chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administration of an expired Shingrix dose to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2459T, expiry date 08-OCT-2023) for prophylaxis.   On 29-NOV-2023, the patient received Shingrix. On 29-NOV-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Shingrix dose to a patient.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2023 An HCP called to report the administration of an expired Shingrix dose to a patient which led to expired vaccine used. The HCP asked for guidance on this situation. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: believes it might be shingles; blistering; rash under her right breast; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2023, the patient received the 1st dose of Shingrix. In NOV-2023, less than 2 months after receiving Shingrix, the patient experienced shingles (Verbatim: believes it might be shingles), blister (Verbatim: blistering) and rash (Verbatim: rash under her right breast). The outcome of the shingles, blister and rash were not resolved.   It was unknown if the reporter considered the shingles, blister and rash to be related to Shingrix.   It was unknown if the company considered the shingles, blister and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-NOV-2023 The reporter was the patient's niece.  She stated that her aunt received her Shingrix one month ago.  About 2 weeks after the dose, she developed a rash under her right breast. It was now blistering and she believed it might be shingles. The reporter did not consent to follow-up.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration of Kinrix instead of Infanrix to a 15 month-old patient; administration of Kinrix instead of Infanrix to a 15 month-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7745R, expiry date 22-AUG-2025) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix instead of Infanrix to a 15 month-old patient) and wrong vaccine administered (Verbatim: administration of Kinrix instead of Infanrix to a 15 month-old patient). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-NOV-2023 A medical assistant report the administration of Kinrix instead of Infanrix to a 15 month-old patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The health care professional (HCP) asked for guidance on this situation. Kinrix was administered as the third dose in the Dtap series. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Incomplete Dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 13-month-old female patient who received MMR (Priorix) (batch number GX27P, expiry date 11-MAY-2024) for prophylaxis.   On 29-NOV-2023, the patient received the 1st dose of Priorix. On 29-NOV-2023, an unknown time after receiving Priorix, the patient experienced incomplete dose administered (Verbatim: Incomplete Dose). The outcome of the incomplete dose administered 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: 29-NOV-2023 The reporter gave a priorix vaccine to a patient earlier and the needle was not tight on the syringe and part of the serum squirted out, the provider wants to know if the recommendation was to repeat this or not, which led to Incomplete dose administered.  The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received HAV (Havrix) (batch number CN3G5, expiry date 19-NOV-2023) for prophylaxis.   On 30-NOV-2023, the patient received Havrix. On 30-NOV-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Havrix). The outcome of the expired vaccine used 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: 30-NOV-2023 A nurse called to inquire, how to proceed and reported they inadvertently administered an expired Havrix dose to a patient today on 30 November 2023 which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLUX, RVX
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine (Flu vaccine VII) for prophylaxis.   On 14-OCT-2023, the patient received RSV vaccine (unknown arm) and Flu vaccine VII (unknown arm). On 15-OCT-2023, 1 days after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was resolved (duration 4 days).   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 30-NOV-2023 The patient was self-reported. She reported that she received both her flu shot and her RSV shot on the same day, and she did not know which brand of either vaccine she received.  She did not remember which arm received which vaccine, but they were not in the same arm.  She stated that the soreness from the flu shot began the next day and lasted for less than 2 days and the RSV vaccine arm's soreness started the next day and lasted 3 or 4 days. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received an expired vaccine (11/30/23) on 12/1/23; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received HAV (Havrix) (expiry date 30-NOV-2023) for prophylaxis.   On 01-DEC-2023, the patient received Havrix. On 01-DEC-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient received an expired vaccine (11/30/23) on 12/1/23). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-DEC-2023 Healthcare professional reported that the patient received an expired Havrix vaccine, which led to expired vaccine used. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: MULTIPLE SCLEROSIS; This spontaneous report received from a patient concerned a 6 decade old adult male of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 18-MAY-2021) dose was not reported, 1 total administered on 18-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 53 years old. No concomitant medications were reported.  On unspecified date he was diagnosed with multiple sclerosis (MS) after receiving the vaccine. In JUN/JUL-2021, the patient started having symptoms of multiple sclerosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of multiple sclerosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231204017-Multiple sclerosis. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Influenza, Pain
Clinical narrative: She has also had COVID-19 twice; she has the flu; Achy; Tired; Headache; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She has also had COVID-19 twice), INFLUENZA (she has the flu), PAIN (Achy), FATIGUE (Tired) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 005C21A and 030B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Obesity and Asthma.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (She has also had COVID-19 twice), INFLUENZA (she has the flu), PAIN (Achy), FATIGUE (Tired) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (She has also had COVID-19 twice), INFLUENZA (she has the flu), PAIN (Achy), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-752133 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752133:Case for Bivalent dose
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: tired and slept for a day; tired and slept for a day; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (tired and slept for a day) and FATIGUE (tired and slept for a day) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concomitant products included ROSUVASTATIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    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 SOMNOLENCE (tired and slept for a day) and FATIGUE (tired and slept for a day). At the time of the report, SOMNOLENCE (tired and slept for a day) and FATIGUE (tired and slept for a day) had resolved.            It was reported that initially all other covid shots and boosters were Moderna and the only reaction patient had with those was that, 10-12 hours after patient was tired and slept for a day and was fine. After the Moderna vaccines slept the day away and was super refreshed and that was it. Patient did not begin new concomitant medications and took the same ones always takes and began taking those like 10 or 15 years ago as kids are age 26 and started taking those when they were in puberty and has no idea of the start date of those medications but was going through changes at that time and is done with the changes.   Treatment medications were not reported.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Lethargy, Pain, Pyrexia
Clinical narrative: Flu-like symptoms, fever, aches, headache, lethargy; Flu-like symptoms, fever, aches, headache, lethargy; Flu-like symptoms, fever, aches, headache, lethargy; Flu-like symptoms, fever, aches, headache, lethargy; Flu-like symptoms, fever, aches, headache, lethargy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms, fever, aches, headache, lethargy), LETHARGY (Flu-like symptoms, fever, aches, headache, lethargy), PAIN (Flu-like symptoms, fever, aches, headache, lethargy), PYREXIA (Flu-like symptoms, fever, aches, headache, lethargy) and HEADACHE (Flu-like symptoms, fever, aches, headache, lethargy) in a 70-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032089) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 50 microgram. On 30-Nov-2023, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms, fever, aches, headache, lethargy), LETHARGY (Flu-like symptoms, fever, aches, headache, lethargy), PAIN (Flu-like symptoms, fever, aches, headache, lethargy), PYREXIA (Flu-like symptoms, fever, aches, headache, lethargy) and HEADACHE (Flu-like symptoms, fever, aches, headache, lethargy). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms, fever, aches, headache, lethargy), LETHARGY (Flu-like symptoms, fever, aches, headache, lethargy), PAIN (Flu-like symptoms, fever, aches, headache, lethargy), PYREXIA (Flu-like symptoms, fever, aches, headache, lethargy) and HEADACHE (Flu-like symptoms, fever, aches, headache, lethargy) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       Concomitant medications were not reported.  It was unknown if the patient had experienced any additional symptoms/events.  Treatment information was not reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism, Skin burning sensation
Clinical narrative: Hyperthyroidism; Felt like my skin was burning off; This spontaneous case was reported by a patient and describes the occurrence of HYPERTHYROIDISM (Hyperthyroidism) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 29-Jul-2021, the patient experienced HYPERTHYROIDISM (Hyperthyroidism) (seriousness criterion medically significant) and SKIN BURNING SENSATION (Felt like my skin was burning off). At the time of the report, HYPERTHYROIDISM (Hyperthyroidism) and SKIN BURNING SENSATION (Felt like my skin was burning off) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No concomitant medications were reported. It was reported that patient had to go to emergency Room due to racing heart rate for over 10 days. Also had skin that felt like it was on fire and melting off my body. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.  Company Comment This spontaneous case concerns a 63-year-old female patient with no medical history who experienced the seriousness criterion medically significant unexpected event of Hyperthyroidism and the unexpected event of skin burn sensation the same day after a dose of mRNA-1273 vaccine. Concomitant medication nor Treatment details were reported At the time of the report, the event´s was resolving. The benefit-risk relationship of mRNA-1273  vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Headache, Musculoskeletal stiffness
Clinical narrative: Heart pain; Fingers toes locking up; Knee and joint pain; headaches; This spontaneous case was reported by a patient and describes the occurrence of ANGINA PECTORIS (Heart pain) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031897) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 50 microgram. On 09-Nov-2023, the patient experienced ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Fingers toes locking up), ARTHRALGIA (Knee and joint pain) and HEADACHE (headaches). At the time of the report, ANGINA PECTORIS (Heart pain), MUSCULOSKELETAL STIFFNESS (Fingers toes locking up), ARTHRALGIA (Knee and joint pain) and HEADACHE (headaches) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 63-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Angina pectoris, which occurred the same day after an unspecified dose of SPIKEVAX 2023-2024 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: after the Moderna vaccines his wife developed AFib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (after the Moderna vaccines his wife developed AFib) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) 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 ATRIAL FIBRILLATION (after the Moderna vaccines his wife developed AFib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (after the Moderna vaccines his wife developed AFib) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Patient stated that it was unknown if it was related with the vaccine but after the Moderna vaccines patient developed AFib, and she did not have any previous family history.  Company comment This spontaneous case concerns a female patient of an unknown age with no medical history and family history reported, who experienced the unexpected, serious (medically significant) AESI of atrial fibrillation, after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) was administered. The vaccination and the event onset dates were not provided. No further clinical information was provided for review. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-752334.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752334:Husband case
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a noncontactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 16:15 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 at 10:30 as dose 5 (booster), single (Lot number: GJ6739), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: faintly positive; (Nov2023) Positive, notes: faintly positive; (Nov2023) Positive, notes: strongly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
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 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Nov2023 at 10:00 as dose 1, single (Lot number: HG2282) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies" (unspecified if ongoing). Concomitant medication(s) included: RINVOQ, start date: 01Aug2023, stop date: 18Nov2023. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 7 (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received Paxlovid from 18Nov2023 to 23Nov2023 as COVID 19 Treatment.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: she got covid infection; She got covid infection; 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 female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunisation; Flu shot (DOSE NUMBER UNKNOWN, SINGLE), for Influenza Immunisation. The following information was reported: COVID-19 (medically significant) with onset Nov2023, 1 month after the suspect product(s) administration, outcome "not recovered", described as "She got covid infection"; VACCINATION FAILURE (medically significant) with onset Nov2023, 1 month after the suspect product(s) administration, outcome "not recovered", described as "she got covid infection". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Caller started the medication (Paxlovid) Tuesday at 7 pm. Had been taking it every 12 hours at 7 am and 7pm. Caller stated this was the first time she got this and had both flu and covid shots. Stated all of her covid 19 vaccines have been Pfizer with the last one (Pfizer covid 19 shot) about 1 month ago. Stated she was surprised that she got covid infection given its been only a month ago since her last shot. Stated she was still having a runny nose and coughing.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative, notes: Rebound With A Positive Test 5 Days After A Negative Test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Start Date 20Nov2023, stop Date 25Nov2023).  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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 71-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Dec2022 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Sulfa antibiotics" (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 "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Nov2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 21Nov2023 to 25Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chapped lips, Dry mouth, Dyspnoea
Clinical narrative: feeling like she lost her breath for a minute/Dyspnoea; Dry mouth; lips cracked; Anxiety; 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 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: "anxiety" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: ANXIETY (non-serious) with onset 2023, outcome "unknown"; DRY MOUTH (non-serious) with onset 2023, outcome "not recovered"; DYSPNOEA (medically significant) with onset 2023, outcome "unknown", described as "feeling like she lost her breath for a minute/Dyspnoea"; CHAPPED LIPS (non-serious) with onset 2023, outcome "unknown", described as "lips cracked".Clinical course: It was reported that patient had had dry mouth, lips cracked, feeling like she lost her breath for a minute but it was really that she had dry mouth all of a sudden. Had anxiety. Wanted to know was that important or a side effect of it. Clarified that she just had anxiety for years. Her mouth felt dry, she drank a little bit of water and it did not do anything for it. Her mouth was still really dry.  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-202300426520 Different patient, different dose/events;
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 19Nov2023, outcome "recovered" (24Nov2023); DRUG INEFFECTIVE (medically significant) with onset 19Nov2023, outcome "recovered" (24Nov2023). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Nov2023) Positive; (24Nov2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 19Nov2023 to 23Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2023 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 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: Got rebound Covid positive test on day 11, after having a negative test on day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 17Nov2023 to 22Nov2023.  No follow-up attempts are possible. No further information is expected.
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 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "codeine allergy" (unspecified if ongoing); "metabolic syndrome" (unspecified if ongoing). The patient took concomitant medications. 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; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. 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 from 21Nov2023 to 26Nov2023. Clinical course: Patient also took concomitant medications multi-vitamin, vitamin c, zinc, & elderberries over the counter from 20Nov2023 to 30Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 75.0
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) from product quality group. The reporter is the patient.  A 75-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Lot number: H64629) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: sulfa drugs" (unspecified if ongoing); "mildly elevated blood pressure" (unspecified if ongoing), notes: managed by medication; "mildly elevated blood pressure and cholesterol" (unspecified if ongoing), notes: managed by medication. The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known Allergies:tetracycline". Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Batch\lot number: GJ3268), administration date: 12May2023, when the patient was 74-year-old, for COVID-19 immunisation; 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 Immunization; 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 12Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Nov2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 12Nov2023 to 17Nov2023.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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.  A 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid treatment from 20Nov2023 to 25Nov2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 47.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing). Concomitant medication(s) included: NYQUIL, start date: 15Nov2023, stop date: 20Nov2023. 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 from 20Nov2023 to 25Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Lipoma, Magnetic resonance imaging
Clinical narrative: I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN5318) at the age of 69 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. The following information was reported: LIPOMA (medically significant), outcome "unknown", described as "I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine". The patient underwent the following laboratory tests and procedures: Biopsy: Benign; Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of lipoma. Clinical course: Patient had a large lipoma removed from his deltoid muscle at about the place where he got injected the vaccine and the location could be confirmed through an MRI that was made and then the surgeon had a record and the biopsy which came up benign. So, those two three documentations about that item. The vaccine was injected all on the right deltoid, all the same and the lipoma was in that area also and the surgeon could explain that better. The first one was at a PRIVACY at PRIVACY. But he was curious if they were related. Patient denied for any other prior or same day vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300354231 Same patient, different dose, partial same event;US-PFIZER INC-202300355543 Same patient, different dose, different event;US-PFIZER INC-202300427158 Same patient, different dose, partial same event;US-PFIZER INC-202300427157 Same patient/event, different dose;
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 contactable reporter(s) (Pharmacist).  A 77-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Jul2021 as dose 1, single (Batch/Lot number: unknown) and in Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 30Oct2023 to 04Nov2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency. However, a contributory role of BNT162b2 to the events Drug ineffective and Covid-19 cannot be ruled out.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Lipoma, Magnetic resonance imaging
Clinical narrative: I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Lot number: EN6200) at the age of 69 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: EN5318, Anatomical location: Deltoid right, Route of administration: Intramuscular), administration date: 29Jan2021, for COVID-19 Immunization, reaction(s): "I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine". The following information was reported: LIPOMA (medically significant), outcome "unknown", described as "I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine". The patient underwent the following laboratory tests and procedures: Biopsy: Benign; Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of lipoma. Clinical course: Patient had a large lipoma removed from his deltoid muscle at about the place where he got injected the vaccine and the location could be confirmed through an MRI that was made and then the surgeon had a record and the biopsy which came up benign. So, those two three documentations about that item. The vaccine was injected all on the right deltoid, all the same and the lipoma was in that area also and the surgeon could explain that better. But he was curious if they were related. Patient denied for any other prior or same day vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300427131 Same patient/event, different dose;US-PFIZER INC-202300354231 Same patient, different dose, partial same event;US-PFIZER INC-202300355543 Same patient, different dose, different event;US-PFIZER INC-202300427158 Same patient, different dose, partial same event;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Lipoma, Magnetic resonance imaging
Clinical narrative: I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine; 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 male patient received bnt162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 70 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EN5318, Anatomical Location: Deltoid Right, Route of Administration: Intramuscular), administration date: 29Jan2021, when the patient was 69-year-old, for Covid-19 immunisation, reaction(s): "I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine"; bnt162b2 (DOSE 2, SINGLE, Batch/lot number: EN6200, Anatomical Location: Deltoid Right, Route of Administration: Intramuscular), administration date: 19Feb2021, when the patient was 69-year-old, for Covid-19 immunisation, reaction(s): "I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine". The following information was reported: LIPOMA (medically significant), outcome "unknown", described as "I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine". The patient underwent the following laboratory tests and procedures: Biopsy: Benign, notes: which came up benign; Magnetic resonance imaging: Unknown results, notes: I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine and the location can be confirmed through an MRI. Therapeutic measures were taken as a result of lipoma. Clinical course: Consumer stated, "He had a large lipoma removed from my deltoid muscle at about the place where they injected the vaccine and the location could be confirmed through an MRI that was made and then the surgeon had a record and the biopsy which came up benign. The vaccine was injected all on the right deltoid, all the same and the lipoma was in that area also.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300427131 Same patient/event, different dose;US-PFIZER INC-202300354231 Same patient, different dose, partial same event;US-PFIZER INC-202300355543 Same patient, different dose, different event;US-PFIZER INC-202300427157 Same patient, different dose, partial same event;