chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose administered after 48 days of first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered after 48 days of first dose) and EXTRA DOSE ADMINISTERED (Additional dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A, 036B21A and 088D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered after 48 days of first dose). On 18-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Additional dose). On 15-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered after 48 days of first dose) had resolved. On 18-Aug-2021, EXTRA DOSE ADMINISTERED (Additional dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was mentioned.   This case was linked to MOD-2021-290978 (Patient Link).
Big red warm round rash and swollen area at injection site.  Appeared next day.  Sore to touch.  Otherwise fine.
This spontaneous prospective pregnancy report was received from a nurse referring to a currently 18 year old female patient with amoxicillin allergy. No other information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 14-JUN-2018 the patient was vaccinated with her second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 25-JUN-2018, the patient was seen in the physician office and it was confirmed she was pregnant. The LMP and EDD were not known. The pregnancy outcome was pending. On an unspecified date, a "routine prenatal lab work" was performed (results not provided). No adverse effects were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "Major Depressive Disorder" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; METHIMAZOLE; PROPRANOLOL; METFORMIN; GLIMEPIRIDE; LANTUS. Past drug history included: Intolerant to erythromycin, reaction(s): "Intolerant". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Experienced Covid rebound. Sxs started Saturday 02Jul2022. Tested positive and continued to test positive along with sxs until Jul162022; (02Jul2022) Positive, notes: Experienced Covid rebound. Sxs started Saturday 02Jul2022. Tested positive and continued to test positive along with sxs until Jul162022. Therapeutic measures were taken as a result of drug ineffective, covid-19 included COVID 19 Treatment with Paxlovid from 19Jun2022 to 23Jun2022.  Clinical course: The patient experienced Covid rebound. Sxs started Saturday, 02Jul2022. Tested positive and continued to test positive along with sxs until 16Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 20 year old female patient who on 17-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine intramuscularly. Concomitant therapy included hormonal contraceptives (unspecified). On 17-JUN-2008 the patient experienced flu like symptoms, fever, stomach ache, stomach pain, nausea, vomiting and headache, she lost 23 pounds after receiving the vaccine. The patient's symptoms went away and came back after the second dose GARDASIL vaccine intramuscularly. The patient's flu like symptoms, fever, stomach pain, nausea, vomiting, headache and weight loss persisted. On unspecified date the patient had an Endoscopy done (results not provided). Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2009. Follow up information has been received for a licensed practical nurse concerning a 20 year old female patient who on 17-Jun-2008 was vaccinated intramusculary with the first 0.5 ml dose of GARDASIL. The nurse is reporting that physician advised the patient not to get the third injection of GARDASIL. Additional information has been requested.
Bilateral arm myalgias and bilateral lower extremity myalgias. Bruise at injection site
Booster; Congestive Heart Failure; Arrhythmia; Heart Attack; This is a spontaneous report from a contactable consumer.  An elderly female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 22Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included covid-19. Historical vaccine inlcuded bnt162b2 dose 1 on 06Jan2021 and dose 2 on 26Jan2021 both for COVID-19 Immunization.The patient's concomitant medications were not reported. The patient experienced congestive heart failure (death, hospitalization, life threatening) on 26Oct2021, arrhythmia (death, hospitalization, life threatening) on 26Oct2021, heart attack (death, hospitalization, life threatening) on 26Oct2021. Therapeutic measures were taken   Lavix, Nitro paste (nitroglycerin); Transferred back to Long-Term Care Facility. The patient died on 30Oct2021. Autopsy was not performed.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart Attack; Arrhythmia; Congestive Heart Failure
About 3 hours After I got my vaccine I couldn?t see straight I was vomiting non stop couldn?t keep food or water down . Had pain in my chest and shooting pain down my back and dizziness ? I had a health visit with my doctor and he ordered me a iv to get fluid in my body
Mom brought her 10-year-old daughter and 12- year-old son to the clinic.  Both got appropriate stickers on check in to show age, per process.  Both kids and mom went to the 5-11 table first (per process).  However, instead of the mom taking the 12-year-old directly to the 12+ table, she had to take to 10 year old out to the car as there were younger kinds in the car.  After the mom cam back from the car, she accompanied the 12-year-old to get his shot.  By that time it was the end of the clinic and things were wrapping up.  Appears 12-year-old was given a  5-11 COVID shot as that is what was documented.  Staff cannot say for sure if a clerical error, so have to go by documentation.
pt recv vax 245PM & 5PM pt spiked a fever of 103-104 & high pitched crying;pt was inconsolable;pt was taken to ER on 22MAY97 & was told was fine;took to see MD 23MAY97 felt it was a rxn to vax & advised against giving pertussis again;
Fever, headache, ache , whole busy heard. Generalized lymph node on left side of my neck
Second dose administered too early: Received second dose only 17 days after first dose, not 21. (Pfizer).
No Adverse Event; Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster; Vial caps and labels for Monovalent and Bivalent look too similar; Vial caps and labels for Monovalent and Bivalent look too similar; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Live follow-up contains non-significant follow up -QE ID added.
Pain in arm; received first dose of Moderna COVID-19 vaccine after receiving two doses of Pfizer COVID-19 vaccine; Moderna Covid-19 dose accidentally given instead of second dose of Shingrix; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Apr-2021. The most recent information was received on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Covid-19 dose accidentally given instead of second dose of Shingrix), PAIN IN EXTREMITY (Pain in arm) and INTERCHANGE OF VACCINE PRODUCTS (received first dose of Moderna COVID-19 vaccine after receiving two doses of Pfizer COVID-19 vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Heart disease, unspecified. Concomitant products included VENLAFAXINE, OMEPRAZOLE, FENOFIBRATE, ATORVASTATIN, LOSARTAN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CARVEDILOL.   On 06-Feb-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1st dose. On 27-Feb-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 2nd dose. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna Covid-19 dose accidentally given instead of second dose of Shingrix) and INTERCHANGE OF VACCINE PRODUCTS (received first dose of Moderna COVID-19 vaccine after receiving two doses of Pfizer COVID-19 vaccine). On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 01-Apr-2021, WRONG PRODUCT ADMINISTERED (Moderna Covid-19 dose accidentally given instead of second dose of Shingrix) and INTERCHANGE OF VACCINE PRODUCTS (received first dose of Moderna COVID-19 vaccine after receiving two doses of Pfizer COVID-19 vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        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.   Treatment information was not provided.  This report refers to a case of wrong product administered for mRNA-1273 with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: TCR included no new information. On 22-Apr-2021: events updated; Sender's Comments: This report refers to a case of wrong product administered for mRNA-1273 with no associated AEs.
On 10/2/12 patient reported that shortly after receiving her vaccination on 9/28/12 she developed a local reaction at the site some swelling, itching, skin warmth. Over the course from 9/28 to 10/2 the swelling remained constant but the itching worsened. I instructed her to take some OTC diphenhydramine prn and put ice on the area and asked her to report back in 1-2 days with her condition.
Extreme fatigue, confusion, extreme headache, loss of balance leading to falling, inability to use arms or legs to get up
Pt recv vax on 3/12/98; 1 hr post vax pt exp cold, clammy, white hands, goosebumps & backache; tx=lie down; pt imp 30 min
Large yellow bruise with scattered small purple  bruises inside from time of vaccine.  Minor arm  pain.  Beginning March 14, noticed swelling and redness surrounding yellow bruise which was still quite large with purple remaining the same as on day of vaccination.  Treated at ER at the Hospital.  Diagnosis Adult Cellulitis.  Prescribed Clindamycin HCl  every 6 hours and Mupirocin Calcium ointment three times daily.  The redness cleared up within three or four days, and the bruise is much smaller and almost gone  as of today, 3/28/2021.  No pain was associated with any of this save from the minor arm pain from the vaccination.
5 x 6 cm area erythema (L) thigh at site of injection 4 crusted vesicles lower back.
Case number PHEH2014US022277 is an initial spontaneous report received from a consumer (who was a medical assistant) on 03 NOV 2013, with the follow-up received on 11 NOV 2014. This report refers to a 43 years old female patient. Her medical history and concomitant medications were not reported. The reporter stated that she got some FLUVIRIN 2014/2015 (batch number: 411201) topically on her when she was withdrawing the vaccine on 03 NOV 2014. No adverse events were reported following the medication error.   11/16/2015: Follow-up report received from a consumer on 11 NOV 2014: Updated vaccine exposure date (03 NOV 2014). Non significant follow up report from Vaccine Adverse Event Reporting System (VAERS) received on 30 March 2015, updated the VAERS ID 561556.
Pt states that for about 12 hours on the day she received the vaccine she noticed tingling through her limbs, veins, and extremities that lasted overnight. Then, about 7 days after she received the vaccine she noticed her hands were swollen. She states they are "arthritic like" and this issue is still present today. She states she is taking advil to help with the pain in her hands.
Patient received first dose of Moderna COVID-19 vaccine on 4/10/21. In the observation lot, patient complained of a scratchy throat. Denied hives or itching. He was assessed by a Dr. and given diphenhydramine 25 mg po x1. He was observed for 30 min and discharged home.
Swelling, breathing problems, requiring oxygen, hives, rash, itching, diarrhea. Also, I was given the TDAP vaccine, despite being allergic to it, when I was pregnant with her and believe this may have also caused vaccine injury to her while she was in utero.
Fully vaccinated 83 year old male admitted with Covid-19 pneumonia.  Symptom onset with cough, dyspnea, fatigue, lethargy on 6/5.
She stopped sleeping and became fussy - discontent 24/7. She did not develop much or roll until 9 MO - 3 MO after last vaccine. Diagnosed with extreme colic - she screams, grunts, groans all day, still doesn't sleep at night - Told Doc - they don't acknowledge. Took to acupuncturist and she did a muscle sensitivity test to try and help figure out symptoms since her PCP doesn't ever have an answer and the DTaP came back as sensitivity and affecting her.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/09/2021 and 03/02/2021. They presented to Emergency Department on 09/25/2021 after about 6 days of shortness of breath and increasing oxygen requirements.. The individual was admitted to hospital 09/25/2021 and tested positive for COVID-19 upon admission. The individual experienced complications of COVID-19 pneumonia and a cardiac arrest. They were transitioned to comfort care only and died in the hospital on 10/01/2021.
stated Daptacel administered instead of ADACEL for 8 years old patient with no reported adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old female patient where it was reported that daptacel (DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE) administered instead of adacel for 8 years old patient 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 POLIO VACCINE (POLIO VACCINE) for Immunisation.  On 01-Sep-2022, the patient received a third dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot C5829BA, expiration date: 01-Mar-2023, via unknown route in unknown administration site as Immunization.  On 01-SEP-2022 the daptacel was administered instead of adacel for 8 years old patient with no reported adverse event (wrong product administered) same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (stated Daptacel administered instead of ADACEL for 8 years old patient with no reported adverse event).  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.
Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They reported throat closing. They were treated by EMS on site with methylprednisolone. Vaccine recipient took their own epinephrine and diphenhydramine. They were transported to emergency department. They reported with an allergic reaction and face swelling. They were administered famotidine. During reexamination, the patient?s symptoms improved and they were discharged to home. Registered 03/03/2021 10:38 AM, Discharged 03/03/2021 1:41 PM.
heart rate elevated; hypertension; not take the second dose; not take the second dose; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL S) taken for lupus, start and stop date were not reported. The patient experienced heart rate elevated and hypertension in 2021 which she observed at the Hospital where she is working with outcome of unknown. Patient was told not to take the second dose and because she is taking Plaquenil (immunosuppressant medication) due to lupus and new medication is Methotrexate which she did not yet take because she is afraid to lower down her immune system. Patient is asking if she needs to take the 2nd dose vaccine because she was told by her Rheumatologist not to take the vaccine which is too risky and the Primary Care Physician said that it is okay to take it.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2015US018002 is an initial spontaneous report from a consumer received on 11 Sep 2015. This report refers to a 14-year-old male patient. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 15 Aug 2015. On an unknown date, after vaccination he experienced scratchy throat, fluid behind ears and mild fever. The outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
50-60 employees @ a nursing home were vaxed w/Engerix-B beginning DEC90; Repoter thinks it was ID; all employees have recvd 3 doses; titer checks now are coming back neg;
12/2021: 2-3 weeks after booster vaccine I started having hand shaking and body shaking; in 02/2022  I went to medical appointment and I was found to be in A-Fib with RVR; required ED visit and lab work was done and I was  found to have Graves Disease and hyperthyroidism requiring treatment and hospitalization.  Annual thyroid labs had always been normal in the past.  Now requires treatment with Methimazole, Propranolol and Eliquis.  3-4 weeks ago began having eye discomfort, dryness and itching which required ophthalmology visit and CT pending to determine if Graves Eye Disease; new Rx Restasis.
By the morning of 9-22-19, there was a red hot welt around the injection site. It was about four and a half inches long and about  3 inches wide. It was not symmetrical. It itches a lot.  That morning I returned to the pharmacy to see if this was a normal expected reaction. I showed the pharmacist my arm. The pharmacist said I could use something to stop the itching and that I should report this as a n adverse reaction.  It is now the evening of 9-24-19 and my arm  is still red and itches, but not nearly as bad as it was. I continue to use something for the itching.
3 pts recvd 3 doses of Engerix-B, 1 pt recvd the vax in the buttock & had no response;