chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported.; a syringe of VAXNUVANCE broke when the needle was attached.; the patient was administered the full dose of VAXNUVANACE from the syringe involved in the product  compliant; This spontaneous report was received from an office manager and referred to a patient of unknown age and gender. The medical history, current conditions and concomitant medications were not provided.  On 22-JUL-2022, awhen the needle was attached to pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), the interior portion of the syringe where the luer-lock was located broke (Syringe issue). The syringe did not broken into 2 or more pieces. The tip of the syringe or Luer lock adaptor did not loose or broken off of the syringe tip. There was no difficulty to attach the syringe needle to the syringe and the needle was 25Dx1 inch eclipse needle. The syringe tip cap attached properly prior to use. The syringe tray intact and undamaged on receipt. The cellophane covered the syringe tray intact and was completely sealed. The syringe carton did not damage prior to use.   Although the luer-lock broke, the vaccine was still able to be administered. Then, on the same day (22-JUL-2022), the patient was vaccinated with the full dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (dose: 0.5 milliliter, lot #U036156, expiration date: 25-MAY-2023; route and strength were unknown) for prophylaxis (Poor quality product administered). A biohazard mailer for retrieval of the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was arranged. On 28-JUL-2022, the product was returned. The pictures of the defective syringe were submitted. No additional information provided. No additional AE reported.
At 17:10, client began experiencing an allergic reaction. Client began experiencing tight throat, tongue swelling, and a raspy voice. (RN), stayed with client until 17:45. RN educated client if symptoms got worse, go to urgent care or the ER. Client was able to talk with no problem with no shortness of breath. RN walked with client to her car, which she able to do no problem.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 05-OCT-2015 (dosage, lot number, and route of administration unknown) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-JUL-2016, the patient was treated by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as chronic herpes zoster, or shingles. The patient was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient developed shortness of breath, cough, chest tightness, and tachycardia
Patients that received vaccines from the affected lots after the temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. Treatment information was not provided.
3/1/18 Patient called stated has been having shortness of breath on exertion/exercise; feels that she tires out easily. We called her doctor (primary care) and they were going to call her.
Approx. 12 hours after injection, arm swollen, red and tender.  Extended below injection site, elbow and into forearm.
Swollen, painful, upper left arm started on 10/31/17. When reported to the pharmacy on 11/1/17, patient stated it had started to get better. Recommended a OTC pain medication for the pain.
Chief Complaint: Fall , Weakness, scalp hematoma.  COVID positive.  O2 requirement,home with home health.
At 5 o'clock started with gastrointestinal issues, Then extreme fatigue and neurological issues.  Next day became hypertensive which remains problematic to this day plus worse breathing  issues requiring  higher concentration of O2.  Fatigue and confusion is  now similar to when I 1st got discharged from the hospital in July 2021
17 years of age patient received the 1st dose of Moderna COVID-19 vaccine; A spontaneous report () was received from a nurse concerning a 17-years-old female patient, who received moderna's covid-19 vaccine (mrna-1273).  The patient's medical history included asthma. Concomitant medications reported included corticoid steroid inhalator for asthma.  On 30 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the left deltoid arm for prophylaxis of COVID-19 infection.  On 30 JAN 2021, the patient received mRNA-1273 vaccine when she was 17 years old. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of the event, vaccine administration at inappropriate age was unknown.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 012M20A) with no associated AEs reported.
A non-serious, spontaneous report of administered FLUMIST to a person over 49 years of age and slightly stuffy nose has been received from a nurse concerning a 61-year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 11-Sep-2009. The only observable change in the patient following FLUMIST was a slightly stuffy nose. The patient recovered from the event of slightly stuffy nose on 14-Sep-2009. Additional information was received on 06-Oct-2009 and incorporated into the narrative: updated outcome.
I get even worse dizzy spells than before, irregular breathing, fast paced heart beat, and higher blood pressure that is normally controlled by hbp meds that ive been on for over a year
the area is increasing becoming very big; Tired; watery eyes; (left eye) become itchy; pain in eye; area became reddish; sore arm; skin rash started spreading; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LACRIMATION INCREASED (watery eyes), EYE PRURITUS ((left eye) become itchy), EYE PAIN (pain in eye) and ERYTHEMA (area became reddish) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ERYTHEMA (area became reddish) and RASH (skin rash started spreading). On 11-Apr-2021, the patient experienced LACRIMATION INCREASED (watery eyes), EYE PRURITUS ((left eye) become itchy) and EYE PAIN (pain in eye). On an unknown date, the patient experienced SWELLING (the area is increasing becoming very big) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (sore arm), LACRIMATION INCREASED (watery eyes), EYE PRURITUS ((left eye) become itchy), EYE PAIN (pain in eye), ERYTHEMA (area became reddish), SWELLING (the area is increasing becoming very big), RASH (skin rash started spreading) and FATIGUE (Tired) outcome was unknown. Not Provided      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.   No concomitant medication details were provided. No treatment medication details were provided.
10 days after receiving vaccine I experience spread hives and throat itchiness. Went to ED. Took Prednisone for the next 7 days with hydroxixyne which totally alleviated all symptoms. Also I went to my Primary Care MD for f/u. After treatment hives started again, then I started to take benadryl orally which kept my symptoms in check but today it came back worse again despite medication.
Tingling right arm; red mark appearance; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red mark appearance) and PARAESTHESIA (Tingling right arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH ERYTHEMATOUS (red mark appearance). On 07-Mar-2021, the patient experienced PARAESTHESIA (Tingling right arm). At the time of the report, RASH ERYTHEMATOUS (red mark appearance) and PARAESTHESIA (Tingling right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported Treatment details included Tylenol.
This Tdap was given as no history of tetanus was known for a long time.  Client had received one on 01-22-2008. This was found when I went to enter the shot, and I should have looked at that prior to administration of the shot.  Cient was informed and no known reaction or complication is known.
She died in the bathroom on the second day.; This is a spontaneous report from a contactable consumer.  This reporter reported similar events for 3 patients. This is 2nd of 3 patients.   A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. It is reported the patient died in upstate. Waiting on the autopsy. She died in the bathroom on the second day. It was not expected. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The outcome of the event was fatal.  Information on Lot/Batch has been requested.; Reported Cause(s) of Death: She died in the bathroom on the second day.
mom states pt wouldn't stand, was breathing funny;twitching occasionally, reduced appetite;fever 102.9;in ER pt was given Ibuprofen which reduced fever;only reduced appetite & low grade fever remain today;pt is also still teething;
I have always been very energetic but since I received the 1st COVID Vaccine, I have been extremely tired. After 12:00 pm. I need to take a nap and am tired for the rest of the day.  Got worse after the 2nd COVID vaccine     Came down with fluid in my lungs.
Experienced a reaction / felt the "Face little puffy"; This case was reported by a pharmacist and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows:  The age at the vaccination was not reported. After receiving dose of Shingrix, the experienced a reaction and felt the face a little puffy. The HCP did not have any other information about the vaccine or the reaction. The reporter consent to follow up.
After about 13 hours I started feeling fluttering heartbeats, body aches, and slight nausea. This continued from 8:00-3:00 when things then got a lot worse.  The nausea increased, body chills started, tingling of body, body aches and vomiting.  This continued until around 11:00 pm when I finally started feeling well enough to get some rest.  I slept through the night and felt much better in the morning.  I still feel very tired, weak, and slightly sick but much better than the first day.
pt w/temp of 104.3 was brought to Er on 28APR98 p/sz @ home w/post ictal sz state;
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose number unknown, single (Lot number: EN6198) at the age of 69 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "IPF" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: Pirfenidone; Gabapentin; Valsartan; Indapamide; Omeprazole; Nifedipine; NAC [Acetylcysteine]; Quercetin; Ezetimibe; Diazepam; Pravastatin. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin", notes: known allergies: Levaquin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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; (Jul2022) Negative, notes: positive test 4 days after testing negative following a full 5 day course of Paxlovid; (28Jul2022) Positive, notes: positive test 4 days after testing negative following a full 5 day course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Treatment included Paxlovid.
Sore and hot muscles near injection; Sore and hot muscles and joint in shoulder area; Sore and hot muscles near injection; Sleepiness; Extreme tiredness; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 13:30 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had a history of allergy (unspecified). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications (unspecified) within two weeks of vaccination. On 20Mar2021, the patient had shot extreme tiredness and sleepiness. On 21Mar2021, the patient experienced very sore and hot muscles near injection and joints in shoulder area painful to raise, however moving helped. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sleepiness, extreme tiredness, sore and hot muscles near injection and joint in shoulder area were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Light headed, fever, chills, no appetite, skin sensitive (like crawling but painful), migraine, heart racing, cough, difficulty breathing. Was like when I had Covid, but all in 1 day. Rate rate was 135 when walking and pulse went to 89 only when standing/walking
Breakthrough case admission after 4 vaccines Moderna 2/20/21 Lot# 023M20A;  Moderna 3/16/21 Lot# 002B21A;  Moderna 12/2/21 Lot# 05H21A;  Moderna 8/22/22 Lot# 082B22A
Intense chest pain, shortness of breath from 6pm to 3am.  Tingling from chest to eyes from 9pm to midnight.  Taken to emergency room.
This initial spontaneous report was received from the mother of an 18 year old female patient. The patient had no drug reactions/allergies. No information regarding medical history, concurrent conditions, or concomitant medications was provided. Historical drug included first dose of meningococcal conjugate vaccine (reported as MCV4) in 2011 (manufacturer not specified). On 13-JUN-2016, the patient received her first dose in the human papilloma virus (HPV) series with GARDASIL 9 (lot # not provided). On 30-JAN-2017, she received her second dose in the series with GARDASIL (lot # not provided). The reporter did not specify whether her daughter received the third dose in the HPV series. On 05-JUN-2018, the patient inadvertently received GARDASIL 9 in the left upper arm (unknown route) (lot # N019104; expiration 02-MAR-2020), but she was supposed to receive the second dose of MCV4 (manufacturer not specified) "because she is going to university and needed the MCV4 vaccine." Since an hour and a half after receiving GARDASIL 9 on 05-JUN-2018, the patient was having severe anxiety. The patient did not seek medical attention and no treatment was given. The anxiety was not recovered at the time of the report. Causality assessment was specified. The reporter asked if NDC 0006412101, lot N019104 and expiration 02-MAR-2018 was a Merck vaccine. The reporter was informed that the lot # matches a lot of GARDASIL 9. Subsequently, the reporter stated she would hire an attorney because her daughter inadvertently received GARDASIL 9 instead of the MCV4. She stated that "the doctor's office put that she received the MCV4 vaccine but the lot number indicated GARDASIL 9. The attorney will handle everything both with Merck and with the doctor." The reporter did not provide consent for her daughter's physician to be contacted.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified and Thyroid disorder. Concomitant products included DILTIAZEM for Heart disease, unspecified, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  On 25 Mar 2021, the patient received the second dose mRNA-1273 (Moderna COVID-19 Vaccine).  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-109626 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No new information.
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old male patient (also reported as 3 year 2 weeks) who recieved 0.25 ml vaccine, while he received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose  dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot UT6259NA via unknown route in unknown administration site. It was also a case of actual medication error due to vaccine underdose. It was unknown if patient 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 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.
Initial unsolicited report received from a Physician on 03-MAR-2017. This case is linked with 2016SA224325. This case involves a patient (onset age and gender were unknown) who was vaccinated with dose of TETANUS TOXOID (TETANUS) (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergic to vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. ist of documents held by sender: none.
2 days after receiving vaccine pressed on swollen lymph node on neck and immediately had syncopal episode
I had experienced chills about 12 hours following the injection; my upper body was extremely sore; I was extremely fatigued; This is a spontaneous report from a non-contactable consumer (patient). A 33-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in left arm on 17Feb2021 at 13:30 (at the age of 33-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included supraventricular tachycardia treated in 2013. The patient's concomitant medications were not reported. Patient had no known allergies. Patient received previously first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in left arm on 23Jan2021 at13:00 (at the age of 33-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no Covid prior to vaccination and not Covid tested post vaccination. On 18Feb2021, at 01:00 the patient experienced chills about 12 hours following the injection. By the next morning, my upper body was extremely sore and I was extremely fatigued. The soreness lasted for about 36 hours following injection. The patient had no treatment for the events. The out-come of soreness was recovered on 19Feb2021 and rest event recovered on unspecified date of Feb2021.  No follow-up attempts are possible. No further information is expected