chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Skin burning sensation
Clinical narrative: skin felt like it was burning; pins and needles; fever of 99.6; aches and pains; patient received vaccine via subcutaneous route with no adverse event; Initial information received on 04-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves a 66-year-old female patient who stated skin felt like it was burning, pins and needles, fever of 99.6 and aches and pains and patient received vaccine via subcutaneous route with no adverse event  after receiving influenza quadrivalent recombinant vaccine [Flublok Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rivaroxaban (Xarelto); verapamil; and paracetamol (Tylenol).  On 03-Oct-2023, the patient received an unknown dose of suspect influenza quadrivalent recombinant vaccine, prefilled syringe (strength, lot, expiry date: unknown) via subcutaneous route in left arm for Prophylactic Vaccination (immunization). Information on batch number was requested and patient received vaccine via subcutaneous route with no adverse event (incorrect route of product administration) (latency: same day)  On 03-Oct-2023 the patient had events of skin felt like it was burning (skin burning sensation), pins and needles (paraesthesia), fever of 99.6 (pyrexia) and aches and pains (pain) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  It was reported, Received 65+ shot at Pharmacy at 11:00 AM. Was fine all day. At 7:00 PM, took xarelto 15 mg and verapamil 240 mg. Within 1/2 hour, my skin felt like it was burning with pins and needles. I developed a fever of 99.6 with Tylenol in my system. I had severe aches and pains .  Relevant laboratory test results included: Body temperature - On 03-Oct-2023: 99.6 UNK  Action taken with quadrivalent recombinant influenza vaccine (Flublok Qiv) was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome:  Unknown for the event patient received vaccine via subcutaneous route with no adverse event and Recovering / Resolving for all other 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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: last time i got the flu shot, i got the flu; Initial information received on 01-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who reported last time i got the flu shot, i got the flu after receiving vaccine Influenza Vaccine.  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 Influenza Vaccine produced by unknown manufacturer (lot number, strength, expiry date, dose, form not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient reported last time i got the flu shot, i got the flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  It was reported "Never got the flu shot since then and I haven't had the flu since then!"  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event, Product label confusion
Clinical narrative: expiration date format on the vaccine was confusing that it led to one staff giving an expired dose of TENIVAC  no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 66 years old female patient and expiration date format on the vaccine was confusing that it led to one staff giving an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Sep-2023, the patient received a dose 1 dose 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection lot U7183AA expiry date: 24-Sep-2023 via intramuscular route in the left deltoid for Immunization and expiration date format on the vaccine was confusing that it led to one staff giving an expired dose of tenivac  no reported adverse event (expired product administered) on the same day following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult.  Reportedly, Healthcare professional called to report that they have been given a near expiry shipment of TENIVAC vaccine on the last week of June 2023. HCP reported that they were given a 3 month window before the TENIVAC vaccine expires. HCP reported that the expiration date format on the vaccine was confusing that it led to one staff giving an expired dose of Tenivac.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expiration date format on the vaccine was confusing that it led to one staff giving an expired dose of tenivac  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 and Regulatory Authority 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: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives; Initial information received on 28-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 88 years old male patient who experienced hives after 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 an unknown date in 2022, the patient received a 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, expiry date and form not reported) via unknown route in unknown administration site as immunization.  On an unknown date in 2022, the patient developed hives (urticaria) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  It was reported "A Clinic wanting to know is there any protocol for administering the FLUZONE Quadrivalent High-Dose in two doses a week apart due to having an 88-year-old male consumer being told that after having the FLUZONE Quadrivalent High-Dose and getting hives, last year, to break the dose in half next time one-week apart."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: adacel was administered to the 78 years old female patient with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is cluster with cases 2023SA300771 and 2023SA300988.  This case involves a 78 years old female patient who was administered vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] 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 INFLUENZA VACCINE INACT SAG 3V (FLUAD); VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX); and PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylactic vaccination (Immunization).  On 25-Sep-2023, the 78 years old female patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day) (Suspension for injection) (lot U7905AA) (expiry date unknown) (Frequency = once) (Strength = standard) via intramuscular route in the deltoid nos (not otherwise specified) for Immunization.  It was reported that "Pharmacist states that ADACEL was administered to three 65 year old and higher patients."  Action taken: Not applicable.  Outcome: 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: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Tremor
Clinical narrative: 3 hours after she received Vaccine her hands and knees started trembling; the vaccine hurt and it was gurgling when it was put in her arm and sounded like bubbles; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 78-year-old female patient (45.35 kg) who stated 3 hours after she received vaccine her hands and knees started trembling and the vaccine hurt and it was gurgling when it was put in her arm and sounded like bubbles after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 15-Sep-2023, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (strength, expiry date, form, lot number: unknown) via unknown route in unknown administration site for influenza. Information on batch number was requested.  On 15-Sep-2023 the patient had events of 3 hours after she received vaccine her hands and knees started trembling (tremor) (latency: 3 hours) and the vaccine hurt and it was gurgling when it was put in her arm and sounded like bubbles (injection site pain) (latency: same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, 3 hours after she received Vaccine her hands and knees started trembling. Trembling lasted about 2 hours. She said it may have been due to her weight maybe. She stated that her husband took the vaccine and had no side effects. Consumer says she received the vaccine at a pharmacy on 15Sep2023 and didn't have any confidence in the woman that gave it to her as she seemed distracted. Says she had it in the left arm and no other vaccines the same day. Says the vaccine hurt and it was "gurgling" when it was put in her arm and sounded like bubbles. Says she only weighs 100 pounds but doesn't know if that has anything to do with it.  It was unknown if any lab data/test results available.  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 events.  Outcome: Recovered / Resolved on an unknown date for the event.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: fluzone quad a patient should receive if the syringe needle was pulled out before the vaccine was all able to be injected and the rest "spritzed out everywhere with no reported adverse event; fluzone quad administered to a 67 years patient with no reported adverse event; Initial information received on 02-Oct-2023 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 67 years old male patient who was administered Influenza quadrival a-b vaccine [Fluzone QIV] with no reported adverse event and patient receive if the syringe needle was pulled out before the vaccine was all able to be injected and the rest "spritzed out everywhere with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2023, the patient received 0.5 ml dose of suspect influenza quadrival a-b vaccine Suspension for injection (lot UG809MA) via intramuscular route in the right deltoid (strength and expiration date: not provided) for Immunisation (incorrect dose administered) (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.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: a pregnant patient was administered with expired FLUZONE QIV from last season with no adverse event; a pregnant patient was administered with expired FLUZONE QIV from last season with no adverse event; Initial information received on 02-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves pregnant patient of unknown age who was administered with expired influenza quadrival A-B vaccine [Fluzone QIV]from last season with no adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  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 02-Oct-2023, the pregnant patient was administered with expired dose of suspect influenza quadrival A-B vaccine, Suspension for injection (dose, strength: not reported) (lot UT7716KA; Expiration Date : 30-Jun-2023) via unknown route in unknown administration site for Immunization from last season with no adverse event (expired product administered) (exposure during pregnancy) (latency on same day).  Relevant prenatal testing after exposure was not reported.  Action taken : not applicable.  Outcome :  Unknown.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: they have administered FLUZONE QUADRIVALENT to a 65-year-old patient instead of a FLUZONE HIGH DOSE QUADRIVALENT (with no reported adverse event); Initial information received on 02-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 65 years old female patient who have been administered influenza quadrival A-B vaccine [fluzone quadrivalent] instead of 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 an unknown date, the patient of 65 year old received a dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot number, strength, dose, expiry date not reported) via unknown route in unknown administration site as immunization instead of influenza quadrival A-B high dose HV vaccine (with no reported adverse event) (wrong product administered) (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: 75.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently administered Fluzone QIV Np instead of the intended Fluzone High Dose QIV to a patient who is over 65 years old with no reported adverse event; Initial information received on 02-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 75 years old male patient who was inadvertently administered fluzone qiv np instead of the intended fluzone high dose qiv to a patient who is over 65 years old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2023, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine, Suspension for injection lot UT8076MA via unknown route in the left deltoid for immunization (strength, expiry date: unknown),  inadvertently administered fluzone qiv np instead of the intended fluzone high dose qiv to a patient who is over 65 years old with no reported adverse event (wrong product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event wrong product administered  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: 75.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired doses of TENIVAC were administered to patients with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid  non-serious case received from a Nurse.  This case is linked to case 2023SA304016.  This case involves a 75 years old female patient to whom administered the expired doses of diphtheria-2/tetanus-5 Adsorbed toxoids No Preservative Adult [Tenivac] were administered to patients 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 Influenza Vaccine for Immunization.  On 27-Sep-2023, the patient received expired dose of 0.5 ml of suspect  diphtheria-2/tetanus-5 Adsorbed toxoids No Preservative Adult Suspension for injection (strength: standard, frequency: once, expiry date: 24-Sep-2023 and lot 47183AA) via intramuscular route in unknown administration site as immunization (expired product administered) (same day latency).  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: 74.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: dose of expired TENIVAC was administered, with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA304012(CLUSTER).  This case involves a 74 years old male patient to whom dose of expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Tenivac) was 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 influenza vaccine and pneumococcal vaccine for Influenza immunisation.  On 28-Sep-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection with lot 47183AA, expiry- 24-Sep-2023 via intramuscular route in the right deltoid or immunization (strength: unknown) expired tenivac was administered, with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered  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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired PENTACEL with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old male patient who was administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] 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 an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ800AA, Expiry date: 01-Oct-2023) (with an unknown strength) via unknown route in unknown administration site for Immunization.  On an unknown date, the patient was administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine with no reported adverse event (expired product administered) (latency: same day).  It was reported, Nurse called stating that they have administered an expired PENTACEL to a patient and wants to know our recommendation moving forward. To be specific, caller wants to know if they need to revaccinate the patient.   Action taken: not applicable.  Outcome: 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: 25.0
Sex: M
Vaccine: FLUC3
Symptoms: Fatigue, Headache, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Stuffy nose; Low grade fever; Headache; Tiredness; This spontaneous case was received on 29-Sep-2023 from other non-healthcare professional (consumer) (reference number: SEQW23-02815) and concerned a 25-year-old, male patient.   The patient's medical history and concomitant medications were not reported.    On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (dose: 0.5 ml, 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 Flucelvax Quadrivalent, the patient experienced low grade fever, headache, sore throat, stuffy nose, and tiredness.   The outcome of all events was unknown.  The reporter assessed the events to be related to Flucelvax Quadrivalent vaccine. As reported, the patient experienced adverse reactions after receiving Flucelvax Quadrivalent vaccine.  Company comment: A 25-year-old male patient was vaccinated with Flucelvax Quadrivalent. After unknown amount of time, the patient experienced oropharyngeal pain, nasal congestion, pyrexia, headache and fatigue. Patient's medical history, concomitant medication and relevant diagnostic findings were not provided. Considering limited information provided, lack of information regarding vaccination date, events onset dates, and unclear temporal relationship, causality of the suspect vaccine is unassessable.; Reporter's Comments: The reporter assessed the events to be related to Flucelvax Quadrivalent vaccine. As reported, the patient experienced adverse reactions after receiving Flucelvax Quadrivalent vaccine.; Sender's Comments: A 25-year-old male patient was vaccinated with Flucelvax Quadrivalent. After unknown amount of time, the patient experienced oropharyngeal pain, nasal congestion, pyrexia, headache and fatigue. Patient's medical history, concomitant medication and relevant diagnostic findings were not provided. Considering limited information provided, lack of information regarding vaccination date, events onset dates, and unclear temporal relationship, causality of the suspect vaccine is unassessable.
Age: 84.0
Sex: F
Vaccine: FLUA4
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Typical soreness in the area of the shot, without radiating; Muscle soreness; This spontaneous case was received on 04-Oct-2023 from a pharmacist via Communications (reference number SEQW23-02973) and concerned an 84-year-old, female patient.   The patient's medical history and concomitant medications were not reported.    On 03-Oct-2023, reported as yesterday, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 0.5, route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number reported was 371626 and the expiry date reported was 30-Jun-2024.  On an unspecified day in Oct-2023, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced soreness in the area of the shot, without radiating and typical muscle soreness.   On 04-Oct-2023, one day after receiving Fluad Quadrivalent, the patient reported to the pharmacist typical soreness in the area of the shot, without radiating and typical muscle soreness. There was no treatment measures associated with the events.  The outcome of the events was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company Comment: The events of vaccination site pain and muscle soreness are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of vaccination site pain and muscle soreness are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, FLUC4
Symptoms: Decreased appetite, Fatigue, Swelling face, Urticaria
Clinical narrative: Patient stats about 24 hours after receiving both COVID and Flu vaccine to left deltoid she started to develop rash to chest, neck and face, arms. She states she had slight swelling and feeling of dry lips. She took a benadrly took a nap and woke up with rash going to abdomen and legs.  She took benadryl this morning due to worsening rash,. She reports never having allergic reaction to anything before.   Assessment- Hives throughout upper body and now legs- Lymph node swelling to left cervical - left deltoid was where both Flu and COVID vaccines were given.   10/8- Vaccines given 10/9- rash develops 10/10 seen at Clinic- given Prednisone 40 mg x 5 days and instructed to take benadryl  OTC - if symptoms do not improve or worsen after starting treatment follow up.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, FLUC4
Symptoms: Lip dry, Lymphadenopathy, Rash, Swelling
Clinical narrative: Patient stats about 24 hours after receiving both COVID and Flu vaccine to left deltoid she started to develop rash to chest, neck and face, arms. She states she had slight swelling and feeling of dry lips. She took a benadrly took a nap and woke up with rash going to abdomen and legs.  She took benadryl this morning due to worsening rash,. She reports never having allergic reaction to anything before.   Assessment- Hives throughout upper body and now legs- Lymph node swelling to left cervical - left deltoid was where both Flu and COVID vaccines were given.   10/8- Vaccines given 10/9- rash develops 10/10 seen at Clinic- given Prednisone 40 mg x 5 days and instructed to take benadryl  OTC - if symptoms do not improve or worsen after starting treatment follow up.
Age: 24.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Chills, Fatigue, Muscle spasms, Myalgia, Sleep disorder
Clinical narrative: Began with fatigue around 3PM progressing into chills, muscle aches, and cramps. The chills and muscle pains prevented sleep.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient forgot they needed a 2nd dose of Shingrix, had first dose on 7Jan2020 and never got a 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient forgot they needed a 2nd dose of Shingrix, had first dose on 7Jan2020 and never got a 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist reported a patient forgot they needed a 2nd dose of Shingrix, had 1st dose and never got a 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up via email
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: lives in a 55 and older community and a lot of older people around her are having the same issue after having received the COVID-19 vaccines.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (lives in a 55 and older community and a lot of older people around her are having the same issue after having received the COVID-19 vaccines.) 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 IMMUNISATION REACTION (lives in a 55 and older community and a lot of older people around her are having the same issue after having received the COVID-19 vaccines.). At the time of the report, IMMUNISATION REACTION (lives in a 55 and older community and a lot of older people around her are having the same issue after having received the COVID-19 vaccines.) outcome was unknown.            Concomitant medication not reported.  The dosage text was reported as unknown. It was reported that the patient was not sure if all these other people have received the Moderna COVID-19 vaccine or not. Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-744892 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744892:Invalid case for Different patients
Sex: M
Vaccine: RVX
Symptoms: Myalgia, No reaction on previous exposure to drug
Clinical narrative: Extreme muscle pain in upper body; This non-serious case was reported by a consumer and described the occurrence of muscle pain in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included heart disorder (was a heart patient, at present time (at the time of reporting) had no issues at all with heart). Previously administered products included Covid vaccine with an associated reaction of no adverse event (never had any issues with other vaccines), Flu vaccine with an associated reaction of no adverse event, Shingles vaccine with an associated reaction of no adverse event and Pneumonia vaccine with an associated reaction of no adverse event. Concurrent medical conditions included blood pressure high (blood pressure normal with medicines). Concomitant products included labetalol and irbesartan.   On 25-SEP-2023, the patient received RSV vaccine. On 25-SEP-2023, less than a day after receiving RSV vaccine, the patient experienced muscle pain (Verbatim: Extreme muscle pain in upper body). The outcome of the muscle pain was not resolved.   It was unknown if the reporter considered the muscle pain to be related to RSV vaccine.     It was unknown if the company considered the muscle pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 30-SEP-2023 The patient also the reporter. The patient's concomitant products included Labetalol 100 mg once per day and Irbesartan 300 mg once per day. The patient was advised to get vaccine and had extreme muscle pain in upper body. The reporter consented to follow-up.
Sex: U
Vaccine: RVX, UNK
Symptoms: Illness
Clinical narrative: I was sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (INFLUENZA SHOT) for prophylaxis.   Previously administered products included Flu shot with an associated reaction of pain in extremity.   On an unknown date, the patient received RSV vaccine and INFLUENZA SHOT. On an unknown date, 1 day after receiving RSV vaccine, the patient experienced sickness (Verbatim: I was sick). The outcome of the sickness was not reported.   The reporter considered the sickness to be possibly related to RSV vaccine.     The company considered the sickness to be possibly related to RSV vaccine.  Additional Information: GSK Receipt Date: 30-SEP-2023 This case was reported by a patient via interactive digital media. The patient got RSV and Flu shot and was sick the next day. The patient thought it was RSV. The patient never got sick with the flu shot accept a sore arm. It was unknown if the reporter considered the sickness to be related to the Flu shot. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Gillian Barres Syndrome; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Gillian Barres Syndrome) (serious criteria GSK medically significant).  The outcome of the guillain barre syndrome was resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt date: 03-OCT-2023 Reporter was a Field Representative who was at an in-service lunch, during in-service a doctor, that field Rep knew previously, mentioned he had the Shingrix vaccine years ago and he developed Gillian Barres Syndrome after getting the vaccine.  The doctor also mentioned that he was fully recovered at present time.  Field Representative reports that this was a casual conversation at a lunch, and he had no other information.  The reporter did not consent to follow-up.
Sex: U
Vaccine: UNK
Symptoms: Illness
Clinical narrative: people is getting very sick with the Covid vaccines; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (people is getting very sick with the Covid vaccines) in a patient of an unknown age and gender 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 ILLNESS (people is getting very sick with the Covid vaccines). At the time of the report, ILLNESS (people is getting very sick with the Covid vaccines) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.  Caller mentioned that people were getting very sick with the Covid vaccines. She said that her daughter told her that someone from a pharmacy told her that they are getting lots of reports that people are getting very sick after vaccination. Caller could not confirm if this was specific form the Moderna vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Abdominal distension, Anal incontinence, Diarrhoea, Flatulence
Clinical narrative: 1. Started Saturday Sept 10th 2023 2. On average has diarreah 5 times a day now its about 3x a day. However there were a few days where he had diarreah up to 10 times per day but most of the time it was mucus or watery stool. 3. He also has  mucus and watery stool when he has passes gas . He can't control it, so he has accidents throughout the day.  This happens at least 5 times a day. He has never had an accident in the past since he's been potty trained. 6. He is in pain prior to having diarreah and  while he is having a bowel movemet. Sometimes it takes him at least 10 minutes to go and only a little bit comes out at a time ( it hurts when he pushes )  7. He is very bloated and passes a lot of gas prior to having a bowel movement
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Redness, swelling below injection site.  Itching during the night but not now.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Headache, Malaise, Nausea, Respiratory rate decreased
Clinical narrative: nausea, headache, slow breathing. stomach ache malaise
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PATIENT WAS GIVEN ANTHRAX VACCINE INSTEAD OF SEASONAL FLU. PATIENT WAS INSTRUCTED TO WAIT 20 MINUTES IN THE CLINIC, NO ADVERSE REACTION/SYMPTOMS NOTED. PATIENT TO FOLLOW UP IN CLINIC IN 1 WEEK. PATIENT HAD ANNUAL ANTHRAX BOOSTER 28 DAYS AGO.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Chills, nausea, vomiting  Passed out!
Age: 51.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: -Pain described as "hot oil" during plunger depression -Red lines coming from injection site -Patient cried out in pain -Reaction for Shingrix ONLY, Not flu -Shingrix given 0.3ML L delt, IM
Age: 8.0
Sex: M
Vaccine: DTAP, HEP, MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient was administered DTAP instead of TDAP vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid; fully vaccinated with 2 boosters
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 3 boosters
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pts Age should have recieved Tdap instead they recived Dtap
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Age of Pt should have recived Tdap given Dtap instead
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 2 boosters
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Facial pain, Groin pain, Headache, Influenza like illness
Clinical narrative: See above, some minor flu like symptoms in addition to the pain and cramping listed above.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms
Clinical narrative: See above, some minor flu like symptoms in addition to the pain and cramping listed above.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 10/03/2023 HOSPITALIZED FOR COVID
Age: 16.0
Sex: F
Vaccine: FLUN4
Symptoms: Dizziness postural, Headache, Postural orthostatic tachycardia syndrome
Clinical narrative: Dizzy unpon standing, Head ache, orthostatic tachycardia
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Induration, Lymphadenopathy, Oedema peripheral, Pain
Clinical narrative: Oct 2- shot received Oct 3- neck lymph nodes sore Oct 4 prickly painful feeling over my ENTIRE body (head to toes) and itchy Oct 5 large welts covering my entire right neck, check bone,  and under chin with bumps, painful, itchy... Left lower arm 4 separate clusters of bumps, red, swollen, itchy.. later that day edema to left arm from wrist (starting point) to elbow all sides of arm.  VERY RED, HOT, PAINFUL, hard, orange peel skin and itchy. could not tolerate anything touching it or using that arm. Caused a lot of pain. had to change watch band X2 spaces due to the swelling Oct 6 nothing new, previous symptoms just getting worse Oct 7 symptoms started to regress Oct 8 symptoms continue to regress Oct 9 (today) symptoms continue to regress, almost at base line as far as physical presentation. continue to have itchiness and prickly feeling all over body. painful but tolerable
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Oct 2- shot received Oct 3- neck lymph nodes sore Oct 4 prickly painful feeling over my ENTIRE body (head to toes) and itchy Oct 5 large welts covering my entire right neck, check bone,  and under chin with bumps, painful, itchy... Left lower arm 4 separate clusters of bumps, red, swollen, itchy.. later that day edema to left arm from wrist (starting point) to elbow all sides of arm.  VERY RED, HOT, PAINFUL, hard, orange peel skin and itchy. could not tolerate anything touching it or using that arm. Caused a lot of pain. had to change watch band X2 spaces due to the swelling Oct 6 nothing new, previous symptoms just getting worse Oct 7 symptoms started to regress Oct 8 symptoms continue to regress Oct 9 (today) symptoms continue to regress, almost at base line as far as physical presentation. continue to have itchiness and prickly feeling all over body. painful but tolerable
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Skin exfoliation, Skin warm, Tenderness, Urticaria
Clinical narrative: Oct 2- shot received Oct 3- neck lymph nodes sore Oct 4 prickly painful feeling over my ENTIRE body (head to toes) and itchy Oct 5 large welts covering my entire right neck, check bone,  and under chin with bumps, painful, itchy... Left lower arm 4 separate clusters of bumps, red, swollen, itchy.. later that day edema to left arm from wrist (starting point) to elbow all sides of arm.  VERY RED, HOT, PAINFUL, hard, orange peel skin and itchy. could not tolerate anything touching it or using that arm. Caused a lot of pain. had to change watch band X2 spaces due to the swelling Oct 6 nothing new, previous symptoms just getting worse Oct 7 symptoms started to regress Oct 8 symptoms continue to regress Oct 9 (today) symptoms continue to regress, almost at base line as far as physical presentation. continue to have itchiness and prickly feeling all over body. painful but tolerable
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Intense swelling , redness, and soreness in the upper left  bicep area  slightly below the injection site, towards the front of the bicep, approx. 2.5-3in in diameter, starting overnight after my injection at approximately 3am ET, along with night sweats, body aches, slight headache, and fatigue, and then starting on 10/09/2023 at approximately 11am ET, intense itching at the 2.5-3in diameter red and swollen area, only moderately improved after taking Benadryl 25mg po and then briefly mostly improved after taking a second Benadryl 25mg po 30 min later, and now, as of 10/10/2023 at 9:10am, slightly decreased swelling and definition of the swollen and red area but still intense itching in that area on the bicep.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site swelling, Night sweats, Pain
Clinical narrative: Intense swelling , redness, and soreness in the upper left  bicep area  slightly below the injection site, towards the front of the bicep, approx. 2.5-3in in diameter, starting overnight after my injection at approximately 3am ET, along with night sweats, body aches, slight headache, and fatigue, and then starting on 10/09/2023 at approximately 11am ET, intense itching at the 2.5-3in diameter red and swollen area, only moderately improved after taking Benadryl 25mg po and then briefly mostly improved after taking a second Benadryl 25mg po 30 min later, and now, as of 10/10/2023 at 9:10am, slightly decreased swelling and definition of the swollen and red area but still intense itching in that area on the bicep.