chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HPV; This spontaneous report was received from a female pharmacy technician (also reported as a healthcare professional (HCP), conflict information) via Customer Center referring to herself. Information about the patient's pertinent medical history, concomitant medications, and drug reactions/allergies was reported as unknown. Information about the patient's concurrent conditions was not reported.  On an unknown date (when the patient was 11 or 12 years old), the patient was vaccinated with what was assumed (by the patient) to be quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) via injection for prophylaxis (vaccination by her mother's choice) (strength and dose were not reported). The vaccine was not available for retrieval and the lot# and expiration date were unknown by the patient. It was unknown where the patient received the vaccine and by whom.    On an unknown date (between the age of 16-20, exact time/date were unknown by the patient), the patient was contracted and diagnosed with human papillomavirus (HPV). On an unknown date, the patient sought for treatment. When she was 20 years old, she was advised by her physician that the HPV was gone and she was medically cleared (outcome reported as recovered). Details of the symptoms or adverse events were not disclosed by the patient. The patient wanted to know if her partner should be vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) due to her own personal medical history. No additional adverse events details were able to be provided.   The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and event human papillomavirus infection was not provided.
pt recv vax & next day pt reported sore arm, sl redness, hard bumps at site;also exp nausea & stomach pains;feels bumpy spot;nausea still noted;
Left eye was red/ Subconjunctival hemorrhage; A spontaneous report was received from a physician, concerning a 86-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Left eye was red/ Subconjunctival hemorrhage (Subconjunctival Hemorrhage).  The patient's medical history was not provided by the reporter. Concomitant medications reported included, baby aspirin every day, high blood pressure medication, amlodipine, tamsulosin, vitamin C, atorvastatin calcium, metoprolol, vitamin D, multivitamin, zinc, alendronate, and docusate sodium.  A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left eye was red, subconjunctival hemorrhage.  The patient's medical history was not provided. Concomitant medications reported were baby aspirin every day, high blood pressure medication, amlodipine, Tamsulosin, Vitamin C, Lipitor, metoprolol, Vitamin D, multivitamin, zinc, alendronate, Colace for drug use for unknown indication.  On 12 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 15 Mar 2021, the patient experienced the event(s) left eye was red, subconjunctival hemorrhage.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.  On 18 Mar 2021 the outcome of event(s), left eye was red, subconjunctival hemorrhage was resolved.   On 12 Mar 2021, prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (lot/batch: 032M20A) by unspecified route on her left arm for prophylaxis of COVID-19 infection.    On 15 Mar 2021, 3 days post vaccination, patient's left eye was red, later the healthcare professional diagnosed it as "Subconjunctival Hemorrhage". Subconjunctival hemorrhage, was the medically significant event. Treatment details were mot reported.  Action taken with mRNA-1273 in response to the event was not reported.   On 18 Mar 2021, the event, Subconjunctival Hemorrhage was resolved.; 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.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 28-JUL-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
itch; swelling; throat was sore; Red; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itch), SWELLING (swelling), OROPHARYNGEAL PAIN (throat was sore) and ERYTHEMA (Red) in a 52-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3915B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 04-Oct-2023, the patient experienced PRURITUS (itch), SWELLING (swelling), OROPHARYNGEAL PAIN (throat was sore) and ERYTHEMA (Red). At the time of the report, PRURITUS (itch), SWELLING (swelling), OROPHARYNGEAL PAIN (throat was sore) and ERYTHEMA (Red) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that after one hour of vaccination patient experienced symptoms of itch, red swelling, throat was sore. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
diarrhea; bad rash; crying excessively; He got two VARIVAX vaccines on 08-AUG-2022.; 10 months old; he only got two vaccines; fever; This spontaneous report was received from a consumer and refers to her 10-month-old son. The patient's medical history included umbilical cord around neck, neonatal asphyxia, resuscitation and intensive care. (reported as his umbilical cord choked him, but he was resuscitated, he had to spend a couple of days in intensive care). The patient's concurrent conditions and concomitant medications were not reported.  On 08-AUG-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (inappropriate age at vaccine administration)(reported as he got two VARIVAX vaccines in each leg - extra dose administered).  On 08-AUG-2022, the patient experienced fever (reported as very high). The reporter stated that she had certain situations where he could not take certain medications (names of medications were not specified by caller). On 09-AUG-2022, he got diarrhea (reported as five times) and bad rash. The patient went to the bathroom so many times that he could not sit down comfortably. He was crying excessively. The mother tried to call a nurse at the emergency room (ER) to get help and was advised to let him sit in a cold tube, which did not work. The mother was given the paper with vaccine report which listed diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (reported as TDAP), varicella virus vaccine live (oka/merck) (VARIVAX), pneumococcal vaccine conj 7v (crm197) (PREVNAR) (also reported as PREVNAR 13), hib vaccine conj (crm197) (HIBTITER) (also reported as HIB), polio vaccine inact 3v (reported as OPV/IV3) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ). According to the consumer, the patient was given only two vaccines on 08-AUG-2022. According to the consumer, the patient was given only two vaccines on 08-AUG-2022. The reporter was confused about what vaccines were administered, because of the vaccines listed on the paper and she only saw 2 shots given. They rushed her to sign the forms without giving time to consent and she thought her son would be getting the vaccines like normal. The reporter also mentioned she wanted to report the doctor.  At the time of reporting, the patient had not recovered from the events. Action taken with varicella virus vaccine live (oka/merck) (VARIVAX) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided. The causal relationship between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.   The causal relationship between the events and the suspect therapies was not provided.
Headache; Muscle and joint pain; Muscle and joint pain; Nausea; Chills; Fatigue; This is a spontaneous report from a contactable consumer (Pfizer employee), the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 05May2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included probiotics (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and unspecified multivitamin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 14Apr2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 07:00, the patient experienced headache, muscle and joint pain, nausea, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, muscle and joint pain, nausea, chills and fatigue was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
At week 22 of my pregnancy, the fetus was diagnosed with supraventricular tachycardia based on stage II ultrasound and fetal heart ultrasound. I was hospitalized at Hospital for 11 days (Aug 25 to Sept 4) and received drug treatment (first digoxin, then digoxin and flecainide) for fetal supraventricular tachycardia to convert the fetus' heart rate to sinus rhythm.  I was discharged while fetus was still in SVT. Fetus converted to sinus rhythm 3 weeks later while I was on digoxin and flecainide.  I had a booster shot (Pfizer) on 11/24/21. Two days after I received the booster shot the fetus went into an SVT episode again which terminated few hours later. I continued taking the same medications and dosages up to the day of labor and delivery (Dec 27) at Hospital. Baby (female, 37 weeks gestation) was born 12/27/21 in sinus rhythm, but went into SVT on Day 2. At that point baby was transferred to the Cardiac Care Unit at Hospital for medical treatment. Baby stayed in the hospital for 22 days and was discharged on daily doses of Propranolol (0.6 ml, 4 times a day) and Flecainide (0.35 ml, 3 times a day). There is no prior history of SVT in our family, parents, or siblings.
extreme vertigo beginning the following day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jun2022 at 15:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies adhesives" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; VITAMIN D NOS. Vaccination history included: Bnt162b2 (Dose 1, unknown manufacturer), for Covid-19 immunization; Bnt162b2 (Dose 2, unknown manufacturer), for Covid-19 immunization; Bnt162b2 (Dose 3, unknown manufacturer), for Covid-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 12Jun2022 at 08:00, outcome "recovered", described as "extreme vertigo beginning the following day". Therapeutic measures were not taken as a result of vertigo.  No follow-up attempts are possible. No further information is expected.
Customer reported that his arm was sore and swollen one week after receiving the second dose of Moderna vaccine.  He mentioned that he took Benadryl on 10/23/21 along with ibuprofen which before, he only took ibuprofen.  After taking both Benadryl and ibuprofen, he was able to raise his right arm.  I advised him to seek medical attention for his arm as soon as possible and continue with Benadryl and ibuprofen.
By the night that I got the shots, I could not lift either arm, and all night I woke up from shoulder pain (either pressure lying on the shoulder and also whenever I tried to lift my arm to turn over). I had to have my husband help me dress. This acute stage lasted a week, and I called the nurse on 11/3/16 to report that the pain was still out of control!
This spontaneous case reported by a consumer, describes the occurrence of chills in an 83-year-old female patient who received mRNA-1273 (batch# 050M20A) for COVID-19 vaccination. No medical history information reported. On Mar 11, 2021, patient received the second dose of mRNA-1273 intramuscular; 1 dosage form. On Mar 11, 2021, patient experienced chills. On Mar 12, 2021, chills resolved. Action taken with respect to mRNA-1273: not applicable. The reporter did not provide any causality assessments, concomitant medication or treatment information. Additional information provided: Patient updated contact information from linked case and consented for safety follow-up. This case linked to MOD-2021-026023 (patient link).
Pt. seated in observation area after receiving first COVID vaccine and informed nurse she was nauseated. Pt. remained seated in chair and became unresponsive with eyes open. There was a thirty second period of time in which pt did not respond to name or questions. Called 911. While on the line with 911, pt was alert and oriented and able to respond to questions being asked by dispatch.  BP taken at 1300 was 106/54 seated and 121/81 lying down. At no time did pt experience shortness of breath, difficulty breathing, or hives. EMS/Fire arrived and transported pt to ED for further evaluation. Pt had not eaten at all the day of vaccine. Pt transported to ED, complained of nausea, given Zofran, monitored, then discharged.
still got the flu and still have it; Initial information received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced still got the flu and still have it while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot Unknown at this time via unknown route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious still got the flu and still have it (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu and still have it).  At time of reporting, the outcome was Unknown for the event still got the flu and still have it.
Swollen lymph nodes after second dose and right arm was very swollen.  Booster was in the left arm in November had really bad swelling and sharp pains in the groin area. Saw doctor and he said to watch a little longer and if not resolved he will do test.
Respiratory illness including sore throat, sinus pain, congestion, cough, fever, and fatigue beginning 5 days post vaccination.
2 days post vax nausea, light temp 4 days later-vomiting, could not swallow anything @ all-severe vertigo, dizziness using Phenegan to keep mild soup down;
0.5 cc Meningococcal Conjugate Vaccine (MCV) given IM left lateral thigh (instead of Prevnar). This is follow-up on menactra vaccine inadvertentily given on 6/27/06. Client was in today. No problems; No fever; No redness or warmth site.
Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves Infant patient (age and gender not reported), who was vaccinated only the HIB portion (third dose) of PENTACEL via intramuscular route (Batch number, expiry date, dose and site of administration were not reported) on 07-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; ROTATEQ for Immunisation; and HEPATITIS B VACCINE for Immunisation (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique because only the hib portion with the supplied diluent was administered. No adverse event experienced from vaccine. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by the sender: none.
Redness on right arm and warm to the touch, used 1 % Hydrocortisone, 2 times daily, site getting better after five days.
The site injected turned red and swelled up to about 3 inches in diameter. the site remained swollen for a week and was hot to the touch. In addition to the site reaction, I became nauseated and had severe headaches for several days. The site is still swollen but has gone down to about an inch and a half in diameter, headaches are still present.
first one like to have killed me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient reported that, first dose liked to had killed him/her.
Patient was lying horizontal in his chair, he had lost consciousness in what appeared to be a syncopal episode. Patient was safely moved to the floor by healthcare team. Patient regained consciousness and appeared to be confused, sweaty, hot, and pale. Patient was assisted to gurney,  laying flat with feet elevated until he reported his dizziness, light-headedness was resolved. patient accepted a water and snack. His color returned to his face. Patient was then alert and oriented. He was discharged from the clinic.
Patient was given 2nd booster dose of covid moderna before the age of 50 and without any high risk concerns. No treatment at the time.
she knows 3 other people with the same symptoms/body pain; shoulders are really painful; legs are like she lost mobility; inflammation; This is a spontaneous report from a contactable consumer, reporting same events under the same suspect product for 4 patients. This is one of the 4 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that she knew 3 other people (patient) with the same symptom, body pain, shoulders are really painful, legs were like lost mobility, inflammation on an unspecified date in 2021. The clinical outcome for the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101182532 same reporter/drug/event, different patient
Feels very warm at times; Hives; Itching/itchiness in her arm pit that was on the right side/the itchiness had migrated or moved to her neck like the front of her neck; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201, Expiry date: unknown) dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 as dose 2, 0.3 ml single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262, Expiry date: unknown) dose 1 via an unspecified route of administration on 05Feb2021 as dose 1, single for COVID-19 immunisation and experienced itchiness at the shot site. The patient reported, after the second shot that evening, she had an itchiness in her arm pit that was on the right side, she used some lotion that didn't do anything. She feels very warm at times but no fever, and her itching is under her chin are primarily. She was taking a shower the next morning and the itchiness had migrated or moved to her neck like the front of her neck, not down into the chest but about 3-4 inches down and then 4-5 days later her husband said you have had that a while. She got some Cortisone cream, the anti-itch stuff that didn't seem to do much and her husband told her she has hives. She clarifies the Cortisone did help but after a while it would wear off but what helped more than anything else, she told her son she was itchy around the neck and he told her is allergy doctor said to take a tablespoon of apple cedar vinegar and that worked the best she had a hard time swallowing it. She says it is Cortisone 10, she does not have the box she just has the tube, the end of it says 20M441 and the other side says expiration Nov2023. She would like to know when should take Benadryl if needed. The outcome of the events was unknown.
Left arm swelling, tenderness, pain inside and outside.  Red, adverse reaction, swollen, itchy, around injection site (see other VAERS).
GIVEN 2 BIVALENT VACCINES. 10/31/2022  03/23/2023
pt recvd vax & devel h/a, bone marrow suppression, diarrhea, repeat infections, anemia & mono-leukocytes; WBC was borderline & had been immunocompromised;
Hives, generalized with fever; onset 5 days, post vax. No treatment.
this is 1 of 5 pt who recv vax & devel a nodule @ inj site 24 to 48hr later;inj site nodule was 4 to 6cm in diameter red, warm, & tender;