chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Surveillance for Rates of Pertussis Disease Among Persons Birth through 59 months of Age Received PENTACEL or Other Pertussis Vaccines. Subject ID: 436559. Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 PERTUSSIS cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of PERTUSSIS disease in a 4-year-old, male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 4 doses of DAPTACEL: lot number C2405AA received on 08 February 2006, lot number C2396AA received on 04 April 2006, lot number C2432AA received on 06 July 2006, and lot number C2553AA received on 21 March 2007 (route and site of administration not reported). More than 3 years after the last dose, on 26 September 2010, the subject developed a cough. Six days later, he developed paroxysmal cough with whoop. He also developed cold-like symptoms and sleep disturbance (start dates not reported). Laboratory treatment consisted of AZITHROMYCIN for 5 days which started on 05 October 2010. The subject was not hospitalized. At the time of final contact on 11 October 2010, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient describes body aches in arms after vaccine. The pain is the same as her previously diagnosed polymyalgia rheumatica which had been in remission for 2 years
PATIENT REPORTED HIGH HEART RATE ON HER APPLE WATCH. WE CHECKED HER BP AND IT WAS 166/123 PULSE 107. 15 MINUTES LATER WE CHECKED IT AGAIN AND IT WAS 168/115
Pt was seen in the office on 3/29/21 with lower leg edema . Positive D-Dimer of 4.18 and positive US for DVT
pt recvd vax; pt had seizure accompanied by high fever; t 103-104; par called 911; pt taken to hosp & ER for blood work;APAP, CXR; pt sent home same day;
Localized reaction to GSK DTaP in LAT. Resulted in raised red, swollen, hot area.
Almost exactly 12 hours after injection of this 2nd dose I experienced extreme chills and almost violent shivering or shaking.  Put on down jacket and got in bed and symptoms subsided in 20-30 minutes.  Got up and symptoms started again, so got back under covers and they subsided in 10 minutes.  I had identical experience with 1st dose on 12/9/2020.  The shivering was the most extreme I've experienced in my life.  Next morning, I was fine both times.
patient is hospitalized after symptoms of cough, shortness of breath, congestion, wheezing, headache, fatigue
onset of fever & a few hours p/vax, T102, fussy, irritable, but cont to nurse;fever inc to 103.8 persisted for 2 days;pt had septic w/u adm & treated w/med until cult negative >48hr;
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA713A) for prophylaxis.   On 07-FEB-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
NOT WELL FROM THE SHOT; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced not well from the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not well from the shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20220250680.
left arm started tingling; roof of my mouth started tingling then my tongue started tingling and felt like it was getting a little larger; heart palpitations; lower half of my face went numb; Right eye also felt weird like vibrating; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 23Dec2020 15:30 at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing prior to vaccination of BNT162B2. Concomitant medication included ibuprofen (ADVIL), ibuprofen and escitalopram oxalate (LEXAPRO). The patient stated, "my left arm started tingling and it was very strong by my finger tips" on 23Dec2020 03:45 PM. The patient stated, "then the roof of my mouth started tingling then my tongue started tingling and felt like it was getting a little larger. Then I got heart palpitations. The mouth tingling went away in ten minutes but then 15 minutes later the lower half of my face went numb and that lasted about 10 minutes. Right eye also felt weird like vibrating" on 23Dec2020. No treatment received for the adverse events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and had no congenital anomaly/birth defect. The outcome of the events was recovered on unspecified date.
08/06/2021 began to fill unwell 05:00 am with extreme pain in middle side of back. Patient has a high pain tolerance and went to urgent care at 09:00am Urgent care, Talking about the symptoms and pain levels then was diagnosed Kidney stones. No history of  Kidney stones, new Diagnosis.
Patient is 2y 2m and should have received a 0.25 ml FLUZONE vaccine for patients 6-36 mo. Patient received FLUZONE 3+ (0.5ml) vaccine. Prior to entering the room, I drew up a 0.5 ml and 0.25 ml dose of the flu vaccine, as patient and his 9yo brother were both receiving the flu vaccines. I had another nurse verify my vaccines prior to entering the room. Once I was in the room, the 2yo was placed on the exam table to get his flu vaccine before his older brother. I grabbed one of the flu vaccines and administered it to the patient. After administration, I realized I gave the patient the 0.5 ml dose of the flu vaccine. I immediately left the room to notify the provider, Dr., who stated no additional adverse effects should occur. I then notified the mother who verbalized understanding and was told to call with any future concerns. The provider was in the room following the vaccine. Patient alert and oriented with no adverse effects noted. (team leader) and (practice manager) were also notified. I spoke with lady at the Health Dept who stated vaccine dose does not need to be repeated and should not expect any adverse effects from the increased dose. Also recommendation to fill out a VAERS report.
Within an hour extreme dizziness, followed by diarrhea. Within a few hours was feeling queasy. Ate lunch. Nauseous by 1:30 PM. Vomiting by 6 PM.
Pfizer BioNTech COVID-19 Vaccine EUA / Moderna COVID-19 Vaccine EUA: Mixed Series Patient received Moderna Vaccine on 8/4/2021 and the Pfizer Vaccine on 8/31/2021.
The caller's mother said that she had arm pain this morning but it is only when she touches it that she feels it; a little bit of a sore arm; feel sleepy after the COVID vaccine, like drunk sleepy, and she dose feel sleepy now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)(patient's daughter).  A 84 year-old female patient received bnt162b2 (BNT162B2), administration date 30Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Sep2021, outcome "recovering", described as "a little bit of a sore arm"; SOMNOLENCE (non-serious) with onset 30Sep2021, outcome "not recovered", described as "feel sleepy after the COVID vaccine, like drunk sleepy, and she dose feel sleepy now"; TENDERNESS (non-serious) with onset 01Oct2021, outcome "unknown", described as "The caller's mother said that she had arm pain this morning but it is only when she touches it that she feels it".  Additional information: Investigation Assessment was no. Reporter inquired if her mother had side effects as well since she mentioned reporting on her and the caller states that her mother went walking yesterday to the pharmacy and was wearing her mask and it was hot weather. Her mother said that she has a little bit of a sore arm but has had no diarrhea. She did feel sleepy after the COVID vaccine, like drunk sleepy, and she dose feel sleepy now but she wass glad that she got it. The thing is the caller's mother's brother got the vaccine and he is 82-years-old and the caller doesn't think that he had any side effects at all. He had his done two weeks ago and his wife also got it and had no side effects. They both did the boosters because they had to fly. Primary/ Prescribing Healthcare Professional Info was not probed since caller stated that she did not want to provide specific patient information. reporter's mother still had a sore arm. The sore arm started a little bit yesterday, 30Sep2021, but she felt it more today but now it is going away. The caller's mother said that she had arm pain this morning but it is only when she touches it that she feels it. She also did not bleed after having the COVID vaccine. The reporter was probed for NDC, lot number and expiry date and caller declined to provide and states that her mother also got this done at #.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of erythromacular rash in a 67-year-old male patient who received SHINGRIX (batch number C523T, expiry date 30th April 2019). On 14th April 2018, the patient received SHINGRIX .5 ml. On an unknown date, the dose was an unknown dose. On 14th April 2018, 5 hrs after receiving SHINGRIX, the patient experienced erythromacular rash. On an unknown date, the outcome of the erythromacular rash was not recovered/not resolved. It was unknown if the reporter considered the erythromacular rash to be related to SHINGRIX. Additional details reported as follows: The patient experienced a few red spots on his lower abdomen and a few on one leg. The reporter did not know which leg. The reporter did not know the site of injection. The reporter neglected to ask for patient initials.
Information has been received from a nurse practitioner concerning a teenage female (age not reported) who on unspecified dates was vaccinated with the first and second doses of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified dates, the patient developed hot flashes after her first and second doses of Gardasil. The onset of the hot flashes began within 24 hours post vaccination and the hot flashes lasted for a couple of days. The patient sought unspecified medical attention. The outcome and action taken with regards to therapy with Gardasil was not reported. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/17/2007. Information has been received from a nurse practitioner concerning a 20 year old female with no illness at the time of being vaccinated who on 14-JAN-2007 was vaccinated with the first dose of GARDASIL (lot # 654389/0961F) injection in the left deltoid at 4:30 PM. On 06-MAR-2007, the patient was vaccinated with the second dose of GARDASIL (lot # 654741/0013U) injection in the left deltoid at 11:30 AM. The patient was not on concomitant medication. On 15-JAN-2007 and 07-MAR-2007, the patient developed hot flashes after her first and second dose of GARDASIL respectively. The onset of the hot flashes began within 24 hours post vaccination and the hot flashes lasted for a couple of days. The patient sought unspecified medical attention. On unspecified dates, the patient recovered from the hot flashes. No additional information is expected.
pt recv vax 910AM & 11AM mom bringing pt back as having a rxn;mom & child sent to ER alert-breathing OK but sl quivering w/lower lip;sent home on amoxicillin as sl redness inner ear;
Patient said she had a sore arm/shoulder for a couple weeks. No swelling but a muscle ache - could not raise arm above shoulder.
I still came down with the Covid a virus, so I guess this is the break through infection; I still came down with the Covid a virus, so I guess this is the break through infection; I feel pretty sick right now; This is a spontaneous report from a contactable Other HCP (patient).   A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot Number: EL9261) via an unspecified route of administration on 10Feb2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot Number: EL9267) via an unspecified route of administration on 03Mar2021, ae at vaccination was 70-years-old, as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. I was tested on Thursday which would have been a what 2 days ago, and I came back positive for COVID-19 Virus and I feel pretty sick right now, it is not a side effect, I guess the vaccine was not effective enough. He stated that I am retired from the healthcare field but not actively working right now on healthcare, I was a nurse. On an unspecified date, it was reported by the patient that I still came down with the COVID a virus, so I guess this is the breakthrough infection. I have a batch number you needed, the first one is EL9261, and the second dose was EL9267. Consumer stated that there is no documented expiration date on his card. There is no side effect I am just sick with the COVID virus and I have taken the COVID shot. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as positive on an unspecified date. The clinical outcome of the event I feel pretty sick right now was not resolved and rest of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, the causal association between the events covid-19 and vaccination failure with the suspect drug BNT162B2 cannot be excluded.
Pt was vaccinated in the supine postiion.  Procedure tolerated well but then had a syncopal event Vitals: 113/63, 76, 10, 96.8.  Pt recovered.  Pt stable and released from the vaccination site.
Client received 2nd dose of Moderna vaccine 3 weeks after 1st dose not 4 weeks.  No complications known.
Hot itchy rash at injection site. Super hot to touch. Round ish rash that is purple red
11-30-2021, I started having a red rash with pinhead bumps that covered from the wrist to almost my elbows on both arms. It was very itchy. I treated the areas with cortisone cream. It lasted for about 2.5 weeks.
pt recv vax 5MA97 & 29MAY97 pt devel a rash consisting of 3-5lesions;
Received >3years dose instead of the pediatric dose. No adverse reaction associated with the error.
Fever, chills, headache, rash on left shoulder 4/30 thru 5/1st.
A Non-serious spontaneous report of administration of full dose in one nostril has been received from a health professional concerning a male child between the ages of 8 and 10 years-old subsequent to FLUMIST. Neither medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 01 Sep 2011. The patient received a full dose of FLUMIST in one nostril. The outcome of the event was unknown.
pt recv vax 16MAR98 & pt exp one vesiculo-pustular lesion on chest;pt also exp nausea;no fever was noted;
LETHARGY; OVERALL ACHES/SORENESS; NO ENERGY; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included anxiety/depression, and concurrent conditions included non alcohol user, non smoker, and dry cough, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage history. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805051, and batch number: 1805051 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced lethargy. On 27-MAR-2021, the subject experienced overall aches/soreness. On 27-MAR-2021, the subject experienced no energy. On 27-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargy, and nausea, and the outcome of overall aches/soreness, tiredness and no energy was not reported. This report was non-serious.
2nd dose of vaccine was postponed for 2 more weeks a day before scheduled dose; Tongue swelled up 4 hours after vaccination; covid arm; bruised; Blistered; tongue had rubbed against her teeth/ Tongue was banging up against teeth; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine was postponed for 2 more weeks a day before scheduled dose), SWOLLEN TONGUE (Tongue swelled up 4 hours after vaccination), VACCINATION SITE REACTION (covid arm), ORAL CONTUSION (bruised) and TONGUE BLISTERING (Blistered) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine was postponed for 2 more weeks a day before scheduled dose), SWOLLEN TONGUE (Tongue swelled up 4 hours after vaccination), VACCINATION SITE REACTION (covid arm), ORAL CONTUSION (bruised), TONGUE BLISTERING (Blistered) and TONGUE DISCOMFORT (tongue had rubbed against her teeth/ Tongue was banging up against teeth). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine was postponed for 2 more weeks a day before scheduled dose) had resolved and SWOLLEN TONGUE (Tongue swelled up 4 hours after vaccination), VACCINATION SITE REACTION (covid arm), ORAL CONTUSION (bruised), TONGUE BLISTERING (Blistered) and TONGUE DISCOMFORT (tongue had rubbed against her teeth/ Tongue was banging up against teeth) outcome was unknown.            Concomitant medication was not provided Treatment medication include Benadryl and Arnica .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to MOD-2021-053378 (Patient Link).
Sore arm.; Diarrhea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm.), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm.), DIARRHOEA (Diarrhea) and VOMITING (Vomiting). At the time of the report, PAIN IN EXTREMITY (Sore arm.), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Four days after vaccination approximately 90% of the body was covered in a rash (pictures available);  most of rash was under arms, legs, and back- none on face;  Rash is explained as blister-like, blotchy, and very red and itchy;  The rash lasted approximately 6-7 weeks and is slowly improving.
I had a severe headache & I was very lethargic and weak I had no strength I just laid in bed for over 3 or 4 days.
site extremly red, swollen & painful;chills, h/a & achy feeling;vaccine in the past w/o problem;
Patient only received 1st dose 28DEC2020; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient only received 1st dose 28DEC2020) 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 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient only received 1st dose 28DEC2020). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient only received 1st dose 28DEC2020) outcome was unknown. Not Provided      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.   no concomitant and treatment medications information were provided.
This is a spontaneous report from a contactable consumer (patient). A 95-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), at the age of 95, via an unspecified route of administration on Feb 22, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Feb 22, 2021, patient experienced itching, which was real bad. She wanted to know what she needs to do about it and if she can use prednisolone ointment for it. The outcome of the event: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
On unspecified dates, the pt received his 1st, 2nd and 3rd doses of Lymerix. Subsequent to his 3rd dose, he experienced paresthesia, arthralgias and myalgias. The most recent information, received on 6/6/00, reports the condition of the vaccinee is unknown.