chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site erythema, Injection site pallor, Limb discomfort, Pruritus
Clinical narrative: Patient was seen in the ED due to "right arm redness, discomfort and itching." The ED notes during the encounter list the following: "Warm and dry.  There is an area of erythema which is blanching in the right bicep vicinity where she received her vaccination."
Sex: M
Vaccine: HPV4
Symptoms: Immunisation reaction
Clinical narrative: brother also had an adverse reaction to the Gardasil vaccination; This spontaneous report has been received from a lawyer, via memo from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (MARRS # 2406USA004435), concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, dose, dose number, lot #, expiry date, anatomical location and route of administration were not provided).   On an unknown date, the patient had an adverse reaction to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination (Immunisation reaction). At the time of reporting, the outcome of the event was unknown   The reporter considered the event to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  This is one of two reports from the same lawyer.; Sender's Comments:  US-009507513-2406USA004435:
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: He is requesting information on if she needs to start the series over and if its appropriate to get the third dose.; No additional AE; This spontaneous report has been received from a Pharmacist, referring a 24-year-old female patient.  The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On an unknown date in 2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection; and on an unknown date in April 2024 (also reported as she received her second dose "on time"), she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection; both administered as prophylaxis (strength, dose administered, route and anatomical location of administration, lot # and expiration date were not provided regarding any of the administration). The reporter was requesting information on if she will need to start the series over and if it will be appropriate to get the third dose (inappropriate schedule of product administration). No additional  adverse event (AE) was reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: FBE reporting AE.  HCP reported to FBE a patient felt dizzy after receiving GARDASIL 9 injection.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a nurse via company representative and refers to an 11-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On 25-JUN-2024, the patient experienced dizzy after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Dizziness). It was unknown whether the patient received treatment. No other information provided.    At the time of reporting, the outcome of the event dizziness was unknown. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable. The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Lot number is being requested and it would be submitted if received.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Underdose, Vomiting
Clinical narrative: while a dose of ROTATEQ was being administered a 2 month old patient vomited twice while the vaccine was attempting to be administered.; The reminder od the vaccine was not administered and the patient did not receive the full dose; This spontaneous report has been received from a physician concerning to a 02-mont-old patient. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 26-JUN-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid at a dose of 2 mL orally, lot number X023474 that was verified to be a valid lot number (expiration date reported as 11-JUL-2024 but upon internal validation established as 11-JUL-2025) as prophylaxis (scheme frequency was not provided). On this day, while a dose of the vaccine was being administered, the patient vomited twice (vomiting). The reminder "od" the vaccine was not administered, and the patient did not receive the full dose (accidental underdose). No further adverse event (AE) information was available. At the reporting time, the outcome of the event of vomiting was unknown.   The causal relationship between the event vomiting and the vaccine was not provided.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported/ No additional AE; HCP called to report VARIVAX was administered to a patient after experiencing a T/E; This spontaneous report has been received from a nurse concerning to a 15-month-old patient. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 08-MAR-2024, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection at a dose of 0.5 mL, lot number X021930 that was verified to be a valid lot number (expiration date reported and validated as 29-AUG-2025) as prophylaxis (scheme frequency, route and anatomical location of administration were not provided). The dose was administered after experienced a temperature excursion (TE) (product storage error). No symptoms, and no additional adverse event were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported/ No additional AE; HCP called to report PROQUAD was administered to a patient after experiencing a T/E; This spontaneous report has been received from a nurse concerning to a 04-year-old patient. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 28-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection at a dose of 0.5 mL, lot number X022920 that was verified to be a valid lot number (expiration date reported and validated as 12-MAR-2025) as prophylaxis (scheme frequency, route and anatomical location of administration were not provided). The dose was administered after experienced a temperature excursion (product storage error). No symptoms and no additional adverse event were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had them and was very painful; very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had them and was very painful) and pain (Verbatim: very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     The company considered the vaccination failure 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: 21-JUN-2024 This case was reported by patient via interactive digital media. The reporter reported that she or he had shingles and was very painful after receiving the Shingrix vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUN-2024 This case was reported by a patient via interactive digital media. The reporter reported that he or she received the 2 vaccine shots and still got Shingles but not as bad as the 1st time without the vaccine, so patient stated that get the vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Longer than recommended 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 (on an unknown date 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: Longer than recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 20-JUN-2024 The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix late second dose; This non-serious case was reported by a consumer 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 (on an unknown date 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: Shingrix late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 20-JUN-2024 A reporter reported asking what the protocol for a patient was who did not get Shingrix within the 2-6 month period for the second dose. The reporter wanted to know do they have to start the series over or can they get the second dose, for example a year after the first dose. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Herpes zoster outbreak/ Suspected vaccination failure; herpes zoster outbreak; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced vaccination failure (Verbatim: Herpes zoster outbreak/ Suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster (Verbatim: herpes zoster outbreak). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster was not reported.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix. It was unknown if the company considered the herpes zoster to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2024 The reporter reported that her primary care physician had several patients with herpes zoster outbreak after Shingrix vaccination. No further information was available regarding these several patients. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. This case had been linked with the case US2024075877, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix. US-GSK-US2024075877:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Blood fibrinogen, Electrocardiogram, Fibrin D dimer, Platelet count
Clinical narrative: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME; This spontaneous report was received from literature. This report concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: obstructive sleep apnea, and non-smoker, and other pre-existing medical conditions included: no known thrombotic risk factors, no personal or family history of clotting disorders, and no recent surgical history or travel history. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced thrombosis with thrombocytopenia syndrome(dose series 1), and was hospitalized (date unspecified).  A 60-year old male with a history of obstructive sleep apnea with no known thrombotic risk factors presented for shortness of breath with two syncopal episodes ten days following administration of the Janssen vaccine. He was a lifelong non-smoker, no personal or family history of clotting disorders, and no recent surgical history or travel history. Labs demonstrated elevated D-dimer of 12.02, TNIH (troponin) of 206.4, platelets 182, fibrinogen 12.02. EKG demonstrated sinus tachycardia. CT Angiography chest demonstrated moderate to severe bilateral pulmonary emboli. Due to hypotension and enlarged RV with strain, the patient received Alteplase. The patient remained hospitalized for 6 days and discharged home with Xarelto and close follow-up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombosis with thrombocytopenia syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: Thrombosis with thrombocytopenia syndrome : The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis with thrombocytopenia syndrome, Troponin
Clinical narrative: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME; This spontaneous report was received from literature. This report concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: obstructive sleep apnea, and non-smoker, and other pre-existing medical conditions included: no known thrombotic risk factors, no personal or family history of clotting disorders, and no recent surgical history or travel history. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced thrombosis with thrombocytopenia syndrome(dose series 1), and was hospitalized (date unspecified).  A 60-year old male with a history of obstructive sleep apnea with no known thrombotic risk factors presented for shortness of breath with two syncopal episodes ten days following administration of the Janssen vaccine. He was a lifelong non-smoker, no personal or family history of clotting disorders, and no recent surgical history or travel history. Labs demonstrated elevated D-dimer of 12.02, TNIH (troponin) of 206.4, platelets 182, fibrinogen 12.02. EKG demonstrated sinus tachycardia. CT Angiography chest demonstrated moderate to severe bilateral pulmonary emboli. Due to hypotension and enlarged RV with strain, the patient received Alteplase. The patient remained hospitalized for 6 days and discharged home with Xarelto and close follow-up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombosis with thrombocytopenia syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: Thrombosis with thrombocytopenia syndrome : The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient sufferes from Multiple Myeloma.  Concurrent medical conditions included Multiple myeloma.    In September 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In December 2023, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Patient was vaccinated in Sep-2023 and got Covid-19 in Dec-2023.  Treatment information was not provided.
Age: 68.0
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 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "known allergies: Sulfa" (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 2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment from 05Jun2024 to 10Jun2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Nasopharyngeal swab
Clinical narrative: atrial fibrillation; 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 22Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Copd" (ongoing); "asthma" (unspecified if ongoing); "emphysema" (unspecified if ongoing); "allergies: Tetracyclines" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (lot number EN6198, dose number 1, prev dose vaccine location Left arm), administration date: 03Mar2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (lot number Ep7534, dose number 2, prev dose vaccine location Right arm), administration date: 24Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 12Mar2022, outcome "not recovered". The event "atrial fibrillation" required physician office visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Unknown Results. Therapeutic measures were taken as a result of atrial fibrillation. The patient went to a Cardiologist, put on medication. Additional information: the lot number of BNT162b2 dose 2 was also reported as Ep7634. No other vaccine in four weeks. No covid prior vaccination.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 multivalent nos (COMIRNATY MULTIVALENT NOS), on 15Sep2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3, single). The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (start date: 14Jun2024, stop date: 19Jun2024)  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; 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)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart stint" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Jun2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 16Jun2024 to 20Jun2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "recovered" (20Jun2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2024) negative, notes: day 4 of Paxlovid; (21Jun2024) negative, notes: day 5; (23Jun2024) negative, notes: day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Jun2024 to 21Jun2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Allergic reactions.This reaction required IV and IM steroid administration to manage; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-767369 (Moderna).  An adult male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to eggs" (unspecified if ongoing); "the patient has a history of a mild COVID-19 infection" (unspecified if ongoing), notes: characterized by a one-day fever that resolved with paracetamol. The patient's concomitant medications were not reported. Vaccination history included: Astrazeneca vaccine (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "mild fever"; Astrazeneca vaccine (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "occasional arrhythmias", "joint pains", "Severe allergic reaction". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; HYPERSENSITIVITY (medically significant), outcome "unknown", described as "Allergic reactions.This reaction required IV and IM steroid administration to manage". Therapeutic measures were taken as a result of hypersensitivity.Clinical course: It was reported that patient was planning to take the new Moderna Covid vaccine (XBB.1.5). After receiving two doses of the AstraZeneca vaccine, the patient had a severe allergic reaction requiring intravenous medications for almost six days. Since the second dose of the AstraZeneca vaccine, the patient occasionally experiences arrhythmias and joint pains, possibly related to vaccination. The third dose (Pfizer vaccine) also resulted in allergic reactions, requiring IV and IM steroid administration. These symptoms persisted for almost four days. Furthermore, the patient had a mild COVID-19 infection before receiving any COVID-19 vaccines. No upper respiratory tract infections were reported in the last five years, except for the aforementioned mild COVID-19 infection. The patient seeks advice on proceeding with vaccination based on the risk-benefit ratio and safety considerations. An urgent response was requested to assist in making an informed decision. The patient would appreciate a response supported by scientific evidence and precautionary measures.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: gave IMOVAX around the bite site which was on the arm as opposed to its indicated route of administration which was supposedly on the deltoid with no reported adverse event; Initial information received on 21-Jun-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age female patient and reporter reported gave rabies (HDC) vaccine [Imovax Rabies] around the bite site which was on the arm as opposed to its indicated route of administration which was supposedly on the deltoid 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 immunoglobulin human anti-rabies (Hyperrab) for Immunisation.  On 21-Jun-2024, the patient received an unknown total dose of suspect rabies (HDC) vaccine, Powder and solvent for suspension for injection (strength, lot number: unknown) (expiry date: 31-Oct-2025) via unknown route as Immunization and gave imovax around the bite site which was on the arm as opposed to its indicated route of administration which was supposedly on the deltoid with no reported adverse event (product administered at inappropriate site) (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 Module of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Unevaluable event
Clinical narrative: they just had a vial and there was an 11th dose that was drawn out of vial and administered to a patient with no reported adverse event; Initial information received on 21-Jun-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 8 years old female patient and reporter reported they just had a vial and there was an 11th dose of POLIOMYELITIS VACCINE (INACTIVATED) IPV (VERO) (IPOL)  that was drawn out of vial and administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Jun-2024, the patient received 0.5 ml total dose of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot W1C831M) (Expiry date: 21-Nov-2025) (Strength: standard) (Frequency: once) via intramuscular route in the right deltoid for immunization.  On 14-JUN-2024, the reporter reported they just had a vial and there was an 11th dose of Poliomyelitis Vaccine (Inactivated) that was drawn out of vial and administered to a patient with no reported adverse event (incorrect dose 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: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Patient states severe shoulder pain occurred after immunization, and is still present
Age: 66.0
Sex: F
Vaccine: HEPAB, PNC20, TDAP, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient reported redness on the skin around the injection site.
Age: 7.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema
Clinical narrative: abdominal redness post pneumococcal vaccination (resolved with A&D ointment)
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Flushing, Headache, Night sweats
Clinical narrative: flushing,pain from head down through spine and light headedness after injection then congestion, runny nose, night sweats, and weakness after days later; pt did go to primary care doctor; symptoms are finally improving
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory tract congestion, Rhinorrhoea, Spinal pain
Clinical narrative: flushing,pain from head down through spine and light headedness after injection then congestion, runny nose, night sweats, and weakness after days later; pt did go to primary care doctor; symptoms are finally improving
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Received wrong vaccine was supposed to receive infarix
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Symptoms consistent with "covid arm."  Swelling, tenderness, redness, itchy, warm tonthe touch at injection site.   Diameter of welt approx 2.5 inches
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Cough, Decreased appetite, Nasal congestion, Pyrexia, Respiration abnormal
Clinical narrative: About three hours after the patient received the vaccines in his thighs he started having stryder, his breathing changed and mom took him to the ED. At the ED he was given Decadron and an albuterol nebulizer treatment.  He did start to have a low grade fever, nasal congestion and cough two days ago. He had low appetite and waking at night with cough. It is thought that he had a reaction to the Pentacel, specifically the DTaP part of the immunization.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Sleep disorder, Stridor
Clinical narrative: About three hours after the patient received the vaccines in his thighs he started having stryder, his breathing changed and mom took him to the ED. At the ED he was given Decadron and an albuterol nebulizer treatment.  He did start to have a low grade fever, nasal congestion and cough two days ago. He had low appetite and waking at night with cough. It is thought that he had a reaction to the Pentacel, specifically the DTaP part of the immunization.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Condition aggravated, Heart rate increased, Influenza virus test negative, Injection site erythema
Clinical narrative: Redness, swelling, and intense itching of site, first 2 days;  intense itching requiring anti-itch cream for two weeks and some itching through 4 weeks; seriously elevated heart rate (normal approx. 48 bpm was 110 bpm) from 12 hours gradually easing to 72 bpm by three weeks and down to normal after one month.  A-fib palpitations first night, one week later.  Had 2 serious cases of RSV in past, with 6-week asthma exacerbation requiring prednisolone, so had looked forward to vaccine.  Now will never get again.  Am I at risk for any reactions to OTHER vaccines now???
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site swelling, Palpitations, SARS-CoV-2 test negative
Clinical narrative: Redness, swelling, and intense itching of site, first 2 days;  intense itching requiring anti-itch cream for two weeks and some itching through 4 weeks; seriously elevated heart rate (normal approx. 48 bpm was 110 bpm) from 12 hours gradually easing to 72 bpm by three weeks and down to normal after one month.  A-fib palpitations first night, one week later.  Had 2 serious cases of RSV in past, with 6-week asthma exacerbation requiring prednisolone, so had looked forward to vaccine.  Now will never get again.  Am I at risk for any reactions to OTHER vaccines now???
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antinuclear antibody increased, Fatigue, Headache, Neuralgia
Clinical narrative: Headache 24/7 lasting until early April, numbness and tingling in my face and lower legs, debilitating fatigue that requires two naps per day plus 8 hours sleep at night, often feeling not well or seriously sick.  All but the headache are ongoing
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antinuclear antibody, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Fatigue
Clinical narrative: Headache 24/7 lasting until early April, numbness and tingling in my face and lower legs, debilitating fatigue that requires two naps per day plus 8 hours sleep at night, often feeling not well or seriously sick.  All but the headache are ongoing
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hypersomnia, Hypoaesthesia, Malaise, Paraesthesia
Clinical narrative: Headache 24/7 lasting until early April, numbness and tingling in my face and lower legs, debilitating fatigue that requires two naps per day plus 8 hours sleep at night, often feeling not well or seriously sick.  All but the headache are ongoing
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Selective IgM immunodeficiency
Clinical narrative: Headache 24/7 lasting until early April, numbness and tingling in my face and lower legs, debilitating fatigue that requires two naps per day plus 8 hours sleep at night, often feeling not well or seriously sick.  All but the headache are ongoing
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP was transferred from CRT with questions regarding 16 yr old female received the first dose of GARDASIL 9 approximately 2 years ago, (exact date unknown), and has requested to received the second dose today; No adverse effects were reported; This spontaneous report was received from a pharmacist and refers to a 16-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, in June 2022 (reported as approximately 2 years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, route of administration and anatomical location were not provided). Then on 20-JUN-2024 (reported as today), the patient had requested to receive the second dose of the suspect vaccine (Inappropriate schedule of product administration) (also reported as interrupted vaccination schedule for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine [yeast] [GARDASIL 9]). No adverse effects were reported (no adverse event).  Additional information is not expected.
Age: 31.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a 31-year-old patient received the first dose of the GARDASIL-9 series on 17-DEC-2023. The customer has not received the 2nd dose of the series at this time / AE onset dose reflects the date of the missed dose being 2 months after the 1st dose; No additional AE reported.; This spontaneous report has been received from a Pharmacist, referring a 31-year-old patient of an unknown gender.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 17-DEC-2023, the patient was vaccinated with the first (1st) dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose administered, route and anatomical location of administration, lot # and expiration date were not provided). It was sated that the patient had not received the 2nd dose of the series at this time (inappropriate schedule of product administration). No additional  adverse event (AE) was reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: RSV
Symptoms: Lymphadenopathy
Clinical narrative: Left clavicular lymph node swelling
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Myalgia
Clinical narrative: Stomach ache, sore muscles, fatigue, headache
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Decreased appetite, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: Within 72 hours, started to feel ill and severe fatigue, headache.  On the 4th day, ran a fever in the range of 101.1-102.7 for 6 days.  Severe headache, loss of appetite, nausea and vomiting, severe swollen lymph nodes in the cervical chain that were the size of cotton balls.  The throat was severely swollen. By the 7th day, rash started on forehead and back of neck.  By day 9, rash spread to the posterior upper arm and diffuse across the back.  Rash is still present at the date of this report-June 29, 2024.   Went to see the Pediatrician and they did not think it was related.  They told her if her throat swelled any more to seek care at an ER.
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Nausea, Pharyngeal swelling, Pyrexia, Rash, Vomiting
Clinical narrative: Within 72 hours, started to feel ill and severe fatigue, headache.  On the 4th day, ran a fever in the range of 101.1-102.7 for 6 days.  Severe headache, loss of appetite, nausea and vomiting, severe swollen lymph nodes in the cervical chain that were the size of cotton balls.  The throat was severely swollen. By the 7th day, rash started on forehead and back of neck.  By day 9, rash spread to the posterior upper arm and diffuse across the back.  Rash is still present at the date of this report-June 29, 2024.   Went to see the Pediatrician and they did not think it was related.  They told her if her throat swelled any more to seek care at an ER.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site swelling
Clinical narrative: Sever chills, aches, muscle pain, headache, fatigue, joint pain, swelling at injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Sever chills, aches, muscle pain, headache, fatigue, joint pain, swelling at injection site.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Pain
Clinical narrative: Injection site had swollen to the size of a baseball in the course of 1-2 days. Painful and extreme fatigue accompanied the swelling. The swelling is just now starring to subside but it's still fairly swollen.
Age: 56.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient received Boostrix and Twinrix in right arm on 3/7/24. She said she felt fine for a week but then her arm got sore. She said it is still intermittently sore and that the pain comes and goes. Recommended ibuprofen or tylenol to assist with pain and to follow up with doctor if she wants.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Face injury, Fall, Syncope
Clinical narrative: Vasovagal syncope. I fainted within about 5-10 minutes after receiving the injection of the vaccine, falling down on my face.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large 10cm x 5cm indurated warm erythematous patch sorrounding injection sites.
Age: 21.0
Sex: M
Vaccine: COVID19-2, HEP, MMR, TDAP
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: Report seizure activity approximately  30 minutes -1 hour after vaccination, patient on ground and unresponsive at outside health fair event. EMS was called and arrived within 2 minutes to asset patient.
Age: 14.0
Sex: U
Vaccine: HEPA, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: At 12:36pm A 14 year old male came in for 6 vaccines today. He only received 3 due to reaction to vaccines. He was given Mcv4 #U7996BB, Tdap#U794BA/HepA#TF27T in left deltoid @ 1237pm with Mcv4 given last. Mother stated patient couldn?t breathe, clammy, dizzy and sweaty. EMS activated. Vital signs was attempted several times but machine could not read. Nurse was able to get vitals in the right leg 103/59, P-76 temp 97.6, o2sats @ 93%. Nurse assisted with communicating with mother and Patient. Nurse assisted with monitoring LOC. At 1252pm EMS has arrived and assessment started. At 1256pm vitals BP-121/63,p-76, o2 says 100% temp 98.8. Patient stable, no transport to hospital. Provider was notified.
Age: 73.0
Sex: F
Vaccine: HEPAB
Symptoms: Seizure, Swelling face
Clinical narrative: swollen face, seizure
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bell's palsy, Eyelid ptosis, Facial paralysis, Lacrimation increased
Clinical narrative: Patient developed Bells Palsy starting on 5/20/24 about a month after getting the Shingrix vaccine. Patient believes this is due to the Shingrix vaccine, Her symptoms have not resolved since. She is experiencing droopy and watery eyes, droopy face.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bell's palsy
Clinical narrative: Patient developed Bells Palsy starting on 5/20/24 about a month after getting the Shingrix vaccine. Patient believes this is due to the Shingrix vaccine, Her symptoms have not resolved since. She is experiencing droopy and watery eyes, droopy face.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pelvic venous thrombosis, Thrombectomy, Vena cava thrombosis
Clinical narrative: Extensive clotting of IVC, left and right iliac veins and dvt of both left and right legs.
Age: 52.0
Sex: F
Vaccine: TYP, VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Headache, Injection site erythema
Clinical narrative: Chills, joint ache, headache, dizziness, soreness at injection site. That was all expected; what was weird is redness at injection site that started 2 days later
Age: 52.0
Sex: F
Vaccine: TYP, VARZOS
Symptoms: Injection site pain
Clinical narrative: Chills, joint ache, headache, dizziness, soreness at injection site. That was all expected; what was weird is redness at injection site that started 2 days later
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Haemorrhage, Pruritus, Rash, Scab
Clinical narrative: Shortly after the second dose I began to have itching and a severe rash, which has worsened over time.  My dermatologist confirmed Grover's Disease for both me and my husband.  His has improved, but mine has worsened over the months resulting in various treatments being tried.   Symptoms include itching, rash, bleeding, blisters and scabbing.  Intense itching caused lack of sleep for months. Symptoms still being treated by healthcare professionals.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Transient acantholytic dermatosis
Clinical narrative: Shortly after the second dose I began to have itching and a severe rash, which has worsened over time.  My dermatologist confirmed Grover's Disease for both me and my husband.  His has improved, but mine has worsened over the months resulting in various treatments being tried.   Symptoms include itching, rash, bleeding, blisters and scabbing.  Intense itching caused lack of sleep for months. Symptoms still being treated by healthcare professionals.