chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The healthcare professional reported that the patient received a dose of Havrix that had been in a below temperature excursion and was not considered stable.  The vaccine administration facility was the same as primary reporter. The healthcare professional reported that below temperature excursion had happened in October (unspecified year). The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Havrix that had been in a below temperature excursion, which led to incorrect storage of drug. This was one of six cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026692:Same reporter US-GSK-US2023026695:Same reporter US-GSK-US2023026693:Same reporter US-GSK-US2023026694:Same reporter US-GSK-US2023026698:Same reporter
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2022, did not come back for their doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in June or July 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-FEB-2023 Reporter's comment: The pharmacist had several patients who received first dose of Twinrix back in June or July 2022 and most of them did not came for their second dose. No further details about patients were provided. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patients did not receive the 2nd dose, which led to incomplete course of vaccination. This case had been linked with US2023AMR028405, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR028405:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 13-May-2022, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th May 2022 via intramuscular route).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's comment: The reporter stated that at the reporting pharmacy the patient had not yet to receive second dose. The pharmacist was not able to access, at the time of the inbound call, the lot number of the Shingrix administered.  The vaccine administration facility for 1st dose was the same as primary reporter.  The reporter had consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination. The details were reported for 1st dose.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received scheme, experienced shingles/suspected vaccination failure; shingles 7 times; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 86-year-old 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, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: Around 2019, the patient received complete scheme of Shingrix around 3 to 4 years ago from reporting, and that during that time frame the patient experienced shingles seven times. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test and time to onset confirming shingles were unknown at the time of reporting. Event outcome for shingles was conservatively captured as recovered as per structural field of source document.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD; This spontaneous report received from a consumer via social media concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose and start therapy date were not reported, 1 in total was administered on an unspecified date in MAR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in JUN-2021, the patient died from an unknown cause of death following vaccination. It was unspecified if an autopsy was performed. It was reported as "vaccinated with J and J one dose", "dead following J and J Covid vaccine" and "It is with great sadness that I tell you all that my son (patient) passed away Monday. I will miss him to the day I die. He was a blessing to everyone that he met and brought joy in everything that he did. Fly with the angels my baby". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20230242008.; Sender's Comments: V0: 20230244421-Dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Disturbance in attention, Dyspnoea, Eye pain, Fatigue
Clinical narrative: Tremor / hand and head internal vibrations and recently visible hand tremors; Eye pain; Shortness of breath; Forgetfulness; Leg pain/Arm pain; Eye pain and Discomfort along with blurred vision; Blurred vision; lack of focus; Headache; Shoulder pain; Fatigued/Tiredness; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremor / hand and head internal vibrations and recently visible hand tremors), EYE PAIN (Eye pain), DYSPNOEA (Shortness of breath), MEMORY IMPAIRMENT (Forgetfulness) and PAIN IN EXTREMITY (Leg pain/Arm pain) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremor / hand and head internal vibrations and recently visible hand tremors), EYE PAIN (Eye pain), DYSPNOEA (Shortness of breath), MEMORY IMPAIRMENT (Forgetfulness), PAIN IN EXTREMITY (Leg pain/Arm pain), EYE PAIN (Eye pain and Discomfort along with blurred vision), VISION BLURRED (Blurred vision), DISTURBANCE IN ATTENTION (lack of focus), HEADACHE (Headache), ARTHRALGIA (Shoulder pain) and FATIGUE (Fatigued/Tiredness). At the time of the report, TREMOR (Tremor / hand and head internal vibrations and recently visible hand tremors), EYE PAIN (Eye pain), DYSPNOEA (Shortness of breath), MEMORY IMPAIRMENT (Forgetfulness), PAIN IN EXTREMITY (Leg pain/Arm pain), EYE PAIN (Eye pain and Discomfort along with blurred vision), VISION BLURRED (Blurred vision), DISTURBANCE IN ATTENTION (lack of focus), HEADACHE (Headache), ARTHRALGIA (Shoulder pain) and FATIGUE (Fatigued/Tiredness) outcome was unknown.            No concomitant and treatment medications were reported. It was reported that prior to Nov-2022 patient was healthy and jogged 5-6 days per week with no health issues. At the time of reporting, it was opposite and after two MRIs no one can tell that what was the wrong with patient. Patient wanted to know what could be causing theses issues. After the booster shot, Patient returned to work but was extremely tired, fatigued and affected much more than previous shots. Now as patient tried to write this, he had to take breaks because of shaking hands and lack of focus. Patient had headache every day without the help of any medication.   This case was linked to MOD-2023-711124 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Memory impairment, Pain in extremity, Tremor, Vision blurred
Clinical narrative: Tremor / hand and head internal vibrations and recently visible hand tremors; Eye pain; Shortness of breath; Forgetfulness; Leg pain/Arm pain; Eye pain and Discomfort along with blurred vision; Blurred vision; lack of focus; Headache; Shoulder pain; Fatigued/Tiredness; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremor / hand and head internal vibrations and recently visible hand tremors), EYE PAIN (Eye pain), DYSPNOEA (Shortness of breath), MEMORY IMPAIRMENT (Forgetfulness) and PAIN IN EXTREMITY (Leg pain/Arm pain) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremor / hand and head internal vibrations and recently visible hand tremors), EYE PAIN (Eye pain), DYSPNOEA (Shortness of breath), MEMORY IMPAIRMENT (Forgetfulness), PAIN IN EXTREMITY (Leg pain/Arm pain), EYE PAIN (Eye pain and Discomfort along with blurred vision), VISION BLURRED (Blurred vision), DISTURBANCE IN ATTENTION (lack of focus), HEADACHE (Headache), ARTHRALGIA (Shoulder pain) and FATIGUE (Fatigued/Tiredness). At the time of the report, TREMOR (Tremor / hand and head internal vibrations and recently visible hand tremors), EYE PAIN (Eye pain), DYSPNOEA (Shortness of breath), MEMORY IMPAIRMENT (Forgetfulness), PAIN IN EXTREMITY (Leg pain/Arm pain), EYE PAIN (Eye pain and Discomfort along with blurred vision), VISION BLURRED (Blurred vision), DISTURBANCE IN ATTENTION (lack of focus), HEADACHE (Headache), ARTHRALGIA (Shoulder pain) and FATIGUE (Fatigued/Tiredness) outcome was unknown.            No concomitant and treatment medications were reported. It was reported that prior to Nov-2022 patient was healthy and jogged 5-6 days per week with no health issues. At the time of reporting, it was opposite and after two MRIs no one can tell that what was the wrong with patient. Patient wanted to know what could be causing theses issues. After the booster shot, Patient returned to work but was extremely tired, fatigued and affected much more than previous shots. Now as patient tried to write this, he had to take breaks because of shaking hands and lack of focus. Patient had headache every day without the help of any medication.   This case was linked to MOD-2023-711124 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extremely tired, fatigued; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Extremely tired, fatigued) in a 55-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extremely tired, fatigued). At the time of the report, FATIGUE (Extremely tired, fatigued) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. It was reported that prior to November of 2022, patient was a healthy 55 year old male that jogged 5-6 days per week with no health issues. It was reported by the patient that after 2 MRI's noone could tell that what was wrong with him. No treatment medications were reported.   This case was linked to MOD-2023-711123 (Patient Link).
Age: 0.67
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Pediatric patient received the Moderna COVID-19 bivalent vaccine as 2nd dose instead of the monovalent vaccine dose.; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric patient received the Moderna COVID-19 bivalent vaccine as 2nd dose instead of the monovalent vaccine dose.) and NO ADVERSE EVENT (No adverse event) in an infant male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric patient received the Moderna COVID-19 bivalent vaccine as 2nd dose instead of the monovalent vaccine dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric patient received the Moderna COVID-19 bivalent vaccine as 2nd dose instead of the monovalent vaccine dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pediatric patient received the Moderna COVID-19 bivalent vaccine as 2nd dose instead of the monovalent vaccine dose.).    No concomitant information was reported. It was reported that patient received the correct dosage of the bivalent vaccine but the incorrect product as 2nd dose. No adverse reactions had been reported by the patient at this time. Age of the patient was 8 months. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-711015 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711015:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: He experienced symptoms consistent with myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (He experienced symptoms consistent with myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (He experienced symptoms consistent with myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (He experienced symptoms consistent with myocarditis) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The reporter stated that post vaccination in Mar-2021, he experienced symptoms consistent with myocarditis. This was a self-exam; no physician was involved.   Optional information claims that while his symptoms were diminishing, they were not completely gone.  Stated that he routinely works out and the length and intensity of his workouts had not been compromised. As previously stated, the diagnosis was determined by using online sources.   He had not previously reported this issue.  Treatment information was not provided. Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the serious (due to medically significant) expected, AESI event of Myocarditis which occurred on an unknown date after a dose of mRNA-1273 vaccine (unknown COVID-19 vaccination schedule). It was reported that post vaccination in Mar-2021, he experienced symptoms consistent with myocarditis. This was a self-exam; no physician was involved. While his symptoms were diminishing, they were not completely gone. He stated that he routinely works out and the length and intensity of his workouts had not been compromised. The diagnosis was determined by using online sources. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, Choking, Dysphagia, Nasal congestion
Clinical narrative: choking in the middle of the night; I've been having problems swallowing; I have a stuffed up nose; I've had Covid twice already since I had that shot.; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (choking in the middle of the night) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHOKING (choking in the middle of the night) (seriousness criterion medically significant), DYSPHAGIA (I've been having problems swallowing), NASAL CONGESTION (I have a stuffed up nose) and COVID-19 (I've had Covid twice already since I had that shot.). At the time of the report, CHOKING (choking in the middle of the night), DYSPHAGIA (I've been having problems swallowing), NASAL CONGESTION (I have a stuffed up nose) and COVID-19 (I've had Covid twice already since I had that shot.) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  Company Comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced a serious (medically Significant) unexpected event of choking unspecified days after receiving a dose of mRNA-1273.222 vaccine. Patient also complained of dysphagia and has been problems swallowing and choking in the middle of night. Patient twice had COVID since vaccination. The details of previous doses were not provided.  There was no information provided about the patient's age, gender, underlying medical conditions, concomitant medications, onset date and clinical course of the events, associated symptoms, final diagnosis, diagnostic and treatment details. The benefit-risk relationship of mRNA-1273.222 vaccine, is not affected by this report.
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: itching; rash; hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), RASH (rash) and URTICARIA (hives) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching), RASH (rash) and URTICARIA (hives). At the time of the report, PRURITUS (itching), RASH (rash) and URTICARIA (hives) had not resolved.            No Concomitant medication was reported.  It was reported that Now patient was having rash, hives and itching and he felt it was from Moderna booster.  No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The patient received expired Bivalent booster beyond 30 days in the refrigerator; No adverse event; Vaccine was administered past 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past 30 days beyond use date), PRODUCT STORAGE ERROR (The patient received expired Bivalent booster beyond 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received expired Bivalent booster beyond 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past 30 days beyond use date), PRODUCT STORAGE ERROR (The patient received expired Bivalent booster beyond 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past 30 days beyond use date) and PRODUCT STORAGE ERROR (The patient received expired Bivalent booster beyond 30 days in the refrigerator).    This case is for the patient number 12, out of 12 patients reported.  Concomitant medication of the patient was not reported.   The reporter was not sure if the patient received any other vaccines at the same time of Bivalent booster.  It was reported that the size of the vials was 2.5 ml and the vials were initially stored in the refrigerator on 13-Dec-2022. The vaccine vials were a case of 10 pcs and 7 vials from the case were used to administer vaccines from 13-Jan-2023 thru 22-Jan-2023. It was also reported that the label on case of vials advised that the vials should have been used before 12-Jan-2023. The vial did not undergo any temperature excursions.  It was unknown if the patient experienced any adverse reactions.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704253 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704253:Master case  1st adult patient
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: contracted the Covid Virus; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (contracted the Covid Virus) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced COVID-19 (contracted the Covid Virus). At the time of the report, COVID-19 (contracted the Covid Virus) outcome was unknown.            No concomitant medications were reported. Patient's husband was reported that after the moderna vaccine patient contracted the Covid Virus. No treatment medications were reported   This case was linked to US-MODERNATX, INC.-MOD-2023-711790 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711790:Case for Husband
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: no adverse event; reported excursion on 14Feb2023; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (no adverse event), PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (Product storage error) in a child female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event), PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, NO ADVERSE EVENT (no adverse event), PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  Maximum temperature: -1.8 C Storage at time of excursion: freezer Excursion duration: unknown for each day starting on 01-Feb-2023 and continued until 14-Feb-2023. HCP can confirm it was not out of range the entire day.   No treatment drugs were reported.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: product storage error; no adverse event; assistants reported excursion on 14Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (assistants reported excursion on 14Feb2023), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (assistants reported excursion on 14Feb2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (assistants reported excursion on 14Feb2023), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (assistants reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medication were reported.  It was reported that one of the medical assistants reported excursion on 14-Feb-2023. Maximum temperature was -1.8 C. At time of excursion vaccine was in freezer. Excursion duration was unknown, was for each day starting on 01-Feb-2023 and continued until 14-Feb-2023. Reporter said they were unable to access and print off the data logger. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer Covid Vaccines, Pfizer Covid Boosters, Pfizer Bivalent Vaccine- have had all the Pfizer Covid Vaccines and Boosters and still got Covid.; Pfizer Covid Vaccines, Pfizer Covid Boosters, Pfizer Bivalent Vaccine- have had all the Pfizer Covid Vaccines and Boosters and still got Covid.; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumonia shots  (They also had whatever pneumonia shots are recommended for those over 80.), for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer Covid Vaccines, Pfizer Covid Boosters, Pfizer Bivalent Vaccine- have had all the Pfizer Covid Vaccines and Boosters and still got Covid. ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Pfizer Covid Vaccines, Pfizer Covid Boosters, Pfizer Bivalent Vaccine- have had all the Pfizer Covid Vaccines and Boosters and still got Covid. He was diagnosed on Monday and started Paxlovid on Monday night. He has not noticed any medical issues, discomfort or bleeding.  Patient stated that he and his wife have had all Pfizer Covid vaccines and booster with the last booster in November. They also had whatever pneumonia shots are recommended for those over 80.  They mask and take precautions but still got Covid.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller's son also tested positive; Caller's son also tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Feb2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Caller's son also tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) positive, notes: tested positive.  Clinical course: Caller's son also tested positive and caller wanted to talk to her provider about all of it. Caller's son had his Covid vaccine on 04Feb2023. That was his fourth one and he has been vaccinated all along and tested positive for Covid. He was sick last week. Figured out tomorrow is 10 days. Caller declined report for her son, isn't that par for the course at this point. Is there a product complaint to report was yes. Description of Product Complaint: Description of complaint, Caller's son had his Covid vaccine on 04Feb2023. That was his fourth one and he has been vaccinated all along and tested positive for Covid. Caller declined report for her son. Product strength and count size dispensed was not provided. Additional lot numbers was not provided.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid positive test date was on 22Dec2022; covid positive test date was on 22Dec2022; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (16Feb2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 70 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL8982) intramuscular, in right arm, on 18Feb2021 as dose 2, single (Lot number: EM9809) intramuscular, in right arm, on 19Oct2021 as dose 3 (booster), single (Lot number: FE3590) intramuscular, in right arm and on 23May2022 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthroscopic surgery" (unspecified if ongoing), notes: Arthroscopic surgery in left arm, previously. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Vaccine name: Flu shot, Anatomical Site of Injection: Right Arm, Number of Previous Doses: (One per year)), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2022, outcome "unknown" and all described as "covid positive test date was on 22Dec2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Positive, notes: covid positive test.  Clinical course: The patient had received 5 vaccines in total. The patient had all of her COVID Boosters in right arm because of arthroscopic surgery in left arm, previously. Her right arm felt great until the 15Nov2022 booster given. Reporter stated the covid positive test date was on 22Dec2022.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 3 (booster), single (Lot number: gh9702) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Dilantin, reaction(s): "Known allergies: dilantin".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid on 13Feb2023 to 16Feb2023.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Your vaccines (Unspecified vaccines) for your corona virus killed my grandmother and father; killed my family members; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Your vaccines (Unspecified vaccines) for your corona virus killed my grandmother and father; killed my family members". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073523 same product and event, different patient;; Reported Cause(s) of Death: Your vaccines (Unspecified vaccines) for your corona virus killed my grandmother and father; killed my family members
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: your vaccines (Unspecified vaccines) for your corona virus killed my grandmother and father; killed my family members; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "your vaccines (Unspecified vaccines) for your corona virus killed my grandmother and father; killed my family members". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073481 same product and event, different patient;; Reported Cause(s) of Death: your vaccines (Unspecified vaccines) for your corona virus killed my grandmother and father; killed my family members
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 61 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8737), on 22Apr2021 as dose 2, single (Lot number: EW0164), on 24Oct2021 as dose 3 (booster), single (Lot number: 32030BD) and on 15Apr2022 as dose 4 (booster), single (Lot number: FT4989) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: then tested positive again 5 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Anti viral COVID 19 Treatment from 02Feb2023 to 07Feb2023.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 3 (booster), single (Lot number: GJ2524) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Treatment with Paxlovid, from 07Feb2023 to 12Feb2023. Known allergies and Other medical history: no. Other medication in 2weeks: No.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: seeing smoke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; latanoprost (LATANOPROST), (Batch/Lot number: unknown); ibuprofen (IBUPROFEN), (Batch/Lot number: unknown); brimonidine tartrate, brinzolamide (SIMBRINZA), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "seeing smoke". The action taken for latanoprost, ibuprofen and brimonidine tartrate, brinzolamide was unknown.  Additional information: Caller stated that her eye doctor had her taking Latanoprost ophthalmic solution, which was from Pfizer and she was taking it with her Simbrinza. On the first night she took nothing extra and was fine. She had taken Ibuprofen at 2am, woke up this morning and it was like smoke was in the house. Clarified that she looked at the lights in the ceiling and guessed that she had a reaction. Wanted to know if she could take Ibuprofen with Latanoprost ophthalmic solution. Was tipped off about something else she was on and told that what information one gets from the manufacturer was not conclusive. Wanted to find out why she was seeing smoke and to know if was this permanent or if would reverse itself. As she was looking it says nothing about don't take Ibuprofen. Wished that she would have known that Latanoprost ophthalmic solution was from Pfizer. She never had any problems until took she took the Covid shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate irregular, Hypersensitivity, Urticaria
Clinical narrative: Immediate allergic reaction; Hives on arms; Trouble breathing; Irregular heartbeat; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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: HYPERSENSITIVITY (non-serious), 1 hr after the suspect product(s) administration, outcome "unknown", described as "Immediate allergic reaction"; URTICARIA (non-serious), 1 hr after the suspect product(s) administration, outcome "unknown", described as "Hives on arms"; DYSPNOEA (non-serious), 1 hr after the suspect product(s) administration, outcome "unknown", described as "Trouble breathing"; HEART RATE IRREGULAR (non-serious), 1 hr after the suspect product(s) administration, outcome "unknown", described as "Irregular heartbeat". Additional information: The pharmacist was seeking for guidance on determining next steps for the patient. The patient developed an immediate allergic reaction within an hour of first dose of Comirnaty. They included hives on arms, trouble breathing, and irregular heartbeat. The pharmacist asked if this would be classified as severe allergic reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 at 14:45 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Aug2021 at 13:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 at 19:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 01Feb2023 to 05Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073973 same patient and drug; different dose and event;