chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Spontaneous hyphaema
Clinical narrative: I had a spontaneous hyphema in my left eye; I also had an arthritis flare up in my left hand; This spontaneous case was reported by a patient and describes the occurrence of SPONTANEOUS HYPHAEMA (I had a spontaneous hyphema in my left eye) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058876) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 05-Nov-2023, the patient experienced SPONTANEOUS HYPHAEMA (I had a spontaneous hyphema in my left eye) (seriousness criterion medically significant) and ARTHRITIS (I also had an arthritis flare up in my left hand). On 13-Nov-2023, SPONTANEOUS HYPHAEMA (I had a spontaneous hyphema in my left eye) and ARTHRITIS (I also had an arthritis flare up in my left hand) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  The vaccine was administered in patient left deltoid. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported. Company comment: This spontaneous case concerns a 57-year-old female patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of SPONTANEOUS HYPHAEMA, and the unexpected and non-serious AESI of ARTHRITIS, 3 days after an unspecified dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. No details of previous doses were provided. No treatment information was reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: heartburn; This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (heartburn) in a 53-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu on 25-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu.    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 18-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced DYSPEPSIA (heartburn). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (heartburn) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events. Patient Took tums otc. There were no lab data/results available.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. Au3917B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Nov-2023, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 18-Nov-2023, PYREXIA (Fever) and CHILLS (Chills) had resolved.            No concomitant and treatment medication were reported.  It was unknown if the patient experienced any additional symptoms/events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 3 weeks after receiving the vaccine, the patient got COVID and was very sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (3 weeks after receiving the vaccine, the patient got COVID and was very sick) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (3 weeks after receiving the vaccine, the patient got COVID and was very sick). At the time of the report, COVID-19 (3 weeks after receiving the vaccine, the patient got COVID and was very sick) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that her daughter in law's mother received a COVID-19 vaccine recently. The reporter was not sure if the patient received the Pfizer or Spikevax vaccine. However, 3 weeks after receiving the vaccine, the patient got COVID and was very sick. Patient experienced loss of taste and smell, tiredness, fatigue, and weakness as symptoms.  No treatment medications were reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Dysmenorrhoea, Heavy menstrual bleeding, Neuralgia
Clinical narrative: heavy painful periods 3 months after shot; heavy painful periods 3 months after shot; hip bursitis; nerve pain; hip pain; This spontaneous case was reported by a patient and describes the occurrence of DYSMENORRHOEA (heavy painful periods 3 months after shot), HEAVY MENSTRUAL BLEEDING (heavy painful periods 3 months after shot), BURSITIS (hip bursitis), NEURALGIA (nerve pain) and ARTHRALGIA (hip pain) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 068h21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DYSMENORRHOEA (heavy painful periods 3 months after shot), HEAVY MENSTRUAL BLEEDING (heavy painful periods 3 months after shot), BURSITIS (hip bursitis), NEURALGIA (nerve pain) and ARTHRALGIA (hip pain). At the time of the report, DYSMENORRHOEA (heavy painful periods 3 months after shot), NEURALGIA (nerve pain) and ARTHRALGIA (hip pain) was resolving and HEAVY MENSTRUAL BLEEDING (heavy painful periods 3 months after shot) and BURSITIS (hip bursitis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.       Concomitant and specific treatment medications were not reported.  Patient experienced heavy painful periods 3 months after shot. nerve pain and IT/hip pain. Patient needed physical therapy for almost 3 months It was unknown if the patient experienced any additional symptoms/events.  Medication Details and reason for taking the medicine was reported as physical therapy, OTC pain pills, acupuncture.  Lab data/results: Patient got hip bursitis as a result from all the nerve pain and was unable to walk for a couple months.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Days after receiving the latest Moderna vaccine I developed a severe psoriasis flare that has now lasted over 4 weeks; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (Days after receiving the latest Moderna vaccine I developed a severe psoriasis flare that has now lasted over 4 weeks) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Psoriasis.    On 26-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 30-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PSORIASIS (Days after receiving the latest Moderna vaccine I developed a severe psoriasis flare that has now lasted over 4 weeks). The patient was treated with CALCIPOTRIENE at an unspecified dose and frequency and BETAMETHASONE at an unspecified dose and frequency. At the time of the report, PSORIASIS (Days after receiving the latest Moderna vaccine I developed a severe psoriasis flare that has now lasted over 4 weeks) was resolving.            No concomitant medications were reported.  Reported that patient had very mild case of psoriasis. Days after receiving the latest Moderna vaccine she developed a severe psoriasis flare that has now lasted over 4 weeks. It was Itchy, burning and very painful. Was prescribed acetonide cream 0.1% that looks to be helping. Calcipotriene and betamethasone did not help.   This case was linked to US-MODERNATX, INC.-MOD-2023-750480 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750480
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product use in unapproved indication, Viral infection
Clinical narrative: I came down with a virus and am still fighting the virus; Medication Details and reason for taking the medicine: Thera-Flu and Flonase in response to the vaccine.; This spontaneous case was reported by a patient and describes the occurrence of VIRAL INFECTION (I came down with a virus and am still fighting the virus) and PRODUCT USE IN UNAPPROVED INDICATION (Medication Details and reason for taking the medicine: Thera-Flu and Flonase in response to the vaccine.) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for Flu.     The patient had no medical history, concomitant disease or risk factor.     On 11-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 11-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PRODUCT USE IN UNAPPROVED INDICATION (Medication Details and reason for taking the medicine: Thera-Flu and Flonase in response to the vaccine.). On 13-Nov-2023, the patient experienced VIRAL INFECTION (I came down with a virus and am still fighting the virus). At the time of the report, VIRAL INFECTION (I came down with a virus and am still fighting the virus) had not resolved and PRODUCT USE IN UNAPPROVED INDICATION (Medication Details and reason for taking the medicine: Thera-Flu and Flonase in response to the vaccine.) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant were provided.  The patient came down with a virus and am still fighting the virus. It was unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine was Thera-Flu and Flonase in response to the vaccine.  No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2023-750400 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750400:Invalid case for many people
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No further AE; Pharmacist reports patient given VARIVAX w031810 exp 10/5/2024 at 27 days instead of 28  days per PI.  No further AE.  No PQC; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, one time, lot #W031810, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). Patient was given the vaccine at 27 days instead of 28 days per PI (Inappropriate schedule of product administration.)  No adverse reaction was reported.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd Dose of Heplisav-B on day 22 of The Series; Initial report received on 21-Sep-2023  A pharmacist reported that a patient (age, gender, race, and ethnicity not available) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the second dose of HEPLISAV-B 22 days later.   Medical history, allergies, and concomitant medications at the time of vaccination were not available.   On 30-Aug-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not available).  On 21-Sep-2023, 22 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not available).   No additional information was available.  Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Given the Second Dose of Heplisav-B 22 Days After the First; Initial report received on 22-Sep-2023  A pharmacist reported that a patient (age, gender, race, and ethnicity not available) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the second dose of HEPLISAV-B 22 days later.   Medical history, allergies, and concomitant medications at the time of vaccination were unknown.   On an unknown date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown).  On an unknown date, 22 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown).   No additional information was reported.  Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired First Dose Administered; Initial Report Received on 09-Oct-2023  A pharmacist reported that a 38-year-old female patient (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.  No relevant concomitant medications were reported.  On 22-Sep-2023, the patient received the first dose of HEPLISAV-B (Lot #937228, expiration date: 30-Aug-2023, and NDC # 43528-003-05) intramuscular in the left deltoid.  Concomitant vaccination given was reported as COVID vaccine (details not reported).  No adverse reactions were experienced by the patient to the reporter's knowledge.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: the spike/adapter broke into 2 parts: a top and a bottom; he spike did not go into the rubber and it locked but did not plunge into it so they used the diluent and it all leaked out and came out of the side; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID:. A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown , single (Lot number: HA3217, Expiration Date: Mar2025) and as dose number unknown , single (Lot number: HF5020, Expiration Date: Feb2025) for immunisation, Device Lot Number: F655, Device Expiration Date: 01May2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the spike/adapter broke into 2 parts: a top and a bottom"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "he spike did not go into the rubber and it locked but did not plunge into it so they used the diluent and it all leaked out and came out of the side". Additional information: The diluent leaked out when the plunger was used, and they now have no diluent to go into the vial and they do not have the sterile diluent product and she is asking for replacement. The pharmacist was putting it together for the system to insert the diluent to mix and the spike did not go into the rubber, and it locked but did not plunge into it so they used the diluent and it all leaked out and came out of the side. Verified that no patient was administered the Abrysvo vaccine with this issue and they reconstituted another one that was in the same package. Based on follow-up on 09Nov2023, it was reported that "The pharmacist who was mixing the product said the spike/adapter broke into 2 parts: a top and a bottom. She tried to plug them back together before adding the diluent, but it leaked out the side. They longer have the adapter pieces. She threw them away". Causality for "the spike/adapter broke into 2 parts: a top and a bottom" and "he spike did not go into the rubber and it locked but did not plunge into it so they used the diluent and it all leaked out and came out of the side" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). 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 (15Nov2023): Follow-up attempts are completed. No further information is expected.  Follow-up (09Nov2023): This is a follow-up report from Product Quality Group, new information included: event medical details added, this case was reassessed as Reportable for device part.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Hypoaesthesia, Laboratory test, Pain in extremity
Clinical narrative: arm pain; left handed numbness/entire left hand is numb; having ongoing elbow, shoulder pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 59-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, 0.5 ml single (Lot number: GL3699, Expiration Date: 31Jul2024) intramuscular, in left deltoid for immunisation; for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Chronic chest pain" (unspecified if ongoing); "atypical chest pain" (unspecified if ongoing); "chronic bilateral low back pain" (unspecified if ongoing). Concomitant medication(s) included: VOLTAREN [DICLOFENAC] taken for back pain; ALBUTEROL [SALBUTAMOL] resp inhalation taken for chronic obstructive pulmonary disease; AMLODIPINE oral taken for hypertension; ASPIRIN [ACETYLSALICYLIC ACID] oral taken for chest pain; ATORVASTATIN oral taken for chest pain; ADVAIR resp inhalation taken for chronic obstructive pulmonary disease. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "left handed numbness/entire left hand is numb"; ARTHRALGIA (non-serious), outcome "not recovered", described as "having ongoing elbow, shoulder pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the Prevenar 20 back in Mar (unspecified year), presented 4 months later with arm pain, specifically in her shoulder and elbow, along with left handed numbness, Entire left hand is numb.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid for treatment of COVID-19 from 06Nov2023 to 10Nov2023. Patient did not had any known allergies nor had medical history.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300377345 Same patient, different drug/events;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Oct2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid (Treatment start date:30Oct2023, Treatment stop date: 03Nov2023). Known allergies- None  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-202300377157 same patient, different drug, different event;
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) 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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 01Nov2023 to 05Nov2023.  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-202300380582 as same patient, different drug/event.;
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Swelling
Clinical narrative: Severe swelling; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "Severe swelling". It was unknown if therapeutic measures were taken as a result of swelling.  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: 62.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot/batch number: En6199, Anatomical location: Left arm), administration date: 09Mar2021, for Covid-19 immunization; bnt162b2 (DOSE 2, SINGLE, Lot/batch number: Fp7534, Anatomical location: Left arm), administration date: 30Mar2021, for Covid-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot/batch number: Wag7386, Anatomical location: Left arm), administration date: 02Oct2021, for Covid-19 immunization; moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Lot/batch number:066k21a, Anatomical location: Right arm), administration date: 31Mar2022, for COVID-19 immunization; bnt162b2 (DOSE 5 (BOOSTER), SINGLE, Lot/batch number: Gj2524, Anatomical location: Left arm), administration date: 24Sep2022, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" 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 07Nov2023 to 12Nov2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381302 Same patient, different product, different dose/event;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 (BNT162B2), on 15Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years 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 Nov2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took Paxlovid from 08Nov2023 to 12Nov2023. Known allergies: No  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-202300381312 Same patient, different drug;US-PFIZER INC-202300381474 Same patient, different events;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she said that she received on 29Sep and she tested positive today for covid; she said that she received on 29Sep and she tested positive today for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 33-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Nov2023, outcome "unknown" and all described as "she said that she received on 29Sep and she tested positive today for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Nov2023) Positive. The patient reported that it was not eve common because it had not been 2 months since she had the booster. it was disappointing to test positive after receiving booster and she had concerned about getting covid again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness all over; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 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. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itchiness all over". Additional information: itchiness all over which started last night at 5:30 (not confirm if it was 5:30 PM or 5:30 AM) No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: feeling a little funny; feeling a little tired; 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 54-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Mar2023 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 covid-19 vaccine (Dose 1, lot number unknown), for COVID-19 immunisation; Moderna covid-19 vaccine (Dose 2, lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 3 (booster), single, lot number unknown), administration date: 2021, for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2023, outcome "unknown", described as "feeling a little funny"; FATIGUE (non-serious) with onset 2023, outcome "unknown", described as "feeling a little tired".  Additional information: the patient reported that she initially received a two injection series of the Moderna COVID-19 vaccine, and then she received two Pfizer covid-19 boosters after that, the first Pfizer booster in 2021 and then another Pfizer booster on 01Mar2023. The patient stated that with the Pfizer covid-19 booster she got on 01Mar2023, she experienced feeling a little funny the first day and feeling a little tired for a couple of days.  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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: having a swollen lymph node under her jaw bone; a light sore throat; weakness; 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 69-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 as dose 1, single (Batch/Lot number: HF9298) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sinus issue" (ongoing), notes: all year round. Concomitant medication(s) included: BISOPROLOL /HCTZ. Vaccination history included: Covid-19 vaccine (DOSE 3, unknown manufacturer), for COVID-19 immunisation, reaction(s): "weakness"; Covid-19 vaccine (DOSE 2, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, unknown manufacturer), for COVID-19 immunisation. The following information was reported: ASTHENIA (non-serious) with onset 09Nov2023, outcome "unknown", described as "weakness"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "having a swollen lymph node under her jaw bone"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "a light sore throat". Therapeutic measures were taken as a result of asthenia, lymphadenopathy, oropharyngeal pain. Additional information: she felt weakness right after her third dose of the vaccine but it just lasted three days. As treatment the patient started by taking B complex because when she first had the weakness, when she had it for 2 days, the pharmacist said to take a B complex, so she took that for several days and then she read that maybe she needed multivitamins other than that so she stopped taking that. So, she started taking her Geritol.
Sex: M
Vaccine: COVID19
Symptoms: Dysphemia, Feeling abnormal
Clinical narrative: stutter after he got the vaccine; part of the body was weird; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHEMIA (non-serious), outcome "unknown", described as "stutter after he got the vaccine"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "part of the body was weird".  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: RSV
Symptoms: Feeling abnormal, Inability to afford medication
Clinical narrative: Almost died from it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COPD" (ongoing), notes: she has a end of stage COPD, and her doctor wanted her to get the abrysvo. The patient's concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "Almost died from it". Clinical course: Caller calling in to check if there is a assistance program for abrysvo, she has a end of stage COPD, and her doctor wanted her to get the abrysvo and its not covered by her insurance and shes on a fixed income. She did have a RSV vaccine last year and a half and almost died from it and she cant afford the $(withheld) for the medication. Caller said she had taken the RSV vaccine before and almost died from it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: RSV
Symptoms: Myocardial infarction
Clinical narrative: 3 heart attacks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old 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 and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "3 heart attacks". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: After all vaccines & boosters, contracted Covid 2 weeks ago; After all vaccines & boosters, contracted Covid 2 weeks ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old 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 included: "C-19", start date: Mar2020 (unspecified if ongoing), notes: My first experience with C-19 was March 2020. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "After all vaccines & boosters, contracted Covid 2 weeks ago". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: C-19 vaccines, Paxlovid and the continuing work your company did in Research and development. After all vaccines & boosters, patient contracted Covid 2 weeks ago. Patient's first experience with C-19 was Mar2020. Patient had phone consults with a virologist and managed symptoms at home. Patient thought Mar2020 was end. Nov2023, was so different. People didn't get the difference. Patient did.  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: U
Vaccine: COVID19
Symptoms: Eczema, Haemorrhage, Pain
Clinical narrative: my hand are bleeding from eczema/Eczema; my hand are bleeding from eczema/Bleeding; this shot did nothing but give me pain/Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers 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: ECZEMA (non-serious), outcome "unknown", described as "my hand are bleeding from eczema/Eczema"; HAEMORRHAGE (non-serious), outcome "unknown", described as "my hand are bleeding from eczema/Bleeding"; PAIN (non-serious), outcome "unknown", described as "this shot did nothing but give me pain/Pain".  Additional information: Ever since the patient got vaccination for COVID the patient's hand were bleeding from eczema, it was very sad how this shot did nothing but gave the patient pain.  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: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got tested she is positive with Covid; got tested she is positive with Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (004756). The reporter is the patient.  A patient (no qualifiers 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got tested she is positive with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient was vaccinated with Pfizer Covid 19 vaccine but had symptoms and side effects (headache ,diarrhea, fever, chills, upset stomach, cough) when she got tested she was positive with Covid. The patient wanted to know if it was normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change
Clinical narrative: has been not feeling hot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 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 included: "allergies to medications" (ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "has been not feeling hot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal
Clinical narrative: It was reported the patient had body temperature regulation problems since; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001471 (Novavax).  A female patient received bnt162b2 (BNT162B2), as dose 2, 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 (Dose 1), for COVID-19 immunisation. The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "It was reported the patient had body temperature regulation problems since".
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Incomplete course of vaccination
Clinical narrative: The patient did not go back for the second dose because they were scared.; felt a little short of breath; chest discomfort; chest discomfort and pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001461.  A 43-year-old male patient received bnt162b2 (BNT162B2), in Aug2021 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: INCOMPLETE COURSE OF VACCINATION (non-serious), outcome "unknown", described as "The patient did not go back for the second dose because they were scared."; DYSPNOEA (non-serious), outcome "unknown", described as "felt a little short of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown"; CHEST PAIN (non-serious), outcome "unknown", described as "chest discomfort and pain". The events "felt a little short of breath", "chest discomfort" and "chest discomfort and pain" required emergency room visit.  Additional information: On 02-NOV-2023, it was reported that a patient started treatment on an unreported day in AUG-2021 with Pfizer BioNTech COVID-19 dose 1 for COVID-19 vaccination. It was reported the patient didn't handle the first dose of his primary series very well. On an unreported date, a couple weeks after receiving the vaccine, the patient felt a little short of breath with chest discomfort and pain. The patient reported going to the ER and seeing their doctor as well as a cardiologist for additional testing. The patient mentioned they were checked for myocarditis, and it was determined he did not have myocarditis. The patient also stated that his heart or lungs were not affected. The patient did not go back for the second dose because they were scared. No further follow-up is anticipated.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of tenivac that was administered to a patient with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who received  expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Vaccine [TENIVAC] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received expired dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Vaccine ,Suspension for injection (lot U7183AA and expiry 24-Sep-23) (expired product administered) (dose and strength: unknown) via unknown route in unknown administration site for prophylactic vaccination (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 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.