chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with asthma, infection, nausea and oppositional defiant disorder (ODD).  On an unspecified date the patient was vaccinated with the first dose of GARDASIL (lot number unknown).  Follow up information was received.  The nurse practitioner reported that on 11-MAY-2007 the patient received her second dose of GARDASIL (lot# 653736/0014U) and then became pregnant.  The date of the last menstrual period was approximately 20-APR-2007.  Concomitant therapy included XOPENEX, ZITHROMAX and PENERGAN TABLETS/SUPPOSITORIES.  There was no adverse event reported.  Medical attention was sought.  On 15-JUN-2007 the patient had an ultrasound that revealed 8 weeks on date.  Additional information was not provided.  The estimated date of delivery is 25-JAN-2008.  Follow-up information was received from a nurse practitioner.  The NP reported that on 22-JAN-2008 the patient had a healthy baby boy weighing 7 pounds 13 ounces and 39 3/7 weeks from LMP.  The patient had a primary c-section for failure to descend.  The patient also had anaemia during pregnancy.  Other medications used during the pregnancy included CLARITIN for allergies, ZOFRAN for hyperemesis and ferrous sulfate for anaemia.  Upon internal review primary c-section for (failure to descend) was considered to be an other medical event.  Additional information is not expected.
I had some injection site soreness. I had a lot of other health symptoms going on too but don't think any other the other symptoms related to the vaccine. That injection site soreness lasted a day. persisted for about a day.
Patient received flu shot on 11/24, came in 11/25 presenting w/ swollen, red and hot to touch left arm from elbow joint to approximately 4 inches up on arm. Advised to take ALEVE (she had at home) and BENADRYL, ice packs.
10-8-09 - slight redness at inj site. Dizziness x 2 hr. Contact MD - Advised keep watch & come to MD office if problems continue 10-9-09 - inj site more red, well defined with edema 3" diam. slight itchy, hot, sore.
Breakthrough case admission after 5 vaccines Pfizer 1/21/21 lot# EL3248;  Pfizer 2/11/21 lot# EL9265;  Pfizer 10/12/21 lot# PAA173697;  Pfizer 4/29/22 lot# FM9992;  Pfizer 9/23/22 lot# GJ5342
Information has been received from a certified nurse practitioner concerning a female who on an unspecified date was vaccinated with first dose of GARDASIL (dose, route and lot number not reported). The certified nurse practitioner reported that the patient developed a nodule on her neck after receiving vaccination with GARDASIL. The reporter verified that the patient did not receive the vaccine at her office and for this reason she cannot provide any patient details concerning this event. The patient sought medical attention by contacting the nurse practitioner. Additional information has been requested.
Physician of pt called to report that pt came in on 08/29/2001 to her office with left deltoid swollen, erythematous and complaint of itching. No report of pain or fever. Placed on steroid cream. Child returned to doctor office on 08/31/2001 with resolution.
Runny nose; Dry cough; This spontaneous case was reported by an other health care professional and describes the occurrence of RHINORRHOEA (Runny nose) and COUGH (Dry cough) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and COUGH (Dry cough). At the time of the report, RHINORRHOEA (Runny nose) and COUGH (Dry cough) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
extreme dizziness, nausea and vomiting for 9 hours fast heartbeat, palpitations for 9 hours overlapping headache
heart racing and palpitations; palpitations; This spontaneous case was reported by a health care professional and describes the occurrence of PALPITATIONS (heart racing and palpitations) and PALPITATIONS (palpitations) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included GLIPIZIDE for Diabetes, NEBIVOLOL for Hypertension.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PALPITATIONS (heart racing and palpitations) and PALPITATIONS (palpitations). At the time of the report, PALPITATIONS (heart racing and palpitations) and PALPITATIONS (palpitations) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood pressure measurement: 135/80, mmHg abnormal, 150/80 mmHg abnormal and 136/86 mmHg abnormal. On 11-Feb-2021, Heart rate: 75 beats/ second (normal) Normal, 71 beats/ second (normal) Normal and 64 beats/ second (normal) Normal. On 11-Feb-2021, Oxygen saturation: 97 % (normal) Normal, 96 % (normal) Normal and 96 % (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication reported
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case is linked to case 2019SA297927, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 60 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   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.
Patient is a 72 year old man with history of COPD and chronic hypoxic respiratory failure requiring 3L of oxygen at baseline, as well as chronic steroids. He initially presented to the ER on 2/18 with worsening shortness of breath and was diagnosed with COVID. He was not requiring any more oxygen than his baseline.  He was treated with steroids and updrafts and was discharged with a prescription for azithromycin.  He returned on 2/20 feeling worse, and at that time was also told to increase his prednisone from 10 mg daily to 40 mg daily.  He returns again today with progressive shortness of breath that he feels is not any better.  He has a mild cough.  He is afebrile.  He continues to require his baseline 3L  3L of oxygen, but does not feel that he can continue to manage at home due to his dyspnea.  He was given 125 mg of solumedrol in the ER as well as Duonebs and admission has been requested.  2/27/2022 discharged: Discharge delay due to personal transport. Patient given education regarding medications, route, dose, purpose, and side effects. Patient also given info on follow up dates and when to call the healthcare provider. Patient has no questions or concerns at this time. Patient to be discharged to private vehicle driven by wife. Peripheral line discontinued prior to discharge. Transport took patient to main entrance in wheelchair with home oxygen.
Initial and follow up information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a 24 year old female with no known drug allergies, no pertinent medical history, who on 30-MAY-2007 was vaccinated with the first dose of GARDASIL (lot # 657736/0389U) 0.5ml intramuscular left deltoid.  It was reported the patient was vaccinated while she was pregnant (last menstrual period 09-MAY-2007).  Concomitant therapy included pre natal vitamins (unspecified).  On 13-MAR-2008 the patient required a C-section due to 'non reassuring fetal heart tone" and "arrested dilation at 5-6 cm".  The infant was a male; birth weight was 7# 4 oz, Apgars 8-9, no problems.  "On 16-JUL-2008, the patient was dating 6 Nl d."  No other adverse events were reported.  Upon internal review, non reassuring fetal heart tone and arrested dilation at 5-6cm that required a C-section were considered to be other important medical events.  This is one of several reports by the same source.  Additional information has been requested.
ARM SORENESS; This spontaneous report received from a consumer concerned a 54 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness. This report was non-serious.
started developing urticaria, which is now chronic 9 months later; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (started developing urticaria, which is now chronic 9 months later) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (started developing urticaria, which is now chronic 9 months later). At the time of the report, URTICARIA (started developing urticaria, which is now chronic 9 months later) had not resolved.            No concomitant medication were reported.  Shortly after receiving the vaccine patient started developing urticaria, which is now chronic 9 months later.  Patient's dermatologist suspects this as a side effect to the vaccine given that it started shortly after receiving the third dose (she has seen this in other patients as well) No treatment information was provided by the reporter.
Narrative:  Patient experienced fever, muscle pain, headache, and chills. A message was sent to the patient's PCP for follow-up regarding his symptoms.
became violently sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (became violently sick) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (became violently sick). At the time of the report, ILLNESS (became violently sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
This case was reported by a consumer and described the occurrence of injection site soreness in a 15-year-old male subject who was vaccinated with HEPATITIS B. A physician or other health care professional has not verified this report. The subject's medical history included PENICILLIN ALLERGY. Previous vaccinations included a completed HEPATITIS B series; manufacturer (unspecified; given in 1997). Concurrent vaccinations given on 12 May 2008 included POLIOMYELITIS vaccine booster dose; manufacturer unspecified. On the afternoon of 12 May 2008, the subject received an unspecified dose of HEPATITIS B vaccine (unknown, right arm). Within one day after vaccination with HEPATITIS B vaccine, the subject experienced injection site soreness. The subject's mother reported that her son inadvertently received an extra dose of HEPITITIS B vaccine on 12 May 2008, even though he had already received a complete HEPITITIS B vaccination series in 1997. The reporter was unsure of the HEPITITIS B vaccine was manufactured by GlaxoSmithKline or Merck. At the time of reporting, the outcome of the events was unspecified.
arm hurting; allergic reaction; tired; a little bit of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting), HYPERSENSITIVITY (allergic reaction), FATIGUE (tired) and FATIGUE (a little bit of fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (arm hurting), HYPERSENSITIVITY (allergic reaction), FATIGUE (tired) and FATIGUE (a little bit of fatigue). At the time of the report, PAIN IN EXTREMITY (arm hurting), HYPERSENSITIVITY (allergic reaction), FATIGUE (tired) and FATIGUE (a little bit of fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information were not provided by the reporter. Treinformation were not provided by the reporter.
Flu shot 10/18..unsure of exact date..Rcvd flu shot  Immediately after flu shot had pain and then begin having other symptoms such as muscle spasms decreased range of motion and pain in my arm.
Mild nausea  (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10  minutes after injection.  Muscle soreness at injection site beginning in the evening.
IS IT NORMAL TO HAVE A HEADACHE FOR OVER 4 DAYS; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (IS IT NORMAL TO HAVE A HEADACHE FOR OVER 4 DAYS) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (IS IT NORMAL TO HAVE A HEADACHE FOR OVER 4 DAYS). At the time of the report, HEADACHE (IS IT NORMAL TO HAVE A HEADACHE FOR OVER 4 DAYS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
21AUG97 8 & 9th days p/vax pt had fever 100;24AUG97 11th day p/vax vax pt rested poorly & had some itch;broke out w/rash & has red raised rash trunk, solid red & raised under eyes;
A report has been received from a Physician concerning a 7 year old, male patient, who had been receiving Nasal FLUMIST (Intranasal), 0.2 Millilitres, Once/Single administration for VACCINATION. FLUMIST (Intranasal) started on an unknown date for vaccination. The patient experienced 102.1 fever. FLUMIST (Intranasal) was continued. The outcome of the event of 102.1 fever was unknown. The report was considered to be non-serious.
Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 months old male patient who was inadvertently vaccinated with an expired dose of PENTACEL lot C5389AA (frequency once) via unknown route in the left thigh on 31-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It is an actual medication error case due to expired vaccine used. It was reported that the patient had PENTACEL that is 14 days after the expiration of product. It was unknown whether the patient had any harm or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Swelling itchy eye after vaccine; itchy eye after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swelling itchy eye after vaccine) and EYE PRURITUS (itchy eye after vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Swelling itchy eye after vaccine) and EYE PRURITUS (itchy eye after vaccine). At the time of the report, EYE SWELLING (Swelling itchy eye after vaccine) and EYE PRURITUS (itchy eye after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Overnight 1/8 /21 developed mild right lower quadrant pain, did not change with NSAIDs or acetaminophen. Given location, went to ER for evaluation and diagnosed with acute appendicitis. Underwent laparoscopic appendectomy 1/9/21.
Approx 1 hr post-vax, began to cry, @ times very loud & different than I've ever heard, fever 102; crying would periodically cease but incident lasted 4 days; APAP used;
Extreme headache (like vertigo without the spinning), vomiting, and diarrhea.
Arm became swollen, hard, hot, bright red, painful to touch for 5 days.  It is still pink a week later. Didn?t happen with shot one.  But not sore like the first shot.  It was definitely a long lastly adverse reaction of some kind.  It was miserable.
Reddened slightly warm some tenderness-no fever. Advised mom to give Benadryl as needed for itching/swelling, Tylenol for fever.
About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red  rash across my chest up to my neck and under both breasts.  All symptoms but the rash improved the following day. I went to have my 8 week pregnancy US 6 days after this second vaccine dose and there was no fetal heart rate. The baby measured 8.7mm and there should be a heart rate  when the baby measures >7mm. I had all of my pregnancy symptoms up through the day of the vaccine and then they disappeared the day my vaccine symptoms improved. I do not have a history of miscarriage.
I woke up Friday morning the 8th I felt a bump under my arm and called my urgent care, no one could give me info.  The bump was hurting me so I went to my Dr and she sent me to get a mammogram which came out normal and you could see the bump ultrasound. I still feel it deep inside my arm but it is not as big as it was before. Dr did not prescribe anything, they wanted it to go down on it's own
2nd booster 4/18/2022 COVID  7/5/2022 (breakthrough)
On 3/2 pneumonia vaccine was given in left arm. Pt on Tuesday 3/3 am, hurt on Tuesday pm, the arm swollen and red, warm to touch and was feverish on Tuesday night this am pulse at 92 just sitting. MD March 5, 2009 11:05 AM. The patient is here today for redness in the arm in which she received her pneumococcal vaccine 3 days ago. The patient received a vaccination on Monday and by Tuesday afternoon she started noticing some soreness then she noticed redness that has increased. Patient has not noticed any purulent drainage, she's felt warm but has not had any measurable temperature.
Redness where the injection site happened. The redness was a large patch on patient's arm. I counseled the patient to inform her doctor as well and to take some benadryl to help with some of the adverse reaction symptoms.
Soreness and heavy feeling in the arm of injection site. Pins and needles feeling at times. Head felt heavy and mind felt cloudy. Slight dizzy feeling and loss of balance. Cold water had a burning/stinging sensation on my skin. Issues with temperature in general - hot water was either too hot to the touch or too cold - never warm enough. Slight fatigue.
15 min after the shot, I filled tingling (pins and needles) on my eye, then it happened random everywhere , from Face, head, hands back, legs, both sides of the body, it is 27 hours after the shot and still happening.
Patient experienced headache, trouble breathing, pain throughout the body, swollen tongue, red and painful eyes. Patient took ADVIL around 4 pm that same day.
I had large, raised "HIVE" looking. looked like a spider bite. very large on legs and arms and hands. after a week, legs still had signs of "HIVE" lasted about a week.
Case previously recorded as MA2009-4224. Initial case report received from a nurse, via Novartis Medical Communication on 11 NOV 2009. The patient under 4 year-old was vaccinated with 0.25 ml of FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009, an off-label indication. No adverse event was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Vaccination in children younger than 4 year-old is an off-label use and unexpected for FLUVIRIN. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008010.