chrisvoncsefalvay/vaers-outcomes huggingface dataset:
23 year old patient was administered a pediatric dose of Engerix-B; 23 year old patient was administered a pediatric dose of Engerix-B; dose was also expired; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 23-year-old male patient who received HBV (Engerix B pediatric) (batch number YX547, expiry date 24th March 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th March 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 25th March 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product and expired vaccine used. On an unknown date, the outcome of the underdose, adult use of a child product and expired vaccine used were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The patient was administered a pediatric dose of Engerix-B (10 mcg), which led to underdose and adult use of a child product. The dose was received on 25th March 2021 and was expired on 24th March 2021, which led to expired vaccine used. The reporter consented to follow up.
After patient received the vaccine and left the table where he got the vaccine, he started to walk to the chair to sit down and fell forward on the floor. After he was assisted up by nurses on the scene, he began to fall back and was gently placed on the ground with his head elevated. It was noted that he had an approximately 0.5 cm cut on his chin. He was alert and oriented. Pressure applied to cut and Band-Aid applied. BP: 102/70. He was supine for approximately five minutes and then was assisted up to a sitting position with his parents at his side. He was given water and observed for 30 minutes. Called Dad on 12/5/2021 who said son is doing well and did not seek further care.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 17 years old male patient who had inadvertently received his booster dose at 14 years old instead of 15 or 16, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a booster dose of suspect MENACTRA (lot number, dose, dose in series, route and site of administration was not reported). This case was actual medication error due to inappropriate age at vaccine administration. It was unknown if the patient had 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. List of documents held by sender: none.
Received order to administer HAVRIX and FLUZONE - Administered HAVRIX and in error FLULAVAL. Once I noticed my error I immediately notified ordering physician. She directed me to see a nurse I work with to see what our protocol is. That nurse said she would call someone at the County Health Dept. - which we left a voicemail asking to give a call back asking for me. In meantime, I spoke with pharmacist/representative from GlaxoSmithKline and told them of the situation and what to look for...they stated that they have done studies in which they have given FLULAVAL to children under 3 (6 months to 35 months) - given 1-2 doses depending whether or not that they were primed (if it was their first dose ever, requiring 2 initially or if they have previously received flu vaccine) and have found pain at injection site, loss of appetite, fever, and febrile convulsions. After my phone call with the manufacturing company, I spoke with someone from the Health Department, she stated to notify parents and complete a vaccine error form. She agreed that the reactions to the FLULAVAL when given to those under 3 yrs of age and are the same possible reactions of many other vaccines that we administer. I then discussed with office manager and together we brought it to the attention of Doctor who runs the office. He decided that I call the parents to notify them of what had happened and due to a slightly higher dose that he received to closely observe for any reaction(s). In the early afternoon, I spoke with patient's father and told him of my error. He stated that he believes that pt has had the flu shot in the past and recalls that all he had was a little temperature - I am unsure if that was given in conjunction with any other vaccinations. I told father that when he discusses with his wife who was unavailable at the time she can call to discuss with me if comfortable or with ordering doctor who did exam. I also stated that we (myself or one of the nurses) would follow up with a phone call to see how pt is doing tomorrow to document our note/vaccine error form. He confirmed on the phone that he has the VIS sheet and understands what to look for regarding reactions and that he should be concerned about. Notified ordering physician of my note.
PATIENT DEVELOPED SHINGLES OUT BREAK IN SMALL AREA ALONG LEFT SIDE ABOUT ON THE WAIST LINE.  PATIENT ALSO HAD A VERY RED AND SWOLLEN ARM FOR ABOUT 3 DAYS.
Patient stated large area of swelling on right arm. The area also became warm to the touch as well. This reaction started about 24 hours after the vaccine was administered. Patient states she has never had a reaction like this in the past to any vaccination.
4/27/16 - pt. seen and given 2nd HPV vaccine and 2nd Hep A. 4/30/16 - pt c/o numbness at inj. site, dizziness, tripping, not able to lift one leg without falling, and feeling very tired. Sent to ER - normal CT of brain; Strep (+) treated with an antibiotic. 5/2/16 - seen in office c/o tiredness, vomiting - (+) Mono Spot; mom feels due to vaccine. 5/5/16 ER - sore throat, fatigue, emesis, unsteady gait; admitted with Dx: Sydenham's chorea and Rheumatic fever.
At irregular intervals I would experience chest pain. The chest pain wouldn't be onset by anything in particular. The pain felt like tightness in the chest around my heart.
Information has been received from a physician concerning an adult pt aged 20-25 years who was vaccinated with hep A virus inactivated. The physician reported that the pt was previously vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced fever. The physician reported that the pt sought unspecified medical attention. Additional information is expected.
Felt lightheaded, dizzy, nauseated and then passed out. Happened almost exactly 36 hours after the vaccine. Regained consciousness after a few minutes and within 25-30 minutes I was fine. This was the identical reaction that I had to my 2nd and 3rd Pfizer Covid vaccines.
Patient came to pharmacy greater than 1 month - stating soreness, bruising and a knot at injection site.
Rash started roughly two weeks post vaccination. It started out small on my back, then slowly grew to cover most of my body. I took benadryl the first night, which helped for a short amount of time, but after that it was not effective. I then ended up at the urgent care clinic to get medications. I was prescribed prednisolone, zyrtec, famotidine, and benadryl. The comes back from time to time, covering small portions of my body.
Immediately following injection, no soreness or redness. 24 hours later, soreness in the area of the injection which lasted 48 hours. All symptoms went away until seven days after the injection, when hives developed around injection site, then a large welt. Pain and itching on and around the welt.
swelling of right arm, where he received the vaccine; Palpable purpura/Some of the purpura was on the left arm and he had a few spots on the upper chest; Blistering; This is a spontaneous report from a contactable physician. An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 09Jan2021 at single dose for COVID-19 vaccination (reported as for "1-B vaccine group, age greater than 75, history of heart disease") in hospital. Co-suspect drug included apixaban (ELIQUIS) orally from 2020 (Has been on Eliquis for over the last year, 12 months) and ongoing at 5 mg, 2 times a day (5mg, 1 tablet by mouth twice daily) for heart failure and atrial fib. Medical history included heart failure, atrial fib. Concomitant medication was not reported. No other vaccines given the same day or 4 weeks prior. Mentions patient did have a flu shot back in Sep2020 (unable to provide NDC, Lot, or expiry), no problems with vaccines in past.  Patient received the first dose Saturday morning of 09Jan2021 with no ill effects. 3-4 days later (Jan2021) patient had swelling of right arm, where he received the vaccine, and then developed palpable purpura. Some of the purpura was on the left arm and he had a few spots on the upper chest. Had no fever, no malaise, just what the patient described as blistering and so they had a dermatologist look at it. All seems to be improving. They were curious as to what this is. The patient feels fine and is ambulatory and the purpura does not itch. Caller does not provide seriousness criteria when queried. Initially it was thought, because the patient was on Eliquis for heart failure and atrial fib, that the Eliquis was related to events, but when the Dermatologist looked at it and stated it maybe excavation they decided to call and find out what Pfizer wanted them to do. Caller states he can give a list of medications if needed. Says patient had a comprehensive biochemical profile done non fasting also on 18Jan2021. Patient was seen by him initially on 19Jan2021. Wants to know whether this is a safety concern or/and if the patient should have the second dose. event requires a visit to physician office. Lab test on 18Jan2021 included Comprehensive Biochemical Profile, Blood Sugar of 116, Creatinine of 1.91, BUN of 43. Action taken of apixaban was dose not changed. Patient was recovering from the events. Relatedness of drug to event swelling of right arm, Palpable purpura and Blistering, feels fine, ambulatory, no fever, no malaise, seen by dermatologist, purpura does not itch, on Eliquis.  Per Source of assessment (Primary Source Reporter) and Method of assessment (Global Introspection) for drug result (Covid-19 vaccine) was Related, of drug result (Eliquis) was unrelated.      Information on the lot/ batch number has been requested.
Employee given expired flu vaccination.  Expiration date of 06/30/21.  No signs or symptoms reported thus far.
Right sore arm; Could hardly stand; Unable to go upstairs; Headache; Feel tired; Sore hip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right sore arm), DYSSTASIA (Could hardly stand), GAIT INABILITY (Unable to go upstairs), HEADACHE (Headache) and FATIGUE (Feel tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 216B21A and 225A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery. Concurrent medical conditions included Iodine allergy (Iodine.).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Right sore arm), DYSSTASIA (Could hardly stand), GAIT INABILITY (Unable to go upstairs), HEADACHE (Headache), FATIGUE (Feel tired) and ARTHRALGIA (Sore hip). At the time of the report, PAIN IN EXTREMITY (Right sore arm), DYSSTASIA (Could hardly stand), GAIT INABILITY (Unable to go upstairs), HEADACHE (Headache), FATIGUE (Feel tired) and ARTHRALGIA (Sore hip) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.
Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's comment: The reporter was the friend of the patient. The reporter states her friend received the first dose of Shingrix the day before reporting. Her friend was experiencing a headache. The reporter did not consent to follow-up. The reporter provided limited information. Additional supportive information: This case has been linked to the case US2022122084 reported by the same reporter.; Sender's Comments:  US-GSK-US2022122084:Same reporter
Cough; stuffy nose and congestion; sore throat; sinus pressure; loss of taste; loss of smell; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 09:45 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant past medical history. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 26Feb2021 at 17:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Prior to 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. On 24Mar2021 at 13:00, the patient experienced cough, stuffy nose and congestion (nasal congestion), sore throat, sinus pressure, loss of taste, and loss of smell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events cough, stuffy nose and congestion, sore throat, sinus pressure, loss of taste and loss of smell were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
2 to 3 days p/vax pt devel muscle & joint aches which have progressivley gotten worse;pt MD tentatively dx arthritis;pt has been treated 1st w/voltaren & then w/daypro w/o success;
This spontaneous report as received from a pharmacist refers to a 66 year old male patient. On 19-MAR-2014 the patient was vaccinated with ZOSTAVAX dose 1. Accidentally, on 25-JUL-2014 the patient was vaccinated with ZOSTAVAX dose 2. No adverse effects were reported. Additional information has been requested.
Report 20010092281 described bitter taste in mouth in a femal in her "thirties" who received hep B vaccine. The vaccinee had no known drug allergies or medical history. She took no concomitant medications. On 03/05/2001, the vaccinee received her first "adult" right deltoid dose of Engerix-b. Six to 12 hours following vaccination, she experienced "bitter taste in moutn." As of 04/06/2001, the event resolved.
Diffuse vesicular rash with some group plaques on his Rt shoulder, bilateral hands and forearms, and bilateral feet and lower legs.
got real sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got real sick) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got real sick). At the time of the report, ILLNESS (got real sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
This spontaneous report was received from an approximately 73 year old female patient, reporting on herself. The patient's concurrent conditions included polymyalgia rheumatica diagnosed in 2015, and allergy to REGLAN and sulfa. The patient's concomitant medications included prednisone (manufacturer unknown). On an unknown date in June 2008, the patient received an unspecified dose of ZOSTAVAX for prevention of shingles (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2011, the patient was diagnosed with shingles by a dermatologist and was treated with an unspecified dose of valganciclovir. On an unspecified date in January 2015, the patient was again diagnosed with shingles at an Urgent Clinic and treated with an unspecified dose of valganciclovir. On 22-JUN-2018 (reported as "2 weeks ago"), the patient was diagnosed with shingles for the third time at an Urgent Clinic, with symptoms that included severe itching, trigeminal nerve pain and red rash on left side of neck. The patient was treated with valganciclovir, gabapentin, and carbamazepine. No lab diagnostics or studies were performed. By the time of the reporting, the patient was not recovered from shingles. The reporter did not assess the causal relationship between ZOSTAVAX and the event.
Sirva and neuropathy - ongoing - from Dec. 2015 - until current - Jan, 2017 - ongoing pain in arm and shoulder. Fever for 4 weeks; itching; pain in back reoccurring; headaches off and on from beginning 2015 - 2017; weakness in left hand arm and shoulder; pain and burn; tingling in arms, hands, shoulder and back - ongoing. Occupational therapy in Aug, 2016. Headaches and ringing in ears on and off.
Day 1: pain at injection site. Day 2: small red welt at injection site, still in pain when pressure applied to area. Day 3: large red, swollen welt at the injection site (~3 inches in diameter, circular). Night of Day 3 I drew a circle around the welt, and took 2 Benadryl before going to bed with the intent of seeking medical intervention on Day 4 if it got worse. Day 4: significant improvement in the welt, swelling went down and pain decreased. Day 5: slight redness in shape of welt (~3 inches in diameter), no pain.
Excessive dizziness and very white (not just pale) for 3 days. Did not want food, very weak.
Left triceps region swollen, red, tight, warm to touch. Red area 5 inches in circumference and tender lasting 7 days through 10/24. Also, general body aches, joint aches, and abnormally tired.
Shingles; including any and all of its sequelae.; This spontaneous report as received from a lawyer and refers to a 66 year old female patient.     In 2018, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for prophylaxis.   As a result of her receipt of  zoster vaccine live(ZOSTAVAX), in 2018, was caused to suffer Shingles, including any and all of its sequelae (ill-defined disorder).  As well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.  Plaintiff required and/or will require more health care and services and did incur medical, health, incidental and related expenses. Plaintiff alleged that Plaintiff will in the future be required to obtain further medical and/or hospital care, attention, and services.  The outcome of herpes zoster and ill-defined disorder was considered as not recovered.   The reporter considered herpes zoster and ill-defined disorder to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, herpes zoster and ill-defined disorder were considered as disabling.
vertigo; increased imbalance issue; achy sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), BALANCE DISORDER (increased imbalance issue), MYALGIA (achy sore arm) and FATIGUE (fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Vestibular vertigo (Significant increase in all conditions to the point the patient is unable to function but 10-15% of the day.) since 2010 and Disorder equilibrium (Patient had learned to manage equilibrium.) since 2010.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (achy sore arm) and FATIGUE (fatigue). On 11-Mar-2021, the patient experienced BALANCE DISORDER (increased imbalance issue). On 12-Mar-2021, the patient experienced VERTIGO (vertigo). On 13-Mar-2021, MYALGIA (achy sore arm) and FATIGUE (fatigue) had resolved. On 14-Mar-2021, BALANCE DISORDER (increased imbalance issue) had resolved. On 15-Mar-2021, VERTIGO (vertigo) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were  Lifewave X39 general wellness 1 patch each morning for general health from 2019 and Lifewave silent night sleep 1 patch before bed for general health from 2019 . No treatment details were reported for first dose events.   This case was linked to MOD-2021-270239 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant follow up received and current conditions added, concomitant medication added and new event.
9/5/21 SOB and cough start 9/10/21: pt presents to ED with SOB/cough and test positive for COVID. treated with remdesivir, Decadron, oxygen and oral zinc discharged 9/13 9/26/21: re-presents switch continued hypoxia leading to further treatment with baratinib discharged 9/30 to follow up with PCP
Systemic: Unable to Sleep-Mild, Additional Details: PT STATES AFTER THE 2ND DOSE 1 WEEK LATER, HE STARTED FEELING OF PASSING OUT BUT DID NOT FULLY PASS OUT BUT COULD NOT MOVE HIS BODY. NOR SURE FOR HOW LONG BUT THINKS LASTED FOR 30 MINUTES. PT DEFACATED HIMSELF DURING THIS TIME. PT ALSO STAES HE SLOWLY LOSES SENSE OF TASTE EVERY 2 WEEKS BUT REGAINS THE SEND OF TASTE. HE STATES HIS ABILITY TO HOLD THIS THOUGHT IS GONE. "NERVE SHOOTING PAIN ON LEFT ELF FELLS ASLEEP AND FELT LIKE IT WAS ON FIRE". "VELCRO RIPPING FROM LEFT SIDE OF HEAD ABOVE EAR"
bilateral ear fullness minutes after receiving the vaccine and associated vertigo. Vertigo resolved on meclizine