chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Skin burning sensation, Tinnitus, Vaccination site rash
Clinical narrative: delerious; Fever; Rash; horrible body aches; Skin on fire; severe headache; pounding a rod into brain; dizzy; lack of concentration; eyes not dilating; ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (delerious) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DELIRIUM (delerious) (seriousness criterion medically significant), PYREXIA (Fever), VACCINATION SITE RASH (Rash), PAIN (horrible body aches), SKIN BURNING SENSATION (Skin on fire), HEADACHE (severe headache), HEADACHE (pounding a rod into brain), DIZZINESS (dizzy), DISTURBANCE IN ATTENTION (lack of concentration), MIOSIS (eyes not dilating) and TINNITUS (ringing in ears). At the time of the report, DELIRIUM (delerious), PYREXIA (Fever), VACCINATION SITE RASH (Rash), PAIN (horrible body aches), SKIN BURNING SENSATION (Skin on fire), HEADACHE (severe headache), HEADACHE (pounding a rod into brain), DIZZINESS (dizzy), DISTURBANCE IN ATTENTION (lack of concentration) and MIOSIS (eyes not dilating) outcome was unknown and TINNITUS (ringing in ears) had not resolved.            This case concerns a 62-year-old female with a serious unexpected event of delirium, and nonserious unexpected dizziness, pain, skin burning sensation, disturbance in attention, miosis, tinnitus, and expected fever, headache, vaccination site rash. Event onset 2 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 62-year-old female with a serious unexpected event of delirium, and nonserious unexpected dizziness, pain, skin burning sensation, disturbance in attention, miosis, tinnitus, and expected fever, headache, vaccination site rash. Event onset 2 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Foot fracture, Headache, Vaccination site pain
Clinical narrative: Broke her leg; Injection arm hurting; Headache; Felt very tired; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of FOOT FRACTURE (Broke her leg) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection arm hurting), HEADACHE (Headache) and FATIGUE (Felt very tired). On 30-Mar-2021, the patient experienced FOOT FRACTURE (Broke her leg) (seriousness criterion hospitalization). The patient was treated with Surgery for Foot fracture. On 30-Mar-2021, FOOT FRACTURE (Broke her leg) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection arm hurting), HEADACHE (Headache) and FATIGUE (Felt very tired) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment medications for the events included hydrocodone and acetylsalicylic acid.   No concomitant medications were reported.  Company Comment  Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hand fracture, Pruritus, Urticaria, Vaccination site pain
Clinical narrative: broken left hand; itching; raised clear bumps on front of thigh; soreness of the injection site of left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAND FRACTURE (broken left hand) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastrointestinal disorder NOS (Taking meds for "intestinal issues"). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, URSODIOL, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and FAMOTIDINE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HAND FRACTURE (broken left hand) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (soreness of the injection site of left arm). On an unknown date, the patient experienced PRURITUS (itching) and URTICARIA (raised clear bumps on front of thigh). The patient was hospitalized from 21-Mar-2021 to 22-Mar-2021 due to HAND FRACTURE. On 22-Mar-2021, VACCINATION SITE PAIN (soreness of the injection site of left arm) had resolved. At the time of the report, HAND FRACTURE (broken left hand), PRURITUS (itching) and URTICARIA (raised clear bumps on front of thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of the events included salve and prednisone.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dyspnoea, Nasopharyngitis, Pneumonia, SARS-CoV-2 test
Clinical narrative: pneumonia; Breathing difficult; Cold; lost her voice; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medically reported history).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (Breathing difficult), NASOPHARYNGITIS (Cold) and APHONIA (lost her voice). On 17-Mar-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 17-Mar-2021 to 20-Mar-2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (pneumonia) was resolving and DYSPNOEA (Breathing difficult), NASOPHARYNGITIS (Cold) and APHONIA (lost her voice) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment: Nebulizer, Hydrocodone, Antibiotics. Prednisone No concomitant product use was reported  Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis, Ultrasound joint
Clinical narrative: Blood Clot in the Left leg; Pain in the Left Leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood Clot in the Left leg) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL and HCTZ for Blood pressure high.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Pain in the Left Leg). On 14-Apr-2021, the patient experienced THROMBOSIS (Blood Clot in the Left leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood Clot in the Left leg) and PAIN IN EXTREMITY (Pain in the Left Leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Ultrasound joint: ultrasound (abnormal) Blood Clot in the Left leg.         Patient did not have a history of Blood Clots. She was Not taking any hormones (Estrogen, Progesterone)Treatment for event included Eliquis for blood clot. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event a causal relationship cannot be excluded.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pathogen resistance, Pneumonia aspiration
Clinical narrative: Multidrug resistant infection; Aspiration Pneumonia; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PNEUMONIA ASPIRATION (Aspiration Pneumonia) and PATHOGEN RESISTANCE (Multidrug resistant infection) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 immunization.     The patient's past medical history included Aspiration (Patient has history of recurrent aspiration) since an unknown date. Concurrent medical conditions included Drug allergy (Cepacol), Cerebral palsy, Spastic quadriplegia, Seizures and Mental disability.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PNEUMONIA ASPIRATION (Aspiration Pneumonia) (seriousness criterion hospitalization). On an unknown date, the patient experienced PATHOGEN RESISTANCE (Multidrug resistant infection) (seriousness criterion hospitalization). The patient was hospitalized from 12-Mar-2021 to 16-Mar-2021 due to PATHOGEN RESISTANCE and PNEUMONIA ASPIRATION. On 16-Mar-2021, PNEUMONIA ASPIRATION (Aspiration Pneumonia) outcome was unknown. At the time of the report, PATHOGEN RESISTANCE (Multidrug resistant infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not reported. Patient was transferred to a  facility for long-term antibiotic treatment.  Regarding Aspiration pneumonia, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Regarding Multidrug resistant infection, very limited information has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-076748 (Patient Link).; Sender's Comments: Regarding Aspiration pneumonia, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Regarding Multidrug resistant infection, very limited information has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: allergic reaction; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (Reference number- 00535257) and transmitted to Sanofi on 25-Mar-2021.  This case involves a female patient (age not reported) who had allergic reaction (allergy to vaccine) while receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past vaccination(s) included Influenza vaccine in 1970 and DTP VACCINE for prophylactic vaccination and experienced itching after receiving DTP VACCINE.  The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided.   On 20-Sep-2012, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot UH714AA and expiry date: 30-Jun-2013) via an unknown route in an unknown administration site for prophylactic vaccination.  On 20-Sep-2012 the patient developed a non-serious allergic reaction (allergy to vaccine) same day following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  The caller had a known allergy to thimerosal. She had an allergic reaction to a flu vaccine but does not know which manufacturer's vaccine it was that caused the reaction. At the time, it was thought her allergic reaction happened due to her thimerosal allergy because even though the outer package of the vaccine she received indicated "thimerosal free", it was later found in the package insert that the product contained a millimicron of thimerosal. She did not have information about what presentation but thinks it was possible that it was from a single dose vial. She summarized that she had only reacted to two types of vaccines in her lifetime. She had reacted mildly with itching to DTP vaccines. She did not receive any more flu vaccines until in 2007 and at that time went into the hospital. She avoided reactions because that entire time she thought it was thimerosal she was allergic to, and as long as she would avoid thimerosal, she thought she was okay. But she did note that her allergist did not believe that thimerosal causes allergic reactions of the type that she experienced.  The details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: 2 month-old male was administered a Pentacel vaccine, but it was not reconstituted with the HIB portion of the vaccine with no adverse event.; Initial information regarding an unsolicited valid non-serious was received from other health professional via Medical Information (Reference number- 00537382) and transmitted to Sanofi on 26-Mar-2021.  This case involves a 2 months old male patient who was administered with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], but it was not reconstituted with the HIB portion of the vaccine (lot UJ336AAA and expiry date: 05-Jul-2021) via intramuscular route at an unknown administration site for prophylactic vaccination on 23-Mar-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was actual medication error due to Inappropriate reconstitution technique (on same day).  The reporter wanted to know if there was any other diluent that can be used on the Pentacel powder and inquire about ordering 0.4% (percent) sodium chloride solution. The error was discovered on the day of reporting. They reported that they will administer stand-alone ActHIB.  At the time of report, the patients experienced 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.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: a patient received an expired dose of ACT-HIB vaccine/ No AE; Initial information received on 29-Mar-2021 and additional information received on 01-Apr-2021 regarding an unsolicited valid non-serious case received from a Other Health Care Professional via nurse via physician via Medical Information (Reference number- 00539890).  This case is linked to case 2021SA112593 (same reporter, sibling).  This case involves a 6 months old male patient who received an expired 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] batch number: UJ143AAA, expiry date: 22-Mar-2021, Frequency: once, Strength: standard via intramuscular route in the left vastus lateralis on 29-Mar-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination respectively.  It was an actual medication error due to expired vaccine used (latency: same day).  Potential Product Technique Complain: No, Caller stated that they gave two different children the product that had expired. Caller wanted to know what should they do. Outbound call made at 1:09 pm on 30-Mar-2021. No response. Voicemail left with case and contact number. Nurse called previously about Act-Hib and is looking for guidance on how to proceed. Treatment: The clinic calling the manufacturer for guidance. Product used, 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 holders 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.
Age: 1.25
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product distribution issue, Product storage error
Clinical narrative: a patient received a dose of PENTACEL which was delayed a day in transit, took too long to deliver to the office/ No AE; a patient received a dose of PENTACEL which was delayed a day in transit, took too long to deliver to the office/ No AE; Initial information received on 29-Mar-2021 regarding an unsolicited valid  non-serious case received from an other health care professional via physician (Reference number- 00539892).  This case involves a 15 months old and unknown gender patient who received a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was delayed a day in transit, took too long to deliver to the office (batch number UJ403AAA, expiry date: 09-OCT-2021) Frequency: once, Strength: standard via intramuscular route in the left thigh on 25-Mar-2021 for prophylactic vaccination (product storage error and product distribution issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  List concomitant or no other vaccines: none.  It was an actual medication error due to incorrect product storage and product shipment delay (latency: same day).  Potential Product Technique Complain: No, Caller states that their PENTACEL was delayed a day in transit but were placed in the fridge as soon as they arrived, the ice packs were still cold. Informed caller that the stability info is only after they have arrived to the facility. Caller stated that three doses were given right when it was delivered, do they need to repeat the doses. How far apart should they be administered. Vaccine given after product took too long to deliver to the office.  Emergency Room/ Doctor Visit date: 25Mar2021, Product used 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 holders 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.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: a patient received an expired dose of Menactra/ No AE; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from an other health care professional (HCP) in the .  This case involves a 16 years old male patient who received an expired 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] Oral solution (batch number: U6565AB and expiry date: 28-MAR-2021, Strength: standard) via intramuscular route in the right arm on 30-Mar-2021 for prophylactic vaccination (Expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.   List concomitant or no other vaccines: None.  It was an actual medication error due to expired vaccine used (latency: same day).  Potential Product Technique Complain: No, Reporter relationship: HCP, Product used and Still using product: No.  No reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Age: 0.17
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Medication error
Clinical narrative: patient received expired dose of Ipol/ no adverse event; Initial information was regarding an unsolicited valid non-serious case was received on 31-Mar-2021 from a Other Health Care Professional (Medical Assistant) via Global Medical Information (GMI) (Reference number- 00542928) and transmitted to Sanofi on 31-Mar-2021 in the United States   This case involves a 2 month-old female patient who was vaccinated with expired dose of IPV (VERO) [IPOL] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); HIB VACCINE (HIB) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  On 30-Mar-2021, the patient received 0.5 mL (once) total dose of suspect IPV (VERO) (lot R1B25 and expiry date 13-Mar-2021) via an intramuscular route at the left vastus lateralis for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  It was also reported that the caller reported that the IPOL was delivered to the clinic on 16-Nov-2020 and it was not suspected to expire so soon on 13-Mar-2021. Product was not still in use.  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 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: 18.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient was administered an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non healthcare professional via Agency (reference number- 00543062) and transmitted to Sanofi on 31-Mar-2021.  This case involves an 18 year old male patient who was administered an expired 0.5ml dose of suspect IPV (VERO) [IPOL] (lot number: R1B251M and expiry date: 13-Mar-2021) via subcutaneous route in the right arm for prophylactic vaccination on 23-Mar-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (lot number and expiry date: not reported), HEPATITIS B VACCINE (lot number and expiry date: not reported) and DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TETANUS DIPHTHERIA) for prophylactic vaccination.   It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter stated that IPOL expired on 13-Mar-2021 and administered to the patient on 23-Mar-2021. The reporter wanted to knowif there was a grace period.  At the time of this 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 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: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received expired dose of MENACTRA vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via call-center via Global Medical Information (GMI) (Reference number- 00545117) and transmitted to Sanofi on 01-Apr-2021 in the United States.  This case involves a 16 years old male patient who received expired second dose of 0.5 mL MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [strength: standard, frequency: once, batch number: U6565AB and expiry date: 28-Mar-2021 via intramuscular route in deltoid not otherwise specified (NOS)] (expired vaccine used) on 30-Mar-2021 for prophylactic vaccination.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to expired product administered (latency: 1 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 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: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered expired dose of IPOL today with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00546482) and transmitted to Sanofi on 02-Apr-2021.  This case involves a 4 years old female patient who received expired dose of IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 02-Apr-2021, the patient received a fourth 0.5 mL dose of suspect IPV (VERO) lot R1B251M, expiry date-13-Mar-2021 via subcutaneous route in the right thigh for prophylactic vaccination.  It was a actual medication error due to expired vaccine used (latency same day).  HCP called because they have a patient who was inadvertenly administered an expired dose of IPOL, to see when it is recommended to repeat the dose.Practice is planning to repeat the dose.  At the time of report there was 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of ActHIB was given with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00549606) and transmitted to Sanofi on 06-Apr-2021.  This case involves a patient with unknown demographics who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] lot UJ112AAC, expiry date- 21-JUN-2020 via unknown route in unknown administration site for prophylactic vaccination on 06-Apr-2021.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was the actual medication error due to expired vaccine used (latency same day).  At the time of report there was 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chills, Dyspnoea
Clinical narrative: I began to feel shortness of breath when walking, tightness in my chest, for the same reason any physical effort made me feel like I was short of breath. (The day before I had presented the common symptoms such as fever, chills, arm pain, muscle pain) however this symptom was off the list, at 11:30 in the morning I had to go to an emergency clinic, they checked me with blood test, urine tests, medical exam, electrocardiogram, and chest X-ray. The doctor told me that everything was fine that I could leave. I had to pay a high bill at the hospital. The following 7 days the sensation was disappearing very slowly. However from day 8 it started again, until now on day 13, I still having sensation of shortness of breath when doing physical exercise, it is something that lasts and does not disappear.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Myalgia, Pain in extremity, Pyrexia, Urine analysis
Clinical narrative: I began to feel shortness of breath when walking, tightness in my chest, for the same reason any physical effort made me feel like I was short of breath. (The day before I had presented the common symptoms such as fever, chills, arm pain, muscle pain) however this symptom was off the list, at 11:30 in the morning I had to go to an emergency clinic, they checked me with blood test, urine tests, medical exam, electrocardiogram, and chest X-ray. The doctor told me that everything was fine that I could leave. I had to pay a high bill at the hospital. The following 7 days the sensation was disappearing very slowly. However from day 8 it started again, until now on day 13, I still having sensation of shortness of breath when doing physical exercise, it is something that lasts and does not disappear.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given vaccine 7 days earlier than due. Firs vaccination was on 4-5-21. Second given 4-19-21
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Day of Vaccination, fatigue 4 hours after.  12 - 13 hours after I woke up with unusual joint pain very intense in my ankles, feet and knees and a bad headache that was not like my usual headaches.  the next day, I felt pretty good, I told my husband I have a leg cramp tin my left leg that does not feel like a charley horse.  I ate a banana, drank lots of water and took a magnesium capsule to help with the leg cramp. and by 1pm I started to develop a headache.  I did not report because I have frequent headaches.  It intensified as the day progressed.  after Sunday, this became a daily occurrence. Early afternoon I would start to get intense headaches and i would go home take benadryl and sinus medicine to help  ease the pain.  Continued on daily until Saturday April 17th when my headache became so bad I could not stand it anymore.  I was nauseous and shaking.  No fever but profuse sweating and weakness.  Went to the ER around 930pm and was released around 12am after they gave me an IV with anti nausea meds and benadryl.  Sunday I was weak with headache all day.  Woke up today (Monday 4/19) with a headache and felt fatigued and severe headache.  It does not feel like a sinus headache nor tension, nor hormonal.  It is my entire head throbbing and left side of my head is sensitive to pressure.  I have not sustained any head injuries in the past year or longer.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Tremor
Clinical narrative: Day of Vaccination, fatigue 4 hours after.  12 - 13 hours after I woke up with unusual joint pain very intense in my ankles, feet and knees and a bad headache that was not like my usual headaches.  the next day, I felt pretty good, I told my husband I have a leg cramp tin my left leg that does not feel like a charley horse.  I ate a banana, drank lots of water and took a magnesium capsule to help with the leg cramp. and by 1pm I started to develop a headache.  I did not report because I have frequent headaches.  It intensified as the day progressed.  after Sunday, this became a daily occurrence. Early afternoon I would start to get intense headaches and i would go home take benadryl and sinus medicine to help  ease the pain.  Continued on daily until Saturday April 17th when my headache became so bad I could not stand it anymore.  I was nauseous and shaking.  No fever but profuse sweating and weakness.  Went to the ER around 930pm and was released around 12am after they gave me an IV with anti nausea meds and benadryl.  Sunday I was weak with headache all day.  Woke up today (Monday 4/19) with a headache and felt fatigued and severe headache.  It does not feel like a sinus headache nor tension, nor hormonal.  It is my entire head throbbing and left side of my head is sensitive to pressure.  I have not sustained any head injuries in the past year or longer.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Pain in extremity, Rash macular
Clinical narrative: Day 2, my arm was sore to touch and move around. Day 3 I noticed my arm was starting to itch, and also had a large red blotch on my left arm around the injection spot. it is now day 5 and the red blotch is still there & itches more than before.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Cyanosis, Fatigue, Headache, Incontinence, Loss of consciousness
Clinical narrative: 10 min post vaccination patient became unconcious With clear signs of siezure *Incontinence *Cyanosis with postictal *headache *nausea *drowsiness *Airway management 30-60 sec *Tireness *Sleeppy *presentacion PT required
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Seizure, Somnolence
Clinical narrative: 10 min post vaccination patient became unconcious With clear signs of siezure *Incontinence *Cyanosis with postictal *headache *nausea *drowsiness *Airway management 30-60 sec *Tireness *Sleeppy *presentacion PT required
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular, Tenderness
Clinical narrative: My left arm is very sore with a 2 inch diameter blotch on it. The blotch is red and raised. When I touch it, it is sore to the touch.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: One hour after vaccination started to run fever had body aches and chills along with headache. These lasted for 4 days. On the 5th day flu like symptoms faded but all she wanted to do was sleep. No appetite. She is 10 days out and is still very sleepy and does not feel like doing anything. The headache has not completely  subsided. I advised her to call her Dr.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: One hour after vaccination started to run fever had body aches and chills along with headache. These lasted for 4 days. On the 5th day flu like symptoms faded but all she wanted to do was sleep. No appetite. She is 10 days out and is still very sleepy and does not feel like doing anything. The headache has not completely  subsided. I advised her to call her Dr.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram T wave inversion, Palpitations
Clinical narrative: palpitations, abnormal EKG - T-wave inversions in II, III, AVF as well as S1Q3T3 pattern
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Injection site pain, Injection site swelling, Neck pain, Paraesthesia
Clinical narrative: After giving the injection the patient had severe pain at the injection site. A few minutes later she struggled to make a fist with her same hand and reported having pain going up her neck. The injection site did swell up a few minutes after the injection as well and she felt tingling in her hands shortly after. Patient was given 25 mg of benadryl after she reported the tingling in her hands. She did not have any difficulty breathing though. She was able to stand up and walk with her parent to the car and was driven to ER by parent to be checked out.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, chills, muscle aches, fatigue starting about 10 hours after vaccine was administered and lasting about 24 hours. After that, chills went away and headache improved. Muscle aches/fatigue continued for another 3-4 days.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Defaecation urgency, Dizziness, Fall, Feeling abnormal, Loss of consciousness
Clinical narrative: I?m a healthcare worker who has worked in Neurology and Behavioral Health for 10 years. I have never had an abnormal EEG due to my history of migraines.   I was in bed when I felt severe lightheadedness and an urgent needed to defacate. My husband lowered the bed to help with the lightheadedness however the need to defacate remained and I went into the bathroom had LOC, hit my head on the door jam, fell to the floor. No tonic/clinic movement was noted by husband. No bowel or bladder incontinence. The LOC remained for 15 seconds. I regained consciousness and was aware of my surroundings but was not clear headed. I crawled to the toilet but was not able to hoist myself onto the toilet. I leaned over the bathtub (Still on my knees) and nearly had another LOC. My husband helped me onto the toilet and I was able to relieve myself and a couple of minutes later while still lightheaded I was able to get back to the bed on my own while holding onto the wall. I texted Dr and made him aware of this incident. He advised me to schedule EEG, carotid ultrasound and CT head on the upcoming Monday. Carotid ultrasound was within normal limits.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan normal
Clinical narrative: I?m a healthcare worker who has worked in Neurology and Behavioral Health for 10 years. I have never had an abnormal EEG due to my history of migraines.   I was in bed when I felt severe lightheadedness and an urgent needed to defacate. My husband lowered the bed to help with the lightheadedness however the need to defacate remained and I went into the bathroom had LOC, hit my head on the door jam, fell to the floor. No tonic/clinic movement was noted by husband. No bowel or bladder incontinence. The LOC remained for 15 seconds. I regained consciousness and was aware of my surroundings but was not clear headed. I crawled to the toilet but was not able to hoist myself onto the toilet. I leaned over the bathtub (Still on my knees) and nearly had another LOC. My husband helped me onto the toilet and I was able to relieve myself and a couple of minutes later while still lightheaded I was able to get back to the bed on my own while holding onto the wall. I texted Dr and made him aware of this incident. He advised me to schedule EEG, carotid ultrasound and CT head on the upcoming Monday. Carotid ultrasound was within normal limits.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Injection site inflammation, Injection site warmth
Clinical narrative: Within  the first hour of administration I felt nauseous. Then vomited 3 times within a few hours after the shot. Was nauseous and clammy for the rest of the day Saturday . By 2pm I felt drained and exhausted and had a headache which  carried over to most of the next day. My injection site was hot and inflamed as well but has gone down over the last 12 hours.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Within  the first hour of administration I felt nauseous. Then vomited 3 times within a few hours after the shot. Was nauseous and clammy for the rest of the day Saturday . By 2pm I felt drained and exhausted and had a headache which  carried over to most of the next day. My injection site was hot and inflamed as well but has gone down over the last 12 hours.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old minor received Moderna Covid Vaccine
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fall, Head injury, Limb injury, Syncope
Clinical narrative: 5-10min after 2nd dose, pt fainted while sitting in waiting room chair.  pt fell forward tipping chair and fell into blood pressure machine.  head was scraped between the eyes--slight bleed.  pt leg was bruised and pant leg torn from falling into machine.  i told technician to call 911 while i went to pt and attempted to sit him up.  pt was unresponsive for 20-30 seconds.  as he came to, he was able to speak.  moved to chair and gave him water as paramedics arrived.  they did full assessment x 20-30min.  pt did not want to be transported to hospital so they asked him to stay for additional 30min.  he then said he was ok to go home.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Insomnia, Nasal congestion
Clinical narrative: Daily minor nosebleeds. Nightly nasal congestion. Difficulty falling asleep. All minor.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills
Clinical narrative: CHILLS STARTING 1 OR 2 WEEKS AFTER 1ST SHOT AND CONTINUING
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is out of age range for the COVID vaccine. Mother lied about patient's age.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Laboratory test, Peripheral swelling, Thrombosis
Clinical narrative: Blood clot left arm, arm swelling
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Blood clot left arm, arm swelling
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Numbness, pain and tingling in lower left leg and foot.  Started 5-7 days after 1st shot and accelerated after 2nd shot
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Mononucleosis heterophile test negative, Oral discomfort, Rash, Streptococcus test negative
Clinical narrative: Rash on the same arm shot was given, on inner thighs, neck, behind knees, small of back and legs.  Burning inside mouth.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cognitive disorder, Confusional state, Suicidal ideation
Clinical narrative: Unable to discern drugs by their name at job, anxiety, cognitive disruptions, suicidal ideation
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Pain in extremity, Peripheral artery aneurysm, Positron emission tomogram abnormal, Ultrasound Doppler abnormal
Clinical narrative: The day after I received the vaccine I felt pain in my right leg. I went to a pain mangagement doctor and he ordered an ultrasound. It revealed that it was negative for a blood clot but it was an psuedo aneurism. I then had a CTA scan that revealed that it was a Popiteal  aneruism. The doctor does not know the cause of this but said that it could be a reaction from the vaccine.