chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Maladministration Engerix-B after expiration date; 4th hep b on patient' s schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 58-year-old male patient who received HBV (Engerix B adult) (batch number AC397, expiry date 08-AUG-2023) for prophylaxis.   On 11-AUG-2023, the patient received the 4th dose of Engerix B adult. On 11-AUG-2023, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: Maladministration Engerix-B after expiration date) and extra dose administered (Verbatim: 4th hep b on patient' s schedule). The outcome of the expired vaccine used and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 11-AUG-2023 The pharmacist reported that a patient received a dose of Engerix-B adult on 11th August 2023 which was expired on 8th August 2023, which led to expired vaccine used. The patient received Engerix B adult as 4th hepatitis b dose on patient' s schedule, which led to extra dose administered. The reporter consented to follow up.
I had a video meeting with the doctor, and she prescribed me with Paxlovid for COVID-19. Some of my symptoms included a bad cough, slight headache, and a bit of an upset stomach.
01/21/2021 the night of the vaccine I had aches, pains and chills. Every since then I have had pains in my joints in my hands and feet. Ongoing.
Sudden never hearing loss; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EJ1685), via an unspecified route of administration at the left arm on 20Jan2021 10:00 at single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient medical history was not reported. The patient was not pregnant. There was no other vaccine in four weeks. Prior to vaccination the patient had no COVID. The patient has not tested for COVID post vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC) and hctz. On 21Jan2021, the patient experienced sudden never hearing loss. It was reported that the event resulted to doctor or other healthcare professional office/clinic visit and Disability or permanent damage. The patient received an oral steroid as treatment. The outcome of the event was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, a possible contributory role of the suspect BNT162B2 in triggering the onset of sudden never hearing loss cannot be excluded. Additional information regarding relevant medical history, etiologic and diagnostic work-up will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
injection itself into L deltoid was not painful. 5-10 minutes after injection I experienced sharp tingling/burning over the medial clavicle and extending into the neck.  there was no rash, redness, swelling, swallowing or breathing difficulty.  At 21 days, I am still experiencing hyperaesthesia and some tingling over the medial clavicle, and a zinging sensation over the clavicle/sternoclavicular joint with L shoulder movement, valsalva or burping. evaluation on site by vaccine provider. telephone consultation with PCP 2 days and 1 week later, and brief telephone consultation with local allergist.  gabapentin for discomfort
Very high fever/Bad reaction; Sick like the flu/Bad reaction; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a child patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced fever (serious criteria hospitalization) and influenza like illness (serious criteria hospitalization). On an unknown date, the outcome of the fever and influenza like illness were not recovered/not resolved.   It was unknown if the reporter considered the fever and influenza like illness to be related to DTPa vaccine.  Additional details were received as follows: The patient never had another shot of vaccine in the past.  The age at vaccination was not reported.  After vaccination, the patient had a very high fever and sick like the flu. The patient ended up in the hospital more than once.  The patient's physician, tried cutting the dose in half and then into a quarter and the patient still had a bad reaction. The measle, smallpox also made the patient sick. The patient had 2 flu shots and ended up in the hospital. This case was linked to case US2019AMR172639, reported by the same reporter.
Continuous Tinnitus in left ear.  I would describe as a high pitched continuous rining.
This spontaneous report as received from a physician refers to a multiple patients of unknown age and gender. On an unknown dates in 2015 multiple patients were vaccinated with a doses of RECOMBIVAX HB (doses, routes and lot numbers were not reported). The doses of RECOMBIVAX HB were exposed to a temperature excursion of 24F for 720 continuous hours from unspecified consecutive days in January to February 2015. The physician noted that those vaccines were not exposed to temperatures below 24F. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Administered second dose of COVID -19 Vaccine in error Pfizer should've been Moderna
HEADACHE, LOCALIZED RASH INDURATION, REDNESS, WARMTH, AND ITCHING OVER THE INJECTION SITE.
3 days p/administration of vax pt's entire jaw-line appeared swollen; elevated temp of 103 noted, poor appetite; nodules behind ears also noted; pt seen by MD, tonsilitis dx & ATB prescribed;
ADACEL that was expired by 9 days was given to 2 patients with no reported adverse event; Initial information received  on 15-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves patients of unknown age and gender and reporter reported Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] that was expired by 9 days was given to 2 patients with no reported adverse event.  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: Unknown, Expiry date: Unknown) (stremgth: Unknown) via unknown route in unknown administration site for immunization.  On an unknown date, the reporter reported Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine that was expired by 9 days was given to 2 patients with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
This spontaneous case report was received from an other healthcare professional on 21-Aug-2018. The report describes a 57-year-old male consumer who "took expired dose of VAXCHORA". The consumer was receiving oral VAXCHORA (lot number: 7000004 and expiry date: 28-May-2018) for cholera prophylaxis. It was reported that the consumer took an expired dose of VAXCHORA on 17-Aug-2018. The action taken with VAXCHORA with respect to the event "took expired dose of VAXCHORA" was not applicable. The clinical outcome of the event "took expired dose of VAXCHORA" was unknown. Sender's Comments: Company's Comment: The causality of the event "took expired dose of VAXCHORA" was considered as not applicable.
Information has been received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 10-OCT-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # L001311, expiration date 06-JUL-2016; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The child contracted chicken pox on 5/17/02. This is a heavy case of chicken pox.
pt presents to ED with generalized weakness, recent falls at home, hematuria, SOB, cough; positive for COVID; elevated cardiac enzymes; acute on chronic kidney leukocytosis and NSTEMI; given remdesivir, antibiotics, O2 supplementation; decrease in O2 sats; pt experienced code blue; suffered rapid decline; pt made comfort measures and passed away in the hospital
Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) negative. Therapeutic measures were taken as a result of suspected covid-19. Clinical course: COVID 19 Treatment: Paxlovid, start date: 07May2022 and stop date: 11May2022. Paxlovid Rebound. Would like guidance on how to proceed. Rebound. Patient put down the wrong date of rebound on previous form. Patient's doctor need guidance on how to treat patient after a rebound from Paxlovid. By day 2 most symptoms gone. By day 6 or so negative antigens until day 10. Now high fever and cough etc. Far worse than original. Patient inquired what to do.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mother called stated that her daughter had a "welt" the 1/2 size of the palm of her hand from her chicken pox shot - Mother will try Benadryl and ice - encouraged to see Dr if worsens. Redness went away on Sunday. Did increase to full palm size with itching.
My right arm that received the H1N1 vaccine is achey, has shooting pains and feels weak at times.  The symptoms were at the worst on 10/31 through 11/2 being pretty much constant.  They have improved somewhat but are still present
No additional AEs.; PROQUAD was administered one time this morning before I called; This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 02-FEB-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, 0.5 ml, lot number T025509 has been verified to be a valid lot number, expiration date 23-JAN-2022 (route of administration, vaccination site were not specified) for prophylaxis.   The temperature excursion was 13.1 degrees Fahrenheit for 20 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported.
Approximately a few months after my 2nd dose vaccination I experienced the following symptoms:  Heart Palpitations that I have never felt before, Slightly Fatigued - I saw a cardiologist and was prescribed with Metoprolol and it did help for a while but the palpitations are still there and comes in an intermittent pattern.
Initial report received on 09 April 2012 from a manufacturer (Manufacturer report number: S2012US01534). A female patient received a dose of INFLUENZA, manufacturer unknown (lot number, route and site not reported) on an unspecified date. The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination, and any adverse event following prior vaccinations were not reported. The following is verbatim as per report. "Patient developed Guillain-Barre syndrome." The date of onset of adverse event was not specified. The patient's outcome was not reported. Documents held by sender: none.
Red, swollen area at injection site. Cold compress, Benadryl. Reaction was at DTaP site.
Stomach aches; Stopped Vivotif after taking the 2nd dose and did not take further doses; A spontaneous report was received from nurse on 11JUL2023 regarding 14-year-old male patient who experienced "stomach aches" (PT: Abdominal pain upper) and "stopped Vivotif after taking the 2nd dose and did not take further doses" (PT: Intentional dose omission). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.   On 05JUL2023, Wednesday, the patient took the first dose of Vivotif and experienced stomach aches. On 07JUL2023, Friday, the patient took the second dose of Vivotif and again reported stomach aches. Reportedly, the patient stopped Vivotif after taking the second dose and did not take further doses. The outcome of the event "stomach aches" was unknown while it was not applicable for "stopped Vivotif after taking the 2nd dose and did not take further doses".  The action taken with Vivotif with respect to the event "stomach aches" was drug withdrawn while it was not applicable for the event "stopped Vivotif after taking the 2nd dose and did not take further doses".  No additional information was reported.  Company comment: It was reported that a consumer received Vivotif and she developed stomach aches (abdominal pain upper) and "stopped Vivotif after taking the 2nd dose and did not take further doses (intentional dose omission). Further information regarding event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain upper is assessed as possible. The causality of intentional dose omission is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer received Vivotif and she developed stomach aches (abdominal pain upper) and "stopped Vivotif after taking the 2nd dose and did not take further doses (intentional dose omission). Further information regarding event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain upper is assessed as possible. The causality of intentional dose omission is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Approximately 24 hrs. after vaccination L deltoid area started to become red, swollen & painful to touch.
Chest Pain almost daily for the past 2 weeks since getting my vaccine dose. It started within the first hour of getting the vaccine. I?ve had the chest pain almost daily regardless of food/rest/hydration/stress levels/heart rate.
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number 5T943, expiry date 30th June 2019) for prophylaxis. On 27th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. In October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced dizziness, fever, stomach cramps, respiratory tract congestion, headache, laryngitis and sore throat. On 27th October 2018, the patient experienced pain in arm, joint pain and pain. On an unknown date, the outcome of the pain in arm, joint pain, pain, dizziness, fever, stomach cramps, respiratory tract congestion, headache, laryngitis and sore throat were unknown. It was unknown if the reporter considered the pain in arm, joint pain, pain, dizziness, fever, stomach cramps, respiratory tract congestion, headache, laryngitis and sore throat to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The case was reported by the healthcare professional for herself. The age at vaccination was not reported. The patient developed sore arm, joint pain, and right side pain on the day of vaccination. The patient also developed dizziness, low grade fever, stomach cramps, chest congestion, headache, bodyache, laryngitis, and sore throat the next day or two days after receiving the vaccine. The reporter gave consent to follow up.
Information has been received from a consumer concerning her son with allergies to wheat, dairy, eggs and nuts who was vaccinated with the second dose of PEDVAXHIB (dose, route, and lot# not reported). Concomitant therapy included DTaP (manufacturer unspecified). The patient had respiratory failure 3 days after the vaccines were given. The consumer stated her child started with a fever and runny nose and then later had trouble breathing. The consumer stated this reaction was to the booster dose (second dose) of the vaccines. No reaction was reported after the first dose of the vaccine. The patient was admitted to a hospital. On unspecified date, the patient recovered. Additional information has been requested.
stiff and inflamed joints where i have had previous injuries.  Also sore throat and hot flashes.
patient described arm was tingling all the way down to the hands, felt weird. like numb feeling
Pt recv vax on 10/10/97; on 10/11/97 pt exp red local rxn;dx=cellulitis; tx=Cipro, moist heat
Burning in the mouth; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Burning in the mouth) 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 ORAL DISCOMFORT (Burning in the mouth). At the time of the report, ORAL DISCOMFORT (Burning in the mouth) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.
been out of work; This case was reported by a consumer via interactive digital media and described the occurrence of activities of daily living impaired in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In September 2022, unknown after receiving Shingles vaccine, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the activities of daily living impaired was not recovered/not resolved.   It was unknown if the reporter considered the activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had been out of work since Sep 2022. The patient was out of work because of the poison that were injecting in people. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
shingles outbreak mouth and on eyelid; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (battling for years). Previously administered products included Shingrix (1st dose received on 1st February 2019, refer case US2019109577) and Zostavax.   In June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had his Shingrix 10 days before the reporting date and had an outbreak in his mouth and on his eyelid. The patient was a dual transplant patient and has been battling shingles for years. The reporter consented to follow up.
Per family, patient has been feeling sick since he was vaccinated, patient went to ER on 02/15/2021, and after few hours at ER patient passed away.
Itchy at site.  Tachycardia appeared @36 hour after booster dose.
Information has been received from a physician concerning a 12 month old male with a history of kidney transplant waiting list, feeding tube, congenital hip dislocation and congenital urinary anomalies, who on 30-JUL-2008 was vaccinated with the first dose of MMR II. Suspect therapy included the first dose of VARIVAX. Concomitant therapy included the third dose of PREVNAR and does not believe to be on immunosuppressive agents. The patient developed hives within 24 hours of the vaccination. The patient was not seen in the office for hives. The child's mother called and reported he was "covered from head to toe with red welts". He was treated with diphenhydramine hydrochloride at a dose of 1/2 teaspoon every 6 hours. The hives resolved within 24 hours of treatment. He is being sent to an allergist for testing. No laboratory tests were performed. No product quality complaint was involved. Additional information has been requested.
Second dose greater than 42 days; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose greater than 42 days) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension, Hyperlipidemia, Purified protein derivative skin test, Eczema and COPD. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Hyperlipidemia, LISINOPRIL for Hypertension.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose greater than 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose greater than 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant follow-up (Added patient Age, medical history and concomitant medications)