chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: severe site pain, left arm, radiated to my scapula through to the front of my shoulder where it is difficult to move my arm; After the first vaccine it started with severe site pain; difficult to move my arm; radiated to my scapula through to the front of my shoulder; This is a spontaneous report from a contactable other health care professional (patient). A 62-year-old non pregnant female patient received bnt162b2 ((PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: #EL0140), dose 1 via an unspecified route of administration, administered in Left Arm on 26Jan2021 03:15 (at age of 62-year-old) as dose 1, single for covid-19 immunization. The patient had no known allergies. Medical history included breast cancer, breast biopsy. Concomitant medications included SERTRALINE, ATORVASTATIN on an unknown date for unspecified indication. No other vaccine in four weeks. No covid prior vaccination and also no covid tested post vaccination. On an unspecified date, the patient experienced severe site pain, left arm, radiated to my scapula through to the front of my shoulder where it is difficult to move my arm, after the first vaccine it started with severe site pain, difficult to move my arm, radiated to my scapula through to the front of my shoulder. It was reported that she had to have a breast biopsy where a benign growth was removed. As of October where she had a breast MRI my breasts were clear from any growths. Treatment received for all the events included with cortisone injections and anti imflamatories. Adverse events resulted in physician or other health care professional office visit. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown on an unspecified date (my breasts were clear from any growths), polymerase chain reaction: negative on 04Jan2021 Nasal Swab. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Conjunctivitis, Erythema of eyelid, Eye pain
Clinical narrative: Symptoms similar to conjunctivitis; Eyes hurt with movement; Eyes red, lining of eye swollen and red; Eyes red, lining of eye swollen and red; Eyes red; fever; chills; headache; This is a spontaneous report from a contactable consumer(patient). A 37-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0171), via an unspecified route of administration, in arm left on 22Apr2021 at 14:30 (age at vaccination 37 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient had any allergy or not. No other vaccine was taken in four weeks. The patient did not have covid prior vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: Er8737), via an unspecified route of administration, in arm left on 01Apr2021at 09:00 (age at vaccination 37 years) as dose 1, single for covid-19 immunisation. On 23Apr2021 at 14:30 the patient had eyes red and lining of eye was swollen and red, his eyes hurt with movement first few days of symptoms, reported the symptoms were similar to conjunctivitis on ,the symptoms occurred overnight after 2nd dose along with other more common side effects such as fever, chills, and headache. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was not tested for covid post vaccination. The patient underwent lab tests included body temperature with unknown results on unknown date. Therapeutic measures were taken as a result of the events Eyes red, lining of eye swollen and red. Eyes hurt with movement first few days of symptoms. Symptoms similar to conjunctivitis with steroid eye drops as well as antibacterial. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Ocular hyperaemia, Pyrexia, Swelling of eyelid
Clinical narrative: Symptoms similar to conjunctivitis; Eyes hurt with movement; Eyes red, lining of eye swollen and red; Eyes red, lining of eye swollen and red; Eyes red; fever; chills; headache; This is a spontaneous report from a contactable consumer(patient). A 37-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0171), via an unspecified route of administration, in arm left on 22Apr2021 at 14:30 (age at vaccination 37 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient had any allergy or not. No other vaccine was taken in four weeks. The patient did not have covid prior vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: Er8737), via an unspecified route of administration, in arm left on 01Apr2021at 09:00 (age at vaccination 37 years) as dose 1, single for covid-19 immunisation. On 23Apr2021 at 14:30 the patient had eyes red and lining of eye was swollen and red, his eyes hurt with movement first few days of symptoms, reported the symptoms were similar to conjunctivitis on ,the symptoms occurred overnight after 2nd dose along with other more common side effects such as fever, chills, and headache. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was not tested for covid post vaccination. The patient underwent lab tests included body temperature with unknown results on unknown date. Therapeutic measures were taken as a result of the events Eyes red, lining of eye swollen and red. Eyes hurt with movement first few days of symptoms. Symptoms similar to conjunctivitis with steroid eye drops as well as antibacterial. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: 48 hours after vaccine, shoulder pain is gone; This is a spontaneous report from a contactable consumer (patient herself).  A 62-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration, administered in right arm as dose 1, single on 30Apr2021 at 14:30 (at the age of 62-year-old) for covid-19 immunisation at pharmacy or drug store. Medical history included osteoporosis and fairly healthy. Patient had known allergies to Penicillin, Codeine, Eggs and gluten. Concomitant medications included alendronate sodium (FOSAMAX) and vitamin d NOS (VITAMIN D NOS) both taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient reported that this was a positive. She had severe shoulder pain for months and diagnosed at Bursitis, x-rays, ultrasound showed nothing. Exercise and Celebrex have not helped. She have not had Covid that she was aware. On 02May2021 07:00 AM, 48 hours after vaccine, her shoulder pain was gone. No treatment was received. At the time of this report, the outcome of event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Hives; itching; redness, lump, itching on injection site; redness, lump, itching on injection site; redness, lump, itching on injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: 8727) via an unspecified route of administration, administered in Arm Left on 23Mar2021 at 14:00 (Age at vaccination: 64 years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included hypertension, osteoporosis, arthritis and intervertebral disc protrusion. The patient's concomitant medications were not reported. Patient did not have covid prior vaccination. Patient did not tested covid post vaccination.  Patient did not received other vaccines in 4 weeks. The patient previously took fluconazole and experienced drug hypersensitivity. The patient experienced hives and itching two and a half days after first dose on 26Mar2021 at 02:00. Hives continue until present time, 11May2021. (Over 7 weeks). The patient experienced redness, lump, itching on injection site a few days after vaccination on an unspecified date in 2021. No treatment was received for the events. Patient received second dose on 13April2021 at 12:30 PM in left arm with lot number  EW0153. The events outcome was reported as not recovered.   No follow-up attempts are required. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch No./lot Number: unknown/ Unable to locate or read the details), via an unspecified route, administered in right arm on 13Apr2021 (at the age of 53 years old) as dose 1, single for covid-19 immunization. Medical history included ongoing chronic kidney disease, hypertension from an unknown date and unknown if ongoing. Concomitant medications received in 2 weeks included losartan (LOSARTAN), carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported. No other vaccine administered in four weeks. Patient had covid prior vaccination. Patient did not test for covid, post vaccination. On 14Apr2021, the patient experienced hacking cough. No therapeutic measures were taken as result of event. The outcome of the event was not recovered. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Agitation, Confusional state, Diarrhoea, Hepatic pain
Clinical narrative: liver pain; kidney pain; confusion; severe agitation; foul smelling; explosive diarrhea; malaise; intestinal distress; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional.  A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0196), via an unspecified route of administration, in Left arm on 07Jul2021 02:00 PM (at the age of 49-years) as DOSE 1, SINGLE for covid-19 immunization. Patient had medical history of bilaterial (left and right) total hip replacement from an unknown date and unknown if ongoing. The patient previously received mucinex and experienced drug hypersensitivity. Concomitant medications included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (SUPER B COMPLEX [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); lisinopril (LISINOPRIL) all taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccine in four weeks. Patient not had COVID prior vaccination and was not tested COVID post vaccination. On 08Jul2021, the patient experienced Liver pain, kidney pain, confusion, severe agitation, foul smelling explosive diarrhea, malaise, intestinal distress. Events considered as non-serious as per the reporter. Patient had not received any treatment for the events reported. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Parosmia, Renal pain
Clinical narrative: liver pain; kidney pain; confusion; severe agitation; foul smelling; explosive diarrhea; malaise; intestinal distress; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional.  A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0196), via an unspecified route of administration, in Left arm on 07Jul2021 02:00 PM (at the age of 49-years) as DOSE 1, SINGLE for covid-19 immunization. Patient had medical history of bilaterial (left and right) total hip replacement from an unknown date and unknown if ongoing. The patient previously received mucinex and experienced drug hypersensitivity. Concomitant medications included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (SUPER B COMPLEX [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); lisinopril (LISINOPRIL) all taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccine in four weeks. Patient not had COVID prior vaccination and was not tested COVID post vaccination. On 08Jul2021, the patient experienced Liver pain, kidney pain, confusion, severe agitation, foul smelling explosive diarrhea, malaise, intestinal distress. Events considered as non-serious as per the reporter. Patient had not received any treatment for the events reported. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Fatigue, Limb discomfort, Myalgia
Clinical narrative: I have bad pain on my left hand I can't lift anything up; I have joint pain; Muscle pain; I have hard time lifting my right arm up; Tiredness; This is a spontaneous report from a contactable consumer. Patient reported that:  A 73-years-old patient of an unspecified gender received bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EWO217), dose 2 via an unspecified route of administration on 05Jun2021 (At the age of 73 years) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included Irregular heart beat, anticoagulant therapy and blood cholesterol abnormal. Concomitant medications included diltiazem XR and Pradaxa taken for anticoagulant therapy, sertraline hydrochloride, atorvastatin taken for blood cholesterol. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot Number and expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date in 2021, the patient experienced bad pain on my left hand I can't lift anything up, joint pain, muscle pain, have hard time lifting my right arm up and tiredness.Treatment: Consumer stated, "All I take is Tylenol but it's not really doing any good right now." The patient underwent lab tests and procedures which included blood test with results as good. The outcome was reported as unknown for all the events.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I have bad pain on my left hand I can't lift anything up; I have joint pain; Muscle pain; I have hard time lifting my right arm up; Tiredness; This is a spontaneous report from a contactable consumer. Patient reported that:  A 73-years-old patient of an unspecified gender received bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EWO217), dose 2 via an unspecified route of administration on 05Jun2021 (At the age of 73 years) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included Irregular heart beat, anticoagulant therapy and blood cholesterol abnormal. Concomitant medications included diltiazem XR and Pradaxa taken for anticoagulant therapy, sertraline hydrochloride, atorvastatin taken for blood cholesterol. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot Number and expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date in 2021, the patient experienced bad pain on my left hand I can't lift anything up, joint pain, muscle pain, have hard time lifting my right arm up and tiredness.Treatment: Consumer stated, "All I take is Tylenol but it's not really doing any good right now." The patient underwent lab tests and procedures which included blood test with results as good. The outcome was reported as unknown for all the events.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Contusion, Fatigue, Headache, Nausea
Clinical narrative: bruising; headache; Arm pain; pain throughout the body especially legs and lower back; pain throughout the body especially legs and lower back; tiredness; nausea; fever; blurred vision; This is a spontaneous report from a Contactable consumer. This 48-year-old Female consumer reported for herself. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0196), dose 2 via an un-specified route of administration, administered in Arm Left in Arm Left on 14Jul2021 10:00 as dose 2, single (age at vaccination 48-years-old) for covid-19 immunization. Medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm Left on 23Jun2021 at 10:00 as dose 1, single for COVID-19 Immunization. On15Jul2021 01:00 Am, the patient experienced bruising, headache, arm pain, pain throughout the body especially legs and lower back, pain throughout the body especially legs and lower back, tiredness, nausea, fever, blurred vision. Patient received Tylenol as treatment for events. The outcome of events were recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: bruising; headache; Arm pain; pain throughout the body especially legs and lower back; pain throughout the body especially legs and lower back; tiredness; nausea; fever; blurred vision; This is a spontaneous report from a Contactable consumer. This 48-year-old Female consumer reported for herself. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0196), dose 2 via an un-specified route of administration, administered in Arm Left in Arm Left on 14Jul2021 10:00 as dose 2, single (age at vaccination 48-years-old) for covid-19 immunization. Medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm Left on 23Jun2021 at 10:00 as dose 1, single for COVID-19 Immunization. On15Jul2021 01:00 Am, the patient experienced bruising, headache, arm pain, pain throughout the body especially legs and lower back, pain throughout the body especially legs and lower back, tiredness, nausea, fever, blurred vision. Patient received Tylenol as treatment for events. The outcome of events were recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error
Clinical narrative: patient was given a dose 28 days after vial of 10 doses was opened with no AE; Initial information was received on 04-Nov-2021 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves a male patient (unknown age) who was received a dose 28 days after vial of 10 doses was opened POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) (Expired product administered).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2021, the patient received a first dose of suspect IPV (VERO) (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  It was reported "Vial of Polio was opened and patient was given a dose 28 days after vial of 10 doses was opened. Office wants to know what to do."  It was unknown if the patient experienced any additional symptoms/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.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Also, the last time I got the flu; Initial information received on 08-Nov-2021 regarding an unsolicited valid serious case received from a consumer (patient) via Regulatory Authority.  This case involves an unknown age male patient who experienced last time got the flu (influenza) after receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious last time i got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event influenza was reported as unknown.  There will be no information available for the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Got sick from the flu; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Regulatory Authority.  This case involves a female patient of unknown age who got sick (Illness), after receiving INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination. The patient's medical history, concomitant therapy, medical treatment(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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; This case was considered as non-case as temperature excursion reported without stability data.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Flinched during the injection and did not get the full injection/no AE; Initial information was received on 09-Nov-2021 regarding an unsolicited valid non-serious case received from a other health professional via (Agency - 00849823).  This case involves a 72 year-old male patient who flinched during the injection and did not get the full injection of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Under dose).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  On 08-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ730AA and 30-Jun-2022) via an intramuscular route at the left arm  for prophylactic vaccination.  It was reported "Pharmacy student is calling to ask if a patient who was getting the FLUZONE HD QUAD, flinched during the injection and she knows he didn't get the full injection, what are the recommendation regarding this".  It was a case of an actual medication error due to vaccine under dose (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event 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.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case two involves an unknown age and gender patient were inadvertently given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] 2020-2021 instead of the 2021-2022, the vaccine expired on 6/2021 (expired product administered). Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7002BA and expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination (expired product administered). It was reported "The patients have been contacted by our office an made aware of the error. Since the vaccine expired on 6/2021 are there any medical concerns, we should be aware of so we can inform the patients". This case was an actual medication error due to expired vaccine used (latency: same day). At the time of reporting, no 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 Regulatory Authority. 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: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Injury associated with device, Syringe issue
Clinical narrative: tip of the syringe broke off flush and the needle went flying through the air and stuck the patient again in the right deltoid; tip of the syringe broke off flush and the needle went flying through the air and stuck the patient again in the right deltoid; Initial information was received on 10-Nov-2021 regarding an unsolicited valid non-serious case received from other health professional via Medical Information - 00851940.  This case involves a 69-year-old male patient receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] the tip of the syringe broke off flush and the needle went flying through the air and stuck the patient again in the right deltoid (Syringe issue, Injury associated with device).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ773AB, expiry date: 30-Jun-2022] via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious tip of the syringe broke off flush and the needle went flying through the air and stuck the patient again in the right deltoid (injury associated with device) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 10-Nov-2021, the patient developed a non-serious tip of the syringe broke off flush and the needle went flying through the air and stuck the patient again in the right deltoid (syringe issue) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "the patient received a Fluzone High-Dose Quadrivalent prefilled syringe dose intramuscularly into the right deltoid. Patient received no concomitant vaccines. After the Fluzone High-Dose was administered, the healthcare provider (HCP) attempted to engage the safety cover for the needle, and the tip of the syringe broke off flush and the needle went flying through the air and stuck the patient again in the right deltoid. The needle was one where the safety mechanism is a plastic flip cap, and the HCP had barely touch that when the needle went flying through the air, so the safety cover on the needle was not engaged. Reporting nurse stated that she is not sure what was really at fault in the incident, the needle, the Fluzone HD syringe, or both, but she wanted to report it just it case there is something that can be done to prevent events like this in the future. When the needle stuck the patient, he was not even aware of it, but the treating HCP was aware of it, and treated the patient's needlestick injury with first aid and covered it with a BandAid, and they do not thing there will be any significant health consequence for the patient."  It was not reported if the patient received a corrective treatment for the events.   At time of reporting, the outcome was unknown for the reported events.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received dose of expired IPOL/no AE; Initial information was received on 10-Nov-2021 regarding an unsolicited valid non-serious case received from a Physician and health care professional via [Medical Information (MI) - 00852064].  This case involves a 12 year-old male patient who received dose of expired vaccine IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 10-Nov-2021, the patient received 0.5 mL dose of suspect IPV (VERO) (Suspension for injection, lot R1F972M and expiration date: 03-Oct-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was reported "Caller/Practice Site Manager reports that patient received dose of expired IPOL on 10Nov2021; they did not catch the expiration date when product was administered; safety report will be completed. Caller would like to know if dose needs to be repeated since expiration date of 03Oct2021 was fairly close to administration date".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event 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: 5.0
Sex: M
Vaccine: FLUC3
Symptoms: Erythema, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Warm to the touch; Swelling; Redness; Soreness/Pain; Temperature of 100.3 F; This spontaneous case from the United States was received on 08-Oct-2021 from pharmacist via Regulatory Authority (reference number: SEQW21-03532) and concerned a 5-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 07-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose 0.5 ml, route of administration and anatomical location not reported) for influenza prevention. The batch number reported was 308466 and expiration date 30-Jun-2022.  On the same day, at night after receiving Flucelvax Quadrivalent, the patient experienced soreness and temperature of 100.3 F. Pharmacist mentioned that the patient was tense during the administration of vaccine.  On 08-Oct-2021, one day after receiving Flucelvax Quadrivalent, the patient developed redness, swelling, warm to the touch and pain. The patient started treatment with Tylenol (paracetamol).  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 5-year-old patient experienced pain, skin warmth, swelling, pyrexia, and erythema within one day after receiving Flucelvax Quadrivalent. The patient's medical history and concomitant drugs were not reported. Due to plausible chronology, causality is assessed as possibly related.; Sender's Comments: A 5-year-old patient experienced pain, skin warmth, swelling, pyrexia, and erythema within one day after receiving Flucelvax Quadrivalent. The patient's medical history and concomitant drugs were not reported. Due to plausible chronology, causality is assessed as possibly related.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Headaches; Redness, swelling, and heat in the injection area; Redness, swelling, and heat in the injection area; Redness, swelling, and heat in the injection area; This spontaneous case was received on 15-Oct-2021 from other non-health professional via Agency (reference number: SEQW21-03982) and concerned a 72-year-old female patient.  The patient's concurrent condition included hypertension.   The patient's concomitant medications included lisinopril, Montelukast (montelukast sodium), Cetirizine (cetirizine hydrochloride) and simvastatin, all for unknown indication. The patient's historical vaccine included unspecified Covid-19 vaccine after which no adverse event was reported.  On 12-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical: deltoid) for influenza prophylaxis. The batch number was not reported.  On the same day, the patient experiened redness, swelling, and heat in the injection area. The size of the reaction was about the area of the palm of her hand.  On 14-Oct-2021, the patient she had headaches, but have not experienced today (15-Oct-2021).  The outcome of the events was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 72-year-old female patient experienced warmth, erythema and swelling on vaccination site along with headache on the same date after receiving Fluad Quadrivalent vaccine. The patient's historical vaccine included unspecified Covid-19 vaccine after which no adverse event was reported. Based on plausible temporal relationship and information provided, causality for the events is assessed as possibly related.; Sender's Comments: A 72-year-old female patient experienced warmth, erythema and swelling on vaccination site along with headache on the same date after receiving Fluad Quadrivalent vaccine. The patient's historical vaccine included unspecified Covid-19 vaccine after which no adverse event was reported. Based on plausible temporal relationship and information provided, causality for the events is assessed as possibly related.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: feel nauseous.; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2021, the patient received Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient received Shingrix vaccine three days ago and felt nauseous. The follow-up could not be possible as no contact details were available.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypotension
Clinical narrative: Low blood pressure; This case was reported by a consumer via call center representative and described the occurrence of low blood pressure in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high (patient informed that he normally had high blood pressure).   On 5th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th November 2021, 1 days after receiving Shingrix, the patient experienced low blood pressure. On an unknown date, the outcome of the low blood pressure was unknown.   It was unknown if the reporter considered the low blood pressure to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient informed that he got his first dose of Shingrix last friday.  The patient stated that he normally had high blood pressure, but the following day, his blood pressure was low.  The patient did not report any symptoms with the low blood pressure.  The patient had followed up with his health care professional. The patient continued to had lower than his normal blood pressure. The patient enquired if there were any reports of this associated with the Shingrix vaccine.  The reporter did not consent to follow-up.
Age: 39.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: the dose administer expired on 18Oct2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 39-year-old female patient who received HAB (Twinrix) (batch number H4A37, expiry date 18th October 2021) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2021, the patient received the 3rd dose of Twinrix (intramuscular) and Twinrix Pre-Filled Syringe Device. On 16th November 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The patient received 3rd dose of expired Twinrix vaccine in left deltoid which led to expired vaccine used. The vaccine got expired on 18th October 2021. The reporter consented to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Headache, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COUGHING BAD; PAIN IN JOINTS/HORRIBLE LEG JOINT PAIN; HEADACHE; COVID-19; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After patient received vaccine, developed side effects such as pain in joints not horrible but noticeable, headache bad not horrible and cough. On 22-OCT-2021, patient experienced covid (suspected clinical vaccination failure). It was reported that later, patient had horrible leg joint pain (reported as "worst pain ever had in life about 4 full days"), developed bad headache again and bad cough that the patient thought the ribs were broken. After two weeks the patient only had cough. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19, pain in joints/horrible leg joint pain, and headache, had not recovered from coughing bad, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000202280.; Sender's Comments: V0: 20211133931-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Inflammation, Vaginal discharge, Vulvovaginal pruritus
Clinical narrative: Bothersome itching occurred near vaginal opening the day after vaccine was administered 11/13/21 (early evening). Assumed the itching was just a coincidence and tried to ignore it. Itching and inflammation increased daily, and massive amount of thick, grimy, yellow discharge coating the entirety of the vaginal opening  was discovered on 11/17/21. OBGYN diagnosed symptoms as yeast infection. For the first and second doses of this vaccine, the only side effects experienced were a sore arm, pressure behind the ears, and a mild headache. This lead me to believe that I?d be experiencing similar side effects with my third vaccine. Through research, I discovered on a forum that other women have been getting this same side effect after receiving their covid vaccine (no matter the manufacturer). I felt it would be the right thing to inform you of this side effect, so it can be disclosed to potential vaccine recipients in the future, and you can include it in your records and statistics.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Arrhythmia, Asthenia, Dizziness, Electrocardiogram ambulatory abnormal
Clinical narrative: Heart arrhythmias. Weakness. Fatigue. Dizziness Heart pain. Visit to the Emergency Room. Visits to the cardiologists.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Supraventricular extrasystoles
Clinical narrative: Heart arrhythmias. Weakness. Fatigue. Dizziness Heart pain. Visit to the Emergency Room. Visits to the cardiologists.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt weird; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt weird) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt weird). At the time of the report, FEELING ABNORMAL (Felt weird) had resolved.            No information was provided on concomitant medication. Treatment information was not provided by the reporter   This case was linked to MOD-2021-375342, MOD-2021-375333, MOD-2021-375327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received on 09-Nov-2021 contains NNI.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa), Drug allergy (Cefdinir), Blood pressure high and Acid reflux (esophageal).Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 2002 to an unknown date for Acid reflux (esophageal), LISINOPRIL from 2017 to an unknown date for Blood pressure high, CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) from 2015 to an unknown date for an unknown indication. On 14-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 12-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021 at 1:00 PM, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 14-Feb-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache) had resolved.Concomitant medication include vitamin supplement.Headache (normal) and a sore arm (that resolved)within one or two days Patient took bed rest. This case was linked to MOD-2021-378122, MOD-2021-378089 (Patient Link). Most recent FOLLOW-UP information incorporated above includes:On 11-Nov-2021: Additional information includes Patient demographics,Medical History,Event Recovered date added 14-Feb-2021.