chrisvoncsefalvay/vaers-outcomes huggingface dataset:
five years patient received Adacel instead of Daptacel, no advesre event; five years patient received Adacel instead of Daptacel, no advesre event; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a five years old female patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of fifth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot U6202BA via intramuscular route in the left thigh on 08-Jul-2019.  The patient's past vaccination(s) included four doses of daptacel vaccine and  concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for Immunization.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event reported post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Developed numbness in fingers and hands since Johnson and Johnson covid vaccine. Reported to doctor who recommended no additional vaccine shots.
Patient had a minor amount of bleeding post-vaccination that was removed with an alcohol swab.  She reports the arm was sore post-vaccination for 2 days and has what she says is a frozen shoulder.  Her pain did not subside,  and her orthopedist diagnosed her with SIRVA.  She claimed the shot was administered too high in her arm.  The patient needed anti-inflammatory drugs and has been in physical therapy for 2 months.  She states she feels almost completely better, but that she will continue to require physical therapy for at least one month.
Painful to touch and warmth at site, induration, redness, itching; ibuprofen for pain.
Nausea and diarrhea for a few hours after vaccination, then weakness in leg muscles starting next day that required assistance  to get up and walk.   Muscle weakness started to improve after approximately 12 hours.  Able to walk without assistance next day.
Pt states that two days after vaccine she developed a fever. On the third day she states she developed severe jaw pain. States she went to urgent care and was given 4mg of steroids and that helped for six days but after that the jaw pain "came back with a vengeance". States since the vaccine she has developed headaches, blurry vision, and is now partially blind without possibility of reversal. On August 14th she states she went to Hospital and was transferred to a different Hospital. States she had surgery on August 15th where they did temporal artery biopsy where she was diagnosed with "Giant Cell Arteritis" and is "a rare disease". States she was given IV steroids in the hospital for 3 days and declares she was prescribed 50mg of steroids daily that she must take for 18 months. States she can no longer drive and can only get around her home. States her primary care doctor is private and her specialist is private (Rheumatology)
5/13/22 - Patient was seen in clinic for Hives.  Patient prescribed 5 days of Prednisone (Orasone) 20 mg., Triamcinolone Acetonide (Triderm) 0.5 Ointment, Zyrtec 10 mg.  Hives went away. 5/16/22 - Patient went to Emergency due to heaviness in both legs/thighs the night before, and loss of control in the right hand the morning of 5/16/22.  MRI detected a 4 mm spot on brain and it was diagnosed as an Acute Stroke. Patient continues to have Hives periodically.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE NEUROPATHY ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Person was awaken from sleep by husband and person noticed welts, rash over entire body mostly on truck from face to legs and even under breast and on back.  Face was swollen and beet red, throat felt strange( slightly tight) , lips were tingling and swollen. Went to Emergency Department
23MAY97 was w/father & had a sz & stopped breathing-called 911;temp in ER 3:22PM t101.7,4PM 103, 4:05PM 102.5, 4:30PM 100.4;pt began to cry & act fussy;give 02-very lethargic;
The pt had mild erythema, pain on palpitations. Injection was given on 5/15/01 and the pt was seen for reaction. The pt was prescribed Atarax, Keflex and Triamcinolone.
Five days after her vaccinations her eyes started to roll under and shake up and down. I thought she was having seizures but they diagnosed her as having Nystagmus. I want to add that she had an eye exam the same day that she received the vaccinations and doctor said her eyes looked great.
Information has been received from an RN concerning a "middle school aged boy" who was vaccinated with varicella virus vaccine live. Subsequently, the pt developed a mild case of chickenpox (a few lesions). Unspecified medical attention was sought. Additional information has been requested.
Papular erythematous, mildly pruritic rash beginning on volar forearms and anterior lower extremities, then appearing on V of chest.  No vesicular lesions or mucosal involvement.  No systemic symptoms.
This spontaneous report as received from a physician via an issue of magazine refers to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported.  It was reported that, the GARDASIL had absolutely no effect on cervical cancer (Vaccination failure) and it had very many adverse effects which destroys lives and also even kills (adverse event) (life threatening and death). It was also reported that cases of Guillian-Barre syndrome, paralysis of the lower limbs, vaccine induced multiple sclerosis (MS) and vaccine induced encephalitis could be found whatever the vaccine. The outcome of many adverse effects which destroys lives and also even kills was reported as fatal. The outcome of the other events were unknown. Upon internal review, Guillian-Barre syndrome, paralysis of the lower limbs, vaccine induced multiple sclerosis (MS) and vaccine induced encephalitis were considered to be medically significant. Additional information has been requested. This case was previously considered valid, but per current process it was determined to be non-valid as no patient identifier. Therefore, it is being sent to distribution for the last time to notify all recipients. This is an amended report. The case will be sent to distribution (previously sent to non-valid).
2 inch slightly indurated pink-colored macule, warm and slightly tender. Treatment: loratadine 10 mg once daily x 7 days. Cephalexin 250 mg, 2 capsules three times daily for 7 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 25Apr2021 as dose 2, single (Lot number: EW0176), in left arm and on 13Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 33 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  Clinical course :No other medication in 2 weeks of Covid-19 vaccination.
12:45 CLIENT REPORTED HAND STARTED FEELING NUMB RIGHT AFTER INJECTION. NO C/O OF TROUBLE BREATHING. CLIENTED STATED THIS HAPPENS AT HOME ALSO AND IS "NORMAL" FOR HER. B/P 110/60, P-88, R-20.  1:00- B/P 112/64, P-84, R-16. DR NOTIFIED AND EMS CALLED. 1:15 B/P 110/62, P-82, R-18. NO TROUBLE WITH BREATHING. A & O X'S 5. 1:17 EMS ARRIVED. 1:23 CLIENT DECLINED EMS SERVICES. EMS DECLINATION SIGNED AND WITNESSED.  OUTCOME: CLIENT LEFT PREMISES DRIVING HER CAR.
Information has been received from a pharmacist referring to a 61 year old male patient. The patient had no medical history or drug reaction. On 27-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expired date were unknown). No concomitant medication was taken. On 29-OCT-2015, the patient called the reporter and stated that she experienced an injection site reaction of swelling, redness, and a "lump". No treatment was given. The outcome of the events was unknown. Additional information has been requested.
Muscle soreness; stiffness in the hand; arm feeling heavy; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26May2021 at 17:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. No relevant medical history reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and ethinylestradiol, levonorgestrel (MARLISSA) for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 05May2021 at 19:15 as a single dose for COVID-19 immunisation. On 27May2021 at 07:00, the patient experienced muscle soreness, stiffness in the hand and arm feeling heavy which was reported to get worse on 06/03/2021 at 03:00. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events, muscle soreness stiffness in the hand and arm feeling heavy was not resolved at the time of report.   No follow-up attempts are needed. Information about lot number cannot be obtained.
presented with worsening shortness of breath, generalized weakness and cough. Positive for covid. Treated with Remdesvir and steroids. pt discharged home
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient was vaccinated with his/her first dose, second dose and third dose of RECOMBIVAX HB (route, strength, lot# and dose were unknown) on 11-FEB-2011, 13-APR-2011 (inappropriate schedule of drug administration) and 23-JUL-2011 (inappropriate schedule of drug administration), respectively. No adverse effects were reported. Additional information has been requested.
pt recvd vax 11JUN93 & w/in 24 hrs pt had mass in lt anterior axilla 6.4cm, tender only to deep palpation; vax was administered in lt detloid & TB in lt forearm;
pain ,redness, and swelling at site of injection. Headache, muscle aches, fever, chills
48 to 72 hours of flu-like symptoms: muscle aches, joint pain, weariness, high temperature, headache.
Tinnitus; did not get 2th dose; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and PRODUCT DOSE OMISSION ISSUE (did not get 2th dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 Positive) in October 2020, Stomach upset, Nausea and Plasma transfusion (Donated COVID plasma). Concurrent medical conditions included Drug allergy (Allergy to eye contact solution) and Allergic reaction to analgesics (Allergy to Naproxen).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced TINNITUS (Tinnitus) and PRODUCT DOSE OMISSION ISSUE (did not get 2th dose). In 2021, PRODUCT DOSE OMISSION ISSUE (did not get 2th dose) had resolved. At the time of the report, TINNITUS (Tinnitus) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. patient stated because of this side effect she is afraid of getting second dose of Moderna covid-19 vaccine. patient reports she has no comorbidities and is overall healthy No Treatment medications were reported.
Presented with fever, sore throat, and SOB.  Recent positive covid test. Dx with Covid PNA, resp failure requiring intubation and septic shock.  Patient did not have any significant symptoms of COVID.  He was having mild cough but no hypoxia.  Initially thought that the fevers was from the recent surgery.  Patient was placed on broad spectrum antibiotics.  Infectious Disease consultation was taken.  Also seen by the orthopedic who did not feel that the patient's symptoms of fever is from the surgical site.  Infectious Disease recommended to continue the Rocephin the patient has been taking.  Patient did not have any further fevers and did not have any hypoxia.  He will be discharged home.
Twelve hours after I received the vaccine began to feel warm and flushed.  My temporal digital thermometer registered 97.6. I then began to feel chills and body aches. With about 30 minutes I developed a bad headache and tried to rest. I took two Advil and had no relief.  My heart felt like it was racing, however, I was not short of breath. I continued to self monitor and see if the Advil might help the headache. The headache and palpitations continued for the next 8 hours. I was extremely frightened.   I came very close to calling 911. I continue to feel lightheaded, headaches and fatigue as of today 5/11/2021
Pt yelled she was having trouble breathing; Assisted to seated position; EMS activated; VS placed EMS started IV and gave Benadryl. Transported to ER and Evaluated. All WNL and MD says nervous attack.
By beginning of May, pain started in both feet (at the forefoot), moved up to both knees, both wrists, 2nd and 3rd PIP joints on right hand swelled up; both TMJ swollen making opening mouth difficult. In August, purple/red rash appeared on left arm around injection site, hot to the touch, sore and itchy.  2 weeks later rash appeared on side of face by left ear, also purple/red, itchy and warm. Smaller rash appearing on right side by ear now.
Light Headache; Some Myalgia; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 27Apr2021 at 11:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included prostate cancer and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not receive any other medication within two weeks of vaccination. Patient had no known allergies to food, medication or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation.  On 28Apr2021 at 05:00, the patient experienced light headache and some myalgia. 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 event light headache and some myalgia was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Large redness, swelling, itching to left arm (TDAP) and mild redness/swelling to right arm (MENVEO).
This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 09-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal (explicitly coded as product leakage). The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses (explicitly considered as drug administration error). There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/30/21. Lot#026L20A; 2nd dose: 01/27/21, Lot# 029L20A; Diagnosed covid positive: 03/31/21; Exposure: Unknown; Symptoms: Nasal  Congestion, loss of smell.
This spontaneous report as received from a 58 year old female patient refers to herself. Year half ago on an unknown date in 2012 the patient was vaccinated with ZOSTAVAX (one time injection, injection, lot# was not reported). Year half ago on an unknown date in 2012 the patient experienced a raised rash which comes and goes and is very itchy, the area on left arm does not tan. The patient did visit dermatologist who did not know how to treat condition. The outcome of a raised rash was reported as not recovered/resolved. Additional information has been requested.
Two patients were vaccinated with adacel which was not viable, no AE; Initial and additional information was received on 31-Dec-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp (office staff).  This case is linked to case 2020SA001845 (same reporter).  This case involves a 38 years old female patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot: U6602AA, expiry date: 25-Feb-2022) via intramuscular route at right deltoid on 30-Dec-2019. It was reported that the vaccine was not viable due to delayed transit.   The patient's medical history, past medical treatment, past vaccination and family history were not provided. At the time of the event, the patient had ongoing cough and nasopharyngitis. Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) on 28-Dec-2019 for Immunisation.  It was an actual medication error due to incorrect product storage.  At the time of reporting, the patient did not experienced any adverse 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 Directive and Module VI of the 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.
11 hrs after receiving, BEXSERO #2, he developed a fever, chills, and headache. He vomited x 5hrs. He was evaluated by Dr. about 22hrs, after all was well-appearing, having only a mild residual headache and no lesions at the injection site.
pt recvd vax & exp fever of 102, gen rash of more than 5 lesions on face & arms;No further details were provided;
Chilis; feeling tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chilis), FATIGUE (feeling tired) and HEADACHE (headache) 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 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chilis), FATIGUE (feeling tired) and HEADACHE (headache). At the time of the report, CHILLS (Chilis), FATIGUE (feeling tired) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
No adverse event; immunocompromised patient, no 3rd dose/1st booster dose administered instead of 3rd dose; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient, no 3rd dose/1st booster dose administered instead of 3rd dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A, 014M20A and 008B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised and Lupus erythematosus since 2019. Concomitant products included HYDROXYCHLOROQUINE for Lupus erythematosus.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient, no 3rd dose/1st booster dose administered instead of 3rd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient, no 3rd dose/1st booster dose administered instead of 3rd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient are immunocompromised asks when they can can get the new bivalent booster dose. They were diagnosed with lupus in 2019 and was on hydroxychloroquine since then.  Patient took 2nd Booster dose on 4-Jun-2022 lot number 014B22A No treatment medication was provided by reporter.