chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Arthralgia, Nausea, Pain
Clinical narrative: I had extreme body and joint aches; I had extreme body and joint aches; Nausea; This spontaneous case was reported by a patient and describes the occurrence of PAIN (I had extreme body and joint aches), ARTHRALGIA (I had extreme body and joint aches) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE for an unknown indication.    No Medical History information was reported.   On 08-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of PNEUMOCOCCAL VACCINE (unknown route) 1 dosage form. On 08-Dec-2023, the patient experienced PAIN (I had extreme body and joint aches), ARTHRALGIA (I had extreme body and joint aches) and NAUSEA (Nausea). At the time of the report, PAIN (I had extreme body and joint aches) and ARTHRALGIA (I had extreme body and joint aches) outcome was unknown and NAUSEA (Nausea) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: parosmia; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (parosmia) in a 47-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 01-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAROSMIA (parosmia). At the time of the report, PAROSMIA (parosmia) had not resolved.            Concomitant medication was not provided.  It was reported that, within 3 days, Patient experienced parosmia - a cigarette-like burning smell that dissipated after about three weeks. It has recently returned.  It was unknown if the patient experienced any additional symptoms/events.   Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. UNK) 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) 1 dosage form. On 11-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  Patient experienced event approximately 3 hours after. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Blood pressure went up everyday; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure went up everyday) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030336) for COVID-19 prophylaxis.     No Medical History information was reported.  On 10-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 50 microgram. On 10-Dec-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced BLOOD PRESSURE INCREASED (Blood pressure went up everyday). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure went up everyday) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: BP was unstable after booster 160 range.  Concomitant product use was not provided by the reporter.  Blood pressure went up everyday - even though she was taking her Blood pressure medication. Blood pressure was unstable after booster 160 range. Patient was not aware this was a side effect from the booster. Patient have taken all Moderna shots from the first shots she received.   It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 44-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2 NOS), on 02Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Ehlers-Danlos" (unspecified if ongoing); "Pots Disease" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Chronic Fatigue Syndrome" (unspecified if ongoing); "Major Depressive Disorder" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Chronic Female Pelvic Pain Syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "Allergies: Cephalexin"; Miconazole, reaction(s): "Allergies: Miconazole"; Codeine, reaction(s): "Allergies: Codeine"; Symbicort, reaction(s): "Allergies: Symbicort"; Sumatriptan, reaction(s): "Allergies: sumatriptan". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included treatment with Paxlovid oral from 07Dec2023 to 11Dec2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported event Drug ineffective , COVID-19 cannot be excluded
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing); "Allergies: Gluten" (unspecified if ongoing); "CAD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Celiac Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment included Paxlovid (treatment start date=30Nov2023, treatment stop date=03Dec2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug bnt162b2, and the events covid 19 and drug ineffective cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 38-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. The patient received oral Paxlovid, lot number GJ3916 from 11Dec2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug bnt162b2, and the events covid 19 and drug ineffective cannot be excluded.
Age: 60.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and 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. 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. Clinical course: Patient had no known allergies. Patient received Paxlovid treatment from 02Dec2023 to 07Dec2023.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency. However, a contributory role of bnt162b2, bnt162b2 omi ba.4-5 to the events Drug ineffective and Covid-19 cannot be ruled out.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: received Pfizer COVID-19 booster in Feb2022 and contracted COVID-19 one month later(Mar2022); received Pfizer COVID-19 booster in Feb2022 and contracted COVID-19 one month later(Mar2022); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID A 45-year-old female patient received bnt162b2 (BNT162B2), in Feb2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "received Pfizer COVID-19 booster in Feb2022 and contracted COVID-19 one month later(Mar2022)". Clinical course: Husband reported that his wife (patient) received Pfizer COVID-19 booster in Feb2022 and contracted COVID-19 one month later (Mar2022).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guilliam Barre; Initial information received on 08-Dec-2023 regarding an unsolicited valid  serious case received from a physician.  This case involves an unknown age and unknown gender patient who experienced guilliam barre after receiving Influenza Vaccine.  The patient's past vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, formulation, expiry date and lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient developed event of guilliam barre (guillain-barre syndrome) (unknown latency). This event was assessed as medically significant.  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Guilliam Barre).  At time of reporting, the outcome was Unknown for the event guilliam barre.; Sender's Comments: Sanofi company comment dated 13-Dec-2023: This case involves an unknown age and unknown gender patient who experienced guilliam barre after receiving Influenza Vaccine. Furthermore, information regarding condition at the time of vaccination excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: PENTACEL was given on 06DEC2023 but only the liquid part was administered and not the lyophilized component with no reported adverse event; Initial information was received on 06-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who was given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] on 06-dec-2023 but only the liquid part was administered and not the lyophilized component 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 (ROTAVIRUS VACCINE) and PREVNAR 15 for Immunisation.  On 06-Dec-2023, the patient received 0.5 ml, 1x (total) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (lot UJ76AA) but only the liquid part was administered and not the lyophilized component with no reported adverse event (single component of a two-component product administered) (latency same day) via intramuscular route in the left thigh for immunization.  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: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: powder component was administered with sterile water and the liquid part was not administered with no reported adverse event; Initial information received on 08-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient where reporter reported that powder component of vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] was administered with sterile water and the liquid part was not administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (prevnar 13) for Prophylactic vaccination.  On 06-Dec-2023, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot UJ851AA and expiration date- 01-Apr-2024) via intramuscular route in the left thigh (strength: not provided) for Immunisation (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered with a Fluzone high-dose QIV instead of a standard Fluzone QIV with no reported adverse event; administered with a Fluzone high-dose QIV instead of a standard Fluzone QIV with no reported adverse event; Initial information received on 08-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 60 years old male patient who was administered with a influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] instead of a standard influenza quadrival A-B vaccine [Fluzone QIV] with no reported adverse event.  The patient's past medical history included Ex-tobacco user. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 08-Dec-2023, a 60 years old male patient received a dose of 0.7 ml once of suspect influenza quadrival A-B high dose HV vaccine (lot: U8135AA; expiry date: 30-Jun-2024; strength: high dose) via intramuscular route in left deltoid arm instead of influenza quadrival A-B vaccine (Suspension for injection) with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day) for immunization.  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: F
Vaccine: FLU4
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: Pharmacist was administering dose of FLUZONE HD QIV where vaccine came out at base of needle instead of tip of needle with no reported adverse event; Initial information was received on 08-Dec-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age female patient to whom pharmacist  administered dose of influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] and came out of base of needle instead of tip of needle with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Dec-2023, the patient received a 0.7 ml, total  dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot U8233AA, expiry date: 30-Jun-2024, strength: standard) via intramuscular route in left deltoid for Immunisation and pharmacist was administering dose of fluzone hd qiv where vaccine came out at base of needle instead of tip of needle with no reported adverse event (incorrect dose administered) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Incorrect route of product administration
Clinical narrative: was inadvertently given a TYPHIM VI vaccine today through subcutaneous route with no reported adverse event; Initial information received on 08-Dec-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 24 years old female patient who was inadvertently given a Typhoid Vi Polysaccharide Vaccine [Typhim VI] today through subcutaneous route 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 yellow fever vaccine live (17d-204) (yf-vax) for prophylactic vaccination; meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi) for prophylactic vaccination; and polio vaccine inact 3v (vero) (ipol [polio vaccine inact 3v (vero)]) for prophylactic vaccination.  On 08-Dec-2023, the patient received 0.5 ml dose of suspect Typhoid Vi Polysaccharide Vaccine Solution for injection (lot number:  W1A361M) (Expiry date: 08-Mar-2025) (Strength: standard) (Frequency: once) via subcutaneous route in the right arm for immunization.  On 08-Dec-2023, the patient was inadvertently given a Typhoid Vi Polysaccharide Vaccine [Typhim VI] today through subcutaneous route with no reported adverse event (incorrect route of product administration) (latency: same day).  It was reported, Nurse calls in to report that they have a patient that was inadvertently given a TYPHIM VI vaccine today through subcutaneous route. They need recommendations whether patient should be revaccinated with the vaccine. This situation is pre-assessed as a medication error/an inappropriate use due to administration of the product in route that is not the recommended by the approved product labeling.   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: RSV
Symptoms: Exposure during pregnancy, Premature delivery
Clinical narrative: have premature baby; mother received Abrysvo; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team and a sales representative.  An infant patient received for immunisation and was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), transplacental, administration details for the mother: as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE BABY (non-serious), outcome "unknown", described as "have premature baby"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "mother received Abrysvo". The baby was delivered premature.  Additional information: The mother received Abrysvo and have premature baby that qualify for Synagis.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.  Follow-up (06Dec2023): This is a spontaneous follow-up report mail trail received in response to query sent regarding the confirmation of primary source.  Updated information: The primary reporter's country and country of primary source has been updated. Case 202300358131 is considered invalid and corresponding information is re-entered under manufacturer report number 202300439359.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/no PQC.; Pharmacist called to report that a dose of PNEUMOVAX 23 that expired on 8/29/2023 was administered to a patient on 9/18/2023. Caller stated product has not had any temperature excursions. Caller stated patient has not reported any symptoms. Caller st; Information has been received from a pharmacist referred to an unspecified patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.       On 18-SEP-2023, the unspecified patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # U032086, expiration date 29-AUG-2023, first dose,(strength, dose, route, and anatomical location were not reported), for prophylaxis (expired vaccine used).   No adverse event was reported.  Follow-up information was received from a pharmacist on 07-DEC-2023.  It was stated that the patient was a 44-years-old female
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody positive
Clinical narrative: Nurse called with a question about RECOMBIVAX HB. Nurse has a 21-year-old employee who received 2 doses out of 3 dose series as a teenager (unknown age). The nurse confirmed that the employee has a recent positive anti-HBsAg titer. Nurse had very lim; Nurse called with a question about RECOMBIVAX HB. Nurse has a 21-year-old employee who received 2 doses out of 3 dose series as a teenager (unknown age). The nurse confirmed that the employee has a recent positive anti-HBsAg titer. Nurse had very lim; This spontaneous report was received from a nurse and refers to a 21-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) dose 1 and 2, administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided).It was stated that the patient received 2 doses out of 3 dose series as a teenager (Inappropriate schedule of product administration).   On an unknown date, the patient had a positive anti-HBsAg titer (Hepatitis B surface antibody positive). The outcome of the event was not provided.  The causality between hepatitis B surface antibody positive and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Cough, Oropharyngeal pain, Pain, Palpitations
Clinical narrative: Day after I had body aches, including jaw, teeth and back, shoulder hand.; All places I have some arthritis; Next day runny nose sore throat dry cough.; Next day runny nose sore throat dry cough.; Next day runny nose sore throat dry cough.; Then heart racing, which is problematic as I have A FIB.; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Day after I had body aches, including jaw, teeth and back, shoulder hand.), ARTHRITIS (All places I have some arthritis), RHINORRHOEA (Next day runny nose sore throat dry cough.), OROPHARYNGEAL PAIN (Next day runny nose sore throat dry cough.) and COUGH (Next day runny nose sore throat dry cough.) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included AFib.    On 06-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 30 milliliter. On 07-Dec-2023, the patient experienced PAIN (Day after I had body aches, including jaw, teeth and back, shoulder hand.), ARTHRITIS (All places I have some arthritis), RHINORRHOEA (Next day runny nose sore throat dry cough.), OROPHARYNGEAL PAIN (Next day runny nose sore throat dry cough.), COUGH (Next day runny nose sore throat dry cough.) and PALPITATIONS (Then heart racing, which is problematic as I have A FIB.). At the time of the report, PAIN (Day after I had body aches, including jaw, teeth and back, shoulder hand.), ARTHRITIS (All places I have some arthritis), RHINORRHOEA (Next day runny nose sore throat dry cough.), OROPHARYNGEAL PAIN (Next day runny nose sore throat dry cough.), COUGH (Next day runny nose sore throat dry cough.) and PALPITATIONS (Then heart racing, which is problematic as I have A FIB.) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant and treatment medications were reported. Company comment This spontaneous case concerns a 68-year-old male patient, with relevant medical history of atrial fibrillation, who experienced the unexpected non-serious AESI of Arthritis that occurred 1 day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS). It was reported that the patient had body aches, including jaw, teeth and back, shoulder hand. All places he had some arthritis. Next day, he had a runny nose, sore throat, dry cough. Then, heart racing, which was problematic as he had atrial fibrillation. No further clinical information was provided. The medical history of atrial fibrillation could be associated with the non-serious event of palpitations. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine in not affected by this report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Day after I had body aches, including jaw, teeth and back, shoulder hand.; All places I have some arthritis; Next day runny nose sore throat dry cough.; Next day runny nose sore throat dry cough.; Next day runny nose sore throat dry cough.; Then heart racing, which is problematic as I have A FIB.; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Day after I had body aches, including jaw, teeth and back, shoulder hand.), ARTHRITIS (All places I have some arthritis), RHINORRHOEA (Next day runny nose sore throat dry cough.), OROPHARYNGEAL PAIN (Next day runny nose sore throat dry cough.) and COUGH (Next day runny nose sore throat dry cough.) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included AFib.    On 06-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 30 milliliter. On 07-Dec-2023, the patient experienced PAIN (Day after I had body aches, including jaw, teeth and back, shoulder hand.), ARTHRITIS (All places I have some arthritis), RHINORRHOEA (Next day runny nose sore throat dry cough.), OROPHARYNGEAL PAIN (Next day runny nose sore throat dry cough.), COUGH (Next day runny nose sore throat dry cough.) and PALPITATIONS (Then heart racing, which is problematic as I have A FIB.). At the time of the report, PAIN (Day after I had body aches, including jaw, teeth and back, shoulder hand.), ARTHRITIS (All places I have some arthritis), RHINORRHOEA (Next day runny nose sore throat dry cough.), OROPHARYNGEAL PAIN (Next day runny nose sore throat dry cough.), COUGH (Next day runny nose sore throat dry cough.) and PALPITATIONS (Then heart racing, which is problematic as I have A FIB.) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant and treatment medications were reported. Company comment This spontaneous case concerns a 68-year-old male patient, with relevant medical history of atrial fibrillation, who experienced the unexpected non-serious AESI of Arthritis that occurred 1 day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS). It was reported that the patient had body aches, including jaw, teeth and back, shoulder hand. All places he had some arthritis. Next day, he had a runny nose, sore throat, dry cough. Then, heart racing, which was problematic as he had atrial fibrillation. No further clinical information was provided. The medical history of atrial fibrillation could be associated with the non-serious event of palpitations. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine in not affected by this report.
Sex: F
Vaccine: RSV
Symptoms: Asthma, Condition aggravated, Dyspnoea
Clinical narrative: breathing difficulty; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An 85-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown ,single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "recovered", described as "breathing difficulty". Therapeutic measures were taken as a result of dyspnoea.  Additional information: The reporter was told that a patient had a Abrysvo RSV Vaccine and this patient has asthma (Intent: History) and she had breathing difficulty which lasted for a week and she is a "late" (as reported). The patient is now fine. They gave her "steroids or something" (as reported) as treatment and she is fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: elevated pulse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: 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; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated pulse". The event "elevated pulse" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that she had 7 vaccines, and this has started with the most recent dose of the vaccine she received which was 3 weeks ago, Friday. The patient mentioned that she was a cancer patient and was also taking Ibrance and it was successful. The patient mentioned that she visited her Pulmonologist of today due to a side effect from Ibrance.  The patient stated that her pulmonologist measured her pulse early in the day and in mid-day and it was 1-2 elevated. The patient stated that this was her first time to have an elevated pulse to that level in six years under treatment and she had a lot of blood pressure and pulse tests.
Sex: U
Vaccine: PNC13
Symptoms: Monoplegia
Clinical narrative: for one whole week, my left arm (vaccine arm) was paralyzed, I could not move my arm at all.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (non-serious), outcome "unknown", described as "for one whole week, my left arm (vaccine arm) was paralyzed, I could not move my arm at all.". The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein), pneumococcal 13-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event monoplegia and the suspect drug PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Emotional distress, Low density lipoprotein increased
Clinical narrative: Immediately after the Pfizer shot, it went back up, it shot back up within 2 years to 212; I got the LDL cholesterol down to 80;  it shot back up; My body became a lot older shortly after the shot. So, I am very distress about this. I feel like I am going to loose my life in the next few years; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2), on 29Jan2021 at 14:00 as dose 1, single (Lot number: EL9265) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "Immediately after the Pfizer shot, it went back up, it shot back up within 2 years to 212"; LOW DENSITY LIPOPROTEIN INCREASED (non-serious), outcome "unknown", described as "I got the LDL cholesterol down to 80;  it shot back up"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "My body became a lot older shortly after the shot. So, I am very distress about this. I feel like I am going to loose my life in the next few years". Additional information: Consumer stated, "I have some additional information for you as well. Several years before the Pfizer shot, my cholesterol was at 260. So, then I became a healthy plant based, vegan and my cholesterol went from 260, every year it dropped and then I got it all the way down to 137. So, my cholesterol was at 137 before this Pfizer shot. Immediately after the Pfizer shot, it went back up, it shot back up within 2 years to 212 and then I had my heart attack. My LDL cholesterol did the same thing. I got the LDL cholesterol down to 80, which is very good and then after the shot, I did two additional blood test and it shot back up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300440570 same reporter/patient, different dose/AE;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: I am not feeling well, I am feeling kind of achy is that a normal; My arms are real sore and I am kind of achy all over; My arms are real sore and I am kind of achy all over; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 74-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years intramuscular for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Nov2023 as 1 df, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; LOSARTAN; FUROSEMIDE; POTASSIUM; CRESTOR; LATUDA; KLONOPIN taken for anxiety. The following information was reported: MALAISE (non-serious) with onset 08Dec2023, outcome "not recovered", described as "I am not feeling well, I am feeling kind of achy is that a normal"; PAIN IN EXTREMITY (non-serious) with onset 08Dec2023, outcome "not recovered", PAIN (non-serious) with onset 08Dec2023, outcome "not recovered" and all described as "My arms are real sore and I am kind of achy all over". Therapeutic measures were taken as a result of malaise, pain in extremity, pain.  Additional information: The patient reported that she had a COVID vaccine on 08Dec2023 and reported not feeling well, was feeling kind of achy, asked if that was normal. The patient reported arms were real sore and was kind of achy all over. The patient also thought it was okay and asked if it was normal just to have a little achiness, her arm was aching. The patient stated she was  okay and did not think it wais necessary. She thought  she will be alright.  She took some Advil and was sure it will help. The patient stated to  call back on Monday if she still feel this way and  informed that she can always call her doctor as well. The patient  got the vaccine from the pharmacy. The patient was also taking antidepressant. The patient stated the events were still persisting a little bit. The patient also reported that she did took a Flu vaccine about 2 weeks ago at the doctor's office.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis, patient hospitalized; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 71-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Oct2023 as dose number unknown, single (Lot number: HF0521) at the age of 71 years for immunisation; for immunisation. The patient's relevant medical history included: "hyperthryoid" (unspecified if ongoing); "prediabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Relevant past drug history: Name of Drug as Reported: No, Reaction: Allergy. The following information was reported: MYELITIS TRANSVERSE (hospitalization, medically significant) with onset 23Nov2023, outcome "not recovered", described as "Transverse myelitis, patient hospitalized". The patient was hospitalized for myelitis transverse (hospitalization duration: 6 day(s)). Hospitalization Prolonged: No. The event "transverse myelitis, patient hospitalized" required physician office visit. It was unknown if therapeutic measures were taken as a result of myelitis transverse.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: Transverse myelitis occurred around 7 weeks after ABRYSVO.  More information including concomitant medication and investigational work- ups such as virology and immunological biomarkers are needed to identify alternative etiologies.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: I have been getting a major diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 2023, outcome "unknown", described as "I have been getting a major diarrhea". Therapeutic measures were taken as a result of diarrhoea. Additional information: the patient got Pfizer COVID-19 vaccine and had a major diarrhea for a week. He took some diarrhea pills over the counter.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Pruritus, Skin irritation, Swelling, Urinary tract infection
Clinical narrative: swelling; skin irritation; itching of her vaginal tissue, buttocks; itching of her vaginal tissue, buttocks; urinary tract infection; yeast infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NVN-20231205-2275 (RA).  A female patient (unknown if pregnant) received COVID-19 Vaccine - Manufacturer Unknown, in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy", start date: 2016 (unspecified if ongoing); "skin sensitivities" (unspecified if ongoing); "allergies to chocolate, cinnamon" (unspecified if ongoing); "allergies to vanilla" (unspecified if ongoing); "allergies to skin adhesive" (unspecified if ongoing); "allergies to milk" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Minivelle, start date: 2016, for Hormone replacement, reaction(s): "excruciating vaginal pain", notes: The only time she has had an issues with Minivelle is when she is not on the medication. She forgotten to place a patch on, or got busy with life and went without a patch.; Minivelle, start date: 2016, for Hormone replacement, reaction(s): "severe vaginal atrophy", notes: The only time she has had an issues with Minivelle is when she is not on the medication. She forgotten to place a patch on, or got busy with life and went without a patch. The following information was reported: SWELLING (non-serious), outcome "recovered"; SKIN IRRITATION (non-serious), outcome "recovered"; VULVOVAGINAL PRURITUS (non-serious), PRURITUS (non-serious), outcome "recovered" and all described as "itching of her vaginal tissue, buttocks"; URINARY TRACT INFECTION (non-serious), outcome "recovered"; FUNGAL INFECTION (non-serious), outcome "recovered", described as "yeast infection". Therapeutic measures were taken as a result of swelling, skin irritation, vulvovaginal pruritus, pruritus, urinary tract infection, fungal infection.