chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Correct dose given, not correct age, no reactions at injection site, no signs, no symptoms of any reaction
Age: 0.17
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Correct dose given, not correct age, no reactions at injection site, no signs, no symptoms of any reaction
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported / No additional AE; Patient received a dose of MMRII on 02FEB2024, but the dose expired on 22SEP2023; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 02-FEB-2024, the patient was vaccinated with an expired dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) injection (lot number U029620 was verified to be valid, expiration date reported and confirmed as 22-SEP-2023) (Expired product administered), administered as prophylaxis by a Healthcare Professional (exact dose, route of administration, and anatomical location were not provided).  No side effects nor additional adverse event (AE) was reported. No other medical information known.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: took a home COVID test became positive.; leg pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (took a home COVID test became positive.) and PAIN IN EXTREMITY (leg pain) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Feb-2024, the patient experienced COVID-19 (took a home COVID test became positive.) and PAIN IN EXTREMITY (leg pain). At the time of the report, COVID-19 (took a home COVID test became positive.) and PAIN IN EXTREMITY (leg pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2024, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  Patient woke up getting chills like felt very cold and a sore throat, leg pain. Took a home COVID test became positive and felt like almost had a heart attack when saw the positive test even because wears a mask all the time.  No treatment medications were provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Oct2021 as dose 2, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Migraine Syndrome" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: GABAPENTIN, start date: 20Jun2019; EFFEXOR, start date: 10Jan2003. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 14Jan2024 until 18Jan2024.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: vitiligo; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 45-year-old 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: VITILIGO (non-serious), outcome "unknown". The event "vitiligo" required physician office visit.  Additional information: The reporter stated patient's dermatologist told patient it's (vitiligo) due to the Pfizer vaccine, as it can trigger autoimmune disorders.  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: Linked Report(s) : US-PFIZER INC-202400032260 Different patient, same drug/event.;
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years 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 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 "COVID 19 Treatment". Therapeutic measures included paxlovid from 24Jan2024 to 28Jan2024 were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 94-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Dec2023 at 14:00 as dose 1, single (Lot number: HF9300) at the age of 94 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild cognitive impairment" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: APIXABAN, start date: 04Sep2023. Other medication in 2weeks brand: Eliquis. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (vaccine administration date: 07Oct2022, vaccine administration time: 01:30 PM, vaccine lot number: GH9703, vaccine lot unknown=False, vaccine dose number: 5, vaccine location: Left arm), administration date: 07Oct2022, when the patient was 93-year-old, for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster); Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1; Manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Day 6; Positive, notes: positive COVID test returned on Day 11. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 23Jan2024 to 28Jan2024.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Moderna/ Dose #5: Moderna/ Dose #6: Moderna/ Dose #7: Pfizer.; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 72-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 at 10:00 as dose 1, single (Lot number: HD9835) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RALOXIFENE, start date: Feb2017; VITAMIN D3, start date: Feb2017; COQ10 [UBIDECARENONE], start date: Feb2021; MAGNESIUM ASPARTATE, start date: Feb2017. The patient also took other concomitant therapy. Vaccination history included: moderna COVID-19 vaccine, bivalent (Dose 6), administration date: 31May2023, when the patient was 72-year-old, for COVID-19 immunization; moderna COVID-19 vaccine, bivalent (Dose 5), administration date: 15Sep2022, when the patient was 71-year-old, for COVID-19 immunization; moderna COVID-19 vaccine (Dose 4), administration date: 21Apr2022, when the patient was 71-year-old, for COVID-19 immunization; moderna COVID-19 vaccine (Dose 3), administration date: 29Oct2021, when the patient was 70-year-old, for COVID-19 immunization; moderna COVID-19 vaccine (Dose 2), administration date: 26Jan2021, when the patient was 69-year-old, for COVID-19 immunization; moderna COVID-19 vaccine (Dose 1), administration date: 29Dec2020, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Oct2023, outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Moderna/ Dose #5: Moderna/ Dose #6: Moderna/ Dose #7: Pfizer."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 18Dec2023 to 29Dec2023.  Clinical course: The patient reported that she thought that 10 days would have been a better dosing for Paxlovid as she was exposed caring for 2 family members with Covid-19 and exposed to a larger viral load. The patient was also taking Women's Multivitamins since Feb2017. The patient had no known allergies.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, 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 male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Gout" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, vaccine administration date: 04Nov2022, vaccine administration time: 02:00 PM, vaccine location: Left arm), administration date: 04Nov2022, when the patient was 68-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Negative; (05Feb2024) Positive, notes: 5th day after end of paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 28Jan2024 to 01Feb2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). No Known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 22Jan2024 to 27Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Lot number: HG4677) at the age of 56 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 5 (Booster), unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 23Jan2024 to 27Jan2024.
Sex: U
Vaccine: PNC20
Symptoms: Injection site pain
Clinical narrative: Patient experienced pain at the injection site due to the vaccine.; This is a spontaneous report received from an Other HCP from a sales representative.  An adult patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Patient experienced pain at the injection site due to the vaccine.". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  Clinical course: it was reported that patient experienced pain at the injection site due to the vaccine. It was unknown if patient received any other vaccines on the same dates as the vaccine(s). It was unknown if patient received any other vaccines within 4 weeks prior to the vaccine(s). It was unknown if patient was taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Concomitant medication(s) included: OLMESARTAN MEDOXOMIL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as COVID 19 treatment from 27Jan2024 to 31Jan2024.  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-202400035249 Same patient, different product and events;
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: after each vaccine felt poorly for 1 day; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-749454 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (primary immunization series), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "after each vaccine felt poorly for 1 day".  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400018350 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: after each vaccine felt poorly for 1 day; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-749454 (Moderna).  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (DOSE 2, SINGLE, Lot# 026D21A), administration date: 01Nov2021, for COVID-19 immunization, reaction(s): "after each vaccine felt poorly for 1 day"; Moderna (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "after each vaccine felt poorly for 1 day"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "after each vaccine felt poorly for 1 day". The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "after each vaccine felt poorly for 1 day".  Additional information: The patient received the second Pfizer booster dose on Fall 2022. The patient mentioned that after each vaccine felt poorly for 1 day and was fine the next day.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400018350 same patient, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain on my left arm; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): US-MO-MOC20231110000111.  A male patient received BNT162b2 (COMIRNATY), as dose number unknown, snigle (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain on my left arm".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity / Mild injection site tenderness (tender to touch); Mild muscle pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: VACCINATION SITE PAIN (non-serious) with onset Jan2024, outcome "unknown", described as "Mild injection site pain and no interference with activity / Mild injection site tenderness (tender to touch)"; MYALGIA (non-serious) with onset Jan2024, outcome "unknown", described as "Mild muscle pain and no interference with activity". Relevant laboratory tests and procedures are available in the appropriate section.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity; Mild injection site tenderness (tender to touch); Mild muscle pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: VACCINATION SITE PAIN (non-serious) with onset Jan2024, outcome "unknown", described as "Mild injection site pain and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset Jan2024, outcome "unknown", described as "Mild injection site tenderness (tender to touch)"; MYALGIA (non-serious) with onset Jan2024, outcome "unknown", described as "Mild muscle pain and no interference with activity".  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
Clinical narrative: she has had all of Pfizer Vaccines and boosters; she has had all of Pfizer Vaccines and boosters; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female 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. Vaccination history included: Bnt162b2 (Primary immunisation series complete.), for COVID-19 Immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (Dose number unknown (Booster), single), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has had all of Pfizer Vaccines and boosters". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19. Clinical course: Patient stated she wanted to just let them know that she had had all of Pfizer vaccines and boosters needed during the worst of covid and she stated she was convinced that it was those that got her through that time. Patient past medical history, family history and social history was unknown.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: I have no good taste of food/food does not taste like it should; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 14Jan2022 as dose 1, single (Lot number: FK9729) and on 07Feb2022 as dose 2, single (Lot number: FK9729), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "not recovered", described as "I have no good taste of food/food does not taste like it should".  Additional information: the patient was trying to figure out why she does not have good taste of food. She said she believe it was a side effect of the vaccine. The patient stated she never had COVID, she never lost her sense of smell but food odes not taste like it should and it hasn't for quite a while. The patient stated if she make tacos, it smells like tacos but 2-23 bites in it taste so bad and she have to spit it out. Her lab work is all good, dentist has checked her teeth and they are all good, with good oral hygiene. The patient stated ice cream does not taste good and she can't eat one thing because the third time, it is not good and does not taste good after that. The patient was asking if anyone else have this effect from Pfizer vaccine.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; long COVID Disease Symptoms since 21Mar2023/had COVID Disease from 21Mar2023 to 28Mar2023; long COVID Disease Symptoms since 21Mar2023/had COVID Disease from 21Mar2023 to 28Mar2023; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-749454.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 (reported as on Fall 2022) as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single) and on 01Nov2021 as dose 2, single (Lot number: 026D21A) 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 21Mar2023, outcome "not recovered" and all described as "long COVID Disease Symptoms since 21Mar2023/had COVID Disease from 21Mar2023 to 28Mar2023"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Clinical course: patient is not sure if 2nd Pfizer Booster dose was a Bivalent or not. Patient had COVID Disease from 21Mar2023 to 28Mar2023. She states that today, 13Nov2023, still has COVID in head, Dizzy, and Malaise.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400035649 same patient, different dose/event;US-PFIZER INC-202400035648 same patient, different dose/event;
Age: 0.42
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: PENTACEL was administered giving only the DTAP/IPV portion, did not reconstitute/administer the HIB portion, with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 5 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)], giving only the DTAP/IPV portion, did not reconstitute/administer the HIB portion, 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 rotavirus vaccine for Prophylactic vaccination; and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 24-Jan-2024, the patient received a standard dose 2 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 mL total (lot UJ853AB, expiry date- 13-APR-2024) via intramuscular route in Right Thigh for Immunization; giving only the DTAP/IPV portion, did not reconstitute/administer the HIB portion, with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, Caller with questions regarding administering the ACTHIB and what diluent to use in order for the dose to be valid.  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: 13.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL reached temperature reached of  9.3 C for 13 mins was administered with no reported adverse event.; punctured IPOL reached temperature reached of  9.3 C for 13 mins was administered with no reported adverse event.; Initial information received on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 13 years old male patient to whom punctured IPV (VERO) [IPOL] reached temperature reached of  9.3 c for 13 mins was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On an unknown date the punctured (IPOL) IPV (VERO) which reached temperature reached of  9.3 c for 13 mins (product storage error) (unknown latency)  On 16-Jan-2024, the patient administered 0.5 ml dose of punctured IPV (VERO), Suspension for injection (strength: not reported) (lot W1C751M; Expiry  date: 18-Nov-2025) via intramuscular route in the right vastus lateralis for Immunization which reached temperature reached of  9.3 c for 13 mins with no reported adverse event (poor quality product administered) (latency: same day).  This situation is unknown if had Human error.   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: 45.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient was administered with punctured ipol with no reported adverse event; Initial information was received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who was administered with punctured IPV (VERO) [IPOL] 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 HEPATITIS A VACCINE (HEPATITIS A VACCINE); and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 17-JAN-2024, the patient received punctured 0.5 ml, 1X-total of suspect IPV (VERO), Suspension for injection (lot W1C751M and expiry 18-NOV-2025) (strength: unknown) (poor quality product administered, latency same day) via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  Reportedly:- Punctured IPOL Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C Duration: As stated above Human error: Unknown Administered: Yes. Does extended stability data cover the excursion: No  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Syncope, Tonic convulsion, Vomiting
Clinical narrative: tonic seizure like motions; fainting; got very sick; violent throwing up; Initial information received on 31-Jan-2024 regarding an unsolicited valid  serious case received from a consumer/non-health care professional.  This case involves a 10 years old male patient who experienced fainting, tonic seizure like motions, violent throwing up and got very sick after receiving Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On 13-Nov-2023, the patient received a dose of 0.5 ml of suspect Influenza Quadrival A-B Vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination(Immunization). The information on batch number was requested.  On 13-NOV-2023 the patient developed fainting (syncope), tonic seizure like motions (tonic convulsion) , violent throwing up (vomiting) and got very sick (illness) (latency : same day) following the administration of Influenza Quadrival A-B Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (fainting, tonic seizure like motions, violent throwing up, got very sick).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events.  Seriousness Criteria : Medically significant for the events fainting, tonic seizure like motions.; Sender's Comments: Sanofi Company Comment dated 05-Feb-2024 : This case involves a 10 years old male patient who experienced fainting, tonic seizure like motions after receiving Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Amnesia, Fall, Head injury, Headache, Influenza A virus test
Clinical narrative: headaches; tonic seizure like motions; unconscious or unresponsive; Initial information received on 31-Jan-2024 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case is linked to case 2024SA037887(CLUSTER).  This case involves a 8 years old male patient who experienced tonic seizure like motions, unconscious or unresponsive and headaches after receiving vaccine influenza quadrival A-B vaccine [fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Nov-2023, the patient received a 0.5 ml dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot number, strength, expiry date not reported) via unknown route in unknown administration site as Immunization.  On 13-NOV-2023 the patient developed a serious tonic seizure like motions (tonic convulsion) and unconscious or unresponsive (loss of consciousness) same day following the administration of influenza quadrival A-B vaccine. This event was assessed as medically significant. On an unknown date the patient developed a non-serious headaches (headache) (unknown latency) following the administration of influenza quadrival A-B vaccine.  Relevant laboratory test results included: Antibody test - On an unknown date:  [0 influenza antibody A and B].  Reporter stated that "the patient's eyes were reported to be open but the patient was unconscious or unresponsive that he was not able to remember what happened and was also reported to have hit their head before falling on the ground. First son has recovered shortly after the incident while the second son had headaches weeks after the event."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the events.; Sender's Comments: Sanofi company comment for information received on 06-Feb-2024: This case involves a 8 years old male patient who experienced tonic seizure like motions, unconscious or unresponsive and headaches after receiving vaccine influenza quadrival A-B vaccine [fluzone QIV]. Further information regarding medical history, concurrent condition during vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza B virus test, Influenza virus test negative, Loss of consciousness, Tonic convulsion, Unresponsive to stimuli
Clinical narrative: headaches; tonic seizure like motions; unconscious or unresponsive; Initial information received on 31-Jan-2024 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case is linked to case 2024SA037887(CLUSTER).  This case involves a 8 years old male patient who experienced tonic seizure like motions, unconscious or unresponsive and headaches after receiving vaccine influenza quadrival A-B vaccine [fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Nov-2023, the patient received a 0.5 ml dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot number, strength, expiry date not reported) via unknown route in unknown administration site as Immunization.  On 13-NOV-2023 the patient developed a serious tonic seizure like motions (tonic convulsion) and unconscious or unresponsive (loss of consciousness) same day following the administration of influenza quadrival A-B vaccine. This event was assessed as medically significant. On an unknown date the patient developed a non-serious headaches (headache) (unknown latency) following the administration of influenza quadrival A-B vaccine.  Relevant laboratory test results included: Antibody test - On an unknown date:  [0 influenza antibody A and B].  Reporter stated that "the patient's eyes were reported to be open but the patient was unconscious or unresponsive that he was not able to remember what happened and was also reported to have hit their head before falling on the ground. First son has recovered shortly after the incident while the second son had headaches weeks after the event."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the events.; Sender's Comments: Sanofi company comment for information received on 06-Feb-2024: This case involves a 8 years old male patient who experienced tonic seizure like motions, unconscious or unresponsive and headaches after receiving vaccine influenza quadrival A-B vaccine [fluzone QIV]. Further information regarding medical history, concurrent condition during vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient was administered a dose of Boostrix on 30Jan2024 from lot number E3594, which had an expiration date of 18Jan2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594, expiry date 18-JAN-2024) for prophylaxis.   On 30-JAN-2024, the patient received Boostrix. On 30-JAN-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient was administered a dose of Boostrix on 30Jan2024 from lot number E3594, which had an expiration date of 18Jan2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-JAN-2024 The nurse manager reported that a 31 year old female patient was administered a dose of Boostrix on 30 January 2024 from lot number E3594, which had an expiration date of 18 January 2024 which led to expired vaccine used. At the time of reporting, the dose has not been repeated. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given just the liquid component of Menveo; given just the liquid component of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patients received Menveo. On an unknown date, an unknown time after receiving Menveo, the patients experienced inappropriate preparation of medication (Verbatim: given just the liquid component of Menveo) and inappropriate dose of vaccine administered (Verbatim: given just the liquid component of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-FEB-2024 The reporter was a Healthcare professional (vaccine coordinator) who reported that between 1 to 10 patients were given just the liquid component of Menveo instead of reconstituted vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a patient less than 10 years of age was administered the one vial presentation of Menveo.; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: a patient less than 10 years of age was administered the one vial presentation of Menveo.). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 02-FEB-2024 The pharmacist reported via sales representative that a patient less than 10 years of age was administered the one vial presentation of Menveo.  The vaccine administration facility was the same as primary reporter. The adverse event was submitted by a sales rep.  No additional adverse event information was included.  The sales representative contact information has been emailed to safety team. The patient received a dose of Menveo at an inappropriate age, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Facial discomfort, Ocular discomfort, Pain, Pruritus
Clinical narrative: Severe pain on one side of my body/ pain; Rash; sharp pain between my breasts; itching; face and especially one eye was affected; face and especially one eye was affected; This non-serious case was reported by a consumer and described the occurrence of hemialgia in a 89-month-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included bell's palsy (believed that many years ago had Bell's Palsey). Concurrent medical conditions included immunodeficiency (sensitive, probably had low immune too). Additional patient notes included no side effects from the first shot. Concomitant products included amlodipine, losartan, acetylsalicylic acid (Aspirin) and atorvastatin calcium (Atorvastin).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced hemialgia (Verbatim: Severe pain on one side of my body/ pain), rash (Verbatim: Rash), chest pain (Verbatim: sharp pain between my breasts), pruritus (Verbatim: itching), facial discomfort (Verbatim: face and especially one eye was affected) and eye discomfort (Verbatim: face and especially one eye was affected). The outcome of the hemialgia and chest pain were not resolved and the outcome of the rash, pruritus, facial discomfort and eye discomfort were not reported.   It was unknown if the reporter considered the hemialgia, rash, chest pain, pruritus, facial discomfort and eye discomfort to be related to Shingles vaccine.     It was unknown if the company considered the hemialgia, rash, chest pain, pruritus, facial discomfort and eye discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JAN-2024 The reporter was a patient. Patient received the Shingles vaccine in 2024. Patient reported that after receiving the Shingles vaccine she experienced pain on her left side and it became severe. Patient had no side effects from the first shot. Patient reported that she had all the symptoms except blisters. Patient had pain and rash after the Shingles vaccine. Patient reported that last several months from reporting day she was experiencing sharp pain between her breasts and some itching but nothing else visible. Patient was told by her physician that it was nothing and she believed that. Many years ago, patient had bell's palsy, diagnosed by physicians. Patient was exposed to children playing. Patient face and especially one eye was affected, that lasted a long time. Patient was sensitive and probably had low immune too, patient did consider herself very healthy. The pain around her left side was on going, she was no longer fatigued, but there was that sharp pain between her breasts. Patient were no treated the symptoms. The reporter consented to follow-up.