chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 76 year old female with a history of shingles who in December 2006, was vaccinated with a 0.5 ml zoster vaccine live (Oka/Merck). Concomitant therapy included hypertension and glaucoma medications. On approximately 15-SEP-2007 the patient developed "worst case" of shingles that she ever had. The patient stated that she had shingles outbreak every couple years since 1979. The patient experienced fever, whole body aches, illness, larger lesions than before and a painful inflamed shoulder. No diagnostic laboratory tests were undertaken. Unspecified medical attention was sought. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Starting on the day of the vaccine 1st dose, I started to feel really bad about 24 hours.  My left arm was significantly painful and I could not move my arm.  I had body aches and extremely fatigue. These symptoms lasted for 3-4 days but the arm pain still lingered on.  3 weeks post vaccine, I had a random nerve pain in my left shoulder blade.  I went to my chiropractor and got a massage.  The pain went down from shoulder blade, down my back and to my left toes.    It felt like pain of  pins and needles and shooting pain.  I took ibuprofen for the pain.  The back pain got better. I also felt numb in my pubic area and left side of buttocks. Also had numbness on my left legs.  I went to the ER and  got a MRI (normal).  I was discharged with no diagnosis.  I went to see my PCP who gave me steroids (methylprednisolone dose pack) and everything resolved except the left arm pain.  I still have decreased mobility with my left arm and I am still having pain when I move my arm in certain direction.
Pfizer first dose, Moderna second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer first dose, Moderna second dose) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In April 2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage form. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer first dose, Moderna second dose). On 14-May-2021, INTERCHANGE OF VACCINE PRODUCTS (Pfizer first dose, Moderna second dose) had resolved.        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 medications were reported.  No treatment information was reported.
-Pain in arm occurred day after 1st dose. Pain so bad that was unable to touch arm or lift water cup without some pain. ~95% resolved by second day -Headache day after first dose. Still occurring at day 2 after vaccine -Diarrhea day of first dose to today. Still occurring
10FEB98 T98.4, c/o swelling hands & ankle-refilled zoloft;12FEB98 MD T98 & migratory joint pain & feet, heat, redness & swelling;ASA & ice ordered, wrist pain, body aches;
Tested positive for COVID-19 on 25Aug2022; Tested positive for COVID-19 on 25Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: EP6955), on 20Apr2021 as dose 2, single (Lot number: EP6955) and on 08Dec2021 as dose 3 (booster), single (Lot number: 331308A) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Aug2022, outcome "not recovered" and all described as "Tested positive for COVID-19 on 25Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient received no other vaccine in four weeks and no covid prior vaccination. Patient tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient did fine with first moderna vaccine then received the second dose and developed hives that have been going on for about a month right now.  The reaction was not anaphylactic and is present all over body.  Patient saw primary care doctor but had not seen before so is referring to a specialist.
patient received GARDASIL 9, a headache came on; Information has been received from a medical assistant referring to a 11 year old male patient. The patient had no medical history, drug allergies or concomitant medication.  On 24-JUN-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose and frequency were unknown; lot # R009614, expiration date 30-NOV-2020) intramuscularly for Human Papillomavirus (HPV) prevention.  On the same day, 10 minutes after the vaccination, the patient experienced headache. Te patient didn't sought medication attention. There were no lab tests performed. The patient received treatment with acetaminophen (TYLENOL). The outcome of headache was unknown. The causality assessment between headache and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported by the reporter.
The following occurred two and half hours after receiving H1N1 shot 12/15/09. Difficulty breathing, rapid heart beat, the patient never experienced any heart problems prior to the vaccine. 12/31/09, 1/4/10, 1/6/10 Records received for ED, Hospital records and cardiology consult for dates of service 12/15/09 to 12/28/09.  Dx:  Atrial fibrillation with rapid ventricular rate.  Two hours after H1N1 vaccine experienced chest tightness, SOB and palpitations. Took Benadryl and presented to ED in atrial fibrillation with ventricular rate of 147.  Given Cardizem bolus and then drip.  Experienced improvement of sx. of chest tightness,SOB, palpitations and control of heart rate. Successfully cardioverted and started on heparin.  Discharged on coumadin and Lovenox.  Followed up on 12/28/09 for persistent hypertension.  Norvasc added to regimen.
I woke up the day after receiving the vaccine with vertigo (I have had this before) and nausea.  I couldn't keep any food down all day.  I did not have a fever and my blood pressure was normal.  There were no symptoms the day of the vaccine (Thursday) and Saturday all symptoms had resolved without taking any medication.
Patient was called post discharge from hospital for a follow-up. He reports that right deltoid is red, swollen, rash, pain. States he thinks injection was given wrong.
Swelling at site of injection from shoulder to elbow, redness with slight fever to area, tender to touch and movement, severe headache and stiff neck.
small rash that has been getting larger; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age (reported as age: 30, unit: unknown) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Laboratory employee received her first dose of vaccine on 19Dec2020. On 01Jan2021, she developed a small rash that has been getting larger that she has been treating with Benadryl. She is calling to see if she can receive the second dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Patient was given initial dose inactivated quadrivalent fluzone vaccine, 10/16/2019. Patient denied any other vaccines and was administered second dose quadrivalent fluzone vaccine 1/15/2020. No adverse symptoms, signs or side effects reported at this time.
Fever Extreme body aches Extreme fatigue  Nausea  Headache all lasted for 2 days fatigue has lasted for 4 Used aleve ibuprofen heating pad sleep
STROKE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and Expiry Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stroke. It was reported that the patient had a stroke 10 days after receiving the J&J vaccine The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s -Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Advrs effect of pertuss vaccine, inc combin w pertuss, subs on 2017-07-28.
On 09/15/2022 I received my Covid-19 vaccine. On 12/21/2022 I was feeling dizzy and fell and broke my nose and went to the emergency room. I was recommended for physical therapy.
Chills day Feb 6, Sick feeling & worse tremors Feb 7-Mar 1, Multiple Seizures Feb `13, & F22.  Extreme sporadic stuttering started Feb 20 and continues till today Mar mad 2nd shot March 1st.  Had multiple seizures Mar 13 preceded by stuttering.  Had 3 extreme whole body seizures Mar 7,  Today Mar 8.
sore muscles; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (sore muscles) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bone pain. Concomitant products included HYDRALAZINE for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore muscles). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (sore muscles) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-062420 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 4/13/2023 ABNL ECHOCARDIOGRAM
Two days following administration, patient reported a red, raised area around the injection site. Area had slight burning and itching and was hot to the touch.
10/13/11 called & had swelling arm - no pain/itching - instructed to warm/cool pk & monitor. 10/27 message left by HD to follow-up. 11/2/11 called & states went to see Dr for swelling & was started on antibiotic. 1wk later had pain in knees & arm joints. Dr started on antibiotic & steroid. Also had splotches that were warm & red on legs, still has. If cont by next Friday will have blood work done. Dr told her allergic reaction from having 3 injections done.
16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old). On 20-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old) had resolved. Not Provided      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 and treatment medication were provided
Pt received second dose of vaccine and within 10 minutes had SOB, audible wheezing, and difficulty speaking.  Pt self administered one dose of Epipen (had own pen present from home) and noticed short term relief of symptoms.  Within 10 minutes, pt had worsening wheezing, difficulty speaking, and tremors.  Pt self administered 2 inhalations of Proair that she had present from home.  EMS was called at this time, and pt was transferred to ED upon arrival.
COVID-19 breakthrough. I had fatigue, slight fever, and headache. It lasted for about 12 days. I tested positive for 16 days on home tests. The fatigue lingered but everything else diminished by the end of the first week.
Patient received Moderna Monovalent .  The Moderna Bivalent was ordered.   The Monovalent had been opened on 12/19/2022 and was at room temp up to the time of the injection. Monovalent should have been discarded at end of day 12/19/22.  Patient kept in clinic for 20" and physician aware.  Patient left clinic in good spirits and no reaction noted/reported.
Per mom, rec'd vaccine on 2/18/10 and had 2 grand mal seizures on 2/19/10. Also rec'd Hep A on 2/18/10. Note patient has long-standing epilepsy traumatic brain injury from shaken baby syndrome.
Dry mouth, lightheaded, dizziness, increased Hear Rate (89), normally in the 50s.  Initial symptoms resolved within 90 minutes.  Increased heart rate lasted longer than other symptoms.  Reports additional metallic taste in mouth the following day.
Approximately 15 minutes after receiving the vaccine she developed numbness and tingling in the left arm and bilaterally hands were cold.  That symptom lasted approximately 30min.  Employee then began to have a stomach ache and felt as thought her vision were off, described as "feeling as though you were wearing the wrong prescription eye glasses". Then approximately 3-4hrs after vaccination she developed left upper back and neck soreness which was prolonged and intense enough for her to seek care by her PMD.  Employee's PMD prescribed a Medrol dose pack and physical therapy which was effective.
The patient did not present a vaccination card. And he already had the modern bivalent vaccine. There were no adverse events or symptoms.
Itching began approximately 30 minutes after vaccine was administered.  Itching started on the right arm and then the left arm and then the legs.  Redness on the arms was noticed.  Redness on the chest, but no itching on the chest.
feeding flush with increased heart rate 99; feeding flush with increased heart rate 99; B/P114/24; This is a spontaneous report from a contactable nurse. A 34-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at left arm on 28Dec2020 11:44 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient received the vaccine at 11:44 AM, approximate 10 mins later (28Dec2020 11:54), the patient complained of (reported as c/o) feeding flush with increased heart rate (HR) 99, respiratory rate (reported as R) 18, blood pressure (B/P) 120/80, oxygen saturation (reported as sats) 99%. On 28Dec2020 11:49 AM, lab data included B/P 114/24, HR 76, R 16, sats 99%, temp 98.1. On 28Dec2020 11:54 AM, lab data included B/P116/75, HR 70. No treatment received for the adverse events. The events outcome was recovered on an unspecified date in Dec2020. No COVID prior vaccination, it was unknown if the patient had been tested for COVID-19 since the vaccination. It was not reported as serious.
Pt presented to ER on 12/19/2014 for altered mental status. Had LP showing WBC 19, Protein 64, glucose 83. VZV and HSV PCR  negative per report. Pt was discharged under viral encephalitis.
Terrible body aches; Difficulty breathing; Headaches; Vomiting; A spontaneous report  was received from a consumer, concerning a 70-year-old female patient who received Moderna (mRNA-1273) and experienced terrible body aches, headaches, vomiting and a lot of difficulty breathing.   The patient's medical history included asthma, high blood pressure and diabetes. Concomitant medication included unspecified asthma, high blood pressure and diabetes medication.   On 18-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On 18-Feb-2021, within 24 hours after vaccination in evening, the patient experienced terrible body aches, headaches, vomiting and a lot of difficulty breathing. The patient was treated with tylenol.  Action taken with the mRNA-1273 was considered as unknown.  The outcome of the events terrible body aches, headaches, vomiting and a lot of difficulty breathing were considered as unknown.; Reporter'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.
Patient received her first booster on Jan 10, 2022 and had a acute ischemic stroke on March 24, 2022. Patient Spent a couple of days at Hospital and was discharged.   No cause of the stroke was found. No blockage, no blood vessel problems,  Damage to brain noted Patient is now on three new maintenance prescriptions for standards of care for stoke patients.
Increasing pain to left arm requiring pain meds, steroids, physicial therapy, consult by Neurology.
Missed period. Cycle lasted 44 days. Started 12/8/2021. Current cycle is 35 days as of 1/11/2022. Still no period. Previously my period has been normal/regular for past year prior to vaccine.
2 days post vax pt had one afebrile sz; subsequent EEG & CT scan abnormal; No further problems, several exam WNL, thriving infant;
Immediately once the vaccine was injected, patient felt a tingling sensation rush through her body. She also experienced a taste in her mouth within 5 minutes of the vaccine and lasted for about 30-60 minutes after the vaccine.
Almost immediately after the influenza vaccine, my already high but stable creatinine level of 3 began to ratchet higher. No other drugs or changes in lifestyle or environment happened when the creatinine began to spike (on 12/13/17 it was 8+).  I'm wondering if there is a correlation between the flu vaccine and the rapid acceleration of creatinine with previous toxicity due to Ifosfamide.
Foggy head/ she is experiencing this for a long time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Foggy head/ she is experiencing this for a long time".  Additional information: Patient mentioned that she read about the listed side effects of this and one of it was foggy head, she mentioned she was experiencing this for a long time and she confirmed that she got the Pfizer booster vaccine and wants to know more about it.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
got COVID-19 in July2022; got COVID-19 in July2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got COVID-19 in July2022". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a lump at the injection site; a lump at the injection site which has become red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a lump at the injection site) and VACCINATION SITE ERYTHEMA (a lump at the injection site which has become red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE MASS (a lump at the injection site) and VACCINATION SITE ERYTHEMA (a lump at the injection site which has become red). At the time of the report, VACCINATION SITE MASS (a lump at the injection site) and VACCINATION SITE ERYTHEMA (a lump at the injection site which has become red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
shaking, chills, fever, muscle aches, fatigue, tinnitus (4/6) nausea, fatigue (4/7-4/9) tinnitus (constant since vaccine administration)
I tested positive for Covid 19 on 3/18 and completed a 5 day course of Lagevrio (because I am on Eliquis). I was symptom free days 5-7 but developed mild URI symptoms on day 8. I restarted my 5 day isolation. I was told I likely had a rebound case of Covid. I have received 5 Covid vaccine doses, the bivalent in September 2022. (Had my immunity waned?) This is my first case of Covid 19 after being very careful for three years. When symptoms abated, I did daily rapid antigen tests but remained very faintly positive so isolation continued. Now on day 11 I am waiting to retest when symptoms are gone and I end my isolation.
Information has been received from a registered nurse referring to a 12 or 13 years old female patient. The patient's medical history concurrent condition and concomitant medications were unknown. On an unknown date (about 6 to 12 months ago), the patient was vaccinated with the first dose of M-M-R II subcutaneously (dose, frequency, lot# and expiration date unknown). On an unspecified date, the patient experienced a measles like rash from "head to toe" after receiving M-M-R II. The rash was ago "itchy and pimply, lasting for about a week". The patient recovered from the event.  The casual relationship between the events and M-M-R II was known. Additional information has been requested.