chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: an expired dose of Engerix B vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received HBV (Engerix B) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   On 30-MAY-2024, the patient received Engerix B. On 30-MAY-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: an expired dose of Engerix B 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: 31-MAY-2024 Nurse stated that yesterday an expired dose of Hepatitis B vaccine, clarified to be Engerix-B, was given to a three year old male patient which led to expired vaccine used.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Administration instead of Bexsero; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3553D, expiry date 28-FEB-2025) for prophylaxis.   On 30-MAY-2024, the patient received the 4th dose of Menveo. On 30-MAY-2024, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Administration instead of Bexsero). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 31-MAY-2024 A nurse called in to report that a male patient, who was 17 years of age at the time of the event, accidentally received a fourth dose of Menveo instead of the prescribed dose of Bexsero which led wrong vaccine administered. Medical information was solicited, which would be provided later on as there was a technical difficulty. The health care professional did consent to receive follow up from the safety team.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: RN reports a 15 month old patient was administered Boostrix. The intention was to give the child their 4th dose of Infanrix; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M7YY5, expiry date 08-DEC-2025) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: RN reports a 15 month old patient was administered Boostrix. The intention was to give the child their 4th dose of Infanrix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 03-JUN-2024 The registered nurse reported a 15 month old patient was administered Boostrix where the intention was to give the child their 4th dose of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received Sihngrix second dose after the 6 months interval.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (2 years ago received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received Sihngrix second dose after the 6 months interval.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 03-JUN-2024 A pharmacist reported that she had received several questions from patients regarding the administration of the Sihngrix second dose after the 6 months interval.  The HCP wanted to know if the series needed to be re started if the patient received the first dose 2 years ago.  The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, Underdose
Clinical narrative: Expired dose was administered; pediatric dose administered to adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HBV (Engerix B 10 mcg) (batch number L9Y4G, expiry date 05-APR-2024) for prophylaxis.   On 25-MAY-2024, the patient received the 1st dose of Engerix B 10 mcg. On 25-MAY-2024, an unknown time after receiving Engerix B 10 mcg, the patient experienced expired vaccine used (Verbatim: Expired dose was administered) and adult use of a child product (Verbatim: pediatric dose administered to adult). The outcome of the expired vaccine used and adult use of a child product were unknown.   Additional Information: GSK receipt date: 03-JUN-2024 The pharmacist reported a colleague gave a vaccine to a patient for Engerix-B pediatric (10 mcg) instead of the adult dose, which led to adult use of pediatric dose. The patient was received vaccine 25th May 2024, which was expired on 5th April 2024, which led to expired vaccine used. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet received the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (5th November 2018 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not yet received the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-JUN-2024 A pharmacist reported that a patient received the first dose of Shingrix 6 years ago.  It appears the patient had not yet received the 2nd dose as the HCP wanted to know should he restart the series or get the 2nd dose now.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: supposed to get Infanrix but received Kinrix instead.; RN states a 16 month old patient was supposed to get Infanrix but received Kinrix instead.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 03-JUN-2024, the patient received Kinrix. On 03-JUN-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: supposed to get Infanrix but received Kinrix instead.) and inappropriate age at vaccine administration (Verbatim: RN states a 16 month old patient was supposed to get Infanrix but received Kinrix instead.). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 03-JUN-2024 The regular nurse stated a 16 month old patient was supposed to get Infanrix but received Kinrix instead, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Physician.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Apr2024 as dose 2 (toppac), single (Lot number: HH3221), in left arm for covid-19 immunisation; BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Lot number: HG2649), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastrooesophageal reflux disease" (unspecified if ongoing). The patient had no known allergy. Concomitant medication(s) included: FAMOTIDINE, start date: 01Dec2009. Vaccination history included: Covid-19 vaccine (Dose 1, single, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, single, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (booster), single, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 (booster), single, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 5 (booster), single, manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 22May2024 to 27May2024.  No follow-up attempts are possible.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect products BNT162B2 OMI XBB.1.5 dose 1 and dose 2 cannot be fully excluded.
Age: 54.0
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 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies; gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 17May2024 to 22May2024.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: sense of smell and taste started fading; sense of smell and taste started fading; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9263) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAROSMIA (non-serious), TASTE DISORDER (non-serious), outcome "unknown" and all described as "sense of smell and taste started fading".  Additional information: A patient called for information about if his symptoms after the administration of the Comirnaty vaccine would last forever. The patient reported that after he received the first dose of the Comirnaty vaccine his sense of smell and tase started fading, and after a couple of weeks of receiving the second dose, the senses were completely gone. The patient reported that he is frustrated because it has passed a lot of time and his senses do not come back, he considered that is dangerous not to be able to smell gas or ammonia, also he reported to be able to taste salt and sugar, but no other flavors of food. The patient reported that he knows other people that have had this very same symptoms, but they could get back their senses after some time. The patient was referred to his Physician for further information and management.
Age: 74.0
Sex: M
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 74-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "pure autonomic failure" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: goji berries" (unspecified if ongoing); "Reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included PAXLOVID from 25May2024 to 29MAY2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2022 as dose 3 (booster), single (Lot number: FG3524) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 08Feb2021 as dose 1, single (Lot number: 010M20A), in left arm and on 10Mar2021 as dose 2, single (Lot number: 030A21A), in left arm for covid-19 immunisation. The patient had no relevant medical history and had no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Jan2022, outcome "unknown"; COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31May2024 to 03Jun2024.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: He had atrial Fib; This is a spontaneous report received from a Nurse.  A male 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "He had atrial Fib". Clinical course: Reporter listen to a conversation between a man and his wife and he just had his Pfizer vaccine (Unspecified Vaccine) and he had atrial Fib which he never had before in his life.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event atrial fibrillation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.,Linked Report(s) : US-PFIZER INC-202400186211 Same reporter/product, different patient/event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Catheterisation cardiac, Computerised tomogram, Echocardiogram, Electrocardiogram
Clinical narrative: He had atrial Fib; This is a spontaneous report received from a Nurse.  A male 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "He had atrial Fib". Clinical course: Reporter listen to a conversation between a man and his wife and he just had his Pfizer vaccine (Unspecified Vaccine) and he had atrial Fib which he never had before in his life.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event atrial fibrillation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.,Linked Report(s) : US-PFIZER INC-202400186211 Same reporter/product, different patient/event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Malaise, Nervous system disorder, Ventricular extrasystoles
Clinical narrative: He had atrial Fib; This is a spontaneous report received from a Nurse.  A male 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "He had atrial Fib". Clinical course: Reporter listen to a conversation between a man and his wife and he just had his Pfizer vaccine (Unspecified Vaccine) and he had atrial Fib which he never had before in his life.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event atrial fibrillation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.,Linked Report(s) : US-PFIZER INC-202400186211 Same reporter/product, different patient/event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Atrial fibrillation, Catheterisation cardiac, Fatigue, Inappropriate schedule of product administration
Clinical narrative: He had atrial Fib; This is a spontaneous report received from a Nurse.  A male 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "He had atrial Fib". Clinical course: Reporter listen to a conversation between a man and his wife and he just had his Pfizer vaccine (Unspecified Vaccine) and he had atrial Fib which he never had before in his life.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event atrial fibrillation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.,Linked Report(s) : US-PFIZER INC-202400186211 Same reporter/product, different patient/event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nervous system disorder, Tremor, Ventricular extrasystoles
Clinical narrative: He had atrial Fib; This is a spontaneous report received from a Nurse.  A male 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "He had atrial Fib". Clinical course: Reporter listen to a conversation between a man and his wife and he just had his Pfizer vaccine (Unspecified Vaccine) and he had atrial Fib which he never had before in his life.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event atrial fibrillation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.,Linked Report(s) : US-PFIZER INC-202400186211 Same reporter/product, different patient/event;
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Discomfort, Dizziness, Gait disturbance, Malaise
Clinical narrative: difficulty walking; shake severely; uneasiness, uncomfortable; uneasiness, uncomfortable; unwell; vomiting; dizziness; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 03Jun2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 56-year-old male patient received BNT162b2 (BNT162B2), in Jan2023 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaacine (DOSE 1, Manufacturer unknown), administration date: Oct2022, when the patient was 54 years old, for COVID-19 Immunization. The following information was reported: DIZZINESS (disability) with onset Jan2023, outcome "not recovered"; MALAISE (non-serious) with onset Mar2023, outcome "recovered", described as "unwell"; VOMITING (disability) with onset Mar2023, outcome "recovered"; GAIT DISTURBANCE (disability), outcome "recovered", described as "difficulty walking"; TREMOR (non-serious), outcome "recovered", described as "shake severely"; ANXIETY (non-serious), DISCOMFORT (non-serious), outcome "unknown" and all described as "uneasiness, uncomfortable". Therapeutic measures were not taken as a result of vomiting, dizziness, tremor, malaise.  Clinical information : Pfizer's vaccine caused pleased the patient shake severely. No admission to hospital due to the events shake severely, Dizziness, Vomiting and Unwell. Took one shot and caused difficulty walking, vomiting.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: difficulty walking; shake severely; uneasiness, uncomfortable; uneasiness, uncomfortable; unwell; vomiting; dizziness; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 03Jun2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 56-year-old male patient received BNT162b2 (BNT162B2), in Jan2023 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaacine (DOSE 1, Manufacturer unknown), administration date: Oct2022, when the patient was 54 years old, for COVID-19 Immunization. The following information was reported: DIZZINESS (disability) with onset Jan2023, outcome "not recovered"; MALAISE (non-serious) with onset Mar2023, outcome "recovered", described as "unwell"; VOMITING (disability) with onset Mar2023, outcome "recovered"; GAIT DISTURBANCE (disability), outcome "recovered", described as "difficulty walking"; TREMOR (non-serious), outcome "recovered", described as "shake severely"; ANXIETY (non-serious), DISCOMFORT (non-serious), outcome "unknown" and all described as "uneasiness, uncomfortable". Therapeutic measures were not taken as a result of vomiting, dizziness, tremor, malaise.  Clinical information : Pfizer's vaccine caused pleased the patient shake severely. No admission to hospital due to the events shake severely, Dizziness, Vomiting and Unwell. Took one shot and caused difficulty walking, vomiting.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, General physical health deterioration, Pain in extremity, Spinal stenosis
Clinical narrative: Spinal stenosis; her health started to deteriorate: hospitalized for pain in back and legs; her health started to deteriorate: hospitalized for pain in back and legs; her health started to deteriorate: hospitalized for pain in back and legs; This is a spontaneous report and received from Consumer or other non HCPs, Program ID.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), 0.3 ml single (Lot number: 3303BD, Expiration Date: 31May2022) at the age of 78 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune Hepatitis" (unspecified if ongoing); "Hypothyroidism/Low thyroid" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Hypertension (slight)" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE, Batch/lot number: EL9266, Anatomical location: Arm, Route of administration: Intramuscular, Expiration date: 21May2021), administration date: 17Feb2021, when the patient was 77-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, 0.3 ML SINGLE, Batch/lot number: EN6206, Anatomical location: Arm, Route of administration: Intramuscular), administration date: 10Mar2021, when the patient was 77-year-old, for COVID-19 immunisation. The following information was reported: BACK PAIN (hospitalization), PAIN IN EXTREMITY (hospitalization), GENERAL PHYSICAL HEALTH DETERIORATION (hospitalization) all with onset Mar2022, outcome "not recovered" and all described as "her health started to deteriorate: hospitalized for pain in back and legs"; SPINAL STENOSIS (hospitalization), outcome "unknown". The patient was hospitalized for back pain, pain in extremity, general physical health deterioration, spinal stenosis (start date: Mar2022, hospitalization duration: 5 day(s)). The events "her health started to deteriorate: hospitalized for pain in back and legs" and "spinal stenosis" required physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of back pain, pain in extremity, general physical health deterioration. Clinical course: Patient was hospitalized for several days for pain in back and shooting pain down legs in Mar2022. Conclusion was spinal stenosis; but onset was shortly after receiving third Pfizer dose of covid vaccine. Pain never did go away. Her overall health started to decline after the 3rd vaccine. She said she never felt right after the 3rd shot, Dose 1 was administered at PM.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400185773 Same patient/vaccine, different events/suspect doses (LOE);US-PFIZER INC-PV202400061360 Same patient/ Vaccine, different dose/events (Dose 4);
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity, Respiratory tract congestion
Clinical narrative: Arm became sore day after vaccine given. 2 days after vaccine, injection site is red, raised, tender to touch, and complaints of cold symptoms (runny nose and congestion)
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Rhinorrhoea
Clinical narrative: Arm became sore day after vaccine given. 2 days after vaccine, injection site is red, raised, tender to touch, and complaints of cold symptoms (runny nose and congestion)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at injection site...told to watch and take ibuprofen if needed
Age: 12.0
Sex: F
Vaccine: COVID19, FLU4, HEP, HEPA, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Patient walking towards the elevators after vaccination visit and had syncopal episode witnessed by parents, but no team members. Parents report that patient felt dizzy and was lowered to the floor, no head injury occurred. MER called. When RN arrived to scene, patient found sitting down on the floor, very pale in appearance. Vital signs taken, initial BP 60s/40s with HR in 100s. 3 minutes later another BP taken, and BP 100s/70s. Blood glucose was found to be 109. Patient reported that she last ate around 1200. Water provided to patient- witnessed her complete 12 oz water bottle. Parents provided candy bar, and patient reported feeling better. Waited in the lobby for 10 more minutes to ensure feeling better.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired COVID Vaccine given to patient
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult patient was given a pediatric dose of Hep A vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Limb mass, Muscle spasms, Pain
Clinical narrative: PT STATES THAT VACCINE "BURNED" GOING INTO ARM. STATED THAT ARM HAS BEEN SORE FOR THE PAST 6 MONTHS. LAST WEEK ( MAY 26-JUNE 1) SHE HAD A CHARLEY HORSE IN ARM AND HAS SINCE LOST USE OF THE ARM. PT HAD APPT WITH MD LAST WEEK WHO SAYS HE CAN FEEL LUMP IN ARM AND IS ORDERING AN ULTRASOUND TO SEE WHAT IS PROBLEM, THEN WILL LOOK AT CORTISONE SHOT OR MRI
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Gait inability, Vertigo
Clinical narrative: Extreme dizziness to the point where the patient could not walk (too unsteady) or see clearly because the room was spinning so badly. This resolved after 3 days.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Ear infection, Influenza virus test negative, Pyrexia, Rash, Respiratory syncytial virus test negative
Clinical narrative: 5 days of fever  followed by rash and ear infection.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative, Urine analysis normal
Clinical narrative: 5 days of fever  followed by rash and ear infection.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Condition aggravated, Eczema, Gastrooesophageal reflux disease, Infant irritability
Clinical narrative: Patient's reflux and fussiness got a lot worse in the 1-2 weeks following vaccine administration. Family attributed it to the rotavirus vaccine.
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Asthma, Increased viscosity of upper respiratory secretion, Influenza, Upper-airway cough syndrome, Wheezing
Clinical narrative: It gave me flu, asthma symptoms of lung wheezing and chronic carrah, that's post nasal drip with constant heavy yellow mucus , it's going on 6months now
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood creatine phosphokinase abnormal, C-reactive protein, Complement factor C3, Dry skin
Clinical narrative: Numerous long term issues developed within a month or so after receiving the vaccine. Started with dry itchy skin and then progressed to join pain,, Dry itchy skin changed to various locations over the last few years while joint pain was pretty consistent. I complained about the symptoms since that time but a diagnosis was not received until recently.  It should be noted that two other family members may have the same diagnosis. They are complaining about some of the same symptoms that started after their vaccine but they have not had all the tests completed or received a formal diagnosis yet.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, HLA-B*27 assay, Laboratory test, Metabolic function test, Pruritus
Clinical narrative: Numerous long term issues developed within a month or so after receiving the vaccine. Started with dry itchy skin and then progressed to join pain,, Dry itchy skin changed to various locations over the last few years while joint pain was pretty consistent. I complained about the symptoms since that time but a diagnosis was not received until recently.  It should be noted that two other family members may have the same diagnosis. They are complaining about some of the same symptoms that started after their vaccine but they have not had all the tests completed or received a formal diagnosis yet.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriatic arthropathy, Red blood cell sedimentation rate, Sjogren's syndrome, X-ray
Clinical narrative: Numerous long term issues developed within a month or so after receiving the vaccine. Started with dry itchy skin and then progressed to join pain,, Dry itchy skin changed to various locations over the last few years while joint pain was pretty consistent. I complained about the symptoms since that time but a diagnosis was not received until recently.  It should be noted that two other family members may have the same diagnosis. They are complaining about some of the same symptoms that started after their vaccine but they have not had all the tests completed or received a formal diagnosis yet.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash vesicular, Respiratory tract congestion
Clinical narrative: Patient developed non-itchy varicella-like rash to thighs /feet/soles and arms/hands/palms. Had mild congestion that was ongoing but no other symptoms. Supportive care discussed.
Age: 57.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Chest pain, Dyspnoea, Tremor
Clinical narrative: Patient stated that after his vaccine was given, that night his blood pressure spiked to 190/120MMHG. He said he went to the emergency room, that night. this happened over the next 3 night. He went to the emergency room 3 different times due to high blood pressure.
Age: 57.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Condition aggravated, Hypertension
Clinical narrative: Patient stated that after his vaccine was given, that night his blood pressure spiked to 190/120MMHG. He said he went to the emergency room, that night. this happened over the next 3 night. He went to the emergency room 3 different times due to high blood pressure.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Ill-defined disorder, Incomplete course of vaccination, Neoplasm malignant
Clinical narrative: Cancer; Health complications; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date (reported when the patient was 45 years old), she was vaccinated with the first and only dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot #, expiry date, route of administration, and anatomical location were not provided) administered for prophylaxis by a health professional.  On an unknown date, the patient developed cancer (neoplasm malignant) and she was being treated for the event (details not provided). Moreover, on an unspecified date, she experienced health complications (ill-defined disorder), therefore she did not complete the series of the suspect vaccine. At the time of reporting, the outcome of the event of health complications and cancer was not known.  The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event of neoplasm malignant was considered as not applicable, while regarding the event of ill-defined disorder was reported as withdrawn.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event of neoplasm malignant was reported as not related, while the causal relationship between the event of ill-defined disorder and the suspect vaccine was not provided.   Upon internal review, the event of neoplasm malignant was determined to be medically significant.  Lot # is being requested and will be submitted if received. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARDASIL 9 vaccine and the reported event of neoplasm malignant cannot be established. Information about patient's medical history, concurrent conditions, concomitant medications, detailed clinical course, final diagnosis, and follow up is needed for further assessment.   Company Comment- No changes to the GARDASIL 9 vaccine product safety information are warranted at this time.  Merck Sharp & Dohme LLC, continues to monitor the safety profile of the product.
Age: 12.0
Sex: M
Vaccine: COVID19, HPV9
Symptoms: Ill-defined disorder, Pyrexia, Tachycardia
Clinical narrative: "nitro insufficiency"; developed a 104F fever and "tachycardia of 130" on 02-MAY-2024.; developed a 104F fever and "tachycardia of 130" on 02-MAY-2024.; This spontaneous report has been received from other health professional via company representative referring a 12-year-old male patient.  The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 29-APR-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as prophylaxis (strength, dose administered, route and anatomical location of administration, lot # and expiration date were not provided). On an unknown date, he was also vaccinated with COVID-19 vaccine (unspecified),  (strength, formulation, dose description, lot #, expiration date, route of administration, and indication were not provided).  On 02-MAY-2024, body temperature was 104 Fahrenheit (F), and heart rate was 130 (units not provided); therefore, on that date, he developed a 104F fever and tachycardia of 130 (pyrexia, tachycardia). On an unknown date (also reported as around the time the patient received COVID vaccine), he also experienced "nitro insufficiency" (Ill-defined disorder). It was stated that the patient sought medical attention by contacting a physician and received ibuprofen and acetaminophen (TYLENOL) as treatment for pyrexia and tachycardia. At the time of this report, the outcome of the events was unknown.   The causal relationship between pyrexia, tachycardia and Ill-defined disorder with both suspect vaccines was not provided.  Lot # is being requested and will be submitted if received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old female patient received BNT162b2 (BNT162B2 NOS), on 15Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 32 years, in right arm 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) with onset May2024, outcome "recovered" (May2024), COVID-19 (medically significant) with onset May2024, outcome "recovered" (2024) and all described as "COVID". The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 26May2024 until 31May2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema multiforme, Pruritus, Rash, Urticaria
Clinical narrative: intense pruritis accompanied by an urticarial rash and erythema multiforme over the trunk and extremities lasting 9 hours and treated with loratadine 10 mg tid and topical 0.8% lidocaine gel.  Afebrile. Duration of treatment approximately 12 hours. (Photos of rash are available with date and time stamp).
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chest pain, Cough, Impaired work ability, Neck pain
Clinical narrative: I am not confident which Tdap variety I received as it was only labeled Tdap. About 24-48 hours after receiving the shot I started to feel pretty significant pain in my shoulder, elbow, chest, neck, and later in my finger tips. I had fever like symptoms and a persistent yet mild cough. This symptoms have lingered past the 72 hour mark and have not subsided. The pain has been bad enough to disrupt my work and sleep as well as require OTC treatment. This was abnormal as I have not had a reaction to shots in the past like this.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: I am not confident which Tdap variety I received as it was only labeled Tdap. About 24-48 hours after receiving the shot I started to feel pretty significant pain in my shoulder, elbow, chest, neck, and later in my finger tips. I had fever like symptoms and a persistent yet mild cough. This symptoms have lingered past the 72 hour mark and have not subsided. The pain has been bad enough to disrupt my work and sleep as well as require OTC treatment. This was abnormal as I have not had a reaction to shots in the past like this.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles/had them couple weeks later got them again; worst pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles/had them couple weeks later got them again) and pain (Verbatim: worst pain). The outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-MAY-2024 This case was reported by a patient via interactive digital media. The patient got the shots and after had them couple weeks and later he/she got them again. The patient had worst pain ever.
Age: 12.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: A healthy 12-year-old child received a fifth dose of a pneumococcal vaccine, it might not have been necessary according to the standard vaccination schedule.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caregiver inadvertently administered an expired Covid vaccine. The Beyond Use Date label 4/5/2024 @ 0525. Pt reported no symptoms or concerns. Patient was offered to be revaccinated but elected to wait until the Fall 2024.
Age: 48.0
Sex: M
Vaccine: IPV, MMR, MNQ
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Left arm is red, hot to touch, swollen,  and hard
Age: 6.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Irritability, Skin warm, Swelling, Urticaria
Clinical narrative: 3/23 woke with a  baseball sized welt that was red and very hot to the touch  and child very fussy (child is non verbal). Grew I in size over the next 48 hrs to the size of a grapefruit and still hot to the touch welted up. Swelling started to decrease on the 26th of March and took another 5 days to completely go away.
Age: 30.0
Sex: M
Vaccine: HPV9
Symptoms: Alopecia areata
Clinical narrative: Patient reported that he started to have alopecia of his beard
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: 6 wks of persistent night pain in arm at injection location
Age: 84.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Urticaria
Clinical narrative: Patient states he developed hives all over body starting around Holiday 2023.  He saw PCP to prescribe steroid cream and he has experienced hives off and on since then.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The second varicella vaccine was inadvertently given 6 days early. The vaccine counts as a valid dose. The patient did not have any adverse reactions to the vaccine dose.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Pt was given the MMR vaccine intramuscular instead of subcutaneously. Pt had no reported adverse effects from injection.  Reviewed improper administration with provider with no new orders.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Mobility decreased, Neck pain, Pain, Sleep disorder
Clinical narrative: Left shoulder pain radiating from the neck to the elbow. Difficulty with moving the left arm forward, up, back. Cannot sleep on left side.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness around the injection site
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Computerised tomogram head normal, Folliculitis, Headache, Neck pain, Pain of skin
Clinical narrative: Patient reported to ED on 6/12/21 with c/o severe headache. Headache is in right back of his head. Pt got second Pheizer covid vaccine on the 8th, pt didn't sleep well that night and started with a headache and headache just keeps getting worse. Pt is light sensiitive with nausea. Head CT negative. Patient went back to ED on 6/18/21 with c/o headache for one week. neck pain; continues to have headache. He has persistent pain and swelling which he localizes to the occipital area of his scalp overlying his hair. Suspected to have foliculitis.  Treating hospital