chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Breast mass, Menstrual disorder
Clinical narrative: the patient developed lumps in both breasts and her menstrual cycle was affected; the patient developed lumps in both breasts and her menstrual cycle was affected; This spontaneous report was received from a Licensed Practical Nurse and the patient's mother, via company representative, and refers to a 15-year-old female patient. The patient's pertinent medical history, concomitant medication, past drug reactions or allergies were unknown by the reporter.  On an unspecified date in 2021 (reported as "recent"), the patient was vaccinated with her first does of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (concentration, vaccination scheme frequency, route and anatomical site of administration, lot number and expiration date were unknown by the reporter) for prophylaxis. It was stated that the patient's mother reported that her daughter developed lumps in both breast (breast mass) and that her menstrual cycle was affected (menstrual disorder). It was unknow by the reporter if any treatment was given for the events, if any lab diagnostics or studies were performed, or if the patient sought for medical attention.  The outcome of the events at the time of the report was unknown by the reporter. The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) with breast mass and menstrual disorder was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AEs; dose of expired vaccine administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions, or allergies was provided.  On 07-OCT-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T014836 has been verified to be valid, expiration date reported and validated as 07-JUL-2021) at a dose of 0.5 milliliter, via intramuscular (dose number, vaccination scheme and anatomical location of vaccination were not reported) for prophylaxis (expired product administered). No additional adverse events (AEs) were reported.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: A dose of GARDASIL 9 was administered to a patient that is 8 weeks and 5 days pregnant; No additional AE reported; This spontaneous prospective pregnancy report was received from a medical assistant, regarding a 34-year-old female patient. The patient's drug reactions or allergies included sulfa allergies; her concomitant medications included doxylamine succinate (+) pyridoxine hydrochloride (BONJESTA) and prenatal vitamins. It was not reported information regarding the patient's medical history or her concurrent conditions. The patient became pregnant with last menstrual period (LMP) calculated as 08-AUG-2021 (and estimated date of delivery (EDD) of 15-MAY-2022), based on a pregnancy gestation reported as 8 weeks and 5 days, at the time of the report.  On 08-OCT-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliters (mL) administered intramuscularly (lot number U007652 has been verified to be a valid lot number, expiration date reported and established as 14-APR-2023) (vaccination scheme frequency, anatomical location of administration were not reported) as routine vaccination (prophylaxis) (exposure during pregnancy). At the time of the report, the pregnancy outcome was pending, the fetal outcome was not provided, and the patient did not experience any additional adverse events (no adverse event).
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Incorrect dose administered, Pain in extremity, Peripheral swelling
Clinical narrative: her arm started to hurt and swell up; her arm started to hurt and swell up/ it looks like a bum wound that extends all the way to her elbow; accidently received the vaccine again; the injection site was swollen and red with bumps; redness with her arm; the injection site was swollen and red with bumps; the injection site was swollen and red with bumps; This spontaneous report was received from a pharmacist and a 63 years old female patient referring to the patient herself.  Concomitant therapies included blood pressure medication, lifitegrast (XIIDRA) and covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE). The patient had seasonal allergies. Information about medical history was not provided.   On an unknown date in September 2020 (also reported as about a year ago), the patient was initially vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (anatomical location: right arm, route reported as injection; strength, dose, lot# and expiration date were not reported) for prophylaxis, with no adverse effects to report. On 05-OCT-2021, the patient was accidently vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, anatomical location: right arm, route reported as injection, lot # U010533, expiration date 29-OCT-2022; strength and frequency were not reported) for prophylaxis again despite not needing the revaccination (incorrect dose administered), a few hours after she received the second dose that her arm started to hurt and swell up. The patient mentioned that over the next few days she was having lots of pain, swelling, and redness with her arm. She mentioned that it was swollen by an inch thick, almost goes 3 quarters around the circumference of her arm, and had a distinct line around it. She mentioned it looked like a bum wound that extended all the way to her elbow. The patient did not seek medical attention but received paracetamol (TYLENOL) and paracetamol (ADVIL) as treatment. The outcome of all events except the event of incorrect dose administered  was not resolved.  The causality between all events except the event of incorrect dose administered and  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional information; a dose of PNEUMOV AX 23 was given today after its labeled expiration date; This spontaneous report was received from a nurse referring a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 11-OCT-2021, a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was given after its labeled expiration date (lot # T010293 with expiration date 30-AUG-2021; dose and route were not reported) for prophylaxis. This vaccine had been stored in the recommended range and had never undergone a temperature excursion. No additional information was reported (no adverse event).
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: not experiencing any adverse side effects; the patient was supposed to receive PREVNAR 13 but was given PNEUMOVAX 23 instead; This spontaneous report was received from a nurse, referring to a 9 week old patient of unknown gender.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-OCT-2021, the patient was supposed to received pneumococcal vaccine conj 13V (CRM197) (PREVNAR 13) but was given pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T035379 with expiration date 31-MAY-2022) instead for prophylaxis (wrong vaccine administered). There was no additional adverse event reported. The nurse stated the mother of patient was called and the patient was not experiencing any adverse side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm really hurt/ pain; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced pain in arm. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and his/her really hurt for 3 days. The patient would go for the second shot in November. The patient was told to keep moving the arm and keep the medication moving through. The patient even applied ice on it for the pain. The patient do believe it was good move getting it. Follow-up would not be possible as no contact details available.
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: stored outside of recommended temperature range; This case was reported by a consumer and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The case was reported by patient herself. Age at vaccination was not reported. The patient received a dose of Fluarix, 2021-2022 formulation at her local pharmacy. The pharmacy called the patient after the administration of the dose at the pharmacy, and informed her that the dose she was administered may be a part of a recall due to the vaccine being stored outside of recommended temperature range which led to incorrect storage of drug. The patient did not mention that she has had any adverse reactions from the dose administered. The date of the vaccine administration was not reported. The reporter gave consent to contact her health care professional.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received an expirated dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E40, expiry date 1st October 2021) for prophylaxis.   On 8th October 2021, the patient received Boostrix. On 8th October 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Medical assistant reported that a patient received a boostrix (single dose vial) dose which was expired on 1st October 2021, which led to expired vaccine used. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Administration after expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9L39Z, expiry date 8th October 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Other health care professional reported that medical assistant administered a dose of Boostrix vaccine which was expired on 8th October 2021, which led to expired vaccine used. The reporter consented to follow up by mail.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Rhinorrhoea
Clinical narrative: Vaccine breakthrough infection; Tested positive for covid19; loss sense of smell; Loss sense of taste; Lack of drug effect; Sniffles; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 266DZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced RHINORRHOEA (Sniffles). On 30-Sep-2021, the patient experienced COVID-19 (Tested positive for covid19), ANOSMIA (loss sense of smell), AGEUSIA (Loss sense of taste) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). On 02-Oct-2021, RHINORRHOEA (Sniffles), ANOSMIA (loss sense of smell) and AGEUSIA (Loss sense of taste) had resolved. At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection), COVID-19 (Tested positive for covid19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter. It was reported that Patient was near an infected unvaccinated person on 21September2021 and got a breakthrough infection from unvaccinated person.  Patient did not take any medicine before or after the vaccine.  Company comment: A 50-year-old male presented with a serious unexpected event of vaccine breakthrough infection, and non-serious COVID-19, rhinorrhoea, anosmia, ageusia, and drug ineffective. Latency 72 days after first dose and 45 days second dose. Event outcomes unknown. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: A 50-year-old male presented with a serious unexpected event of vaccine breakthrough infection, and non-serious COVID-19, rhinorrhoea, anosmia, ageusia, and drug ineffective. Latency 72 days after first dose and 45 days second dose. Event outcomes unknown. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccine breakthrough infection
Clinical narrative: Vaccine breakthrough infection; Tested positive for covid19; loss sense of smell; Loss sense of taste; Lack of drug effect; Sniffles; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 266DZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced RHINORRHOEA (Sniffles). On 30-Sep-2021, the patient experienced COVID-19 (Tested positive for covid19), ANOSMIA (loss sense of smell), AGEUSIA (Loss sense of taste) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). On 02-Oct-2021, RHINORRHOEA (Sniffles), ANOSMIA (loss sense of smell) and AGEUSIA (Loss sense of taste) had resolved. At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection), COVID-19 (Tested positive for covid19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter. It was reported that Patient was near an infected unvaccinated person on 21September2021 and got a breakthrough infection from unvaccinated person.  Patient did not take any medicine before or after the vaccine.  Company comment: A 50-year-old male presented with a serious unexpected event of vaccine breakthrough infection, and non-serious COVID-19, rhinorrhoea, anosmia, ageusia, and drug ineffective. Latency 72 days after first dose and 45 days second dose. Event outcomes unknown. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: A 50-year-old male presented with a serious unexpected event of vaccine breakthrough infection, and non-serious COVID-19, rhinorrhoea, anosmia, ageusia, and drug ineffective. Latency 72 days after first dose and 45 days second dose. Event outcomes unknown. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Breast cancer metastatic
Clinical narrative: I have found accounts of hundreds of others online who are in a similar situation; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of BREAST CANCER METASTATIC ) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER METASTATIC  (seriousness criterion medically significant). At the time of the report, BREAST CANCER METASTATIC  outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.  Company Comment: This case concerns a patient of an unknown age and gender with no reported medical history who experienced the unexpected event Breast cancer metastatic. The event occurred after unspecified dose and dates after mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event and dosing details were ont disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) in not affected by this report.  Breast cancer is a medical important event. There is very limited details to clinically assess this event.; Sender's Comments: This case concerns a patient of an unknown age and gender with no reported medical history who experienced the unexpected event Breast cancer metastatic. The event occurred after unspecified dose and dates after mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event and dosing details were ont disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) in not affected by this report.  Breast cancer is a medical important event. There is very limited details to clinically assess this event
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clotting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (blood clotting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clotting) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clotting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.  Company comment: This case concerns an uknown age and gender patient with no medical history provided, who experienced the unexpected event of Thrombosis(seriousness criterion medically significant). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine).On an unknown date, the patient experienced THROMBOSIS (blood clotting).The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns an uknown age and gender patient with no medical history provided, who experienced the unexpected event of Thrombosis(seriousness criterion medically significant). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine).On an unknown date, the patient experienced THROMBOSIS (blood clotting).The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: U
Vaccine: FLUX
Symptoms: Incorrect dose administered
Clinical narrative: high dose flu shot usually reacts on me; Initial information received on 07-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves a patient (unknown age and gender) whom high dose flu shot usually reacted (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 developed a non-serious high dose flu shot usually reaction (vaccination complication) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  It was reported "Going to wait until after my grandson's wedding Oct 16th. The high dose flu shot usually reacts on me."  At time of reporting, the outcome was unknown for the event.  There will be no information on the batch number for this case.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: A LITTLE SORE ARM A COUPLE OF DAYS; Initial information was received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves a 85-year-old and unknown gender patient who experienced a little sore arm a couple of days (pain in extremity) after receiving INFLUENZA VACCINE and COVID-19 VACCINE.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine.  The patient had no medical history, concomitant disease or risk factor.  Medical treatment, concomitant medication, vaccination 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: not reported) via unknown route in the right arm for prophylactic vaccination.  On an unknown date, the patient received a booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (batch number and expiry date: not reported) via unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious a little sore arm a couple of days (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  It was reported "NO REPERCUSSIONS WHATSOEVER OTHER THAN A LITTLE SORE ARM A COUPLE OF DAYS. NO BIG DEAL!!! THAT IS WHAT I DO. I AM 85 YEARS OLD AND COUNTING!! I DARE all of you to do the same.!!!"  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, the outcome was unknown from the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Fever; Initial information received on 11-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves an adult patient (unknown age and gender) who had fever (pyrexia), 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 (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  There were no laboratory 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 on the batch number for this case.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information was received on 10-Oct-2021 regarding an unsolicited valid non-serious social media  case from a consumer/non-healthcare professional.  This case involves adult female patient who had sore arm (pain in extremity), after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE for immunisation.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sore arm (pain in extremity) (unknown latency) for a couple of days following the administration of INFLUENZA VACCINE.  It was reported "hello, The following potential adverse event has been found on a public post for Flu Shot on social media. Since this is a public post on the social media we are assuming the consumer is referring to the Sanofi flu vaccine. I recently got flu shot. I got covid booster last week. It did not cause side effects like the first 2. Only sore arm a couple of days."  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 any corrective treatment for the event.  On an unknown date, the patient was recovered from the reported event.  There will be no information available on the lot number for this case.
Age: 7.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: gave a FLUZONE HIGH DOSE to a 7 year old with no adverse event; gave a FLUZONE HIGH DOSE to a 7 year old with no adverse event; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case from a pharmacist via Regulatory authority (reference number 00806937).  This case involves a seven-year-old and unknown gender patient who was by mistakenly given dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to product administered to patient of inappropriate age and overdose (latency: same day).  It was reported "A pharmacist is calling because a substitute pharmacist thinks he gave a FLUZONE HIGH DOSE to a 7 year old. Are there any negative effects and what should they do? When the pharmacist was asked for additional information she states that she is not 100% it happened yet and she needs to figure that out first. She states that the pharmacist who potentially administered the vaccine might be calling in as well to get information."  At the time of report no adverse event was reported and the outcome of the event 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 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.
Age: 8.0
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HDQ administered to an 8 year old patient with no adverse event; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and other healthcare professional via regulatory authority (under reference 00806950).  This case involves a 8-year-old patient (unknown gender) who received QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) [product administered to patient of inappropriate age].  The patient medical history, past medical treatment, vaccination, concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Inappropriate age at vaccine administration (same day latency).  It was reported "pharmacist reports that another pharmacist administered the FLUZONE HDQ to an 8 year old and is requesting any information about it. He also asks for information regarding under 65 administered."  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: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Gaze palsy, Influenza like illness, Pyrexia
Clinical narrative: low grade fever; bad headache; severe chills; diarrhea; flu like symptoms; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a via consumer non health care professional under reference number: US-SANOFI-00807408.  This case involves a 65 years old female patient who was experienced low grade fever (pyrexia), bad headache (headache), severe chills (chills), diarrhea and flu like symptoms (influenza like illness) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing Reaction to preservatives.  On 07-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site prophylactic vaccination.   On 09- Oct-2021, the patient developed a non-serious low grade fever (pyrexia), bad headache (headache), severe chills (chills), diarrhea and flu like symptoms (influenza like illness) two days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "A consumer of FLUZONE HIGH-DOSE, reporting a possible adverse reaction to the vaccine, consumer states she never gets the flu but decided to get the High-Dose formulation because she turned 65 this year, she stated she received the vaccine on Thursday 07Oct2021 and by Saturday 09Oct2021"  She states she is hypersensitive to preservatives but understand there are not any preservatives in the shot, she has recovered form the symptoms but inquires if studies are being conducted regardless of gender, she states studies in the 1970 used to be conducted on men only Management of Adverse Events and Product Technical Complaints Pasteur AE Reporting Refunds/Credits will not be issued due to adverse events.   No laboratory data reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was recovered from all the events.  There will be no information on the batch number for this case.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Syringe issue, Underdose
Clinical narrative: all the medication did not go into the patient, no AE; While administering Menactra the medication was leaking out between the needle and the syringe because it was not tight enough or connected correctly, no AE; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case from a nurse practitioner and consumer non health care professional via Media Information (under reference number 00808548).  This case involves a 16 years old female patient who was administered with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and while administering the medication was leaking out between the needle and the syringe because it was not tight enough or connected correctly (syringe issue), and because of which all the medication did not go into the patient (underdose).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication was given to the patient.  On 12-Oct-2021, the patient received 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (injection, lot U7191AA and expiration date: 18-Jan-2023)via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose and also a case of syringe leak (same day latency).  It was reported "The nurse practitioner is reporting that the syringe leaked while she was administering Menactra to a patient and she would like to know if the patient should receive another dose and is that safe and if so when should they receive it and do they have to wait a specific amount of time. The nurse practitioner states that she never had this happen before and she just attempted to administer Menactra to a patient and she noticed that the medication was leaking out between the needle and the syringe because it wasn't tight enough or connected correctly. She states that all the medication didn't go into the patient. She states that she pulled up the medication from the vial without any issues."  No laboratory data reported.  The nurse will revaccinate the patient.  At time of reporting, no adverse event was reported and the outcome was unknown for the reported events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, Medication error
Clinical narrative: Yf-Vax that was administered intramuscularly instead of by the recommended subcutaneous route, with no reported AE; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case from a physician. This case involves a patient of (unknown demographics) who experienced YELLOW FEVER VACCINE - US [YF-VAX] that was administered intramuscularly instead of by the recommended subcutaneous route (incorrect route of product administration).  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 0.5 ml dose of suspect YELLOW FEVER VACCINE - US (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 subcutaneous injection formulation administered by other route (same day).  It was reported "Physician reports a nurse gave YF-VAX by the intramuscular route instead of subcutaneous route. Do we have to re-dose it. Will it still last for life, or would a booster be needed."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported 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.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACT-HIB was reconstituted with store water instead of the diluent it came with, no reported adverse event; Initial information received on 12-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00809033.  This case involves a one years old female patient who was received HAEMOPHILUS TYPE B (HIB) VACCINE[ACT-HIB] (product preparation error).  The patient's medical history, past medical treatments, vaccinations and family history were not provided..  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX)  and WATER FOR INJECTION (STERILE WATER) for Immunisation.  On 12-Oct-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ525AAB and expiry number:11-JUL-2022 via intramuscular route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to Wrong solution used in drug reconstitution (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: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error
Clinical narrative: patient received a fluzone high dose quadrivalent today, patient did have the same shot two weeks ago and the patient forgot, with no reported adverse event; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional via Regulatory authority (under reference:00809230).  This case involves a 77-year-old female patient who received a INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] today, patient did have the same shot two weeks ago and the patient forgot (extra dose administered).   The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 12-Oct-2021, the patient received a second dose of 0.7mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ733AA and expiry date: 30-June-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  This was an actual case of medication error due to extra dose administered (same day latency).  It was reported "medical assistant is calling to report that a patient received a FLUZONE HIGH DOSE QUADRIVALENT today in the office. The patient did have the same shot two weeks ago and the patient forgot. The husband called the doctors office today to advise."  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: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally received an ACTHIB vaccine that expired on 04OCT2021 with no reported adverse event; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and consumer non health care professional via Medical Information (MI) number: 00809297.  This case involves a one years old female patient who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered).  The patient's medical history, medical treatments, vaccinations, and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ404AA and expiry date: 04-OCT-2021 via intramuscular route in unknown administration site for prophylactic vaccination.  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: 72.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine accidentally administered/ no AE; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/non-healthcare professional via call center via Medical Information (Reference number- 00810513).  This case involves a 72-year-old male patient was vaccinated with an expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL); HEPATITIS A VACCINE (HEPATITIS A VACCINE); and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  On 13-Oct-2021, the patient received a 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number: R2A741M and expiry date: 05-Oct-2021) via an intramuscular route at a the left arm for prophylactic vaccination.  It was an actual medication error case 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: She received Pfizer Covid 19 vaccination. It should have been Moderna. She received her 1st Moderna shot on 9-18-21