chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes outbreak after receiving second dose; This spontaneous case was reported by a physician and describes the occurrence of HERPES VIRUS INFECTION (herpes outbreak after receiving second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (herpes outbreak after receiving second dose). At the time of the report, HERPES VIRUS INFECTION (herpes outbreak after receiving second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported. The reporter called to ask if patient can take antiviral medication due to herpes outbreak after receiving second dose of Moderna vaccine 5 days ago.
The evening of February 4, 2023, I started to have abdominal pain. It proceeded to diarrhea. Within two hours, it turned into bloody diarrhea. On February 5, 2023, it was just blood which caused me to seek immediate care by the night of February 6, 2023. I was prescribed FLAGYL. I was told to take it every 8 hours for 10 days. In addition to that, I was given CIPRO 500mg and was told to take one tablet every 5 hours for 10 days. The diagnosis was Colitis with Rectal Bleeding. I have finished treatment, but I'm still experiencing irritable bowel and diarrhea. I am supposed to follow-up with my GI doctor.
This spontaneous case reported by a consumer, describes the occurrence of fatigue (very tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 024M20A) for COVID-19 vaccination. Concomitant products included lisinopril for hypertension. On Feb 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 15, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced fatigue (very tired). At the time of the report, fatigue (very tired) outcome: unknown. Action taken with mRNA-1273 in response to the event: not applicable. Treatment information not provided. This case linked to MOD-2021-049728, MOD-2021-049728 (patient link).
CHILD SEEN 05/03/2019 FEVER X2 DAYS AFTER VACCINE ADMINISTRATION 4/29/1/2019 T-max - 102.3, RIGHT LEG PAIN, RED RASH ON PT'S CHEST AND ABDOMEN AND RASH HAD SPREAD TO FACE, NECK, ARMS AND LEGS
Coughing, sometimes uncontrollable, like a bronchitis cough, watery eyes, feeling warmer, maybe mild fever
Arthritis flared up in right and left hand after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis flared up in right and left hand after the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007BZIA and 022M20A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis.On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis flared up in right and left hand after the 2nd dose). At the time of the report, ARTHRITIS (Arthritis flared up in right and left hand after the 2nd dose) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant information was not provided.It was reported that patient's arthritis flared up right and left hand. Also sated that index finger and thumb of the patient had swollen a  little.Treatment information was not provided. This case was linked to MOD-2021-386282 (Patient Link). Sender's Comments: This case concerns a male patient of an unknown age, with a history of arthritis, who experienced the unexpected non-serious AESI of ARTHRITIS. The event occurred on an unknown date after the second dose mRNA-1273. The rechallenge was not applicable as the outcome of the event is unknown. The history of arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Hives to trunk, arms, groin face neck and lip area began 11 days post vaccine.  Treatment include Benadryl with no improvement.
Muscle aches, headache, chills, very tired, painful injection site(both doses)
Severe body aches, fever, intractable pain. Pt presented to clinic approximately 24 hours after shot. Sent to ER.
Mouth ulcers & minor gum bleeding. It happened after the first dose as well / ulcers appeared after the second dose and they went away faster; however one has come up again, 2 weeks later; Mouth ulcers & minor gum bleeding. It happened after the first dose as well; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration on 21Apr2021 at 11:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included common variable immunodeficiency (CVID) - hypogammaglobulinemia. The patient was allergic to fluoroquinolone antibiotics. 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 vaccination. The patient received unspecified concomitant medication within two weeks of vaccination. On 22Apr2021 at 12:00, the patient experienced mouth ulcers and minor gum bleeding. On an unknown date, the events happened after the first dose as well. She took ZICAM tablets when the ulcers appeared after the second dose and they went away faster, however one had come up again, 2 weeks later. Therapeutic measures were taken as a result of the events which included treatment with piroxicam (ZICAM) tablets. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mouth ulcers and minor gum bleeding which happened after the first dose as well and ulcers appeared after the second dose and they went away faster, however one had come up again, 2 weeks later 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.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with allergy to penicillin and Cephalosporin's and who on 26-NOV-2013, was vaccinated with a dose of ZOSTAVAX (lot # J0083808) (dose and route not reported). Concomitant therapies included Losartan potassium (manufacturer unknown), Coumadin, Hydrochlorothiazide (manufacturer unknown), Simvastatin (manufacturer unknown) and Amlodipine. The pharmacist reported that on 05-DEC-2013, the patient developed an itchy rash on her face and stomach following the administration of ZOSTAVAX. Prednisone and Benadryl were given as a treatment for the experience. No lab diagnostic studies were performed. At the time of the report, the patient was recovering. The relatedness for itchy rash on face and stomach and ZOSTAVAX was unknown. Additional information has been requested.
After administering the vaccine to the patient, I realized that I gave her an expired vaccine dose. (over 24 hours old). The pt did not experience or complain of any adverse side effect or reactions during the 15 minute waiting period after giving her the vaccine. Pt was discharged home in good condition. This event was reported to my supervisor and a report was made.
Pain whole upper arm and shoulder. No redness or swelling. 11/11/2015 and 11/12/2015 - can not lift arm or move in certain positions - EXTREME pain. Made appointment with orthopedic specialist.
Suspected vaccination failure; Now I have "after shingles" / I got two shots of the shingle vaccine; I have the pain but no blisters / still have the pain; This case was reported by a consumer via and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (when the patient was little) and measles (twice).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient had chicken pox when the patient was little. The patient also had measles twice. The patient got two shots of the shingle vaccine and  experienced shingles and had pain but no blisters.  At the time of reporting the patient still had the pain. The patient advised to get the shingle vaccine.  This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not provided.
Aching body; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 23Feb2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Feb2021, the patient experienced aching body. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event aching body was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacy technician concerning a male pt who was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). Subsequently the pt experienced a local site reaction post vaccination. The pt called the office on approximately 10/12/05 to report a red, raised, warm area at the injection site, and feeling of fatigue. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Temperature of 103 within hours post vax, lasting 24 hours on and off. Numerous breakouts/rash over entire body, crying, sleeplessness. Rash lasting well over a week.
Strange taste in mouth at time of injection  Pain and swelling in arm  Stiff neck Nausea Headache  Ringing in ears Very tired Nausea  Diarrhea
Tiredness; Soreness in arm; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 03May2021 at 17:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient previously received no medication. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021, the patient experienced tiredness and soreness in arm. The clinical outcome of the events tiredness and soreness in arm was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
PATIENT CALLED TO SAY THAT HE HAD AN ADVERSE EFFECT TO FLU SHOT. I ASKED PATIENT TO COME TO SHOW ME. HE SAID THAT HE COULD NOT DRESS OR MOVE HIS ARM. HIS ARM WAS NOT RED, NO RAISED BUMP AND PATIENT WAS ABLE TO PUT ARM BEHIND HIS BACK AND RAISE AND LOWER HIS ARM. I THANKED HIM AND TOLD HIM TO CONTINUE TO USE HIS ARM AND IF NO BETTER IN A COUPLE OF DAYS TO SEE HIS PHYSICIAN.
pt recv vax 6MAR97 & 6APR97 pt devel a fine, gen rash over body & a fever;8APR97 pt presented to MD who dx rash as roseola;
Early onset menopause. I had reg FSH levels and regular menstrual cycles up until I received my second dose of Moderna, the following month,  may 2021,  I missed my period for the first time in my life besides pregnancy. My FHS was tested at 1.6 mIU/ml and a year later, after shot  on 8/25/21 was 71 mIU/ml. I had breakthrough bleeding once, but have since then not had a period since 7/27/22. I want to mention I was regular prior to shot, had a baby naturally 6 years prior.
Felt slight headache, sensation of chest burning. Palpitations. Vitals wnl.
This spontaneous report as received from a nurse practitioner refers to a 21 year old female patient. In approximately 2005, at approximately 14 years of age, the patient was vaccinated with the complete series of GARDASIL (route and lot # not reported). The nurse reported that on 01-MAR-2013, the patient had abnormal PAP smear test. The patient underwent a colposcopy with a negative result. The patient did not seek medical attention. The outcome of abnormal PAP smear test was unknown. Additional information has been requested.
This spontaneous report was received from a from a registered nurse who reported that four unspecified patients received improperly stored GARDASIL 9 (lot# M007764, expiration date 30-JAN-2018) on 21-SEP-2016 and one unspecified patient received improperly stored GARDASIL 9 (lot# M007764, expiration date 30-JAN-2018) on 14-OCT-2016. No adverse effects were reported. No further information was provided. Follow up information has been received on 05-JAN-2017. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: , MERCK 1610USA010829:Mfr number.
Seen at ER 8/27/2012 due to hand laceration received Tdap. Days following had increased BP, and change in personality. Last tetanus x 8-10 yr ago without incident states arm did not "get sore" like all other times.
pt recvd vax & 1 month later had antibody titers drawn; pt had adequate titers to tetanus & pneumococcus but not diphtheria;
No adverse event; drug exposure during pregnancy; inadvertently gave an expired dose to a patient on 13Feb2023; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy), EXPIRED PRODUCT ADMINISTERED (inadvertently gave an expired dose to a patient on 13Feb2023) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 052C22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Feb-2023, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and EXPIRED PRODUCT ADMINISTERED (inadvertently gave an expired dose to a patient on 13Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 13-Feb-2023, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently gave an expired dose to a patient on 13Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and EXPIRED PRODUCT ADMINISTERED (inadvertently gave an expired dose to a patient on 13Feb2023).    No concomitant and treatment medications were reported.  Individual vial size reported as 5.5 mL   Vial was refrigerated on 13-feb-2023.  Vial did not undergo any temperature excursions.  Company comment: This spontaneous case concerns a pregnant woman of unknown age with no relevant medical history reported, who experienced unexpected non-serious event of Maternal exposure during pregnancy(drug exposure during pregnancy) with no adverse event that occurred in the context of first dose of mRNA-1273 vaccine in COVID-19 vaccination series. Additionally, Expired product administered was also reported as a non-serious event. It was reported that, inadvertently expired dose was administered( Dose administered after 30-day Use By Date or after manufacturer date of expiry). No further information regarding patient's medical history, menstrual history , obstetric history, last menstrual period, estimated date of delivery, outcome of pregnancy, relevant imaging studies were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
2 wks p/flu shot onset of progressive ascending motor weakness-GBS; resulting in quadreparesis;
MEDI-0003805 is not serious spontaneous case from a consumer involving sore throat. The reporter causality is not provided to FluMist. An office manager in a physician's office reported that a 33 year old female and 3 other office staff experienced headache and sore throat 2 days after receiving FluMist vaccine on 26Oct05. The patient recovered. The reporter causality is not provided. Follow up - Patient's  DOB received.
ACHY; SWEATING; ARM PAIN; CHILLS; HEADACHE; This spontaneous report received from a parent concerned a 20 year old male. 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) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced achy. On 2021, the subject experienced sweating. On 2021, the subject experienced arm pain. On 2021, the subject experienced chills. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, achy, arm pain, headache and sweating was not reported. This report was non-serious.
Proquad vaccine was expired when administered, expiration date of 02/16/22. Pt reported no signs or symptoms.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
did twice after vaccine/Suspected vaccination failure; did twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient received shingles vaccine got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. The patients contact details were not provided hence follow up not possible.
Swollen tongue; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced SWOLLEN TONGUE (Swollen tongue). At the time of the report, SWOLLEN TONGUE (Swollen tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided. Treatment information included Benadryl.
Fever; nauseous; dizziness; sinus issues; fatigue; bit of cough; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (nauseous), DIZZINESS (dizziness), SINUS DISORDER (sinus issues) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (Fever), NAUSEA (nauseous), DIZZINESS (dizziness), SINUS DISORDER (sinus issues), FATIGUE (fatigue) and COUGH (bit of cough). At the time of the report, PYREXIA (Fever), NAUSEA (nauseous), DIZZINESS (dizziness), SINUS DISORDER (sinus issues), FATIGUE (fatigue) and COUGH (bit of cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to -MODERNATX, INC.-MOD-2021-074542 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-074542:1st dose
1st 5 days pt was pale white, not responsive, limp; 6th day sz began eyes twitching, drooling, tight fists, heavy & loud (snoring sound) breathing, stiff neck, staring spells
Pt is a 5 1/2 yo male with Mowat-Wilson Syndrome. He has an underlying seizure d/o but no seizure for about 1 month. Had a typical seizure about 12 hours after vaccine. Got rectal DIASTAT at home.
BOOSTER SHOT WAS GIVEN TO PATIENT ONE MONTH EARLY  (2ND DOSE WAS 5/25/21-BOOSTER SHOULD HAVE BEEN GIVEN 11/25/21.