chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient had no known allergies. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid treatment start date: 29Jan2024, stop date: 02Feb2024) were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug BNT162b2 omi xbb.1.5 and events vaccination failure and covid 19 cannot be excluded.
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain
Clinical narrative: Patient experiencing pain more than 6 months at the injection site or upper arm pain; Patient experiencing pain more than 6 months at the injection site or upper arm pain; This is a spontaneous report received from an Other HCP from a sales representative.  An elderly female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovered with sequelae" and all described as "Patient experiencing pain more than 6 months at the injection site or upper arm pain". It was unknown if therapeutic measures were taken as a result of pain in extremity, vaccination site pain.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as COVID-19 treatment from 03Feb2024 to 07Feb2024.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400042123 Same reporter and patient, different drug and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment; COVID 19 treatment; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Sep2023 as dose 5 (booster), single), in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2023, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "recovered" (07Feb2024) and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2024) Negative. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 02Feb2024 to 06Feb2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Physician.  A 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Sep2023 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 04Feb2024 to 09Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug and events covid 19 and vaccination failure cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Lot number: hg4629) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid received from 06Feb2024 to 11Feb2024 for Treatment of COVID-19. No known allergies.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: sick with Covid; sick with Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "sick with Covid". Clinical course: It was reported that reporter's sister was sick with Covid and they both got the Pfizer vaccines, they got them all.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400041822 Same reporter/product, different patient;
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Rash
Clinical narrative: Severe pain in her shoulder; She still is in a lot of pain from the injection and the way she feels with her shoulder pain.; Rash; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Jan2024 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset Jan2024, outcome "unknown"; ARTHRALGIA (non-serious) with onset Jan2024, outcome "not recovered", described as "Severe pain in her shoulder"; VACCINATION SITE PAIN (non-serious) with onset Jan2024, outcome "unknown", described as "She still is in a lot of pain from the injection and the way she feels with her shoulder pain.".  Additional information: The patient said she had the vaccine on Wednesday, 24Jan and she had a few issues with it and mentioned she is feeling severe pain in her shoulder and it's been 3 and a half weeks since she got it. She is asking what she needs to do. She stated it was in her arm. She verified it was the Pfizer RSV vaccine. She just wanted to report what occurred and that in her case she still is in a lot of pain from the injection and the way she feels with her shoulder pain. She wanted to report it so if other people have it. She wanted to know if there were other people that experienced shoulder and arm pain after being injected with ABRYSVO vaccine. The site where she had the pain had a rash then she went back to the pharmacy where she had the injection and she was told that it was common and it will get better. She said she started to get some pain and then it started to get some really bad pain in her shoulder and it has been three and a half weeks for the pain and everything. She said she doesn't know what to do with it because she cannot lift her arm to pull her hair or anything else because of a bad shoulder pain.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 28Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "excessive hair shedding" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "gastritis", start date: 2023 (unspecified if ongoing); "atypical lobular hyperplasia of breast", start date: 2023 (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Furadantin, reaction(s): "Allergy"; Gantrisin eye drops, reaction(s): "Allergy". Vaccination history included: BNT162b2 (vaccine lot number=GJ2524, Dose 5, vaccine location=Left arm), administration date: 20Sep2022, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (vaccine lot number=FP4554, Dose 4, vaccine location=Left arm), administration date: 12May2022, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (vaccine lot number=FF8841, Dose 3, vaccine location=Left arm), administration date: 11Nov2021, when the patient was 51-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (vaccine lot number=EP6955, Dose 2, vaccine location=Left arm), administration date: 26Mar2021, when the patient was 51-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Lot number: Unknown, Dose 1, vaccine location=Left arm), administration date: 05Mar2021, when the patient was 51-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Feb2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Rebound symptoms on 15Feb2024 after first symptoms on 03Feb2024 or 04Feb2024, tested positive 05Feb2024, started Paxlovid on 06Feb2024 and completed Paxlovid on 10Feb2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6198), in right arm, on 01Apr2021 as dose 2, single (Lot number: ER8737), in right arm, as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 20Jan2022 as dose 4 (booster), single (Lot number: FJ1611) at the age of 33 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thalassaemia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (start date:07Feb2024, stop date: 08Feb2024).  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 15Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 06Feb2024 to 11Feb2024 for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Age: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Cough, Extra dose administered, Nasal congestion, Pyrexia
Clinical narrative: No adverse event but patient patient received 3 influenza vaccinations this season (her first season of vaccination) instead of the recommended 2 doses.  The first one was given 10/24/23, 2nd dose 11/20/23, and 3rd dose 2/7/24. Because the second dose was given 1 day early, the provider missed that it was done since it was still triggering being due; therefore, the 3rd dose was accidentally given. Patient also received her MMR, Varicella and Hep A vaccine that same day.  Did develop a fever and URI the following evening-increased cough, nasal congestion and persistent fever. Was started on cefdinir for her ears on 2/7/24 but was refusing to take it/gagging on it so not taking it consistently. Was then seen on 2/12/24 and was started on Augmentin for her B/L ear infection since not taking the cefdnir well. Covid test done which was negative.
Age: 1.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test negative, Upper respiratory tract infection
Clinical narrative: No adverse event but patient patient received 3 influenza vaccinations this season (her first season of vaccination) instead of the recommended 2 doses.  The first one was given 10/24/23, 2nd dose 11/20/23, and 3rd dose 2/7/24. Because the second dose was given 1 day early, the provider missed that it was done since it was still triggering being due; therefore, the 3rd dose was accidentally given. Patient also received her MMR, Varicella and Hep A vaccine that same day.  Did develop a fever and URI the following evening-increased cough, nasal congestion and persistent fever. Was started on cefdinir for her ears on 2/7/24 but was refusing to take it/gagging on it so not taking it consistently. Was then seen on 2/12/24 and was started on Augmentin for her B/L ear infection since not taking the cefdnir well. Covid test done which was negative.
Sex: U
Vaccine: PNC13
Symptoms: Balance disorder, Guillain-Barre syndrome, Monoplegia
Clinical narrative: I had Guillain-Barre; I have no balance; My legs were paralyzed/ I've been dealing with paralysis off and on in my legs; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Jul2017 as dose number unkown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (DOSE NUMBER UNKNOWN, lot number unknown), for Immunization. The following information was reported: PARALYSIS (medically significant) with onset Jul2017, 1 day after the suspect product(s) administration, outcome "not recovered", described as "My legs were paralyzed/ I've been dealing with paralysis off and on in my legs"; GUILLAIN-BARRE SYNDROME (medically significant), outcome "not recovered", described as "I had Guillain-Barre"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "I have no balance". Clinical course: In Jul2017, patient was given the Prevnar 23 (as reported) vaccine. The day after, patient woke up and patient's legs were paralyzed. When patient tried to check with the doctor, he had left the practice and no one would tell patient where he went. Patient saw that there had been a class action suit for Prevnar 13 (which patient got way before the Prevnar 23). patient had been dealing with paralysis off and on in patient's legs and patient  had no balance. When patient saw the neurologist, he informed patient that had Guillain-Barre. Still suffering.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer". Clinical course: the reporter saw the ad about outdoing cancer and had to respond that the mRNA COVID shot gave the reporter's dad and millions of others cancer.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: TTOX
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Injury, Paralysis
Clinical narrative: Paralyzed with CIDP; Paralyzed with CIDP; my husband was injured from a tetanus shot; Initial information received  on 09-Feb-2024 regarding an unsolicited valid Social Media serious case received from a physician.  This case involves Adult male patient who was paralyzed with cidp,and was injured from a tetanus shot.  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 of suspect TETANUS TOXOID produced by unknown manufacturer via unknown route in unknown administration site for immunization (strength, dose, batch number and expiry date- Unknown). Information on the batch number was requested  On an unknown date the patient was paralyzed with cidp (paralysis) (chronic inflammatory demyelinating polyradiculoneuropathy) and was injured from a tetanus shot (injury) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for all the events; Sender's Comments: Sanofi Company Comment dated 15-Feb-2024: This case involves Adult male patient who was paralyzed with cidp,and was injured from a tetanus shot. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Epistaxis, SARS-CoV-2 test positive
Clinical narrative: bloody nose; I got COVID; Initial information received on 14-Feb-2024 regarding an unsolicited valid  non-serious courtesy case received via partner Pfizer from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced bloody nose and covid after receiving vaccine influenza quadrival A-B high dose HV vaccine [efluelda].  The patient's past vaccination(s) included COVID-19 VACCINE on 29-JAN-2021 with 0.3 dose, intramuscular, Batch: EL9261 and COVID-19 VACCINE on 18-FEB-2021 with 0.3 dose, intramuscular, Batch: EM9809. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Chronic respiratory disease with started before may-1969, peritoneal dialysis in 20-Sep-1998, Aortic stenosis in 2006 with Bovine replacement in 2011, Current one is wearing out and Skin cancer in 2002. Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Prophylactic vaccination; and REMDESIVIR (REMDESIVIR) for COVID-19.  On 01-Oct-2021, the patient received a 0.5 (units unspecified) dose of suspect influenza quadrival A-B high dose HV vaccine (lot UJ749AA, with unknown strength, form and expiry date) via intramuscular route in unknown administration site. On 19-Sep-2022 he/she also received a 0.7 (units unspecified) dose of the same vaccine (lot UJ904AD, with unknown strength, form and expiry date) via intramuscular route in unknown administration site both as prophylactic vaccination.  On an unknown date the patient developed a bloody nose (epistaxis) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine. On 02-OCT-2022 the patient got covid (covid-19) 1 year 1 day following the administration of influenza quadrival A-B high dose HV vaccine.  It was reported "I had a bloody nose from me to beginning 29-Jan-2021 to 17-May-2023. In addition to the shots I had Evushield infusion. 16-Dec-2023 I again tested positive for COVID. I was admitted to hospital for remdesivir. The shot on 22-Sep-2023 was the only one I didn't have a bloody nose after. All other shots were given on the arm. Usually the left. Not one of my doctors have all the information. Everything they have is provided by me."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event Epistaxis and for Covid patient was treated with monoclonal antibodies via infusion.  At time of reporting, the outcome was Unknown for the events.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered with an expired QUADRACEL with no reported adverse event; Initial information received on 12-Feb-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who was administered with an expired Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine Live (ENDERS-EDMONSTON), Mumps vaccine Live (JERYL LYNN), Rubella vaccine Live (WISTAR RA 27/3), Varicella Zoster vaccine Live (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On 12-Feb-2024, the patient received an expired, 0.5 ml dose (dose 1) of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine Suspension for injection of lot C5970AA and expiry: 02-Feb-2024 via intramuscular route in the right upper thigh for immunization, with no reported adverse event (expired product administered) (latency: same day).  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 Directive and Regulatory Authority 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.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: only the liquid part is administered, lyophilized component was not administered with no reported adverse event; Initial information received on 13-Feb-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who was administered only with the liquid part of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)], lyophilized component was not administered with no reported adverse event .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 15V (CRM197) (Vaxneuvance); Hepatitis B Vaccine (Hepatitis B Vaccine); and Rotavirus Vaccine Live Reassort Oral 5V (Rotateq), all for Immunisation.  On 13-Feb-2024, the patient had received only with the liquid part [0.5 ml (dose: 2)] of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) (lot UJ981AA; expiry date: 11-Feb-2025; strength not reported) via intramuscular route in the left thigh for prophylactic vaccination and lyophilized component was not administered with no reported adverse event (single component of a two-component product administered) (Latency: same day). It was also reported that Pentacel was not reconstituted.  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 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.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: accidentally administered YF-VAX intramuscularly to a patient today when it should be administered subcutaneously with no reported adverse event; Initial information received on 14-Feb-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case reports the nurse accidentally administered yellow fever vaccine [YF-VAX] intramuscularly to a patient (unknown age and gender) today when it should be administered subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Feb-2024, the nurse accidentally administered to patient  unknown dose of suspect yellow fever vaccine, Solution for injection, (lot number, strength and expiry date not reported) via intramuscularly route in unknown administration site for Prophylactic Vaccination when it should be administered subcutaneously with no reported adverse event (incorrect route of product administration) (latency: on same day).  Nurse states she is a field nurse and she does not have the patient's information, event details, YF-VAX's lot number and expiration date.    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 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.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion, lowest temperature is 1 C for duration: less than 24 hours/ thermometer recorded the lowest temperature the whole time of 2.75 C,the other one recorded 1 C so they are really not sure with no reported adverse event; YF-VAX administered to a patient post excursion with no reported adverse event; Initial information received on 14-Feb-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient where reporter reported yellow fever vaccine [YF-VAX] temperature excursion, lowest temperature is 1 c for duration: less than 24 hours/ thermometer recorded the lowest temperature the whole time of 2.75 c,the other one recorded 1 c so they are really not sure with no reported adverse event and yf-vax administered to a patient post excursion with no reported adverse event.  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 of suspect yellow fever vaccine Solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (product storage error) and (poor quality product administered) (latency- same day).  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 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.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Thrombocytopenia
Clinical narrative: Developed Thrombocytopenia
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Ear pain, Gingival pain, Glossodynia, Hypoaesthesia oral
Clinical narrative: 1) The day after the vaccine a 4" in diameter welt appeared at the vaccine site. 2) Two days after the vaccine my lips & tongue tip felt like they were stinging. Three days after the vaccine my gums on the left side of my mouth, my lips more on the left side, my roof of my mouth, my left ear area started stinging & my tongue tip felt numblike. I had these symptoms for the first time in early December but they slowly went away until they were gone about a week or so before the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Oral pain, Pain, Urticaria, Vaccination site reaction
Clinical narrative: 1) The day after the vaccine a 4" in diameter welt appeared at the vaccine site. 2) Two days after the vaccine my lips & tongue tip felt like they were stinging. Three days after the vaccine my gums on the left side of my mouth, my lips more on the left side, my roof of my mouth, my left ear area started stinging & my tongue tip felt numblike. I had these symptoms for the first time in early December but they slowly went away until they were gone about a week or so before the vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I have developed a visible tremor of my dominant hand.  This is most obvious when I am drinking from a glass.
Age: 74.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient received heplisav-b instead of Hib vaccination. had gotten twinrix a few days earlier
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Arteriogram carotid normal, Hypoaesthesia, Migraine, Scan with contrast normal
Clinical narrative: Patient is a 33 y.o. male with no pertinent past medical history who presents to the Emergency Department with transient left eye vision abnormality and left face numbness.   Patient here with his wife.  Patient reports that it 2:20 PM he was sitting on the couch with his head "at a weird angle" and he noticed vision abnormality to the left temporal visual field.  He describes it as a loss of peripheral vision with only a small portion of intact vision to the left lateral inferior area.  Right eye vision was normal.  Denies headache or eye pain.  Denies recent injury.  The symptoms lasted about 20 minutes.  The patient called his wife when he noticed the symptoms she says that he was not slurring his words and he sounded normal.  The patient states that he was able to operate his phone and call his wife without issue.  He is concerned that he may have had a stroke.  He did have some left face numbness which lasted approximately 1 hour but has resolved.  Never had similar symptoms.  No family history of stroke.  Patient has no known medical problems.  He does not smoke cigarettes.  He drinks alcohol, approximately 1 drink per day, no other drug use.  He denies lightheadedness, dizziness, chest pain, shortness of breath, nausea, vomiting, abdominal pain, weakness.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Tunnel vision, Visual field defect, Visual impairment
Clinical narrative: Patient is a 33 y.o. male with no pertinent past medical history who presents to the Emergency Department with transient left eye vision abnormality and left face numbness.   Patient here with his wife.  Patient reports that it 2:20 PM he was sitting on the couch with his head "at a weird angle" and he noticed vision abnormality to the left temporal visual field.  He describes it as a loss of peripheral vision with only a small portion of intact vision to the left lateral inferior area.  Right eye vision was normal.  Denies headache or eye pain.  Denies recent injury.  The symptoms lasted about 20 minutes.  The patient called his wife when he noticed the symptoms she says that he was not slurring his words and he sounded normal.  The patient states that he was able to operate his phone and call his wife without issue.  He is concerned that he may have had a stroke.  He did have some left face numbness which lasted approximately 1 hour but has resolved.  Never had similar symptoms.  No family history of stroke.  Patient has no known medical problems.  He does not smoke cigarettes.  He drinks alcohol, approximately 1 drink per day, no other drug use.  He denies lightheadedness, dizziness, chest pain, shortness of breath, nausea, vomiting, abdominal pain, weakness.
Age: 64.0
Sex: U
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: Swelling and tenderness to site of injection and arm.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jun2022 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Off label use, Seizure
Clinical narrative: He is having severe seizure and they put drip in him; they gave him the covid shot and flu shot and shingles shot all at once; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown) for immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series complete but unknown manufacturer.), for COVID-19 immunization. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening), outcome "unknown", described as "He is having severe seizure and they put drip in him"; OFF LABEL USE (non-serious), outcome "unknown", described as "they gave him the covid shot and flu shot and shingles shot all at once".  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. Follow-up (16Feb2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blindness, Eye irritation
Clinical narrative: Vision loss right eye in November.  Blurry like if someone threw mud in your eye. Called eye doctor and for appt, got appt on 11/28 or 11/29.  Sent us the next day to Ophthalmologist for swelling of the ocular nerve. Then went next day to ophthalmologist.  He could not give direct diagnosis until he ran blood work and MRI.  In December diagnosed with nonarteric ischemic ocular neuropathy.  Said nothing they can do, but should not get worse or move to other eye.  Gave some eye drops to try to help.  On February 18, blurry vision started in left eye.  Went back to ophthalmologist on 2/19/2024, ordering 2nd MRI, more blood work and asking for a neuro ophthalmologist consult.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blindness unilateral, Blood test, Magnetic resonance imaging, Optic ischaemic neuropathy, Optic neuritis
Clinical narrative: Vision loss right eye in November.  Blurry like if someone threw mud in your eye. Called eye doctor and for appt, got appt on 11/28 or 11/29.  Sent us the next day to Ophthalmologist for swelling of the ocular nerve. Then went next day to ophthalmologist.  He could not give direct diagnosis until he ran blood work and MRI.  In December diagnosed with nonarteric ischemic ocular neuropathy.  Said nothing they can do, but should not get worse or move to other eye.  Gave some eye drops to try to help.  On February 18, blurry vision started in left eye.  Went back to ophthalmologist on 2/19/2024, ordering 2nd MRI, more blood work and asking for a neuro ophthalmologist consult.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vision blurred
Clinical narrative: Vision loss right eye in November.  Blurry like if someone threw mud in your eye. Called eye doctor and for appt, got appt on 11/28 or 11/29.  Sent us the next day to Ophthalmologist for swelling of the ocular nerve. Then went next day to ophthalmologist.  He could not give direct diagnosis until he ran blood work and MRI.  In December diagnosed with nonarteric ischemic ocular neuropathy.  Said nothing they can do, but should not get worse or move to other eye.  Gave some eye drops to try to help.  On February 18, blurry vision started in left eye.  Went back to ophthalmologist on 2/19/2024, ordering 2nd MRI, more blood work and asking for a neuro ophthalmologist consult.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; patient received a third dose of MMRII in error.; Spontaneous information has been received from a medical assistance, regarding a patient of unknown age or gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not provided.   On an unspecified date in 20202, the patient received the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the second dose was on November 2023 (dose, route, anatomical location, lot # and expiration date not reported) as prophylaxis. On 29-JAN-2024, the patient received an accidental third dose (Extra dose administered) of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (valid lot # W029538 with expiration date stablished on 15-SEP-2024) (dose, route, anatomical location, not reported) as prophylaxis. No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE where products have been administered to patients.; This spontaneous report was received from a certified medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 05-FEB-2024, the patient was vaccinated with an improperly dose of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, rHA, 0.5 milliliter, valid lot #X022923, expiration date: 12-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion occurred at 5.8F for 15 minutes. No additional adverse event was reported.
Sex: F
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: Streptococcus 23-valent vaccine response: not protective; Literature Report.  Information has been received from the authors in a published literature article entitled as stated above concerning to a 10 year old female patient. On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown) (dose, route and lot # not reported).         On an unknown date, the patient's response to streptococcus 23-valent vaccine was found to be: not protective (vaccination failure). At the time of the report, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports from the same article (2402USA003803).; Sender's Comments:  US-009507513-2402USA003803:
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Injection site pain; Fatigue; Headche next day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site pain), fatigue (Verbatim: Fatigue) and headache (Verbatim: Headche next day). The outcome of the injection site pain, fatigue and headache were not reported.   It was unknown if the reporter considered the injection site pain, fatigue and headache to be related to Arexvy.     It was unknown if the company considered the injection site pain, fatigue and headache to be related to Arexvy.   Additional Information: GSK Receipt date: 10-NOV-2023 This case was reported by patient via (Open field AE monitoring) interactive digital media.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac operation
Clinical narrative: OPEN HEART SURGERY; This spontaneous report received from a consumer via social media concerned two patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose (dose number in series 1), start therapy date were not reported for covid-19 prophylaxis. Batch number was not reported. The company is unable to request the batch number. No concomitant medications were reported.  On an unspecified date, the patients had to have an open heart surgery (dose number in series 1) shorty after getting the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of open heart surgery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Cardiac operation. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient came in for HEP B. After administered then realized it was expired (02/15/24).  Immediately contacted Immunization hotline, who advised to revaccinate patient and low concern for side effects at this time.