chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 at 07:30 as dose 1, single (Lot number: EL1284), in left arm and on 26Jan2021 at 08:00 as dose 2, single (Lot number: EL1203) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cough Asthma with Exercise" (unspecified if ongoing); "Cough Asthma with Exercise" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling and pain around injection site 2 1/2 inch (6.35 cm) diameter; Swelling and pain around injection site 2 1/2 inch (6.35 cm) diameter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 17:00 as dose 1, single (Lot number: GJ3277) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic leg pain" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX QUAD taken for immunisation, on 26Sep2022 as dose 1, single. Past drug history included: Benadryl, reaction(s): "Known allergies: Benadryl". The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 05Oct2022, outcome "unknown" and all described as "Swelling and pain around injection site 2 1/2 inch (6.35 cm) diameter". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site pain.  Additional information: the patient's adverse effects were treated with applying ice on the area. She had no COVID prior to vaccination. She was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; 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), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity; SINGULAIR; ORAL CONTRACEPTIVE NOS.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included anti-viral drug Paxlovid from 15Sep2022 to 29Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Paxlovid taken from second day of Covid symptoms and positive test  23Sep - 27Sep; Paxlovid taken from second day of Covid symptoms and positive test  23Sep - 27Sep; Fully Vaccinated 2nd Pfizer 12Mar2021 Booster Pfizer 02Sep2021 Booster Moderna 31Mar2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 02Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2022 at 09:00 as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid taken from second day of Covid symptoms and positive test  23Sep - 27Sep"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Fully Vaccinated 2nd Pfizer 12Mar2021 Booster Pfizer 02Sep2021 Booster Moderna 31Mar2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: Rebound infection testing positive and moderate to severe nasal drip; (23Sep2022) Positive, notes: positive test 243Sep -27Sep; (24Sep2022) Positive, notes: positive test 243Sep -27Sep; (25Sep2022) Positive, notes: positive test 243Sep -27Sep; (26Sep2022) Positive, notes: positive test 243Sep -27Sep; (27Sep2022) Positive, notes: positive test 243Sep -27Sep; (02Oct2022) Positive, notes: positive again 02Oct2022; (05Oct2022) Unknown result, notes: Nasal congestion and drip on going as of 05Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Fully Vaccinated 2nd Pfizer 12Mar2021 Booster Pfizer  Booster Moderna 31Mar2022. The patient was given Paxlovid as treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (28Sep2022) Negative; (04Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid, Lot number: GD8756, from 20Sep2022 to 25Sep2022 as treatment for COVID-19).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, COVID-19, Drug ineffective, Heart rate
Clinical narrative: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 at 12:15 as dose 1, single (Batch/Lot number: unknown), in right arm and on 03Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 82 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Macular degeneration" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Doxycycline-dizzy, reaction(s): "Known allergies: doxycycline-dizzy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (05Oct2022) Normal; Body temperature: (05Oct2022) Normal; Heart rate: (05Oct2022) Normal; Oxygen saturation: (05Oct2022) Normal; SARS-CoV-2 test: (04Oct2022) Negative, notes: Home covid tests 04Oct and 05Oct were normal; (05Oct2022) Negative, notes: Home covid tests 04Oct and 05Oct were normal. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19 cannot be completely excluded.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, SARS-CoV-2 test
Clinical narrative: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 at 12:15 as dose 1, single (Batch/Lot number: unknown), in right arm and on 03Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 82 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Macular degeneration" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Doxycycline-dizzy, reaction(s): "Known allergies: doxycycline-dizzy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (05Oct2022) Normal; Body temperature: (05Oct2022) Normal; Heart rate: (05Oct2022) Normal; Oxygen saturation: (05Oct2022) Normal; SARS-CoV-2 test: (04Oct2022) Negative, notes: Home covid tests 04Oct and 05Oct were normal; (05Oct2022) Negative, notes: Home covid tests 04Oct and 05Oct were normal. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19 cannot be completely excluded.
Sex: U
Vaccine: PNC13
Symptoms: Irritability
Clinical narrative: irritability; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as 0.5 ml, single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IRRITABILITY (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling and pain at the injection site; swelling and pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received meningococcal group b Rlp2086 (TRUMENBA), as single dose (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "swelling and pain at the injection site". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: every dose made her sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "every dose made her sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "every dose made her sick".  Additional information: The patient reported that every dose of the Pfizer COVID-19 vaccine (original primary series and two booster doses) made her sick. She suspected that this reaction was caused by gluten or an egg-derived ingredient. She took a third booster dose from Moderna and that vaccine didn't make her sick at all.  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-202201206645 Same patient/drug/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): Moderna.  A male patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Antidepressant" (unspecified if ongoing); "Digestion" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; SIMVASTATIN taken for blood cholesterol abnormal; SERTRALINE taken for antidepressant therapy; OMEPRAZOLE taken for dyspepsia; VITAMIN D3. Vaccination history included: BNT162b2 (Dose Number: 1, Manufacturer: Pfizer, Lot number: EN6201), administration date: 10Feb2021, for Covid-19 Immunization, reaction(s): "mild headache"; BNT162b2 (Dose Number: 2, Manufacturer: Pfizer, Lot number: EN6198), administration date: 03Mar2021, for Covid-19 Immunization, reaction(s): "mild headache"; BNT162b2 (Dose Number: 3, Manufacturer: Pfizer, Lot number: EW0186), administration date: 12Oct2021, for Covid-19 Immunization, reaction(s): "mild headache". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "mild headache".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201202012 same patient/event, different dose number;US-PFIZER INC-202201202013 same patient/event, different dose number;US-PFIZER INC-202201202011 same patient/event, different dose number;
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: useless arm syndrome / my lifting capacity would drop in the arm (by about 30% to 50%, or more.) that it was given in for 3-4 days after day 2 of the vaccine being in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "useless arm syndrome / my lifting capacity would drop in the arm (by about 30% to 50%, or more.) that it was given in for 3-4 days after day 2 of the vaccine being in the arm".  Additional information: The reported that every time they had a vaccine or booster, they would get useless arm syndrome; their lifting capacity would drop in the arm (by about 30% to 50%, or more) that it was given in for 3-4 days after day 2 of the vaccine being in the arm. It got so bad their shoulder took over for lifting to the point where the patient nearly hurt their shoulder. They had to actually stop doing hard work, sawing branches, because their left arm could not handle a 50-pound log by itself, which was really, really sad. The patient said it was awful to get this, to feel that 25 pounds up and down was heavy.  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: Feeling abnormal
Clinical narrative: the pfizer covid vaccine I received a couple of years ago that is still making uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 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: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "the pfizer covid vaccine I received a couple of years ago that is still making uncomfortable".  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: Biopsy, Granuloma annulare, Nasopharyngitis
Clinical narrative: A slight head cold; a ring worm on the right side of rib cage / pread to 90% of torso diagnosed as Granuloma Annulare; 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), on 16Dec2021 as dose 3 (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: BNT162b2 (Dose: 01), administration date: 08Jan2021, for COVID-19 Immunization; BNT162b2 (Dose: 02), administration date: 28Jan2021, for COVID-19 Immunization. The following information was reported: GRANULOMA ANNULARE (non-serious) with onset Dec2021, outcome "not recovered", described as "a ring worm on the right side of rib cage / pread to 90% of torso diagnosed as Granuloma Annulare"; NASOPHARYNGITIS (non-serious) with onset 23Dec2021, outcome "recovered", described as "A slight head cold". The event "a ring worm on the right side of rib cage / pread to 90% of torso diagnosed as granuloma annulare" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nasopharyngitis, granuloma annulare.  Additional information: On 23Dec2021, patient developed a slight head cold which was treated and relieved with OTC pseudoephedrine (SUDAFED). Sometime before 27Dec2021, patient noticed what appeared to be a ring worm on the right side of rib cage. It was treated with OTC antifungal cream with no improvement that spread to 90% of torso. After seeking medical attention from numerous physicians, a biopsy was preformed and diagnosed as Granuloma Annulare.   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: Aggression, Anaphylactic reaction, Feeling abnormal, Lymphoma, Malaise
Clinical narrative: Lymphoma; anaphylaxis; crazy; going to kill somebody; just do not feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 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: ANAPHYLACTIC REACTION (medically significant), outcome "not recovered", described as "anaphylaxis"; LYMPHOMA (medically significant), outcome "not recovered"; MALAISE (non-serious), outcome "unknown", described as "just do not feel well"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "crazy"; AGGRESSION (non-serious), outcome "unknown", described as "going to kill somebody". The events "anaphylaxis" and "lymphoma" required physician office visit. Clinical course: After vaccination for COVID-19, patient had anaphylaxis and still was going troubling with the side effect after the vaccination and was diagnosed by allergist after that with Lymphoma. The patient just did not feel well, patient was crazy. The patient was going to kill somebody.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Blood pressure decreased, Device dislocation, Device placement issue, Infusion site erythema, Infusion site inflammation
Clinical narrative: blood pressure dropped; oxygen saturation decreased; old site was red and inflamed; old site was red and inflamed; got sick from flu shot; Initial information received Regulatory Authority, on 30-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 66-year-old male patient (79 kg) who experienced blood pressure dropped, oxygen saturation decreased, old site was red and inflamed, got sick from flu shot after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included treprostinil sodium (Remodulin); riociguat (Adempas); rivaroxaban (Xarelto); and macitentan (Opsumit).  Patient began therapy with Remodulin (treprostinil sodium concentration 10 mg/ml) on 10-Jan-2018 for primary pulmonary arterial hypertension (ongoing medical history). The current dose was reported as 0.062 ug/kg, continuous via subcutaneous (SQ) route. Patient reported that his subcutaneous Remodulin site fell out (device dislocation). He tried to start a new subcutaneous Remodulin site three times without success (device placement issue). He had been without Remodulin for about 40 minute before he was able to insert a site with registered nurse verbal assistance and restarted the CADD pump infusion. Remodulin was dose temporarily withheld due to the event of device dislocation.   On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, dose, frequency: unknown) (lot number and expiry date: not reported) via subcutaneous route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date in Sep-2022, the patient developed non-serious events of, old site was red and inflamed (infusion site erythema), (infusion site inflammation), blood pressure dropped (blood pressure decreased), oxygen saturation decreased, got sick from flu shot (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available.  Action taken with Influenza Vaccine was not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for all events.  The reporter's causality for the events of oxygen saturation decreased and blood pressure decreased with influenza vaccine was considered to be possibly related.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Oxygen saturation decreased
Clinical narrative: blood pressure dropped; oxygen saturation decreased; old site was red and inflamed; old site was red and inflamed; got sick from flu shot; Initial information received Regulatory Authority, on 30-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 66-year-old male patient (79 kg) who experienced blood pressure dropped, oxygen saturation decreased, old site was red and inflamed, got sick from flu shot after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included treprostinil sodium (Remodulin); riociguat (Adempas); rivaroxaban (Xarelto); and macitentan (Opsumit).  Patient began therapy with Remodulin (treprostinil sodium concentration 10 mg/ml) on 10-Jan-2018 for primary pulmonary arterial hypertension (ongoing medical history). The current dose was reported as 0.062 ug/kg, continuous via subcutaneous (SQ) route. Patient reported that his subcutaneous Remodulin site fell out (device dislocation). He tried to start a new subcutaneous Remodulin site three times without success (device placement issue). He had been without Remodulin for about 40 minute before he was able to insert a site with registered nurse verbal assistance and restarted the CADD pump infusion. Remodulin was dose temporarily withheld due to the event of device dislocation.   On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, dose, frequency: unknown) (lot number and expiry date: not reported) via subcutaneous route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date in Sep-2022, the patient developed non-serious events of, old site was red and inflamed (infusion site erythema), (infusion site inflammation), blood pressure dropped (blood pressure decreased), oxygen saturation decreased, got sick from flu shot (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available.  Action taken with Influenza Vaccine was not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for all events.  The reporter's causality for the events of oxygen saturation decreased and blood pressure decreased with influenza vaccine was considered to be possibly related.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion at low temperature of 29.0F for 45 minutes, with no adverse event; vaccine administered post temperature excursion with no adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA409526 , 2022SA409520 and 2022SA409694(CLUSTER).  This case involves Adult and unknown gender patient to whom Influenza quadrival A-B vaccine [Fluzone Quadrivalent] was administered post temperature excursion and temperature excursion at low temperature of 29.0f for 45 minutes, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that Influenza quadrival A-B vaccine had temperature excursion at low temperature of 29.0f for 45 minutes, with no adverse event (product storage error) (latency: Unknown)  On 23-Sep-2022, the patient received a  dose of suspect Influenza quadrival A-B vaccine, suspension for injection (lot UT7689LA; formulation, strength, dose and expiry date  not reported) via unknown route in unknown administration site for prophylactic vaccination post temperature excursion with no adverse event (poor quality product administered) (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.; Sender's Comments:  SAD20220927002156:
Sex: U
Vaccine: FLU4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: patient received FLUZONE QIV NP from pre-filled syringes after a temperature excursion occurred, with no reported adverse event; Temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes, with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to cases 2022SA409520(CLUSTER), 2022SA409928(CLUSTER) and 2022SA409694(CLUSTER).  This case involves an adult patient (unknown gender) who received Influenza Quadrival A-B Vaccine [Fluzone QIV] np from pre-filled syringes after a temperature excursion occurred and temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient received 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation, frequency, route: unknown) (lot number: UT7689LA and expiry date: 30-Jun-2023) in unknown administration site for Immunization and patient received fluzone qiv np from pre-filled syringes after a temperature excursion occurred, with no reported adverse event (poor quality product administered) (latency: same day) and a temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event (product storage error) (latency: same day).  It was reported, the cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case. Doctor states that she was told that the vaccines are no longer viable and has discarded all of them. Doctor asked for specific guidance on whether these patients needed to be re-vaccinated before they contacted the patients. This situation is reported as a medication error due to vaccines being administered post-excursion.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable for all events.  At time of reporting, the outcome was Unknown for all events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Device breakage, No adverse event, Occupational exposure to product, Syringe issue, Underdose
Clinical narrative: stated vaccine leaked all over the medical assistant attempting to use the vaccine with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 28 years old female patient stated INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] vaccine leaked all over attempting to use the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Sep-2022 the vaccine leaked all over the medical assistant attempting to use the vaccine with no reported adverse event (occupational exposure to product). Operations manager stated that they received one broken Flublok quadrivalent prefilled syringe (lot UJ903AA, exp date: 30-Jun-2023). crack noted in the glass part in between the sticker and where the needle is attached. vaccine leaked all over the medical assistant due to the crack.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: received doses post excursion with no adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 7 years old male patient who received doses post excursion with no adverse event while receiving vaccines IPV (VERO) [IMOVAX POLIO].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 26-Sep-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml total (lot V1A022M, expiry date: 17-Feb-2024) via subcutaneous route in the left arm for immunisation.  On 26-Sep-2022 the patient received doses post excursion with no adverse event (poor quality product administered) same day latency following the administration of IPV (VERO).  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 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: 5.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL administration of vaccine post temperature excursion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional on 03-Oct-2022. number: 01304843   This case involves a 5-year-old female patient to whom experienced IPV (VERO) [IPOL] administration of vaccine post temperature excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA409280.   Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) for Prophylactic vaccination; Hepatitis A Vaccine for Prophylactic vaccination; and Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar RA 27/3), Varicella Zoster Vaccine Live (OKA/Merck) (Proquad) for Prophylactic vaccination.  Health care professional office inquired about the stability of vaccines after a temperature excursion of IPOL at 54.3 degrees Fahrenheit for 2 hours and 45 minutes cause by power outage not due to a human error.   On 29-Sep-2022, the patient administration of vaccine post temperature excursion a 3rd dose of suspect IPOL vaccine at dose 0.5ml once (lot: V1A022M, expiry date: 17-Feb-2024) via subcutaneous route in the left thigh for prophylactic vaccination with no reported adverse event (poor quality product administered) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Post excursion vaccine was administered with no adverse event; Initial information was received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case 2022SA409280.  This case involves a 7 years old female patient received IPV (VERO) [IPOL] Post excursion vaccine was administered with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); and INFLUENZA VACCINE (FLU VACCINE) for prophylactic vaccination.  On 03-Oct-2022, the patient started taking IPV (VERO) solution for injection via subcutaneous route in right thigh (Batch number - V1A022M, Expiration date: 17-FEB-2024) for prophylactic vaccination.  On 03-Oct-2022, Post excursion vaccine was administered with no adverse event (poor quality product administered) (latency: 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: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Needle issue, Syringe issue
Clinical narrative: while administering a dose of fluzone high dose quadrivalent the needle popped off of the prefilled syringe resulting in about 1/2 of the medication to leak out with no reported adverse event; Initial information received on 04-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves a 76 years old male patient and while administering a dose of fluzone high dose quadrivalent the needle popped off of the prefilled syringe resulting in about 1/2 of the medication to leak out with no reported adverse event while receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2022, the patient, while administering a dose of fluzone high dose quadrivalent the needle popped off of the prefilled syringe resulting in about 1/2 of the medication to leak out at dose of 0.7 mL TOTAL via intramuscular route in the left deltoid (lot - UJ882AB, expiry date: 30-Jun-2023) for Immunization with no reported adverse event (incorrect dose administered) (latency : same day)  Caller reporting while administering a dose of fluzone high dose quadrivalent the needle popped off of the prefilled syringe resulting in about 1/2 of the medication to leak out of the syringe. Caller reporting they have since discarded that entire batch of needles and have not had any further issues.   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: 76.0
Sex: M
Vaccine: UNK
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Allergic reaction to the Seqirus vaccine; Itchiness, rash and hives on mostly my arms and a bit on my legs; Itchiness, rash and hives on mostly my arms and a bit on my legs; Itchiness, rash and hives on mostly my arms and a bit on my legs; This spontaneous case was received on 26-Sep-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-03512) and concerned 76-year-old, male patient.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included unspecified flu vaccine shots received for over 20 years with no ill effect, as reported.  On 07-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular (IM) and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On the same date, after receiving Fluad Quadrivalent, the patient had a fairly severe allergic reaction with itchiness, rash and hives mostly on his arms and a bit on his legs.   On unspecified date in Spe-2022, the patient visited physician's office and physician confirmed patient's belief that it was allergic reaction to the Seqirus vaccine and advised him to take a different vaccine next year. The patient got steroid cream from his doctor which seemed to help.   At the time of initial reporting, the patient was recovering from the events. As reported, it largely faded after three weeks, but there was still some itching at wrist and back of elbows.   The reporter assessed the events of 'allergy to vaccine', 'extremities itchy sensation of', 'rash on legs & arms' and 'hives' to be related to Fluad Quadrivalent. As reported, the patient believed it was an allergic reaction to the Seqirus vaccine.   The case was assessed as non-serious.  Company comment: The events of allergy to vaccine, extremities itchy sensation of, rash on legs & arms and hives are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Reporter's Comments: As reported, the patient believed it was an allergic reaction to the Seqirus vaccine.; Sender's Comments: The events of allergy to vaccine, extremities itchy sensation of, rash on legs & arms and hives are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Age: 8.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Crying, Nasal congestion
Clinical narrative: Patient returned to pharmacy counter during 15 minute waiting period post flu vaccine adminstration, conplaining of nasal congestion, itching and itchy bump on face and torso, patient was conscious and able to breath through mouth with no trouble. pt's blood pressure was immediately taken and mothr consented to pt. receiving a dose of diphenhydramine according to patient's reported weight( 50lb, gave 0.4ml of diphenhydramine 50mg/ml=20mg). A few minutes after diphenhydramine IM injection, pt reported feeling sleepy but much better with improved nasal congestion and no more itchiness. blood pressure was measured every 2 to 5 minutes and consistentlybetween 100/70 to 110/80 and pulse around 70 to 80. Pt was released after approximately 30 minutes of onitoring, mother was advised to contact primary care pediatrician for follow up, to onitor child throughout next day (give oral diphenhydramine and call emergency services as appropriate).
Age: 8.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nasal congestion, Pruritus, Swelling, Swelling face
Clinical narrative: Patient returned to pharmacy counter during 15 minute waiting period post flu vaccine adminstration, conplaining of nasal congestion, itching and itchy bump on face and torso, patient was conscious and able to breath through mouth with no trouble. pt's blood pressure was immediately taken and mothr consented to pt. receiving a dose of diphenhydramine according to patient's reported weight( 50lb, gave 0.4ml of diphenhydramine 50mg/ml=20mg). A few minutes after diphenhydramine IM injection, pt reported feeling sleepy but much better with improved nasal congestion and no more itchiness. blood pressure was measured every 2 to 5 minutes and consistentlybetween 100/70 to 110/80 and pulse around 70 to 80. Pt was released after approximately 30 minutes of onitoring, mother was advised to contact primary care pediatrician for follow up, to onitor child throughout next day (give oral diphenhydramine and call emergency services as appropriate).
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Tendonitis, X-ray abnormal
Clinical narrative: on 10/3 developed left shoulder pain, xray showed calcific tendonitis
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Flatulence
Clinical narrative: Nausea, upset stomach, gas, chills/shaking, fever, skin sensitivity, injection site pain, body aches, loss of appetite, tiredness
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Nausea, Pain, Pyrexia, Sensitive skin
Clinical narrative: Nausea, upset stomach, gas, chills/shaking, fever, skin sensitivity, injection site pain, body aches, loss of appetite, tiredness
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor
Clinical narrative: Nausea, upset stomach, gas, chills/shaking, fever, skin sensitivity, injection site pain, body aches, loss of appetite, tiredness
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient was administered an "un-reconstituted" dose. 0.2mL of concentrate
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Received vaccines on 10/6/22 at approx 10:20 am at office. That night at approx 1:00am was noted to have generalized tonic clonic seizure lasting 1 minute. No prior hx of seizures. Per mother, EMS called and pt evaluated at hospital, where per mother's report, the patient was febrile (no documentation of fever available to me). Subsequently returned to baseline neurologic status and discharged. Presented to urgent care on evening of 10/7/22 for follow up, which is where I was the examining physician. Physical exam normal. VAERS report submitted by me, unknown whether also submitted by hospital.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injury associated with device
Clinical narrative: Error: Patient Accidentally Stuck by Needle-