chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain
Clinical narrative: had aches; had a full body reaction, but nothing allergic; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (had aches), IMMUNISATION REACTION (had a full body reaction, but nothing allergic), CHILLS (chills) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 047C21A and 030B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (had pneumonia 1 day after getting the flu shot) and Flu shot (history of reaction to the flu shot in the past). Past adverse reactions to the above products included Adverse reaction with Flu shot; and Pneumonia with Flu shot.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, the patient experienced PAIN (had aches), IMMUNISATION REACTION (had a full body reaction, but nothing allergic), CHILLS (chills) and PYREXIA (fever). In April 2022, PAIN (had aches), IMMUNISATION REACTION (had a full body reaction, but nothing allergic), CHILLS (chills) and PYREXIA (fever) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-679863, MOD-2022-679857 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Immunisation reaction, Pain, Pyrexia
Clinical narrative: had aches; had a full body reaction, but nothing allergic; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (had aches), IMMUNISATION REACTION (had a full body reaction, but nothing allergic), CHILLS (chills) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 047C21A and 030B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (had pneumonia 1 day after getting the flu shot) and Flu shot (history of reaction to the flu shot in the past). Past adverse reactions to the above products included Adverse reaction with Flu shot; and Pneumonia with Flu shot.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, the patient experienced PAIN (had aches), IMMUNISATION REACTION (had a full body reaction, but nothing allergic), CHILLS (chills) and PYREXIA (fever). In April 2022, PAIN (had aches), IMMUNISATION REACTION (had a full body reaction, but nothing allergic), CHILLS (chills) and PYREXIA (fever) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-679863, MOD-2022-679857 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Palpitations, Panic attack, Thirst
Clinical narrative: Nasal Swab: positive; Nasal Swab: positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 at 08:30 as dose 1, single (Lot number: EN6199), in left arm, on 29Mar2021 at 08:00 as dose 2, single (Lot number: EP6955), in left arm and on 16Nov2021 at 12:15 as dose 3 (booster), single (Lot number: 32030BD) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "unknown" and all described as "Nasal Swab: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive. Clinical course: No known allergies. Prior to vaccination, the patient did not have COVID.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201336176 same patient/drug, different dose/event;
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab: positive; Nasal Swab: positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 at 08:30 as dose 1, single (Lot number: EN6199), in left arm, on 29Mar2021 at 08:00 as dose 2, single (Lot number: EP6955), in left arm and on 16Nov2021 at 12:15 as dose 3 (booster), single (Lot number: 32030BD) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "unknown" and all described as "Nasal Swab: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive. Clinical course: No known allergies. Prior to vaccination, the patient did not have COVID.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201336176 same patient/drug, different dose/event;
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Had COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had COVID-19) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (Had COVID-19). At the time of the report, COVID-19 (Had COVID-19) outcome was unknown.            No concomitant medication were reported.              No treatment information was provided by the reporter.   This case was linked to MOD-2022-680224 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Feeling cold
Clinical narrative: Had COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had COVID-19) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (Had COVID-19). At the time of the report, COVID-19 (Had COVID-19) outcome was unknown.            No concomitant medication were reported.              No treatment information was provided by the reporter.   This case was linked to MOD-2022-680224 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient had been deprived of an appropriate amount of energy/Unable to build strength back up; With the cold setting in he is having trouble keeping warm at night.; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Patient had been deprived of an appropriate amount of energy/Unable to build strength back up) and FEELING COLD (With the cold setting in he is having trouble keeping warm at night.) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in January 2022.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Patient had been deprived of an appropriate amount of energy/Unable to build strength back up) and FEELING COLD (With the cold setting in he is having trouble keeping warm at night.). The patient was treated with IBUPROFEN at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency. At the time of the report, ASTHENIA (Patient had been deprived of an appropriate amount of energy/Unable to build strength back up) and FEELING COLD (With the cold setting in he is having trouble keeping warm at night.) had not resolved.            No concomitant medications were reported.  It was reported that he has not been able to fully recovered since receiving the most recent booster of the Moderna COVID-19 vaccines. He has been deprived of an appropriate amount of energy. With the cold setting in he was having trouble keeping warm at night. He has been trying to build his strength back up, but has been unable. He discussed his symptoms with his health care professional who was unable to find anything to latch onto to make progress. He needed to heat up all his drinking water over the past month.   This case was linked to MOD-2022-680234 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Feeling cold
Clinical narrative: Patient had been deprived of an appropriate amount of energy/Unable to build strength back up; With the cold setting in he is having trouble keeping warm at night.; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Patient had been deprived of an appropriate amount of energy/Unable to build strength back up) and FEELING COLD (With the cold setting in he is having trouble keeping warm at night.) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in January 2022.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Patient had been deprived of an appropriate amount of energy/Unable to build strength back up) and FEELING COLD (With the cold setting in he is having trouble keeping warm at night.). The patient was treated with IBUPROFEN at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency. At the time of the report, ASTHENIA (Patient had been deprived of an appropriate amount of energy/Unable to build strength back up) and FEELING COLD (With the cold setting in he is having trouble keeping warm at night.) had not resolved.            No concomitant medications were reported.  It was reported that he has not been able to fully recovered since receiving the most recent booster of the Moderna COVID-19 vaccines. He has been deprived of an appropriate amount of energy. With the cold setting in he was having trouble keeping warm at night. He has been trying to build his strength back up, but has been unable. He discussed his symptoms with his health care professional who was unable to find anything to latch onto to make progress. He needed to heat up all his drinking water over the past month.   This case was linked to MOD-2022-680234 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane  and vaccine was not viable; No adverse event; Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2022 at 11:09 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 30-Sep-2022 at 11:09 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with moderna bivalent vaccine after a temperature excursion due to hurricane and vaccine was not viable).    Concomitant product use was not provided by the reporter.  Patient did not reported any adverse events.   Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient was vaccinated with this vaccine after the excursion; No adverse event; patient was vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Diabetes and Hypothyroidism.    On 03-Oct-2022 at 10:24 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 03-Oct-2022 at 10:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion).    Concomitant products were not reported.  It was reported that moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events.   Treatment medications were not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna bivalent vaccine was administered after a temperature excursion due to hurricane fiona and the vaccine was not visible.; No adverse event; Moderna bivalent vaccine was administered after a temperature excursion due to hurricane and the vaccine was not visible.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna bivalent vaccine was administered after a temperature excursion due to hurricane and the vaccine was not visible.), POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperature excursion due to hurricane and the vaccine was not visible.) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. A57162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Hypothyroidism and Hypertension.    On 03-Oct-2022 at 10:14 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 03-Oct-2022 at 10:14 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperature excursion due to hurricane and the vaccine was not visible.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna bivalent vaccine was administered after a temperature excursion due to hurricane and the vaccine was not visible.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna bivalent vaccine was administered after a temperature excursion due to hurricane and the vaccine was not visible.), POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperature excursion due to hurricane and the vaccine was not visible.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna bivalent vaccine was administered after a temperature excursion due to hurricane and the vaccine was not visible.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperature excursion due to hurricane and the vaccine was not visible.).    It was reported as unknown that the patient had ever been diagnosed with tested positive for COVID-19.  No concomitant medications were reported.  The Moderna Bivalent vaccine was administered after a temperature excursion due to hurricane and the vaccine was not viable and no adverse events were reported.  No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was vaccinated with this vaccine after the temperature excursion; No adverse event; patient was vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism.    On 03-Oct-2022 at 10:00 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 03-Oct-2022 at 10:00 AM, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the temperature excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the temperature excursion). Concomitant products were not reported. It was unknown if patient was ever diagnosed or tested positive with COVID-19. It was unknown if patient had any acute illness at the time of vaccination and up to one month before. It was reported that moderna bivalent vaccine was administered after a temperature excursion. Patient did not report any adverse events. Treatment medications were not reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was vaccinated with this vaccine after the excursion; No adverse event; Patient was vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Hypertension, Depression, Anxiety, Cholesterol high and Gout.    On 04-Oct-2022 at 9:40 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Oct-2022 at 9:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion).    Concomitant products were not reported.  It was unknown whether patient even been diagnosed or tested positive for COVID-19. It was reported that moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events.   Treatment medications were not reported.
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Fatigue, Induration, Lymph node pain, Lymphadenopathy
Clinical narrative: lymph node is hard and painful; swelling of lymph node; extreme fatigue; she has experienced chills; This spontaneous report was received from a pharmacist referring to herself, a 39 years old female patient. The patient had eye swelling and "tickle" in her throat to influenza vaccine inact split 3v (AFLURIA) in 2020 and influenza vaccine (FLUZONE) in 2021 (Flu vaccines). The patient's pertinent medical history included narcolepsy. Information about concomitant therapies was not provided.    On 07-NOV-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # W011264, expiration date not reported, upon internal validation established as 05-SEP-2024, 0.5 milliliter, intramuscular in the left deltoid) for protection from HPV (prophylaxis).    On 08-NOV-2022, the patient woke up with extreme fatigue and swelling of lymph node above left clavicle. At that time, the lymph node was soft and "squishy". The lymph node was now (as of 11-NOV-2022) hard and painful. The patient denied fever but had experienced chills. The patient did not seek medical attention. The patient asked if these symptoms were expected and how long she should expect them to last. The outcome of the events was reported as not recovered. The causality assessment was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: A nurse is reporting an AE on behalf of a patient. The caller states that a pediatric patient received PROQUAD intramuscularly instead of subcutaneously. No additional AE details were provided and no additional AE's were reported. No PQC.; A nurse is reporting an AE on behalf of a patient. The caller states that a pediatric patient received PROQUAD intramuscularly instead of subcutaneously. No additional AE details were provided and no additional AE's were reported. No PQC.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On 15-NOV-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant Human albumin (rHA)) 0.5 ml, lot # W017570, expiration date: 29-NOV-2023 (strength and anatomical location were not provided) administered intramuscularly instead or subcutaneously for prophylaxis (Incorrect route of product administration). There was no additional adverse event (AE) details provided and no additional AE reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE; Nurse reporting VAQTA was administered after expiration. No additional AE. No PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient medical history, concomitant medications, drug allergies or reactions was not provided.       On 23-NOV-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA), 0.5 milligram, lot # U031911 expiry date 11-NOV-2022, for prophylaxis (expired product administered) (dose number frequency and administration route was not provided) .
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Rheumatoid arthritis
Clinical narrative: arthritis started acting up real bad/worsening of arthritis/just reacted in her body/bad reaction with Enbrel and her covid-19 shot/started to have a reaction; took Enbrel at a dose 50 mg, every other week, which was off label use; This serious spontaneous report (USASP2022202388) was reported to company on 21/NOV/2022 by a consumer and involves a female patient whose arthritis started acting up real bad/worsening of arthritis/just reacted in her body/bad reaction with enbrel and her covid-19 shot/started to have a reaction [PT: rheumatoid arthritis] while receiving Enbrel, Single Dose Prefilled Syringe. Off label use was reported. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis, high blood pressure, diabetes. The patient's concomitant medications included Cimzia (certolizumab pegol).The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date in 2018. From an unknown date in 2018, the patient took Enbrel at a dose 50 mg, every other week, which was off label use. The patient took the COVID-19 (coronavirus disease of 2019) shot on 17/MAR/2021. When she took her Enbrel on 18/MAR/2021 and started to have a reaction. On an unknown date in MAR/2021, the patient had a bad reaction with Enbrel and her covid-19 shot. The patient took the covid-19 shot and Enbrel the same week and it just reacted in her body. The arthritis started acting up real bad/worsening of arthritis. The patient stopped Enbrel on an unknown date in MAR/2021. The patient reported that now she tried something new for her rheumatoid arthritis. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Syringe was withdrawn on an unknown date in MAR/2021 for the event rheumatoid arthritis. The consumer reported that the event rheumatoid arthritis was possibly related to Enbrel. The causal relationship between the event rheumatoid arthritis and Single Dose Prefilled Syringe was not provided by the consumer. The reporter did not and would never have access to lot number. No further information has been requested.  Comment: This safety report does not necessarily reflect a conclusion by company that etanercept, single dose prefilled syringe, caused or contributed to the adverse event(s) reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  Enbrel is under agreement with company.
Sex: U
Vaccine: COVID19, HEP
Symptoms: Adverse event, Chest pain, Dizziness, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Adverse Event NOS; Accelerated Heart Rate; Chest Pain; Lightheadedness; Initial Report Received on 14-Sep-2022   This report was received from Novavax concerning a patient reported that she, a 41-year-old female (race and ethnicity unknown) received an unknown dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 10-Aug 2022 and a dose 2 of a Novavax COVID-19 vaccine on 19-Aug-2022, and then experienced chest pain, dizziness, and increased heart rate.  Medical history, allergies, and concomitant medications were not reported.   On 16-Jul-2022, the patient received dose 1 of the Novavax COVID-19 vaccine, adjuvanted 10 µg/mL administered intramuscularly (Lot #, expiration date, NDC #, and injection site not reported).  On 19-Jul-2022, the patient had a positive COVID 19 SARS-CoV-2 test and COVID infection.  On 10-Aug-2022, the patient received an unknown dose of a hepatitis B dose of HEPLISAV-B (Lot # 935841; expiration date, NDC #, injection site, and route of administration not reported).   On 19-Aug-2022, 10 days after receiving the HEPLISAV-B injection, the patient received dose 2 of the Novavax COVID-19 vaccine, adjuvanted 10 µg/mL administered intramuscularly (Lot # 430IMF0l3; expiration date, NDC #, and injection site not reported). On the same date (19-Aug-2022), three hours after the Novavax COVID-19 vaccine, the patient experienced lightheadedness, increased heart rate to 100  120 beats per minute (bpm) (baseline heart rate was 80 bpm), and chest pain located in the center of the chest.   On 20-Aug-2022, 11 days after receiving the HEPLISAV-B vaccine and 2 days after receiving the Novavax COVID-19 vaccine, the patient went to the emergency room (ER) for continued symptoms, which lasted for several days. Details of the ER visit were not reported.  At the time of report on 15-Sep-2022, the dizziness was reported as recovered/resolved and the increased heart rate and chest pain were recovering/resolving.   No additional information was provided.  The causal relationship between Novavax COVID-19 vaccine and the reported events was assessed as possible by the manufacturer.  Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Second Dose Three Months After First; Initial Report Received on 15-Sep-2022  A registered pharmacist reported that a 40-year-old male patient (race and ethnicity unknown) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Jun 2022 and then received the second dose three months later.  Medical history was not reported and concomitant medication at the time of vaccination included omeprazole. Allergies was reported as unknown.   On 08-Jun-2022, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, injection site, and route of administration not reported).   On 15-Sep-2022, 100 days after receiving the first dose HELPLISAV-B injection, the patient received the second dose of HEPLISAV-B (Lot # 937234, expiration date 12-Sep-2023, NDC # 43528-003-05) intramuscularly in the right deltoid. The patient did not experience any adverse reactions.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: :  The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose of Heplisav-B; Initial Report Received on 22-SEP-2022  This is a spontaneous report received from a pharmacist regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 22-Sep-2022, dose 2 of HEPLISAV B (Lot #935840, expiration date 11-Sep-2022, NDC # 43528-0003-05), intramuscular in the left deltoid, was administered for hepatitis B immunisation.   The dose administered was  reportedly 11 days past the expiration date. The patient has not reported any adverse reactions.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Heplisav-B stored at -8°C for 38 hours.; Initial Report Received on 26-Sep-2022  This is a spontaneous report, received from a pharmacist regarding a female patient, aged 54 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 20-Sep-2022, dose 1 of HEPLISAV B (Lot #39TZ2, expiration date 07-SEP-2023, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation.   The vaccine administered was reported as being stored at -8° C for 38 hours.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Heplisav-B stored at -8°C for 38 hours; Initial Report Received on 26-Sep-2022  This is a spontaneous report, received from a pharmacist regarding a female patient, aged 40 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 19-Sep-2022, dose 1 of HEPLISAV B (Lot #935845, expiration date 06-Nov-2022, NDC #43528-0003-05), route and site not specified, was administered for hepatitis B immunisation.   The vaccine administered was reported as being stored at -8° C for 38 hours.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pruritus, Rash papular, Vaccination failure
Clinical narrative: received both vaccines, I have shingles/ Suspected vaccination failure; shingles on left outer thigh; raised red area; patch of blisters.; itchy blisters; This case was reported by a consumer and described the occurrence of vaccination failure in a 67-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had bouts of shingles since age of 30 and she had one or two episodes a year, always had been on an extremity, on a forearm or an outer thigh).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, generalized raised red spots limbs, blister and pruritus. On an unknown date, the outcome of the vaccination failure, generalized raised red spots limbs, blister and pruritus were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, generalized raised red spots limbs, blister and pruritus to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 24-Nov-2022 Reporter's comment: The patient was 67 years old. The patient received both shingles vaccines in the last year to supposedly prevent mire shingles outbreaks. The patient currently had shingles on her left outer thigh.  The same severity.  A raised red area with a patch of itchy blisters. The patient stated that the vaccine did not work at all. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only given liquid vial; Only given liquid vial; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The student health nurse shared that they had a medication error with the 2-vial presentation of Menveo. The reporter was only given liquid vial and the reporter asked to return to be revaccinated.  This lead to them switching to MenQuadfi since Menactra was no longer available. The reporter did not consent to follow-up. Additional supportive information: The patient only received liquid vial of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I did not receive the recommended 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1 injection of zoster shingles vaccine on 20th May 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, 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: 21-Nov-2022 Reporter's comment: The patient asked that he/she what do now or start fresh and get the first shot followed up by the second or do just get the second shot later on the day of reporting. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: redness at the injection; swelling at the injection; myalgias; fatigue,; headache,; nausea; diarrhea; This case was reported by a physician and described the occurrence of injection site erythema in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 18th November 2022, the patient received the 2nd dose of Shingrix. On 19th November 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, myalgia, fatigue, headache, nausea and diarrhea. On an unknown date, the outcome of the injection site erythema, injection site swelling, myalgia, fatigue, headache, nausea and diarrhea were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, myalgia, fatigue, headache, nausea and diarrhea to be related to Shingrix.     Additional Information: GSK receipt date: 21-NOV-2022 Reporters comment: The physician reported that patient (reporters husband) received the second dose of shingrix vaccine and experienced myaligias, headache, fever, nausea and injection site redness and swelling The reporter consent to follow-up. Additional Supportive information: This case has been linked to the cases US2022AMR173968 reported by the same reporter. The reporter agrees to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2022AMR173968:same reporter - reporter´s case
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: redness at the injection; swelling at the injection; myalgias; fatigue,; headache,; nausea; diarrhea; This case was reported by a physician and described the occurrence of injection site erythema in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 18th November 2022, the patient received the 2nd dose of Shingrix. On 19th November 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, myalgia, fatigue, headache, nausea and diarrhea. On an unknown date, the outcome of the injection site erythema, injection site swelling, myalgia, fatigue, headache, nausea and diarrhea were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, myalgia, fatigue, headache, nausea and diarrhea to be related to Shingrix.     Additional Information: GSK receipt date: 21-NOV-2022 Reporters comment: The physician reported that patient (reporters husband) received the second dose of shingrix vaccine and experienced myaligias, headache, fever, nausea and injection site redness and swelling The reporter consent to follow-up. Additional Supportive information: This case has been linked to the cases US2022AMR173968 reported by the same reporter. The reporter agrees to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2022AMR173968:same reporter - reporter´s case
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Fatigue, Pain, Tremor
Clinical narrative: shaking; chills; severe body aches; fatigue,; abdominal pain; This case was reported by a physician and described the occurrence of tremor in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received Shingrix. On 19th November 2022, less than a day after receiving Shingrix, the patient experienced tremor, chills, general body pain, fatigue and abdominal pain. On an unknown date, the outcome of the tremor, chills, general body pain, fatigue and abdominal pain were unknown.   It was unknown if the reporter considered the tremor, chills, general body pain, fatigue and abdominal pain to be related to Shingrix.     Additional Information: GSK receipt date: 21-NOV-2022 Reporters comment: The reporter stated on 19th Nov 2022 the patient had shaking chills, severe body aches, fatigue, abdominal pain occurred within 24 hours of injection. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive information: This case has been linked to the cases US2022AMR173954 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR173954:same reporter - husband case
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patients get injection site pain; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 22nd November 2022, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's comment: HCP (Health Care Professional) mentioned in general he had seen patients get injection site pain. The reporter did not consent to follow-up.