chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional (office staff). This case involves a 16 months old female patient who was vaccinated with a dose of 0.25 ml dose of DAPTACEL lot C5065AA; expiry date: 08-Oct-2018 via intramuscular route in the right thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included 0.5 ml dose of ACT-HIB for Immunisation; and 0.25 ml dose of FLUARIX for Immunisation. It was a case of actual medication error due to expired vaccine used. No adverse events have been reported after observation for 10 minutes. 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.
Pt. states that after receiving the 3rd dose of Phizer 11/13/2021, started experiencing symptoms 11/14/2021 of blurriness in the Left eye with light "streaks. Primary visit 11/14/2021 with recommendations of admission to the Hospital for Observation/ Discharged 11/16/2021 with Follow-Up Ophthalmologist. Ophthalmologist visit 11/16/2021 confirmed bleeding behind the Left eye with slight swelling. 12/2021 Follow-Up appointment with Increased swelling in Left eye, Steroid Injection preformed. 2nd Steroid Injection 01/2022 preformed, blurriness has subsided with limited "Peripheral vision". Follow-Up appointment scheduled with Ophthalmologist 02/17/2022.
One week after receiving the Johnson & Johnson vaccine, several small bruises (6-8) appeared on the back of my left leg. Throughout the day, my leg developed a soreness that, after reading a 10 Feb 2021 story in the newspaper about COVID vaccine recipients developing immune thrombocytopenia caused me to seek medical treatment in the afternoon of 4/6/2020. I first visited an urgent care facility where my high blood pressure (130/98) combined with my slight lightheadedness, soreness in the leg and observes bruising were enough for the tending physician to recommend rushing to the ER for bloodwork to be performed immediately. I was admitted to the ER in the early evening with an elevated blood pressure (~150/111) and the bruising still prevalent. The tending nurse practitioner authorized a complete blood count (CBC) and discharged me an hour later when the results came back ?extremely close to normal,? noting that my platelet count of 194 was no immediate cause for concern. Since then, the bruising and soreness has subsided.
the patient received both doses of his Pfizer COVID-19 vaccination & now months after has tested positive for COVID-19 and is currently in the hospital.; the patient received both doses of his Pfizer COVID-19 vaccination & now months after has tested positive for COVID-19 and is currently in the hospital.; This is a spontaneous report from a contactable consumer or other non-hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date in 2021 (Lot Number: EW0158, Expiry date: Unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states that he received both doses of Pfizer COVID-19 vaccination and now months after has tested positive for COVID-19 and is currently in the hospital. He stated that patient was in the ER right now and is pretty sure the ER will complete a report. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Administered Engerix Instead of Heplisav-B for Second Dose; Initial Report Received on 08-Sep-2021 and 10-Sep-2021  A nursing operation supervisor in the US reported that a 32 year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Engerix as the second dose of the series.  The patient did not have any allergies. No other relevant medical history was reported.   No relevant concomitant medications were reported.   On 10-Aug-2021, the patient received the first dose of HEPLISAV-B (Lot # 934601, expiration date 16-Mar-2022, and NDC # 43528-002-05; serial # not reported) in the right deltoid.  On 08-Sep-2021, the patient received the second dose with Engerix (Lot # and expiration date not available) from a licensed practical nurse instead of HEPLISAV-B. No adverse effects were reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
strong side effects as pain( muscular, joint)headacche , chills , nousea , vomiting and high fever ( 92-94);
Day 7 post injection I developed a greater than silver dollar size area of redness along with a pea size lump at the injection site, along with itching- left deltoid. I informed Dr of same, and was advised to take Benadryl, and go to urgent care if necessary. The area of redness increased over the next 2-3 days. Day14 the area continued red, but skin was now also dry and scaly. It's now day 22, the area remains dry, scaly, and bruised. I've sent pictures to Dr. via email. I'm still taking Benadryl 1-2 times/day for the itching.
right arm pain all the way down her arm with swelling on her hand; swelling on her hand; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 14May2021 14:00 (Batch/Lot Number: EW0183) as 1ST DOSE, SINGLE for covid-19 immunisation administered in Hospital. Medical history included Singles shot (had the shingles shot 5 weeks before the Covid vaccine). Concomitant medication(s) included levothyroxine sodium at once a day; amlodipine besilate at once a day for hypertension; nebivolol hydrochloride (BYSTOLIC) for hypertension. The patient experienced significant right arm pain all the way down her arm, right after vaccine with swelling on her hand on 14May2021, about 6 hours after vaccine. She is very concerned and is asking if she should get the second dose with her 2nd dose due on 9Jun2021. She had blood work at the doctor's office because he said she was bleeding on the inside, making her blood count go low. That was in March. Treatment was received as Tylenol for the events. Outcome of event for swelling on her hand was recovered on an unspecified date and for the other event it was recovering.   Follow-up attempts are possible. further information is expected.
Developed symptoms of hyperglycemia around Nov 1992, with diagnosis of Type 1 Diabetes Mellitus in early December 1992. Now on insulin pump for dm management.
Pt states she had swelling and pain at injection site that became discolored.  She went to urgent care center and was diagnosed with cellulitis at the injection site.  She was given a course of antibiotics
This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # N009802 and M045653 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002736: US-009507513-1708USA002735: US-009507513-1708USA002737: US-009507513-1708USA002090:
the mom told clinic was seen on 2NOV92 that pt recvd DTP on 1AUG92 & that had a series of intermittent, high-pitched screams which lasted for 24-48 hrs p/DTP; there was no associated high fever or leg pain;
Shivers. Chills.  Body aches , fever 101.2 tympanic  Sore left arm
Fever, chills, body aches for approximately 24 hours the day after getting the second dose.
Patient is on a catch up schedule was given DTaP instead of TDaP. No adverse reaction to vaccine.
Pt developed erythema (6cm x 6cm) and mild induration at site of influenza vaccine over a time course of 24 hrs. No respiratory symptoms. Pt treated with oral Prednisone x 2 days and steroid, given oral antihistamine x 3 days.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. On 08-FEB-2018 the patient was vaccinated with one dose of improperly stored VARIVAX (lot # N023960, expiry date: 01-SEP-2019), (dose, frequency and route were not reported) for prophylaxis. It was reported that the vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown). VARIVAX was exposed to temperature of 6 degree Fahrenheit (F) to 14 F for 36 minutes. No adverse effects reported. Product quality complaint was not involved. There was no previous temperature excursion reported. The digital data logger was involved. Sender's Comments: US-009507513-1803USA003566: US-009507513-1803USA003698: US-009507513-1803USA003697: US-009507513-1803USA003686: US-009507513-1803USA003699: US-009507513-1803USA003695.
Took shot on Wed.  Thurs lethargic, Fri fever, sore throat, took hot bath and to bed with chills, woke up with achy body, still sore throat but by noon cleared.  Spit up phlegm for two days.  Tonsils were swollen on Fri, but normal on Sun.  I have not been ill for 16 years, am cared for by a prevention doctor, with clear heart, immune system strong, no other problems. I used Echinesia, and gargled with Listerine, bed rest.  I continued to spit up muccous for two days, with a mild fever.
I had been around a family member who tested positive for COVID-19 and a few days later I had a fever of 103. I went to get tested and it was positive. I had muscle aches and congestion. I was nauseous. I did not lose my sense of smell or taste. It has been two months and I still have a heightened sense of smell which started about a month after I was sick. It is like a chemical smell that is always there. I did not lose my sense of smell or taste during the illness. I had a cough and I was very tired. It lasted for about four weeks before the fatigue and the muscle aches went away. The fever, coughing and congestion lasted about one week. My family members did not catch the disease from me. I saw my doctor but I was told to treat the symptoms and I was not prescribed anything.
Swelling and redness of eye and eye area Oral medication, topical medication, and eye patch/heat mask Diagnosis: Meibomian eye dysfunction and chalazion
Rash on the forearm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the forearm after first dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Congenital heart disease NOS.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on the forearm after first dose). At the time of the report, RASH (Rash on the forearm after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.    No treatment medications were reported.   This case was linked to MOD-2021-416284 (Patient Link).
pt recvd vax 27MAY94 exp a fever of 102; & 1 wk later 3JUN94 & exp swelling of knee & wrist, nausea, vomiting, h/a, & myalgia; pt adm to hosp where was found to have leukocytosis;
Extreme fussiness since she was born, eczema onset showed two weeks after she was born and has gotten progressively worse over (she is currently five months old). Terrible sleeping due to extreme itching all over her body. Eczema patches all over her body (face, chest, abdomen, legs, arms, back), including diaper rash. She has been diagnosed with Atopic Eczema. Possible food/environmental allergies. Cradle cap for the first two-three months. I have tried all sorts of treatments: Baby's JarroDophilus probiotics (drops), Kid-e-Col for colic and teething, aloe vera lotion, Vitamin E oil, Cera Ve moisturizing cream (active ingredient: dimethicone 1.2%) Aveeno colloidal oatmeal bath, Aquaphor diaper rash cream, Jojoba oil, my own breastmilk, Eucerin eczema relief for babies (active ingredient: colloidal oatmeal 1%), Tom's baby sunscreen lotion (active ingredient: zinc oxide 20%), extra virgin olive oil, apple cider vinegar (Bragg organic), Organic Virgin Coconut Oil (cold pressed and unrefined), pure Shea butter, lavender essential oil, pure castille soap for babies, 99% certified active aloe whole leaf aloe vera mixture Aloe Life skin gel, bees wax, 1% hydrocortisone over the counter, neosporin, VitD drops, sun therapy, diet changes to organic....
This case was reported by a healthcare professional via a sales representative and described the occurrence of nonspecific reaction in a subject of unspecified age and gender who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (.5 ml, unknown). In 2009, at an unspecified time after vaccination with BOOSTRIX, the subject experienced nonspecific reaction. The medical assistance reported that two subjects reacted to BOOSTRIX. No specific complaints about the appearance or characteristics of the BOOSTRIX were provided. The sales representative had limited information. She could not provide details on the type of reaction the subjects experienced or whether the reaction was local or systemic. The reported believed that a quality assurance problem may have caused the adverse event. No specific physical complaints with the product's appearance, etc. were provided. The medical assistant just thought that the adverse event could be due to a bad lot of BOOSTRIX since two subjects reacted. It was unknown which presentation of BOOSTRIX (vial or prefilled syringe) was used. Please see A0774664A for the second report of unspecified reaction to BOOSTRIX. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the unspecified reaction was possibly related to vaccination with BOOSTRIX. Follow-up received as quality statement performed on 15 May 2009: As per quality statement, the BOOSTRIX vaccine lot AC52B031AB met the requirements of the specifications and was confirmed as suitable for vaccination purpose.
Vomiting, temperature 102, drowsy for 3-4 days beginning 11/22/2003.  Seen 12/03/2003 for bronchitis and ruptured left tympanic membrane.
Case had covid vaccines x 2 with last dose administered on 2/17/2021. Developed symptoms of Covid 19 on 8/17/2021. Case had a positive COVID 19 lab test on 8/18/2021 was admitted to Medical Center. Case Expired while still hospitalized on 8/21/2021.
It felt weird from the get go. I felt it go into my arm. That night I could barely move my left arm. It got better, but in the days that followed I got a pain in my neck and shoulder. I thought maybe I slept wrong. I ended up going to a physical therapist, a massage therapist, and a chiropractor to get some relief. I had some numbness and tingling down the left side of my arm with my ring finger and my pinky. I got no relief from that. I went to my doctor and he found a knot under my arm. I thought the swelling from that might have hit a nerve. My PCP sent me to another doctor, who is a surgeon. He ordered an ultrasound. When that came back, it came back as a swollen lymph node. I went and had a biopsy done. When it came back everything looked good. Last week, I was taking off my dress and I was like "oh that hurts!". The lump under my arm was bigger and was hurting. I am having another ultrasound done Friday. It is still swollen and it has been like this since a few days after Jan 6 2021.
Pfizer-BioNTech COVID-19 Vaccine EUA  2 Days following the vaccine both my Psoriasis (Plaque, Guttate, and Intertriginous) began to flare. It had been in remission for many months prior to this. I also had the usual chills and general malaise.
received too soon the 2nd dose by mistake/Second dose administered at <21 days after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received too soon the 2nd dose by mistake/Second dose administered at <21 days after the first dose) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039d21a and 039d21a) for COVID-19 vaccination.     No medical history information were reported.  Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), HYDROXYZINE, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), FERROUS SULFATE, PARACETAMOL (TYLENOL) and SUCRALFATE (CARAFATE) for an unknown indication.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received too soon the 2nd dose by mistake/Second dose administered at <21 days after the first dose). On 01-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received too soon the 2nd dose by mistake/Second dose administered at <21 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication use was reported.
Hives, red, itchy and painful rash at site of injection about 2 inches long and wide. It is the 3rd day and I still have it, it is not improving.
The patient stated she was diagnosed with an "infection at the injection site" after she received the first dose of a SHINGRIX vaccine. She discribed her arm as being "swelled, red and hot" She was treated at an emergency department and given antibiotics for this.
One week after immunization, developed erythema and induration 7 X 11 cm at the site of immunization
My wife had just been admitted to the hospital. I had just come from visiting her, I had chills, and fever. I went back to the emergency room so they could test me for COVID-19, I tested positive. I was not given the antiviral oral medication; I was given the infusion for three days. I did have a headache, sore throat. By Sunday I started to feel a little better. I have no long-term symptoms.
Typically reported aches along with flushness of skin, especially both arms. Adverse condition was mild blue and black bruising over 10 to 15% of both legs - calves and thighs.  Majority of bruising faded over a 6 to 8 hour following its discovery.
EMPLOYEE STATED THAT SHE BEGAN TO GET A HEADACHE AND MOUTH WATERING FEELING ABOUT AN HOUR AND A HALF AFTER GETTING THE VACCINATION. SHE REPORTED THAT THE NEXT MORNING WHEN SHE WOKE UP, HER RIGHT ARM WHERE SHE RECEIVED THE VACCINATION WAS SWOLLEN, PAINFUL, WARM TO TOUCH, AND THERE WAS A HUGE KNOT AT THE INJECTION SITE. UPON ASSESSMENT OF THE AFFECTED SITE, HER RIGHT ARM IS STILL WARM TO TOUCH, SLIGHTLY SWOLLEN AND FIRM. SHE REPORTS NO OTHER SYMPTOMS AT THIS TIME.
Ramsay Hunt Syndrome; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-AUG-2015, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: to prevent shingles (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). On an unknown date, reported as shortly after received ZOSTAVAX vaccine, the patient suffered herpes zoster and Ramsay Hunt Syndrome. As a result of these symptoms, the patient was seen and treated and was still under their care. As a direct and proximate result of the patient's use of the ZOSTAVAX vaccine, the patient symptoms have resulted in physical limitations not presented prior to use the vaccine. The patient also experienced mental and emotional distress due to resulted physical limitations and seriousness of patient condition. Patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, also the patient had suffered and incurred damages, included medical expenses, the loss of accumulations; and other economic and non-economic damages.  The outcome of herpes zoster and herpes zoster oticus were not recovered. The reporter considered herpes zoster and herpes zoster oticus to be related to ZOSTAVAX.  Upon internal review, herpes zoster oticus was determined to be a medically significant event.
PATIENT REPORT ANXIETY, DIZZINESS, HEADACHE.  NO SHORTNESS OF BREATH. SYMPTOM START AS THE  PT PULLED UP TO OBSERVATION PT APPEARED PALE. VS ; HR 65 O2 SAT 97%  PT INSTRUCTED TO HYDDRATE AND LIE DOWN IN CAR PT STARTED FEELING BETTER AFTER ABOUT  5 MINS PT LEFT SITE FEELING WELL
approx 15 days p/vax pt devel Idiopathic Thrombocytopenia Purpura (ITP);pt has responded to IVIG therapy;
Night sweat; Body aches; Tired; The injection arm, below the injection site is quite red and very very sore; The injection arm, below the injection site is quite red and very very sore; fever 101.3 the next day; Episode of being cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Episode of being cold), NIGHT SWEATS (Night sweat), PAIN (Body aches), PYREXIA (fever 101.3 the next day) and FATIGUE (Tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FEELING COLD (Episode of being cold) and PYREXIA (fever 101.3 the next day). On 24-Feb-2021, the patient experienced NIGHT SWEATS (Night sweat), PAIN (Body aches), FATIGUE (Tired), VACCINATION SITE ERYTHEMA (The injection arm, below the injection site is quite red and very very sore) and VACCINATION SITE PAIN (The injection arm, below the injection site is quite red and very very sore). At the time of the report, FEELING COLD (Episode of being cold), NIGHT SWEATS (Night sweat), PAIN (Body aches), PYREXIA (fever 101.3 the next day), FATIGUE (Tired), VACCINATION SITE ERYTHEMA (The injection arm, below the injection site is quite red and very very sore) and VACCINATION SITE PAIN (The injection arm, below the injection site is quite red and very very sore) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 101.3f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.