chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got a bad case of the Flu; Initial information received on 10-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported still got a bad case of the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (batch lot number, strength, form, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event of still got a bad case of the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event still got a bad case of the flu.
Sex: U
Vaccine: FLUX
Symptoms: Condition aggravated, Cough
Clinical narrative: coughing a lot now it's worst; Initial information received on 10-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult patient of an unknown gender who was coughing a lot then it's worst after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any  concomitant disease or risk factor.    On an unknown date in Dec-2022, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, with an unknown formulation and strength, ( lot number and expiry date: not reported)  via unknown route in unknown administration site for flu(influenza). Information regarding batch number has been requested.  On an unknown date in Dec-2022,  the patient was coughing a lot then it was worst (cough) (latency: unknown) following the administration of INFLUENZA VACCINE.. It is unknown if there were lab data/results available  Action taken:  not applicable.  Corrective treatment: not reported  Outcome: unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 11-Dec-2022 regarding an unsolicited valid Social media non-serious case from a consumer/non-health care professional.  This case involves an unknown age and unknown gender patient who got the flu after receiving vaccine Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, dose, lot number, expiry date: not reported) via unknown route in unknown administration site for flu vaccination (Influenza immunization).  On an unknown date the patient got the flu (influenza) (latency: unknown) following the administration of influenza vaccine.  It was reported "as took the flu shot in October and I still got the flu been a week and it been horrible think I might be getting over it".  It is unknown if there were lab data/results available.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event.  The outcome was Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm is a little sore; Initial information received on 09-Dec-2022 regarding an unsolicited valid Social media non-serious case from a consumer/non-health care professional.  This case involves Adult and unknown gender patient whose arm is a little sore after receiving vaccine Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, frequency, formulation, dose, lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date the patient's arm is a little sore (pain in extremity) (unknown latency) following the administration of influenza vaccine.  It was reported "as Just got his Wednesday. his arm was a little sore and that's it. He had a business to run and can't afford to get sick".  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.   The outcome was Unknown.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 08-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult female patient who experienced flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any concomitant disease or risk factor. It is unknown if there were lab data/results available   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer , with an unknown formulation and strength (lot number and expiry date: not reported)  via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.. It is unknown if there were lab data/results available  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.; Sender's Comments:  Husband case (SanofiPVPortal20221212000256):
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu everytime she got the shot; Initial information received on 09-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who got the flu everytime she got the shot after receiving vaccine influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, batch number, expiry date: unknown via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had a non-serious got the flu everytime she got the shot (influenza) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment  At time of reporting, the outcome was Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 10-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: got my flu shot, and still got the flu; Initial information received on 10-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got my flu shot, and still got the flu while receiving vaccine influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown)  via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had a non-serious got my flu shot, and still got the flu (vaccination failure) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: woman received MENQUADFI while pregnant with no adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 16-year-old female patient who was exposed to vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] in context of woman received menquadfi while pregnant with no adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was exposed to MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE at 26 weeks of pregnancy, during third pregnancy trimester for MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  The date of last menstrual period was reported as 22-Mar-2022. The estimated due date is 10-Jan-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had previous pregnancies.  On 19-Sep-2022, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation: unknown) Strength: standard at dose of 0.5ml total (lot number: U7447AC and expiry date: 20-Sep-2024) via intramuscular route in the left deltoid for Immunization and woman received menquadfi while pregnant with no adverse event (exposure during pregnancy) (latency: same day).  It was reported, she would like to know if she should be put on the registry? The patient was transferred to them for prenatal care. She received the vaccine at another clinic location.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown. Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 48.0
Sex: F
Vaccine: COVID19-2, FLU4, PNC15
Symptoms: Fatigue, Injection site bruising, Malaise, Nodule, Pyrexia
Clinical narrative: Fatigue, fever, malaise  Red hot raised firm painful lump in each arm. On left at influenza site size is approximately 2.5 inch x 2.5 inch x 0.5 inch. On right arm 1.5 inch x 1.5 inch x 0.25 inch with a bruise at infection site of 0.5 inch x 0.5 inch. Both sites are tender to light touch and the pain interrupts sleep.  Actual brands of influenza and pneumonia vaccines are guesses. I do not have that information.
Age: 48.0
Sex: F
Vaccine: COVID19-2, FLU4, PNC15
Symptoms: Skin reaction, Skin warm, Sleep disorder, Swelling, Tenderness
Clinical narrative: Fatigue, fever, malaise  Red hot raised firm painful lump in each arm. On left at influenza site size is approximately 2.5 inch x 2.5 inch x 0.5 inch. On right arm 1.5 inch x 1.5 inch x 0.25 inch with a bruise at infection site of 0.5 inch x 0.5 inch. Both sites are tender to light touch and the pain interrupts sleep.  Actual brands of influenza and pneumonia vaccines are guesses. I do not have that information.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash on leg, body, arm; Body itchy; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced generalized rash and pruritus. On an unknown date, the outcome of the generalized rash and pruritus were unknown.   It was unknown if the reporter considered the generalized rash and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-DEC-2022. Reporter's Comment: The reporter stated that the patient got his first Shingrix shot in his right arm.  The patient was due for his second Shingrix dose in a few weeks.  The patient said about 3 weeks to a month after getting the first Shingrix shot, he had a rash break out on his leg, body and arm.  The patient also said some parts of his body were itchy. The reporter declined consent for healthcare professional follow-up. The reporter did not give consent to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administred; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA602A, expiry date 31st August 2022) for prophylaxis.   On 21st November 2022, the patient received Menveo. On 21st November 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 05-DEC-2022 Reporter's comment: The reporter stated that the expired dose of Menveo was administered to a patient on 21st November 2022. Additional Supportive Information: The expired dose of Menveo was administered to a patient which leads to expired vaccine used.  The reporter gave consent to follow up vis postal.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced side effects, and ended up in [name redacted] at hospital for 2 days. Horrible. Discharge information was not reported. As per the patient, "[Name redacted] I had side effects ended up in [name redacted] at hospital for 2 days... horrible.. ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221222838-side effects. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: extremely sick; Initial information received on 11-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Social Media.  This case involves a patient of unknown age and gender who got extremely sick after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 1985, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, route, frequency, formulation, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. It gets people extremely sick many times including me , never again since 1985.   On an unknown date in 1985. the patient got extremely sick (illness) (unknown latency) following the administration of influenza vaccine.  Reportedly, Haven't had a flu shot since 1985 when it got me extremely sick. Really Haven't been sick since. It gets people extremely sick many times including me , never again since 1985.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event, Product preparation error
Clinical narrative: Medical assistant administered ACTHIB to 15-month-old patient and the diluent was expired with no reported adverse event; Medical assistant administered ACTHIB to 15-month-old patient and the diluent was expired with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient and it was reported medical assistant administered acthib to 15-month-old patient and the diluent was expired with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for immunisation; influenza vaccine inact split 4V (Fluzone quadrivalent) for immunisation; and diphtheria vaccine toxoid, HIB vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3V (MRC 5), tetanus vaccine toxoid (Pentacel) for immunisation.  On 09-Dec-2022, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (lot number- U7178AA and expiry date- 30-Nov-2022; strength, formulation: unknown) via unknown route in unknown administration site for immunization.   On an unknown date, it was reported that medical assistant administered ACTHIB to 15-month-old patient and the diluent was expired with no reported adverse event (expired medical agent used) (vaccine preparation error) (latency: unknown) following the administration of HIB (PRP/T) vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old patient who received DTPa-HBV-IPV (Pediarix) (batch number AZ472, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 2nd December 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 5-DEC-2022. Reporter's Comment: The reporter stated that a dose of Pediarix that had expired on 28th November 2022 had been administered to a patient. The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow up. Additional Supportive Information: The patient received a dose of Pediarix that had already expired, which lead to expire vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Death, Expanded disability status scale
Clinical narrative: DEATH; COVID-19 INFECTION; This spontaneous report was received from literature. This report concerned a 62 year old of unspecified sex, race and ethnic origin. The objective of this study was to report the demographics of patient who developed SAR-CoV-2 (severe acute respiratory syndrome coronavirus 2) after being vaccinated.  The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis (MS). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included ocrelizumab for multiple sclerosis.  In this report, (ocrelizumab) patients vaccinated, 31 patients developed a documented COVID-19 infection with a mean age of 46.8 (12.7) and a median disease duration of 11.3 [4.0. 19.6] years. 17% had PMS (Progressive multiple sclerosis). Median time on OCR was 42.8 [20.1, 50.4] months. 60% had been on OCR for 3 years or more. Median time from first vaccine to positive COVID-19 test was 7.3 [4.8, 8.9] months. Median time from last dose of OCR to positive COVID-19 test was 4.5 [3.2, 5.7] months. COVID-19 negative patients were older with a mean age of 52.3 (12.3), p=0.03. There were no other significant differences based on median disease duration, MS pattern, and median time on OCR. Median EDSS for patients who developed COVID-19 (19 patients) was 2 [2.0, 6.5].  On an unspecified date, the patient experienced covid-19 infection who had received ocrelizumab for 3.6 years. Laboratory data (dates unspecified) included: Expanded disability status scale (EDDS) 8.0. The patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. The authors concluded that, the patients hospitalized for a COVID-19 infection were older, and the patient who died had an EDSS of 8.0. This data was alignment with previous reports that older and more disabled patients were at risk for more severe disease. This report was serious (Death).; Sender's Comments: V0: 20221216464-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: ALMOST DIED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient had been previously vaccinated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total was administered for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse event following vaccination with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 01 total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was hospitalized (date unspecified) and was in the hospital for 3 weeks on a respirator and almost died (Dose number in series 2). Number of days hospitalized was 21 days and discharge information was not reported. As per the consumer, "another friend was fully vaccinated and boosted and spent 3 weeks in the hospital on a respirator and almost died". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost died was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from the same reporter is linked to 20221222696, 20221222719, 20221222695 and 20221222669.; Sender's Comments: V0: 20221222717-almost died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: On December 5th,tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (On December 5th,tested positive for Covid) 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.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    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 and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, received dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form, dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2022, the patient experienced COVID-19 (On December 5th,tested positive for Covid). At the time of the report, COVID-19 (On December 5th,tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2022, SARS-CoV-2 test: Positive.         No concomitant medication information was provided. It was reported that patient had four Pfizer Covid vaccines, and one Moderna covid booster. No treatment medications were provided
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: On December 5th,tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (On December 5th,tested positive for Covid) 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.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    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 and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, received dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form, dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2022, the patient experienced COVID-19 (On December 5th,tested positive for Covid). At the time of the report, COVID-19 (On December 5th,tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2022, SARS-CoV-2 test: Positive.         No concomitant medication information was provided. It was reported that patient had four Pfizer Covid vaccines, and one Moderna covid booster. No treatment medications were provided
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got my shot and had a very bad case of the flu for almost a month; Initial information received on 09-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp (non healthcare provider)  This case involves an unknown age and unknown gender patient who got influenza vaccine and had a very bad case of the flu for almost a month.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunisation).  On an unknown date the patient got shot and had a very bad case of the flu for almost a month (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 11-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu , after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In September 2022, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, with an unknown formulation and strength, ( lot number  and expiry date: not reported)  via unknown route in unknown administration site for flu (influenza) . Information regarding batch number has been requested  On 24-NOV-2022  at night, the patient developed a non-serious  event of flu (influenza) (latency: 2 months approximately) following the administration of INFLUENZA VACCINE. The patient was still dealing with the symptoms  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event flu.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Expired vaccine was administered in error with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 18 months old male patient who was administered expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel] in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza Vaccine (Influenza Vaccine) for Immunisation; Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) for Immunisation; and Hepatitis A Vaccine (Hepatitis A) for Immunisation.  On 09-Dec-2022, the patient received 0.25 ml total standard dose of expired suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) vaccine Suspension for injection in error with no reported adverse event (expired product administered) latency: same day (with an unknown batch number and dose number) (Expiry date: 12-May-2022) via intramuscular route in the left thigh for immunization.  Action taken: not applicable.  Outcome: Unknown   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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptomatic side effects reported. No additional AE details or PQC.; Inbound call from HCP reporting a patient was inadvertently administered an expired dose of MMR-II.; Subcutaneous injection formulation administered by other route; This spontaneous report was received from a medical assistant, referring to a 12-month-old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant medications included sterile diluent (manufacturer unknown) (lot # T033839), hepatitis a vaccine (+) inactivated (VAQTA) (lot # W002894), varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U022320) and influenza vaccine (FLU [INFLUENZA VACCINE]) (lot # 57R2C).   On 21-NOV-2022, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #T037030, expiration date: 03-NOV-2022) intramuscularly at right lateral thigh for prophylaxis (strength was not provided) (expired product administered; incorrect route of product administration). Physician addressed with parents. The vaccine was not available to return, as it was single use. It was also reported that the vaccine was discarded. The vaccine was used according to the instruction. The operator was trained. No symptomatic side effects were reported. No additional adverse event (AE) details or product quality complaint (PQC) (no adverse event). The outcome of event expired product administered was recovered.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The shots were two years apart; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose in July 2020).   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 05 DEC 2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient reported that the patient received 1st dose in July 2020, then went on a different insurance plan and they would not pay for the second shot. The patient went on this year and got the second shot.  But the pharmacist said the shots were too far apart and the patient had to have both shots again. The patient went for the second shot on the day of reporting and a different pharmacist said  he/she didn'tneed the second shot since he/she had two even though they were two years apart. The patient asked who was right. The patient had not any side effects. Additional supportive information: As patient received 2nd dose 2 years after 1st dose which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2021, 2nd dose in 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th Dec 2021.).   On 29th September 2022, the patient received the 2nd dose of Shingrix. On 29th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 05-DEC-2022 Reporters comment: The pharmacist reported that the patient did not get second dose until 29th September 2022. At that time of call, reporter did not have the lot number/ expiration date information of the two doses The reporter consented to follow-up. Additional Supportive information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: Idiopathic pulmonary fibrosis
Clinical narrative: PULMONARY FIBROSIS (IPF); This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 4 weeks after the vaccination, the patient experienced pulmonary fibrosis (IPF). It was reported that, "I had the J and J and 4 weeks later diagnosed with Pulmonary Fibrosis (IPF). It's been down hill since then I will not get another vaccine".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary fibrosis (IPF). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221229098-pulmonary fibrosis (IPF). The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Increased tendency to bruise, Injection site pain, Off label use, Weight increased
Clinical narrative: IF HE LEAN AGAINST THE WALL HE BRUISE THERE (EASY BRUISING); PUT ON A LITTLE BIT OF WEIGHT; PAINFUL AT THE INJECTION; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a 63 year old white male of an unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: failed back surgery, and little sinusitis (but that could be from dust), and concurrent conditions included: chronic pain, colitis (for 15 years), and alcohol user (only when on vacation), and other pre-existing medical conditions included: The patient had no known allergies. The patient had been off to work and retired from 14 to 15 months and he used to walk a lot. The patient had never had covid. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, frequency 1 total, dose 1 administered on 5-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 62 years old.  It was unknown whether patient had any adverse event following covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, frequency 1 total, dose 2 administered on 18-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 62 years old.  It was unknown whether patient had any adverse event following covid-19 vaccine ad26.cov2.s (dose number in series 2).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, frequency 1 total, dose 3 administered to left arm on 03-JUN-2022 for covid-19 prophylaxis which was an off label dosing frequency (Off label use) (dose number in series 3). Age at time of vaccination 63 years old. Concomitant medications included cefradine (Vicodin) and fentanyl for pain management. On an unspecified date, the patient experienced only side effect following vaccination was if he lean against the wall, he bruise there (easy bruising) and he was confident and happy with the vaccine. The patient used naproxen drug as treatment medication for bruising. He stopped taking drug and currently not bruising (dose number in series 2). The patient had put on a little bit of weight, and experienced painful at the injection site (dose number in series 2). The patient recovered from if he lean against the wall he bruise there (easy bruising), and the outcome of put on a little bit of weight, painful at the injection and off label dosing frequency was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion; No Adverse event; Patient received these vaccines post excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (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)) (Unknown), 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 received these vaccines post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported.  The nurse reported that, there was temperature excursion on 01-Nov-2022 in the refrigerator. At the time of excursion, the vials were in refrigerated storage. It was individual vials and vial size was unknown. The maximum or minimum temperatures reached at time of excursion was minimum 34.8 F (Fahrenheit) and maximum at 42.49 F  for 14 Minutes duration. The vials were moved from freezer to refrigerator in less than 30 days. On visual inspection vials were in normal state.  The patient received the vaccine post excursion and remaining vials were discarded.   No treatment medications were reported.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Spikevax) (batch no. AS1417B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.   On 08-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Dec-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .25 milliliter. On 12-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medications were not reported.  The patient was administered a dose more than 12 hours after the initial vial puncture. It was punctured on 7DEC2022 and administered on 12DEC2022. Treatment medications were not reported.