chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC15, PNC21, PPV
Symptoms: Loss of consciousness, Muscle twitching, Nerve injury, Tinnitus
Clinical narrative: the pharmacist hit a nerve in my arm/my arm started to twitching; pt passed out; tinnitus/ I keep hearing myself breathing and hear my heart rate; This spontaneous report was received from a patient of unknown gender and age via Pfizer. The patient's concurrent conditions included a cancer in leg. The patient's medical history and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with an unspecified pneumonia vaccine (dose, route of administration, anatomical location, lot # and expiration date were not provided), for prophylaxis. The pharmacist hit a nerve in the patient's arm and the arm started twitching. The patient went home and passed out. When the patient regained consciousness and started talking again, kept hearing breathing and heart rate. It was tinnitus in the patient's ear. When the patient talked, it went back out and then it went to the brain and then went back out and went through the patient's ear. The outcome of passing out was considered as recovered on an unknown date. The outcome of other events was not provided.  Causality assessment was not reported.   Upon internal review, the events of nerve injury and passing out were considered to be medically significant.   Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: HIV infection
Clinical narrative: We have a male patient who is under 45 years old who is diagnosed with HIV who was previously vaccinated with the 4-valent series; This spontaneous report was received from a company representative and refers to a male patient of unknown age (reported as under 45 years old). The patient's concurrent conditions included high risk sexual behavior. His medical history, concomitant therapies, and previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, at a dose of 0.5 milliliter, administered intramuscularly (IM) for prophylaxis, as a 3-dose series (strength, vaccination scheme, anatomical site of injection, lot number, and expiration date were not provided).  On an unknown date, the patient was diagnosed with HIV (HIV infection). The outcome of the event was not reported.   The causal relationship between HIV infection and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.   Upon internal review, the event of HIV infection was determined to be medically significant.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported,; a patient received improperly stored vaccine.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 18-OCT-2024, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), lot # reported as y026666 with expiration date reported as 29-MAY-2025 (dose, route and frequency were not reported) for prophylaxis.    The vaccine was stored during 24 minutes at 8.6 Celsius degrees. There were no previous temperature excursions. No additional adverse events were reported.  Lot # y026666 is an invalid lot number for hepatitis a vaccine, inactivated.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A HCP called to inquire about whether he needed to restart the series of GARDASIL 9 for a patient who was 21 at the time of his first dose in May of 2023; No adverse event; This spontaneous report was received from a pharmacist referring to a 22-year-old patient, gender was not provided.  Information regarding the patient's concurrent conditions, medical history, allergies or drug reactions, or concomitant medications was not provided.  On a unspecified date in May 2023, at the age of 21 years old, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (dose, route of administration, anatomical location, lot number, and expiration date were not reported). However, the patient did not follow the vaccination schedule after this dose (Inappropriate schedule of product administration).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: administration of one dose of MMR II following a temperature excursion.; No other AE; This spontaneous report was received from an office manager concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, lot # Y000225 with expiration date of 03-JAN-2024 for prophylaxis (strength, dose, route of administration, anatomical site of injection were not provided). The temperature excursion was reported that the doses were exposed to a temperature excursion (TE) of 47.9 Degree Fahrenheit (F) for 6 hours 0minutes 0 seconds. No previous excursions were reported. No side effects or symptoms, and no additional adverse event (AE) was reported.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose of Menveo (2 vial) was administered to a 16 years old male patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA983A, expiry date 13-SEP-2024) for prophylaxis.   On 08-OCT-2024, the patient received Menveo. On 08-OCT-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose of Menveo (2 vial) was administered to a 16 years old male patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2024 The medical assistant called to report that they administered an expired dose Menveo (2 vial) to a patient, which led to an expired vaccine used. First the HCP (health care professional) said that it was administered on Monday 07-OCT-2024, then her supervisor took over the call and said it was administered day before reporting. The reporter wanted to know did they have to repeat the dose and how long did they have to wait to repeat the dose.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: sore arm which was normal vaccine reaction; patient already had vaccine last year and was re-vaccinated; This is a spontaneous report received from a Pharmacist from medical information team, Program ID: .  A 71-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 2, single (Lot number: HM9865, Expiration Date: Apr2025) at the age of 71 years for immunisation, Device Lot Number: HM9865, Device Expiration Date: Apr2025. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Abrysvo (dose 1), for immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm which was normal vaccine reaction"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "patient already had vaccine last year and was re-vaccinated".  Additional information: A pharmacist did not realize that the patient already had the vaccine last year and she re-vaccinated the patient this year not knowing that. On 18Oct2024, the pharmacist informed that the patient thought vaccine was annual, pharmacist did not catch it was also given last year. The patient had a sore arm which was normal vaccine reaction.  Follow-up (25Sep2024): This is a spontaneous follow-up report received from a pharmacist. Updated information: reporter data (added: last name), patient data (added: age at vaccination), and suspect product data (added: lot number and expiration date).  Follow-up (18Oct2024): This is a spontaneous follow-up report received from a pharmacist. Updated information: reaction data (sore arm which was normal vaccine reaction).
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Decreased appetite, Dehydration, Diarrhoea, Fatigue
Clinical narrative: Dehydration; Decreased appetite; Headache; Fever; nausea; substantial diarrhea; Fatigue; chils; Initial information received on 14-Oct-2024 regarding an unsolicited valid  serious case received from a consumer/Non-Healthcare Professional as courtesy case from Pfizer  This case involves an unknown age and female patient who experienced dehydration, headache, fever, nausea, decreased appetite, substantial diarrhea, fatigue and chills after receiving Tozinameran (Comirnaty) and Influenza quadrivalent recombinant vaccine [Flublok].  The patient's past vaccination(s) included Covid-19 Pfizer on 18-MAR-2021 (dose 1 EN6198, left arm), on 04-AUG-2021 (dose 2, EP7533, left arm) and on 20-NOV-2021 ((Dese 3) Booster FJ1611, left arm). The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy, Drug hypersensitivity and Childhood asthma.  Concomitant medications included Fluticasone propionate, Salmeterol xinafoate (Advair) for Asthma; Tiotropium bromide monohydrate (Spiriva) for Asthma; and Loratadine (Claritin) for Hypersensitivity.  On 08-Sep-2024, the patient received unknown dose (dose 1) of suspect Influenza quadrivalent recombinant vaccine (formulation, strength, lot number and expiry date not reported) via unknown route in the right arm and unknown dose (dose 1) of suspect COMIRNATY not produced by Sanofi Pasteur (formulation, strength, lot number and expiry date not reported) via intramuscular route in the left arm both for prophylactic vaccination.  There will be no information available on the batch number for this case.  On an unknown date the patient developed dehydration, headache, fever (pyrexia), nausea, decreased appetite, substantial diarrhea (diarrhoea),  fatigue and chils (chills) (unknown latency).  The patient was hospitalized for the events during 1 days. (hospitalization during 1 days).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events; Sender's Comments: Sanofi Company Comment dated 23-OCT-2024: This case involves an unknown age and female patient who experienced dehydration, headache, fever, nausea, decreased appetite, substantial diarrhea, fatigue and chills after receiving Tozinameran (Comirnaty) and Influenza quadrivalent recombinant vaccine [Flublok]. Further information regarding concurrent condition during vaccination, tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Dehydration; Decreased appetite; Headache; Fever; nausea; substantial diarrhea; Fatigue; chils; Initial information received on 14-Oct-2024 regarding an unsolicited valid  serious case received from a consumer/Non-Healthcare Professional as courtesy case from Pfizer  This case involves an unknown age and female patient who experienced dehydration, headache, fever, nausea, decreased appetite, substantial diarrhea, fatigue and chills after receiving Tozinameran (Comirnaty) and Influenza quadrivalent recombinant vaccine [Flublok].  The patient's past vaccination(s) included Covid-19 Pfizer on 18-MAR-2021 (dose 1 EN6198, left arm), on 04-AUG-2021 (dose 2, EP7533, left arm) and on 20-NOV-2021 ((Dese 3) Booster FJ1611, left arm). The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy, Drug hypersensitivity and Childhood asthma.  Concomitant medications included Fluticasone propionate, Salmeterol xinafoate (Advair) for Asthma; Tiotropium bromide monohydrate (Spiriva) for Asthma; and Loratadine (Claritin) for Hypersensitivity.  On 08-Sep-2024, the patient received unknown dose (dose 1) of suspect Influenza quadrivalent recombinant vaccine (formulation, strength, lot number and expiry date not reported) via unknown route in the right arm and unknown dose (dose 1) of suspect COMIRNATY not produced by Sanofi Pasteur (formulation, strength, lot number and expiry date not reported) via intramuscular route in the left arm both for prophylactic vaccination.  There will be no information available on the batch number for this case.  On an unknown date the patient developed dehydration, headache, fever (pyrexia), nausea, decreased appetite, substantial diarrhea (diarrhoea),  fatigue and chils (chills) (unknown latency).  The patient was hospitalized for the events during 1 days. (hospitalization during 1 days).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events; Sender's Comments: Sanofi Company Comment dated 23-OCT-2024: This case involves an unknown age and female patient who experienced dehydration, headache, fever, nausea, decreased appetite, substantial diarrhea, fatigue and chills after receiving Tozinameran (Comirnaty) and Influenza quadrivalent recombinant vaccine [Flublok]. Further information regarding concurrent condition during vaccination, tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 78.0
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: received expired vaccine (with no reported adverse event); Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to US-SA-2024SA305001 (cluster case).  This case involves a 78 years old and unknown gender patient who received expired 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 09-Oct-2024, the patient received 0.7 ml of dose of expired influenza quadrival A-B high dose HV vaccine (formulation- unknown, strength- high dose, lot UT8131CA and expiry date- 30-Jun-2024) once via unknown route in the left arm for immunization with no reported adverse event (expired product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. ; Sender's Comments:  US-SA-2024SA305001:Master case (cluster case) US-SA-2024SA305001:02259596 (patient 1) 00096963
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: given a dose of pentacel post excursion with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to US-SA-2024SA304909 (Master case).  This case involves 5 months old male patient who was given a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] post excursion 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 ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On an unknown date, the patient received a standard 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (lot UJ975AA and expiry 23-Nov-2024) (strength: standard) via unknown route in unknown administration site for Immunization; post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Caller states they had a temperature excursion on some Sanofi vaccines. She had already used the online stability calculator to determine they were no longer viable, but they had already administered a menquadfi and a pentacel after the excursion. She was asking if those vaccines need to be repeated.  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.; Sender's Comments:  US-SA-2024SA304909:Master case
Age: 4.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: given a dose of MENQUADFI post excursion with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked with US-SA-2024SA304909, US-SA-2024SA305031, US-SA-2024SA305413, US-SA-2024SA305112, US-SA-2024SA305508, US-SA-2024SA305062.  This case involves a 4 years old male patient who was given a dose of Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (lot- UJ975AA and expiration date- 23-NOV-2024) via unknown route in unknown administration site for Immunisation and patient given a dose of menquadfi post excursion with no reported adverse event (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA304909: US-SA-2024SA305031: US-SA-2024SA305413: US-SA-2024SA305112: US-SA-2024SA305508: US-SA-2024SA305062:
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: given a dose of menquadfi post excursion with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to US-SA-2024SA304909 (Master case).  This case involves 16 years old male patient who was given a dose of Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a standard dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (lot UJ975AA) (with an unknown dose and expiry date) via unknown route in unknown administration site for Immunization; post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Caller states they had a temperature excursion on some Sanofi vaccines. She had already used the online stability calculator to determine they were no longer viable, but they had already administered a menquadfi and a pentacel after the excursion. She was asking if those vaccines need to be repeated.  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.; Sender's Comments:  US-SA-2024SA304909:master case US-SA-2024SA305074:
Age: 1.83
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: child was given the vaccine one day after it had expired, with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who was given the hib (prp/t) vaccine [ACT-HIB] vaccine one day after it had expired, 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 Proquad and MMR vaccines for Immunisation.  On 07-Oct-2024, the patient received a 0.5 ml dose of suspect Powder and solvent for solution for injection of hib (prp/t) vaccine (lot UJ975AB, expiry date: 06-Oct-2024, strength: standard) via unknown route in unknown administration site as Immunization and the patient was given the vaccine one day after it had expired, with no reported adverse event (expired product administered) (Latency: same day).    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dysphagia, Eye swelling, Grunting, Pyrexia
Clinical narrative: fever of 102.0 F; anaphylactic reaction 20 minutes after injection; audible grunting with his breathing; eyes swelling; frequent swallowing; Initial information received on 16-Oct-2024 regarding an unsolicited valid  serious case received from a nurse.  This case involves a 2 years old male patient who experienced fever of 102.0 F and anaphylactic reaction 20 minutes after receiving Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone].  The patient's past vaccination(s) included Fluzone [Influenza Vaccine] with first dose on 12-Oct-2022, second dose on 13-Jan-2023, third dose on 25-Sep-2023. The patient's past medical history, medical treatment(s) and family history were not provided.   On 08-Oct-2024, the patient received a dose 4 with dosage 0.5 ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine (lot U8435AA, with unknown expiry) (Strength: Standard, Frequency: yearly) via intramuscular route in unknown administration site as immunization.  On 08-OCT-2024 the Patient had an anaphylactic reaction 20 minutes after injection (anaphylactic reaction) with symptoms of nasal clearing, audible grunting with his breathing (grunting), eyes swelling (eye swelling), frequent swallowing (dysphagia) following the administration of Influenza USP Trival A-B Subvirion No Preservative Vaccine. Patient had a doctor visit the following day on 09-Oct-2024 and experienced fever of 102.0 F (pyrexia) (Latency: 1 day) following the administration of Influenza USP Trival A-B Subvirion No Preservative Vaccine.  Relevant laboratory test results included: Pyrexia - On 09-Oct-2024: 102.0 F (Fahrenheit) Respiratory rate - On 08-Oct-2024: 28 UNK [28]  Action taken: not applicable.  The patient was treated with Paracetamol (Tylenol) for Pyrexia.  At time of reporting, the outcome was Unknown for the events.  Seriousness: Anaphylactic reaction and its symptoms were assessed as medically significant.; Sender's Comments: Sanofi company comment for information received on 23-Oct-2024: This case involves a 2 years old male patient who experienced fever of 102.0 F and anaphylactic reaction 20 minutes after receiving Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone]. Further information regarding medical history, concurrent condition during vaccination, concomitant medication and tolerance, allergic history excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: fever of 102.0 F; anaphylactic reaction 20 minutes after injection; audible grunting with his breathing; eyes swelling; frequent swallowing; Initial information received on 16-Oct-2024 regarding an unsolicited valid  serious case received from a nurse.  This case involves a 2 years old male patient who experienced fever of 102.0 F and anaphylactic reaction 20 minutes after receiving Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone].  The patient's past vaccination(s) included Fluzone [Influenza Vaccine] with first dose on 12-Oct-2022, second dose on 13-Jan-2023, third dose on 25-Sep-2023. The patient's past medical history, medical treatment(s) and family history were not provided.   On 08-Oct-2024, the patient received a dose 4 with dosage 0.5 ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine (lot U8435AA, with unknown expiry) (Strength: Standard, Frequency: yearly) via intramuscular route in unknown administration site as immunization.  On 08-OCT-2024 the Patient had an anaphylactic reaction 20 minutes after injection (anaphylactic reaction) with symptoms of nasal clearing, audible grunting with his breathing (grunting), eyes swelling (eye swelling), frequent swallowing (dysphagia) following the administration of Influenza USP Trival A-B Subvirion No Preservative Vaccine. Patient had a doctor visit the following day on 09-Oct-2024 and experienced fever of 102.0 F (pyrexia) (Latency: 1 day) following the administration of Influenza USP Trival A-B Subvirion No Preservative Vaccine.  Relevant laboratory test results included: Pyrexia - On 09-Oct-2024: 102.0 F (Fahrenheit) Respiratory rate - On 08-Oct-2024: 28 UNK [28]  Action taken: not applicable.  The patient was treated with Paracetamol (Tylenol) for Pyrexia.  At time of reporting, the outcome was Unknown for the events.  Seriousness: Anaphylactic reaction and its symptoms were assessed as medically significant.; Sender's Comments: Sanofi company comment for information received on 23-Oct-2024: This case involves a 2 years old male patient who experienced fever of 102.0 F and anaphylactic reaction 20 minutes after receiving Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone]. Further information regarding medical history, concurrent condition during vaccination, concomitant medication and tolerance, allergic history excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Dry skin, Rash, Rash pruritic
Clinical narrative: Broke out into small bumps all over both arms and small spots on left thigh. The bumps cause itchiness and leave skin very dry.
Sex: F
Vaccine: FLU3
Symptoms: Head discomfort, Headache, Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: left arm red swollen from shoulder to elbow. tingling down left arm to center of the left palm. pressure pain in head on right side
Sex: F
Vaccine: FLU3
Symptoms: Vaccine positive rechallenge
Clinical narrative: left arm red swollen from shoulder to elbow. tingling down left arm to center of the left palm. pressure pain in head on right side
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pain, Product complaint
Clinical narrative: severe pain during injection; pain; that it burns; Product Complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Flu Seasonal TIV Dresden (Fluarix 2008-2009 season) (batch number 72RF2) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Fluarix 2008-2009 season. On an unknown date, immediately after receiving Fluarix 2008-2009 season, the patient experienced injection site pain (Verbatim: severe pain during injection), pain (Verbatim: pain), burning sensation (Verbatim: that it burns) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain, pain, burning sensation and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site pain, pain and burning sensation to be related to Fluarix 2008-2009 season.     It was unknown if the company considered the injection site pain, pain and burning sensation to be related to Fluarix 2008-2009 season.   Additional Information: GSK Receipt Date: 01-OCT-2024 The age range of the vaccinated person (patient) was 38 to under 52 years old. After applying Fluarix vaccine, the patient reported pain during the injection, that it hurts so bad that it burns. The patient had severe pain when getting the injection. This was 1 of the 6 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024121101:same reporter different patient US-GSK-US2024AMR125751:same reporter different patient US-GSK-US2024AMR125752:same reporter different patient US-GSK-US2024AMR125753:same reporter different patient US-GSK-US2024AMR125754:same reporter different patient
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles). Previously administered products included Shingrix (received 1st dose few years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2024 This case was self-reported by patient. The patient stated that she got a first shot of Shingrix a few years ago and then the second shot just a couple of  weeks ago.  Dates of administration, lot numbers and expiration dates were unknown by the patient. The reporter mentioned that she got shingles in the past but clarified that it happened before the first Shingrix dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Vaccination error
Clinical narrative: injections were supposed to be a Covid vaccine (unspecified) and FLUZONE HIGH- DOSE, however; the RN only administered one of the medications, with no reported adverse event; Initial information received on 13-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Elderly female patient who had injections were supposed to be a covid vaccine (unspecified) and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD], however; the rn only administered one of the medications, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) strength, expiry date, lot number not reported via unknown route in unknown administration site for Immunization and injections were supposed to be a covid vaccine (unspecified) and fluzone high- dose, however; the rn only administered one of the medications, with no reported adverse event (incorrect dose administered) (latency: same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  Reportedly "This situation is pre-assessed as a medication error/a inappropriate use due to failing to properly identify the medication prior to administration."   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: F
Vaccine: FLU3
Symptoms: Deafness unilateral, Sudden hearing loss
Clinical narrative: Sudden hearing loss left ear
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: urticaria -reaction to left neck area, left arm, braw line/torso area on both left and right
Age: 68.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Dizziness, Dizziness postural
Clinical narrative: Dizziness when I roll over in bed and when I stand up after waking
Age: 40.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness
Clinical narrative: Passed out, didn't come to for about 10 seconds. Recovered quickly after.
Age: 14.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain lower, Loss of consciousness, Tension
Clinical narrative: New right lower abdomen stomach pain (probably unrelated), in the morning described her body feeling "tense". She then passed out while getting ibuprofen. Was ready to sit up in about 5 minutes. Full recovery pending.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received high dose vaccine. Employee notified. Employee exhibiting no side effects at this time.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given COVID vaccine for age 12 and up. No adverse reaction at that time.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: No reaction. Patient given RSV Arexvy an should have RSV  Abrysvo
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given COVID vaccine for age 12 and up. No adverse reaction.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: vaccinated on 9/23, sharp cramp to right arm when hyperextended backwards on 9/27. sporadically was doing that until yesterday 10/23 at 1:00 am and sharp pain constant 7/10. alternating tylenol and motrin and tylenol since yesterday (does help some). today if she has to use her arm it "drops".
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was given in error, patient was supposed to get Hib instead. Patient has no symptoms of adverse reactions. Vaccine was given at 1440.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Swelling face
Clinical narrative: Upper lip swollen and puffy, headache
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered dtap/ipv , pt is 8 yo, did not catch that should have given tdap instead
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Occupational exposure to product
Clinical narrative: The immunizer (pharmacy tech) gave the source patient a vaccine and as she was activating the safety device on the BD safety glide needle tip, she grazed the tip of finger on the used needle before the safety device was activated fully. The graze did break the glove but did not draw blood. Tech (immunizer) immediately informed the pharmacist and we instructed her to wash her hands in hot soapy water for 3+ minutes and started our needlestick protocol.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Loss of consciousness, Urinary incontinence
Clinical narrative: Patient got vaccine at 1pm and at 1:05pm presented out of it and sweating. He passed out while sitting in the chair. He was out for a few seconds and while out he lost control of his bladder. He came around but was still out of it. 911 was called and when they arrived, He could answer what his name was after asking a few times. Medics took blood pressure, and it was low.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Member requested the flu vaccine accidentally.  He previously received his flu vaccine the week before.  He meant to request the COVID Vaccine
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea and diarrhea.
Age: 10.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash macular
Clinical narrative: Mother called health department in AM on 10/23  telling me she noticed a faint reddish-pink circular non-raised rash to case's upper arms,abd.,bilateral flank areas,and upper thighs.She denied associated itching and stated the various sized circular blotches had no central distinguishing characteristics.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was incorrectly administered the Flucelvax flu vaccination, after have already received the FluMist at recent office visit.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: dizzy & light headed & vomiting & diahrrea the following day. Brand of vaccine is Adeceo .05 dosagse
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no signs or symptoms have been present
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Palpitations
Clinical narrative: patient states "racing heart" and "muscle spasm"
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Dissociation, Dizziness, Dysgeusia, Lethargy
Clinical narrative: I experienced a strong metallic taste approximately 3 minutes after injection, this metallic taste last approximately 2 minutes and was accompanied by dizziness. The next 14 hrs up until bedtime, I experienced a dissociated experience, fogginess and lethargy.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Rash, Rash pruritic, Swelling face
Clinical narrative: Woke up with swelling of eyes/face on 10/23. Swelling went down through the day but developed an itchy rash later in the day. Rash got worse overnight on 10/23. Swelling of lips and rash all over body on morning of 10/24
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Malaise, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Cough, nasal congestion, sore throat, generalized malaise
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash to perineal area and back. Non-raised, non-itchy
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Exposure during pregnancy, Immediate post-injection reaction, Pruritus
Clinical narrative: Patient 13w0d pregnant at time of vaccination. Immediately after vaccination patient complained of entire left arm redness and itching that lasted for approximately one hour.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood test normal, Chest discomfort, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: I experienced significant chest pain and tightness, along with shortness of breath and pain when I took a deep breath. Though the chest pain is gone, I still have shortness of breath when I attempt to do any kind of exercise, like walking. I was previously doing high intensity exercise in 50 minute sessions 2-3 times a week.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Electrocardiogram normal, Painful respiration
Clinical narrative: I experienced significant chest pain and tightness, along with shortness of breath and pain when I took a deep breath. Though the chest pain is gone, I still have shortness of breath when I attempt to do any kind of exercise, like walking. I was previously doing high intensity exercise in 50 minute sessions 2-3 times a week.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Feeling cold, Hypoaesthesia, Motor dysfunction
Clinical narrative: Symptoms: weakness, motor dysfunction: unable to grasp/squeeze  - felt like hand cramping ? numbness, tingling, pain in neck/shoulder - I thought I would sleep and feel better - symptoms progressed to increased numbness tingling, neck/should pain - spasms end of fall/winter - coolness-felt cold, increased cramping  Increasing frequency of cool to cold sensation in addition to continued numbness, tingling, perceived weakness, cramping up arm - band like - shoots down right arm - most notable in middle finger and thumb   MAY 2024 - Prothrombin Fragment 1 + 2 868 H treatment lovenox sq 30mg x 30days - resolution of symptoms within 2 weeks; symptoms returned 2-3 months later with accompanying upper chest/throat pressure.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neck pain, Paraesthesia
Clinical narrative: Symptoms: weakness, motor dysfunction: unable to grasp/squeeze  - felt like hand cramping ? numbness, tingling, pain in neck/shoulder - I thought I would sleep and feel better - symptoms progressed to increased numbness tingling, neck/should pain - spasms end of fall/winter - coolness-felt cold, increased cramping  Increasing frequency of cool to cold sensation in addition to continued numbness, tingling, perceived weakness, cramping up arm - band like - shoots down right arm - most notable in middle finger and thumb   MAY 2024 - Prothrombin Fragment 1 + 2 868 H treatment lovenox sq 30mg x 30days - resolution of symptoms within 2 weeks; symptoms returned 2-3 months later with accompanying upper chest/throat pressure.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Technician processed and administered incorrect vaccine based on age.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased, Pain in extremity, Tenderness, X-ray limb
Clinical narrative: Unable to move arm starting within 3 hours of injection, still unable to move 72 hours after. Severe pain and tenderness within the upper arm. Went an urgent care visit and x-rays were taken. Was prescribed Naproxen 500mg  and told to return of symptoms persist.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Wrong technique in product usage process, X-ray limb normal
Clinical narrative: Unable to move arm starting within 3 hours of injection, still unable to move 72 hours after. Severe pain and tenderness within the upper arm. Went an urgent care visit and x-rays were taken. Was prescribed Naproxen 500mg  and told to return of symptoms persist.
Age: 32.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Chills, Fall, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Approximately 14 hours after receiving vaccine (12:30am), developed strong chills/shivering which lasted for 1-2 hours, followed by hot sensation and sweating. Approximately 18 hours after receiving vaccine (4:30am), patient got up to shower to cool down and while standing in the shower, fainted and fell to the floor of the shower. Patient experienced nausea before and after fall. By 22 hours after receiving the vaccine (8:30am), chills and sweating had subsided.
Age: 32.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Syncope
Clinical narrative: Approximately 14 hours after receiving vaccine (12:30am), developed strong chills/shivering which lasted for 1-2 hours, followed by hot sensation and sweating. Approximately 18 hours after receiving vaccine (4:30am), patient got up to shower to cool down and while standing in the shower, fainted and fell to the floor of the shower. Patient experienced nausea before and after fall. By 22 hours after receiving the vaccine (8:30am), chills and sweating had subsided.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Our technician processed and administered incorrect vaccine based on age.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation
Clinical narrative: Patient called 10/24/24 10:50a said she got bilateral knee burning sensation 3 days after the fluad vaccine was given to her.  She would check with md to make sure, but she thought it might have been vaccine's side effects
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported by patient. Vaccine is a one lifetime dose and patient received a second dose.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Our technician processed and administered incorrect vaccine based on age.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Glassy eyes, Hypotonia
Clinical narrative: Patient was very worked up and upset about getting a shot.  He was crying and fighting trying not to get shot.  Within seconds of receiving vaccine, patient stopped struggling and started going limp, his eyes appeared glazed over.  Laid patient on the floor and elevated his legs.  V/S taken - B/P 110/69, pulse 75, Resp 22.  Within a few minutes he was feeling better.  Provided glass of water and helped patient to his feet and then to a chair.  Patient recovered and left with his mother and siblings a few minutes later.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None reported. Patient is otherwise well after receiving High Dose Flu vaccine, which isn't age appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sore arm  & shoulder pain
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received High Dose Flu vaccination, which isn't age appropriate. Spoke with mother who reported no adverse events. Child's provider office informed of the error.