chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Fatigue, Laziness
Clinical narrative: after getting the vaccines, she is feeling tired and lazy; after getting the vaccines, she is feeling tired and lazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), LAZINESS (non-serious), outcome "unknown" and all described as "after getting the vaccines, she is feeling tired and lazy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller already had the 2 primary vaccines in Jan, she hadn't gotten the booster yet since then as her antibodies were high, they were now in Oct and her antibodies were still high, asking when she could get the booster, after getting the vaccines, she was feeling tired and lazy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : 202201262963 same patient, different vaccine dose/AE.;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Sore; My body got so tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "My diaphragm is paralized in the up position" (unspecified if ongoing), notes: My diaphragm is paralized in the up position; "phrenic ner is damaged from an icd implanted in 2013" (unspecified if ongoing), notes: phrenic ner is damaged from an icd implanted in 2013; "icd implanted", start date: 2013 (unspecified if ongoing), notes: phrenic ner is damaged from an icd implanted in 2013. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, The first one as in Jan), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Sore"; FATIGUE (non-serious), outcome "unknown", described as "My body got so tired".  Clinical course: Back in Jan-Feb when she/he got her/his first and second Pfizer vaccines. Was not a good sight for her/him. The first one as in Jan and #2 was 6 weeks later. The first was no issues. The second one made her/him so sore. Her/his body got so tired she/he had to force herself /himself out of bed after a weeks time. No more vaccines. Her/his diaphragm was paralyzed in the up position and her/his phrenic ner was damaged from an icd implanted in 2013. Some people the work, some don't. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Joint swelling
Clinical narrative: had an unusual amount of swelling in the shoulder; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "had an unusual amount of swelling in the shoulder".  Additional information: Event took place after use of product. The patient received PCV20 and had an unusual amount of swelling in the shoulder.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion due to door gasket that was replaced, reached a minimum of 33.6 degrees F for 5 minutes & a maximum temperature of 50.9 degrees F for 500 minutes with no reported adverse event; the vaccines were given post excursion with no reported adverse event; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter reported that temperature excursion due to door gasket that was replaced, reached a minimum of 33.6 degrees Fahrenheit for 5 minutes & a maximum temperature of 50.9 degrees f for 500 minutes and the vaccines were given post excursion with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  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 of suspect IPV (VERO) (lot: V1B901M Expiry date: 02-Jun-2024, lot: U1A452M Expiry date: 20-Feb-2023) via unknown route in unknown administration site as Immunization.  On an unknown date the caller reported a temperature excursion due to a door gasket that was replaced and caused the excursion. The temperature of the refrigerator reached a minimum of 33.6 degrees Fahrenheit for 5 minutes and a maximum temperature of 50.9 degrees Fahrenheit for 500 minutes (product storage error) (unknown latency) and all the vaccines were given post excursion with no reported adverse event (poor quality product administered) (unknown latency).  It was reported "The vaccines involved were DAPTACEL, ACT-HIB, IPOL (opened), QUADRACEL, and PENTACEL, MENQUADFI, ADACEL. and caller does not have the patient information at this time. IPOL-OPEN-CLOSED. First time product used : No Still using product : No"   Action taken with was not applicable.  It was not reported if the patient received a corrective treatment for the events.  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: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Rash, Urticaria
Clinical narrative: developed a rash on different areas of her body; now changed into hives/blisters (on her chin, back and arms); Initial information regarding an unsolicited valid non-serious case received via patient on 21-Oct-2022.  This case involves an 84-year-old female patient who experienced developed a rash on different areas of her body and now changed into hives/blisters (on her chin, back and arms) while receiving vaccine Influenza Quadrival A-B HIGH DOSE HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 03-Oct-2022, the patient received suspect Fluzone High-Dose Quadrivalent vaccine at dose 0.7 ml total at (unknown: formulation, strength, lot number, route in unknown administration site) for influenza vaccination.  On 03-OCT-2022, the patient developed a non-serious developed a rash on different areas of her body (rash) and now changed into hives/blisters (on her chin, back and arms) (urticaria) following the administration of Fluzone High-Dose Quadrivalent vaccine.  Action taken: Not applicable.  Corrective treatment: The patient was treated with Triamcinolone Acetonide for Rash and Urticaria.  At time of reporting, the outcome was Not Recovered for both events.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Cough, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: high fever; cough; sore throat; a lot of cold-like symptoms; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves an unknown age male patient who experienced high fever, cough, sore throat and a lot of cold-like symptoms while receiving vaccines influenza vaccine and COVID-19 VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer and COVID-19 vaccine not produced by Sanofi Pasteur both at an unknown dose (lot number, expiry date: not reported) for immunization.  On an unknown date the patient developed a non-serious high fever (pyrexia), cough, sore throat (oropharyngeal pain), a lot of cold-like symptoms (nasopharyngitis) (unknown latency)  2 days following the administration of influenza vaccine and (unknown latency) following the administration of COVID-19 vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for all the events.
Age: 16.0
Sex: U
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 16 year old that received the FLUBLOK instead of the Quad,with no reported adverse event; a 16 year old that received the FLUBLOK instead of the Quad,with no reported adverse event; Initial information received on 23-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old (unknown gender) patient who received the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] instead of the quad, 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 total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation) and a 16-year-old that received the flublok instead of the quad, with no reported adverse event (wrong product administered) and (product administered to patient of inappropriate age) (unknown latency).  It was reported, Pharmacist asked Does the child need to be re-vaccinated. I just couldn't find anything in the literature. The only thing I could see was that it was egg-free and I wasn't understanding why it's only for 18 years and up. This was a mistake on my part, I just want to rectify and take it from there. This situation is reported as a medication error due to administration to a patient under 18 years of age.   Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) was not applicable.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 13.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of FLUBLOK to a pediatric patient with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 years old female patient and there was administration of flublok (INFLUENZA QUADRIVALENT RECOMBINANT VACCINE) to a pediatric patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2022, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation, strength: unknown) lot UJ909AA, expiration date: 30-Jun-2023 via intramuscular route in the left deltoid as Immunization.  On 22-OCT-2022 there was an administration of flublok to a pediatric patient with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (administration of FLUBLOK to a pediatric patient with no reported adverse event).  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: 17.0
Sex: U
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old was given flublok qiv with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old (unknown gender) patient who was given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2022, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Immunization and 17 year old was given flublok qiv with no reported adverse event (product administered to patient of inappropriate age) (latency; same day).  It was reported, She says that the patient is fine but they would like to know information about its use to younger patients and if they should revaccinate. This situation is reported as a medication error due to administration to a patient younger than indicated.   Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: received 2 FLUZONE HIGH DOSE QUADRIVALENT within 24 days in error with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 71 years old male patient who received 2 INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within 24 days 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 30-Sep-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength and lot number not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  On 24-Oct-2022, the patient received 0.7 mL dose of same vaccine (formulation, strength and lot number not reported) via intramuscular route in the right deltoid for prophylactic vaccination.  On 24-Oct-2022, the patient received 2 fluzone high dose quadrivalent within 24 days in error with no reported adverse event (inappropriate schedule of product administration) (latency: same day of dose 2) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, pharmacist states that a patient received 2 FLUZONE HIGH DOSE QUADRIVALENT within 24 days in error. She states that today the patient was confused and came in to the Pharmacy requesting a FLUZONE HIGH DOSE QUADRIVALENT vaccine despite having received the vaccine 24 days prior. The Pharmacist did not catch this until after the vaccine was given and she was documenting it.   Action taken was 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.
Sex: U
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: having dizziness after getting the second flu vaccination; Initial information received on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced having dizziness after getting the second flu vaccination while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In September 2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  In October 2022, patient received 2nd dose INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.    On an unknown date the patient developed a non-serious having dizziness after getting the second flu vaccination (dizziness) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (having dizziness after getting the second flu vaccination).  At time of reporting, the outcome was Unknown for the event having dizziness after getting the second flu vaccination.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: redness at the injection site and surrounding area; Initial information received  on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 71 years old female patient who had redness at the injection site and surrounding area after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s)and family history were not provided. Patient had no concomitant and other vaccines.   On 22-Oct-2022, the patient received a 0.7ml 1X(once) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ932AD and expiry date: 30-Jun-2023) via intramuscular route in the right arm for prophylactic vaccination.  On 24-OCT-2022 the patient developed a non-serious event of redness at the injection site and surrounding area (vaccination site erythema) 2 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Patient had no swelling, no itchiness, no change in breathing, only redness.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event   Outcome: Not Recovered
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: dose of fluzone high dose quadrivalent was inadvertently administered to a pregnant patient with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 34 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in context of dose of fluzone high dose quadrivalent was inadvertently administered to a pregnant patient with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported dose of fluzone high dose quadrivalent was inadvertently administered to a pregnant patient with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 24-Oct-2022, the patient received 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation and strength not reported; lot UJ928AA and expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for prophylactic vaccination.  On 24-Oct-2022, (latency: same day) a dose of fluzone high dose quadrivalent was inadvertently administered to a pregnant patient with no reported adverse event (exposure during pregnancy) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, a dose of FLUZONE HIGH DOSE QUADRIVALENT was inadvertently administered to a pregnant patient.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: Pentacel vaccine was to be administered, but the nurse did not reconstitute the HIB portion of the vaccine, The child received only the DTaP/ IPV portion of the vaccine with no adverse events; Pentacel vaccine was to be administered, but the nurse did not reconstitute the HIB portion of the vaccine, The child received only the DTaP/ IPV portion of the vaccine with no adverse events; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who experienced pentacel vaccine was to be administered, but the nurse did not reconstitute the hib portion of the vaccine, the child received only the dtap/ ipv portion of the vaccine with no adverse events while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  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),  HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 18-Oct-2022, the patient received 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6970BA and expiry 31-Jan-2023, strength- standard) (formulation: unknown) was to be administered, but the nurse did not reconstitute the hib portion of the vaccine (product preparation error), the child received only the dtap/ ipv portion of the vaccine (single component of a two-component product administered) with no adverse events (latency same day) via intramuscular route in vastus lateralis site for prophylaxis vaccination.  It was reported that "Treatment- separate ActHIB (lot-UJ659AA) will be administered".   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  Outcome: unknown, for both events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: Product administered to patient of inappropriate age
Clinical narrative: 12-year-old patients that received the fluzone high-dose quadrivalent accidently with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA443951.  This case involves a 12 years old and unknown gender patient who received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] accidently with no reported adverse event t inappropriate age.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.7 ml dose once of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE ( formulation and lot number: unknown) via unknown route in unknown administration site for Immunization with no reported adverse event (product administered to patient of inappropriate age) (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: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a dose of the vaccine on 7sep2022 and received another dose of the vaccine on 25oct2022 with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 69 years old male patient who received a dose of the vaccine on 07-Sep-2022 and received another dose of the vaccine on 25-Oct-2022 with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE once (formulation and strength not reported; lot UJ917AD) via intramuscular route in unknown administration site for prophylactic vaccination.  On 25-Oct-2022, he also received 0.7 mL total dose of the same vaccine once (formulation and strength not reported; lot UJ917AD) via intramuscular route in the left arm for prophylactic vaccination.  On 25-Oct-2022, the patient received a dose of the vaccine on 7sep2022 and received another dose of the vaccine on 25oct2022 with no reported adverse event (inappropriate schedule of product administration) (latency: same day of dose 2) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, a patient received a dose of the vaccine on 7SEP2022 and received another dose of the vaccine today 25OCT2022.  Action taken was 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: 30.0
Sex: M
Vaccine: FLUC3
Symptoms: Chills, Muscle spasms, Seizure
Clinical narrative: Seizure; Both of his legs had Charley horses; Shivering; This spontaneous case was received on 24-Oct-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-04920) and concerned a 30-year-old, male patient.  The patient's concurrent conditions included allergy to bees and amoxicillin. The patient was not taking any concomitant medications.  On 10-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration: intramuscular; anatomical location: not reported) for prevention of influenza disease. The batch number reported was 942394 and the expiry date was 25-Jun-2023.  On 11-Oct-2022, by 11:00 pm, one day after receiving Flucelvax Quadrivalent, the patient had a seizure that lasted for about three to four minutes. The patient also experienced some shivering, both of his legs had Charley horses.  On the same date, the patient recovered from all events. The patient stated that all the symptoms stopped three to four minutes after starting.  The reporter did not provide a causality assessment.  The event of seizure was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 30-year-old, male patient was vaccinated with Flucelvax Quadrivalent. One day following vaccination, the patient had a seizure that lasted for about three to four minutes. The patient also experienced some shivering and muscle spasms. The patient was not taking any concomitant medications. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship. Agency criteria for generalised tonic-clonic seizure could not be assessed due to insufficient information.; Sender's Comments: A 30-year-old, male patient was vaccinated with Flucelvax Quadrivalent. One day following vaccination, the patient had a seizure that lasted for about three to four minutes. The patient also experienced some shivering and muscle spasms. The patient was not taking any concomitant medications. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship. Agency criteria for generalised tonic-clonic seizure could not be assessed due to insufficient information.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Product administration error
Clinical narrative: Sore arm; Let's take a half dose of Afluria Quadrivalent and two weeks later the other half; This spontaneous case was received on 24-Oct-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-04974) with additional information (being processed together) received via Agency on the same day, from an other non-healthcare professional (consumer) and concerned an elderly  (over 65 years of age) female patient,  The patient's concurrent conditions included asthma and thimerosal allergy. The patient's historical conditions included flu, over the period of 10 years when the patient stopped taking the flu vaccine. The patient's concomitant medications included an unspecified inhaler. The patient's historical vaccines included multiple influenza virus vaccines (brand not specified) on unspecified dates '20/30 years ago', for unreported indication, however, one year the patient got very sick (see linked case: 202206184). At some point her doctor said that she 'cannot have this anymore'.  On an unspecified date in Oct-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact sag 4v; dose: reported as half dose; route of administration and anatomical location were not reported) for active immunization against influenza disease caused by influenza virus subtypes A and B. The batch number was not reported, As reported, the doctor came up to the patient and stated that she should take a half dose of Afluria Quadrivalent and two weeks later the other half.   On 19-Oct-2022 the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 0.5 ml and  'full dose'; route of administration and anatomical location were not reported) (explicitly codded as 'Product administration error') for active immunization against influenza disease caused by influenza virus subtypes A and B. The batch number was not reported.  On an unspecified date in October 2022, after receiving half a dose of Alfuria Quadrivalent, patient experienced a sore arm.  The outcome of the events was not reported.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  The case is linked to 202206184 (the same patient and reporter).  Company comment: The event of pain in arm  is assessed as possibly related to Afluria Quadrivalent due to plausible temporal relationship. Product administration error is assessed as not related to Afluria Quadrivalent  as per company conventions.; Sender's Comments: The event of pain in arm  is assessed as possibly related to Afluria Quadrivalent due to plausible temporal relationship. Product administration error is assessed as not related to Afluria Quadrivalent  as per company conventions.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Very sick; This spontaneous case was received on 24-Oct-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-04974) with additional information received on the same day (being processed together) (reference number: SEQW22-04965), and concerned a female patient of an unreported age.   The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine, the patient got very sick.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  This case is linked with the case 202206182 (the same patient).  Company comment: Due to lack of information and unclear temporal relationship, causality for 'sickness' is assessed as unassessable.; Sender's Comments: Due to lack of information and unclear temporal relationship, causality for 'sickness' is assessed as unassessable.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Rotator cuff syndrome, Scintillating scotoma, Tendon disorder
Clinical narrative: Injection Tues Nov 30, 2021 in left shoulder EXPIRATION 11/2021.. [Next day, scintillating scotoma in Right visual field (have only had Left field before and since.] Tues Dec 12 lifted weights (shoulder exercises) and experienced pain and 'tearing' sound in left shoulder. April 21 visit with sports medicine: "RIGHT shoulder pain which was most c/w with rotator cuff tendinopathy vs. Partial tear." The pain has subsided over the year, but the 'tearing' sound continues.  I AM CONCERNED THAT THE LOT WAS ESSENTIALLY EXPIRED.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to covid vaccine booster
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Aortic dilatation, Chest pain, Computerised tomogram, Electrocardiogram ST-T segment abnormal
Clinical narrative: The patient presents with localized, right sided chest wall pain onset last night (Oct 10) ~7 hours prior to arrival. He endorses worsening pain with deep breaths, and is improved with massaging or holding the area. He tried icing the area and took ibuprofen and tylenol last night that subsided his pain from a 9/10 to a 2/10 at rest. The pain was persistent into this morning that increases to a 4/10 with breathing. He has a history of inflammation in the rib cage that normally presents in the left chest wall or sternum. In the past, he has been prescribed antibiotics and oral steroids to treat inflammation with improvement. He states this pain presents in a similar character to previous episodes, and normally occurs this time of year. He does not have history of blood clots and denies recent prolonged travel.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram normal, Intensive care, Laboratory test, Musculoskeletal chest pain, Painful respiration
Clinical narrative: The patient presents with localized, right sided chest wall pain onset last night (Oct 10) ~7 hours prior to arrival. He endorses worsening pain with deep breaths, and is improved with massaging or holding the area. He tried icing the area and took ibuprofen and tylenol last night that subsided his pain from a 9/10 to a 2/10 at rest. The pain was persistent into this morning that increases to a 4/10 with breathing. He has a history of inflammation in the rib cage that normally presents in the left chest wall or sternum. In the past, he has been prescribed antibiotics and oral steroids to treat inflammation with improvement. He states this pain presents in a similar character to previous episodes, and normally occurs this time of year. He does not have history of blood clots and denies recent prolonged travel.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pleuritic pain, Pulmonary embolism, Troponin
Clinical narrative: The patient presents with localized, right sided chest wall pain onset last night (Oct 10) ~7 hours prior to arrival. He endorses worsening pain with deep breaths, and is improved with massaging or holding the area. He tried icing the area and took ibuprofen and tylenol last night that subsided his pain from a 9/10 to a 2/10 at rest. The pain was persistent into this morning that increases to a 4/10 with breathing. He has a history of inflammation in the rib cage that normally presents in the left chest wall or sternum. In the past, he has been prescribed antibiotics and oral steroids to treat inflammation with improvement. He states this pain presents in a similar character to previous episodes, and normally occurs this time of year. He does not have history of blood clots and denies recent prolonged travel.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Impaired work ability
Clinical narrative: Fever, chills, intense body aches, muscle pain, joint pain, significant fatigue,  brain fog, I could hardly get out of bed. My arm started to swell and became hot and sore on 10/31/2022  at about 7 am ("covid arm" which I also got with the first 2 covid vaccines last year). Inability to go to work. Inability to perform normal daily tasks. Significant fatigue persists
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Fever, chills, intense body aches, muscle pain, joint pain, significant fatigue,  brain fog, I could hardly get out of bed. My arm started to swell and became hot and sore on 10/31/2022  at about 7 am ("covid arm" which I also got with the first 2 covid vaccines last year). Inability to go to work. Inability to perform normal daily tasks. Significant fatigue persists
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Fever, chills, intense body aches, muscle pain, joint pain, significant fatigue,  brain fog, I could hardly get out of bed. My arm started to swell and became hot and sore on 10/31/2022  at about 7 am ("covid arm" which I also got with the first 2 covid vaccines last year). Inability to go to work. Inability to perform normal daily tasks. Significant fatigue persists
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angioedema, Injection site urticaria, Swelling, Urticaria
Clinical narrative: Approximately 9 hours after receiving the vaccine I developed hives on my forehead and scalp, as well as hives at vaccine site (left arm). I then developed angioedema of my lower lip and tongue the following morning (approximately 16 hours after vaccine), which required me to go to the emergency room. I was given steroids which improved the swelling, will be taking them for 4 days, as well as Benadryl.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Soreness at the site noted immediately after and continued to be present for 72 hours. Large red mark around injection site noted around 0800 and at 72 hours, went away on day 4.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant information was reported. It was reported that none of the patients were pregnant. Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022.  No treatment information was provided.  This case is reported for 18th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-665494, US-MODERNATX, INC.-MOD-2022-665704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665494: US-MODERNATX, INC.-MOD-2022-665704:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient caught Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient caught Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M1A, 939904, 001B21A and 031LZ0A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, the patient experienced COVID-19 (Patient caught Covid-19). At the time of the report, COVID-19 (Patient caught Covid-19) outcome was unknown.    Concomitant medication was not provided. After first 3 doses patient did not experienced adverse events.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280, US-MODERNATX, INC.-MOD-2022-666063, US-MODERNATX, INC.-MOD-2022-666248, US-MODERNATX, INC.-MOD-2022-666249, US-MODERNATX, INC.-MOD-2022-666250, US-MODERNATX, INC.-MOD-2022-666251, US-MODERNATX, INC.-MOD-2022-666252, US-MODERNATX, INC.-MOD-2022-666255, US-MODERNATX, INC.-MOD-2022-666279, US-MODERNATX, INC.-MOD-2022-666295, US-MODERNATX, INC.-MOD-2022-666286, US-MODERNATX, INC.-MOD-2022-666283, US-MODERNATX, INC.-MOD-2022-666282, US-MODERNATX, INC.-MOD-2022-666281 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666277:Patient 7 US-MODERNATX, INC.-MOD-2022-666280:Patient 16 US-MODERNATX, INC.-MOD-2022-666284:patient 9 US-MODERNATX, INC.-MOD-2022-666063:Patient 1 US-MODERNATX, INC.-MOD-2022-666248:Patient 2 US-MODERNATX, INC.-MOD-2022-666249:Patient 3 US-MODERNATX, INC.-MOD-2022-666250:Patient 4 US-MODERNATX, INC.-MOD-2022-666251:Patient 5 US-MODERNATX, INC.-MOD-2022-666252:Patient 6 US-MODERNATX, INC.-MOD-2022-666255:Patinet 7 US-MODERNATX, INC.-MOD-2022-666279:Patient 15 US-MODERNATX, INC.-MOD-2022-666295:Patient 12 US-MODERNATX, INC.-MOD-2022-666286:Patient 10 US-MODERNATX, INC.-MOD-2022-666283:Patient 8 US-MODERNATX, INC.-MOD-2022-666282:Patient 18 US-MODERNATX, INC.-MOD-2022-666281:patient 17