chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a physician via a company representative, and refers to a 16 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On an unspecified date, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly for HPV prevention (strength, dose, dose number, anatomical location, lot number and expiration date were not reported). On an unknown date, after administration of GARDASIL 9, the patient had a stroke. It was unknown if the patient sought medical attention, if received treatment or if laboratory diagnostics or studies were performed. The outcome of the cerebrovascular accident was unknown. The reporter did not assess the causal relationship between vaccination with GARDASIL 9 and the event. Upon internal review the event cerebrovascular accident was considered to be medically significant.
For about six hours I felt extremely tired, weak, feverish, chills, and achy.
The morning of the 11th, I woke up quite nauseous and felt sick for a couple of days.  On the 22nd I woke up with very swollen lymph nodes above my left collarbone and in my left armpit as well as a dull headache.  I also had a dry, hacking cough.  Tuesday, the 23rd, the swelling was quite uncomfortable and prompted me to go to the doctor -- he did a chest x-ray and bloodwork, I'm going in for an ultrasound on my lymph nodes on Thursday, 24 March.  The swelling in the lymph nodes has gone down a bit, to the extent that I can now lift my left arm, however today (Wednesday, 23 March) I woke up with a fever (102), extreme nausea, diarrhea, the headache is gone and the cough has subsided, but I cannot eat -- I'm drinking water and taking Tylenol for the fever.  My pulse ox has been fluctuation between 90 - 94 all day; I am extremely exhausted and waiting for the fever to break.
Received shots on 12/03/2002. Since 12/03/2002, swelling and redness, brought pt to office on 12/05/2002. 2-3 + edema from left deltoid to antecub, hot and redness assoc. with edema. ice packs applied intermittantly. Gave Children's Benadryl 2 tap now then
immed p/vax x 6d tender skin, x 4d fever to 101.4, x6d nausea & severe abd pain;25d p/vax 4d fever 100.7 on & off, severe stomachache;
Eve after PE/vaccines T 102.7 1st febrile seizure 2 min Tx Cer- at ER UBC 59, LP negative,LP Nl, Faint rash, firm .
I received the  moderna vaccine 1/10/22 at 9:15 a.m. felt nausea late that night and took Zofran 4mg.  1/11/22 at around 6 a.m. I woke up in pain to left arm and within the hour pain was all over body, had nausea, itching all over including eyes, runny nose and tingling sensation to my tongue, and kept having to clear my throat.  I also had muscle spasms and shortness off breath with tightness to chest and upper back areas.  I took 50mg of Benadryl tablet at 7:10 a.m. felt a little better and then 4 hours later the reaction started again.  Around 12:30 p.m. I went to Hospitals ER and was treated there. 1/11/22 I left message with my primary doctor informing him of what occurred and will follow up with him. 1/12/22 I called pharmacy and informed the technician of what occurred and she informed the pharmacist; on 1/10/22 pharmacist was present in the pharmacy.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), CHILLS (Chills) and VOMITING (Vomiting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol and Heart disease, unspecified (7 stents). Concurrent medical conditions included Blood pressure high, Penicillin allergy, Drug allergy (Sulfa) and Allergic reaction to analgesics (Ibuprofen). Concomitant products included AMLODIPINE, LOSARTAN, HYDROCHLOROTHIAZIDE, EZETIMIBE, OMEPRAZOLE, METFORMIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 03-Feb-2021, the patient experienced CHILLS (Chills) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information included: ice cold packs..   This case was linked to MOD-2021-057541 (Patient Link).
Within a few minutes of shot flushed cheeks sparing nasolabial folds, blanching confluent  pink macular rash proximal arms and legs few macules on chest abdomen, stable vitals no wheezing, rash did not appear itchy,  Cetirizine was given, rash resolved within an hour. no other symptoms.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 19-MAR-2013, the patient was vaccinated with dose 1 of VAQTA (lot#, expiry not reported) and on 21-AUG-2013, the patient received dose 2 of VAQTA (lot#, expiry not reported). No adverse effects reported. Additional information has been requested.
Severe pain at site of injection so bad can't lift arm up all the way, radiates in to the neck. Swelling and redness at the site of injection painful to touch. Upset stomache. My arm was tender right after the injection seemed to get steadily worse by the hr, pain woke me up around 02:00AM unable to sleep on left side because of pain. Woke up around 07:00AM Realized pain radiated into my neck and now have an upset stomche (cramps)and the pain is much worse and now the injection site is elevated and warm and painful to the touch. Not getting better with tylenol switched to Ibuprofen. No treatment at this time by a doctor. Self treatment with Ibuprofen for swelling.
Client was observed for 30 minutes. She walked out of the building then felt "funny" so returned, stating she felt her throat was starting to feel like it was closing.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored PROQUAD (lot# R015739, expiration date: 02-DEC-2019; lot# R011216, expiration date: 15-OCT-2019, strength, dose, frequency and route were unknown) for prophylaxis reconstituted with well stored sterile diluent (Product storage error). The vaccines had temperature excursion of 15 degree F to 46 degree F (18.9F) for 7 hours 18 minutes. Previous temperature excursion was 15 degree F to 46 degree F (14.5 F) for 48 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.
2/11/21 Foreign body sensation in Right eye, self treated for corneal abrasion but continued to worsen with erythema, photophobia. 2/22/21 Seen by ophthalmology. Possible corneal abrasion but not convinced. rec to return if no improvement. Symptoms worsened with right sided head neuralgia (especially tip of ear) and a blister lesion in between eyebrows 2/26/21 Seen by optho. Dx with opthomologic/corneal shingles Treated for 3 months with valtrex 3 gm, optho steriod drops. resolved by 4/6/21. Stopped all treatment Reoccurred July 4, 2021, retreated x1.5 months. Resolved 3rd COVID vax/booster given  10/1/21. Reoccurred 10/24/21 - now on suppression until 10/2022
Client experienced a tingling sensation in the throat after vaccination. The tingling subsided after a few minutes.
Patient had redness about an inch and a half away from the second injection site which was the flu shot. She also had some swelling in her armpit and lymph nodes along her side. She said her left breast was also sore. She had some nausea and malaise as well. I advised her to take some benadryl and if the redness spread or if her symptoms got any worse to contact her physician.
Arm sore 6 hours after shot, pain level growing,  remaining for 2 days, then lessening.  Felt ok up to 10 hrs after shot-no symptoms. Awoke 1 hr  after retiring cold and shaking, headache, slightly dizzy, lower back ache. Took an Advil. Had taken 1 four hrs prior w/dinner and 1/8mg Xanax at bedtime. Woke early morning with more extreme above symptoms + very nauseous and threw up 4 times through morning.  Fever 101-102 for 18 hrs, slept all day only getting up to urinate. No food but able to hydrate. Extreme feeling of malaise and fatigue, dizziness, persistent head and body aches. Next day better, fever 100.5, slept alot. Next day and 1/2 felt abnormally high energy and 3 following nights of sleeping 3-4 hrs. Equalized by Tues.- 5 days after shot. Equilibrium off thru Mon.
tested positive for COVID; tested positive for COVID; back pain; heavy cold symptoms; fatigue; Experienced a sore arm for 24 hours; This is a spontaneous report from a contactable Nurse (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her vaccine in the left arm deltoid on 23Dec2020. The patient experienced a sore arm for 24 hours in Dec2021. On 31Dec2020, she experienced back pain, heavy cold symptoms and fatigue. On 05Jan2021, the patient was tested positive for COVID. On 09Jan2021 she lost taste and smell. On 14Jan2021, she tested negative for COVID. As of today, 19Jan2021, she has not been able to go back to work. Event took place after use of product. The outcome of event sore arm was recovered on an unspecified date. The outcome of event COVID-19 was recovered on 14Jan2021. The outcome of the other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Approx 40 minutes after receiving 1st Pfizer dose, client c/o "pressure inside throat" and rated pain 5/10. V/S taken at 1:51pm BP 138/70, HR 66, RR 14.   At 1:55pm, 50 g liquid benadryl was offered and accepted by client; taken PO. At 2:00pm, V/S taken BP 150/90, HR 66, RR 18 and pressure in throat rated 2/10. At 2:27pm, V/S taken HR 120/82, HR 60, RR 16, AOx3. Client denied any feeling of pressure in throat and left site unaccompanied, unassisted, and with a steady gait.
p/recv vax pt exp swelling & burning @ inj site; T103; nausea & vomiting, chills, h/a;10/18, myalgias & arthralgias; 10/19 test revealed serum LDH inc 231U/L; WBC 17.0 1000/uL; erythrocyte sedimentation rate 57 mm/hr;
PATIENT EXPERIENCED CHEST TIGHTNESS AND BROKE OUT IN HIVES 2 HOURS AFTER THE PFIZER COVID VACCINE. SHE VISITED THE ER AND WAS PRESCRIBED WITH BENADRYL FOR  HIVES ACCORDING TO PATIENT.
2/23/2021, 6:30 PM facial flushing, 10:30 PM diminished. 2/24/2021,  3 am awakened from restful sleep, sinus congestion progressed to bronchial congestion to chest tightness to difficulty breathing, throat tightening sensation, tongue tingling progressed to thickened sensation, slight difficulty swallowing water. Symptoms occurred over the course of 1.5 hrs.  4:45 am symptoms spontaneously ended. 5:00 am symptoms no longer present, body fatigue,  restful sleep.
Reactive arthritis in hands, feet,  right knee and right hip - ongoing but less severe.  Stabbing pains in finger joints and feet. Sore hip and instability around artificial knee. Finger joints noticeably enlarged.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity; "POTS" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity; "Fibromyalgia" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity; "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity; "sleep apnea" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity; "obesity" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity. Concomitant medication(s) included: EVUSHELD, start date: 12Jul2022, stop date: 12Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: testing positive again; (17Jul2022) positive, notes: tested positive for Covid on 17Jul2022; (24Jul2022) negative, notes: tested negative after Paxlovid on 24Jul; (28Jul2022) positive, notes: testing positive again (before it even reached the C line, so very strong). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient reported that she tested positive for Covid on 17Jul2022, then tested negative after Paxlovid on 24Jul. Symptoms got significantly worse again on 28Jul and after she learned about rebound infections she just retested myself and am testing positive again (before it even reached the C line, so very strong). Adverse event start date was 28Jul2022 and patient was recovering.  No follow-up attempts are possible. No further information expected.
5 minutes after vaccination pt was in a chair and stated she did not feel well. Pt has vasovagal syncope. Blood pressure 97/57. Pt was extremely sweaty.
Itching all over my body from 5-7 minutes post injection to 24 hours after injection.  Also developed COVID arm of day 8 or 9 after the first shot.
12 month old got Ipol vaccine instead of pneumonia vaccine, no AE; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from other health professional.   This case involves a 1 years old male patient who was vaccinated with 0.5 ml of IPV (VERO) [IPOL] (fourth dose, batch numbers: R1B25 / QFAA2047 Expiration date: 13-Mar-2021 and 30-Jun-2021) vaccine instead of PNEUMOCOCCAL VACCINE (batch number and expiration date not reported), via intramuscular route in vastus lateralis for prophylactic vaccination on 19-Oct-2020 (PT: wrong product administered).  The patient's past vaccination  included IPOL on 19-DEC-2019 for prophylactic vaccination.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Joint aches, arm soreness, Fever of 102.2, fatigue, nausea, chills, headache
tested positive for hpv on a pap smear; This spontaneous report was received from a consumer, concerning herself as an approximately 22 years old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  Starting in 2009, the patient received 3 vaccinations with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) administered intramuscularly for prophylaxis (strength, dose, anatomical location, lot #, and expiration date were not provided).   In 2016 (also reported as 6 years ago and as in 1996; conflicting information), the patient tested positive for human papillomavirus (HPV) on a pap smear. The patient sought medical attention but no treatment was given for the event. At the time of reporting, the outcome of the event was unknown.   No causality was provided.
At injection site: red, hard, itchy, hot, raised skin roughly 4 inches in diameter began to appear with 18 hours of receiving the injection. Wednesday, August 11th at around 4pm was when I received the vaccine. I noticed this thing on my arm the next day around 1pm. It?s gotten bigger, more red, and more itchy. It is still going strong Sunday morning at 3:15?.3 1/2 days after receiving the vaccine. Benadryl nor ibuprofen seem to help much but cold feels wonderful. So does lightly scratching it.
01/05/2022: Event occurred after 2nd vaccine. Patient presents with altered mental status. No respiratory distress.  Diminished breath sounds right hemithorax, some basilar crackles left lung. Covid positive, no increased oxygen requirement, will admit due to this altered mental status, may be due to some opioid withdrawal as after the 100 mcg of fentanyl I gave during the procedure patient to improve. Remains in hospital- 01/10/2022.
High blood pressure  184/98 180/90 This persisted for three weeks  Beta blocker had to be given 1-2 times daily Benecar 20-30 mg
Had dT on 5/28/08 and was fine until night of 5/29/08 then started having trouble lifting her arms.  Woke up on 5/30/08 and had a lot of trouble getting out of bed due to pain and aches in her knees and some in muscles of legs and arms.  Finally got out of bed and walked to bathroom and it hurt her to get off toilet because of knee pain.  Patient seen on 6/4/08 for this complaint and started to feel a little better.  Did not have any acute arthritis on that date.  Both shoulders hurt more than elbows and wrists.  Was about to have back surgery and the dT did not increase her back pain.  She had no local reaction to the immunization or any reported fever.  Had to have some assistance to arise from a chair.  Did have muscle tenderness on exam.  CPK, ESR and CBC were ordered and were all normal.  Temp was 97.7, BP 134/82 and pulse was 88.  Was seen again on 7/1/08 three weeks after her back surgery and reported that the soreness from her dT was 50% better than on 6/4/08.  Reported it was still hard to lift arms and knees up.  I did not see any significant problems on examination.  She has not contacted me since that time and has gone to pain management for her back.
Large welt at site of injection that is warm to the touch, painful, and red. Pt states she is nausea.
Swollen, right arm (shoulder to elbow). Received steroid shot & oral steroids.
This case was reported by a nurse via sales rep and described the occurrence of neck pain in a 17-year-old female patient who received BEXSERO. Concomitant products included MENVEO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, 14 days after receiving BEXSERO, the patient experienced neck pain (serious criteria other: as per reporter), fatigue (serious criteria other: as per reporter) and fibromyalgia (serious criteria other: as per reporter). On an unknown date, the outcome of the neck pain, fatigue and fibromyalgia were recovered/resolved. The reporter considered the neck pain, fatigue and fibromyalgia to be related to BEXSERO. Additional details were reported as follows: This case was previously reported to a doctor. The age at vaccination was not reported. About 2 and a half weeks after receiving BEXSERO, the patient experienced the noted side effects. The patient was seen at the local emergency room, but it was not known by the sales representative if the patient was admitted. The sales representative stated about a meningococcal quadrivalent product, which was believed to be MENVEO. The reporter was not sure when the MENVEO was received by the patient. All the questions were asked but limited information was provided by the representative.
DOS 12/18 Mild tenderness, mild redness and warmth skin condition, arm pain Rx Methylprednisolone, Ranitidine.
7 days after the shot I experienced the following at the site of the injection: -Noticeable swelling -Itching -Redness -Heat at site -Soreness
Contracted Covid-19; Contracted Covid-19; This is a spontaneous report from a contactable consumer(patient). A 43-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in arm left on 25Mar2021 (Lot Number: EL3248) as dose 2, single (at the age of 43-year-old) and received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in arm left on 04Mar2021 (Lot Number: EL3248) as dose 1, single for COVID-19 immunization in Workplace clinic. The patient's medical history was none. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient not had COVID. Concomitant medication included colecalciferol (VIT D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient experienced contracted covid-19 on 12Nov2021.The patient was test post vaccination for COVID test. The patient underwent lab test which included PCR was positive (Nasal Swab) on 12Nov2021. No treatment received for the events. Outcome of the event COVID-19 was recovering.
Temp of 101.7 with chills, joint pain, headache, nausea.
lightheaded, nausea, vomiting, chills, rigors, pain and stiffness bilateral arms & legs, back pain
- pt came into the clinic after being vaccinated 24 hours ago at  another facility with fever, body aches and lost of tase
Patient has Psoriasis on her arms and after receiving this years flu vaccine her Psoriasis became worse with breaking out on other areas her body but especially both sides of her neck.
No initial symptoms or adverse events to report, but on the evening of 01/17/21, I felt something through the sleeve of my sweatshirt. Later that evening, upon getting ready for bed, there was a noticeable red, raised welt in the area where I received the vaccine. Today I have felt chilled all day, and my face has felt warm and flushed but no fever. Welt has improved but is still noticeably visible.
about 1pm he felt extremely weak, and then went into incredible shaking, even his spine shaking and that lasted almost 2 hours, at 2 am he got diahrrea and had that horrible, felt drained
pt recvd vax; w/in  1-2 days of vax, pt c/o soreness at inject site; became black & blue;w/in several days began to note itching of arms, legs & back; persistent to present w/ some rash;