chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had to receive the 1st dose twice; Patient received the 1st dose for the second time 45 days after the first time; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient had to receive the 1st dose twice) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose for the second time 45 days after the first time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient had to receive the 1st dose twice) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose for the second time 45 days after the first time). At the time of the report, EXTRA DOSE ADMINISTERED (Patient had to receive the 1st dose twice) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose for the second time 45 days after the first time) outcome was unknown.            No concomitant medication was reported.  Caller stated he first received the first shot in Jan-2021, then due to some confusion regarding the vaccination site, 45 days after one nurse told him to do the first dose all over again, so he received the first shot again on 03-Mar-2021 and 30 days later he received the second shot, after that on 04-Nov-21, he received his first booster, so would like to know how long should he wait for the second booster.  No treatment information was provided.   This case was linked to MOD-2022-539720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow up information was received contains no new information.
myocarditis; EF 70%; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient in his 60's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; EJECTION FRACTION ABNORMAL (non-serious), outcome "unknown", described as "EF 70%". The patient underwent the following laboratory tests and procedures: Ejection fraction: 70 %, notes: EF 70% being evaluated. Therapeutic measures were taken as a result of myocarditis, ejection fraction abnormal.  Clinical course: Patient experienced myocarditis s/p receiving 3rd booster of Pfizer vaccine. EF 70% being evaluated and treated by a cardiologist specializing in Covid-19 related cardiac issues.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. 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.
Severe body aches, fever, tachycardia, leukocytosis resulting in admission for observation on 4/3/2021. Patient just admitted inpatient at the time of report.
No additional AEs; temperature excursion with VAQTA which was administered to a patient; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, drug reactions, concurrent conditions and concomitant therapies were not provided.  On 01-JUN-2021, the patient was vaccinated with an incorrect stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T020109, expiration date reported as 26-JAN-2022, 0.5 milliliter, for prophylaxis (strength and route were not reported). The administered dose experienced a temperature excursion of 47.1 degree Fahrenheit for 15 minutes. No previous temperature excursion. A digital data logger was not involved. No adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
had them really being tired; her husband had a headache; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for her husband.  A male patient of unspecified age had received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 13APR2021 as a single dose for COVID-19 immunisation. Past medication included Tylenol. The patient medical history included knee pain. Caller stated she was reading what to expect and she read not to take tylenol before the vaccine and she took tylenol 600 mg before the vaccine for knee pain. Caller stated she is having knee surgery but HCP said to wait until she had the vaccines and wanted to know if she should protected even though she took the tylenol before the vaccine and asked are they doing research on how tylenol affects the vaccine. Caller stated she is overly tired and everything so the vaccine must be protecting her immune system and had to go back to bed after she got up and was up a couple of times during the night and patient had a headache. At the time of reporting, the outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Woke up in the middle of the night with a sore arm and chills (shaking so hard I could not sleep.) Took temperature the next morning and was 101.2. Had headache, tiredness/weakness and temperature the entire following day. Continue to feel weak.
Patient reported redness and swelling at first. Then she said it got very bumpy under the skin and very hot.
upper/ mild back pain; nerve issues down left arm; weakness in fingers/hands upon awakening each day; super tight left shoulder/neck side; super tight left shoulder/neck side; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on (20Aug2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient).  A 49-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EW0175, expiration date was not reported), via intramuscular route, in left arm, on 01May2021(at the age of 49-year-old), at dose 2, single for covid-19 immunization at Pharmacy/drug store. The patient had no medical history. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8729, expiration date was not reported), via intramuscular route, in left arm, on 08Apr2021, (at the age of 49-year-old) at dose 1, single for covid-19 immunization. The patient experienced upper/ mild back pain (4 days after second dose) which started in lower back then moved to bra line, nerve issues down left arm, weakness in fingers/hands upon awakening each day, super tight left shoulder/neck side. The events onset date was on 05May2021 at 18:00. The seriousness criteria was persistent/significant disability/incapacity and the event required visit to intensive care unit with treatment of chiropractor, acupuncture, Herbal supplement. The patient underwent lab tests and procedures which included blood test, urine analysis, magnetic resonance imaging cervical/thoracic: normal on an unspecified date, COVID-19 CoV-2 RNA on 30Mar2021, COVID-19 on 05Jul2021; both tested negative. The outcome of the events was recovering (not yet fully recovered).
He had headaches on the same day; Second dose also in February, two  weeks a part; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (He had headaches on the same day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose also in February, two  weeks a part) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HEADACHE (He had headaches on the same day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose also in February, two  weeks a part). In February 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose also in February, two  weeks a part) had resolved. At the time of the report, HEADACHE (He had headaches on the same day) outcome was unknown.            No treatment medication was provided.  Patient was on concomitant medication- blood thinners, heart medications, blood pressure, cholesterol, diabetes and pain medications.   This case was linked to MOD-2021-377203.
A few weeks after receiving the second dose, I started having heart palpitations. I noticed that it would beat real fast. I could feel it more at night when I would lay down. It didn't affect me when I was exercising, but I experienced heavy beats. My father has heart valve problems so I visited with my doctor on 04/27 and he did an EKG. The EKG came back normal. As of today, I still have a heavy beating heart. It's not fast anymore, but it still beats hard. This mainly happens at night, when I bend down or lift something heavy.
Within 10 minutes of shot was dizzy, cold clammy hands. Fingers were red and collapsed in mom's arms. Was conscious and breathing okay B.P. 100/80 pulse 114
Vaccine given around 10:30 am on 08/07/18. Pt was feeling well. Around 3:00 am on 08/08/18 mom noticed pt. feeling unwell, temp 102.5 degrees F vomiting. Went to sleep around 5:30 am after keeping MOTRIN down. As of 8:30 am pt. still asleep and appears well to mom.
Patient received the 12+Pfizer vaccine instead of the Pedi dose for 5-11 years
Information has been received from a physician's assistant concerning a 21-year-old male with no pertinent medical history and no drug allergies or reactions, who in 1998 was vaccinated with Varivax. Last week (approximately 01-JAN-2007) the patient experienced chicken pox and had fever, myalgia and his entire body was covered with lesions. The patient was in the emergency and at his physician's office and was diagnosed with chicken pox. No diagnostic studies or laboratory tests were performed. Treatment was acyclovir. At the time of this report, the patient had not recovered completely. It was also noted that the patient's mother had shingles in the last week and a half. No additional information to report. There was no product quality complaint. Additional information has been requested.
Dose 1-Chronic diarreha (3-5/day) 26 Mar to present. I've lost 10-15 lbs. Dr ran stool tests, no harmful bacteria. Dose 2-23 Apr- Severe joint pain both hips & shoulders. Numbness legs & arms. Affected balance & abiity to walk. One fall due to numbness in left leg, hip down. Using cane to avoid falling, to present day. At night, both feet burn.
received first dose of Shingrix 2 years ago (2019) and would like the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years before the reporting date in the year 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was a pharmacy student. The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose till the time of reporting which led to incomplete course of vaccination. The reporter asked if the patient could get the second dose of Shingrix.  The patient would like to receive the second dose of Shingrix.  The reporter was unable to provide the vaccine details.  The reporter did not consent to follow-up.
Information has been received from a registered nurse concerning an approximately 40 year old female who on an unknown date was vaccinated with a dose of MMR II (lot no., dose and route not reported). The nurse reported that the patient had negative rubella titers but positive titers for mumps and measles. No adverse effect was noted. Additional information has been requested.
blood pressure was high at 160/90; Injection site reddish and oval shaped; Itching around the injection site; Left eye blood covered inside; Kind of sleepy; A spontaneous report was received from a consumer who was also a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported left eye blood covered inside (eye haemorrhage), feeling kind of sleepy (somnolence), itching around injection site (injection site pruritus), injection site reddish and oval shaped (injection site erythema), and high blood pressure at 160/90 (blood pressure increased).  The patient's medical history was not provided. Concomitant medications included flecainide acetate and finasteride.  On 29 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Feb 2021, the patient felt kind of sleepy.  On 05 Feb 2021, his left eye was covered with blood inside and he felt itchiness at the injection site.   On 07 Feb 2021, the injection site became very red and was oval in shape and it was about two an half by four inches. On that same day, his blood pressure was high at 160/90.  He said his normal blood pressure was 20/70.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The event of blood pressure was high at 160/90 was not resolved at the time of this report.   The outcome of  left eye blood covered inside, kind of sleepy, itching around injection site, and  injection site reddish and oval shaped was unknown.; Reporter'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.
Thiss spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. Patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients received doses of improperly stored RECOMBIVAX HB (lot# K006682, expiration date: 17-DEC-2015, lot# J013394, expiration date: 25-AUG-2016 or lot# J014855, expiration date: 16-APR-2016), dose and route were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Swelling of lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Swelling of lymph nodes) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001658) for COVID-19 vaccination.     no medical history was reported.     On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced LYMPHADENOPATHY (Swelling of lymph nodes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (Swelling of lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications were provided.
Pt recvd vax  12NOV92 & exp diarrhea, nausea, & vomiting;
Appx 1-2 weeks after first shot and worse after 2nd shot, developed blurry spots in left eye. Was H35.341 Macular Hole. Had to have vitrectomy surgery. Left with some wavy vision in left eye. Also got blurry vision H43.821 VitreoAdhesion right eye (small amount of pulling). Got worse after 2nd shot (more open area in scan- pulled away further). A few days after 3rd shot, vision in left eye got wavier and VitreoAdhesion in right eye got worse (open area in scan doubled - pulled away even further). Vision got blurrier.
Information has been received from a pediatric nurse practitioner referring to a 4 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 26-APR-2018, the patient was vaccinated with the first dose of PROQUAD (therapy type: rHA, subcutaneous, lot # N020620, expiration date auto generated as 22-JAN-2019; dose were not reported) and the first dose of VAQTA (intramuscular, lot# N020689, expiration date auto generated as 22-OCT-2018) for prophylaxis. Both of the drugs were freeze temperature excursion. The patient's dose were valid and not recommended to repeat. No treatment was given to the patient. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA006349.
No adverse effects reported; Pharmacist states patient received dose of PNEUMOV AX 23 that was improperly stored.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information on pertinent medical history, concomitant medication and drug allergies/reactions was not reported.  On 07-OCT-2019 the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (Lot # S012246, expiration date 10-FEB-2021; dose, frequency and route were not provided) for prophylaxis.  The administered dose of the vaccine experienced a temperature of 68 Fahrenheit (F). Time frame was 8 hours. Previous temperature excursion was 57F for 2 hours. The digital data logger was involved.  No adverse effects were reported.
pt recv vax & 15-20min later pt devel diffuse urticarial rash all over body-responded well to epi & DPH;
Fever, chills, aches. Vomiting. Started w/in 10 hours of the vaccine and was previously well. 36 hours later, pt. largely improved with some headache persisting.
PT recd 10JUN91; exp'd n/v/d, gen. myalgia & rt-sided tender abdomin; rx for n/v & PT will be given a gallbladder workup; 48 hrs later PT slightly improved; reporter indicated events not related to vax; no ADR to 2nd dose given on 10JUL91
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "past stroke" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (the first dose), for covid19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 01Mar2021, outcome "recovered" (2021), described as "headache". Therapeutic measures were taken as a result of headache included some ibuprofen.  Additional Information: the patient is the reporter mother. No other vaccine in four weeks. No covid prior to vaccination and no covid test post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 62 year old male patient. On an unknown date, the patient inadvertently received a dose of pediatric RECOMBIVAX HB 2.5 mcg/0.5 ml (lot #, batch #, dose and route of administration were not provided) as his first dose of the series. No adverse effects were reported. Additional information has been requested.
Ringing in ears; This is a spontaneous report from a contactable consumer (patient).   A 76-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3246) at single dose, in the left arm, on 25Jan2021, at 04:45 PM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was unknown. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included metoprolol, gabapentin, triamcinolone acetonide (SYMCORT), chlorthalidone and doxepin. On 26Jan2021, the patient experienced ringing in ears. No treatment was received. Clinical outcome of the adverse event was unknown at time of this report. Post the vaccination, the patient has not been tested for COVID-19.
Patient presented with transient fever and confusion 1 day after receiving COVID-19 booster (Moderna)  similar to his presentation last year in October 2022 1 day after COVID 19 booster (COVID 19- Pfizer at that time).
Pt recv vax on 10/14/97; within 15 min post vax pt exp itching, vax site red & swollen w/ erythema near site
06/03/2021- Patient presented to the emergency department complaining of drainage from his left-sided pacemaker site for several weeks. Patient was experiencing chills, however he was negative for fevers. He was subsequently admitted for further management of pacemaker pocket infection and IV antibiotics.  He was transferred to a Medical Center on 6/10/2021 for further infection management.
Myalgia fatigue, itching/pain/erythema/swelling at injection site
On 8/17/00, pt developed a fever of 102. Parent gave Tylenol and Motrin. Fever on 8/18/00 was 104. Complained of headache and neck ache.
Fever to 102 degrees F and vesicular zoster-like rash on (L) volar forearm (injection was given (L) deltoid). Body aches.
Information has been received from a consumer concerning her 6 year old son who has a pcn allergy and a Ceftin allergy. In approximately 1996 at the age of 15 months, the pt was vaccinated with varicella vaccine. On 10/04/2001, the pt developed varicella along with 7 other students at his school. The pt had received medical attention for his experience. The consumer also reported that 14 other pts developed chicken pox after vaccination with varicella vaccine. Follow-up info has been received from the pt's physician who reported that on 03/19/1996, the pt was vaccinated with the first dose of varicella vaccine and MMR vaccine. In October 2001, the pt developed chicken pox. Subsequently, the pt recovered. The physician also reported that the pt's siblings three females and one male developed chicken pox after vaccination with varicella. No further info is available.