chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Malaise, Myalgia
Clinical narrative: flu like symptoms; malaise; soreness in muscles in legs/ muscle aches; has a headache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), MYALGIA (soreness in muscles in legs/ muscle aches) and HEADACHE (has a headache) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), MYALGIA (soreness in muscles in legs/ muscle aches) and HEADACHE (has a headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), MYALGIA (soreness in muscles in legs/ muscle aches) and HEADACHE (has a headache) had resolved.            No concomitant medications were reported.  The symptoms were resolved in 24 hours.  Patient received Pfizer vaccine for her 4th dose. The patient had mild flu-like symptoms, including pain and soreness in muscles and legs. This happened when the patient comes down with viral infection. The patient had a headache, malaise, muscle aches, and nausea. The patient experienced same symptoms after receiving the Pfizer Comirnaty 2023-2024 formula vaccine as 4th dose but it was lasting a really long time and it comes and goes. The event of nausea was a new thing for the patient after receiving the 4th dose and the patient had called the physician and had an appointment.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-766630, US-MODERNATX, INC.-MOD-2024-766779 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2024: Live non-significant follow-up received on 01-May-2024: Reference number added; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-766630:Same reporter (Father's case) US-MODERNATX, INC.-MOD-2024-766779:Same reporter (Brother's case)
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The reporter had a COVID diagnosis in 2022 or 2023; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The reporter had a COVID diagnosis in 2022 or 2023) in a 66-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna on 19-Mar-2021, Moderna on 16-Apr-2021 and Moderna on 04-Dec-2021. Past adverse reactions to the above products included No adverse event with Moderna, Moderna and Moderna. Concurrent medical conditions included Chronic lymphocytic leukaemia (Patient was monitored with this for 20 years for chronic lymphocytic lymphoma).    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 (The reporter had a COVID diagnosis in 2022 or 2023). At the time of the report, COVID-19 (The reporter had a COVID diagnosis in 2022 or 2023) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) COVID test positive in 2022 or 2023.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. Patient received dose 4 as Moderna covid-19 vaccine on 07-May-2022. Patient received Moderna bivalent vaccine as dose 5 on 10-Nov-2022 and dose 6 on 28-Jul-2023. It was reported that forty days took to cleared out the COVID-19 infection for patient. No treatment medications provided by the reporter.   This case was linked to MOD-2024-766759 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2024: Live non-significant follow-up information received, and reference number updated.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hiccups, Muscular weakness
Clinical narrative: patient had weakness in his legs; hiccups making it difficult to breathe; difficult to breathe; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCULAR WEAKNESS (patient had weakness in his legs), HICCUPS (hiccups making it difficult to breathe) and DYSPNOEA (difficult to breathe) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Thyroid cancer. Concomitant products included LENVATINIB MESILATE (LENVIMA) from 06-Apr-2022 to an unknown date for Thyroid cancer, PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In April 2024, the patient experienced MUSCULAR WEAKNESS (patient had weakness in his legs) (seriousness criterion hospitalization), HICCUPS (hiccups making it difficult to breathe) (seriousness criterion hospitalization) and DYSPNOEA (difficult to breathe) (seriousness criterion hospitalization). The patient was hospitalized from 26-Apr-2024 to 30-Apr-2024 due to DYSPNOEA, HICCUPS and MUSCULAR WEAKNESS. In April 2024, MUSCULAR WEAKNESS (patient had weakness in his legs), HICCUPS (hiccups making it difficult to breathe) and DYSPNOEA (difficult to breathe) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Patient has no side effects to the report. The patient was diagnosed differentiated thyroid cancer, ICD C73 and taking lenvima from 06-Apr-2022 as per the enrollment form.  Patient was hospitalized from 4/26-4/30, due to a reaction from a Moderna COVID vaccine. No treatment medications were reported. Company comment-This is a spontaneous case concerning a male patient of an unknown age with no relevant medical history, who experienced the serious (hospitalization) unexpected events muscular weakness, hiccups and dyspnoea on an unknown date after a dose of SPIKEVAX NOS vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. It was reported patient was hospitalized for 4 days due to a reaction from a Moderna COVID vaccine. The patient had weakness in his legs, and hiccups making it difficult to breathe. No further details were provided for medical review. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue
Clinical narrative: she was feeling tired; HCP stated they had given a 65 year-old patient today, 30APR2024 with Spikevax 2023-2024 formula with 0.5ml dose with lot number AU3916D and expiration date on 29APR2024; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (she was feeling tired) and EXPIRED PRODUCT ADMINISTERED (HCP stated they had given a 65 year-old patient today, 30APR2024 with Spikevax 2023-2024 formula with 0.5ml dose with lot number AU3916D and expiration date on 29APR2024) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3916D) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (First dose with lot number 013A21A and expiration on March 31 but no info on the year.) on 04-Mar-2021, Moderna (Second Dose with lot number lot 006B21A but no info regarding the date of expiration date.) on 01-Apr-2021, Moderna (Third Dose with lot number 077C21B and expiration on January 14 but no info on the year.) on 02-Dec-2021, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Fourth Dose with lot number 010H22A and expiration on MAY 23 but no info on the year. HCP added this vaccine was bivalent.) on 27-Oct-2022 and Spikevax (Fifth Dose which was a Spikevax formula with lot number 3031047 but no info on the expiration date.) on 18-Oct-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna, Moderna and Spikevax.    On 30-Apr-2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 30-Apr-2024, the patient experienced FATIGUE (she was feeling tired) and EXPIRED PRODUCT ADMINISTERED (HCP stated they had given a 65 year-old patient today, 30APR2024 with Spikevax 2023-2024 formula with 0.5ml dose with lot number AU3916D and expiration date on 29APR2024). At the time of the report, FATIGUE (she was feeling tired) had not resolved and EXPIRED PRODUCT ADMINISTERED (HCP stated they had given a 65 year-old patient today, 30APR2024 with Spikevax 2023-2024 formula with 0.5ml dose with lot number AU3916D and expiration date on 29APR2024) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No relevant medical history/conditions, allergy, concomitant diseases and risk factor were reported. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP called to report that their facility had administered an expired Moderna vaccine and wanted to know if the vaccine was valid. That was the patient's second dose with the Spikevax 2023-2024 formula but it was her 6th dose already with the Moderna COVID-19 vaccine.  No treatment information was provided.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental disorder, Thought insertion
Clinical narrative: I'm being inundated and attacked by thought; caller got a vaccine, and it is affecting his mental health; This spontaneous case was reported by a patient and describes the occurrence of THOUGHT INSERTION (I'm being inundated and attacked by thought) and MENTAL DISORDER (caller got a vaccine, and it is affecting his mental health) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced THOUGHT INSERTION (I'm being inundated and attacked by thought) and MENTAL DISORDER (caller got a vaccine, and it is affecting his mental health). At the time of the report, THOUGHT INSERTION (I'm being inundated and attacked by thought) and MENTAL DISORDER (caller got a vaccine, and it is affecting his mental health) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered THOUGHT INSERTION (I'm being inundated and attacked by thought) to be related. No further causality assessment was provided for MENTAL DISORDER (caller got a vaccine, and it is affecting his mental health).    Concomitant medication was not reported. Patient stated that, he got a vaccine, and it was affecting is mental health. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2024: Live follow-up contains non-significant information. Additional reference numbers added.
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Myalgia, Oropharyngeal pain
Clinical narrative: sore throat; stiff joints; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), JOINT STIFFNESS (stiff joints) and MYALGIA (muscle pain) 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 27-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Oct-2023, the patient experienced OROPHARYNGEAL PAIN (sore throat), JOINT STIFFNESS (stiff joints) and MYALGIA (muscle pain). At the time of the report, OROPHARYNGEAL PAIN (sore throat), JOINT STIFFNESS (stiff joints) and MYALGIA (muscle pain) had not resolved.            It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. The treatment medication was not reported by reporter.
Age: 26.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Blood test, Crying, Dizziness, Panic attack
Clinical narrative: panic attacks; gagging; light sensibility; weaker; I was crying; I was screaming; dizzy; This spontaneous case was reported by a patient and describes the occurrence of PANIC ATTACK (panic attacks), RETCHING (gagging), PHOTOPHOBIA (light sensibility), ASTHENIA (weaker) and CRYING (I was crying) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 007C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DIAZEPAM (VALIUM) for an unknown indication.    The patient's past medical history included Anxiety.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient started DIAZEPAM (VALIUM) (unknown route) at an unspecified dose. On 19-Jun-2021, the patient experienced PANIC ATTACK (panic attacks), RETCHING (gagging), PHOTOPHOBIA (light sensibility), ASTHENIA (weaker), CRYING (I was crying), SCREAMING (I was screaming) and DIZZINESS (dizzy). At the time of the report, PANIC ATTACK (panic attacks), RETCHING (gagging), PHOTOPHOBIA (light sensibility), ASTHENIA (weaker), CRYING (I was crying), SCREAMING (I was screaming) and DIZZINESS (dizzy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: no cancer, no tumors.         Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Patient stated he felt extremely dizzy, like fell on the floor. Patient stated that he went to many doctors, neurologists and ENT and they couldn't find anything. No MRI reported as patient did not get MRI yet. Patient did blood work and like there was no cancer, no tumors, nothing but patient was still in the process that sometimes it was better sometimes it was not good. No treatment information was reported.
Age: 26.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Photophobia, Retching, Screaming
Clinical narrative: panic attacks; gagging; light sensibility; weaker; I was crying; I was screaming; dizzy; This spontaneous case was reported by a patient and describes the occurrence of PANIC ATTACK (panic attacks), RETCHING (gagging), PHOTOPHOBIA (light sensibility), ASTHENIA (weaker) and CRYING (I was crying) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 007C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DIAZEPAM (VALIUM) for an unknown indication.    The patient's past medical history included Anxiety.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient started DIAZEPAM (VALIUM) (unknown route) at an unspecified dose. On 19-Jun-2021, the patient experienced PANIC ATTACK (panic attacks), RETCHING (gagging), PHOTOPHOBIA (light sensibility), ASTHENIA (weaker), CRYING (I was crying), SCREAMING (I was screaming) and DIZZINESS (dizzy). At the time of the report, PANIC ATTACK (panic attacks), RETCHING (gagging), PHOTOPHOBIA (light sensibility), ASTHENIA (weaker), CRYING (I was crying), SCREAMING (I was screaming) and DIZZINESS (dizzy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: no cancer, no tumors.         Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Patient stated he felt extremely dizzy, like fell on the floor. Patient stated that he went to many doctors, neurologists and ENT and they couldn't find anything. No MRI reported as patient did not get MRI yet. Patient did blood work and like there was no cancer, no tumors, nothing but patient was still in the process that sometimes it was better sometimes it was not good. No treatment information was reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Illness, Insomnia, Psychomotor hyperactivity
Clinical narrative: was a very hyper; cannot sleep; Sick; Tired; I got one time COVID in 2022; This spontaneous case was reported by a patient and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (was a very hyper), INSOMNIA (cannot sleep), COVID-19 (I got one time COVID in 2022), ILLNESS (Sick) and FATIGUE (Tired) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes (diabetic for last 15 years, that's all).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (I got one time COVID in 2022). On an unknown date, the patient experienced PSYCHOMOTOR HYPERACTIVITY (was a very hyper), INSOMNIA (cannot sleep), ILLNESS (Sick) and FATIGUE (Tired). At the time of the report, PSYCHOMOTOR HYPERACTIVITY (was a very hyper) and INSOMNIA (cannot sleep) had not resolved, COVID-19 (I got one time COVID in 2022) had resolved and ILLNESS (Sick) and FATIGUE (Tired) outcome was unknown.            The concomitant medication was not reported by reporter.  In 2020, he received the Moderna vaccine. He received 2 shots and 1 booster, leading to increased hyperactivity. The hyperactivity persisted for about three months, making it difficult for him to sleep. Despite seeking medical help and trying various medications, the issue remained unresolved. The hyperactivity gradually decreased after 3-4 months, but the sleeping problem persisted. He consulted multiple doctors, including a psychiatrist, primary care physician, and pulmonary specialist, but found only temporary relief. He visited a specialist in pulmonary medicine who conducted a sleep test and prescribed him medication for anxiety. The medication was only temporary, and his dosage has been adjusted over time. Currently, he was undergoing treatment with a neurologist who specializes in sleep disorders and follows their recommendations. He mentioned contracting COVID in 2022 after receiving the vaccine but recovered after a 5-day course of prescription medication. The hyperactivity began a month after the booster shot. He was sick and tired. It had been three years, and he barely manage to get 2-3 hours of sleep. He was getting tired of these things. Additionally, he mentioned that his upcoming medical appointment was scheduled for 1 JUN 2024.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus/loud whooshing sound in his ears; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 03May2024, this case now contains all required information to be considered valid.  This is a spontaneous report and received from Consumer or other non HCPs.  A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: TINNITUS (non-serious), outcome "not recovered", described as "Tinnitus/loud whooshing sound in his ears". Therapeutic measures were taken as a result of tinnitus.  Additional information: the patient (68 at the time of the report), said that a loud whooshing sound in his ears had accompanied every moment since his first shot, but that his entreaties to colleagues at the agency and prevention to explore the phenomenon, tinnitus, had led nowhere. In despair that he might "never hear silence again," he has sought solace in meditation and his religious faith.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Depression, Nasopharyngitis
Clinical narrative: he caught a cold which she also caught; depressed after getting the RSV vaccine; depressed after getting the RSV vaccine/ she had a history of taking antidepressants; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 77-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2023 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "antidepressants" (unspecified if ongoing), notes: had a history of taking antidepressants. The patient's concomitant medications were not reported. The following information was reported: DEPRESSION (non-serious) with onset 2023, outcome "unknown", described as "depressed after getting the RSV vaccine"; DISEASE RECURRENCE (non-serious) with onset 2023, outcome "unknown", described as "depressed after getting the RSV vaccine/ she had a history of taking antidepressants"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "he caught a cold which she also caught". Therapeutic measures were taken as a result of nasopharyngitis, depression, disease recurrence.  Additional information: The patient was asking for other side effects other than the normal side effects of Abrysvo RSV vaccine. She advised that by the end of Oct last year, she had her senior flu shot and then 2 weeks later had the Pfizer RSV vaccine shot, she was 77 years old then and now 78. She mentioned that her husband had 2 shots also, neither was RSV vaccine and he caught a cold which she also caught. She was given medications for it, antibiotic, Z pack but they could not get rid of it. She then started to feel depressed, in which she asked if Abrysvo causes depression. She also mentioned that before Oct, she was fine and then was depressed after getting the RSV vaccine. She is presently taking antidepressant but on a low dose. She advised she had a history of taking antidepressants and stopped taking them and she felt fine afterwards.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: My sister has developed cancer; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "My sister has developed cancer". The patient didn't have cancer in her family.
Age: 76.0
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 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Mar2024 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. No Known allergies. Concomitant medication(s) included: XANAX, start date: 24Apr2024, stop date: 26Apr2024. Vaccination history included: Covid-19 vaccine (Dose number: 5, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 4, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 3, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 1, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 27Apr2024 to 01May2024. This case was reported as non-serious.
Age: 30.0
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 30-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Mar2024 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "chronic constipation" (unspecified if ongoing); "GERD/LPRD" (unspecified if ongoing); "asthma" (unspecified if ongoing); "ulcerative laryngitis" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "plantar fasciitis" (unspecified if ongoing); "vaginismus" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, 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 (lot number: HL3797) received from 26Apr2024 to 01May2024.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Poor quality product administered, Product quality issue, Skin odour abnormal
Clinical narrative: the shot gave him the virus; the shot gave him the virus; Musty smell they have/ He wants to get the smell out of his sweat and out of his body; felt like they gave him a dirty shot; felt like they gave him a dirty shot; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), in 2021 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. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for covid-19 immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer: Unknown), for covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "the shot gave him the virus"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT QUALITY ISSUE (non-serious), outcome "unknown" and all described as "felt like they gave him a dirty shot"; SKIN ODOUR ABNORMAL (non-serious), outcome "unknown", described as "Musty smell they have/ He wants to get the smell out of his sweat and out of his body".  Additional information: Patient had 3 of the vaccines. He started with the first 2 and should have stopped there. He has not gotten another vaccine since 2021. He said that he felt like they gave him a dirty shot that he received at (withheld). He said that what he means by dirty is the musty smell they have. He wants to get the smell out of his sweat and out of his body. He messed up by getting the vaccine to begin with. Stated that Pfizer tricked people into getting the vaccine. His sense are haywire. He said that he had the virus and said that the shot gave him the virus.
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Caller says there is a musty smell that comes out of pores when going out of hot shower then added later on that it "happens everywhere"; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for covid-19 immunization; Bnt162b2 (DOSE 2), for covid-19 immunization. The following information was reported: PAROSMIA (non-serious), outcome "not recovered", described as "Caller says there is a musty smell that comes out of pores when going out of hot shower then added later on that it "happens everywhere"". Additional information: Caller is trying to figure out where the cure is because he had an adverse effect from his 3rd shot of the Pfizer-Biontech Covid vaccine. Caller says there is a musty smell that comes out of pores when going out of hot shower then added later on that it "happens everywhere" that even the other people he come across with who had the vaccine, he could smell both musty odors which become harder and become combined. This smell heightens other things. Taking the 3rd shot was the worst mistake he ever made. He is still on this weird phase.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Blindness unilateral, Glaucoma, Hallucination, SARS-CoV-2 antibody test
Clinical narrative: each time I took that shot and came home, I had a psychedelic effect.; now I am blind in my right eye; diagnosed with glaucoma; I have been diagnosed with Arthritis; This is a spontaneous report and received from Consumer or other non HCPs from medical information team, Program ID.  A 67-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FP7138) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HALLUCINATION (medically significant), outcome "unknown", described as "each time I took that shot and came home, I had a psychedelic effect."; BLINDNESS UNILATERAL (medically significant), outcome "unknown", described as "now I am blind in my right eye"; GLAUCOMA (medically significant), outcome "unknown", described as "diagnosed with glaucoma"; ARTHRITIS (non-serious), outcome "unknown", described as "I have been diagnosed with Arthritis". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive.  Additional information: The patient experienced a psychodelic experience after taking the shots. She saw multiple flowers when she closed her eyes the day she had the shots. She was wondering if the shots caused this. She took four and the last one was on 27Aug2022 (date not clarified) and each time she took that shot and came home, she had a psychedelic effect. She closed her eyes and she will see flowers. It's colorful flowers. They just kept appearing. They would appear. Patient stated further, "Right, each time I took the shot. I took four. I completed, you know, the 'two' series and now I am blind in my right eye. I have asked around to see if anybody else. You just talk to people, when you ask people what kind of effect they had? I went to the doctor up because I wear glasses and I have been diagnosed with Arthritis. That's why I am calling you back to see if that (incomplete sentence) and I was diagnosed with glaucoma. I don't know if I should not have taken it because I had glaucoma. I just don't know. I am trying to find out from you because I don't want to lose my other eye. I didn't take it this year not this year last year, I haven't taken it since 2022. Like I said that was the effect that it had on me and then eventually I lost vision in my right eye, that's why I called." When asked if have any question regarding the vaccine, consumer stated, "That's what I am saying, the COVID-19 is when I took the vaccine that's when I had these problems with my eye. I would still have this psychedelic effect and then next thing I am blind in my right eye."
Age: 67.0
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 Consumer or other non HCP. A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Dec2023 at 16:00 as dose 1, single at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (dose 9, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 8, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 7, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 6, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 5, manufacturer unknown), for Covid-19 immunization; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: anti viral from 26Apr2024 to 30Apr2024.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 will be requested and submitted if and when received.
Age: 68.0
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 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Mar2024 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (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; Covid-19 vaccine (Dose 7 (Booster), Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Apr2024, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2024) Positive; (May2024) Negative; (May2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included Paxlovid from 28Apr2024 to 02May2024. Clinical course: patient was tested positive for covid, took Paxlovid first day and for 5 days, no symptoms and negative test. 4 days later she began to get symptoms of soar throat, laryngitis. Tested positive again.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.      adverse event: positive for covid, took Paxlovid first day and for 5 days, no symptons and negative test. 4 days later I began to get symptoms of soar throat, laryngitis. Tested positive again.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: BP rose; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "BP rose".  Additional information: The patient would like to know if there was any call-ins, reports of persons who had the Pfizer Covid vaccine have their blood pressure skyrocket all of a sudden or for no reason. She mentioned she had all the tests done to her and could not explain why her BP rose. She never ever had high blood pressure before. She wanted to know if this is related to her body. She knows they are really bad side effects long term.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Pain, Respiratory viral panel
Clinical narrative: vaccine failure; PCR positive for COVID-19 infection; achy; Tired; This is a literature report from product quality group for the following literature source(s).  A 59-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hepatitis C" (unspecified if ongoing); "alcoholic cirrhosis" (unspecified if ongoing); "liver transplant" (unspecified if ongoing); "respiratory symptoms" (unspecified if ongoing), notes: admitted to the hospital. Concomitant medication(s) included: TACROLIMUS. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "vaccine failure"; COVID-19 (medically significant), outcome "unknown", described as "PCR positive for COVID-19 infection"; PAIN (non-serious), outcome "unknown", described as "achy"; FATIGUE (non-serious), outcome "unknown", described as "Tired". The patient underwent the following laboratory tests and procedures: Respiratory viral panel: Negative; SARS-CoV-2 test: positive. Case report: A 59-year-old man exhibited vaccine failure following administration of COVID 19 vaccine Pfizer BioNTech for immunisation against COVID-19 infection. The man with history of hepatitis C, alcoholic cirrhosis and liver transplant, was admitted to the hospital due to respiratory symptoms. He was receiving tacrolimus. He had received two doses of COVID 19 vaccine Pfizer BioNTech [Pfizer-BioNTech; dosages and routes not stated] a year ago. However, he tested PCR positive for COVID-19 infection, suggesting vaccine failure. Later, he experienced severe cellular rejection following COVID-19 infection. The man was treated with bolus methylprednisolone and dose of tacrolimus was increased. Eventually, his liver enzymes improved and entirely normalised 2 months after the infection. The patient was tired and achy after the second dose of the Pfizer Covid-19 vaccine.  Follow-up (08May2024): This is a literature follow-up report for the following literature source(s). Updated information:  Added new reporter, updated drug coding, lab data, added new events tired and pain.; Reporter's Comments: A respiratory viral panel was negative except COVID-19 PCR was positive. He was vaccinated with two doses of [COVID-19-Vaccine-Pfizer-BioNTech] a year ago.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: vaccine failure; PCR positive for COVID-19 infection; achy; Tired; This is a literature report from product quality group for the following literature source(s).  A 59-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hepatitis C" (unspecified if ongoing); "alcoholic cirrhosis" (unspecified if ongoing); "liver transplant" (unspecified if ongoing); "respiratory symptoms" (unspecified if ongoing), notes: admitted to the hospital. Concomitant medication(s) included: TACROLIMUS. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "vaccine failure"; COVID-19 (medically significant), outcome "unknown", described as "PCR positive for COVID-19 infection"; PAIN (non-serious), outcome "unknown", described as "achy"; FATIGUE (non-serious), outcome "unknown", described as "Tired". The patient underwent the following laboratory tests and procedures: Respiratory viral panel: Negative; SARS-CoV-2 test: positive. Case report: A 59-year-old man exhibited vaccine failure following administration of COVID 19 vaccine Pfizer BioNTech for immunisation against COVID-19 infection. The man with history of hepatitis C, alcoholic cirrhosis and liver transplant, was admitted to the hospital due to respiratory symptoms. He was receiving tacrolimus. He had received two doses of COVID 19 vaccine Pfizer BioNTech [Pfizer-BioNTech; dosages and routes not stated] a year ago. However, he tested PCR positive for COVID-19 infection, suggesting vaccine failure. Later, he experienced severe cellular rejection following COVID-19 infection. The man was treated with bolus methylprednisolone and dose of tacrolimus was increased. Eventually, his liver enzymes improved and entirely normalised 2 months after the infection. The patient was tired and achy after the second dose of the Pfizer Covid-19 vaccine.  Follow-up (08May2024): This is a literature follow-up report for the following literature source(s). Updated information:  Added new reporter, updated drug coding, lab data, added new events tired and pain.; Reporter's Comments: A respiratory viral panel was negative except COVID-19 PCR was positive. He was vaccinated with two doses of [COVID-19-Vaccine-Pfizer-BioNTech] a year ago.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.
Age: 1.17
Sex: U
Vaccine: MEN, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HCP stated that a 14 month old patient was administered MenQaudfi in error instead of Menveo, with no adverse event; Initial information received on 01-May-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 14 months old and unknown gender patient who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (menqaudfi) in error instead of MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (menveo), with no adverse event.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection via intramuscular route in unknown administration site for immunization (strength, dose, batch number and expiry date- unknown) in error instead of menveo, with no adverse event (wrong product administered) (latency same day). Information on the batch number was requested.   It is unknown if there were lab data/results available  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired daptacel was administered with no adverse event; Initial information received on 26-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who had received expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Apr-2024, the patient received a expired 0.5 ml (millimeter) dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine  (strength: standard, Frequency: once and expiry date: 06-Apr-2024 and lot C5980AB) via intramuscular route in unknown administration site as Immunization (expired product administered) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.