chrisvoncsefalvay/vaers-outcomes huggingface dataset:
accidentally received another dose of tenivac with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 88 years old female patient who accidentally received another dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine (flu vaccine VII) for Prophylactic vaccination.  On 27-Sep-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot- U7679AA and expiration date- 21-Mar-2025) via intramuscular route in the left deltoid (strength: not provided) for Immunisation (extra dose administered) (latency- same day).  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
2nd dose of pfizer covid vaccination today with a prior h/o scalp itchiness but no rash , angioedema  or anaphylaxis with the first dose of covid vaccination 3 weeks ago. pt today with itchy palmar rash but no generalized itchiness no angioedema no anaphylaxis . exam remarkable for palmar urticarial rash with sparing of the dorsum  no urticaria elsewhere no angioedema no anaphylactic signs. pt noted improvment of pruritis and rash after 25mg of oral benadryl..  pt called for family member to provide home due to mild sedation from the benadryl. pt observed for a full hour without any other sequelae
This spontaneous prospective pregnancy report received from a medical assistant concerning to 22 years old female patient. On 16-JAN-2013, the patient was vaccinated with a dose of GARDASIL lot # H014645; Exp date. 27-MAR-2015; (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient was now pregnant. The pregnancy was normal to date. The approximately last menstrual period (LMP) was on 18-DEC-2012 and an estimate delivery date (EDD) of 24-SEP-2013. The patient was exposed to GARDASIL during trimester 1. A blood screen for anti D bodies was performed and was positive. The outcome of the event was unknown. The reporter considered that the event to be not related to GARDASIL. Follow up information was received. Date of birth and ethnicity of the patient were updated. There were no known drug allergies. On an unknown date in April 2010, the patient had delivered a baby weighing 3.2 kilograms (Anti D Rh negative). Since 05-DEC-2012 to 14-DEC-2012, the patient had taken acyclovir (orally, daily). The patient smokes 5-10 cigarettes per day and drinks ethanol occasionally. Last menstrual period (LMP) was on 19-DEC-2012 (previously reported as 18-DEC-2012). Pregnancy was ongoing at the time of reporting. On 16-JAN-2013, the patient was vaccinated with 0.5 milliliter (ml) of GARDASIL and it was discontinued on the same day. The patient was continuing the care with the physician. Additional information has been requested.
Aching legs during midnight Mass, during night severe pain, Sunday some discomfort much milder.  None on Monday.
Her husband got his first dose on 09Feb2021 and afterwards tested positive for COVID on 13Feb2021; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reports that her husband got his first dose on 09Feb2021 and afterwards tested positive for COVID on 13Feb2021. She reports that he was instructed to wait 90 days after testing positive to have his second dose but now asking, what was the recommended timing, does he have to start the series over. Caller reports that she has spoken with their healthcare professional but are not getting guidance from him. Confirmed Pfizer COVID vaccine. Spoke from attached documentation. Referred to HCP/Pharm for guidance. Caller reports that she filed a report with DSU last night, no reference number for that encounter. The patient underwent lab test and procedure which included COVID-19 test: Positive on 13Feb2021. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch numbers cannot be obtained.
2-3 hrs p/vax given pt c/o discomfort not wanting to use rt arm; some redness around inject site; next morning, pts upper arm bright red, swollen down to elbow; pt taken to MD in afternoon; no cellulitis; Thurs AM upper arm turning purplish
This case was reported by a pharmacist, who was also the consumer, that described the occurrence of fever in a 22-year-old male subject who was vaccinated with ENGERIX B vaccine. On an unspecified date in 2005, the subject received the 1st dose of ENGERIX B vaccine (1 ml, unknown, left arm). Less than one day after with vaccination with ENGERIX B, the subject experienced fever, malaise and sore arm. Twenty-four hours after vaccination with ENGERIX B, the event were resolved. The reporting pharmacist/consumer considered the events to be probably related to vaccination with ENGERIX B.
20-30min p/vax rt deltoid became sore & sensitive that noc 23OCT inc pain of rt arm w/swelling, redness also rt leg aching;24OCT sweating, chills, fever;sx increasing in intensity on Saturday w/intense h/a & insomnia;
This spontaneous case reported by a nurse, describes the occurrence of head discomfort (complaining of a heavy head) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 31, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced head discomfort (complaining of a heavy head). At the time of the report, head discomfort (complaining of a heavy head) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
The patient had body aches, chills, and a reddened area of the upper arm. On 12/19/00 the area was the size of a nickle that expanded to a 4 inch area. It was red and hot.  The patient was treated with antibiotics, then the patient had three reddened areas. The patient was told to put heat on it by the doctor.  Fever is gone, arm is sore but redness lightened "took 10 days".
rapid heartrate that went up to 185 BPM; her heartrate was between 88-99 BPM; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (rapid heartrate that went up to 185 BPM) and TACHYCARDIA (her heartrate was between 88-99 BPM) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced TACHYCARDIA (rapid heartrate that went up to 185 BPM) and TACHYCARDIA (her heartrate was between 88-99 BPM). On 06-Feb-2021, TACHYCARDIA (rapid heartrate that went up to 185 BPM) had resolved. At the time of the report, TACHYCARDIA (her heartrate was between 88-99 BPM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a licensed practical nurse via company representative refers to a patient of unknown age. On an unknown date in 2010, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On 22-MAR-2013, the patient was to be vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse effect was reported. Additional information is not expected.
she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness of breath; kind of fatigued; This is a spontaneous report received from a contactable consumer reporting for his wife (patient). This 64 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), single dose, dose 1  via an unknown route of administration in the left arm on 17Mar2021 at 08:30 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included aortic aneurysm  from 2012 to 2012, thyroid problems and headache. There was no family history. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. There were no events following prior vaccinations. Concomitant medications were not reported. In Mar2021, a week after vaccine administration, the patient was kind of fatigued. She went to the doctor in Mar2021 because she was feeling bad and they said they could hear wheezing in the stethoscope when they listened to her lungs. She was sent her for x-ray and they are waiting on the results. He said that this can also be symptoms of something going on with her thyroid and he has been trying to get her to go to the doctor. He stated she goes up and down the stairs at work and hasn't had problems but has noticed she feels weak and he has noticed she is getting more fatigued everyday. On 24Mar2021, the patient had no energy and her blood sugar has been dropping sometimes at lunch and has never had problems with it before. it is not all the time but when she comes home for lunch after she eats, it drops low. It happens sometimes at lunch, never at breakfast nor supper. In Mar2021, the patient experienced shortness of breath for the last couple of weeks, especially with the stairs. The patient went to the physician's office on 07Apr2021. Laboratory tests included blood work  due to the patient's thyroid problems, blood sugar decreased and chest x-ray all on 07Apr2021. The clinical outcome of weak, shortness of breath, feeling bad, wheezing, fatigued and blood sugar dropped was unknown.    No follow-up attempts are needed. No further information is expected.
Three to five days post vax, the pt experienced "papular skin lesions" first on the chest and then on the face. It was reported that the lesions would recede within 3 days and new ones would develop. The lesions also progressed to the shoulder and hands since the original breakout. the total number of lesions may have exceeded 50. It was reported that the pt's appetite and activity levels are normal. She is afebrile. Unspecified medical attention was sought. the pt's papular skin lesions persisted.  Follow-up information reported that the pt's rash consisted of a "small number of vesicles that appeared sequentially for 4 weeks following vaccination. On 12/2/99, the pt recovered.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical facility as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated by at an Urgent Care facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The outcome of the events were considered to be not recovered. Additional information has been requested.
pt recv vax & exp lightheadedness, faintness, weakness, & drowsiness; pt felt that would pass out & devel t99.4; BP was 138/84, pulse 100 & resp pattern was 16;
rash to torso front and back extensive.  scattered fine  minimal rash to arms  treated with zyrtec, Benadryl, and steroid cream.  responded with less itching
on 21APR93 pt recvd vax & w/in 1 hr p/vax devel urticarial rash w/mildly swollen lips & feet; returned to office-given adrenalin & Decadron;
High shrill shrieking p/vax for 3 hrs p/fully recovered 1 day p/ no temp;
pain in my arm; This is a spontaneous report from a contactable consumer. A male patient of age 68 unit- unknown received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included deafness (Deaf individual). The patient's concomitant medications were not reported. Patient received first dose in the morning. On an unspecified date the patient experienced pain in arm. Patient asked if its good idea to put some ice on it. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Several pts recvd 3 doses of Engerix-B JAN92-/FEB92 & had non response in unk # of pts;
This case was reported by a consumer via call center representative and described the occurrence of sinus pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis. On 4th April 2019, the patient received the 1st dose of SHINGRIX. On 5th April 2019, 1 days after receiving SHINGRIX, the patient experienced sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat. On an unknown date, the outcome of the sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat were recovering/resolving. It was unknown if the reporter considered the sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX the patient experienced sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat. The reporter stated that, the patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Swollen hands; Chicken pox/hives like symptoms; Chicken pox; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right  arm on 31Mar2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included known allergy to shrimp on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 20:00, the patient experienced swollen hands and chicken pox/hives like symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen hands and chicken pox/hives like symptoms was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
4 hours after the shot I became dizzy and very tired.  An hour later I had a fever of 99.7 and my body ached like I had the flu.  I rested through the night and became better.  My body still aches.
arm hurt; little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and FATIGUE (little bit tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 045B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt) and FATIGUE (little bit tired). At the time of the report, PAIN IN EXTREMITY (arm hurt) and FATIGUE (little bit tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported. .   This case was linked to MOD-2021-118214 (Patient Link).
I had a fever of 103 for four days and nerve pain all over my body, including my scalp. It was difficult to touch my skin, put on my clothing and sit. On Feb 14 I blacked out and fell off my deck (approximately 6 feet in height). I sustained a concussion, multiple lacerations including both knees and legs, both hands, face, head, mouth, and fractured two teeth. I broke toes on my left foot, bruised my ribs on the left side and sustained a large hematoma on my left hip and glute.  I?m still struggling with post concussive syndrome and still have some swelling in my hip and knees. I have a collection of scar tissue in my upper right lip and have had one crown done on one of my teeth fractures. I still need one more which will be done in January.
On 09/08/2022 I received my Covid-19 vaccine. On 01/28/2023 I was experiencing headache, sore throat, fatigue, lost of appetite. After reaching out to my doctor i was diagnosed with Covid-19. I was prescribed Paxlovid. Symptoms lasted approx. one week.
slight pain on my  waist/pain is stronger and spreading all across my waist; 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 PAIN (slight pain on my  waist) and PAIN (pain is stronger and spreading all across my waist) 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 PAIN (slight pain on my  waist) and PAIN (pain is stronger and spreading all across my waist). At the time of the report, PAIN (slight pain on my  waist) and PAIN (pain is stronger and spreading all across my waist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Biting episodes and screaming on 4/18/01, for hours after. Had generalized convulsion on 4/27/01 X approx. for a few minutes. As per mom, after the episode of convulsion, the child became limp and decreased speaking. Follow-up by neurology clinic for decreased speaking and weakness.
Rash (hives) on back, spreading to chest, neck, face. Continued to worsen, persists today and required doctor visit.
Severe muscle pain at site of injection and surrounding muscle tissue. This was followed by reactivation of latent herpes simplex virus 1 infection.
Patient received his vaccine and sat down in an alternate chair. He stated that he started to feel dizzy and then passed out. The patient regained consciousness fairly quickly. He did fall on the ground out of the chair, but did not hit his head. EMTs were called and he was checked out. He was able to leave saying he felt much better.
Sorethroat; Very hot face/ Hot flushes facial; Agitated; Diarrhea; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sorethroat), HOT FLUSH (Very hot face/ Hot flushes facial), AGITATION (Agitated), DIARRHOEA (Diarrhea) and HEADACHE (Severe headache) in a 63-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sorethroat), HOT FLUSH (Very hot face/ Hot flushes facial), AGITATION (Agitated), DIARRHOEA (Diarrhea) and HEADACHE (Severe headache). At the time of the report, OROPHARYNGEAL PAIN (Sorethroat), HOT FLUSH (Very hot face/ Hot flushes facial), AGITATION (Agitated), DIARRHOEA (Diarrhea) and HEADACHE (Severe headache) outcome was unknown.            Patient is taking other medication. No treatment information provided.
VAGINAL BLEEDING 5 DAYS AFTER  CYCLE HAS ENDED; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight was not reported and height was 66 inches. The patient's past medical history included spotting after cycle.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate, and venlafaxine hydrochloride. On 29-MAY-2021, the subject experienced vaginal bleeding 5 days after cycle has ended. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vaginal bleeding 5 days after cycle has ended. This report was non-serious.
dizzy; got down; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (got down) and CHILLS (chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2DA) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced CHILLS (chills). On 24-Feb-2021, the patient experienced DIZZINESS (dizzy) and ASTHENIA (got down). At the time of the report, DIZZINESS (dizzy), ASTHENIA (got down) and CHILLS (chills) outcome was unknown.            No concomitant medications were provided. No treatment information provided.
Immediate dizziness, weakness, nausea-recovered in 1/2 hour.  Head between knees and cold pack to neck were only treatment.