chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Rash macular, Skin disorder
Clinical narrative: large red spot with spots of degrading skin on the left deltoid; large red spot with spots of degrading skin on the left deltoid; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious), SKIN DISORDER (non-serious) all with onset 16Nov2022, outcome "unknown" and all described as "large red spot with spots of degrading skin on the left deltoid".  Additional information: On 16Nov2022, the patient had large red spot with spots of degrading skin on the left deltoid. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: Didn't feel well; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  A 69-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 19Aug2020 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU VACCINE VII), on 18Aug2020 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 18Aug2020 as dose number unknown, single (Batch/Lot number: unknown) for varicella immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Didn't feel well".  Additional information: The patient was given PCV13 on 19Aug2020; Given high dose quad flu & shingles on 18Aug2020. Didn't feel well.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: burning sensation on my upper back; prickly feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jul2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious) with onset 2021, outcome "unknown", described as "burning sensation on my upper back"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "prickly feeling".  Additional information: Since the patient received the Covid-19 vaccine (two doses) back in Jul2021, felt a burning sensation on upper back (all the way across from shoulder to shoulder) with a prickly feeling. The skin does not feel hot to the touch. This happened numerous times each day. It lasts for around 20 seconds.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200116511 same reporter, suspect product and AE/different dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested COVID positive; tested COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004281.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 12Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Nov2022, outcome "unknown" and all described as "tested COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2022) Positive, notes: It was reported that the patient tested, COVID positive on the morning of 18Nov2022.  Clinical course: On 18Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine dose 1, dose 2, and was administered dose 3 on 12Feb2022 for COVID-19 immunisation. It was reported that the patient tested COVID positive on the morning of 18Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 2 weeks prior to taking COVID booster that he tested positive for COVID; 2 weeks prior to taking COVID booster that he tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 10Aug2021 as dose 1, single (Lot number: FA6780) and on 31Aug2021 as dose 2, single (Lot number: FC3183) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: Other medicines unknown blood pressure medication: Has been taking a few years, low dose; "Psoriasis" (unspecified if ongoing), notes: Other medicines unknown medication for Psoriasis: taking a few years,only takes a half a dose. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "2 weeks prior to taking COVID booster that he tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: It was like 2 weeks prior to taking Covid booster that he tested positive for Covid.  Clinical course: Prior Vaccinations (within 4 weeks): No but, had Covid right before that. He told them he just had Covid and asked if he should be taking the booster. Went to the ER and they told him he should have waited 3 months. It was like 2 weeks prior to taking Covid booster that he tested positive for Covid. Was released to come back to work. Clarified that he went to the ER and they explained that he should not have taken the booster and should have waited 3 months.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I caught COVID; I caught COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "I caught COVID". The patient was hospitalized for drug ineffective, suspected covid-19 (hospitalization duration: 90 day(s)). Clinical course: During the phone call received regarding reenrollment in PAP for Celontin, the patient stated, "I caught Covid and misplaced all of my paperwork here. I was in the hospital for 3 months. It was a bad one and I had all of my shots from Pfizer. I am due for the next booster."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: really sore injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "really sore injection site". Additional information: When patient had his initial Pfizer vaccine, he ended up having really sore injection site, but what made it worse was that immediately after the injection, he went to work and literally loaded up 55 tons of raw gemstone (as reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel was given to infant with no reported adverse event; Initial information received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Infant patient of unknown genger who was administered Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine Suspension for injection (strength, dose, frequency, lot number and expiry date: not reported) via intramuscular route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient was with was administered Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] no reported adverse event (product administered to patient of inappropriate age) (latency: Same day).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (Quadracel was given to infant with no reported adverse event).  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.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: been sick twice; Initial information received on 01-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown age and unknown gender patient and been sick twice after receiving 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 a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for influenza.  On an unknown date the patient developed a non-serious event of been sick twice (illness) (unknown latency) following the administration of influenza vaccine.  Reportedly, Got mine, Been sick twice, I'll never get another one.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (been sick twice).  At time of reporting, the outcome was Unknown for the event been sick twice.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 03-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves patient of unknown demographics who was sick while receiving vaccine Influenza vaccine..  The patient's past  medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient was sick (illness) (unknown latency) following the administration of Influenza vaccine.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Had to go to hospital for a couple days and she got the flu; Initial information received on 02-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had to go to hospital for a couple days and she got the flu 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, route, batch number, expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with serious event of had to go to hospital for a couple days and she got the flu (influenza) (unknown latency) following the administration of influenza vaccine.   No lab data was reported.  It was reported This case is received from Social Media. Be careful out there. My friend had the flu shot over a month ago. Had to go to hospital for a couple days and she GOT THE FLU. You still need the vaccine!  Action taken was not applicable.  It was not reported if the patient received a corrective treatment   At time of reporting, the outcome was Unknown   The patient was hospitalized for this event.; Sender's Comments: Sanofi Company Comment dated 07-Dec-2022: This case involves an unknown age female patient who had to go to hospital for a couple days and she got the flu after receiving vaccine influenza vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, therapy details, any family history and any relevant medical history of patient, any concurrent conditions precludes comprehensive case assessment.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Yes I did ,still got type A flu; Initial information was received on 01-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and gender patient who reported yes i did, still got type a flu after receiving 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 an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of event yes i did, still got type a flu (influenza) (unknown latency) following the administration of influenza 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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: received the flu shot, still came down with the flu. ugh; Initial information was received on 03-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient with unknown demographics who received the Influenza vaccine flu shot, still came down with the flu.  The patient's past medical history, 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) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination and still came down with the flu (influenza) (unknown latency).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm a little bit sore but not bad; Initial information received on 03-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from  Patient.  This case involves an unknown age and unknown gender patient who had arm a little bit sore but not bad after receiving 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 a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient developed a non-serious event of arm a little bit sore but not bad (pain in extremity) (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 (Arm a little bit sore but not bad).  At time of reporting, the outcome was Unknown for the event arm a little bit sore but not bad.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got the shot and the worse flu ever and 2 weeks later the worse flu; Initial information received on 04-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 the shot and the worse flu ever and 2 weeks later the worse flu 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 a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for prophylactic vaccination (Immunisation)  On an unknown date the patient  got the shot and the worse flu ever and 2 weeks later the worse flu (influenza) (latency : 2 weeks ) 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 for the event
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Influenza
Clinical narrative: Got mine last month now I have the flu; I feel terrible for a week now; Initial information was received on 01-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient with unknown demographics who got Influenza vaccine last month now have the flu and feel terrible for a week.  The patient's past medical history, 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) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination last month now have the flu (influenza) and feel terrible for a week now (feeling abnormal) (unknown latency). Must have been a weaker flu shot.  Action taken: Not applicable.  Corrective treatment: Not reported for both the events.  Outcome: Unknown for both the events.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got a variant of the flu; Initial information received on 03-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 still got a variant of 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 a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for prophylactic vaccination (Immunisation)  On an unknown date the patient  still got a variant of the flu(influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Reportedly "My daughter got hers but still got a variant of the flu"  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
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: influenza; Initial information received on 03-Dec-2022 regarding an unsolicited valid Social Media serious case via consumer/non-hcp.  This case involves Adult and unknown gender patient who had influenza 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 (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for influenza.  On an unknown date the patient had an event of 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.  Outcome: Unknown.  Seriousness Criteria: the event caused hospitalization.; Sender's Comments: Sanofi company comment dated 07-Dec-2022: This case involves Adult and unknown gender patient who had influenza after receiving influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, hospitalization details, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 02-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 had flu , after receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) 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 in Nov-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 prophylactic vaccination.  On an unknown date the patient developed a non-serious event of  flu (influenza) (latency: unknown) 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.
Sex: U
Vaccine: FLUX
Symptoms: Cough
Clinical narrative: coughing; Initial information received on 02-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 coughing , after receiving vaccine INFLUENZA VACCINE.  The patient's past  medical treatment(s), vaccination(s) 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 in Oct-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 prophylactic vaccination.  On an unknown date in 01- Nov-2022, the patient developed a non-serious  event of coughing (cough) (unknown latency) following the administration of INFLUENZA VACCINE. At the time of repot, the patient still had cough.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (coughing).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event coughing.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Did'nt work got it two weeks later, with no reported adverse events; Initial information received on 02-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer.  This case involves an unknown age and unknown gender patient for whom influenza vaccine didn't work got it two weeks later, with no reported adverse event.  The patient's past medical history, 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 (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic immunization.  On an unknown date, the patient got influenza vaccine which didn't work got it two weeks later, with no reported adverse events (vaccination failure) (unknown latency) following the administration of influenza vaccine.   It was reported, Did't work got it two weeks later.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: The event of vaccination failure was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 07-Dec-2022: This case involves an unknown age and unknown gender patient for whom influenza vaccine didn't work got it two weeks later, with no reported adverse event. Furthermore, information regarding condition at the time of vaccination, previous vaccination history, medical history of the patient, lab data excluding other predisposing etiologies, intervention (if any) and corrective treatment/medical management would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial expired on 25-Nov-2022 and taken out from freezer on 02-Dec-2022; No adverse event; expired dose administered to 1 patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to 1 patient), PRODUCT STORAGE ERROR (Vial expired on 25-Nov-2022 and taken out from freezer on 02-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Dec-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to 1 patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 25-Nov-2022 and taken out from freezer on 02-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to 1 patient), PRODUCT STORAGE ERROR (Vial expired on 25-Nov-2022 and taken out from freezer on 02-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired dose administered to 1 patient) and PRODUCT STORAGE ERROR (Vial expired on 25-Nov-2022 and taken out from freezer on 02-Dec-2022).    No concomitant medications were provided by the reporter.  Pharmacist administered a pediatric vaccine for a pediatric patient on 03-Dec-2022 and realized later that expiration date on vial was 25-Nov-2022. It was taken out of the freezer on 02-Dec-2022.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Dec-2022: Live significant follow up received contains patient information and secondary reporter updated.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; patient received a half dose of the Moderna Covid-19 bivalent booster dose vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received a half dose of the Moderna Covid-19 bivalent booster dose vaccine) and NO ADVERSE EVENT (No Adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Dec-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received a half dose of the Moderna Covid-19 bivalent booster dose vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received a half dose of the Moderna Covid-19 bivalent booster dose vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient received a half dose of the Moderna Covid-19 bivalent booster dose vaccine).    No concomitant medications were reported.   Patient received additional booster.  No treatment medication was provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administred an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administred an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 02-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administred an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administred an expired vaccine) 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 (administred an expired vaccine).    It was reported that DOB, Weight and height of the patient were unknown. It was unknown if patient was on any Concomitant medications.  It was unknown if patient had any allergies or ever had COVID positive test or diagnosis. It was unknown if patient had history relating to mentioned AE both Acute and Chronic illnesses at the time of vaccination. It was unknown if patient received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Patient received Monovalent vaccine of individual vial with vial size of 5.5 mL. The vial was initially stored in the refrigerator on 28-Nov-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Diagnosed with cancer; This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (Diagnosed with cancer) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 prophylaxis.     Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM/HCTZ), PRAVASTATIN SODIUM (PRAVACHOL), ESCITALOPRAM and MOLNUPIRAVIR for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NEOPLASM MALIGNANT (Diagnosed with cancer) (seriousness criterion medically significant). The patient was treated with ANASTROZOLE for Cancer, at a dose of 1 milligram. At the time of the report, NEOPLASM MALIGNANT (Diagnosed with cancer) outcome was unknown.            Patient received the original series and a booster for Moderna. Patient was on cancer medications from the last two dose.  Company Comment: This spontaneous case concerns a 64-year old female patient, with no medical history reported, who experienced a serious (medically Significant) unexpected event of neoplasm malignant unspecified days after receiving a dose of mRNA-1273 vaccine. Patient received 2 doses of mRNA-1273 before was diagnosed with Neoplasm. There was no information provided about  underlying medical conditions, indications of concomitant medications, type and site of cancer, stage, clinical course of the event, associated symptoms, final diagnosis, and diagnostic details. Patient received Anastrozole as treatment for cancer. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   This case was linked to MOD-2022-682623 (Patient Link).; Sender's Comments: This spontaneous case concerns a 64-year old female patient, with no medical history reported, who experienced a serious (medically Significant) unexpected event of neoplasm malignant unspecified days after receiving a dose of mRNA-1273 vaccine. Patient received 2 doses of mRNA-1273 before was diagnosed with Neoplasm. There was no information provided about  underlying medical conditions, indication of concomitant medications, type and site of cancer, stage, clinical course of the event, associated symptoms, final diagnosis, and diagnostic details. Patient received Anastrozole as treatment for cancer. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: influenza vaccine/got /still got sick; Initial information was received on 03-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a non-health-care professional.  This case involves an unknown age and unknown gender patient who got vaccinated with  influenza vaccine/got /still got sick after receiving 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 a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Influenza immunisation  On an unknown date the patient developed a non-serious event of influenza vaccine/got /still got sick (illness) (unknown latency) following the administration of influenza vaccine.  No lab data were reported.  Action taken: applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient with unknown demographics who still got the flu after being vaccinated with 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 a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for influenza immunization.  On an unknown date, the patient still got the flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got flu shot still got the flu; Initial information received on 04-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 flu shot (influenza vaccine)  and still got the flu.   The patient's past  medical treatment(s), vaccination(s) 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 a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer,  (lot number  and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, the patient got flu shot still got the 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 (got flu shot still got the flu).  At time of reporting, the outcome was Unknown for the event got flu shot still got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got really sick; Initial information was received on 02-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who got really sick after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 2021, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of got really sick (illness) (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 (got really sick).  At time of reporting, the outcome was Unknown for the event got really sick.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 doses of the product FLUZONE QIV NP in a span of 5 weeks with no adverse event; Initial information was received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 years old male patient who stated received 2 doses of the product fluzone qiv np in a span of 5 weeks with no adverse event after receiving influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UT7701LA, expiry date: 30-Jun-2023, strength: standard frequency: total) via intramuscular route in right deltoid for Immunization.  On 29-Nov-2022 the patient developed a non-serious event of event patient received 2 doses of the product fluzone qiv np in a span of 5 weeks with no adverse event (extra dose administered) (Latency: same day) following the administration of influenza quadrival A-B 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 02-Dec-2022 from other health professional: Classification, Therapy start date, frequency, Dose, Location, Route, New event (extra dose administered) were updated. Text amended accordingly.
Age: 0.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 8 months old was given quadracel with no reported ae; Initial information received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 8 months old female patient who was given Quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE ) with no reported ae (adverse event)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 16-Nov-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE  lot U7526AA, expiration date:07-Sep-2024, via intramuscular route in the left thigh for prophylactic vaccination.  On 16-Nov-2022 the 8 months old was given quadracel with no reported ae (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE . The patient used the product for the first time.  Action taken was not applicable.  corrective treatment :None  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.At time of reporting, the outcome was Unknown for the event vaccination complication
Age: 1.5
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired PENTACEL was administered to one of their patients in October with no reported adverse event; Initial information was received on 05-Dec-2022 regarding an unsolicited valid  non-serious case received from a healthcare professional.  This case involves a 18 months old female patient who was administered expired Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (VERO)] to one of their patients in october 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: Hepatitis A vaccine (Hepatitis A) and Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for prophylactic vaccination.  On 06-Oct-2022, the patient received expired Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at a dose of 0.5 ml (lot UJ57AA, expiration date: 11-Sep-2022) via intramuscular route in the right thigh for immunization to one of their patients in October with no reported adverse event (expired product administered) (unknown latency).    Action taken: Not applicable.  Corrective treatment: Not reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.