chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The caller says that most of the patients report they have a sore injection site arm for a day./The patient had a reaction of a sore left injection site for 1 day.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (The caller says that most of the patients report they have a sore injection site arm for a day./The patient had a reaction of a sore left injection site for 1 day.) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The caller says that most of the patients report they have a sore injection site arm for a day./The patient had a reaction of a sore left injection site for 1 day.). At the time of the report, VACCINATION SITE PAIN (The caller says that most of the patients report they have a sore injection site arm for a day./The patient had a reaction of a sore left injection site for 1 day.) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that patient had a sore left injection site arm for a day. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750826, US-MODERNATX, INC.-MOD-2023-750828, US-MODERNATX, INC.-MOD-2023-750829 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2023: Follow up received and added patient details and added references.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750829:Same reporter, different patient US-MODERNATX, INC.-MOD-2023-750828:Same reporter, different patient US-MODERNATX, INC.-MOD-2023-750826:Same reporter, different patient
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient had a sore injections site arm; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Patient had a sore injections site arm) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Patient had a sore injections site arm). At the time of the report, VACCINATION SITE PAIN (Patient had a sore injections site arm) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750747 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750747:Same reporter, different patient
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient had a sore injection site arm for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient had a sore injection site arm for a day) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Patient had a sore injection site arm for a day). At the time of the report, VACCINATION SITE PAIN (Patient had a sore injection site arm for a day) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750747 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750747:Same reporter, different patient
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The patient complains of a sore injection site arm for a day.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The patient complains of a sore injection site arm for a day.) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) 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 VACCINATION SITE PAIN (The patient complains of a sore injection site arm for a day.). At the time of the report, VACCINATION SITE PAIN (The patient complains of a sore injection site arm for a day.) had resolved.        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 concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750747 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750747:Same reporter, different patient
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Rhinorrhoea
Clinical narrative: Caller continually have running nose and no taste; Caller continually have running nose and no taste; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Caller continually have running nose and no taste) and AGEUSIA (Caller continually have running nose and no taste) in a 61-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy, Hypercholesterolemia and Hypertension.    In 2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced RHINORRHOEA (Caller continually have running nose and no taste) and AGEUSIA (Caller continually have running nose and no taste). At the time of the report, RHINORRHOEA (Caller continually have running nose and no taste) and AGEUSIA (Caller continually have running nose and no taste) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patients took vaccine about 10 days. He has had running nose and no taste. Even when they put salt on stuff they can't taste stuff. This was the patient 4th dose. Patient was on cholesterol and high blood pressure medication.  Treatment medication was not reported. Company comment: This spontaneous case concerns a 61-year-old male patient, with no relevant medical history reported, who experienced the unexpected and non-serious AESI of AGEUSIA after the fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. Since the vaccination date and the onset date of the event were not reported, latency could not be properly assessed. No details of previous doses were provided. No treatment information was reported. No further clinical information was available for medical review. The reported rhinorrhea could be a risk factor for ageusia. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750835 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750835:Wife case
Age: 0.17
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max temperature reached: 8-11°C on 04Oct2023 for 8 hours and 30 minutes/4 patients were involved with no reported adverse event; Max temperature reached: 8-11°C on 04Oct2023 for 8 hours and 30 minutes/4 patients were involved with no reported adverse event; Initial information received on 16-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case is linked to case 2023SA358554.  This case involves a 2 months old male patient and reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated) Ipv (Vero) (Ipol)/max temperature reached: 8-11°c on 04oct2023 for 8 hours and 30 minutes/ patients were involved with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2023, the patient received an unknown dose of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (with an unknown strength, expiry date, lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, temperature excursion for Poliomyelitis Vaccine (Inactivated) Ipv (Vero) (Ipol)/max temperature reached: 8-11°c on 04oct2023 for 8 hours and 30 minutes/ patients were involved with no reported adverse event(product storage error, unknown latency) (poor quality product administered, Latency: same day).   It was reported, An office manager is reporting multiple temperature excursion and would like to know if the vaccine is still viable for use. She stated that she called regarding the temperature excursion but was informed to call the manufacturer instead. She also mentioned that the vaccines were never frozen. Products: IPOL, VAXELIS, PENTACEL Opened products: IPOL. Reason: They were calibrating the log tags Max temperature reached: 8-11°C on 04Oct2023 for 8 hours and 30 minutes. Duration out of labelled range: Yes Human error:  Yes Does extended stability data cover the excursion: No Administered to a patient: Yes 4 patients were involved. Previous excursion Yes 17Oct2023 | 10:23PM - 10:26PM (3 minutes) | -16°C to -19°C 23Oct2023 | 12:31PM - 12:46PM (15 minutes) | -19°C 26Oct2023 to 09Nov2023 | -24°C This situation is pre-assessed as a medication error/an inappropriate use due to vaccines being administered to a patient post-excursion.    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: 2.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: box was left out and was not refrigerated for 5 days and vaccines were administered post excursion with no reported adverse event; box was left out and was not refrigerated for 5 days and vaccines were administered post excursion with no reported adverse event; Initial information received on 14-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 2 years old patient of unknown gender and it was reported box was left out and was not refrigerated for 5 days and influenza quadrival A-B vaccine [Fluzone Quadrivalent] vaccine was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2023 at 08:15 AM, the patient received a dose of 0.5 ml once of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: U8200AA; expiry date: 30-Jun-2024) via unknown route in the unknown administration site for Immunization and it was reported that box was left out and was not refrigerated for 5 days and vaccines were administered post excursion with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion ,box was left out and was not refrigerated duration: 5 days with no reported adverse event; box was left out and was not refrigerated, vaccines were actually delivered on 08NOV2023 and administered to patient on 14NOV2023 with no reported adverse event; Initial information received on 14-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a 12 years old unknown gender patient who was administered Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] on 14nov2023 with no reported adverse event and temperature excursion ,box was left out and was not refrigerated duration: 5 days with no reported adverse event and box was left out and was not refrigerated, vaccines were actually delivered on 08nov2023.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2023, the patient received dose of 0.5 ml suspect INFLUENZA QUADRIVAL A-B VACCINE once (lot U8200AA and expiry date: 30-Jun-2024) (Unknown formulation and strength)  via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date there was temperature excursion ,box was left out and was not refrigerated duration: 5 day  with no reported adverse event (product storage error)(unknown latency), Influenza Quadrival A-B Vaccine were actually delivered on 08nov2023 and administered to patient on 14nov2023 with no reported adverse event (poor quality product administered)  (latency: same day)   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Disability, Gait inability, Headache, Impaired work ability, Malaise
Clinical narrative: had a headache and due to this, the patient had to stop working for several days; unable to walk/felt so sick that he cannot walk; having a migraine/had a headache; felt very sick; Initial information received on 16-Nov-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 62 years old male patient who had a headache and due to this, the patient had to stop working for several days, unable to walk/felt so sick that he cannot walk, having a migraine/had a headache and felt very sick after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical treatment included Influenza Vaccine. The patient's past medical history, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (lot: UT8148LA) (formulation; strength; expiry date, route, administration site not reported) for Prophylactic vaccination (Immunisation).  On an unknown date the patient had a headache and due to this, the patient had to stop working for several days (impaired work ability); unable to walk/felt so sick that he cannot walk (gait inability); had migraine/had a headache (migraine) and felt very sick (malaise) (unknown latency).  Reportedly, patient also mentioned that his wife was starting to have the sickness that he had and he was afraid that his wife may transfer it to her father who was already old. Consumer reported that he has been taking flu vaccines and pneumonia vaccines yearly but this is the first time that this had happened.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.  The event impaired work ability was assessed as leading to disability.; Sender's Comments: Sanofi Company Comment dated 21-Nov-2023: This case involves a 62 years old male patient who had a headache and due to this, the patient had to stop working for several days, after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]. Time to onset is unknown. Further information on allergy history, patient's medical history, family history, concomitant medication, laboratory investigation, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Migraine
Clinical narrative: had a headache and due to this, the patient had to stop working for several days; unable to walk/felt so sick that he cannot walk; having a migraine/had a headache; felt very sick; Initial information received on 16-Nov-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 62 years old male patient who had a headache and due to this, the patient had to stop working for several days, unable to walk/felt so sick that he cannot walk, having a migraine/had a headache and felt very sick after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical treatment included Influenza Vaccine. The patient's past medical history, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (lot: UT8148LA) (formulation; strength; expiry date, route, administration site not reported) for Prophylactic vaccination (Immunisation).  On an unknown date the patient had a headache and due to this, the patient had to stop working for several days (impaired work ability); unable to walk/felt so sick that he cannot walk (gait inability); had migraine/had a headache (migraine) and felt very sick (malaise) (unknown latency).  Reportedly, patient also mentioned that his wife was starting to have the sickness that he had and he was afraid that his wife may transfer it to her father who was already old. Consumer reported that he has been taking flu vaccines and pneumonia vaccines yearly but this is the first time that this had happened.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.  The event impaired work ability was assessed as leading to disability.; Sender's Comments: Sanofi Company Comment dated 21-Nov-2023: This case involves a 62 years old male patient who had a headache and due to this, the patient had to stop working for several days, after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]. Time to onset is unknown. Further information on allergy history, patient's medical history, family history, concomitant medication, laboratory investigation, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient who received a flu shot and then they received their second one 10 days later in error with no reported adverse event; Initial information received on 16-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient where he/she received influenza quadrival a-b vaccine [Fluzone QIV] and then they received their second one 10 days later in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 2 of suspect influenza quadrival a-b vaccine Suspension for injection lot number not reported via unknown route in unknown administration site and 1 other doses were administered on unknown dates for suspect vaccine (strength, expiration date: not provided) for Immunisation (inappropriate schedule of product administration) (latency- same day)  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient that got a fluzone high dose quadrivalent with no reported adverse event; Initial information received on 17-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 57 years old female patient who got a Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Nov-2023, the patient received 0.7 ml total dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (lot number: U8162EA, Expiry date: 30-Jun-2024) (Frequency: once) (Strength: High dose) via intramuscular route in the left deltoid for immunization.  On 17-Nov-2023, the patient Influenza Quadrival A-B High Dose Hv Vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, Medical Assistant called in to ask If there are going to be any adverse event for a 57-year-old patient that got a fluzone high dose quadrivalent. This situation is reported as a misuse as per local labelling due to vaccine being given to a patient under 65 years of age.    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: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: vaccine was running down the patient's arm (with no reported adverse event); vaccine was running down the patient's arm (with no reported adverse event); Initial information received on 17-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 36 years old female patient who was administered the Influenza Quadrival A-B Vaccine[Fluzone QIV] which was running down the patient's arm (with no reported adverse event).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination.  On 17-Nov-2023, the patient received a 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine (lot U8201BA, expiry date: 30-Jun-2024 with unknown strength) via intramuscular route in the right arm as Immunization.  On 17-NOV-2023 while administration of vaccine to the patient the vaccine was running down the patient's arm (with no reported adverse event) (accidental exposure to product) (exposure via skin contact) same day following the administration of Influenza Quadrival A-B Vaccine.  It was reported "when the medical assistant was administering the fluzone qiv np pre-filled syringe, it began to leak and the vaccine ran down the medical assistant's gloves and the patient's arm. she believes that there is a crack where you attach the needle to the syringe (at the luer-lock tip) because this is where the leaking was coming from. The medical assistant confirms that the vaccine never got on her own skin, it was only on her glove. They did not notice the crack until they were administering the vaccine and it started leaking out "   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: 44.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: TYPHIM that expired on 02Nov2023 was administered on 13Nov2023/medication error/an inappropriate use due to expired vaccine administered with no reported adverse event; Initial information was received on 17-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 44 years old female patient who received typhoid vi polysaccharide vaccine [Typhim Vi] that expired on 02nov2023 was administered on 13nov2023/medication error/an inappropriate use due to expired vaccine administered with no reported adverse event.  The patient's past 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 (TDAP) for Prophylactic vaccination; and meningococcal vaccine for Prophylactic vaccination.  On 13-Nov-2023, the patient received a dose 1 of 0.5 ml of suspect typhoid vi polysaccharide vaccine (Solution for injection) (lot U2A471M , Expiry date : 02-Nov-2023, strength was unknown) via intramuscular route in the left deltoid for prophylactic vaccination (Immunization) and typhim that expired on 02nov2023 was administered on 13nov2023/medication error/an inappropriate use due to expired vaccine administered with no reported adverse event (expired product administered) (latency : same day).  Action taken with typhoid vaccine (Typhim Vi) was not applicable.  At time of reporting, the outcome was Unknown for the event typhim that expired on 02nov2023 was administered on 13nov2023/medication error/an inappropriate use due to expired vaccine administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given age 5-11 yr old Covid vaccine.  Patient will turn 5 on 12/11/2023.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Electroencephalogram normal, Loss of consciousness, Ultrasound scan normal
Clinical narrative: THE MORNING FOLLOWING THE INJECTION, I PASSED OUT 2 TIMES.  THE SECOND TIME RESULTING IN PARAMEDICS AMBULANCING ME TO EMERGENCY ROOM.  SERVERAL TESTS WERE PERFORMED OVER A 3 DAY STAY AT THE HOSPITAL WITH NO EXPLANATION AS TO WHY I MAY HAVE PASSED OUT.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Brain scan normal, Cardiac function test normal, Gait disturbance, Hypoaesthesia
Clinical narrative: The patient states that the morning after the vaccination (Tuesday, November 21st, 2023) that he awakened to the right side of his body being numb from his upper arm to his feet. The patient also stated that he had trouble walking. These symptoms persisted until just this morning (Friday, November 24th, 2023). The patient visited the Emergency Room to have these symptoms checked. The Emergency Room did a "brain scan" and a heart check and these both came back as normal.  The patient really feels that these symptoms were brought about the RSV vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysarthria, Seizure, Tremor, Unresponsive to stimuli
Clinical narrative: Pt experienced seizure after Spikevax.  She started shaking in the chair, became momentarily nonresponsive, then started having slurred speech.  Pt has long history of seizures after multiple medications and vaccinations.  She has received multiple vaccinations with no reaction.  This was a know potential reaction.  She was under observation in the pharmacy and her husband was present.  She recovered over approx 15 minutes and left with her husband needing no care.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary arterial stent insertion, Feeling hot, Laboratory test, Magnetic resonance imaging, Sleep disorder
Clinical narrative: My body was hot,and I could not sleep I went to Hospital on 04/18/2021. I had a heart stent installed. Previously,I was in above average health,taking no prescriptions,and had no hospital stays.
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Muscle spasms, Product use issue, Wrong product administered
Clinical narrative: Patient received the non-FDA approved vaccine (Arvexy) instead of the vaccine approved for use in pregnancy (Abrysvo). Patient was 32 weeks pregnant at time of vaccination. Patient has spoken with her doctor and is monitoring the cramping she is experiencing.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Cellulitis - redness, swelling, pain, itchiness
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Mobility decreased, Pain in extremity
Clinical narrative: Patient informed pharmacist on 11/24/23 about how she is having  trouble raising her right arm. She stated both arms are sore and her right side is sore. These symptoms started the morning after the last two vaccinations she received on 9/8/23. She received Meloxicam from doctor  on 09/15/23 and then Naproxen on 11/24/23. The patient is feeling some pain relief as of 7:30pm on 11/24/23.
Age: 11.0
Sex: M
Vaccine: PNC20
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Vaccine was administered by error and out of recommended age.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal distension, Abdominal pain, Blood bilirubin increased, Chromaturia, Computerised tomogram abdomen normal
Clinical narrative: fever intermittent 101-103, 7 days; headaches/migraines 9 days; orange urine, pale stools 3 weeks; abdominal pain/fullness 2 weeks; itching starting on hands and feet, then torso 3 weeks; unexplained bruising; fatigue 4-6 weeks
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Faeces discoloured, Fatigue, Headache, Hepatic mass
Clinical narrative: fever intermittent 101-103, 7 days; headaches/migraines 9 days; orange urine, pale stools 3 weeks; abdominal pain/fullness 2 weeks; itching starting on hands and feet, then torso 3 weeks; unexplained bruising; fatigue 4-6 weeks
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hepatitis viral test negative, Lymphocyte count increased, Migraine, Pruritus, Pyrexia
Clinical narrative: fever intermittent 101-103, 7 days; headaches/migraines 9 days; orange urine, pale stools 3 weeks; abdominal pain/fullness 2 weeks; itching starting on hands and feet, then torso 3 weeks; unexplained bruising; fatigue 4-6 weeks
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Scan with contrast normal, Ultrasound liver abnormal, White blood cell count increased
Clinical narrative: fever intermittent 101-103, 7 days; headaches/migraines 9 days; orange urine, pale stools 3 weeks; abdominal pain/fullness 2 weeks; itching starting on hands and feet, then torso 3 weeks; unexplained bruising; fatigue 4-6 weeks
Age: 8.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: Gave the 12+ year old dose instead of pediatric dose; followed up with pt father. He reports everyone doing well. Patient has a sore arm but no other SEs.
Age: 10.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Incorrect dose administered
Clinical narrative: Gave 12+ year old dose instead of pediatric dose
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Eye movement disorder, Muscle rigidity, Nausea, Seizure
Clinical narrative: Pt received firth the Fluzone Quadravalent in his left arm.  Then Spikevax  inhis right arm. Within 10 seconds of receiving Spikevax pt started to get rigid, his eyes slightly rolled back and was not responding to his name. HIs mother helped me get him to the floor. Had a hard time keeping him on his side. I asked Mom  if  I should call 911 and she said "No, it's has been a while since he has had a seizure."  According to the consent form pt has never had a reaction to  previous vaccines. Pt was coherent after 5 minutes and was able to sit up. He felt a little nausea but did not throw up. Mom recorded the event to report it to the MD. Approx 10 minutes after the second shot pt said he fell well enough to stand up. He was able to stand on his own and he and his mother left the pharmacy.  Pt has had multiple COVID shots in the past with no reaction
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt received firth the Fluzone Quadravalent in his left arm.  Then Spikevax  inhis right arm. Within 10 seconds of receiving Spikevax pt started to get rigid, his eyes slightly rolled back and was not responding to his name. HIs mother helped me get him to the floor. Had a hard time keeping him on his side. I asked Mom  if  I should call 911 and she said "No, it's has been a while since he has had a seizure."  According to the consent form pt has never had a reaction to  previous vaccines. Pt was coherent after 5 minutes and was able to sit up. He felt a little nausea but did not throw up. Mom recorded the event to report it to the MD. Approx 10 minutes after the second shot pt said he fell well enough to stand up. He was able to stand on his own and he and his mother left the pharmacy.  Pt has had multiple COVID shots in the past with no reaction
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Pyrexia
Clinical narrative: Fever, chills, stomach cramps, diarrhea  lasted about 2 hours
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: patient received 2 Spikevax moderna vaccination in left arm instead of one  patient was told sideeffects such as muscle soreness was likely to be worse than usually.  patient told to report back to us anything more serious or unusually if they occured
Sex: U
Vaccine: RAB, RAB
Symptoms: Asthenia, Brain fog, Cough, Eye pain, Fatigue
Clinical narrative: Re: post treatment for dog bite out of country 10/23/23 and subsequent injections of Rabies vaccine/Rabavert (4) and Hyperrab (4 injections).  I tried to download your form (see above) on line and fill out to expedite this information after sharing same with provider on 11/22. She was very helpful with website, however your website either wanted me to download on Adobe (I wasn't willing to add this free 7-day trial and then pay for), thus trying to send online and again would not allow me to do this either as would not accept my DOB and age 78.  It appears you are going to get this information the old fashion way (FAX).  I was in another country for two weeks from 10/14-29 of this year.  I stayed in a local home in a community for multiple feral dogs being fed by neighbors. 10/23/23 at 1:25 pm while walking to my placement a small terrier bite back of LLE behind knee. Immediately bruised with erythema and pain. Called local on-site group to let them know and saw local MD at program office. Dr. checked site and prescribed Clarithromycin 500mg bid for 5 days. Could not take medication due to nausea, thus cleaned wound twice daily and monitored. Never heard from MD on rabies injection thus waiting till returned to my country (29th) to receive first injection November 2 in ED.  Outcome was satisfactory with exception of multiple side effects from Rabies injections listed.  Side effects: fatigue, cough, difficulty with movements, irritability, muscle pain, stiffness in all joints, and generalized weakness.  I have to preface this is change in time (2 hours difference from other country and state), and time change (total of three hours) which also impacted my three weeks post trip/injections.  Also nausea, orbital pain right eye, and occasionally feeling like in a fog.
Sex: U
Vaccine: RAB, RAB
Symptoms: Irritability, Joint stiffness, Mobility decreased, Myalgia, Nausea
Clinical narrative: Re: post treatment for dog bite out of country 10/23/23 and subsequent injections of Rabies vaccine/Rabavert (4) and Hyperrab (4 injections).  I tried to download your form (see above) on line and fill out to expedite this information after sharing same with provider on 11/22. She was very helpful with website, however your website either wanted me to download on Adobe (I wasn't willing to add this free 7-day trial and then pay for), thus trying to send online and again would not allow me to do this either as would not accept my DOB and age 78.  It appears you are going to get this information the old fashion way (FAX).  I was in another country for two weeks from 10/14-29 of this year.  I stayed in a local home in a community for multiple feral dogs being fed by neighbors. 10/23/23 at 1:25 pm while walking to my placement a small terrier bite back of LLE behind knee. Immediately bruised with erythema and pain. Called local on-site group to let them know and saw local MD at program office. Dr. checked site and prescribed Clarithromycin 500mg bid for 5 days. Could not take medication due to nausea, thus cleaned wound twice daily and monitored. Never heard from MD on rabies injection thus waiting till returned to my country (29th) to receive first injection November 2 in ED.  Outcome was satisfactory with exception of multiple side effects from Rabies injections listed.  Side effects: fatigue, cough, difficulty with movements, irritability, muscle pain, stiffness in all joints, and generalized weakness.  I have to preface this is change in time (2 hours difference from other country and state), and time change (total of three hours) which also impacted my three weeks post trip/injections.  Also nausea, orbital pain right eye, and occasionally feeling like in a fog.
Age: 45.0
Sex: M
Vaccine: HEP, MMR, VARCEL, MMR, VARCEL, FLU4
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: they began to develop symptoms of Guillen Burriersyndrome; This spontaneous report as received from the medical assistant, referring to a 45-year-old male patient. The patient did not have pertinent medical history, drug reactions or allergies. Information regarding concomitant medications was not provided. No known allergies  On 18-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Injection, dose of 0.5 ml, lot # X020654, expiration date 21-OCT-2024, intramuscular, for prophylaxis (anatomical site of vaccination not reported), and with varicella virus vaccine live (oka/merck) (VARIVAX) injection, dose 0.5 ml, lot # X017485, expiration date 25-JUN-2025, intramuscular, for prophylaxis (anatomical site of vaccination not reported). The reporter confirmed that the doses given were the first in the patient's series.  On 11-NOV-2023, the patient began to develop symptoms of guillain-barre syndrome (reported asGuillen Burrier Syndrome). The reporter stated that the patient was currently hospitalized in Intensive Care Unit receiving treatment, but information regarding hospitalization course was unknown at this time. At the reporting time, the patient had not recovered from the event.  The causality assessment was not provided.  Upon internal review the event guillain-barre syndrome was determined to be medically significant. The reporter considered guillain-barre syndrome to be a disability event.
Age: 45.0
Sex: M
Vaccine: HEP, MMR, VARCEL, MMR, VARCEL, FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: they began to develop symptoms of Guillen Burriersyndrome; This spontaneous report as received from the medical assistant, referring to a 45-year-old male patient. The patient did not have pertinent medical history, drug reactions or allergies. Information regarding concomitant medications was not provided. No known allergies  On 18-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Injection, dose of 0.5 ml, lot # X020654, expiration date 21-OCT-2024, intramuscular, for prophylaxis (anatomical site of vaccination not reported), and with varicella virus vaccine live (oka/merck) (VARIVAX) injection, dose 0.5 ml, lot # X017485, expiration date 25-JUN-2025, intramuscular, for prophylaxis (anatomical site of vaccination not reported). The reporter confirmed that the doses given were the first in the patient's series.  On 11-NOV-2023, the patient began to develop symptoms of guillain-barre syndrome (reported asGuillen Burrier Syndrome). The reporter stated that the patient was currently hospitalized in Intensive Care Unit receiving treatment, but information regarding hospitalization course was unknown at this time. At the reporting time, the patient had not recovered from the event.  The causality assessment was not provided.  Upon internal review the event guillain-barre syndrome was determined to be medically significant. The reporter considered guillain-barre syndrome to be a disability event.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC20, RV5
Symptoms: Autopsy, Cardiac arrest, Crying, Death, Fatigue
Clinical narrative: He was extremely tired the first 2 or 3 days and also had a fever. The highest it got was 103.9°. Then he started screaming crying while he was drinking his formula like something was wrong or it was hurting him somehow then on the 7th day I woke up to my baby boy dead beside me. He was ½ purple and already cold. I tried everything to save him but it was already too late.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC20, RV5
Symptoms: Peripheral coldness, Pyrexia, Screaming, Skin discolouration
Clinical narrative: He was extremely tired the first 2 or 3 days and also had a fever. The highest it got was 103.9°. Then he started screaming crying while he was drinking his formula like something was wrong or it was hurting him somehow then on the 7th day I woke up to my baby boy dead beside me. He was ½ purple and already cold. I tried everything to save him but it was already too late.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC20, RV5
Symptoms: Death, Poor feeding infant, Sepsis neonatal
Clinical narrative: He was extremely tired the first 2 or 3 days and also had a fever. The highest it got was 103.9°. Then he started screaming crying while he was drinking his formula like something was wrong or it was hurting him somehow then on the 7th day I woke up to my baby boy dead beside me. He was ½ purple and already cold. I tried everything to save him but it was already too late.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Circumstance or information capable of leading to medication error, Poor quality product administered
Clinical narrative: Doctor gave mmr vaccine 2 weeks after giving a different live vaccine making this one invalid due to a lack of education on the offices part. The office stated this happens all the time at multiple offices indicating more education and a better tracking system should be implemented. The school districts system caught the error. It would seem the doctors giving the immunizations should have a better tracking system and education than a school/school nurse. Doctor is now advising patient will either need to have another mmr vaccine or given a titer, but unsure on the long term outcomes that go with these decisions.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal pain, Arthralgia, Back pain, Irritability, Myalgia
Clinical narrative: Pain in lower back, pain in abdominal muscles, pain in hips and hip joints (pain around the entire mid-section). Pain going up muscle on left side of back, pain going up muscle on left abdomen. Pain has been significant and continues; exacerbated by any lifting. Pain level is significant. Pain currently is more intense on left side. Irritability. I've taken baclofen, meloxicam , and acetaminophin, rested, applied heat, performed/performing  a significant amount of stretching once it became possible.  I have pending referrals to a neurologist and allergist.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Daily rash on shins, ankles, stomach around belly button, arms, and hands
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea