chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Nausea
Clinical narrative: stomach nausea; covid; flu; Initial information received on 18-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 experienced stomach nausea, covid and 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, dose, expiry date, formulation not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed stomach nausea (nausea), covid (covid-19) and flu (influenza) at the same time (unknown latency) following the administration of Influenza vaccine.  It was reported "I got mine last month just because my doctor had it and covid 2 weeks ago."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Mobility decreased
Clinical narrative: so sick the next day; patient couldn't hardly move; Initial information received on 19-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 was so sick the next day and patient couldn't hardly move after receiving 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 not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date the patient was so sick the next day (illness) and patient couldn't hardly move (mobility decreased) (unknown latency) following the administration of influenza vaccine.  Flu shot for over 60 peeps, covid and pneumonia....I was so sick the next day .couldn't hardly.move!  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: get sick with flu twice; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves male patient (unknown age) who get sick with flu twice after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on the batch number was requested  On an unknown date the patient got sick with flu twice  (Influenza) (unknown latency).  Reporter Commented: 53 years of never getting a flu shot and never contracted the flu. No Covid shot was exposed a few times no covid. Watched my dad get flu shot ever year and every year get sick with flu twice. No thx(therapeutic) ill stick to my immune system working.   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.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Influenza, Nausea
Clinical narrative: mostly stomach nausea; covid; flu; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an Adult and unknown gender patient who experienced mostly stomach nausea, covid and 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, dose, expiry date, formulation not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed stomach nausea (nausea), covid (covid-19) and flu (influenza) at the same time (unknown latency) following the administration of Influenza vaccine.  It was reported "I got mine last month just because my doctor had it and covid 2 weeks ago."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Neck pain, Pain in extremity
Clinical narrative: Sore arm; all the flu symptoms; sore neck; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves adult and unknown gender patient who experienced sore arm, all the flu symptoms and sore neck after receiving 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 not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation. Information on the batch number was requested.  On an unknown date the patient developed sore arm (pain in extremity), all the flu symptoms (influenza) and sore neck (neck pain) (unknown latency) following the administration of influenza vaccine.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: sorry both time i got mine i got the flu so no thx; Initial information received on 19-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 sorry both time i got mine i got the flu so no thx 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, dose, expiry date, form not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient reported sorry both time i got mine i got the flu so no thx (influenza) (unknown latency) following the administration of Influenza Vaccine.  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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu vaccine rarely works. Every time I got the flu vaccine, I got the flu as well; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received via patient.  This case involves an unknown age and unknown gender patient who stated flu vaccine rarely works. every time i got the flu vaccine, i got the flu as well after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, lot number, expiry date: unknwon) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had an event of flu vaccine rarely works. every time i got the flu vaccine, i got the flute as well (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if any lab data/test results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got the flu shot 2x & both times got sick as a dog 1; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves an unknown age female patient who experienced got the flu shot 2x & both times got sick as a dog 1 after receiving Influenza Vaccine.  The patient's past, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown strength, formulation, expiry date and lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient got the flu shot 2x & both times got sick as a dog 1 (illness) (unknown latency).  It was reported, i du not du any kind of vaxines &\or shots got the flu shot 2x & both times got sick as a dog 1 of the 2x i was pregnant with my son it caused major problems for me & i so swar off any of the covid vaxines & boosters after what i heard about them.  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A Patient did not remember that FLuzone HD was already administered 3 weeks ago, and received additional dose today again with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient where a patient did not remember that vaccine influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] was already administered 3 weeks ago, and received additional dose today again 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 influenza quadrival a-b high dose hv vaccine (lot U8130DA and expiration date- 30-Jun-2024) via unknown route in unknown administration site (dose, formulation, strength: not provided) for Immunisation (extra dose administered)  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: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: patient was given 2 doses of FLUZONE HD QIV 3 weeks apart with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 74 years old female patient who was given 2 doses of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] 3 weeks apart 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 elasomeran (Spikevax) for Prophylactic vaccination.  Patient received one dose 3 weeks ago, then On 19-Oct-2023, the patient again received a standard dose of suspect influenza quadrival A-B high dose HV vaccine (with an unknown formulation) at a dose of 0.7 mL total (lot U8130DA, expiry date- 30-JUN-2024) via intramuscular route in the right arm for Immunization.  On 19-OCT-2023 the patient was given 2 doses of fluzone hd qiv 3 weeks apart with no reported adverse event (extra dose administered) (latency- same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Pharmacist called in asking for safety data and recommendations for FLUZONE HD QIV following its administration to a patient 3 weeks apart; patient did not remember that she already received one dose 3 weeks ago, and had another dose today 19Oct2023. Treatment: None   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: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of TENIVAC was administered to a patient with no reported adverse event; Initial information was received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom expired dose of 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.   On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) (lot U7183AA, expiration date: 24-Sep-2023 , unknown strength) via unknown route in unknown administration site for Immunization and expired dose of tenivac was administered to a patient 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.  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: 16.0
Sex: U
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine was administered to 16 year old patient with no adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old (unknown gender) patient to whom influenza quadrivalent recombinant vaccine [Flublok] was administered with no 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 was administered with unknown dose of suspect influenza quadrivalent recombinant vaccine (lot QFAA2335 and Expiration Date: 30-June-2024; Dose, strength, formulation not reported) via unknown route in unknown administration site for Prophylactic vaccination to 16 year old patient with no adverse event (product administered to patient of inappropriate age) (latency on same day).  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: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: doctors administered Flublok Quadrivalent to a 16 year old female patient with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 16 years old female patient and Nurse reported that the doctors administered Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv] to a 16 year old female patient 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 16 year old female patient received a unknown dose of suspect Influenza Quadrivalent Recombinant Vaccine (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization) (product administered to patient of inappropriate age) (same day latency). Information on the batch number was requested.  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: 0.25
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered a PENTACEL today/The expiration date of the administered PENTACEL is 09Oct2023 with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 months old and unknown gender patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] which was expired on 09oct2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2023, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (expiry date: 09-Oct-2023) (with an unknown strength, lot number) via unknown route in unknown administration site for immunization.  On 20-Oct-2023, the patient was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine which was expired on 09oct2023 with no reported adverse event (expired product administered) (latency: same day).  It was reported, Nurse stated that one of their practices administered a PENTACEL today, 20Oct2023, to 3-month-old patient. The expiration date of the administered PENTACEL is 09Oct2023. Nurse was asking about revaccination recommendations. This situation is reported as a medication error due to administration of an expired vaccine. The nurse refused to provide any facility/clinic information. She also said that she does not have any patient information aside from the age.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Hypersensitivity, Lip swelling, Pharyngeal swelling
Clinical narrative: she may have had anaphylaxis with it; Initial information received on 20-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 78 years old female patient where she may have had anaphylaxis with it after receiving vaccine Influenza quadrival a-b multidose vaccine preserved [Fluzone].  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Allergy to antibiotic and Hypersensitivity.  On an unknown date, the patient received a dose of suspect influenza quadrival a-b multidose vaccine preserved Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation. Information on the batch number was requested.  On an unknown date the patient may have had anaphylaxis with it (anaphylactic reaction) (unknown latency) following the administration of influenza quadrival a-b multidose vaccine preserved.   She stated that last year she received Flublok and had an allergic reaction that was not anaphylaxis. She described the reaction as lip swelling, chest tightness, and throat swelling. She took an allergy pill prior to receiving Flublok last year. She says, "it was sort of ok. They just monitor me for 3 hours." She believes she may have had more of a problem with a Fluzone vaccine in the past. She does not know the particular Fluzone vaccine with which she may have had more trouble. She was asked and she does not believe it was the high-dose Fluzone. She believes it was many years ago that she had Fluzone and she may have had anaphylaxis with it. She is not sure. She may have had Fluzone that was drawn from a multi-dose vial, but she is unsure of that too. Product used : Used Still using product : No  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 Recovered / Resolved on an unknown date for the event.  Seriousness criteria- Medically significant for event.
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of PENTACEL was inadvertently administered today with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who was inadvertently administered an expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 20v (crm197) (prevnar 20) for immunisation; hepatitis b vaccine (hepatitis b [hepatitis b vaccine]) for immunisation; and rotavirus vaccine (rotavirus vaccine) for immunisation.  On 23-Oct-2023, the patient received 0.5 ml (Dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ786AA, Expiry date: 12-Oct-2023) (Strength: Standard) (Frequency: once) via intramuscular route in the left thigh immunization.  On 23-Oct-2023, the patient was inadvertently administered an expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] today 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.
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired TENIVAC/vaccine was administered 5 days after the expiration date with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 50 years old male patient who received an expired tenivac/vaccine was administered 5 days after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Sep-2023, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot U7183AA, expiry date: 23-Sep-2023 via intramuscular route in the right deltoid for immunization, an expired tenivac/vaccine was administered 5 days after the expiration date with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.   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: 0.33
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired pentacel with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4-month-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.  Concomitant medications included rotavirus vaccine live reassort oral 5V (Rotateq) and Vaxudence for Prophylactic vaccination.  On 16-Oct-2023, the patient received a dose 2 of 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ786AA, expiry date: 12-Oct-2023) via intramuscular route in the right thigh for Immunization and administered an expired pentacel 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: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Injected limb mobility decreased, Injection site pain, Myalgia, Sleep disorder
Clinical narrative: The next day couldn't move the arm; Injection site it was sore; The muscle pain went to the back of the neck, to the back muscles; This spontaneous case was received on 18-Oct-2023 from other non-healthcare professional (consumer) via Regulatory Authority (reference number: SEQW23-03524) and concerned a 72-year-old, female patient.  The patient had no relevant medical history. The patient's concomitant medications included gabapentin, atenolol, levothyroxine, omeprazole, unspecified multivitamin, magnesium, and calcium, all used for unspecified indication.  On 14-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On the same date, after receiving Fluad Quadrivalent, the patient's injection site was sore. During that night, the patient reported that it was hard to sleep because it was extremely sore and painful.  On 15-Oct-2023, reported as the next day after receiving Fluad Quadrivalent, the patient couldn't move the arm.  On an unspecified day in Oct-2023, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced muscle pain.  On 16-Oct-2023, it improved a little bit, but the muscle pain went to the back of the neck, to the back muscles. The patient took gabapentin as usual, also used ice and heating pad.  At the time of initial reporting, the patient was recovering from the events of 'vaccination site pain' and 'mobility decreased', and had not recovered from the event of muscle pain. As reported, at the time muscle still were painful.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 72-year-old patient experienced vaccination site pain on the same date, after receiving the suspect product Fluad Quadrivalent. Thereafter, within four days after vaccination, the patient developed decreased mobility and myalgia. Based on suggestive temporal relationship and the absence of confounders, causality for the event vaccination site pain is assessed as probably related. Causality for the remaining events (decreased mobility and myalgia) is assessed as possibly related, due to plausible temporal relationship,; Sender's Comments: A 72-year-old patient experienced vaccination site pain on the same date, after receiving the suspect product Fluad Quadrivalent. Thereafter, within four days after vaccination, the patient developed decreased mobility and myalgia. Based on suggestive temporal relationship and the absence of confounders, causality for the event vaccination site pain is assessed as probably related. Causality for the remaining events (decreased mobility and myalgia) is assessed as possibly related, due to plausible temporal relationship,
Age: 70.0
Sex: F
Vaccine: FLUC3
Symptoms: Eye swelling, Fatigue, Headache, Pain, Pruritus
Clinical narrative: Swelling on the eyes; Body pain; Feeling itchy from head to toe; Headache; Fatigue; This spontaneous case was received on 19-Oct-2023 from a other non-healthcare professional (consumer) via Company (reference number: SEQW23-03584) and concerned a 70-year-old, female patient.  The patient's concurrent conditions included asthma, hypertension, osteoarthritis, osteoporosis, migraine, and some problems with allergies. The patient's concomitant medications included metoprolol, Claritin (clarithromycin), unspecified nasal spray and unspecified inhaler, all used for unreported indications.  On 17-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.    On 18-Oct-2023, one day after receiving Flucelvax Quadrivalent, the patient woke up feeling itchy from head to toe, had swelling on the eyes, headache, body pain and fatigue. The patient received treatment with Claritin, Benadryl (diphenhydramine hydrochloride) and acemetacin.  At the time of initial reporting, on 19-Oct-2023, the patient had not recovered from the events. As reported, the patient was still having symptoms.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 70-year-old patient developed eye swelling, general body pain, pruritus, headache, and fatigue one day after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 70-year-old patient developed eye swelling, general body pain, pruritus, headache, and fatigue one day after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Feeling abnormal, Irritability, Stress, Tinnitus
Clinical narrative: Very stressful/great anxiety; Annoying; Tinnitus; This spontaneous case was received on 19-Oct-2023 from other non-health care professional (consumer) via Company (reference number: SEQW23-03559) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On an unspecified day in Dec-2022, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location: not reported) for influenza immunization. The batch number was not reported.  On an unspecified day in Dec-2022, ever since receiving influenza vaccine, the patient had tinnitus.  On an unspecified date, the patient felt terrible, very stressful and annoying. As reported, it was causing her great anxiety and the great fear to get anymore vaccines.  At the time of initial reporting, the patient had not recovered from the event of tinnitus.  The outcome of the events of 'anxiety', and 'feeling irritated' was not reported.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A patient of unspecified age experienced tinnitus, anxiety, and irritability an unknown amount of time after receiving the suspect product influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported events is unassessable.; Sender's Comments: A patient of unspecified age experienced tinnitus, anxiety, and irritability an unknown amount of time after receiving the suspect product influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported events is unassessable.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: persistent right shoulder pain x 2 weeks
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; HCP called to report inadvertent administration of PROQUAD to a patient after a temperature excursion that occurred on 10/12/2023. Limited patient demographics provided. No additional AE/PQC.         ?    Names of vaccines involved (including lot/e; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date in October 2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection (lot#: X007087, expiration date: 04-SEP-2024; strength, dose, and route of administration were not reported) for prophylaxis. The vaccine administered inadvertently experienced a temperature excursion on 12-OCT-2023 at -12.4C for 18 minutes without any other previous temperature excursion (product storage error). No additional adverse events (AE) were reported (no adverse event).
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: HCP reported an 18 YO female received a third dose of Bexsero; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st of Bexsero on an unknown date) and Bexsero (received 2nd of Bexsero on an unknown date).   On an unknown date, the patient received the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: HCP reported an 18 YO female received a third dose of Bexsero). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2023 The healthcare profession (Physician) reported an patient received a third dose of Bexsero which led to Extra dose administered. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Fever, deep cough,  dizziness, headache, body aches.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Colitis, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal
Clinical narrative: Patient presented to the ER with diarrhea. Patient tested positive for Covid-19. CT scan showed findings consistent with colitis and possible pneumonia. Patient received IV abx, steroids. Patient went into afib with RVR and was started on Lopressor, Lovenox/Warfarin. Diarrhea was improved at discharge. Patient passed walk study. Patient was discharged home.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test positive, Walking distance test normal
Clinical narrative: Patient presented to the ER with diarrhea. Patient tested positive for Covid-19. CT scan showed findings consistent with colitis and possible pneumonia. Patient received IV abx, steroids. Patient went into afib with RVR and was started on Lopressor, Lovenox/Warfarin. Diarrhea was improved at discharge. Patient passed walk study. Patient was discharged home.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Hypoxia, Walking distance test normal
Clinical narrative: Patient diagnosed with acute respiratory failure with hypoxia related to Covid-19 pneumonia. Patient was placed on High-Flo nasal cannula, 5LNC, and weaned to room air by discharge. Patient passed walk study. Patient received Remdesivir, steroids. Patient was discharged home with home health
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Chills, Cough, Dyspnoea
Clinical narrative: Patient presented with worsening shortness of breath, cough, fever, and chills. Patient tested positive for Covid-19. Patient received IV steroids, antibiotics and remdesivir. Chest xray showed central opacities, required 2L during hospital stay. Patient passed walk study. Patient discharged home.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Lung opacity, Pyrexia, SARS-CoV-2 test positive, Walking distance test normal
Clinical narrative: Patient presented with worsening shortness of breath, cough, fever, and chills. Patient tested positive for Covid-19. Patient received IV steroids, antibiotics and remdesivir. Chest xray showed central opacities, required 2L during hospital stay. Patient passed walk study. Patient discharged home.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Dyspnoea
Clinical narrative: Patient presented to the ER with fever, chills, dry cough, mild SOB, diarrhea and mild nausea. Patient was diagnosed with sepsis r/t Covid-19 infection. Patient received IV steroids. Patient was discharged home. Home health refused by patient.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sepsis
Clinical narrative: Patient presented to the ER with fever, chills, dry cough, mild SOB, diarrhea and mild nausea. Patient was diagnosed with sepsis r/t Covid-19 infection. Patient received IV steroids. Patient was discharged home. Home health refused by patient.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Dyspnoea, Productive cough, Respiratory tract congestion
Clinical narrative: Patient arrived to the ER with c/o SOB onset 4 weeks ago, worsening in the past 2 weeks.  Patient reports having a productive cough with green phlegm and chest congestion. Pt 02 sat was in the 80's at home. Patient diagnosed with acute hypoxemic respiratory failure secondary to Covid-19 pneumonia. Patient received IV Decadron, IV abx. Patient discharged home with home o2.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Sputum discoloured
Clinical narrative: Patient arrived to the ER with c/o SOB onset 4 weeks ago, worsening in the past 2 weeks.  Patient reports having a productive cough with green phlegm and chest congestion. Pt 02 sat was in the 80's at home. Patient diagnosed with acute hypoxemic respiratory failure secondary to Covid-19 pneumonia. Patient received IV Decadron, IV abx. Patient discharged home with home o2.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Chills, Computerised tomogram thorax normal, Condition aggravated
Clinical narrative: I received COVID vaccine (Spikevax) late afternoon on 10/13/2023. In addition to my typical reaction to past COVID vaccines (severe chills, presumed fever, severe HA, arthralgia, N/V), I developed severe facial and periorbital edema as well as severe swelling of hands and feet. I have both Cutaneous Mastocytosis and Indolent Systematic Mastocytosis (CM, ISM, both diagnosed in 2023); the rash associated with CM was triggered. Additionally, I had moderate lightheadedness and vertigo as well as hypotension as per home blood pressure monitor. I have two Epipens with me at all times as ISM is associated with a high incidence of anaphylaxis due to mast cell activation but did not use them. Note: ISM is a chronic myeloproliferative neoplasm associated with exceedingly high mast cell burden. Triggers cause degranulation of these mast cells. Typically, ISM is associated with a non-immunologic reaction as opposed to an immunologic IgE-mediated reaction. I had no angioedema, hives, or difficulty breathing which are more commonly associated with the latter. I did not seek treatment at a hospital. Instead, I received IV fluids (3 L D5W or LR) at home for dehydration, treated the N/V with prochlorperazine and ondansetron (not at same time, both prescribed prior to vaccine administration based on history), and maintained my regimen of cetirizine 10 mg TID, cimetidine 200 mg BID, and Singulair 10 mg QD. My symptoms gradually improved over 3 days with the exception of vertigo, dizziness, severe HA, difficulty maintaining balance, and nausea. I sought treatment in the ED on 10/18/2023 for worsening symptoms. I received 1 L LR and an unknown dose of IV ondansetron. I was worked up for a PE and MI. CT with contrast was negative for both); repeat troponin levels and 12-lead ECG were normal. I was subsequently released. (Yes, in hindsight I know I should have self administered epinephrine and sought emergency medical care on 10/14 and/or 10/15/2023).
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Electrocardiogram normal, Face oedema, Headache
Clinical narrative: I received COVID vaccine (Spikevax) late afternoon on 10/13/2023. In addition to my typical reaction to past COVID vaccines (severe chills, presumed fever, severe HA, arthralgia, N/V), I developed severe facial and periorbital edema as well as severe swelling of hands and feet. I have both Cutaneous Mastocytosis and Indolent Systematic Mastocytosis (CM, ISM, both diagnosed in 2023); the rash associated with CM was triggered. Additionally, I had moderate lightheadedness and vertigo as well as hypotension as per home blood pressure monitor. I have two Epipens with me at all times as ISM is associated with a high incidence of anaphylaxis due to mast cell activation but did not use them. Note: ISM is a chronic myeloproliferative neoplasm associated with exceedingly high mast cell burden. Triggers cause degranulation of these mast cells. Typically, ISM is associated with a non-immunologic reaction as opposed to an immunologic IgE-mediated reaction. I had no angioedema, hives, or difficulty breathing which are more commonly associated with the latter. I did not seek treatment at a hospital. Instead, I received IV fluids (3 L D5W or LR) at home for dehydration, treated the N/V with prochlorperazine and ondansetron (not at same time, both prescribed prior to vaccine administration based on history), and maintained my regimen of cetirizine 10 mg TID, cimetidine 200 mg BID, and Singulair 10 mg QD. My symptoms gradually improved over 3 days with the exception of vertigo, dizziness, severe HA, difficulty maintaining balance, and nausea. I sought treatment in the ED on 10/18/2023 for worsening symptoms. I received 1 L LR and an unknown dose of IV ondansetron. I was worked up for a PE and MI. CT with contrast was negative for both); repeat troponin levels and 12-lead ECG were normal. I was subsequently released. (Yes, in hindsight I know I should have self administered epinephrine and sought emergency medical care on 10/14 and/or 10/15/2023).
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Mastocytosis, Nausea, Periorbital oedema, Peripheral swelling
Clinical narrative: I received COVID vaccine (Spikevax) late afternoon on 10/13/2023. In addition to my typical reaction to past COVID vaccines (severe chills, presumed fever, severe HA, arthralgia, N/V), I developed severe facial and periorbital edema as well as severe swelling of hands and feet. I have both Cutaneous Mastocytosis and Indolent Systematic Mastocytosis (CM, ISM, both diagnosed in 2023); the rash associated with CM was triggered. Additionally, I had moderate lightheadedness and vertigo as well as hypotension as per home blood pressure monitor. I have two Epipens with me at all times as ISM is associated with a high incidence of anaphylaxis due to mast cell activation but did not use them. Note: ISM is a chronic myeloproliferative neoplasm associated with exceedingly high mast cell burden. Triggers cause degranulation of these mast cells. Typically, ISM is associated with a non-immunologic reaction as opposed to an immunologic IgE-mediated reaction. I had no angioedema, hives, or difficulty breathing which are more commonly associated with the latter. I did not seek treatment at a hospital. Instead, I received IV fluids (3 L D5W or LR) at home for dehydration, treated the N/V with prochlorperazine and ondansetron (not at same time, both prescribed prior to vaccine administration based on history), and maintained my regimen of cetirizine 10 mg TID, cimetidine 200 mg BID, and Singulair 10 mg QD. My symptoms gradually improved over 3 days with the exception of vertigo, dizziness, severe HA, difficulty maintaining balance, and nausea. I sought treatment in the ED on 10/18/2023 for worsening symptoms. I received 1 L LR and an unknown dose of IV ondansetron. I was worked up for a PE and MI. CT with contrast was negative for both); repeat troponin levels and 12-lead ECG were normal. I was subsequently released. (Yes, in hindsight I know I should have self administered epinephrine and sought emergency medical care on 10/14 and/or 10/15/2023).