation, anger, depression as a direct result of the second dose of the covid vaccine  The change was very noticeable and has not gotten any better. This appears to be a permanent escalation in the severity of her symptoms. I would say she has advanced  a stage to stage 5. We are now considering adding a new drug for her to take to try and level things out.   She also appeared to have a slight fever for 48 hours after.
I am  4 years menopausal. After a week and a half my nipples became sore and I had pain in lower pelvic area.
I developed eczema within a month after shot #3 (Moderna Booster 1). In each subsequent booster (both Moderna and Pfizer), symptoms markedly increased within a week or so of the shot, as did gout flares after shot #3.  I have no idea if these flares were caused by the shots, exacerbated by them, or a coincidence. Gout flares have not recurred following shots #4 and #5, but this may be due to a change and an increase in dosage of of gout medication. Eczema remains a chronic problem that appears to be exacerbated by boosters, but that may not be the cause as the condition is ongoing. My promary care physician is listed on this form, but the dermatologist who has been treating me for eczema.
SILVER DOLLAR SIZED RED, RAISED AREA ON LEFT UPPER ARM.  WARM TO TOUCH.  NOTICED THE NIGHT VACCINE WAS ADMINISTERED (02/19/08).
Swollen optic nerve in left eye. Vision blurry. Had MRI done and was neg. for tumor and MS
sore at the injection site; Pain; administered the diluent component; administered the diluent component; This case was reported by a pharmacist and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number F93YS, expiry date 8th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist reported that the patient's arm was sore at the injection site, pain, but no other symptoms were reported by the patient.  The pharmacist consulted with medical information. The reporter did not consent to follow up.
Very high fever; Very sick; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Very high fever) and ILLNESS (Very sick) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Very high fever) and ILLNESS (Very sick). At the time of the report, PYREXIA (Very high fever) and ILLNESS (Very sick) outcome was unknown. Not Provided          Relevant concomitant medications were not reported.  Treatment medication was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-043171 (Patient Link).
Severe headache still going on Joint pain Severe tiredness still going on Nausea Muscle pain
balance was significantly worse; spascisity in muscles; spascisity in muscles had increase; This case was reported by a consumer via call center representative and described the occurrence of balance disorder in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cerebral palsy.   On 17th June 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2022, 3 weeks after receiving Shingrix, the patient experienced balance disorder, spasticity and condition aggravated. On an unknown date, the outcome of the balance disorder, spasticity and condition aggravated were recovered/resolved.   It was unknown if the reporter considered the balance disorder, spasticity and condition aggravated to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-Aug-2022 Reporter's comment: The patient self reported the case. The patient stated that he had cerebral palsy and got his first shingrix vaccine on 17th June 2022 on right arm.  He stated that about 3 weeks after the vaccine, he noticed his balance was significantly worse and the spasticity in his muscles had increased.  He stated that this lasted for about 3 weeks and had cleared up.  The reporter denied to follow up.
swollen arm, hot and itchy and hard, just stared yesterday, still persisitent today.  also the same after the day of the injection but went away.
HA resolved with Tylenol. Achy, chills and arm soreness resolved with Ibuprofen. All symptoms completed resolved.
I stayed my 30 minutes as directed in a room since I have needed IV Benedryl in past with blood transfusions. Toward the end of my 30-minute wait, I noticed my lips tingling/swelling.    I ALWAYS carry an antihistamine with me, so  I walked out to my car and noticed that my lips felt full.  I needed to run my tongue around them and I immediately took a Zyrtec.  I never did feel short of breath, but with many times in my life getting giant hives due to allergies/ blood transfusion ( secondary to my hemophilia), I feel this was a type of allergic reaction.  I've never had the lip-tingling thing before with any other vaccine.  I've had both pneumonia and both Shingrix vaccines and always get my influenza vaccine since I'm immunosuppressed and work in a Doctors office daily.
Tender arm; Metallic taste in his mouth within an hour. He tried to eat something, but he couldn't taste it; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender arm) and DYSGEUSIA (Metallic taste in his mouth within an hour. He tried to eat something, but he couldn't taste it) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced TENDERNESS (Tender arm) and DYSGEUSIA (Metallic taste in his mouth within an hour. He tried to eat something, but he couldn't taste it). At the time of the report, TENDERNESS (Tender arm) outcome was unknown and DYSGEUSIA (Metallic taste in his mouth within an hour. He tried to eat something, but he couldn't taste it) was resolving. Unknown          No concomitant information was reported.  No treatment information was reported.
It started off with a persistent dry cough.  That progressed into a cough with phlegm.  fever, and an extremely sore throat for about 24 hours. Once I tested positive for COVID-19 at home, I called the doctors office and they wanted to do a test as well. I tested positive at the doctors office as well and they prescribed me Paxlovid. Once I started taking Paxlovid on March 14, 2023, the symptoms started to subside.
pt had immun 930AM  @ 1215 pt was twitching & eyes were glossy; seen in ER & temp was 102; pt was treated w/APAP; t104;
pt recv vax 3AUG95&in NOV95 pt devel a classic herpes zoster rash on lt hand,which proceeded to upper arm&responded over a two-wk period to time in a classic fashion;
Vaccine was given to minor by mistake when vaccine is indicated for 18 years and older. Patient feels fine today 10/23 (24 hours later), but wanted reported in case of issues.
fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension.  Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.
Soreness, redness, swelling within a few inches of the injection site in the medial upper arm. Told patient to take BENADRYL for a few days to see if it improved. Told to contact doctor and pharmacy if reaction worsened or didn't improve.
Patient had a rash covering her body with blistering on the backs of her knees. Her right thigh and upper leg were extremely inflamed and red at least 2 inches from the injection sight-in a circle. It was very hard to touch and painful for her. This was following the DTaP shot. It has been 3 days and it is still this way.
1st shot , tingling lips and itchy tongue, slight swelling of tongue!Started within 5-10 min of vaccine!!Lasted 15 -25min!! 2nd shot- itchy tongue, throat swelling, flemy throat, horse voice,tongue swelling!All happened very quickly, went away within 1-2 hrs! Was very sleepy afterwards and had bad headache!!
Case number PHEH2014US019159, is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 45-year-old male patient. Past medical history and concomitant medication was not reported. On 18 Sep 2014, the patient was inadvertently vaccinated with FLUVIRIN (batch number: 14120010 intramuscularly at a dose of 1.0 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
tightness in chest; confusion; cold sweats; raised pulse rate; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in chest), CONFUSIONAL STATE (confusion), COLD SWEAT (cold sweats), HEART RATE INCREASED (raised pulse rate) and FATIGUE (tiredness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHEST DISCOMFORT (tightness in chest), CONFUSIONAL STATE (confusion), COLD SWEAT (cold sweats), HEART RATE INCREASED (raised pulse rate), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, CHEST DISCOMFORT (tightness in chest), CONFUSIONAL STATE (confusion), COLD SWEAT (cold sweats), HEART RATE INCREASED (raised pulse rate), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
She woke up with an itchy red rash. It got bigger the next day. So far she has tried cortisone cream to relieve the itching.
Patient had redness all around the arm, stiffness, and burning pain in arm. Reaction occurred within 12 hours and worsened. It was initially itching then it stopped and burning and pain began.
Hives from head to toe.  Puritis.  No breathing difficulties.  Reaction occurred with in 15-30 minutes of receiving vaccination.  Patient has received flu vaccination many times in the past without reaction.  Patient seen in the ER and treated with Solumedrol 125mg IM, Benadryl 50mg po and released.
About a month after my vaccination with the booster Moderna vaccine, I started to feel some random sharp pain and burning sensation by the lower back on the side of my lower hip area, It would be down the leg all the way to the toes however it is not always in the same spot. A little bit of pain and burning that feels like pressing on a bruise. This was affecting my ability to sleep on my side, went to the doctor, and suspected that it was sciatica. After doing light stretching I kept doing stretches that assisted in sciatica related pain. I was not given any scans, however, the doctor stated that I should continue improving if I continue to stretch. I am still continuing to feel the pain and debating on going to physical therapy.
This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 80-year-old male patient who received SHINGRIX (batch number J4D5J, expiry date 19th August 2019) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included drug allergy (was allergic to Thimerosal). On 19th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th August 2018, less than a day after receiving SHINGRIX, the patient experienced vesicular rash, burning sensation skin and itchy rash. On an unknown date, the outcome of the vesicular rash, burning sensation skin and itchy rash were unknown. The reporter considered the vesicular rash to be probably related to SHINGRIX. It was unknown if the reporter considered the burning sensation skin and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Within 24 hours, the patient began to experience a rash on the left arm. The rash was further described as, going up and down the arm from below the injection site towards the elbow, almost like the shingles rash, like poison ivy, a bunch of little bumps which burned and itched. The patient stated the rash felt like shingles.
Patient had a focal seizure that generalized to a tonic clonic seizure on 3/15/2019 and a second generalized tonic clonic seizure on 3/25/2019. Patient has seen a neurologist and is now taking levetiracetam. No further seizures reported.
Burning pain in right elbow lasting to date 03/30/2019. Pain & weakness is forearm muscles same time. Difficult to lift small objects.
12 mo had febrile seizure 11 days after 12 mo vaccines. Brought to Emergency Room, several dxed tests on 3/2/08 CXR showed lower airway disease, flu (-), albuterol tx. Seen 3/3/08 in office, had aerosol tx for wheezing, dxed OM - tx Amoxil, Prednisone
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M204 or 022M20A and 007B21A or 007821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OXYCODONE, SEMAGLUTIDE (OZEMPIC), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION HYDROCHLORIDE (WELLBUTRIN), METFORMIN, MULTIVITAMINS [VITAMINS NOS], ZINC and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). At the time of the report, VACCINATION SITE PAIN (Arm soreness) outcome was unknown.            Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Blood pressure measurement: decreased (Low) Decreased. In December 2020, SARS-CoV-2 test: positive (Positive) Positive.     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.   No concomitant medication was reported.  No treatment medications were reported.