chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 08-Dec-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 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 medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   In October 2021, 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.  In Nov and Dec-2021, the patient developed non serious flu (influenza) approximately after a month following the administration of INFLUENZA VACCINE.  It was reported "Got the flu shot in October and then had the the flu for 3 weeks in November and December"  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  On an unknown date, the patient was recovered from the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves patient (unknown gender and age) who had flu (influenza), after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. 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 (Suspension for injection, lot number and expiration date were not reported) via unknown route in 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. It was reported "Got mine and 4 weeks later I'm on my 5th day of the flu, Horrible" 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. At time of reporting, the outcome was unknown for the reported event. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: haven't had a shot for over 20 years as patient was allergic to them; Initial information was received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult patient (unknown gender) who experienced haven't had a shot for over 20 years as patient was allergic to them (allergy to vaccine) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), 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 not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious haven't had a shot for over 20 years as patient was allergic to them (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Illness
Clinical narrative: Sick; Initial information received on 11-Dec-2021 regarding an unsolicited valid social media serious case received from a consumer or non-healthcare professional via social media.  This case involves Adult and unknown gender patient who experienced sick (illness) after receiving INFLUENZA VACCINE and corona virus disease 2019 (COVID-19) VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's 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 and expiry date 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 not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sick (illness) (2 week latency) following the administration of INFLUENZA VACCINE and (unknown latency) following the administration of COVID-19 VACCINE.  It was reported "watch out I got sick for almost 2 weeks, after getting shot, beware so many other people are getting sick from flu vaccine and covid 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 event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUR4
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: flu; Initial information received on 12-Dec-2021 regarding an unsolicited valid  non-serious case received from a consumer or non-healthcare professional.  This case involves a 23 years old male patient who had flu (influenza) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient's medical treatment(s), vaccination(s) and family history were not provided.  On 05-Oct-2021, the patient received a 0.5 ml total of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [frequency : once, lot U7328DA, expiry date : 30-jun-2022] via intramuscular route in unknown administration site for prophylactic vaccination.  On 12-Dec-2021, the patient developed a non-serious flu (influenza) 2 months 7 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "He is my son and he was tested positive for the flu at the Hospital on 12-Dec-2021."  It was unknown if the patient experienced any additional symptoms/events  Relevant test was included- 12-Dec-2021- tested positive for the flu.   It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the patient recovering for the reported event.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: deathly sick; Initial information was received on 12-Dec-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 demographic patient (unknown age and unknown gender) who experienced deathly sick (illness) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), 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 not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious deathly sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "You "think" it's just a flu shot, then you find out later that you were a lab rat involved in an experiment. While I was in the military, I got deathly sick from every flu shot. Now with this fake pandemic going around the only thing on the people's mind is getting their jab of death into everyone. So go right ahead, earn your Darwin Award. As for me, I'll keep my blood pure & jab free."  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: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information was received on 14-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves an unknown age male patient who got the flu (influenza) after receiving INFLUENZA VACCINE.  The patient had no 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 got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "every time my dad got a flu shot he got 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: Influenza
Clinical narrative: Only time I got the flu was when I got the flu shot; Initial information received on 12-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via Agency.  This case involves adult patient (unknown demographic) who had got the flu was when patient got the flu shot after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's 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 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 got the flu was when patient got the flu shot (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Only time I got the flu was when I got the flu shot. Never again. It's a crap shoot anyway. I am done lining big Pharma's pockets."  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 reported event.  There will be no information available on the batch number for this case.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adacel was administered to a patient who was 8 years and 2 months old/ No AE; Initial information received on 07-Dec-2021 regarding an unsolicited valid non-serious case received from a other health care professional via Medical Information (MI) number: 00888557.  This case involves an eight years two months old male patient who was administered a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE, VARICELLA ZOSTER VACCINE and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccinations.  On 07-Dec-2021, the patient received a 0.5 ml fifth (total) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Oral solution lot number: C5863AA, expiry date: 13-Apr-2023, frequency: once, strength: standard via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "Caller stated that they had a dose of ADACEL was administered to a patient who was 8 years and 2 months old. Caller stated that ADACEL is advised for 10 years of age and older. Caller asking if this is okay or what should be done. Caller mentions they use Pediarix in there office for DTaP (diphtheria, tetanus, and acellular pertussis) which is not supposed to be administered past 6 years of age and this child is 8 years and 2 months but does not know why the Medical Assistant gave him Adacel today."  Product used: Used, First time product used: Yes and Still using product: No.  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: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, Product storage error
Clinical narrative: A patient received a non-viable FLUZONE QUADRIVALENT from shipment no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (MI) (Reference number- 00890492) and transmitted to Sanofi on 08-Dec-2021.  This case is linked to case 2021SA415315 (Same reporter).  This case involves a 56 year old male patient who was received non-viable INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 08-Dec-2021 from shipment which was in transit since Sept 20, 2021 (Product storage error).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 08-Dec-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7376MA, expiry: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Incorrect product storage (latency same day).  It was reported "Pharmacist called to report that two patients were administered "non-viable" FLUZONE QUADRIVALENT today 08Dec2021. Pharmacist reports that they received a shipment of (12) FLUZONE QUADRIVALENT today. Pharmacist reports that two (2) patients received the FLUZONE QUAD vaccine today from that shipment. RPh reports that it was discovered later in the day that the packing slip says the package was in transit since September. Registered Pharmacist (RPh) reports the product was cold upon receipt so no one noticed the packing slip date. RPH spoke with and was advised that vaccines were non viable since the packaging slip reports that it was in transit since Sept 20, 2021. Pharmacy also received (11) boxes of FLUZONE HD in that same package. No patients received the FLUZONE HD vaccine. RPh is inquiring about re-vaccination for these patients and how soon?"  No other 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: Medication error, Wrong technique in product usage process
Clinical narrative: two patients were administered "non-viable" FLUZONE QUADRIVALENT with no reported adverse event; Initial information received on 09-Dec-2021 regarding an unsolicited valid non-serious case from a Pharmacist via Media information (under the reference 00872588).  This case is linked to case 2021SA415946(CLUSTER).  This case involves two patients who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (poor quality product administered).  The patients' medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 08-Dec-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7376MA and expiry date: 30-Jun-2022) via intramuscular route in 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  pharmacist called to report that two patients were administered "non-viable" FLUZONE QUADRIVALENT today 08Dec2021. Pharmacist reports that they received a shipment of (12) FLUZONE QUADRIVALENT today. Pharmacist reports that two (2) patients received the FLUZONE QUAD vaccine today from that shipment.  Reporter stated that RPh reports that it was discovered later in the day that the packing slip says the package was in transit since September. RPh reports the product was cold upon receipt so no one noticed the packing slip date. RPH spoke with and was advised that vaccines were non viable since the packaging slip reports that it was in transit since Sept 20, 2021. Pharmacy also received (11) boxes of FLUZONE HD in that same package. No patients received the FLUZONE HD vaccine. (12) FLUZONE QUAD with LOT# UT7376MA EXP: 6/30/2022 (11) FLUZONE HD with LOT# UJ7S0AC EXP: 6/30/2022 RPh is inquiring about re-vaccination for these patients  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.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: she ordered a vaccine and the pharmacist didn't make it clear that it had to go in the refrigerator so it was at room temperature for a couple of days; Initial information was received on 09-Dec-2021 regarding an unsolicited valid non-serious case from a consumer / non healthcare professional via Agency (under reference 00891725).  This case involves an unknown age female patient who was administered with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] of which she ordered a vaccine and the pharmacist didn't make it clear that it had to go in the refrigerator so it was at room temperature for a couple of days (product storage error).  The patient's medical history, 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 MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual case of medication error due to incorrect product storage.  It was reported that she ordered a vaccine and the pharmacist didn't make it clear that it had to go in the refrigerator so it was at room temperature for a couple of days in a really cool house that always has the air conditioning running and her doctor asked her to call the company to see if we think it is still ok to use. She wants to know if she has side effects does that mean it is working.  At the time of report, 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.  There will be no information on batch number for this case.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: mistakenly gave an expired vaccine/ no AE; Initial information was received on 09-Dec-2021 regarding an unsolicited valid non-serious case from a Physician via Media Information (under reference- 00892151) and transmitted to Sanofi on 09-Dec-2021.  This case involves a 27-year-old female patient who mistakenly gave an expired RABIES VACCINE [IMOVAX RABIES]. with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 08-Dec-2021, the patient received 1 ml (total) dose of suspect RABIES VACCINE [lot T1B813M and expiry date 07-Dec-2021] via intramuscular route in the left arm for prophylactic vaccination.  It was reported "Caller states that she mistakenly gave an expired IMOVAX vaccination to a patient that is a veterinary student on 08DEC2021. Caller states that she thought the date was 07DEC2021 but it was actually 08DEC2021 and the IMOVAX expired on 07DEC2021. Caller asked for information on how to proceed in this situation. Caller states that she would like to get an answer because the patient will be leaving to return to school soon. Caller asked if IMOVAX was an inactivated vaccine and if she could revaccinate the patient immediately".  It was a case of actual medication error due Expired vaccine used (latency was on same day).  At the time of reporting, patient had 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 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: M
Vaccine: FLU4
Symptoms: Respiratory tract congestion, Sinus congestion, Sinus disorder, Wrong product administered
Clinical narrative: sinus problems as well as chest congestion; MD stated patient was to have a allergy shot instead of the 2nd vaccine; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from a physician via Agency (under the reference 00893233).  This case involves a 59 years old male patient who had sinus problems as well as chest congestion (sinus congestion) and md stated patient was to have a allergy shot instead of the 2nd INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 25-Oct-2021, the patient received a first dose of suspect FLUZONE QUADRIVALENT (0.5 ml, lot UJ705AB and expiration date: 30-Jun-2021) via intramuscular route in the right deltoid and on 27-Nov-2021 he also received a second dose of the same vaccine (0.5 ml, lot UJ695AA and expiration date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed a non-serious sinus problems as well as chest congestion (sinus congestion) (unknown latency) following the administration of vaccine.  It was an actual medication error due wrong vaccine administered (same day latency).  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The patient was recovering from the event sinus congestion.   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: 66.0
Sex: F
Vaccine: RAB
Symptoms: Exposure to communicable disease, Product dose omission issue
Clinical narrative: missed her day 3 vaccine; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from pharmacist via phone via Agency (Reference number- 00893374).  This case involves a 66 years old female patient who missed day 3 dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (product dose omission issue).  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 RABIES (HDC) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for unknown indication.  It was an actual medication error due to missed dose (same day).  It was reported "Caller reported she has a patient who presented on day 7 after exposure and missed her day 3 vaccine. Caller wants to know how to proceed with IMOVAX RABIES series.".   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.  There will be no information on batch number for this case.
Age: 10.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This case involves a 10-year-old female patient who was by mistakenly given dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age). The patient past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included NA (SODIUM). On 08-Dec-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ724AA and expiry date: 30-Jun-2022) (Oral solution) (0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml) (Frequency once) via intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error case due to product administered to patient of inappropriate age (latency: same day). It was reported "FLUBLOK vaccine was given to a 10 year old and wants to know what would happen or do they need to give another age appropriate flu shot?". 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: 11.0
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: the patient missed his dose on day 3/ no AE; Initial information was received on 13-Dec-2021 regarding an unsolicited valid non-serious case received from a Pharmacist via Agency (Reference number- 00895881).  This case involves a 11-year-old male patient who missed his dose on day 3 with no adverse event (Product dose omission issue) while receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 06-Dec-2021, the patient received a dose (once) of suspect RABIES (HDC) VACCINE [lot number not reported, and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination, Post exposure immunization and Product used for unknown indication.  It was reported "Caller reporting the patient received his first dose of IMOVAX on day zero on 06Dec2021 and missed his dose on day 3. Caller reporting that the patient is coming in today, on day 7, to receive second dose. Caller with question on whether he needed to restart series or just continue the schedule".  It was a case of actual medication error case due to Missed dose (latency was on the same day).  At the time of report, 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.  There will be no information available on batch number for this case.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: Tenivac was administered subcutaneously instead of intramuscular with no A/E; Initial information was received on 14-Dec-2021 regarding an unsolicited valid  non-serious case from a pharmacist via physician (under Inquiry Number: 00897326).  This case involves a 53 years old female patient who was administered DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] subcutaneously instead of intramuscular with no adverse event (incorrect route of product administration).   The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 13-Dec-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number: C5779AA and expiry date: 02-Mar-2024) via subcutaneous route in the right arm for prophylactic vaccination.  It was reported "She wants to know if there any additional steps that need to be taken. The Pharmacist reported that she does not have specific information on needle size used or where on the right arm the dose was injected and that she was calling on behalf of one of their ambulatory centers; and that pharmacovigilance (PVG) can follow up with her if need be."  It was a case of an actual medication error due to inappropriate route of vaccination (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: 12.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered in error to a 12 year old /no AE; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from a other healthcare professional via call center via Agency (Reference number- 00897856).  This case involves a 12-year-old (unknown gender) patient who erroneously received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  It was reported "What is the next steps for them to do?"  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: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Product preparation issue
Clinical narrative: ACTHIB product was reconstituted with 0.7ml of sterile water and administered with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and physician via Agency (Reference number - 00898182) and transmitted to Sanofi on 14-Dec-2021.  This case is linked to case 2021SA421272 (same reporter).  This case involves 1 year old male patient administered HIB (PRP/T) VACCINE [ACT-HIB] product was reconstituted with 0.7ml of sterile water (product preparation error).  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 14-Dec-2021, the patient received fourth 0.5ml total dose of suspect HIB (PRP/T) VACCINE (lot: UJ636AAA and expiry date: 26-Feb-2023) (Frequency = once) (Strength = standard) (Dosage form : Single dose Vials) via unknown route in the left thigh for prophylactic vaccination and product was reconstituted with 0.7ml of sterile water (product preparation error).  It was reported "Caller would like to know if the dose is valid? Caller would also like to know how soon should they repeat the dose? No further information provided by the reporter".  This case was an actual medication error due to wrong solution used in drug reconstitution (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.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Abnormal sensation in eye, Accidental exposure to product, Exposure during pregnancy, Eye irritation, Medication error
Clinical narrative: Pregnant patient was going to administer the IMOVAX rabies vaccine; tingling to her eye; irritation to her eye; product was squirted into her right eye; Initial information received on 15-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional via Media Information (under the reference: 00899722).  This case involves a 30 years old female patient who had tingling to her eye (abnormal sensation in eye), irritation to her eye (eye irritation), product was squirted into her right eye (accidental exposure to product)and pregnant patient was going to administer the RABIES VACCINE [IMOVAX RABIES]( exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  Patient was exposed to the vaccine at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing medical history Pregnant.  On 15-Dec-2021, the patient received a dose of suspect RABIES VACCINE [frequency-once, lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On 15-Dec-2021, the patient developed a non-serious tingling to her eye (abnormal sensation in eye), irritation to her eye (eye irritation) same day following the administration of RABIES VACCINE. It was an actual medication error due to Accidental contact of product with eye and special situation due to exposure during pregnancy (latency same day).  It was reported "Medical assistant states they have a patient who works at a veterinary clinic; states the patient was going to administer the IMOVAX rabies vaccine, but the product was squirted into her right eye. Medical assistant also reports that the patient is pregnant. Medical assistant reports that the patient completed an eye wash; states the patient reports irritation and tingling to her eye, but denies any pain."  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported events.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUC3
Symptoms: Adverse event, Renal disorder
Clinical narrative: Adverse event with kidneys; This spontaneous case was received on 05-Oct-2021 with additional information received on 07-Oct-2021 (being process together) from other non-health professional via customer service centre and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, indication, route of administration and anatomical location: not reported).   On an unspecified date, unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced unspecified adverse event with kidneys.  The outcome of the event was not reported.  The reporter assessed the event of 'kidney disorder' as related to Flucelvax Quadrivalent. As reported, it was adverse reaction to kidneys with influenza vaccine.  Company comment: A patient of an unreported age and gender was vaccinated with Flucelvax Quadrivalent. An unknown amount of time following vaccination, the patient experienced unspecified adverse event with kidneys. There is lack of information regarding the vaccination date and event onset date. Information regarding medical history and concomitant medications was not provided. Causal role of the suspect vaccine is unassessable, due to lack of information provided and unclear temporal relationship.; Reporter's Comments: As reported, it was adverse reaction to kidneys with influenza vaccine.; Sender's Comments: A patient of an unreported age and gender was vaccinated with Flucelvax Quadrivalent. An unknown amount of time following vaccination, the patient experienced unspecified adverse event with kidneys. There is lack of information regarding the vaccination date and event onset date. Information regarding medical history and concomitant medications was not provided. Causal role of the suspect vaccine is unassessable, due to lack of information provided and unclear temporal relationship.
Sex: M
Vaccine: FLUA4
Symptoms: Influenza like illness
Clinical narrative: Feeling like he has the flu; This spontaneous case was received on 06-Dec-2021 from other non-healthcare professional via Agency (reference number: SEQW21-05843) and concerned an adult male patient of an unknown age.   The patient's current condition includes alpha-gal allergy. The patient's  concomitant medications were not reported.  On unspecified date in Nov-2021, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated virus surface antigen (subunit), egg-derived, MF59; rout of administration, anatomical location: not reported and dose: 0.5 ml) for influenza prophylaxis. The batch number was not reported.  On unspecified date Nov-2021, after receiving Fluad Quadrivalent, the patient stated he felt like he had flu, also he did not have any adverse effect other than that. He stated his flu like feeling lasted only one day after receiving the vaccine.The patient was inquiring if the vaccine might raise the Alpha Gal antigen in his blood. He asked was there any canine component in this vaccine.   On unspecified date in Nov-2021, the patient had recovered from the event.   The reporter did not provide casuality assessment.  Company comment: The event of 'Flu like symptoms' was assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The event of 'Flu like symptoms' was assessed as related to Flucelvax Quadrivalent.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pancreatitis
Clinical narrative: Pt admitted to Hospital on 15 Dec 2021 for pancreatitis. After investigation, no obvious etiology to explain the pancreatitis. Still pending autoimmune labs. Pt did receive J&J COVID booster 5 days prior and so possible that may be a AR, but cannot prove it.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Full blood count, Inflammatory marker test, Muscle tightness, Neck pain
Clinical narrative: Woke up in the middle of the night with sever tight neck and pain with rotational motion of neck. Proceeded to go to the ER in the morning when pain did not resolve on its own.  Decadron given Toradol Given Occipital Nerve block bilaterally multiple trigger point injections  no treatments fixed the issue which has improved but is still present
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve block, Pain, Sleep disorder
Clinical narrative: Woke up in the middle of the night with sever tight neck and pain with rotational motion of neck. Proceeded to go to the ER in the morning when pain did not resolve on its own.  Decadron given Toradol Given Occipital Nerve block bilaterally multiple trigger point injections  no treatments fixed the issue which has improved but is still present
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: After 8 hours, then chills, extreme fatigue, nausea and all over soreness for 3-4 days.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 13-DEC-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose: 0.5 milliliter, lot # S039311, expiration date: 04-DEC-2021 as prophylaxis (route of administration and anatomical location were not provided) (expired product administered).  No temperature excursion and no additional information was provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccinated twice, STILL get shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The patient self-reported the case. The age at vaccination was not reported. The patient was vaccinated twice and still get shingles. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: SOME ACHINESS; FELT A LITTLE TIRED; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced some achiness, and felt a little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some achiness, and felt a little tired. This report was non-serious. This case, involving the same patient is linked to 20211223299. This case, from the same reporter is linked to 20211223201.