chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm swelled up to my elbow; red; hot; Initial information was received on 22-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown age and gender patient who experienced arm swelled up to my elbow (peripheral swelling), red (erythema) and hot (skin warm) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date (Wednesday), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious arm swelled up to my elbow (peripheral swelling), red (erythema) and hot (skin warm) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for all events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves adult and unknown gender patient who got the flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient medical treatment(s), vaccination(s), concomitant medication, 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 and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient got the flu (influenza) (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event got the flu. There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Feeling abnormal, Malaise
Clinical narrative: This case involves a 69-year-old female patient who had iron low (blood iron decreased), more tired; fatigued; exhausted (fatigue) and does not feel well; feels like she was hit by a truck (malaise) after receiving INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [REMODULIN]. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient medical treatment(s), vaccination(s), concomitant medication, and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension. Concomitant medications included BOSENTAN (BOSENTAN); SILDENAFIL CITRATE (REVATIO); BOSENTAN (TRACLEER [BOSENTAN]); and IRON for Iron low. On 10-Feb-2017 REMODULIN (TREPROSTINIL SODIUM) dosage was changed to dosage unknown. On an unknown date, the patient started taking therapy of REMODULIN (TREPROSTINIL SODIUM) formulation unknown dosage unknown iv nos (intravenous not otherwise specified) (with an unknown batch number) for secondary pulmonary arterial hypertension. It was reported that the patient had low iron and had 2 iron infusions on 11- Oct -2021 and 18 -Oct -2021. She had been more tired. On 03-Nov-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. On 03-Nov-2021, the patient had a flu shot. Thereafter, the patient felt like she was hit by a truck and did not feel well. The patient was very exhausted/fatigued (fatigue previously reported). On an unknown date the patient developed a non-serious iron low (blood iron decreased), more tired; fatigued; exhausted (fatigue) and does not feel well; feels like she was hit by a truck (malaise) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of TREPROSTINIL SODIUM and following the administration of INFLUENZA VACCINE. Detail of laboratory data were not reported. Action taken with TREPROSTINIL SODIUM (REMODULIN) was unknown. It was not reported if the patient received any corrective treatment for the events. At time of reporting, the outcome was unknown for the events. The reporter did not provide causality for the events of blood iron decreased, malaise and fatigue. There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves a female patient of unknown age who got sick the last 8 years she took it (illness) when received vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment, vaccination, concomitant medication 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious got sick the last 8 years she took it (illness) (unknown latency) following the administration of INFLUENZA VACCINE. Laboratory details were not reported. It was not reported if the patient received a corrective treatment for the event. At the time of reporting, the outcome was unknown for the event (illness). The reporter assessed the causal relationship for the event (illness) with the INFLUENZA VACCINE as not reported. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves a patient (Unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "No thanks every time I get the shot I get the flu Haven't had the shot in 4 years and haven't had the flu." It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, outcome of the event was unknown. The reporter did not report the causality of event with suspect. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Massively sick; Initial information was received on 28-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown age and gender patient who experienced massively sick (illness) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious massively sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "Thanks, but you can keep your poison".   It was unknown if there were lab data/results available.  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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: get sick; Initial information was received on 24-Nov-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Regulatory Authority (under reference number - US-SA-SAC20211130000274).  This case involves patient of unknown age and gender who experienced get sick (illness), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious get sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  No additional laboratory data was reported.  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.  There will be no information available on batch number for this case.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Cough, Illness, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: bad cough; fever; sick; Running nose; stopped up nose; Initial information was received on 27-Nov-2021 regarding an unsolicited valid non-serious case from social media via a consumer/non-healthcare professional.  This case involves a patient (demographics unknown) who experienced bad cough (cough), fever (pyrexia), sick (illness), running nose (rhinorrhoea) and stopped up nose (nasal congestion) after receiving INFLUENZA VACCINE and Corona virus disease (COVID-19).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), past vaccination(s), concomitant medications 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 and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bad cough (cough), fever (pyrexia), sick (illness), running nose (rhinorrhoea) and stopped up nose (nasal congestion) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  It was reported "Have two Covid shots, flu shot and they told me cannot have pneumonia shot last one have to wait another year. Been sick 7 days non stop bad cough, running and times stopped up nose, like fever. Worried this goes into pneumonia usually does bronchiole then that. Must get over due for procedure Dec 8".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the events.  The reporter did not report causality of events with suspect.  At time of reporting, the outcome of the events was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: ended up with serious complications; Initial information received on 27-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) who ended up with serious complications (vaccination complication) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination  On an unknown date the patient ended up with serious complications (vaccination complication, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were laboratory data/results available.  It was reported "So much advertising! Folks need to discuss this and any other medicine with their doctor before taking it! I agree that Flu vax helps to prevent fatal pneumonia. I just disagree with the incessant advertising and push to vax. By the way, a friend of mine who followed advertisement's advice ended up with serious complications from flu vax. People, do it after you have evaluated risks and benefits with your physician."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 26-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media (under reference number: US-SA-SAC20211201000391).  This case involves adult patient of unknown gender patient who experienced flu (influenza) when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (influenza).  The reporter assessed the causal relationship for the event (influenza) with the INFLUENZA VACCINE as not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 28-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional (under reference number:).  This case involves Adult and unknown gender patient who experienced flu  (influenza)  after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication 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 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 developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu shot got the flu; Initial information received on 26-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional under reference number: US-SA-SAC20211201000474.  This case involves an unknown age and unknown gender patient who experienced got the flu shot got the flu (influenza) after receiving INFLUENZA VACCINE.   The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was unknown if the patient had any 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event  got the flu shot got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event (got the flu shot got the flu).  At time of reporting, the outcome was Unknown for the event got the flu shot got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Sick; Initial information received on 28-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer non health care professional (under reference number: US-SA-SAC20211201000485).  This case involves an unknown age and unknown gender patient who experienced sick (illness) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication 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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  At time of reporting, the outcome of the event was reported as unknown
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: get sick every time I get one; Initial information received on 29-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional (under reference number: US-SA-SAC20211201000749).  This case involves Adult and unknown gender patient who experienced get sick every time i get one (illness) after receiving INFLUENZA VACCINE.   The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   It was unknown if the patient had any 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 developed a non-serious event get sick every time i get one (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Glossodynia, Insomnia, Pain in extremity
Clinical narrative: difficulty sleeping last night secondary to pain; soreness in upper arms bilaterally; tongue sensitivity to hot temperature and mint in mouthwash; Initial information received on 29-Nov-2021 regarding an unsolicited valid non-serious courtesy case from a consumer. This case involves a female patient age unknown who experienced tongue sensitivity to hot temperature and mint in mouthwash (glossodynia), soreness in upper arms bilaterally (pain in extremity) and difficulty sleeping last night secondary to pain (insomnia), after receiving INFLUENZA VACCINE and COVID-19 VACCINE and while treated with LENVATINIB MESILATE [LENVIMA]. The patient's past medical treatment included PEMBROLIZUMAB [KEYTRUDA] infusion. The patient's past vaccinations, concomitant medications and family history were not provided. At the time of the event, the patient had ongoing medical history of Malignant neoplasm of endometrium (C54.1) Endometrial cancer which was diagnosed. On 22-Oct-2021, the patient started taking LENVIMA (LENVATINIB MESILATE) 20 mg once daily route unknown (with an unknown batch number and expiry date) for Endometrial cancer. On an unknown date in 2021, the patient experienced a non-serious tongue sensitivity to hot temperature and mint in mouthwash (glossodynia) few days following the administration of LENVATINIB MESILATE. On 04-Nov-2021, 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 and a booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccinations. On an unknown date the patient experienced non-serious events soreness in upper arms bilaterally (pain in extremity) and difficulty sleeping last night secondary to pain (insomnia) (unknown latency) following the administration of LENVATINIB MESILATE, INFLUENZA VACCINE and COVID-19 VACCINE. Action taken with LENVATINIB MESILATE (LENVIMA) was unknown. It is unknown if the patient experienced any additional symptoms/ events. There were no laboratory data/ results available. The patient had spoke with oncologist's office and was advised okay to take MOTRIN [IBUPROFEN] for pain in extremity. At time of reporting, the outcome of the events was reported as unknown. There will be no information on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves a patient of unknown demographics who had flu (Influenza) after receiving INFLUENZA VACCINE. The patient's past vaccination(s) included INFLUENZA VACCINE. The patient had flu every time when the patient received the INFLUENZA VACCINE. It was unknown if the patient had any other medical history, concomitant disease, or risk factor. The patient's past medical treatment(s) and family history were not provided. Details for the concomitant medications was not reported. 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 developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Flu Shot Fridays You missed the point of my comment, every time I get the flu shot I get the flu." It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. 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. There would be no information available on batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case involves patients with an unknown age and gender who received an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no reported adverse event (expired product administered). The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided. On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7035NA and expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). It was reported "The caller stated that there were several employees that received the expired dose of FLUZONE QUADRIVALENT Prefilled syringe (PFS). The caller estimated about NINE employees, but did not have any patient specific information to provide. The caller did not know the date of administration." At the 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. 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: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: This case is linked to case 2021SA394804 (same reporter). This case involves a two-month-old female patient who accidentally received only part of a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and not the HiB portion (product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Nov-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID ACPERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (0.5ml, lot UJ504AAA, expiry date: 29-May-2022) via an unknown route at an unknown administration site for prophylactic vaccination. It was a potential medication error due to Inappropriate reconstitution technique (latency: same day). It was reported "Caller says that a nurse accidentally gave only part of a dose of Pentacel and not the Hib portion. Caller wants to know about next steps and side effects to look for." 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: 15.0
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product dose omission issue
Clinical narrative: This case involves 15-year and 5-months-old and unknown gender patient is missing fourth dose of IPV (VERO) [IPOL] series (product dose omission issue). Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On an unknown date, the patient is missing fourth dose of suspect IPV (VERO) (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination (product dose omission issue). It was reported "Business manager states that they have a patient who is 15 years and 5 months old who came from another practice; upon reviewing her medical chart, they found that she is missing a dose in her IPV series. Business manager asks if the patient could receive QUADRACEL to make up for the missing dose in her IPV series". This case was an actual medication error due to missed dose (latency: same day). At the time of reporting, no 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. There will be no information available on the batch number for this case.
Age: 50.0
Sex: F
Vaccine: TTOX, UNK
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: This case involves a 50-year-old female patient who received TUBERCULIN TEST [TUBERSOL] instated of TETANUS TOXOID (wrong product administered) which was given via intramuscular route (incorrect route of product administration). The patients medical history included Dog bite. The patients medical treatments, vaccinations, concomitant medication and family history were not provided. On 23-Nov-2021, the patient received a dose of suspect TUBERSOL (TUBERCULIN TEST) (solution for injection, lot number and expiry date not reported) via an intramuscular at an unknown administration site instated of TETANUS TOXOID (lot number and expiry date not reported) for prophylactic vaccination. It was an actual medication error case due to wrong vaccine administered and wrong route of administration (latency: same day). It was reported "The Pharmacist reported that due to the consume receiving Tubersol in error there has not been any reported adverse effects. A Pharmacist reporting a medication error with TUBERSOL described as a female being given TUBERSOL and not the prescribed Tetanus vaccine and the TUBERSOL was given via intramuscular route. The Pharmacist reported that the consumer was due to get a Tetanus vaccine due to having a dog bite; that the caller does not have any more information on the consumer or the event; that they are a regional poison control center looking up the information on behalf of a providers office that the event took place." At the 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 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. There will be no information available on the batch number for this case.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This case involves an eight-years-old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation. On 08-Nov-2021, the patient received a 0.5 mL (once) dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination. It was an actual medication error due to product administered to patient of inappropriate age. (latency: same day). It was reported "on November 8, 2021, an 8-year-old patient was immunized with a dose of Quadracel. As the patient is under vaccinated, can this dose count as a catch up dose?" At time of reporting, no adverse event reported. There will be no information available on the batch number for this case. 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: 62.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, Overdose, Product administered at inappropriate site
Clinical narrative: This case involves a 62 years old male patient one of the nurses administered the remaining contents of a multidose vial of IPV (VERO) [IPOL] (overdose) and vaccine administered at inappropriate site with no reported adverse event. The patient's medical history, past medical treatments, vaccinations, and family history were not provided. Concomitant medications included HEPATITIS B VACCINE; HIB VACCINE; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE); MENINGOCOCCAL VACCINE B; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13; VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for prophylactic vaccination; and BORTEZOMIB for Multiple myeloma. On 24-Nov-2021, the patient received a dose of suspect IPV (VERO) (lot number: T1E872M and expiry date: 10-Oct-2022) via subcutaneous route via abdomen for prophylactic vaccination. It was a case of actual medication error due to overdose and vaccine administered at inappropriate site (latency: same day). It was reported "Pharmacist clarifies that the exact dose of IPOL administered is unknown; states the nurse said she gave, "several mL's". Pharmacist states the dose could have been up to 4.5 mL. Pharmacist asks what they should monitor for." At the 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.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: This case involves a patient of (unknown demographics) who were vaccinated with suspect product INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] were activated on 20-Nov-2021 (product storage error) and reconstituted product stored and administered to patient on next day (wrong technique in product usage process) with no reported adverse event. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccines were not provided. On 22-Nov-2021, the patients received a 0.7mg {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ773AA and expiry date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to incorrect product storage and wrong technique in product usage process (latency was on same day). At the time of report, no adverse event reported. Event outcome was 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 Directive 2001/83/EC and Module VI. 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: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This case involves a 15-year-old male patient receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] mistakenly (product administered to patient of inappropriate age). The patient medical history, past medical treatment, vaccination, concomitant medication, and family history were not provided. On 24-Nov-2021, the patient received a 0.5 mL total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [frequency: once, strength: standard, lot QFAA2154, expiry date: 30-Jun-2022] via intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error case due to Inappropriate age at vaccine administration (latency: same day). It was reported "doctor states that a 15-year-old patient mistakenly received a FLUBLOK QUADRIVALENT vaccination in his practice on 24NOV2021. Doctor asked if FLUBLOK QUADRIVALENT would give as strong of a response for this patient as other age-appropriate flu vaccines. Doctor also asked if there were any side effects or warnings that he needed to be aware of for this patient." At the 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 Directive 2001/83/EC and Module VI. 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: Expired product administered
Clinical narrative: several doses of FLUZONE QIV PFS and FLUZONE HD QIV were activated on 20Nov2021 and then administered on 22Nov2021, 23Nov2021, and 24Nov2021; Initial information received on 24-Nov-2021 regarding an unsolicited valid non-serious case from other healthcare professional via Agency (under the reference 00872588).  This case involves 22 patients who received a dose each of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Wrong technique in product usage process) on 22-Nov-2021, 23-Nov-2021 or 24-Nov-2021 after the vaccine was activated on 20-Nov-2021.  The patients' medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 22-Nov-2021, 23-Nov-2021 or on 24-Nov-2021 each of the patients received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7325KA, UT7384NA and expiry date: 30-JUN-2022) which was activated on 20-Nov-2021 via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to Wrong technique in product usage process (latency : same day).  It was reported "Caller states several doses of FLUZONE QIV PFS and FLUZONE HD QIV were activated on 20Nov2021 and then administered on 22Nov2021, 23Nov2021, and 24Nov2021. Caller is looking for information on if they need to revaccinate and if there are any other issues that may arise from administering on a later date after activation."   Reporter stated that the syringe cap was removed from the Fluzone Quadrivalent syringes and the needles were attached on 20 Nov 2021, and then the activated syringes were not administered to the patients by the end of the business day.  At the time of reporting, no adverse event 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: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: This case involves a 19 years old female patient who was administered with the expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines or concomitant medication(s) were given to the patient. On 28-Nov-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (once in total, standard,  lot number U6787AA and expiry date 11-Aug-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (same day latency). It was reported "Medical Assistant calling to report that a patient received and expired dose of MENACTRA. Caller is wanting to know if the dose is valid or if needs to be repeated. MENACTRA U6787AA EXP 08-Nov-2021." 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.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally gave an expired FLUZONE HIGH-DOSE VACCINE (2020-2021 rather than 2021-2022 vaccine) with no ae; Initial information received on 29-Nov-2021 regarding an unsolicited valid  non-serious case received from a pharmacist via Agency number: 00876413.  This case involves an unknown age and unknown gender patient who was administered an expired dose of  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and expiry date  not reported via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the 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: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of FLUZONE QUADRIVALENT was administered inadvertently, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via physician via Agency (Reference number- 00877775) and transmitted to Sanofi on 30-Nov-2021.  This case involves a 29 year old female patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] inadvertently (Expired product administered).  The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided.  She had no other vaccines.   On 24-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE produced by Sanofi Pasteur (lot number: UT7058JA and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency same day).  It was reported "Nurse reported that an expired dose of FLUZONE QUADRIVALENT was administered inadvertently to a patient by a medical assistant on 24NOV2021. The FLUZONE QUADRIVALENT expired on 30JUN2021. The caller would like to know if this is a valid dose and how to proceed. Product: FLUZONE QUARIVALENT (pre-filled syringe (PFS)). Caller stated that the patient did not have any adverse reactions and did not require Doctor or emergency room (ER) visit post administration"  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.