chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cerebral infarction/Dizziness and Giddiness/blurry vision, altered speech, headache, difficulty with speech; hypertension; Meniere's Disease affecting the left ear/ moderate Sensorineural Hearing Loss in left ear; severe Sensorineural Hearing Loss in right ear; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 14-JAN-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered blurry vision, altered speech, headache, difficulty with speech and was diagnosed with dizziness and giddiness, hypertension, cerebral infarction, severe sensorineural hearing loss in right ear and moderate sensorineural hearing loss in left ear and Meniere's Disease affecting the left ear. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was not recovered. The causality assessment was considered as related by the lawyer.  All the aforementioned events were considered to be disabling by the lawyer. Upon internal review, cerebral infarction, severe sensorineural hearing loss in right ear and moderate sensorineural hearing loss in left ear and Meniere's disease were determined to be medically significant.
content leaked out, other dose administered; plunger issue/syringe leak/looked like the plunger was loose/content leaked out; Pharmaceutical product complaint; This case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 9722R, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe issue and pharmaceutical product complaint 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: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The reporter reported that the patient received a dose of Flulaval pre filled syringe where the vaccine ran out while she was depressing the plunger. The one nurse shared that it looked like it leaked out below the where you attach the syringe. The reporter started to report this as a quality issue at the GRC, case #01528098, on 13th October 2022. At that time, the reporter had limited information and it was not clear if this happened while the nurses were preparing the vaccine dose or while they were administering the dose. The reporter finally received feedback from the nurses that administered the vaccines, and they shared that the incidents happened while they were administering the vaccines.  The nurses said that it looked like the plunger was loose. Two times the vaccine contents leaked out of the top and 2 times the vaccine contents leaked out of the bottom.  The nurses shared that each time they felt that the patient did not receive any of the dose and it was a failed attempt, so they threw the dose away and administered another dose. The reporter shared that the patient did not have any reaction to the dose given. Although the patient did not have reactions to the vaccine dose given, the reporter reporting this in case it falls into the category of maladministration. The reporter did not consent to follow up. This was three of four cases, reported by the same reporter. Additional Supportive Information: The vaccine leaked out and had plunger issue, looked like the plunger was loose and other dose was administered, which led to accidental underdose, syringe issue and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2022AMR154683:Same reporter US-GSK-US2022AMR154589:Same reporter US-GSK-US2022AMR154685:Same reporter
Contracted breakthrough case of COVID-19 about 1 month after vaccinating. Symptoms were just like a head cold. Ran low grade fever. Lost appetite but no loss of smell or taste.
A female patient received by error a Bexsero expired vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31-DEC-2022) for prophylaxis.  On 21-MAR-2023, the patient received Bexsero. On 21-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: A female patient received by error a Bexsero expired vaccine). The outcome of the expired vaccine used was 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: GSK Receipt Date: 22-MAR-2023 The pharmacist had reported that a patient received by error a Bexsero expired vaccine. The reporter consented to follow-up via email. At the time of reporting, the patient received a dose of expired Bexsero vaccine, which had led to expired vaccine used.
Patient reported feeling hot/flushed, numbness and tingling in the thighs and face and numbness in the arm. No trouble breathing, injection site looked completely normal. Patient took a clonazepam tablet to calm down.
Pt was vaccinated at our clinic and experienced an adverse reaction to the vaccine. Pt was in the exit area after his vaccine and began experiencing vasovagal symptoms. Pt also had a vasovagal response to his first vaccine. Pt vomited initially, but then reported he did not feel nauseous. Pt was brought to the floor so he could lay down. He was able to respond to questions and speak with his dad. He reported feeling drowsy. His vitals were stable. He remained at our clinic longer for evaluation. Eventually he was able to sit up in his father's lap and left the clinic with his family. His dad was given instructions to continue monitoring him and let him rest afterward.
Swelling; Redness; itching; Pain at the injection site; moderate headache; mild nausea; Mild Joint pain; Low grade Fever; Chills; Mild muscle body aches; Fatigue; Pain at the injection site; Swelling at the injection site; Headache; Joint pain; Nausea; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (itching), the second episode of VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (moderate headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced the first episode of VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). On 02-Mar-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (itching), the second episode of VACCINATION SITE PAIN (Pain at the injection site), HEADACHE (moderate headache), NAUSEA (mild nausea), ARTHRALGIA (Mild Joint pain), PYREXIA (Low grade Fever), CHILLS (Chills), MYALGIA (Mild muscle body aches) and FATIGUE (Fatigue). At the time of the report, SWELLING (Swelling), the last episode of VACCINATION SITE PAIN (Pain at the injection site), HEADACHE (moderate headache), NAUSEA (mild nausea) and ARTHRALGIA (Mild Joint pain) outcome was unknown and ERYTHEMA (Redness), PRURITUS (itching), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), PYREXIA (Low grade Fever), CHILLS (Chills), MYALGIA (Mild muscle body aches) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient reported no adverse events after 1st and 2nd Moderna monovalent booster dose.  No treatment information was provided.
HPV given 8-9-17, (L) arm swelling and pain noticed on 8-16-17. (L) deltoid with raised slightly warm mass. No fever, numbness or weakness. Increased pain with activity. Tx: 5 days prednisone 40 mg Q day to help with swelling.
27NOV redness; 29NOV swelling 2" below inject site to elbow & aching, warm to touch;
On Tuesday July 29th at 10:00am patient had an immunization shot (tetanus, hepatitis A and epatitis B vaccine). They said she wasn't required to get the hepatitis shots but the new school kids coming into the district are. So I decided to get them with the tetanus shot that was due. On Wednesday at 6:00pm after she slept most of the day which she normally doesn't do, she was sitting on a chair and passed out then went into a seizure(her body stiffened up and her hands curled for about 1 minute) then she passed out for around 3 minutes. We called 911 and they took her into the Hospital for tests, in the ambulance they gave her glucose and said her blood sugar was alittle low(which could be from not getting a snack in the afternoon when she was sleeping) and that her blood pressure was a little low. At the hospital they did a EKG and a CAT scan on her brain which turned out ok. We went to have an EEG done 2 days later and the neurolgist wants to see her back in 1 month. We went to her primary care doctor to get the EEG referal and she wants to see her back in 1 week. She checked her out as well. Since the seizure she hasn't had anymore. She just has been sleeping more. She said she only had a couple sips of water on Wednesday the day she had the seizure.
Patient came for his Moderna COVID-19 booster vaccine and was given vaccine that has been on room temp for 53-hours. Patient denies of any adverse effects at this time.
Patient passed out just after getting to work. She hit her head - cheek & chin - causing abrasion/contusion. This was NOT wittnessed; she does NOT recall passing out or hitting her head. A co-worker noticed something wasn't right & had her sit down. They called my wife who picked her up & brought home & rested. Approximately 5.5 hours later, after feeling "better," she got up to get something to eat. While returning to bed (to rest & eat the small container of applesause) she felt as though she were going to pass out again & quickly sat down on the steps. However, she did not call for me (I was in the room nextdoor) for a few minutes... seemingly having "zoned out" but she does not think she lost consciousness.
PT came into the office for her yearly physical on 8/10/22. While in the office, they requested the Pfizer covid booster.  12+ year covid dosage (30 mcg) instead of the 5-11 yr doseage (10 mcg). What had happened is I saw her 2012 birth year and thought that she was 12. I drew up the 30 mcg dose and administered dosage. Today 8/10/22 , a day after the event, notified the provider and mom of event. Aria is feeling fine besides a really sore arm.
A non-serious spontaneous report of flu and nausea has been received from a parent/non health professional concerning a forty six-month-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 24-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 31-Oct-2009, after seven days of vaccination, the patient experienced nausea and flu with symptoms of congestion, fever, headache, sore throat and nausea. In Oct-2009 nasal swab was taken which tested positive for flu. The outcome of the reported events was not resolved.
Redness, rash with small papules, itchiness of chin, cheeks. BPs 134/93 (pulse 75), 130/88 (pulse 69). O2 sat 100%. Benadryl 25 mg PO.
'the first one put me in the bed'; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BEDRIDDEN (non-serious), outcome "unknown", described as "'the first one put me in the bed'".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever x 1 day. Itching, vomiting x 1. 7.5 cm x 5.0 cm mild erythema and mild induration on left arm.
Patient presents to the clinic with shortness of breath, weakness, and syncope. Patient was admitted for further evaluation and treated with remdesivir.
woke up morning after vaccine feeling fatigued, difficult to get out of bed, diffuse body aches, low grade fever (100), chills, difficult to do household duties and did not leave the house for 2 days.  symptoms responded to every 4-6 hour dosing of acetaminophen and ibuprofen.  by day 2 was able to do household activity a little easier.  day 3 symptoms resolved.
Arm Soreness; Flu-like symptoms; No energy; Nausea; Muscle Aches; Very bad fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (No energy), NAUSEA (Nausea) and MYALGIA (Muscle Aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Soreness), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (No energy), NAUSEA (Nausea), MYALGIA (Muscle Aches) and FATIGUE (Very bad fatigue). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (No energy), NAUSEA (Nausea), MYALGIA (Muscle Aches) and FATIGUE (Very bad fatigue) outcome was unknown.
COVID infection following COVID vaccine series 03/31, Pfizer, dose #1 04/21, Pfizer, dose #2 12/26 COVID swab, result: detected 12/23 pt cc: fatigue, headache, myalgias, exposure: unknown 12/26 pt admit ED cc: " fatigue, myalgia, rhinorrhea and headache since last night" dx: COVID-19 LOS: 1 day 12 26 SARS-COV-2 Variant Sequencing: pending 12/30 clinically resolved
Reporting administration error.   We contacted Pfizer for expiration dates, pfizer vaccine specialist advised that the expiration dates are deemed viable at the time of vaccine administration.  Pfizer vaccine vials only include manufacturer dates on the box and vials. Therefore, we contacted pfizer to obtain expirations dates directly from them.   No adverse reaction reported from the patient at the time of vaccination.  No adverse reaction reported since the administration of vaccination.
12/01/21 presents to ED for "worsening shortness of breath, myalgias and fevers and chills". PMHx of "CHF, status post renal transplant, type 2 diabetes, BPH, hypothyroidism, hypertension".
This spontaneous report as received from a pharmacist refers to a 78 year old female patient who was allergic to naproxen 250 mg tablet. On 24-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # J000436, expiry date 10-APR-2014) (strength, dose, frequency, route and site unspecified). Concomitant medication was unspecified. Patient's pertinent medical history included "lots of medications". On 24-MAY-2013, the patient after receiving the ZOSTAVAX, developed a raised red inflamed area at the injection site. The patient also stated that she developed soreness of her arm. The patient went to the pharmacy for medical attention, and she was informed by pharmacy to use a hydrocortisone cream and to take an unspecified pain reliever for treatment. No laboratory diagnostics studies were performed. The outcome of the events was reported as recovering/resolving. Additional information is not expected.
lost hearing in one of my ears; he had pain after his injections; This spontaneous case was reported by a consumer and describes the occurrence of EUSTACHIAN TUBE DYSFUNCTION (lost hearing in one of my ears) and VACCINATION SITE PAIN (he had pain after his injections) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A, 020B21A and 032F21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (myocardial infarction two years ago) in 2019.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced EUSTACHIAN TUBE DYSFUNCTION (lost hearing in one of my ears) and VACCINATION SITE PAIN (he had pain after his injections). At the time of the report, EUSTACHIAN TUBE DYSFUNCTION (lost hearing in one of my ears) and VACCINATION SITE PAIN (he had pain after his injections) outcome was unknown.            Concomitant product was not provided. Treatment medication was not reported. Patient taking a string of medications following a heart attack two years ago was reported.   This case was linked to MOD-2021-382420, MOD-2021-382441 (Patient Link).
Expired vaccine. No temperature excursion occurred. Moderna determined vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration." No adverse event reported.
Patient was asleep and awoke approximately 3 hours after vaccination with tremors. Over then next 2-3 wks, developed Left sides weakness, numbness, tingling. Developed Left leg limp. Approximately 3-4 wks after vaccine, developed Right upper arm weakness along with worsening Left sided symptoms. Had migraine headaches, developed stuttering, numbness and tingling in face. Complain of feeling diaphramatic symptoms stuttering worsened with increased fatigue. Weight loss of 25 lbs. Treatment - under care of primary physician, doctor name reported. Plan has been: bedrest, nutritional  and herbal supplements from a nutritionist, chiropractic care, specialist and hospital. IgG taken orally, "Super ESS" for re-myelination of nerves. Complain of her mother had a "bad reaction" many years ago to a shot. Mother required hospitalization. 04/19/07-records received from providers. DX: Syndrome is partly anxiety but more likely reflex dysautonomia associated with the  nervous system being hyperactive. C/O left shin numbness, front of her head bilaterally and down into the neck. Paresthesias across forehead and into left side of face. Spread down into shoulder and to elbow.
Had shingles shot, still got them/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles shot, still got them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
genital herpes outbreak; genital herpes outbreak; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8736), via an unspecified route of administration in left arm on 21Apr2021 (age at the time of vaccination was 28-year-old) single dose for COVID-19 immunisation. The patient's medical history included genital herpes from 2014, the patient had rare outbreaks usually only when she was not taking her medications or she was stressed. The patient had allergic to Indomethacin. The patient's concomitant medication in two weeks included acyclovir. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. The two weeks after received vaccine on 24May2021, the patient had a herpes outbreak. The patient did not receive treatment in response to the events. The outcome of the event was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.  Follow-Up (12Jul2021): No Follow-up attempts are completed. No further information is expected.