chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Administration only of liquid component; Administration only of liquid component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA984A, expiry date 31-DEC-2025) for prophylaxis.   On 06-MAR-2024, the patient received Menveo. On 06-MAR-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administration only of liquid component) and inappropriate dose of vaccine administered (Verbatim: Administration only of liquid component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 06-MAR-2024 Patient was administered just 1 vial out of 2 vial presentation of Menveo.  Administration only of liquid component, confirmed which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received late; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included b-cell lymphoma. Previously administered products included Shingrix (1st dose received in November 2022). Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 06-MAR-2024 Patient got a first dose in November 2022 and a second dose in November 2023.  Nurse mentioned patient went through B Cell lymphoma and was immunocompromised but did not add any additional information. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: she developed Shingles after she received both dosages of Shingrix/suspected vaccination failure; she developed Shingles after she received both dosages of Shingrix/lack of effect; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: she developed Shingles after she received both dosages of Shingrix/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she developed Shingles after she received both dosages of Shingrix/lack of effect). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 07-MAR-2024 The reporter reported that she developed Shingles after she received both dosages of Shingrix. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Adverse event, Electroencephalogram, Tinnitus
Clinical narrative: PULSES IN EAR; COVID VACCINE PUT "GRAPHENE OXIDE" IN HIS SYSTEM; MAKING HIM GO CRAZY; This spontaneous report received from a patient concerned a male of unspecified age. Initial information was processed with additional information received on 20-FEB-2024. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) .5 ml, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced pulses in ear, covid vaccine put "graphene oxide" in his system, and making him go crazy (dose series 1). Laboratory data (dates unspecified) included: EEG Results not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid vaccine put "graphene oxide" in his system, making him go crazy and pulses in ear was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be 90000314192 - this customer preference case has been assessed and does not represent a product quality complaint. the disposition and root cause determination were documented properly based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: General physical condition abnormal
Clinical narrative: Health conditions; This spontaneous report received from a patient via social media and it was unknown if it was a J&J managed social media site concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose series:1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced health conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of health conditions was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she got covid and she was sick for 3 days being positive in Covid for the next 10 days; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she got covid and she was sick for 3 days being positive in Covid for the next 10 days) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (she got covid and she was sick for 3 days being positive in Covid for the next 10 days). At the time of the report, COVID-19 (she got covid and she was sick for 3 days being positive in Covid for the next 10 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient claimed that had 7 Moderna vaccination so far and she was getting to get the next vaccine, but she got covid and she was sick for 3 days being positive in Covid for the next 10 days. Patient was going to have the 8th vaccine. No treatment medication was reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hangover, Pollakiuria
Clinical narrative: had a circle of pain around his entire stomach right above his groin; feels like "hangover" from the night; urination more often than normal; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (had a circle of pain around his entire stomach right above his groin), HANGOVER (feels like "hangover" from the night) and POLLAKIURIA (urination more often than normal) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032472) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 12-Mar-2024, the patient experienced ABDOMINAL PAIN UPPER (had a circle of pain around his entire stomach right above his groin), HANGOVER (feels like "hangover" from the night) and POLLAKIURIA (urination more often than normal). At the time of the report, ABDOMINAL PAIN UPPER (had a circle of pain around his entire stomach right above his groin), HANGOVER (feels like "hangover" from the night) and POLLAKIURIA (urination more often than normal) was resolving.            No concomitant medication was reported.  Patient went to sleep around 01:00 12-Mar-2024 and within an hour or so was awoken to a pain in his stomach and thought he might need to urinate, so he went and sat on the toilet, was able to urinate but had a circle of pain around his entire stomach right above his groin. Patient was about to wake up his wife to take him to the ER but decided to stick it out for a while. It took him a little while to get up from the toilet. Patient laid down in bed for a few minutes or so, still had pain but dozed off. Woke up 3 or 4 more times during the night with the pain and had urination more often than normal. At morning - felt like hangover from the night, but may be because he hasn't eaten yet, but there's irritation in there around midsection, otherwise feels perfectly fine. Generally healthy, not an invalid. Patient has had six or seven total COVID vaccines up to now - unsure of how many.  No treatment information was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had COVID after receiving vaccination on September 2023; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (had COVID after receiving vaccination on September 2023) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Dec-2023, the patient experienced COVID-19 (had COVID after receiving vaccination on September 2023). On 01-Jan-2024, COVID-19 (had COVID after receiving vaccination on September 2023) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative and Positive.     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 product use was not provided by the reporter.  Suspect vaccine dosage text was reported as first dose.  It was reported patient vaccinated in late Sep-2023 with SPIKEVAX and experienced mild COVID during Christmas. Traveling during Christmas (25th of December), lady at the airplane window was coughing. Patient had some congestion and overall mild symptoms.  Patient had 2 COVID tests, first was negative and second test was positive.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-763090 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-763090:Husband Case
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: none
Age: 60.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient recieved Abrysvo on 2/24/2024 and a Prevnar 20, he returned on 3/9/24 for Twinrix and Shingrix first dose...BUT he was given another dose of Abrysvo
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Rheumatoid arthritis, Rheumatoid factor increased, X-ray
Clinical narrative: Symptoms of rheumatoid arthritis started 6 months after covid vaccine. three years later, still experiencing debilitating RA symptoms.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, erythema, warmth in area of approx 3in diameter at injection site, mom noticed it approximately 36 hours after injection during bathtime
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Nov2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: avocado" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 29Feb2024 to 05Mar2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted Covid-19 after receiving the Pfizer Covid-19 vaccination.; contracted Covid-19 after receiving the Pfizer Covid-19 vaccination.; This is a spontaneous report received from an Other HCP. Other Case identifier(s): MOD-2024-762622 (Moderna), MOD-2024-762623 (Moderna).  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, patients received various Pfizer doses prior to getting contracted with Covid-19.), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Mar2024, outcome "not recovered" and all described as "contracted Covid-19 after receiving the Pfizer Covid-19 vaccination.".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-PV202400033279 Same reporter/event, different dose/patient;US-PFIZER INC-202400060737 Same reporter/event, different dose/patient;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 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: "Arrythmia" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received other vaccine and medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 28Feb2024 to 04Mar2024  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER),SINGLE, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER),SINGLE, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 26Feb2024 to 02Mar2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Lot number: HD9876) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 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 Feb2024, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid from 28Feb2024 to 04Mar2024).  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400060843 same patient, different drug/event;
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Long COVID; Long COVID; This is a spontaneous report received from a Nurse from medical information team, Program ID.  A 48-year-old female patient received BNT162b2 (BNT162B2), in Mar2022 as dose 1, single (Batch/Lot number: unknown), in right arm and in Jul2022 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Long COVID". Clinical course: Patient was diagnosed with long COVID in Jul2023.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with BNT162b2 cannot be fully excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 29Feb2024 to 04Mar2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 35-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Feb2024 at 20:00, outcome "recovered" (Feb2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Feb2024) Positive; (Feb2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course details: Patient received COVID 19 Treatment with Paxlovid from 20Feb2024 to 25Feb2024. Covid positive on 20Feb2024. Tested negative for COVID in Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19 / congestion, positive test (home test kit); Treatment of COVID-19 / congestion, positive test (home test kit); This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sarcoidosis in lungs" (unspecified if ongoing); "allergic to scallops" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number unknown, single, Vaccine location: Left arm), administration date: Oct2022, when the patient was 76 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Feb2024, outcome "unknown" and all described as "Treatment of COVID-19 / congestion, positive test (home test kit)". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19, Total lung capacity
Clinical narrative: Has COVID now again; Has COVID now again; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "Lungs are working at 78% at the moment" (ongoing); "Hospitalized" (not ongoing), notes: was put an IV medication. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 28Feb2021, when the patient was 73-year-old, for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Has COVID now again". The patient underwent the following laboratory tests and procedures: Total lung capacity: 78 %. Clinical course: Patient said she had all COVID-19 vaccines from Pfizer. She got the first one on her birthday (date withheld), when she was 73-year-old. She had COVID before and had COVID now again. The first time she was hospitalized and was put an IV (intravenous) medication. Her lungs were working at 78% at the moment. She always wore mask and took all precautions; she did not know how she got infected again.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 77.0
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 Consumer or other non HCP.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 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 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; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 29Feb2024 to 05Mar2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 11:30 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history and had no known allergies. 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 (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 2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 01Mar2024 to 05Mar2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body height, Cough, Nasopharyngitis, Pneumonia, Weight
Clinical narrative: Pneumonia; cold; Coughing; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 78-year-old female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PNEUMONIA (medically significant), outcome "unknown"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; COUGH (non-serious), outcome "unknown", described as "Coughing". The patient underwent the following laboratory tests and procedures: Body height: Probably 5'5; Weight: Probably about 150.  Patient comment: patient wanted to know what kind of shot she should get for pneumonia, so it was more medical question. She did about a week or two weeks ago, she was coughing this. Patient said, past couple of weeks she had a cold but she had taken, she had all the other shots (Unspecified shots) and stuff like COVID (Captured as COVID Shot) and stuff like that and had no problems or no reactions from them. Patient was not sure, nor  remember if she had Pfizer vaccine. Patient does not have her vaccine card. Patient reported that she was going to the doctors for physical in April. She was going like once a year but now the doctor wanted twice a year. Patient got nasal spray and some cough medicine, Guaifenesin 600 milligrams 2 tablets twice a day daily and the nasal spray was fluticasone propionate 50 milligrams, believe to be twice a day also.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Dec2023 at 12:00 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: "CLL." (unspecified if ongoing); "History of nerve tumors." (unspecified if ongoing); "Allergies: Non-ionic contrast dye" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 4 (Booster), Single; Manufacrturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single; Manufacrturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single; Manufacrturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1, Single; Manufacrturer: Unknown), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "COVID 19"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 07Mar2024 to 11Mar2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody increased
Clinical narrative: 3 weeks after having a Pfizer Covid vaccine my routine bloodwork revealed an increase of my ANA 1:160, speckled.; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Feb2024 as dose 1, single (Lot number: HM7006) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FISH OIL; MAGNESIUM GLYCINATE. The patient also took other concomitant therapy. 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, manufacturer unknown), for covid-19 immunisation. The following information was reported: ANTINUCLEAR ANTIBODY INCREASED (non-serious) with onset 29Feb2024 at 15:00, outcome "not recovered", described as "3 weeks after having a Pfizer Covid vaccine my routine bloodwork revealed an increase of my ANA 1:160, speckled.". The event "3 weeks after having a pfizer covid vaccine my routine bloodwork revealed an increase of my ana 1:160, speckled." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of antinuclear antibody increased. Clinical course: No Allergy. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included Multivitamin, fish oil, magnesium glycinate, birth. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bariatric by-pass surgery", start date: Nov2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Location of injection: Arm Left), administration date: 05May2023, when the patient was 65-year-old, for COVID-19 Immunization; Covid-19 vaccine (Primary Immunization series completed (manufacturer unknown)), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Feb2024) Positive, notes: I first tested positive on 29Feb; (12Mar2024) Positive, notes: still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss after injection; This is a spontaneous report received from a Physician.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown), for covid-19 immunisation; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown), for covid-19 immunisation. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Hair loss after injection".  Batch/lot number is not provided, and it cannot be obtained.
Age: 57.0
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 Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 4 (Booster), Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as patient was being treated with Paxlovid.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US037637_NC (Novartis).  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown".  Clinical course: The patient reported that I got to meet the Rapid Response Team at our hospital, the injections were given in infusion lab, due to an anaphylactic reaction. I also had the Covid vaccine 5 days earlier they cannot tell me if it was the Covid vaccine Xolair or combination thereof. I was very sad as though there was working for me, but it was the 16th that I had had. I will not have the Xolair or Covid vaccine as they cannot determine exactly what caused the reaction  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Fatigue, Oral pain, Oropharyngeal pain, Stomatitis
Clinical narrative: A month later sores erupted in mouth which spread all around; A month later sores erupted in mouth which spread all around; A month later sores erupted in mouth which spread all around, even throat; Now heart misfires when fatigued.; Now heart misfires when fatigued.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: ORAL PAIN (non-serious), STOMATITIS (non-serious), outcome "unknown" and all described as "A month later sores erupted in mouth which spread all around"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "A month later sores erupted in mouth which spread all around, even throat"; CARDIAC DISORDER (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Now heart misfires when fatigued.".  Additional information: Patient had a COVID booster December 1922 (as reported) from a pharmacy. A month later, sores erupted in mouth which spread all around, even throat. Biopsy showed nothing. Patient lived with this pain daily. Now, heart misfires when fatigued.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Hot flush, Hyperhidrosis, Insomnia
Clinical narrative: so tired and weak from the lack of sleep; so tired and weak from the lack of sleep; so tired and weak from the lack of sleep; intense hot flashes with a lot of sweating; intense hot flashes with a lot of sweating; restless bilateral legs and arms (which cannot take medication for); restless bilateral legs and arms (which cannot take medication for); muscle pain; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-761253 (Moderna).  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX) for covid-19 immunisation. The patient's relevant medical history included: "rheumatoid arthritis", start date: 2000 (ongoing); "Fibromyalgia", start date: 2000 (ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (dose number unknown), for Covid-19 immunization, reaction(s): "adverse event NOS". The following information was reported: INSOMNIA (non-serious), FATIGUE (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "so tired and weak from the lack of sleep"; HOT FLUSH (non-serious), HYPERHIDROSIS (non-serious), outcome "unknown" and all described as "intense hot flashes with a lot of sweating"; RESTLESS LEGS SYNDROME (non-serious), RESTLESS ARM SYNDROME (non-serious), outcome "unknown" and all described as "restless bilateral legs and arms (which cannot take medication for)"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Restless arm syndrome, Restless legs syndrome
Clinical narrative: so tired and weak from the lack of sleep; so tired and weak from the lack of sleep; so tired and weak from the lack of sleep; intense hot flashes with a lot of sweating; intense hot flashes with a lot of sweating; restless bilateral legs and arms (which cannot take medication for); restless bilateral legs and arms (which cannot take medication for); muscle pain; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-761253 (Moderna).  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX) for covid-19 immunisation. The patient's relevant medical history included: "rheumatoid arthritis", start date: 2000 (ongoing); "Fibromyalgia", start date: 2000 (ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (dose number unknown), for Covid-19 immunization, reaction(s): "adverse event NOS". The following information was reported: INSOMNIA (non-serious), FATIGUE (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "so tired and weak from the lack of sleep"; HOT FLUSH (non-serious), HYPERHIDROSIS (non-serious), outcome "unknown" and all described as "intense hot flashes with a lot of sweating"; RESTLESS LEGS SYNDROME (non-serious), RESTLESS ARM SYNDROME (non-serious), outcome "unknown" and all described as "restless bilateral legs and arms (which cannot take medication for)"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Anaemia, Bacterial test negative, Biopsy bone normal, C-reactive protein increased
Clinical narrative: right after vaccine, chest pain. Then patient became anemic, hair loss, and fatigued. Couple month slater, bloody diarrhea for 3 weeks. Another flare up of bloody diarrhea in April. Another flare up of bloody diarrhea in May, ended up being hospitalized for 6 days for fever, dehydration. fever, bloody diarrhea. Found out she had microscopic colitis. September she had another flare up, and neuropathy in feet. screamign in pain all night long. took her to hospital, she was admitted for 2 months. 5 surgeries in foot to debride "pus" all labs and pathogens came back negative for any bacterial infection, instead only inflammation. Full body MRI showed abscesses in spleen, backed up liver, lesions in lower extremities, pus continue to drain from foot after plastic surgery closed incision with donor skin graph, fevers for 2 months. No drs can figure out pt's health. Calling pt a mystery. She is currently wheelchair bound. Foot drained again after getting PM23 vaccine couple weeks ago. This proves vacinnes is causing her inflammation. She's a thriving 3 grader, and had to remove her from school over this mess. Robbed her of her childhood. shame!
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Colitis microscopic, Debridement, Dehydration, Diarrhoea haemorrhagic
Clinical narrative: right after vaccine, chest pain. Then patient became anemic, hair loss, and fatigued. Couple month slater, bloody diarrhea for 3 weeks. Another flare up of bloody diarrhea in April. Another flare up of bloody diarrhea in May, ended up being hospitalized for 6 days for fever, dehydration. fever, bloody diarrhea. Found out she had microscopic colitis. September she had another flare up, and neuropathy in feet. screamign in pain all night long. took her to hospital, she was admitted for 2 months. 5 surgeries in foot to debride "pus" all labs and pathogens came back negative for any bacterial infection, instead only inflammation. Full body MRI showed abscesses in spleen, backed up liver, lesions in lower extremities, pus continue to drain from foot after plastic surgery closed incision with donor skin graph, fevers for 2 months. No drs can figure out pt's health. Calling pt a mystery. She is currently wheelchair bound. Foot drained again after getting PM23 vaccine couple weeks ago. This proves vacinnes is causing her inflammation. She's a thriving 3 grader, and had to remove her from school over this mess. Robbed her of her childhood. shame!
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Incisional drainage, Inflammation, Laboratory test normal, Liver disorder
Clinical narrative: right after vaccine, chest pain. Then patient became anemic, hair loss, and fatigued. Couple month slater, bloody diarrhea for 3 weeks. Another flare up of bloody diarrhea in April. Another flare up of bloody diarrhea in May, ended up being hospitalized for 6 days for fever, dehydration. fever, bloody diarrhea. Found out she had microscopic colitis. September she had another flare up, and neuropathy in feet. screamign in pain all night long. took her to hospital, she was admitted for 2 months. 5 surgeries in foot to debride "pus" all labs and pathogens came back negative for any bacterial infection, instead only inflammation. Full body MRI showed abscesses in spleen, backed up liver, lesions in lower extremities, pus continue to drain from foot after plastic surgery closed incision with donor skin graph, fevers for 2 months. No drs can figure out pt's health. Calling pt a mystery. She is currently wheelchair bound. Foot drained again after getting PM23 vaccine couple weeks ago. This proves vacinnes is causing her inflammation. She's a thriving 3 grader, and had to remove her from school over this mess. Robbed her of her childhood. shame!