chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: patient may not have received a complete dose of Arexvy; patient may not have received a complete dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 77-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3B252, expiry date 12-MAY-2026) for prophylaxis.   On 02-DEC-2023, the patient received Arexvy. On 02-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient may not have received a complete dose of Arexvy) and inappropriate dose of vaccine administered (Verbatim: patient may not have received a complete dose of Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: RA receipt date:29-DEC-2023 The reporter reported that a patient might not received a complete dose of Arexvy which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Reporter also reported that the patient might had received the adjuvant only or a complete, reconstituted dose, they were unsure. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Cataract operation
Clinical narrative: had cataract surgery 2 weeks ago; This serious case was reported by a consumer via call center representative and described the occurrence of cataract operation in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Shingrix (intramuscular). In DEC-2023, between 5 and 6 months after receiving Shingrix, the patient experienced cataract operation (Verbatim: had cataract surgery 2 weeks ago) (serious criteria clinically significant/intervention required). The outcome of the cataract operation was unknown.   It was unknown if the reporter considered the cataract operation to be related to Shingrix.     It was unknown if the company considered the cataract operation to be related to Shingrix.   Additional Information: RA Receipt Date: 29-DEC-2023 This case is self-reported by the patient. It was reported that he had one Shingrix vaccine and was due for his second Shingrix vaccine on 1st March 2024.  The patient had cataract surgery 2 weeks prior to the reporting date and he referred to health care professional (HCP). The reporter did not consented to the follow-up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dyspepsia, Herpes zoster, Rash
Clinical narrative: rash; shingles; indigestion problems; Reporter states that his stomach pain has reduced today; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-OCT-2023, the patient received the 1st dose of Shingrix. On 14-DEC-2023, 57 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). In DEC-2023, the patient experienced rash (Verbatim: rash), indigestion (Verbatim: indigestion problems) and stomach pain (Verbatim: Reporter states that his stomach pain has reduced today). The patient was treated with valaciclovir hydrochloride (Valtrex). In DEC-2023, the outcome of the rash was resolved.  On 21-DEC-2023, the outcome of the shingles was resolved. The outcome of the indigestion was not reported and the outcome of the stomach pain was resolving.   It was unknown if the reporter considered the shingles, rash, indigestion and stomach pain to be related to Shingrix.     It was unknown if the company considered the shingles, rash, indigestion and stomach pain to be related to Shingrix.   Additional Information: RA Receipt date: 27-DEC-2023 The patient self-reported this case. The patient received Shingles vaccine and 4 days before reporting, he was to get the second vaccine on 18th December 2023, he got shingles. Patient treated with Valtrex for 7 days and the rash disappeared. Patient had indigestion problems. Patient asked a question that, was there any way the shingles may be internal. Patient eat toast and drink tea for some relief. Patient asked that when he should schedule the second vaccine. Patient also stated that his stomach pain had reduced on reporting day. The reporter requested to consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Illness, Inappropriate schedule of product administration
Clinical narrative: Unable to hear/ hearing loss; unspecified illness including hearing loss; having received the Shingrix dose #1 and #2 more than 6 months apart.; This serious case was reported by a consumer via call center representative and described the occurrence of deafness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st March 2023).   On 07-NOV-2023, the patient received the 2nd dose of Shingrix. On 07-NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: having received the Shingrix dose #1 and #2 more than 6 months apart.). On an unknown date, the patient experienced deafness (Verbatim: Unable to hear/ hearing loss) (serious criteria GSK medically significant) and illness (Verbatim: unspecified illness including hearing loss). The outcome of the deafness and illness were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the deafness and illness to be related to Shingrix.     It was unknown if the company considered the deafness and illness to be related to Shingrix.   Additional Information: GSK receipt date: 02-JAN-2024 The patient self-reported this case. The patient stated that she had potential side effect question. The patient had a timeline of things that had happened, and she want to know if it could be due to this time, she waited in between taking the second dose. The patient developed was that she could not hear as well.  She stated she did not know what was going on, but she had developed an illness and wondered if her symptoms or illness might had something to do with having received the Shingrix dose 1st and 2nd more than 6 months apart.  The reporter did not want to answer any further questions over the phone. The reporter was willing to provide further information (example MD contact information) if safety sends her a letter. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.25
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient administered Booxtrix and an IPV (non-GSK) in addition to the non-GSK DTAP; supposed to administer just a non-GSK DTAP vaccine (diphtheria, tetanus, pertussis) to the patient but administered Boostrix; 15-Months-old patient received Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (DTaP vaccine) for prophylaxis.   Concomitant products included Polio vaccine inact (Ipv).   On 02-JAN-2024, the patient received Boostrix (intramuscular) and DTaP vaccine. On 02-JAN-2024, an unknown time after receiving Boostrix, the patient experienced overdose (Verbatim: patient administered Booxtrix and an IPV (non-GSK) in addition to the non-GSK DTAP), wrong vaccine administered (Verbatim: supposed to administer just a non-GSK DTAP vaccine (diphtheria, tetanus, pertussis) to the patient but administered Boostrix) and inappropriate age at vaccine administration (Verbatim: 15-Months-old patient received Boostrix). The outcome of the overdose, 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: 02-JAN-2024 The HCP (health care professional) reported that she was supposed to administer just a non-GSK DTAP vaccine (diphtheria, tetanus, pertussis) to the patient but administered Boostrix and an IPV (non-GSK) in addition to the non-GSK DTAP on the day of reporting, which led to overdose and wrong vaccine administered. The 15-Months-old patient received Boostrix, which led inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 42-year-old patient received a dose of Infanrix.; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 42-year-old male patient who received DTPa (Infanrix) (batch number 9R2D7) for prophylaxis.   On 07-AUG-2023, the patient received Infanrix. On 07-AUG-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 42-year-old patient received a dose of Infanrix.). The outcome of the inappropriate age at vaccine administration 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: 02-Jan-2024 The Vaccine Administration Facility was the same as Primary Reporter A physician called to inform that back in, a 42-year-old patient received a dose of Infanrix. which led to inappropriate age at vaccine administration. The reporter consented to follow up,
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: they came down with Covid on 09Dec2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (they came down with Covid on 09Dec2023) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 09-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (they came down with Covid on 09Dec2023). At the time of the report, COVID-19 (they came down with Covid on 09Dec2023) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.       The concomitant medication was not reported by reporter.   The patient did not have any side effects.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-754628 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-754628:Wife case
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Nausea
Clinical narrative: very weekness; My knees hurt especially when I bend down; nautous; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weekness), ARTHRALGIA (My knees hurt especially when I bend down) and NAUSEA (nautous) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 23-Sep-2021, the patient experienced ASTHENIA (very weekness), ARTHRALGIA (My knees hurt especially when I bend down) and NAUSEA (nautous). At the time of the report, ASTHENIA (very weekness), ARTHRALGIA (My knees hurt especially when I bend down) and NAUSEA (nautous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. No treatment medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus) in a 73-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant and treatment medications were reported.   It was unknown if the patient experienced any additional symptoms/events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Loss of consciousness
Clinical narrative: Unresponsive; Chills; extreme fatigue; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Unresponsive), CHILLS (Chills) and FATIGUE (extreme fatigue) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 12-Dec-2023, the patient experienced LOSS OF CONSCIOUSNESS (Unresponsive) (seriousness criteria hospitalization and medically significant), CHILLS (Chills) (seriousness criterion hospitalization) and FATIGUE (extreme fatigue) (seriousness criterion hospitalization). At the time of the report, LOSS OF CONSCIOUSNESS (Unresponsive), CHILLS (Chills) and FATIGUE (extreme fatigue) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant and treatment medications were reported.  The patient was unresponsive for several hours, chills prior to the event, kept in hospital for 3 days.   It was unknown if the patient experienced any additional symptoms/events.  Company comment-This spontaneous case concerns a 75-year-old female patient with no medical history reported who experienced the serious (medically significant and hospitalization) unexpected event loss of consciousness and the serious (hospitalization) events fatigue and chills the following day a dose of Spikevax 2023-2024 vaccine was administered. It was reported patient was unresponsive for several hours, had chills prior to the event. She was put in hospital for 3 days. With extreme fatigue not resolving. Diagnosis was likely adverse effects from vaccination. The benefit-risk relationship of Spikevax 2023-2024 vaccine is not affected by this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye discharge, Eye pain, Headache, Myalgia
Clinical narrative: red achy eyes stuck shut with eye mucus like conjunctivitis; achy joints the next day; headache; achy muscles; woke up with red achy eyes stuck shut with eye mucus like conjunctivitis; Full sinuses; red achy eyes stuck shut with eye mucus like conjunctivitis; This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (Full sinuses), OCULAR HYPERAEMIA (red achy eyes stuck shut with eye mucus like conjunctivitis), EYE PAIN (red achy eyes stuck shut with eye mucus like conjunctivitis), ARTHRALGIA (achy joints the next day) and HEADACHE (headache) in a 49-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 27-Dec-2023, the patient experienced SINUSITIS (Full sinuses), OCULAR HYPERAEMIA (red achy eyes stuck shut with eye mucus like conjunctivitis), ARTHRALGIA (achy joints the next day), HEADACHE (headache), MYALGIA (achy muscles) and EYE DISCHARGE (woke up with red achy eyes stuck shut with eye mucus like conjunctivitis). On an unknown date, the patient experienced EYE PAIN (red achy eyes stuck shut with eye mucus like conjunctivitis). At the time of the report, SINUSITIS (Full sinuses), ARTHRALGIA (achy joints the next day), MYALGIA (achy muscles) and EYE DISCHARGE (woke up with red achy eyes stuck shut with eye mucus like conjunctivitis) outcome was unknown and OCULAR HYPERAEMIA (red achy eyes stuck shut with eye mucus like conjunctivitis), EYE PAIN (red achy eyes stuck shut with eye mucus like conjunctivitis) and HEADACHE (headache) was resolving.            No concomitant medication was reported.  It was reported that, patient woke up with red achy eyes stuck shut with eye mucus like conjunctivitis. Full sinuses and headache. It was unknown if the patient experienced any additional symptoms/events  Treatment information was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Sinusitis
Clinical narrative: red achy eyes stuck shut with eye mucus like conjunctivitis; achy joints the next day; headache; achy muscles; woke up with red achy eyes stuck shut with eye mucus like conjunctivitis; Full sinuses; red achy eyes stuck shut with eye mucus like conjunctivitis; This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (Full sinuses), OCULAR HYPERAEMIA (red achy eyes stuck shut with eye mucus like conjunctivitis), EYE PAIN (red achy eyes stuck shut with eye mucus like conjunctivitis), ARTHRALGIA (achy joints the next day) and HEADACHE (headache) in a 49-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 27-Dec-2023, the patient experienced SINUSITIS (Full sinuses), OCULAR HYPERAEMIA (red achy eyes stuck shut with eye mucus like conjunctivitis), ARTHRALGIA (achy joints the next day), HEADACHE (headache), MYALGIA (achy muscles) and EYE DISCHARGE (woke up with red achy eyes stuck shut with eye mucus like conjunctivitis). On an unknown date, the patient experienced EYE PAIN (red achy eyes stuck shut with eye mucus like conjunctivitis). At the time of the report, SINUSITIS (Full sinuses), ARTHRALGIA (achy joints the next day), MYALGIA (achy muscles) and EYE DISCHARGE (woke up with red achy eyes stuck shut with eye mucus like conjunctivitis) outcome was unknown and OCULAR HYPERAEMIA (red achy eyes stuck shut with eye mucus like conjunctivitis), EYE PAIN (red achy eyes stuck shut with eye mucus like conjunctivitis) and HEADACHE (headache) was resolving.            No concomitant medication was reported.  It was reported that, patient woke up with red achy eyes stuck shut with eye mucus like conjunctivitis. Full sinuses and headache. It was unknown if the patient experienced any additional symptoms/events  Treatment information was not provided.
Sex: F
Vaccine: RSV
Symptoms: Vocal cord thickening
Clinical narrative: developed a nodule on her vocal cord; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from a sales representative.  An elderly female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOCAL CORD THICKENING (non-serious), outcome "recovering", described as "developed a nodule on her vocal cord". The event "developed a nodule on her vocal cord" required physician office visit. It was unknown if therapeutic measures were taken as a result of vocal cord thickening. Additional information: Patient shared that she developed a nodule on her vocal cord around the time she received her RSV immunization. She shared that ENT HCP reported the incident.   Batch/lot number is not provided, and it cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19/positive test; Treatment of COVID-19/positive test; This is a spontaneous report received from a Consumer or other non HCP.  A 28-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19/positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient has no known allergies. Patient received Paxlovid treatment for Covid-19 from 12Dec2023 to 16Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Rash, Skin test positive
Clinical narrative: developed a skin rash; This is a spontaneous report received from a Pharmacist from medical information team.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "developed a skin rash". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller had inquiry regarding the presence of "tuberculin purified protein derivative" in PREVNAR 20, since potential consumer/patient of PREVNAR 20 was subjected to a skin test in which patient developed a skin rash. Caller is concerned with potential cross-sensitivity of patient to similarly structured substances that may be contained in PREVNAR 20.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, RSV
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: Patient confirmed he received the Comirnaty and RSV bivalent protein subunit R per his shots record. Patient just wanted to confirm if he did receive the RSV vaccine; Patient confirmed he received the Comirnaty and RSV bivalent protein subunit R per his shots record. Patient just wanted to confirm if he did receive the RSV vaccine; had a sore arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Patient confirmed he received the Comirnaty and RSV bivalent protein subunit R per his shots record. Patient just wanted to confirm if he did receive the RSV vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm".  Additional information: Patient went to the Clinic to get his vaccinations updated and his doctor told him to get his Covid-19 booster and RSV vaccine. The lady in the clinic had his Covid-19 booster ready for administration and also gave him a handout of the Comirnaty vaccine, the patient then asked if this is the replacement for the RSV to which the lady responded yes. He was then given the RSV shot and had a sore arm for 24 hours or so. Patient confirmed he received the Comirnaty and RSV bivalent protein subunit R per his shots record. Patient just wanted to confirm if he did receive the RSV vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Injection site soreness in her arm; This is a spontaneous report received from a Pharmacist from medical information team.  An adult patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 17Nov2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2023, outcome "not recovered", described as "Injection site soreness in her arm". Additional information: Caller calling on behalf of a patient who received a shot over a month ago on 17Nov2023. Since the injection the patient has reported injection site soreness in her arm now for over a month. States yesterday the patient came in and reported ongoing mild to moderate soreness at the injection site. Asking if there is any additional information outside of the 7-day window in the PI related to anticipated duration of injection site soreness. Confirmed her patient is at least 60 years of age or older. The event was assessed as non-serious.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 21Dec2023 to 26Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Nurse.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 14Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ALS (Amyotrophic lateral sclerosis)" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid from 15Dec2023 to 19Dec2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccines in this patient cannot be completely excluded.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Physician.  A 49-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 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (24Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes paxlovid from 19Dec2023 to 24Dec2023. Clinical course: This is his first time having COVID. He tested negative 24Dec2023 after finishing his last dose of Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccine failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 54.0
Sex: F
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 Nurse.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Thyroidectomy" (not ongoing); "Known allergies: Contrast dye" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes paxlovid from 16Dec2023 to 20Dec2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 administration.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report and received from Consumer or other non HCPs.  A 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Augmentam, reaction(s): "Known allergies: Augmentum". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 17Dec2023 to 20Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 68.0
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 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 14:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Nov2023 to 19Nov2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
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 92-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 left arm for covid-19 immunization. The patient's relevant medical history included: "AMD" (unspecified if ongoing); "GA" (unspecified if ongoing). Concomitant medication(s) included: DORZOLAMIDE, start date: 01Jan2020; LATANOPROST, start date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid received from 21Dec2023 to 25Dec2023 for COVID-19 Treatment. Other medication in 2weeks products included dorzolamide and latanoprost 01Jan2025, Other medication in 2weeks start date on 01Jan2020. Patient still have runny nose or stuffed bise need nose drops to be able to breathe at night. Treatment included nasal spray. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; J & J, Moderna and Pfizer / BioNTech; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Oct2021 as dose 2 (booster), single (Lot number: FH8020) at the age of 55 years for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)), on 10Mar2021 as dose 1, single) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 3 (booster), single (Lot number: 065K21A), on 09Sep2022 as dose 4 (booster), single (Lot number: A57144B), on 11Jul2023 as dose 5 (booster), single) and on 13Oct2023 as dose 6 (booster), single (Lot number: 3031894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "over weight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021, outcome "unknown", described as "J & J, Moderna and Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, 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 from 18Dec2023 to 23Dec2023. Clinical course: Patient did not have known allergies.
Age: 48.0
Sex: M
Vaccine: COVID19, 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 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "Crohns" (unspecified if ongoing). Concomitant medication(s) included: SKYRIZI [RISANKIZUMAB RZAA]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as covid-19 treatment from 19Dec2023 to 24Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300457513 Same patient, different drug and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient was treated with PAXLOVID for COVID-19 treatment; Patient was treated with PAXLOVID for COVID-19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2), on 10Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "CVID" (unspecified if ongoing); "ILD" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "allergies: morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient was treated with PAXLOVID for COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Report about covid treatment was yes.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid treatment.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary fibrosis
Clinical narrative: pulmonary fibrosis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 52-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY FIBROSIS (medically significant), outcome "unknown". The clinical course was reported as follows: The patient indicated she has pulmonary fibrosis and she is looking to get the Respiratory syncytial virus (RSV) vaccine. She also indicated she had received the COVID shot and it put inflammation in her lungs, but she didn't get COVID.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: menquadfi was administered post excursion with no reported adverse event; Initial information received on 20-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient and who had administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Dec-2023, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (strength: standard, frequency: once, lot U7938AA and expiry date: Feb-2026) via intramuscular route in the left deltoid as Immunization after post excursion with no reported adverse event (poor quality product administered) (same day latency).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient vaccinated with a vaccine that was expired with no reported adverse event; Initial information received from country on 28-Dec-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was vaccinated with a Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Dec-2023, the patient received an unknown dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183aa) (Expiry date: 24-Sep-2023) via unknown route in unknown administration site for immunization.  On 28-Dec-2023, the patient was vaccinated with a Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult that was expired with no reported adverse event (expired product administered) (latency: same day).  It was reported, We would like to know if this vaccine is still effective for this patient or would they need to be revaccinated at this time.  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: 11.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: menquadfi was administered again by her pediatrician with no reported adverse event; Initial information was received on 29-Dec-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11 years old female patient to whom meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered again by her pediatrician with no reported adverse event.  The patient's past vaccination(s) included MENQUADFI on 16-AUG-2023. The patient's past medical history, medical treatment(s) and family history were not provided.   On 28-Dec-2023, the patient received an unknown dose (dose 2) of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot U7938AA, expiry date: 23-Sep-2024, unknown strength) via unknown route in unknown administration site for Immunization and menquadfi was administered again by her pediatrician with no reported adverse event (extra 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: 1.17
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.5ml dose instead of 0.25 ml dose
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dry eye, Eye irritation, Fatigue
Clinical narrative: Headache, muscle and joint aches, chills alt w feeling flushed/feverish, dry irritated eyes, fatigue, dizziness over past 24 hours increased
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle and joint aches, chills alt w feeling flushed/feverish, dry irritated eyes, fatigue, dizziness over past 24 hours increased