chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of labial swelling in a 16-Year-old female subject who was vaccinated with HEPATITIS A vaccine (unspecified manufacturer). Concurrent medical conditions included acne and heavy period. Concurrent medications included ZIANA, ORTHO TRI-CYCLEN LO, TYLENOL NO. 3, unspecified Antibiotic, Lignocaine gel and Duraplast spray. On an unspecified date in February 2009, the subject received 1st dose of HEP A vaccine (unspecified manufacturer, unknown). On an unspecified date, the subject received the 2nd dose of HEP A vaccine (unspecified manufacturer, unknown). At an unspecified time after vaccination with the first dose of HEP A vaccine, the subject experienced labial swelling and vaginal yeast infection. Outcome of the events was unspecified. Causality was not specified. At an unspecified time after vaccination with the second dose of HEP A vaccine, the subject experienced labial swelling and vaginal yeast infection. The events were unresolved at the time of reporting. The healthcare professional considered the events were possibly related to vaccination with HEP A vaccine. The subject's next follow-up was on 27 April 2009. Follow-up was received from the reporting healthcare professional on 8 June 2009: The HEP A vaccine was confirmed as HAVRIX (GlaxoSmithKline). Concurrent medical conditions included dysmenorrhea. The subject denied history of sexual activity ever. Concurrent vaccination included MENACTRA, non-GSK manufacturer, intramuscular, left deltoid given on 22 January 2009. On 22 January 2009 the subject received 1st dose of HAVRIX (intramuscular, left deltoid). On 23 January 2009, 1 day after vaccination with HAVRIX, the subject experienced labial swelling, vaginal yeast infection and vaginal swelling. The events resolved on an unspecified date. On 16 April 2009 the subject received 2nd dose of HAVRIX (intramuscular, left deltoid). On 20 April 2009, 4 days after vaccination with HAVRIX, the subject experienced labial swelling, vaginal yeast infection and vaginal swelling. It was reported that the symptoms were milder after the 1st dose of HAVRIX. The subject also experienced cellulitis. This case was assessed as medically serious by GSK. The subject had been treated with an unknown medication without relief by her primary care provider. She was seen by a gynecologist on 20 April 2009 and potassium hydroxide slide was negative for yeast, the subject was noted to have mild cellulitis. The subject was treated with KEFLEX and an unknown medication. At the time of reporting the events were resolved; the follow-up scheduled for 27 April 2009 was cancelled.
Patient showed no antibodies; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation on unspecified date. The patient experienced patient showed no antibodies (antibody test negative) (non-serious) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included antibody test: negative on unspecified date.    The information on the lot/batch number has been requested.
Chills; fever - 102; headache; joint/muscle pain, extreme fatigue; nausea; increased heart rate. Called dr office: recommended fluids, Tylenol, rest; slept for 20 hours; symptoms began to disappear after 36 hours.
Narrative: COVID infection following COVID vaccine series 01/04, Pfizer, dose #1 01/25, Pfizer, dose #2 01/03 COVID swab, result: detected 01/03 pt cc: cough, exposure: unknown 01/03 pt admit to ED cc: cough dx: COVID+ LOS 1 day
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with an expired 0.5 ml dose of M-M-R II (lot # 667879/0788Z expiration date 16-JUN-2012), SQ on 11-JUL-2012. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
pt had already completed course of Pfizer in February , his MD had done a blood assay to  test for the antigen it came back as negative and his MD recommended he get the moderna vaccine now - no reaction yet but unsure due to different vaccine
On day following vax, child cried uncontrollably for 4 hrs (6PM to 10PM) & was hard to control. A decreased appetite was also noted.
Low-grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low-grade fever) and CHILLS (chills) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PYREXIA (Low-grade fever) and CHILLS (chills). At the time of the report, PYREXIA (Low-grade fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Received 2nd Dose 2 Weeks Later; Initial Report Received on 18-Feb-2020  A nurse reported that a female  received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 31-Jan-2020 in the left deltoid.  Relevant medical history and concomitant medications were not reported.    On 14-Feb-2010, 15 days after having received the first injection, the patient received the second injection (Batch Number 933840, Expiration 19-Apr-2021) in the left deltoid.  The nurse reported that there have been no reported adverse reactions to the injections.   No further information was provided.    The reporter did not provide a serious assessment for the event.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sore arm, limited mobility as lifting her arm is too painful, difficulty sleeping due to pain. Patient indicated that it started since she got immunized and it is still not resolved. Patient is taking Gabapentin for the nerve pain.
- I experienced extreme fatigue, headache and nerve tingling for 2 weeks after the vaccine. What has persisted and worsened is nerve tingling on my back, both sides of face and head. Now I am experiencing burning sensation as well in these areas
4-year old consumer that received the Fluzone Quadrivalent in subcutaneously with a one-inch needle, no AE; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UJ305AA via subcutaneous route in the right arm on 09-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (QUADRACEL) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  It was a case of actual medication error due to Inappropriate route of vaccination.  At the time of reporting, no adverse event was reported.  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.
Chronic hives all over my body. Itchiness and burning. Usually triggered by scratching/rubbing.
After the shot at 5 pm, I began vomiting at 7 pm. I vomited 5 times in 12 hours. My fever reached 101° at 12 pm, before two doses of Tylenol brought it down to 98.5° 10 hours later.
itching; developed rash/ He said that he has rashes in his ankles.; and hives for about a month already/ hives in his ankles./ he has hives in his chest and in the back.; "reddish patches, pretty good size, about a couple of inches, kinda flat, spots, and they are itchy."; non-severe allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumeror other non HCP) from medical information team. The reporter is the patient.   An 82 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Unknown manufacturer, Primary Immunization completed), for Covid-19 Immunization, reaction(s): "did not experience any side effects"; Covid-19 vaccine (Dose: 2, Unknown manufacturer, Primary Immunization completed), for COVID-19 Immunization, reaction(s): "did not experience any side effects". The following information was reported: PRURITUS(Medically Significant), outcome "unknown", described as "itching"; RASH(non-serious), outcome "unknown", described as "developed rash/ He said that he has rashes in his ankles."; URTICARIA(non-serious), outcome "unknown", described as "and hives for about a month already/ hives in his ankles./ he has hives in his chest and in the back."; RASH ERYTHEMATOUS(non-serious), outcome "unknown", described as "reddish patches, pretty good size, about a couple of inches, kinda flat, spots, and they are itchy."; HYPERSENSITIVITY(non-serious), outcome "unknown", described as "non-severe allergic reaction ". Therapeutic measures were taken as a result of pruritus. The case was reported as non-serious. Caller stated that he already received the first two doses of the vaccine and did not experience any side effects. He said that when he received the booster dose, he developed rash and hives for about a month already. He said that he has rashes and hives in his ankles. He also stated that he has hives in his chest and in the back. He described the rash and hives as "reddish patches, pretty good size, about a couple of inches, kinda flat, spots, and they are itchy." He was also aware that rashes and hives are signs non-severe allergic reaction from the vaccine. He mentioned that his daughter gave him ketoconazole and hydrocortisonefor the itching which helped a little.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient had faint feeling, chills, temperature normal, blood pressure 164/90 pulse 60. Chief complaint was unusual taste and numbness of lips. Symptoms improved over 30-45 min period
Patient reported pain and decreased range of motion in the left arm and shoulder that started the morning after the vaccination was administered, and has continued for 3 to 4 weeks.  Patient was seen by her primary care physician last week, who stated that she has a SIRVA.  Patient stated that physician only did a physical exam, and did not perform any ultrasounds or scans of any kind to confirm.  Patient states that range of motion and pain in the arm/shoulder area has improved slightly over the past few days.
now it's faded, it's not red but more pink and the inflammation has got down a little but the arm is; inflammation and redness on the injection arm that circles the lump and then radiated more; inflammation and redness on the injection arm that circles the lump and then radiated more; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 01-Feb-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE INFLAMMATION (inflammation and redness on the injection arm that circles the lump and then radiated more), INJECTION SITE ERYTHEMA (inflammation and redness on the injection arm that circles the lump and then radiated more) and LIMB DISCOMFORT (now it's faded, it's not red but more pink and the inflammation has got down a little but the arm is) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History) since an unknown date.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (inflammation and redness on the injection arm that circles the lump and then radiated more) and INJECTION SITE ERYTHEMA (inflammation and redness on the injection arm that circles the lump and then radiated more). On 01-Feb-2021, the patient experienced LIMB DISCOMFORT (now it's faded, it's not red but more pink and the inflammation has got down a little but the arm is). On 31-Jan-2021, INJECTION SITE INFLAMMATION (inflammation and redness on the injection arm that circles the lump and then radiated more) and INJECTION SITE ERYTHEMA (inflammation and redness on the injection arm that circles the lump and then radiated more) was resolving. At the time of the report, LIMB DISCOMFORT (now it's faded, it's not red but more pink and the inflammation has got down a little but the arm is) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Information has been received from a Billing Coordinator concerning a her niece who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported). Subsequently on an unspecified date the patient developed tongue ulcers and fever. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, healthcare provider name and contact information. No further information is available.
On 9/26/08 spoke with patient's mom and she denies any adverse effects.
Slight soreness at injection site.   Lasted about 48 hours.  No treatment.  not significant enough to limit my activity.
The first thing that happened was immediate feeling of neck ache. I could actually feel the vaccine travel up to my neck. The neck stiffness and ache still remains. On day 2, I had body aches, chills, flu like nausea and a low grade fever. The body aches and chills resolved within a day, however the fever and flu like symptoms did not. In addition, I have had lethargy and tiredness (but with problems sleeping ). These symptoms have persisted since March 12th. Dr. ran lab tests that all came back normal. There has been no specific treatment.
Initial and follow up information has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history, drug reactions and allergies of the patients were not reported. On unknown dates, the unspecified patients received improperly stored doses of GARDASIL 9, lot # L011846, expiration date 16-JUN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Ataxia, vesicular rash with erythematous base on trunk, legs and arms. Treated with Acyclovir and 1 dose VZIG.  Nurse follow up on 08/24/04 states: "vaccine reaction."
Patient stated she was feeling tightness with itchy throat. STAT RN was called and RN took over patient. Patient cohearnet and able to verbalzie symptoms. agreed to go to UC.
4/19/12 Gardasil shot 4/25/12 Swollen glands in back of neck 4/27/12 Saw doctor. Started 1000 mg Amoxicillin 2x's a day 5/01/12 Extreme fatigue, body aches, soe throat, face rash. High Liver count. Started on prednisolone 5/03/12 Severe headaches 5/05/12 Numbness and tingling in right arm. 5/06/12 Numbness and tingling in both arms. 5/08/12 Numbness and tingling in left leg. Sharp shootng head pains, Right hand weak. Swollen glands gone. 5/11/12 All numbness and tingling gone. Left arm and left leg (knee) weak. No grip in left han. 6/01/12 Still has body aches in feet, ankel, fingers, knees, wrists, fingers, legs and back. Left knee still weak, let hand still weak. Still getting shootng pains in head. By mid afternoon extreme fatigue sets in. Still get bad headaches from pressure on back of head when resting head back. 6/06/12 Started Physical Therapy for headaches. Still having shooting hed pains and headaches. Left hand and knee still weak and ache. Left wrist and elbow aches and throbs. Occasional ear pain. Lower back pain. Overall body aches. Complains of arms and legs tingling when she wakes up in the morning.
pt recv vax & exp severe pain in arm (not stated which arm);MD said would go away in a few days;pain was described as stomach wrenching & cont;had limited ROM;about 1mo later still exp pain & returned to MD;
MRN: 7049276; DOB: 5/9/1952; dose #1: 3/23/21 Lot # EN6208 ? LD site; dose #2: 4/13/21 Lot # ER8732 ? LD site; Patient had a history of chronic back pain.  She recently underwent spine stimulator placement.  She presented to the emergency room with some nonspecific complaints to include fatigue, myalgias, and some increasing confusions from baseline per her family.  She got a second dose of the COVID-19 vaccine on 4/13 and following day, she had been feeling poorly.
Swelling under left armpit (in the vicinity of lymph nodes) Chills Night Sweats Congestion Headache Mild cough Fatigue Tiredness
asked if it will get rid of his tumor; This is a spontaneous report from a non-contactable consumer (patient himself) report from a Pfizer-sponsored program.  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date, NDC number was not reported), dose 1 via an unspecified route of administration on an unspecified date May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of the Pfizer COVID vaccine about 5 months ago. He has not received 2nd dose and not sure what to do and said something about it is not for the COVID and asked if it will get rid of his tumor on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician and the consumer for the Pregnancy Registry for Gardasil concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on 20-MAR-2007 was vaccinated with first dose of Gardasil (lot number unknown) 0.5 mL injection. Concomitant therapy included vitamins (unspecified). The patient found out that she became pregnant on 25-MAR-2007. The patient sought medical attention. No ill effects were reported at this time. the estimated date of delivery is 30-DEC-2007. No further details were provided. Additional information has been requested.
Initial report received on 01 July 2009 from a health care professional.  A 47 year old female patient received ADACEL (lot number C3066), MENACTRA (U2915AA) both intramuscularly in the right deltoid, and RECOMBIVAX (lot number 0438Y) intramuscularly in the left deltoid on 26 June 2009 at 09:00 PM.  Post vaccination, the patient developed a lump at the injection site, specific arm was not specified.  The lump persisted at the time of the report.  No further information was provided.  Follow up information received on 17 July 2009 from a health care professional who reported that the number of previous doses of vaccine were unknown.  The patient experienced a lump at the right deltoid on 13 July 2009.  The patient had improved by the time she was seen in the health center.  The patient did not receive treatment.  No further information was provided.  Follow up information received on 24 July 2009 from a health care professional who stated that the patient was seen for a visit in the health center on 20 July 2009.  At the time of the visit, her condition was improved.  The patient did not return for further follow up.  No further information was provided.  List of Documents held by Sender:  none.
01/13/2022-01/17/2022 Same thing and recommended capsule study done as outpatient. GI Bleed 02/02/2021 emergency room 2 unit of blood hemoglobin dropped below 5. Diagnostic could find source of bleeding Colonoscopy, Endoscopy upper GI, CT scan and MRI.
Information has been received from a licensed practical nurse concerning a 12 year old female with no known drug allergies or medical history who on 03-AUG-2007 was vaccinated with her first dose of Gardasil.  On 07-SEP-2007, the patient was vaccinated with her second dose of Gardasil, intramuscularly in the left arm (Lot#657868/0523U).  There was no concomitant medication.  On 07-SEP-2007 the patient experienced an itchy arm.  The itchiness was located on the same arm as the vaccination but not at the injection site.  The area that was itchy had no visible signs and was not raised or red.  The itchiness resolved before the patient left the office.  Additional information has been requested.
Pt. states (L) arm started hurting immediately following injection. States certain positions are very painful. Hurts to lift (L) arm up. All pain is in (L) shoulder area. No visible external redness or swelling.
my tongue started burning and I developed thrush symptoms. On the tongue only.; my tongue started burning and I developed thrush symptoms. On the tongue only.; This is a spontaneous report from a contactable healthcare professional.  A 53-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the left arm on 23Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "on 24Dec2020, my tongue started burning and I developed thrush symptoms. On the tongue only".  The patient received no treatment. The outcome of recovered with sequelae.   Information about lot/batch number has been requested.