chrisvoncsefalvay/vaers-outcomes huggingface dataset:
04/05/2022 I started having achy legs mostly my calves, between my hip and knee and stiffness walking. my calves . I went to Dr. and was tested for CK levels.  My levels were at about 1000 and normal range is 200. I had an older prescription of Celebrex that I started taking. At that time there was no treatment and was told that they would keep monitoring the leg pain.  I was referred to a Rheumatologist, MD for ongoing symptoms as my condition was not improving, I have been tested every three months since onset of symptoms. My Internist suggested that I lower my BMI as he suspects a fatty liver may be causing the high CK levels. I also saw a Cardiologist and ruled out any cardiac conditions. My condition has improved slightly but still feel stiffness in my legs at walking. .
3-1/2 inch red circle 2 inches below the injection site; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE ERYTHEMA (3-1/2 inch red circle 2 inches below the injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (3-1/2 inch red circle 2 inches below the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (3-1/2 inch red circle 2 inches below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
I had gotten an ultra sound at 9 weeks the baby looked great with a healthy heartbeat, when I had gotten anther ultrasound it showed the baby stopped growing at 9 weeks and 5 days with no heartbeat. Which would have been 2 days prior to recieving the H1N1 vaccine. I am having a D&C done due to the miscarriage. 12/1/09 Medical records received for date 10/27/09 11/27/09. OB records indicate 2 OB OV, no complications noted.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), on 21Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VAGIFEM; METROGEL; CALCIUM; VITAMIN D3; BIOTIN; CHROMIUM PICOLINATE; TURMERIC [CURCUMA LONGA]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) Positive; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks: Vagifem, Metrogel, Calcium, Vitamin D3, Biotin, Chromium Picolinate and Turmeric. Patient had no known allergies. Patient received Paxlovid (anti-viral) from 18Jul2022 to 23Jul2022 for COVID-19 treatment. On 27Jul2022 tested positive for COVID again. The next day developed a runny nose. Patient did not receive treatment for AE but recovering from the symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates since 09-NOV-2015, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L017138 with exp. 13-AUG-2016, (dose and route were not provided). No adverse effects were reported. The temperature excursion was 13.89F, during 65 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Pt states since she got the Covid booster, she began to have a rash that spreads from one area to another. It's so itchy she scratches herself raw. She hasn't changed detergents and even rewashed all clothes. She uses All Sensitive Skin Laundary detergent which she has used since her son was born. No new foods or other products. One day on the back the next on the leg and another on the arm or breast area. On exam she has excoriations on the the breasts. There is an eczematous type reddish rash on both upper breast areas
BLOOD CLOT IN THE HEART; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified origin. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in the heart, as per reporter "Meanwhile we have become your lab rats. I have already lost a relative to your experimental gene therapy. A blood clot in the heart. All my other unvaccinated relatives who got Covid are alive and well today. This is like playing roulette with a needle. Because they are using this experimental gene therapy on the public now to vacinnate for Covid. The problem is it has harming people with heart conditions and killing them. My relative died recently from a blood clot in the heart after being vaccinated. They do not know the harmful side effects or are not releasing it. They already said they will not release the data they have on this for 75 years. Why? What are they afraid of?". It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of blood clot in the heart on an unspecified date. This report was serious (Death). This case is a duplicate of 20211260756.; Sender's Comments: V0: 20211261187- covid-19 vaccine ad26.cov2.s -blood clot in the heart. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: BLOOD CLOT IN THE HEART
No reaction other than left arm pain with the first 4 shots.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Aug2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "HIV Positive" (unspecified if ongoing); "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Known allergies: (Augmentin)", notes: Known allergies: Augmentin. Vaccination history included: BNT162b2 (Dose 2, single, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "Left arm pain"; BNT162b2 (Dose 1, single, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "Left arm pain". The patient had COVID prior vaccination and was not tested for COVID post vaccination. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "No reaction other than left arm pain with the first 4 shots.".  Additional information: The patient reported left arm pain that evening. Dizziness, weakness, nausea, vomiting, tiredness, headache and feeling unwell started the next day. No reaction other than left arm pain with the first 4 shots.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201167373 same patient, vaccine, event, different dose;
Nausea, heart palpitations  it?s been 5 days and still have symptoms
Red hard lump on the leg that was hot to the touch.  He also developed hives during the following two weeks.  Walked with a limp for 4-5 days.
Fatigue, muscle aches in legs, headache, 100.3 degree fever, all lasting roughly 24 hrs. Also pain at the injection site from day of the injection, lasting 3 days.
This spontaneous report as received from a Licensed Practical Nurse referring to a unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored M-M-R II lot # L009213 with expiration date: 17-MAR-2017 and lot # L027591 with expiration date: 23-JUL-2017 (dose and route were not provided). No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow up.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD 10/17/2022 ADULT OBSTRUCTIVE SLEEP APNEA, MILD J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/1/2022 ADULT OBSTRUCTIVE SLEEP APNEA, MILD G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD 10/17/2022 MALE BULBOUS URETHRAL STRICTURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/1/2022 MALE BULBOUS URETHRAL STRICTURE
This spontaneous report as received from a health worker office manager refers to a 13 month old female patient. Pertinent medical history and drug/ reactions/allergies were not reported. On 10-MAY-2013, the patient was vaccinated with a first dose of PROQUAD (merck)0.5 ml (lot number an expiration date were not reported). Other suspect therapies included VARIVAX (merck) 0.5ml. Concomitant medications were unspecified by reporter. On 10-MAY-2013, the patient had inadvertently received "PROQUAD (merck) and VARIVAX (merck)" together instead of PROQUAD (merck) and MMR II." The patient had gotten a 0.5mL dose of both PROQUAD (merck) and VARIVAX (merck). No adverse experiences were reported. The patient sought medical attention was still in physician's office. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist.  An adult patient of an unspecified race and gender received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling on an unspecified date with outcome of unknown.
Went to pharmacy to get a flu shot and pneumonia short, I'm 66 other than high blood pressure no major health issues. The pharmacist asked if I had a pneumonia shot before I said yes Prevnar 13 last year They gave me a pneumovax 23 shot. Bad reaction redness swelling from my elbow to the back of my shoulder blade and right front chest. Fingers going numb wrist hurt to much to pick things or do much .Went to my Drs walk in clinic 2 days later as it wasn't getting any better they have me a prescription of predisone to try to counter the reaction. Will see if that helps any they said if the swelling and redness didn't go away in a couple of days to come back.
facial swelling (may have started within day after, he doesn't recall), including nares, oral cavity - getting worse daily, swelling and redness just distal to vaccination site, swelling, redness opposite arm of vaccination.
Patient with increasing pain/burning at the injection site and right arm after Zoster vaccine. Pain still occurring about 3 months after injection. MD visit for further work-up with CT and MRI in December. Also given gabapentin for pain in right arm.
knot the size of a turkey egg at the injection site; fever; her systolic was high and other times her diastolic was high; rapid pulse; body aches; chills; thought that she was going to die the night; This case was reported by a pharmacist via call center representative and described the occurrence of injection site mass in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number CZ455, expiry date 16th September 2022) for prophylaxis.   Previously administered products included Zostavax (received 3 to 4 years ago), flu vaccine (received the flu vaccine with no issues) and tetanus vaccine.   On 13th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, less than a day after receiving Shingrix, the patient experienced injection site mass, fever, blood pressure abnormal, pulse rapid, general body pain, chills and malaise. On an unknown date, the outcome of the injection site mass, fever, blood pressure abnormal, pulse rapid, general body pain, chills and malaise were unknown.   It was unknown if the reporter considered the injection site mass, fever, blood pressure abnormal, pulse rapid, general body pain, chills and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and that day there was a knot the size of a turkey egg at the injection site. Now the knot was the size of a poached egg. The knot was not hard and has a fluid consistency. She had fever, chills, body aches, and she thought that she was going to die the night of  13th October 2020. She had a rapid pulse. At times her systolic was high and other times her diastolic was high. The only side effect that she didn't have that was listed on the leaflet was diarrhea according to the patient.  At 15 years of age, the patient claims that she had a tetanus vaccine and had an adverse events, however, she received the flu vaccine with no issues. She got the Zostavax vaccine 3 to 4 years ago. The reporter consented to follow up.
patient in the past choose not to receive the 2nd dose for reasons undisclosed; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient in the past choose not to receive the 2nd dose for reasons undisclosed).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 05-OCT-2023 The reporter would like any pertinent data on shingles prevention rate after 1st dose of Shingrix. Reporter reported that Shingrix was a 2 dose series but had at least one patient in the past choose not to received the 2nd dose for reason undisclosed. Reporter would like any data supporting possible benefit patients received after 1st dose of Shingrix so he could reply that information to patients in case they ask him about it. The reporter consented to follow up. The reporter reported that till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
nausea, vomiting, diarrhea, and developed rash to L shoulder  on11/4/22.  the following week developed rash to face and chest.
temp-max 102.5;screaming spell lasting followed by intermittent crying 1/2h-3/4h over a 12hr period;refused to feed;
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of ROTATEQ (lot # L008054, expiry date: 30-NOV-2016) (dose unspecified) orally, which had been improperly stored under 10 degree centigrade 72 hours, and later under 1 degree centigrade for 8 hours. Other suspect and concomitant therapies were not reported. This is one of several reports received from same source. Additional information has been requested.
Vaccine received Mon. 7/2/12 - after a few hours Pt. got a red welt. On Tues. 7/3/12, pt experienced flu-like symptoms (achy, nausea, headache) that lasted until Thurs. (7/5/12).
Numbness on left side of face, cheek, chin, ear, behind ear, upper neck. Tingly lips, slight difficultly swallowing. Was NOT in anaphylaxis.
Had fever and chills in the middle of the night. Uncontrollable shaking for about 30 minutes.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Mild
Progressively increasing weakness in arms and legs culminating in the inability to breathe with subsequent  intubation.  Received IVIG 400mg/kg IV x 5 doses. Tracheostomy placed 6/2/21. At the present time (6/29/21) she remains hospitalized off the ventilator with the tracheostomy. She continues to slowly recover
1150H - vaccinator was handed a moderna .25ml vaccine instead of a pfizer .30ml 1205H - vaccinator reported incident to the nurse in charge 1211H - nurse in charge contacted supervisor after advising patient, NIC was advised to educate patient on the need to receive the same dosage of moderna today to be considered fully vaccinated 1215H - patient agreed then refused by the time of the second administration  1225H - called supervisor and was advised to educate patient that he needs to get the pfizer dose .30ml in 5 mos to be considered fully vaccinated 1230H - patient was educated. Patient did not have any adverse reaction to the shot during the observation period of 30 minutes and agreed that he understood the education 1235H - patient left the clinic
Ear pain; Sore throat; Deep cough radiating down neck; This is a spontaneous report from a contactable nurse (who is also the patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 05Jan2021 16:00 (Batch/Lot Number: EK9231), as dose 1, single, at age 62 years old, for COVID-19 immunisation, at a hospital. The patient was not pregnant at the time of vaccination. Medical history included Von Willebrand's disease (as reported) from unknow dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines prior to the COVID-19 vaccine. On 25Jan2021, the patient experienced ear pain, sore throat and deep cough radiating down neck. These continued throughout 5 treatments of antibiotics and had not subsided. The events resulted to physician's office visit. The patient underwent COVID-19 nasal swab on an unspecified date with an unknown result. The outcome of the events was not resolved.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of ear pain,sorethroat,cough. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gastro-intestinal disorder NOS (GI problems), Abdominal cramps and Diarrhea.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 27-Feb-2021, PAIN IN EXTREMITY (Sore Arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were given.  No treatment information was given.   This case was linked to MOD-2022-547107, MOD-2022-547108, MOD-2022-547110 (Patient Link).
Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of June received the invalid dose, so all families are being notified of the possible error and offered re-vaccination.
Patient called the pharmacy today stating that he had experienced heart/chest pain that set on 2nd day after getting his first BOOSTER (3rd dose) of Pfizer covid vaccine. He complained that on the first day after getting vaccine he only felt flu like symptoms, but on second day he started to experience a very odd pain on right side of the chest and shoulder blade area. Patient has improved and been feeling better for the past 7 days.
soreness at the injection site; joint pain; nauseousness; headache; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), NAUSEA (nauseousness) and INJECTION SITE PAIN (soreness at the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HEADACHE (headache) and MYALGIA (muscle pain). On 22-Apr-2021, the patient experienced ARTHRALGIA (joint pain) and NAUSEA (nauseousness). On an unknown date, the patient experienced INJECTION SITE PAIN (soreness at the injection site). At the time of the report, HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), NAUSEA (nauseousness) and INJECTION SITE PAIN (soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pain in right UE, shoulder/arm/elbow/forearm/to fingers after vaccination, lasted 3 days. Elbow/finger pain abated but shoulder discomfort remain, worse with certain movements.
Extensive inflammatory reaction 2" distal from injection site marked by induration, erythema, high warmth left lower half upper arm.
Pt recvd vax on 22JUL92 & exp inability to think clearly, generalized bright red rash, itching, arthralgia, & flu-like sx including diarrhead, nausea, chills, myalgia, dizziness, sweating, fever & lightheadness;