chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Extreme muscle aches; mild chills; moderate/severe headache; extreme pain at the injection site (left arm); moderate pain throughout left arm; low grade fever of 99.0; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 17:45 as dose 4 (booster), single (Lot number: GJ2524) at the age of 25 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anemia" (unspecified if ongoing); "Known allergies: lamb" (unspecified if ongoing), notes: Known allergies: lamb; "Birth control" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: ibuprofen", notes: Known allergies: ibuprofen; Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. Vaccination history included: Covid-19 vaccine (DOSE 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; Manufacturer Unknown), for COVID-19 immunization.  The following information was reported: MYALGIA (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "Extreme muscle aches"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "extreme pain at the injection site (left arm)"; PYREXIA (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "low grade fever of 99.0"; CHILLS (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "mild chills"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "moderate pain throughout left arm"; HEADACHE (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "moderate/severe headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, chills, headache, vaccination site pain, pain in extremity, pyrexia.  Additional information: no other vaccine in four weeks. Other medications in two weeks was birth control. AE treatment with Tylenol. vaccine facility type at pharmacy or Drug Store. No covid prior vaccination and  covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Extreme muscle aches; mild chills; moderate/severe headache; extreme pain at the injection site (left arm); moderate pain throughout left arm; low grade fever of 99.0; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 17:45 as dose 4 (booster), single (Lot number: GJ2524) at the age of 25 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anemia" (unspecified if ongoing); "Known allergies: lamb" (unspecified if ongoing), notes: Known allergies: lamb; "Birth control" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: ibuprofen", notes: Known allergies: ibuprofen; Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. Vaccination history included: Covid-19 vaccine (DOSE 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; Manufacturer Unknown), for COVID-19 immunization.  The following information was reported: MYALGIA (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "Extreme muscle aches"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "extreme pain at the injection site (left arm)"; PYREXIA (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "low grade fever of 99.0"; CHILLS (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "mild chills"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "moderate pain throughout left arm"; HEADACHE (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "moderate/severe headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, chills, headache, vaccination site pain, pain in extremity, pyrexia.  Additional information: no other vaccine in four weeks. Other medications in two weeks was birth control. AE treatment with Tylenol. vaccine facility type at pharmacy or Drug Store. No covid prior vaccination and  covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: myalgia; chills; fever; headache; diaphoresis; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for COVID-19 Immunization.The Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Had no Known allergies.  The following information was reported: CHILLS (non-serious) with onset 11Dec2022 at 12:00, outcome "recovering"; HYPERHIDROSIS (non-serious) with onset 11Dec2022 at 12:00, outcome "recovering", described as "diaphoresis"; PYREXIA (non-serious) with onset 11Dec2022 at 12:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 11Dec2022 at 12:00, outcome "recovering"; MYALGIA (non-serious) with onset 11Dec2022 at 12:00, outcome "recovering". Therapeutic measures were not taken as a result of myalgia, chills, pyrexia, headache, hyperhidrosis.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye irritation, Eye pruritus, Lacrimation increased
Clinical narrative: watery drainage; increased tearing; dry eyes; itchy eyes; irritated eyes; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 57-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid", start date: 2005 (ongoing); "Menopause", start date: 12Feb2019 (ongoing); "Migraine HA's", start date: 2005 (ongoing); "hormone disbalance" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID oral taken for hypothyroidism, start date: 13Dec2016 (ongoing); ARMOUR THYROID oral taken for hypothyroidism, start date: Aug2005; ESTRADIOL topical taken for menopause, start date: 12Feb2019 (ongoing); TESTOSTERONE topical taken for hormone level abnormal, start date: 12Feb2019 (ongoing); PROGESTERONE oral taken for hormone level abnormal, start date: 12Feb2019 (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Date: 13Apr2021, Route of Administration: Intramuscular, Batch/Lot Number: Not Available / Provided at Time of Report Completion), administration date: 13Apr2021, when the patient was 55-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2nd, Date: 04May2021, Route of Administration: Intramuscular, Batch/Lot Number: Not Available / Provided at Time of Report Completion), administration date: 04May2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "dry eyes", "itchy eyes", "irritated eyes", "tearing eyes", "watery drainage". The following information was reported: DRY EYE (non-serious) with onset 2022, outcome "unknown", described as "dry eyes"; LACRIMATION INCREASED (non-serious) with onset 2022, outcome "unknown", described as "increased tearing"; EYE IRRITATION (non-serious) with onset 2022, outcome "unknown", described as "irritated eyes"; EYE PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "itchy eyes"; LACRIMATION INCREASED (non-serious) with onset 2022, outcome "unknown", described as "watery drainage".  Additional information: Prior Vaccinations (within 4 weeks) was none. The patient experiences dry, itchy plus irritated eyes associated tearing and watery drainage. Relevant tests were none.   The patient considered the Pfizer product had a causal effect to the adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick".  Additional information: It was reported that after spending the last year and a half (from the day of this report) being sick from the Pfizer vaccine, the patient ignored everything she saw related to the vaccines. Age of the patient was also reported as 43 (units not provided).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: It was reported that vaccine made patient so sick for months.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201369200 same  drug/reporter, different patient/AE;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he has Covid-19; he has Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the parent.  A 30-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "he has Covid-19".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: she had trouble swallowing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHAGIA (non-serious), outcome "unknown", described as "she had trouble swallowing".  Additional information: The patient stated that she got her first Pfizer covid-19 vaccine and had a bad reaction to it. Patient mentioned that she had trouble swallowing and wants to know if it's okay to get the Pfizer new vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My lymphnodes under my arms became very swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "My lymphnodes under my arms became very swollen".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu for 2 weeks now; Initial information received on 11-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age male patient who had the flu for 2 weeks now 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 (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for flu vaccination  On an unknown date the patient developed a non-serious event of has had the flu for 2 weeks now (influenza) (unknown latency) following the administration of influenza vaccine.  Reportedly, My husband got his flu shot and has had the flu for 2 weeks now. I've never had a flu shot and have never had the flu. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (has had the flu for 2 weeks now).  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: swelling about 2 inches down; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious Social media case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was diagnosed with swelling about 2 inches down 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 suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with a non-serious event of swelling about 2 inches down (swelling) (unknown latency) following the administration of influenza vaccine.  It was reported " I got my flu shot. The dr didn't put a band-aid on it and the next day I had swelling about 2 inches down. 3 weeks. Still there. I asked for the 65 and over. Never had a problem before. It doesn't hurt. Probably some crap so called vaccine ".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Sick; Initial information received on 12-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced sick after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for flu (Influenza immunisation).  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of influenza vaccine. It was reported Happened to me Sick 1 week.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: recovered on an unknown date for the event sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Now I have the flu; Initial information was received on 11-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced now flu while 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: not reported) via unknown route in unknown administration site (form, strength, expiry date: unknown) for flu vaccination.  On an unknown date the patient developed a non-serious event of flu (influenza) (latency: unknown) following the administration of influenza vaccine.  Action taken with influenza vaccine was 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: Dizziness, Headache
Clinical narrative: headache; dizziness; Initial information was received on 12-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves Elderly and unknown gender patient who experienced headache and dizziness while 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: not reported) via unknown route in unknown administration site (strength, form, expiry date: unknown) for flu.  On an unknown date the patient developed a non-serious event of headache and dizziness (latency: unknown) following the administration of influenza vaccine.  It was reported, "Some needed it, some don't, it'll just give the headache and dizziness, no, I don't need it for 77 years."  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 13-Dec-2022 regarding an unsolicited valid Social Media non-serious case via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had flu 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, batch lot number, expiry date: unknown) via unknown route in unknown administration site for Flu.  On an unknown date the patient had a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported Got the flu shot in Sept. and had the flu after November.  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: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got shot and I have the flu; Initial information received on 12-Dec-2022 regarding an unsolicited valid Social Media non-serious case via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who stated i got shot and i have the flu 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, batch lot number, expiry date: unknown) via unknown route in unknown administration site for flu.  On an unknown date the patient had a non-serious event of i got shot and i have the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported the shot does not keep u from getting the flu just not as bad I got shot and I have the flu many viruses out there with different types of strains I believe.  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: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: feel sick; Initial information received on 12-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who feel sick while receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for Flu.  On an unknown date the patient developed a non-serious feel sick (illness) (unknown latency) following the administration of influenza vaccine.  It was reported, "I've had that "vaccination" exactly once, in my 62 years of mostly healthy life. It made me feel sick for two days! I've never gotten it since, and have been just fine!"  It is unknown if there were lab data/results available.    Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Recovered / Resolved on an unknown date for the event feel sick.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient was given YF-Vax reconstituted with sterile water with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown age and gender was given yellow fever vaccine - [YF-VAX] reconstituted with sterile water 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 unknown dose of suspect yellow fever vaccine - (dose, strength, frequency, formulation, lot number and expiry date unknown) reconstituted with sterile water with no reported adverse event (product preparation error) (unknown latency) via unknown route in unknown administration site for Immunization.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3, FLUA3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received two doses of INFLUENZA HD with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown age and demographics who was administered two doses of influenza HD (FLUAD and Influenza USP Trival A-B high dose subvirion vaccine [Fluzone HD]) 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 FLUAD not produced by Sanofi Pasteur (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient received a dose of suspect Influenza USP Trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, dose, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for influenza.  On an unknown date, the patient had a non-serious event receiving two doses of influenza HD (Influenza USP trival A-B High Dose subvirion vaccine and FLUAD) with no reported adverse event (extra dose administered) (unknown latency).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received two doses of INFLUENZA HD with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received two doses of influenza hd with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient inadvertently received a dose of fluzone high dose quadrivalent with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid non-serious case received from  other health professional.  This case involves 63 years old male patient who inadvertently received a dose of influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] with no reported adverse event.  Concomitant medication included moderna bivalent booster.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Dec-2022, the patient inadvertently received 0.7 ml dose of suspect influenza influenza quadrival A-B high dose HV vaccine frequency: once with (Strength = high dose) (lot UJ918AA and expiry date:30-Jun-2023) (form: unknown) via intramuscular route in the right deltoid for immunization, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue, Single component of a two-component product administered
Clinical narrative: only the liquid part of the vaccine was given and the powder portion was not mixed in with it with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid  non-serious case via other health professional.  This case involves a 3-year-old male patient and the reporter reported only the liquid part of the vaccine was given and the powder portion was not mixed in with it with no reported adverse event after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; and varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 13-Dec-2022, the patient received 0.5 mL of suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (batch lot: UJ678AAA) (strength: unknown) (expiry date: 09-Sep-2023) via intramuscular route in unknown administration site for immunization.  On 13-Dec-2022 the patient had a non-serious event of only the liquid part of the vaccine was given and the powder portion was not mixed in with it with no reported adverse event (product preparation issue) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  Action taken with diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  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: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event, Product preparation error
Clinical narrative: powder portion of the vaccine had not expired, but the diluent expired inadvertent administration of an expired product to a patient with no reported adverse event; patient received a dose of ACTHIB that had been reconstituted with an expired diluent with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 15 months old female patient who experienced powder portion of the vaccine had not expired, but the diluent expired inadvertent administration of an expired product to a patient with no reported adverse event and patient received a dose of ACTHIB that had been reconstituted with an expired diluent with no reported adverse event after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 13v (crm197) (prevnar 13) and Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination.  On 12-Dec-2022, the patient received a Dose-4 of suspect HIB (PRP/T) VACCINE(Dose-0.5mL)(Frequency-Total)(Duration-1 day)( Strength = standard)(Formulation- Powder and solvent for solution for injection)  via intramuscular route on left leg for immunization.(Powder: Lot #: UJ604AA, Expiration date: 13MAR2023 ,Diluent: Lot #: U7172AB, Expiration date: 29OCT2022)  On 12-Dec-2022 the patient developed a non-serious events powder portion of the vaccine had not expired, but the diluent expired inadvertent administration of an expired product to a patient with no reported adverse event (Expired product administered), patient received a dose of acthib that had been reconstituted with an expired diluent with no reported adverse event (product preparation error)  following the administration of HIB (PRP/T) VACCINE.(Latency- Same day)  Action Taken : not applicable.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Nausea
Clinical narrative: Sharp chest pain that started in the right lower side of the chest 24 hours after vaccination. The next day sharp pain moved into the left lower side of the chest along with dizziness, nausea, and tightness of the whole chest. 72 hours after vaccine administered pain persist on both the left and right lower sides of the chest on a pain scale of 5 out of 10. Dizziness, nausea, and tightness of the whole chest also continue to persist.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Dyspnoea, Nasal congestion, Oropharyngeal pain, Productive cough
Clinical narrative: I received the Pfizer Bivalent booster on 9/12/2022. On 12/8/2022, I woke up with some chest congestion, nasal congestion, and a sore throat. I took a home antigen test and got a negative result. None of the symptoms resolved by 12/9/2022, so I took another antigen test, which came back positive this time. I went to an urgent care on 12/10/2022 to be evaluated and to get a PAXLOVID prescription, which they wrote for me. I began taking the PAXLOVID that very day. On 12/14/2022, I took another antigen test and got a negative result. I then took another test on 12/15/2022 and got another negative result. When I developed the aforementioned symptoms, they progressively got worse until 12/11/2022. On 12/10/2022 and 12/11/2022, I had labored breathing and a very productive cough. When I woke up on 12/12/2022, though, I felt noticeably better. Even though I felt better, though, I continued to take the entire course of PAXLOVID. I concluded my isolation on 12/15/2022. At the time of this writing, I feel fine, generally speaking. I still have some nasal congestion, which could be caused by an allergy rather than COVID-19, as I have a history of allergies.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I received the Pfizer Bivalent booster on 9/12/2022. On 12/8/2022, I woke up with some chest congestion, nasal congestion, and a sore throat. I took a home antigen test and got a negative result. None of the symptoms resolved by 12/9/2022, so I took another antigen test, which came back positive this time. I went to an urgent care on 12/10/2022 to be evaluated and to get a PAXLOVID prescription, which they wrote for me. I began taking the PAXLOVID that very day. On 12/14/2022, I took another antigen test and got a negative result. I then took another test on 12/15/2022 and got another negative result. When I developed the aforementioned symptoms, they progressively got worse until 12/11/2022. On 12/10/2022 and 12/11/2022, I had labored breathing and a very productive cough. When I woke up on 12/12/2022, though, I felt noticeably better. Even though I felt better, though, I continued to take the entire course of PAXLOVID. I concluded my isolation on 12/15/2022. At the time of this writing, I feel fine, generally speaking. I still have some nasal congestion, which could be caused by an allergy rather than COVID-19, as I have a history of allergies.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I received a seasonal flu vaccine at the same time (drugstore), but do not have the information as to what type.
Age: 83.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test normal, Computerised tomogram normal, Facial paralysis, Magnetic resonance imaging normal
Clinical narrative: I had a little bit of a fever and body aches for a couples. A week after the flu shot, I got Bell's Palsy, It started from the back of my neck and my face started to droop. I went to the ER and they did a CAT scan, MRI, blood test.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I had a little bit of a fever and body aches for a couples. A week after the flu shot, I got Bell's Palsy, It started from the back of my neck and my face started to droop. I went to the ER and they did a CAT scan, MRI, blood test.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Expired
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Muscular weakness, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient states that after 1 month his arm is still painful. He can not sleep on that arm. He also states pain when raising arm and a numbness or weakness in his left hand.
Age: 58.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Photopsia, Scan abnormal, Vitreous detachment, Vitreous floaters
Clinical narrative: On November 29, 2022, I experienced flashes and floaters in my right eye. I called my eye doctor. They referred me to a Retina Specialist. The following day, the Retina Specialist diagnosed me with Posterior Vitreous Separation. I'm still experiencing the same symptoms. They are being monitored. I have a follow up in January.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: RN diluted the vaccine with 1/3ml sterile diluent and administered a 0.2ml dose. The vaccine is supposed to de deleted with 2.2ml. Incorrect dilution caused vaccine to be an incorrect dose.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given the high dose instead of the regular dose.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Covid-19.  Doctor prescribed Paxlovid.  Now I test negative for the Covid-19 virus
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthropathy, Blood potassium decreased, Blood test, Differential white blood cell count, Electrocardiogram
Clinical narrative: On December 6, I was walking with my husband and suddenly slumped over to the left side into him. My left knee buckled and I felt like I had blanked out. I couldn't remember what happened. I didn't fall to the ground and I was supported by him. I was able to stand straight again after a few seconds had passed and continued to walk. I walked about 15 more minutes to get home and I just remember feeling dazed and very tired. I phoned my doctor's office who suggested I get checked out at the ER. I went to the ER and they did blood work and an EKG. Upon coming into the ER, I had very high blood pressure which was 196/102. Discharge was 150/90. They suggested I take my blood pressure and see my doctor within a few days. It was 10 days before I could see her. In that time, I took my blood pressure about 5 times and it was all okay except for one which was 147/93. The others were within a few points of 120/80. I've been tired but I've been able to function normally. At the time of the event, I felt like I couldn't function normally that evening. Besides being fatigued, I carry on with normal activities of daily life. My doctor today recommended doing more labs for typhoid and she has checked my potassium which was slightly low coming out of the ER. There's also been an order for a Holter monitor. Whenever that is put on me, I'll get the data for that. I have an appointment with an electrophysiologist in early January. Before this incident, I did not have any symptoms that I'm aware of. For example, I did not feel heart palpitations. I didn't have any symptoms, it just came as a surprise. I was feeling somewhat more fatigued than normal in the weeks before the event.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fall, Fatigue, Feeling abnormal, Full blood count abnormal, Hypertension
Clinical narrative: On December 6, I was walking with my husband and suddenly slumped over to the left side into him. My left knee buckled and I felt like I had blanked out. I couldn't remember what happened. I didn't fall to the ground and I was supported by him. I was able to stand straight again after a few seconds had passed and continued to walk. I walked about 15 more minutes to get home and I just remember feeling dazed and very tired. I phoned my doctor's office who suggested I get checked out at the ER. I went to the ER and they did blood work and an EKG. Upon coming into the ER, I had very high blood pressure which was 196/102. Discharge was 150/90. They suggested I take my blood pressure and see my doctor within a few days. It was 10 days before I could see her. In that time, I took my blood pressure about 5 times and it was all okay except for one which was 147/93. The others were within a few points of 120/80. I've been tired but I've been able to function normally. At the time of the event, I felt like I couldn't function normally that evening. Besides being fatigued, I carry on with normal activities of daily life. My doctor today recommended doing more labs for typhoid and she has checked my potassium which was slightly low coming out of the ER. There's also been an order for a Holter monitor. Whenever that is put on me, I'll get the data for that. I have an appointment with an electrophysiologist in early January. Before this incident, I did not have any symptoms that I'm aware of. For example, I did not feel heart palpitations. I didn't have any symptoms, it just came as a surprise. I was feeling somewhat more fatigued than normal in the weeks before the event.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of personal independence in daily activities, Mean platelet volume increased, Memory impairment, Metabolic function test abnormal, Platelet count decreased
Clinical narrative: On December 6, I was walking with my husband and suddenly slumped over to the left side into him. My left knee buckled and I felt like I had blanked out. I couldn't remember what happened. I didn't fall to the ground and I was supported by him. I was able to stand straight again after a few seconds had passed and continued to walk. I walked about 15 more minutes to get home and I just remember feeling dazed and very tired. I phoned my doctor's office who suggested I get checked out at the ER. I went to the ER and they did blood work and an EKG. Upon coming into the ER, I had very high blood pressure which was 196/102. Discharge was 150/90. They suggested I take my blood pressure and see my doctor within a few days. It was 10 days before I could see her. In that time, I took my blood pressure about 5 times and it was all okay except for one which was 147/93. The others were within a few points of 120/80. I've been tired but I've been able to function normally. At the time of the event, I felt like I couldn't function normally that evening. Besides being fatigued, I carry on with normal activities of daily life. My doctor today recommended doing more labs for typhoid and she has checked my potassium which was slightly low coming out of the ER. There's also been an order for a Holter monitor. Whenever that is put on me, I'll get the data for that. I have an appointment with an electrophysiologist in early January. Before this incident, I did not have any symptoms that I'm aware of. For example, I did not feel heart palpitations. I didn't have any symptoms, it just came as a surprise. I was feeling somewhat more fatigued than normal in the weeks before the event.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Influenza like illness
Clinical narrative: I have felt very sick since my shingles vaccine (Shingrix). Within about five hours, I had severe flu-like symptoms including: muscle aches, extreme fatigue, nausea, dizziness, lack of appetite and chills. The left arm where I got the vaccine is very sore. Those symptoms have slightly, but not fully, subsided 24 hours after the time of the vaccine. I am still feeling muscle aches, fatigue and dizziness and soreness at the injection site. I have taken Advil a few times since the vaccine, but it has not helped very much.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Myalgia, Nausea
Clinical narrative: I have felt very sick since my shingles vaccine (Shingrix). Within about five hours, I had severe flu-like symptoms including: muscle aches, extreme fatigue, nausea, dizziness, lack of appetite and chills. The left arm where I got the vaccine is very sore. Those symptoms have slightly, but not fully, subsided 24 hours after the time of the vaccine. I am still feeling muscle aches, fatigue and dizziness and soreness at the injection site. I have taken Advil a few times since the vaccine, but it has not helped very much.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Hypersensitivity, Nodule
Clinical narrative: patient got a allergic reaction with a lump on left arm