chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Two pediatric doses of Engerix-B given to adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 41-year-old male patient who received HBV (Engerix B 10 mcg) (batch number 5M93R, expiry date 05-APR-2024) for prophylaxis.   On 19-NOV-2023, the patient received the 2nd dose of Engerix B 10 mcg (unknown arm). On 19-NOV-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced adult use of a child product (Verbatim: Two pediatric doses of Engerix-B given to adult patient). The outcome of the adult use of a child product was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-NOV-2023 Nurse calls to report on the same day two pediatric Engerix-B doses were given to an adult patient, which led to Adult use of a child product. One on each arm. The reporter consented to follow up via email agreed.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Infection, Necrosis
Clinical narrative: necrosis in her arm; Infection; This serious case was reported by a consumer via call center representative and described the occurrence of necrosis in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced necrosis (Verbatim: necrosis in her arm) (serious criteria GSK medically significant) and infection (Verbatim: Infection). The outcome of the necrosis was not resolved and the outcome of the infection was not reported.   It was unknown if the reporter considered the necrosis and infection to be related to Arexvy.     It was unknown if the company considered the necrosis and infection to be related to Arexvy.   Additional Information: GSK Receipt date: 21-NOV-2023 The reporter was a patient. The reporter reported that she received Arexvy vaccine and developed a necrosis in her arm. Patient mentioned that she had to go to emergency room in 2 opportunities, developed an infection and during reporting time was under a treatment with plastic surgery. Patient informed she already reported this incident but could not found documentation about it. Reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Administration of Arexvy in pregnant patient; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4L5M7) for prophylaxis.   On 02-NOV-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Administration of Arexvy in pregnant patient). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 20-NOV-2023 A OBGYN contacted GSK via phone inquiring about Arexvy and what information is available about the usage of Arexvy in pregnant patients after a nurse accidentally administered a dose to 5 patients. The healthcare professional was unsure if they could give consent for follow-up.  The vaccine administration facility is the same as primary reporter. Agreed to have call escalated to team. This case is one out of 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023161828:Different patient US-GSK-US2023161829:Different patient
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: nurse accidentally administered a dose to pregnant patient; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7) for prophylaxis.   On 14-NOV-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: nurse accidentally administered a dose to pregnant patient). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 20-NOV-2023 A OBGYN contacted GSK via phone inquiring about Arexvy and what information is available about the usage of Arexvy in pregnant patients after a nurse accidentally administered a dose to 5 patients. The healthcare professional was unsure if they could give consent for follow-up.  The vaccine administration facility is the same as primary reporter. Agreed to have call escalated to team. This case is one out of 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023161830:Different patient US-GSK-US2023161829:Different patient US-GSK-US2023161826:Different patient US-GSK-US2023161825:Different patient
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Arexvy in pregnant patients after a nurse accidentally administered a dose to 5 patients; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4L5M7) for prophylaxis.   On 17-NOV-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy in pregnant patients after a nurse accidentally administered a dose to 5 patients). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 20-NOV-2023 A OBGYN contacted GSK via phone inquiring about Arexvy and what information is available about the usage of Arexvy in pregnant patients after a nurse accidentally administered a dose to 5 patients. The healthcare professional was unsure if they could give consent for follow-up.  The vaccine administration facility is the same as primary reporter. Agreed to have call escalated to global team. This case is one out of 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023161828:Different patient US-GSK-US2023161825:Different patient US-GSK-US2023161826:Different patient US-GSK-US2023161830:Different patient
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs). Concomitant products included HYDROCHLOROTHIAZIDE from 10-Jan-2017 to an unknown date for an unknown indication.    On 06-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Oct-2023, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (fever). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-Nov-2023 to 06-Nov-2023 for COVID-19 treatment, at an unspecified dose and frequency. On 08-Oct-2023, PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) had resolved.            The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient had previously received a COVID-19 Vaccine. Device date was reported as 10-Nov-2023.
Sex: F
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: no adverse event; when the plunger did not work. It was hard to push and the vaccine did not go; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (when the plunger did not work. It was hard to push and the vaccine did not go) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032707) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3032707) for COVID-19 prophylaxis.    No Medical History information was reported.   On 22-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2023, the patient experienced DEVICE ISSUE (when the plunger did not work. It was hard to push and the vaccine did not go). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, DEVICE ISSUE (when the plunger did not work. It was hard to push and the vaccine did not go) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (when the plunger did not work. It was hard to push and the vaccine did not go).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (when the plunger did not work. It was hard to push and the vaccine did not go).    Concomitant product use was not provided by the reporter.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem. The Spikevax syringe device was malfunctioned and the type was CIRM.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2023: Live follow up received contains PQC report and reference numbers added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chills, Fatigue, Headache, Myalgia
Clinical narrative: exacerbated asthma; redness of injection site; soreness of injection site; Headache; body aches; fatigue; fever; chills; vomiting; This spontaneous case was reported by a patient and describes the occurrence of ASTHMA (exacerbated asthma), VACCINATION SITE ERYTHEMA (redness of injection site), VACCINATION SITE PAIN (soreness of injection site), HEADACHE (Headache) and MYALGIA (body aches) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031416) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 22-Nov-2023, the patient experienced ASTHMA (exacerbated asthma), VACCINATION SITE ERYTHEMA (redness of injection site), VACCINATION SITE PAIN (soreness of injection site), HEADACHE (Headache), MYALGIA (body aches), FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills) and VOMITING (vomiting). At the time of the report, ASTHMA (exacerbated asthma), VACCINATION SITE ERYTHEMA (redness of injection site), VACCINATION SITE PAIN (soreness of injection site), HEADACHE (Headache), MYALGIA (body aches), FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills) and VOMITING (vomiting) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms or events.  No treatment medication was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vomiting
Clinical narrative: exacerbated asthma; redness of injection site; soreness of injection site; Headache; body aches; fatigue; fever; chills; vomiting; This spontaneous case was reported by a patient and describes the occurrence of ASTHMA (exacerbated asthma), VACCINATION SITE ERYTHEMA (redness of injection site), VACCINATION SITE PAIN (soreness of injection site), HEADACHE (Headache) and MYALGIA (body aches) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031416) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 22-Nov-2023, the patient experienced ASTHMA (exacerbated asthma), VACCINATION SITE ERYTHEMA (redness of injection site), VACCINATION SITE PAIN (soreness of injection site), HEADACHE (Headache), MYALGIA (body aches), FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills) and VOMITING (vomiting). At the time of the report, ASTHMA (exacerbated asthma), VACCINATION SITE ERYTHEMA (redness of injection site), VACCINATION SITE PAIN (soreness of injection site), HEADACHE (Headache), MYALGIA (body aches), FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills) and VOMITING (vomiting) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms or events.  No treatment medication was reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Epistaxis, Overdose, Tremor
Clinical narrative: Severe bloody nose and tremors in hands and chronic cough; Severe bloody nose and tremors in hands and chronic cough; Severe bloody nose and tremors in hands and chronic cough; Patient took 10 milliliter vaccine dose; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Severe bloody nose and tremors in hands and chronic cough), COUGH (Severe bloody nose and tremors in hands and chronic cough), EPISTAXIS (Severe bloody nose and tremors in hands and chronic cough) and OVERDOSE (Patient took 10 milliliter vaccine dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 10 milliliter. In November 2021, the patient experienced OVERDOSE (Patient took 10 milliliter vaccine dose). On 25-Nov-2021, the patient experienced TREMOR (Severe bloody nose and tremors in hands and chronic cough) and COUGH (Severe bloody nose and tremors in hands and chronic cough). On an unknown date, the patient experienced EPISTAXIS (Severe bloody nose and tremors in hands and chronic cough). At the time of the report, TREMOR (Severe bloody nose and tremors in hands and chronic cough) and COUGH (Severe bloody nose and tremors in hands and chronic cough) had not resolved and EPISTAXIS (Severe bloody nose and tremors in hands and chronic cough) and OVERDOSE (Patient took 10 milliliter vaccine dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient had severe bloody nose and tremors in hands and chronic cough. It was unknown if the patient experienced any additional symptoms or events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Pain
Clinical narrative: Severe bloating; pain; Started having diarrhea the day after receiving the vaccine, and it has continued through today (>1 month); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Started having diarrhea the day after receiving the vaccine, and it has continued through today (>1 month)), ABDOMINAL DISTENSION (Severe bloating) and PAIN (pain) in a 49-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Asthma, Vasovagal syncope Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 07-Sep-2022 and Syncope. Previously administered products included for Product used for unknown indication: Flu on 09-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu. Concurrent medical conditions included Asthma and Lactose intolerance. Concomitant products included ALPHA-D-GALACTOSIDASE (BEANO), TILACTASE (LACTAID) and PROBIOTICS NOS for Lactose intolerance.    On 23-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 24-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DIARRHOEA (Started having diarrhea the day after receiving the vaccine, and it has continued through today (>1 month)). On an unknown date, the patient experienced ABDOMINAL DISTENSION (Severe bloating) and PAIN (pain). At the time of the report, DIARRHOEA (Started having diarrhea the day after receiving the vaccine, and it has continued through today (>1 month)) had not resolved and ABDOMINAL DISTENSION (Severe bloating) and PAIN (pain) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Treatment medications were not reported.   Reported that patient started taking a probiotic, beano, and lactaid in case patient have developed a lactose intolerance instead.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Gestation period when reaction/event was observed in the fetus: 17 weeks; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. Date of last menstrual period: 17Jul2023. The patient was 11 weeks pregnant at the time of exposure to bnt162b2 omi xbb.1.5. The patient was 11 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 22Apr2024. 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 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 06Oct2023, outcome "unknown", described as "Gestation period when reaction/event was observed in the fetus: 17 weeks"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 08Nov2023 to 13Nov2023.  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 current available limited information in the case provided, the causal association between  the events Vaccination failure and Covid-19 and the use of suspect product cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300384755 same patient, different drug/event;
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 6 (booster), single (Lot number: GU9694) at the age of 65 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 06Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Lot number: SA5MC), in left arm, on 26Feb2021 as dose 2, single (Lot number: O4MZ0A), in left arm, on 17Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm, on 17Apr2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm, on 24Apr2023 as dose 7 (booster), single (Batch/Lot number: unknown), in left arm and on 24Sep2023 as dose 8 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Aug2021, outcome "unknown", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) positive, notes: positive test results. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 10Nov2023 to 15Nov2023. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384617 same patient, different product/event;
Age: 85.0
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) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm and on 08May2023 as dose number unknown (booster), single (Lot number: GL2042) at the age of 85 years, in left arm 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 included: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 08Nov2023 to 12Nov2023. Clinical Course: Patient had no known allergies.  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: Linked Report(s) : US-PFIZER INC-202300384626 same patient, different product/event;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 72-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Lot number: HG4665) at the age of 72 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "cardiac arrhythmia (PVCs)" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 01Nov2023 until 05Nov2023.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Muscle tightness, Palpitations
Clinical narrative: feel my muscles tightening/my body to lock up from neck, down arms, and thoracic area of back; had pain in my sternum; heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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, SINGLE), administration date: Feb2021, for COVID-19 immunisation, reaction(s): "feel my muscles tightening/my body to lock up from neck, down arms, and thoracic area of back", "heart palpitations"; Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for Covid-19 Immunization, reaction(s): "pain in my sternum". The following information was reported: MUSCLE TIGHTNESS (medically significant), outcome "unknown", described as "feel my muscles tightening/my body to lock up from neck, down arms, and thoracic area of back"; BONE PAIN (medically significant), outcome "unknown", described as "had pain in my sternum"; PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations". Therapeutic measures were taken as a result of muscle tightness, bone pain. Clinical Course: It was stated that the patient had been sick since her first vaccine in Feb2021. She stated that the vaccine caused her body to lock up from neck, down arms, and thoracic area of back. Her husband could feel her muscles tightening. She felt her heart palpitations and had pain in her sternum. She stated that she endured one month of Medrol treatments, plus a trigger point injection in thoracic and epidural for Lumbar.  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-PV202300189774 same patient/drug, different dose/events (Dose 1 OMI XBB.1.5);US-PFIZER INC-202300385261 same patient/drug/events, different dose (Dose 1);US-PFIZER INC-202300385263 same reporter/patient, different product/ event.;
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccine brand other: Moderna: dose 1, dose 2, dose 3 / vaccine brand other: Pfizer / BioNTech: dose 4, dose 5; Treatment of COVID-19; Treatment of 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 54-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Lot number: HD9876) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Juvenile rheumatoid arthritis" (unspecified if ongoing); "kidney disease stage 1" (unspecified if ongoing); "IC" (unspecified if ongoing); "heart attack age 19 in 1989", start date: 1989 (unspecified if ongoing); "multiple joint surgeries" (not ongoing); "Known allergies: Sulfa ,Ceftin , Macrobid, Amoxicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: GJ2524, Location of injection: Left Arm), administration date: 24Sep2022, for COVID-19 immunisation; moderna (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: 053E21A, Location of injection: Left Arm), administration date: 30Aug2021, for Covid-19 Immunization; moderna (DOSE 2, SINGLE, Batch/Lot No: 016B21A, Location of injection: Left Arm), administration date: 05Apr2021, for Covid-19 Immunization; moderna (DOSE 1, SINGLE, Batch/Lot No: 03A21A, Location of injection: Left Arm), administration date: 08Mar2021, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Nov2023, outcome "recovered" (11Nov2023) and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered", described as "vaccine brand other: Moderna: dose 1, dose 2, dose 3 / vaccine brand other: Pfizer / BioNTech: dose 4, dose 5". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: I had a severe headache and went to urgent care where I tested positive; (11Nov2023) Negative, notes: Tested negative on 11Nov. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 06Nov2023 to 11Nov2023.  Clinical course as: Patient had a severe headache and went to urgent care where she tested positive. Started Full dose of Paxlovid on 06Nov2023 the first day of symptoms. She ended treatment after 5 days. Tested negative on 11Nov.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384706 same patient, different product/event (Paxlovid case);
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Jul2022 as dose number unknown , single (Batch/Lot number: unknown) at the age of 59 years, in left arm 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 Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 04Nov2023 to 08Nov2023. Patient had no known allergies.  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-202300384796 same patient, different drug/AE;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing). 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: Treatment of Covid-19; (Nov2023) Negative, notes: positive antigen test on 18Nov.(after two prior negative tests); (Nov2023) Negative, notes: positive antigen test on 18Nov.(after two prior negative tests). 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-202300384558 same patient, different event/ drug;
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 44 years 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), 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 drug ineffective, covid-19 with Paxlovid (start date 06Nov2023, stop date 11Nov2023).  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-202300384560 same patient, different event/ drug;
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna dose 4-6, pfizer dose 1-3; 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 57-year-old male patient received bnt162b2 (BNT162B2), on 03Feb2021 at 19:15 as dose 1, single (Lot number: EL9265), in left arm, on 24Feb2021 at 15:30 as dose 2, single (Lot number: EN6201), in left arm and on 09Oct2021 at 17:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 55 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 at 15:00 as dose 4 (booster), single (Lot number: 00ZM21A), in right arm, on 10Sep2022 at 13:00 as dose 5 (booster), single (Lot number: AS7143C), in left arm and on 18Sep2023 at 11:45 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild high blood pressure" (unspecified if ongoing); "chronic dry mouth / loss of some salivary gland function" (unspecified if ongoing); "loss of some salivary gland function" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022 at 15:00, outcome "unknown", described as "Moderna dose 4-6, pfizer dose 1-3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) positive, notes: COVID 19 Treatment; (Nov2023) negative, notes: 2 days after rapid tested/home tested negative for COVID-19; (17Nov2023) positive, notes: I once again tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Pfizer-Paxlovid started date from 09Nov2023 to14Nov2023 for treatment of COVID-19.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Bipolar depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 09Nov2023 to 14Nov2023. 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.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She had the two original Pfizer Covid vaccines, then two Pfizer Covid booster had Covid in between those.; She had the two original Pfizer Covid vaccines, then two Pfizer Covid booster had Covid in between those.; 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 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), outcome "unknown" and all described as "She had the two original Pfizer Covid vaccines, then two Pfizer Covid booster had Covid in between those.".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201269009 same patient/reporter, different doses/event;
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; Afib/atrial fibrillation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male 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: "arthritis" (unspecified if ongoing); "Blood pressure issues" (unspecified if ongoing); "cholesterol issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2023, outcome "unknown", described as "Afib/atrial fibrillation"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The events "covid-19" and "afib/atrial fibrillation" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment on unknown dates.  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-202300385743 same reporter/different patient;US-PFIZER INC-202300385793 same patient, different drug;
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 10:15 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes 2" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, stop date: 09Nov2023. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3, (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4, (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid start date as 10Nov2023 and stop date as 15Nov2023.  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-202300385574 Same patient, different product/event;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer", start date: 2020 (unspecified if ongoing); "Allergy to Sulfa" (unspecified if ongoing); "Allergy to penicillin" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: Jan2007; FENOFIBRATE, start date: Jan2019. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (Booster), Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 (Booster), Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative, notes: Tests were negative on days 7 and 8; (Nov2023) Negative, notes: Tests were negative on days 7 and 8. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had Paxlovid treatment from 12Nov2023 to 17Nov2023.  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-202300385709 same patient/reporter, different drug/event;
Sex: F
Vaccine: COVID19, FLUX, RSV, TDAP
Symptoms: Foetal death
Clinical narrative: Baby lost the heartbeat; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation; for immunisation; bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient was 35 weeks pregnant at the event onset. The patient is expected to deliver one baby(s). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOETAL DEATH (medically significant), 5 days after the suspect product(s) administration, outcome "unknown", described as "Baby lost the heartbeat". Clinical course: The patient' mother got the vaccine when she was 35 and half weeks pregnant. 5 days later, the patient's baby lost the heartbeat.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v , 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-202300392033 mother/baby case;
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Fall, Mobility decreased
Clinical narrative: Lost all mobility; fell off; Brain fog is severe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "parkinson's" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunisation. The following information was reported: BRAIN FOG (non-serious) with onset Nov2023, outcome "unknown", described as "Brain fog is severe"; MOBILITY DECREASED (disability) with onset Nov2023, outcome "unknown", described as "Lost all mobility"; FALL (disability) with onset Nov2023, outcome "unknown", described as "fell off". Clinical course: Patient who had parkinson's lost all mobility. Patient's wife finally got him into bed after he fell off his motorized scooter 3 times. Warning. Red Flag. They'll pass on the next vaccine.  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-PV202300190645 Same reporter/different patient;US-PFIZER INC-202300392049 Same patient/product, different dose/events;US-PFIZER INC-202300392048 Same reporter/different patient;