chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reported AE for expired Measles, Mumps, Rubella and Varicella, Virus Vaccine Live (PROQUAD) that was inadvertently administered to a patient.; No symptoms reported.; This spontaneous report was received from  a medical assistant concerning a patient of unspecified age and gender.   The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were (unknown or not provided) by reporter.  On 01-AUG-2023, the patient was invertedly vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) (PROQUAD), subcutaneous injection, albumin status recombinant human albumin (rHA), 0.5 milliliter, administered for prophylaxis (Lot No. U031562 has been verified to be a valid lot number, expiration date reported as 06-APR-2023 and confirmed upon internal validation) (strength, and route of administration were not provided) (Expired product administered). No symptoms (No adverse event) or temperature excursions (TE) were reported.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse issues or side effects were reported surrounding the administration of the expired; dose of PNEUMOVAX 23 that expired on 07/30/2023; This spontaneous report was received from a medical assistant referring to a 20-year-old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 02-AUG-2023, the patient was vinadvertently accinated with pan expired neumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5mL via injection in the right deltoid, lot # U034712 with expiration date 30-JUL-2023, for prophylaxis (strength and route of administration were not reported). The facility recognized the incident on the same date. The vaccine did not experience any temperature excursions. No adverse issues or side effects were reported surrounding the administration of the expired vaccine. The person who administered the vaccine was an experienced medication aide and the product had been disposed of and was not available for retrieval.
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of the group along with Moderna. Treatment details was not reported by the reporter. This case contains information about 12th patient out of 25 patients. Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a non-health professional and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The suspect product dosage text was reported as unknown. No concomitant medication was reported. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors were part of the group along with Moderna. No treatment medication was reported.  This case contains information about patient 13th out of 25 patients. Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 15 out of 25.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that cancer rates for jabbed Moderna Cancer patients was up 300 percent. No treatment medication was reported. This case contains information about 16th patient out of 25 patients.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that cancer rates for jabbed Moderna Cancer patients was up 300 percent. No treatment medication was reported. This case is reported for patient 20 out of 25 patients.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.            It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication details not reported by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that the those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine is poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of it along with Moderna.  Treatment details was not reported by the reporter.  This case contains information about 23rd patient out of 25 patients.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of the group along with Moderna. Treatment details was not reported by the reporter. This case contains information about 24th patient out of 25 patients.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a non-health professional and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. An autopsy was not performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The suspect product dosage text was reported as unknown. No concomitant medication was reported. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors were part of it along with Moderna. No treatment medication was reported.  This case contains information about patient 25th out of 25 patients.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case; Reported Cause(s) of Death: Cancer
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jun2023, outcome "recovered" and all described as "Tested positive for Covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2023) Positive, notes: Covid test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271876 same patient, different vaccine dose number, different event;
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal pain, Arthralgia, Bursitis, Chills, Headache
Clinical narrative: left arm almost to to elbow became red, hard & painful, & today itchy. I could not use the arm until this morning. Add'l, I had fever, chills, sore throat, swollen painful right wrist, mild case of bursitis in the right shoulder, head ache, neck pain & other aches in the abdominal area.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Joint swelling
Clinical narrative: left arm almost to to elbow became red, hard & painful, & today itchy. I could not use the arm until this morning. Add'l, I had fever, chills, sore throat, swollen painful right wrist, mild case of bursitis in the right shoulder, head ache, neck pain & other aches in the abdominal area.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Neck pain, Oropharyngeal pain, Pyrexia
Clinical narrative: left arm almost to to elbow became red, hard & painful, & today itchy. I could not use the arm until this morning. Add'l, I had fever, chills, sore throat, swollen painful right wrist, mild case of bursitis in the right shoulder, head ache, neck pain & other aches in the abdominal area.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: lymph node swelling under L arm that went into scapula region Narrative:  Employee will be going to see Urgent Care for his pain by his shoulder that is described as "tearing"  Other Relevant History:
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: An additional patient, who was 17 years old, received two doses of PROQUAD; No additional AE reported; This spontaneous report was received from a physician and refers a patient of a 17-years-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient received two doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dosage form, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse events were reported.  This is one of two reports from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-AUG-2023 Pharmacist had a patient who received the first dose of Shingrix 3 years ago, and never got the second dose, which led incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Non-Hodgkin's lymphoma
Clinical narrative: A literature review found one case of NHL (Non-Hodgkin's lymphoma) that developed shortly after Moderna COVID-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of NON-HODGKIN'S LYMPHOMA (A literature review found one case of NHL (Non-Hodgkin's lymphoma) that developed shortly after Moderna COVID-19 vaccination) in a patient of an unknown age and gender 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 NON-HODGKIN'S LYMPHOMA (A literature review found one case of NHL (Non-Hodgkin's lymphoma) that developed shortly after Moderna COVID-19 vaccination) (seriousness criterion medically significant). At the time of the report, NON-HODGKIN'S LYMPHOMA (A literature review found one case of NHL (Non-Hodgkin's lymphoma) that developed shortly after Moderna COVID-19 vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.  ID was reported.  Company comment: This is a spontaneous case concerning a patient of nknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) event of Non-Hodgkin's lymphoma. The event occurred after a dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-736010, US-MODERNATX, INC.-MOD-2023-735263 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2023: Follow-up information included no new information. On 03-Aug-2023: Follow-up information included no new information. On 03-Aug-2023: Follow-up information included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736010:same reporter US-MODERNATX, INC.-MOD-2023-735263:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.            It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication details not reported by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that the those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine is poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of it along with Moderna.  Treatment details was not reported by the reporter.  This case contains information about 17th patient out of 25 patients.  Company comment: This is a fatal spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (death/medically significant) event of neoplasm malignant. The event occurred after a dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of the group along with Moderna. Treatment details was not reported by the reporter. This case contains information about 18th patient out of 25 patients.  Company comment: This is a fatal spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (death/medically significant) event of neoplasm malignant. The event occurred after a dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a non-health professional and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The suspect product dosage text was reported as unknown. No concomitant medication was reported. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors were part of it along with Moderna. No treatment medication was reported.  This case contains information about patient 19th out of 25 patients.  Company comment: This is a fatal spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (death/medically significant) event of neoplasm malignant. The event occurred after a dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case; Reported Cause(s) of Death: Cancer
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breast cancer
Clinical narrative: Breast cancer; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER (Breast cancer) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    In December 2022, the patient received fourth 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 BREAST CANCER (Breast cancer) (seriousness criterion medically significant). The patient was treated with Surgery (Double mastectomy, Lymph node removal) for Breast cancer. At the time of the report, BREAST CANCER (Breast cancer) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered BREAST CANCER (Breast cancer) to be not related.    No concomitant medication was reported.  Patient had breast cancer in both her breasts. Her lymph nodes were removed.  Patient was taking medications for breast cancer, aromatase inhibitor, to prevent a reoccurrence.  Company comment: This is a spontaneous case concerning a 74 years-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of breast cancer. The event occurred after a fourth dose of mRNA-1273.222 vaccine. Patient had double mastectomy with lymph node removal. She is on treatment with aromatase inhibitors. No further information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was not recovered. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Age: 1.0
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion product administered to patient with no reported adverse event; Initial information was received on 07-Aug-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 1 years old and unknown gender patient who experienced temperature excursion product administered to patient with no reported adverse event after receiving IPV (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination  (Immunization). The information on the batch number was requested.  On an unknown date, the patient had temperature excursion product administered to patient with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, Temperature the product reached: 47.6 Fahrenheit = 8.67 Celsius Duration: less than 30 minutes Data Logger is present, but only tracks temperature every 30 minutes, by the next 30 minutes temperature is already back down, so the nurse was not able to say how long the temperature excursion was. It was not alerted or anything, since she said she was just inserting vaccines inside the refrigerator since they just got a delivery that day, she said she is assuming that it was the reason why the products had temperature excursion.  Action taken: applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Pain
Clinical narrative: Unconscious; body was sore; This serious case was reported by a consumer via interactive digital media and described the occurrence of unconscious in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced unconscious (Verbatim: Unconscious) (serious criteria GSK medically significant) and general body pain (Verbatim: body was sore). The outcome of the unconscious was not reported and the outcome of the general body pain was resolved.   It was unknown if the reporter considered the unconscious and general body pain to be related to Shingrix.     It was unknown if the company considered the unconscious and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-AUG-2023 The case was received from the patient via interactive digital media. The reporter stated that after receiving the first shot of Shingrix hours after patient was unconscious in ambulance. She do not know if it was related or not to Shingrix. The patient body was sore for a while. The follow-up would not required per process.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Mental status changes, Oxygen saturation decreased
Clinical narrative: Presented via EMS w/ SOB, SaO2 low 80's on RA, AMS. Tx w/ steroids, abx, Vit C, Zinc, Remdesivir.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Malaise, Respiratory tract congestion
Clinical narrative: Arrives to the ED c/o COVID-like symptoms of cough, congestion, dyspnea for the past 7 days. Txs zinc, singulair, antitussives and antipyretics,empiric doxycyline,supplemental 02.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Cough, Diarrhoea, Dyspnoea
Clinical narrative: Presents to the ED via EMS c/o COVID-like symptoms, which began 2 days ago. Specifically, pt complains of congestion, coughing, SOB, diarrhea, and fever.   Noted to be having Acute respiratory failure with hypoxia.  Volume overload, Pneumonia due to COVID-19 virus.  Tx.Decadron, remdesivir therapy 4-5 L of nasal cannula oxygen. Sent home on O2.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hypervolaemia, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: Presents to the ED via EMS c/o COVID-like symptoms, which began 2 days ago. Specifically, pt complains of congestion, coughing, SOB, diarrhea, and fever.   Noted to be having Acute respiratory failure with hypoxia.  Volume overload, Pneumonia due to COVID-19 virus.  Tx.Decadron, remdesivir therapy 4-5 L of nasal cannula oxygen. Sent home on O2.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Constipation, Dyspnoea, Haematemesis, Hip fracture
Clinical narrative: Presents to the ED c/o coffee ground emesis starting today. She also notes constipation. She also tested positive for COVID-19 2 days ago and her facility has put her on NC for low SpO2.  shortness of breath.   Lives in Nursing Home since hip fracture.  Tx.ocontinue isolation/ quarantine precautions. + mucinex  ,Decadron tx given.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: Presents to the ED c/o coffee ground emesis starting today. She also notes constipation. She also tested positive for COVID-19 2 days ago and her facility has put her on NC for low SpO2.  shortness of breath.   Lives in Nursing Home since hip fracture.  Tx.ocontinue isolation/ quarantine precautions. + mucinex  ,Decadron tx given.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Positive airway pressure therapy, Vomiting
Clinical narrative: Presents to the ED arriving by EMS with hx of  c/o SOB onset 0100 this morning. EMS states sats at 72% on RA.Placed on CPAP.  had vomiting.  She developed coughing spells and shortness of breath.  Her symptoms gradually worsened and EMS was called.  Patient has been started on treatment for COVID-19 due to underlying disease conditions such as SLE on immunosuppression.  Continue oxygen supplementation and wean as tolerated.  Weaned down to 6 L of oxygen via nasal cannula.  Patient is fully vaccinated against COVID and also had a booster dose apparently.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Hypoxia, Malaise, Pyrexia
Clinical narrative: Chief Complaint;  Covid Like Symptoms (fever cough x 2 days/ weakness +vaccinated 88%on ra placed on 2L/nc 94%).   DC home. Tx.  oxygen supplement,IV steroids, monitor for airway obstruction/ worsening hypoxia, inhaled bronchodilators
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Dizziness, Fall, Head injury
Clinical narrative: Chief Complaint: Fall (has been having repeated falls at home, tested COVID +, uknown LOC, hit head, - thinners, dizziness present).  COVID-19 pneumonia- currently on room air - tested positive on 01/10/2022 - no treatment warranted at this time. discharged to SNF.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, SARS-CoV-2 test positive
Clinical narrative: Chief Complaint: Fall (has been having repeated falls at home, tested COVID +, uknown LOC, hit head, - thinners, dizziness present).  COVID-19 pneumonia- currently on room air - tested positive on 01/10/2022 - no treatment warranted at this time. discharged to SNF.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Hypoxia, Oxygen saturation decreased
Clinical narrative: Admitted here for COVID-19 pneumonia with hypoxemia.   received 2 doses of COVID 19 vaccine and not received the booster dose yet presenting to ED. Her O2 saturation has been decreasing to 87%.  Treatment for COVID 19 PNA with Vit C and zinc and decadron.  minimal o2 requirement.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Presents to the ED c/o SOB for three weeks.  Pt states that she was exposed to COVID on 12/25/21 but had a negative COVID test on 12/28/21. The patient was COVID positive 1/15/2022.   From assisted living who presented with shortness of breath.  Tx.  She was placed on 4 L nasal cannula.  Patient on Decadron.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Pyrexia
Clinical narrative: Presents to the ED c/o increased shortness of breath x2 days.  Patient was diagnosed with COVID on January 4, 2022 and was doing well until 2 days ago we started with increased cough and fever. He did receive the COVID vaccine in February of 2021, but did not receive a COVID booster. Tx.  IV steroid, vitamin-C, zinc, 2 L by nasal cannula.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, COVID-19 pneumonia, Troponin increased
Clinical narrative: Admitted to the hospital AFib with RVR, mild troponin elevation and found to have COVID-19 pneumonia with acute hypoxic respiratory failure.  Tx.  remdesivir therapyand  oxygen.  home oxygen therapy as well as home health services including skilled nursing care, skilled physical and occupational therapy.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Atrial fibrillation, COVID-19, COVID-19 pneumonia, Cough
Clinical narrative: Presents to the ED c/o SOB for 2-3 days.  According to EMS, pt was 50% on RA that went up to 70% on O2. Associated sx include cough and congestion  asthma, paroxysmal atrial fibrillation, hypertension, obstructive sleep apnea.  Sars cov 2 Detected.  diagnosed of Covid-19 pneumonia.  Tx.  IV steroids On high-flow oxygen.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypertension, Obstructive sleep apnoea syndrome, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Presents to the ED c/o SOB for 2-3 days.  According to EMS, pt was 50% on RA that went up to 70% on O2. Associated sx include cough and congestion  asthma, paroxysmal atrial fibrillation, hypertension, obstructive sleep apnea.  Sars cov 2 Detected.  diagnosed of Covid-19 pneumonia.  Tx.  IV steroids On high-flow oxygen.