chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram, Headache, SARS-CoV-2 test
Clinical narrative: severe abdominal pain; headache; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 09:15 (Lot number: EW0169) at the age of 33 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was none, and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 04May2021 09:00, outcome "recovering", described as "severe abdominal pain"; HEADACHE (non-serious) with onset 04May2021 09:00, outcome "recovering", described as "headache". The events "severe abdominal pain" and "headache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain, headache.  Additional information: The patient 2 weeks after the first dose experienced severe abdominal pain, headache. Therefore, went to the emergency room 4 times, blood work and CT scan were good. Still don't know the nature of that pain. The patient neither received other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. covid test post vaccination (Nasal Swab) on 30May2021 resulted negative. The device date was 30May2021.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: Lethargy; Body ache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in left arm, administration date 06Feb2021 08:50 (Lot number: EL3248) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diuretic therapy" (ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for diuretic therapy, start date: 2012 (ongoing). Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EK9231) intramuscularly at 08:10 AM, in left upper arm), administration date: 16Jan2021, when the patient was 68 years old, for COVID-19 immunisation, reaction(s): "Minimal soreness at injection site", "headache", "some lethargy". The following information was reported: LETHARGY (non-serious) with onset 06Feb2021 15:00, outcome "recovered" (Feb2021), described as "Lethargy"; PAIN (non-serious) with onset 06Feb2021 15:00, outcome "recovered" (Feb2021), described as "Body ache". Therapeutic measures were not taken as a result of lethargy, pain.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: 1st dose - body felt heavy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset Jun2021, outcome "recovered" (2021), described as "1st dose - body felt heavy". It was unknown if therapeutic measures were taken as a result of discomfort.  Additional information: It was also reported that after receiving 2nd dose of vaccine, the patient  experienced bad headache (felt like nerve pain), achy body, body felt heavy, stomach ache, mild fever, chills nonstop, shivering all night, feels weak and sleepiness. Awareness Date was reported as 01Jul2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: shortness of breath; chest discomfort; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest discomfort".  Additional Information: It was reported that, Patient #2 was not vaccinated by this office but child reported shortness of breath and chest discomfort following vaccination for Covid. Country of Occurrence: PRIVATE, Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: FLUX
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This case involves a 27 years old male patient who had clinic accidentally gave him the high dose of flu shot and it was unintended with no reported adverse event 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 lot number not reported in unknown administration site for unknown indication. On an unknown date the patient developed a non-serious clinic accidentally gave him the high dose of flu shot and it was unintended with no reported adverse event (incorrect dose administered) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (clinic accidentally gave him the high dose of flu shot and it was unintended with no reported adverse event). At time of reporting, the outcome was Unknown for the event clinic accidentally gave him the high dose of flu shot and it was unintended with no reported adverse 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.; Sender's Comments:  SAD20211214001805.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Malaise, Paralysis
Clinical narrative: This case involves an unknown age and unknown gender patient who got so sick, patient could not even describe how he/she felt while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided. In 1990, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination. On an unknown date the patient developed a non-serious event "got so sick, patient could not even describe how he/she felt" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that "I had never taken a flu shot until 1990 and my fiancé who was 16 years older than me convinced me to take one when he got his. I got so sick I could not even describe how I felt. He became paralyzed from Guillian Barre Syndrome. President halted flu shots after so many people got GBS, so we assumed that had been dealt with. Apparently not. A couple years ago my doctor asked me if I wanted a flu shot. I told him why I did not. He told me that he had a friend who was in critical condition with GBS after flu shot. My D-I-L (daughter in law) worked as a nurse and gave the doctor she worked for a fu shot. She was so upset when she saw how he deteriorated with GBS that she stopped being a nurse. We just never know. I have not had cold, flu or a kind of stomach virus in at least 30 years, either. But I do stay home most of the time during flu season. Am VERY CAREFUL to wash my hands right after I do grocery shopping once a month, and wash them again after I put things away that other people had touched." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got so sick, patient could not even describe how he/she felt). At time of reporting, the outcome was Unknown for the event got so sick, patient could not even describe how he/she felt.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: became paralyzed from Guillian Barre Syndrome; became paralyzed from Guillian Barre Syndrome; Initial information received on 20-Dec-2021 regarding an unsolicited valid Social Media serious case received via a consumer/non-healthcare professional.  This case involves an adult male patient who became paralyzed from guillian barre syndrome 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 with unknown (formulation, strength, dosage, dosage frequency, route, lot number and administration site) produced by unknown manufacturer.  On an unknown date (unknown latency) the patient developed serious became paralyzed from guillian barre syndrome (paralysis), (guillain-barre syndrome)  following the administration of Influenza vaccine. Both the events were assessed as medically significant.  Action taken with Influenza vaccine was not applicable for both the events.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for both the events.; Sender's Comments: This case involves an adult male patient who became paralyzed from guillian barre syndrome after receiving vaccine Influenza vaccine produced by unknown manufacturer. However, information on patient's health condition at the time of vaccination, relevant medical history, previous vaccination tolerance and other relevant laboratory data was not provided. Rationale or medical condition of the patient  was also not provided. Based upon the reported information, the role of an individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves Adult female patient who got so sick and could not even describe how she felt 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 with unknown (formulation, strength, dosage and dosing frequency) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunisation. On an unknown date the patient developed a non-serious event "got so sick and could not even describe how i felt" (illness) (unknown latency) following the administration of Influenza vaccine. It was reported that "I had never taken a flu shot until 1990 and my fiancé who was 16 years older than me convinced me to take one when he got his. I got so sick I could not even describe how I felt. He became paralyzed from Guillian Barre Syndrome. They halted flu shots after so many people got GBS, so we assumed that had been dealt with. Apparently not. A couple years ago my doctor asked me if I wanted a flu shot. I told him why I did not. He told me that he had a friend who was in critical condition with GBS after flu shot". Action taken with Influenza vaccine was not applicable. It was not reported if the patient received a corrective treatment for the event (got so sick and could not even describe how I felt). At time of reporting, the outcome was Unknown for the event got so sick and could not even describe how i felt.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves Adult and unknown gender patient who haven't had the flu since about '74 while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In 1970, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number; formulation: not reported) via unknown route in unknown administration site for flu (prophylactic vaccination). On an unknown date the patient developed a non-serious event "haven't had the flu since about '74" (influenza) (unknown latency). It was reported "I never had the flu till I got my first flu shot in 1970. Had it each year for the next 3 or 4 years. Have never had another flu shot. Haven't had the flu since about '74." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (Haven't had the flu since about '74). At time of reporting, the outcome was Unknown for the event haven't had the flu since about '74.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves an unknown age and gender patient who experienced sick this month, 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 (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination. On an unknown date, the patient developed a non-serious event " sick this month" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported"Got one last month and sick this month." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (sick this month). At time of reporting, the outcome was Unknown for the event sick this month.
Sex: U
Vaccine: FLUX
Symptoms: Bursitis
Clinical narrative: This case involves an unknown age and unknown gender patient who had bursitis and shoulder still bothers to this day 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 an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number; formulation; strength: not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed non-serious events "bursitis", "shoulder still bothers to this day" (musculoskeletal discomfort)  (unknown latency). It was reported "I got my flu shot this year, as I do every year, but it is getting harder and harder to do as I will no longer go to the local pharmacy to get the shot and more Doctors are no longer providing the service. Two years ago, I got the flu shot at the Pharmacy and ended up with Bursitis, as diagnosed by my primary care physician, and my shoulder still bothers me to this day." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for the event bursitis and was Not Recovered / Not Resolved for the event shoulder still bothers to this day.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves Adult and unknown gender patient who experienced 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 lot number not reported via unknown route in unknown administration site. On an unknown date the patient had flu (influenza) (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 (flu). At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: This case involves an unknown age and unknown gender patient who experienced every time I got it, I got the flu while receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. 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 USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date the patient every time I got it, I got the flu (influenza) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (Every time I got it I got the flu). At time of reporting, the outcome was Unknown for the event every time I got it I got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves an unknown age and unknown gender patient who experienced got so sick 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 lot number not reported via unknown route in unknown administration site as prophylactic vaccination. On an unknown date the patient developed a non-serious got so sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I will never get a flu shot again Had one 2 years ago I got so sick & laid on the bathroom floor for 2 days". Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got so sick). At time of reporting, the outcome was Unknown for the event got so sick.
Sex: U
Vaccine: FLUX
Symptoms: Injury
Clinical narrative: This case involves Adult and unknown gender patient who got injured from a flu injection 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 an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number; formulation; strength: not reported) via unknown route in unknown administration site. On an unknown date the patient developed a non-serious event "got injured from a flu injection" (injury) (unknown latency). There were no 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 got injured from a flu injection.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves Adult patient of unknown gender who had got a flu shot were the years at some point got the flu while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s),concomitant medication, 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 (strength, route, frequency, lot number and expiry date was not reported) via unknown route in unknown administration site for Flu. On an unknown date the patient developed a non-serious event " got a flu shot where the years at some point got the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got a flu shot were the years at some point got the flu). At time of reporting, the outcome was Unknown for the event got a flu shot were the years at some point got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick; Initial information received on 27-Dec-2021 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 sick 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 lot number not reported via unknown route in unknown administration site. for prophylactic vaccination.  On an unknown date the patient developed a non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: Got the flu when I was in high school, got the flu shot about 8 years ago,got sick, no more shots for me".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick).  At time of reporting, the outcome was Unknown for the event got sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: 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 lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "they have the flu i had one when i was five "(influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "this is a public post on the Sanofi flu shot campaign Flu Shot Fridays, we are assuming the consumer is referring to the Sanofi flu vaccine. Author/ Reporter Comment: I am not a doctor and unless you're really vulnerable way older and have issues with your health I've known people who get the flu shot every year and every year they have the flu I had one when I was five in my mid-60s go in strong keep it moving and exercising no flu so I go with what works I think over inoculation doesn't give you any time to build up your own immunity". Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (they have the flu I had one when I was five). At time of reporting, the outcome was Unknown for the event they have the flu i had one when i was five.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves an unknown age and unknown gender patient who experienced 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 lot (form, strength, dose, frequency, route, lot number, expiry date unknown) in unknown administration site as prophylactic vaccination. On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was 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: Malaise
Clinical narrative: got sick every time; Initial information received States on 28-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced got sick every time 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 lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious got sick every time (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick every time).  At time of reporting, the outcome was Unknown for the event got sick every time.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: IPOL that was not suitable for use post-excursion to a 4 month old patient, no AE; IPOL that was not suitable for use post-excursion to a 4 month old patient, no AE; Initial information received on 15-Dec-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (under reference number 00899982).  This case involves a 4 months old female patient who received IPV (VERO) [IPOL] that was not suitable for use post-excursion (product storage error) (poor quality product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included a dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE); HIB VACCINE; PNEUMOCOCCAL VACCINE and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  The patient's visit on 07-Dec-2021 was a well-baby visit; and the patient has not had any other encounters per her chart.  On 07-Dec-2021, the patient received a 0.5 ml second dose of suspect IPV (VERO) (standard, once in total, lot T1D481M and expiry date:25-Jul-2022) via intramuscular route in the left vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage and poor quality vaccine administered (same day latency).  It was reported "Caller reports that they administered IPOL that was not suitable for use post-excursion to a 4 month old patient. Caller asks: Would the dose of IPOL be considered a valid dose? Should we re-vaccinate the patient? If we need to re-vaccinate the patient, how soon can it be done? Refunds/Credits will not be issued due to adverse events."  Reporter states that the patient did not require any treatment after receiving.  At time of reporting, no adverse event was reported.  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.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: This case involves a 8 months old female patient who had experienced an event was only given the liquid portion of the vaccine and HCP would like to know if he powder portion of the vaccine can be reconstituted and given as a separate injection with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE injection (strength: unknown) at the dose of 0.6 ml once via route intramuscular (batch number: UJ473AAA, expiry date: 09-jul-2022) via unknown administration site for indication prophylactic indication. On 20-DEC-2021 the patient developed a non-serious event "was only given the liquid portion of the vaccine and HCP would like to know if he powder portion of the vaccine can be reconstituted and given as a separate injection with no reported adverse event" (product preparation issue) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) /HIB(PRP/T) VACCINE. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. At time of reporting, the outcome was Unknown for the event was only gave the liquid portion of the vaccine and HCP would like to know if he powder portion of the vaccine can be reconstituted and given as a separate injection with no reported adverse 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. 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: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of QUADRACEL was inadvertently administered to a patient yesterday with no reported adverse event; Initial information received on 21-Dec-2021 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 4 years old male patient to whom an expired dose of quadracel was inadvertently administered to a patient yesterday with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 21-Dec-2021, the patient received a  0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, Suspension for injection, (frequency: total) ( lot C5688AA; expiry date: 26-Nov-2021) via intramuscular route in the right thigh for immunization.  On 21-DEC-2021 the patient developed a non-serious event of "an expired dose of quadracel was inadvertently administered to a patient yesterday with no reported adverse event" (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (an expired dose of QUADRACEL was inadvertently administered to a patient yesterday with no reported adverse event).  At time of reporting, the outcome was Unknown for the event an expired dose of quadracel was inadvertently administered to a patient yesterday with no reported adverse 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.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: received ADACEL PFS on 20Dec2021, but the product expired on 09Dec2021 with no reported adverse event; Initial information received on 21-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 years old female patient who received Adacel pfs(prefilled syringe) on 20 Dec 2021, but the product expired on 09 Dec2021 with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Dec-2021, the patient received a primary dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, prefilled syringe, via intramuscular route, (with an unknown frequency, strength) lot number C5687AA, expiration date: 09-Dec-2021 in the left arm.  On 20-DEC-2021 the patient developed a non-serious event "received Adacel pfs on 20 Dec2021, but the product expired on 09 Dec2021 with no reported adverse event "(expired product administered) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received ADACEL PFS on 20Dec2021, but the product expired on 09Dec2021 with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received Adacel pfs on 20 Dec2021, but the product expired on 09 Dec2021 with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This case involves an unknown age and unknown gender patient who took fluzone high dose quadrivalent twice within approximately a month with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation. On 27-Oct-2021, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site as prophylactic vaccination. On an unknown date the patient developed a non-serious event "fluzone high dose quadrivalent twice within approximately a month with no reported adverse event" (inappropriate schedule of product administration) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable. It was not reported if the patient received a corrective treatment for the event (Fluzone High Dose Quadrivalent twice within approximately a month with no reported adverse event). At time of reporting, the outcome was Unknown for the event fluzone high dose quadrivalent twice within approximately a month with no reported adverse 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.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant patient had the exposure to MENACTRA with no reported adverse event; Initial information was received on 21-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 17 years old female patient who was pregnant and had the exposure to menactra and meningitis b vaccine with no reported adverse event while being treated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGITIS B VACCINE Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient had the exposure to MENACTRA and MENINGITIS B VACCINE with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past vaccination(s) included MENB in 2015. The patient's past medical history, medical treatment(s) and family history were not provided. The patient had <<XX>> previous pregnancy/ies.   On 21-Dec-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength and formulation: unknown) at the dose of  0.5 ml (once) via route intramuscular (batch number: U69528A, expiry date: unknown) in unknown administration site for prophylactic vaccination.  On 21-Dec-2021, the patient received a dose of suspect MENINGITIS B VACCINE not produced by Sanofi Pasteur (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.   On 21-DEC-2021 the patient developed a non-serious event "pregnant patient had the exposure to menactra and meningitis b vaccine with no reported adverse event" (exposure during pregnancy) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and MENINGITIS B VACCINE  Action taken: applicable.  At time of reporting, the outcome was Unknown for the event pregnant patient had the exposure to menactra and meningitis b vaccine with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of pre-filled syringe TYPHIM VI was administered to a patient by accident with no reported adverse event; Initial information received from on 22-Dec-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 33 years old male patient who was administered expired dose of pre-filled syringe typhim vi  by accident with no reported adverse event while receiving vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Dec-2021, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE pre-filled syringe lot R2A87, expiry date: 11-Oct-2021 via intramuscular route in left shoulder site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "expired dose of pre-filled syringe typhim vi" was administered to a patient by accident with no reported adverse event (expired product administered) (unknown latency) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  It was reported "Pharmacist states an expired dose of pre-filled syringe TYPHIM VI was administered to a patient by accident. Pharmacist states the patient is no longer planning on traveling our of the country, so they are unsure whether they should still revaccinate the patient as is looking for some guidance."  Action taken with TYPHOID VACCINE (TYPHIM VI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired dose of pre-filled syringe TYPHIM VI was administered to a patient by accident with no reported adverse event).  At time of reporting, the outcome was Unknown for the event expired dose of pre-filled syringe typhim vi was administered to a patient by accident with no reported adverse 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.
Age: 15.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Chest pain, Headache
Clinical narrative: intermittent chest pain; headache; Initial information was received on 22-Dec-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 year old male patient who experienced intermittent chest pain and headache while receiving vaccines IPV (VERO) [IPOL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 20-Dec-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6984AA with expiration date 18-Mar-2023 via intramuscular route in the left deltoid (unknown formulation) and a dose from 0.25 mL to 2 mL of suspect IPV (VERO) via intramuscular route in the left deltoid (with unknown formulation, lot number and expiration date) for prophylactic vaccination.  On 20-DEC-2021 the patient developed a non-serious event "intermittent chest pain" (chest pain) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of IPV (VERO). On 20-DEC-2021 the patient developed a non-serious event "headache" following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of IPV (VERO).  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) and POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (intermittent chest pain and headache).  At time of reporting, the outcome was Unknown for the event intermittent chest pain and was Unknown for the event headache.
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently administered Daptacel (DTaP) instead of the intended vaccine, Boostrix (Tdap) with no reported adevrse event; Initial information received on 22-Dec-2021 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced inadvertently administered daptacel (dtap) instead of the intended vaccine, boostrix (tdap) with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunization; and INFLUENZA VACCINE (INFLUENZA) for Immunization.  On 21-Dec-2021, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5829BA via intramuscular route in the left deltoid for prophylactic vaccination.  On 21-DEC-2021 the patient developed a non-serious event "inadvertently administered daptacel (dtap) instead of the intended vaccine, boostrix (tdap) with no reported adverse event" (wrong product administered) (latency-Same day) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "patient was inadvertently administered Daptacel (DTaP) instead of the intended vaccine, Boostrix (Tdap). Yesterday, the patient would have been one day short of her 12th birthday. The Daptacel was administered intramuscularly into the left deltoid. Concomitant vaccines were the meningococcal vaccine and the influenza vaccine".  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered daptacel (dtap) instead of the intended vaccine, boostrix (tdap) with no reported adverse 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.