chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Aphonia
Clinical narrative: I immediately lost my voice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 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: APHONIA (non-serious), outcome "unknown", described as "I immediately lost my voice".  Additional information: Reportedly, Serious was no. The patient had been to the Facility 12 times, they don't know what to think and the patient asked if loss of voice was an after effect of Pfizer shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Insomnia, Magnetic resonance imaging
Clinical narrative: Couldn't lay down to sleep; Numbness in forehead; Pain in left side of face; Oyster like bubbles in his eye and halfway up his forehead; Splitting headache; Shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Nov2021 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: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "Shingles"; HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "Splitting headache"; INSOMNIA (non-serious), outcome "unknown", described as "Couldn't lay down to sleep"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in forehead"; FACIAL PAIN (non-serious), outcome "not recovered", described as "Pain in left side of face"; CONJUNCTIVAL CYST (non-serious), outcome "unknown", described as "Oyster like bubbles in his eye and halfway up his forehead". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: In early Nov2021 he got his COVID-19 Vaccine shot and woke up with splitting headache for 5 or 6 days. On 5th or 6th day he woke up with shingles up on forehead and up and down his back. Had shingles for 7 and half months. Worst was first 5 months. Had a headache a 9 out of a 10. Couldn't lay down to go to sleep had to go from one easy chair to another. When the pain did subside he fell asleep easily. Lucky to get an hour or two of sleep a night. After a few months his pain finally got down to a 2 or 3 to get a few hours sleep and continued throughout 7th or 8th month he had shingles. Asked his HCP about the numbness in his forehead and pain in the left side of his face and his HCP said just to work with it. Then after he got his first shingles vaccination, clarified he got the first shot and then the second shot, then got diagnosed with COVID-19. His headache still remains and half of forehead is still numb. Has pain shooting from his left eye socket corner to his nose. Has had 2 or 3 MRIs, couple of CAT scans, and the they told him there is nothing to do. He can't live with it. His headache was caused by COVID-19 Vaccine shot he got. The pain was constant and never quits but he did get it down to a 2 or 2 and half on the scale. Got the COVID-19 Vaccine shot and got the severe headache the next day then had the severe headache for 4 or 5 days and then had shingles. forehead. Aware the 4 to 5 days are discrepant as caller previously provided time frame of 5 to 6 days. Documented as provided by the caller. There is a product complaint to report, Description of complaint includes that Had the COVID-19 Vaccine and was diagnosed with COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Couldn't lay down to sleep; Numbness in forehead; Pain in left side of face; Oyster like bubbles in his eye and halfway up his forehead; Splitting headache; Shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Nov2021 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: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "Shingles"; HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "Splitting headache"; INSOMNIA (non-serious), outcome "unknown", described as "Couldn't lay down to sleep"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in forehead"; FACIAL PAIN (non-serious), outcome "not recovered", described as "Pain in left side of face"; CONJUNCTIVAL CYST (non-serious), outcome "unknown", described as "Oyster like bubbles in his eye and halfway up his forehead". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: In early Nov2021 he got his COVID-19 Vaccine shot and woke up with splitting headache for 5 or 6 days. On 5th or 6th day he woke up with shingles up on forehead and up and down his back. Had shingles for 7 and half months. Worst was first 5 months. Had a headache a 9 out of a 10. Couldn't lay down to go to sleep had to go from one easy chair to another. When the pain did subside he fell asleep easily. Lucky to get an hour or two of sleep a night. After a few months his pain finally got down to a 2 or 3 to get a few hours sleep and continued throughout 7th or 8th month he had shingles. Asked his HCP about the numbness in his forehead and pain in the left side of his face and his HCP said just to work with it. Then after he got his first shingles vaccination, clarified he got the first shot and then the second shot, then got diagnosed with COVID-19. His headache still remains and half of forehead is still numb. Has pain shooting from his left eye socket corner to his nose. Has had 2 or 3 MRIs, couple of CAT scans, and the they told him there is nothing to do. He can't live with it. His headache was caused by COVID-19 Vaccine shot he got. The pain was constant and never quits but he did get it down to a 2 or 2 and half on the scale. Got the COVID-19 Vaccine shot and got the severe headache the next day then had the severe headache for 4 or 5 days and then had shingles. forehead. Aware the 4 to 5 days are discrepant as caller previously provided time frame of 5 to 6 days. Documented as provided by the caller. There is a product complaint to report, Description of complaint includes that Had the COVID-19 Vaccine and was diagnosed with COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Conjunctival cyst, Facial pain, Headache, Herpes zoster
Clinical narrative: Diagnosed with COVID-19; Diagnosed with COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Diagnosed Covid.  Clinical course: In early Nov2021 he got his COVID-19 Vaccine shot. Then after he got his first shingles vaccination, clarified he got the first shot and then the second shot, then got diagnosed with COVID-19. Unable to clarify which shingles vaccine name as caller declined report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Insomnia, Magnetic resonance imaging
Clinical narrative: Diagnosed with COVID-19; Diagnosed with COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Diagnosed Covid.  Clinical course: In early Nov2021 he got his COVID-19 Vaccine shot. Then after he got his first shingles vaccination, clarified he got the first shot and then the second shot, then got diagnosed with COVID-19. Unable to clarify which shingles vaccine name as caller declined report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Diagnosed with COVID-19; Diagnosed with COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Diagnosed Covid.  Clinical course: In early Nov2021 he got his COVID-19 Vaccine shot. Then after he got his first shingles vaccination, clarified he got the first shot and then the second shot, then got diagnosed with COVID-19. Unable to clarify which shingles vaccine name as caller declined report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, 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: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) positive, notes: strongly positive; (Mar2023) positive, notes: very faint positive; (Mar2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid rebound after resolution of symptoms and very faint positive line on rapid test on day 6 (day 0 = positive test and symptoms, day 1 = first day of Paxlovid), nasal congestion and cough returned and began worsening, and rapid tests were strongly positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand=Pfizer / BioNTech, Vaccine administration date=12Oct2021, Vaccine dose number=3 / Vaccine brand other=Moderna Booster, Vaccine administration date=04Aug2022, Vaccine dose number=4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6204), in left arm and on 12Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 04Aug2022 as dose 4 (booster), single (Lot number: AR4504B), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 19Jan2023 as dose 5 (booster), single (Lot number: 023H224), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ciprofloxacin, reaction(s): "Known allergies: ciprofloxacin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Aug2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, Vaccine administration date=12Oct2021, Vaccine dose number=3 / Vaccine brand other=Moderna Booster, Vaccine administration date=04Aug2022, Vaccine dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: I continued to test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received paxlovid treatment from 23Mar2023 to 28Mar2023.
Sex: U
Vaccine: COVID19
Symptoms: Laboratory test, Secondary immunodeficiency
Clinical narrative: tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines.; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: SECONDARY IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines.". The patient underwent the following laboratory tests and procedures: secondary immune deficiencies/secondary immune: Positive. Therapeutic measures were taken as a result of secondary immunodeficiency. Clinical course: 3 patients have tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines. All have been diagnosed and started on IVIG. Patients were not treated with any biologics prior to testing positive for secondary immune deficiency  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case, however, a possible contributory role of the suspect drug to the reported event "tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines" cannot be completely excluded based on temporal association. The information on clinical course, relevant medical history, concomitant medications, recent lab data, and concurrent medical condition is needed for better assessment. This case will be re-assessed when additional information becomes available.,Linked Report(s) : US-PFIZER INC-202300141698 same reporter/drug/event, different patients;US-PFIZER INC-202300141697 same reporter/drug/event, different patients;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I initially thought dizzy spells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 at 09:00 as dose 1, single (Lot number: IN6206) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Possible IgG present for gluten" (unspecified if ongoing), notes: Have been gluten free 25 years at time of vaccination (suggest autoimmune reactions); "Possibly relevant hypothyroid diagnosed at age 16" (unspecified if ongoing), notes: Onset date: No symptoms at time of vaccination. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "I initially thought dizzy spells". Therapeutic measures were taken as a result of dizziness.  Additional information: Family medical history relevant to adverse events (AES): None.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300029003 Same patient, same product (dose 2), different event.;US-PFIZER INC-202300035945 Same patient, same product (LOE), different event.;
Sex: U
Vaccine: COVID19
Symptoms: Disease progression, Gingivitis, Sinusitis
Clinical narrative: pushed a lot of the infection down into my gums; Interacted with my sinus infections where it has pushed a lot of the infection down into my gums; Interacted with my sinus infections where it has pushed a lot of the infection down into my gums; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sinus infections" (ongoing). The patient's concomitant medications were not reported. The following information was reported: GINGIVITIS (non-serious), outcome "unknown", described as "pushed a lot of the infection down into my gums"; SINUSITIS (non-serious), DISEASE PROGRESSION (non-serious), outcome "unknown" and all described as "Interacted with my sinus infections where it has pushed a lot of the infection down into my gums".  Additional Information: The patient reported that there are billions of people all over the world who are constantly dealing with sinus infections. It was reported that after receiving the Covid vaccine, it interacted with patient's sinus infections where it had pushed a lot of the infection down into the patient's gums. The patient requested to further develop the vaccine, as it could really improve billions of people lives and they would not have to take off from work so much and asked to review the request seriously.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: Since my 4 VX shots I haven't had one episode of the EBV reactivating; Since my 4 VX shots I haven't had one episode of the EBV reactivating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have chronic active EBV" (unspecified if ongoing); "Every 6/8 weeks swollen neck lymph nodes for years" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "Since my 4 VX shots I haven't had one episode of the EBV reactivating".  Additional Information: Patient had chronic active EBV. Every 6/8 weeks swollen neck lymph nodes for years. Since patient's 4 VX shots patient haven't had one episode of the EBV reactivating.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Severely sick after vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Severely sick after vaccine".  Additional information: Patient was tired of all of them because even though she got the vaccine & did everything to prevent her family from getting Covid & she got severely sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal disorder, Musculoskeletal stiffness, Periarthritis, Vaccination site pain
Clinical narrative: Right Shoulder completely frozen; No right arm function/ loss of arm function; Started with stiff neck on right side; Pain in area of right arm where vaccine was given; Pain in shoulder/ pain in the front & back of shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: 32030BD), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Anatomical location: Left Arm), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, Anatomical location: Left Arm), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Jan2022, outcome "unknown", described as "Pain in area of right arm where vaccine was given"; ARTHRALGIA (non-serious) with onset 09Jan2022, outcome "unknown", described as "Pain in shoulder/ pain in the front & back of shoulder "; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 09Jan2022, outcome "unknown", described as "Started with stiff neck on right side"; MUSCULOSKELETAL DISORDER (non-serious) with onset 12Jan2022, outcome "unknown", described as "No right arm function/ loss of arm function"; PERIARTHRITIS (non-serious) with onset 12Jan2022, outcome "unknown", described as "Right Shoulder completely frozen".  Additional information: On 09Jan2022, started with stiff neck on right side with pain in arm & shoulder. Right Shoulder completely frozen on 12Jan2022. No right arm function on 12Jan2022 with severe pain in Right arm & shoulder. Majority of pain has been in the area of right arm where vaccine was given with pain in the front & back of shoulder too.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Having had COVID twice after being vaccinated to me means they don't work; Having had COVID twice after being vaccinated to me means they don't work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Having had COVID twice after being vaccinated to me means they don't work".  Clinical course: COVID after shots: Patient stated, "honestly she is not a supporter of vaccines. Having had COVID twice after being vaccinated to her means they don't work."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis atopic
Clinical narrative: Atopic dermatitis after the injection of Pfizer Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): us_-017025-PV.  A 71-year-old male patient received BNT162b2 (BNT162B2 NOS), 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: DERMATITIS ATOPIC (non-serious), outcome "not recovered", described as "Atopic dermatitis after the injection of Pfizer Covid Vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15-month-old patient was inadvertently administered QUADRACEL instead of the intended PENTACEL with no reported AE; 15-month-old patient was inadvertently administered QUADRACEL instead of the intended PENTACEL with no reported AE; Initial information received on 14-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient to whom inadvertently administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)] instead of the intended pentacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included Varicella zoster vaccine (Varicella Vaccine) for Immunisation.  On 14-Mar-2023, the patient received a dose of 0.5 mL dose 4 (primary/booster) of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine, solution for injection, (strength: standard, lot number: U7564AA and expiry date: 08-Nov-2024) via intramuscular route in the left thigh for immunisation.  On 14-MAR-2023 the 15-month-old patient was inadvertently administered quadracel instead of the intended pentacel with no reported ae (wrong product administered) (product administered to patient of inappropriate age) (latency: same day) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine.  On follow up it was reported that, "After receiving quadracel patient had no adverse reaction."   No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.  Additional information received on 04-Apr-2023 from other healthcare professional. Dose number 4 of suspect product was added. Clinical course updated and text amended accordingly.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired QUADRACEL was administered to a patient, with no reported adverse event; Initial information received on 03-Apr-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 4-year-old male patient to whom an expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] was administered to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunisation.  On 03-Apr-2023, the patient received 0.5ml total dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE Suspension for injection (strength: standard) (lot number: C5862BA, expiry date: 01-Apr-2023) via intramuscular route in the right thigh for Immunization and on the same day expired quadracel was administered to a patient, with no reported adverse event (expired product administered).  It was reported, caller requesting next steps to take.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was 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: 0.58
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Pentacel dose that was administered had expired with no reported adverse event; Initial information received on 03-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old male patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] dose that was administered had expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE for Prophylactic vaccination.  On 03-Apr-2023, the patient received dose 3 at 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection, (lot UJ644AAA; expiry date: 02-Apr-2023) via unknown route in the right vastus lateralis for immunization with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  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: 8.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Ipol administered after the excursion at 134.70F for 6 minutes due to a refrigerator malfunction with no reported adverse event; Ipol administered for 8 year old patient with no reported adverse event; Initial information received  on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional via office manager.   This case involves a 8 years old male patient for whom poliomyelitis vaccine (inactivated) [IPOL] being administered after the excursion at 134.70 f for 6 minutes due to a refrigerator malfunction with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B vaccine for Immunisation.  It was reported that Office Manager reported a temperature excursion involving punctured, and administered after the excursion, IPOL at 134.70F for 6 minutes due to a refrigerator malfunction on 18-MAR-2023 (not human error). The product was not supported by the extended stability data (product storage error).  On 21-Mar-2023, post excursion, the 8 year old patient received a dose of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection of standard strength at dose of 0.5 ml (lot: V1B901M, expiry date: 02-Jun-2024) via intramuscular route in the deltoid nos for prophylactic vaccination with no reported adverse event (product administered to patient of inappropriate age) (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 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: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired DAPTACEL was administered to a patient with no reported AE; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old female patient who reported that expired daptacel was administered to a patient with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (lot C5828AA,Expiry date: 30-Mar-2023) (strength : unknown) via intramuscular route in the left deltoid for Immunization.  On an unknown date the patient developed a non-serious event of expired daptacel was administered to a patient with no reported ae (expired product administered) (unknown latency) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Daptacel) was not applicable.  At time of reporting, the outcome was Unknown for the event expired daptacel was administered to a patient with no reported ae.  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: 10.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: ipol stored at 134.70F for 6 minutes, with no reported adverse event; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 10 years old female patient who reported that ipol stored at 134.70f for 6 minutes, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine; influenza vaccine INACT SPLIT 4V (QUADRIVALENT influenza vaccine); and HPV VACCINE.  On 28-Mar-2023, the patient received a unknown dose of suspect ipv (VERO) (Suspension for injection) (lot V1B901M, Expiry date: 02-JUN-2024) (with unknown strength) via intramuscular route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of ipol stored at 134.70f for 6 minutes, with no reported adverse event (product storage error) (unknown latency) following the administration of ipv (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (Ipol) was not applicable.  At time of reporting, the outcome was Unknown for the event ipol stored at 134.70f for 6 minutes, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: adacel being administered post excursion with no reported adverse event; Initial information received on 04-Apr-2023 regarding an unsolicited valid non-serious case received via office manager. GMI number: 01562233.   This case involves 8 years old male patient who experienced Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] being administered post 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 cases 2023SA107297, 2023SA108312, 2023SA107202 and 2023SA108228.  Concomitant medications included Hepatitis B vaccine for Prophylactic vaccination.  It was reported that office manager reported a temperature excursion involving administered after the excursion, unopened ADACEL at 134.70F for 6 minutes due to a refrigerator malfunction on 18-MAR-2023 (not human error). The product did not support by the extended stability data, and the caller informed that ADACEL has been administered after the excursion. This situation is reported as a medication error due to IPOL and ADACEL being administered post excursion.    On 21-Mar-2023, the 8-year-old patient administered post excursion suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection at dose 0.5ml once (lot: U7549AA, expiry date: 04-Nov-2024) via intramuscular route in the deltoid nos 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 for the event poor quality product administered.     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: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: ADACEL at 134.70F for 6 minutes due to a refrigerator malfunction with no reported adverse event; administered after the excursion, with no reported adverse event; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 10 years old female patient and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was unopened at 134.70 f for 6 minutes due to a refrigerator malfunction event and administered after the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine (Hepatitis B vaccine); influenza vaccine inact split 4V (Fluzone quadrivalent); and HPV vaccine (HPV vaccine) for prophylactic vaccination (immunisation).  On 18-Mar-2023 diphtheria-2/tetanus/5 AC pertussis vaccine was unopened at 134.70 f for 6 minutes due to a refrigerator malfunction with no reported adverse event (product storage error) (unknown latency) and On 28-Mar-2023, the patient received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine at dose of total (1x) 0.5 ml (lot number: U7549AA, expiry date: 04-Nov-2024, strength, formulation, administration site: Unknown) via intramuscular for Immunization (Immunisation) administered after the excursion, with no reported adverse event (poor quality product administered) (latency: same day)  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the 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. Cluster AE cases: 01562152, 01562191, 01562224, 01562233, 01562239 and 01562252
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: I received the Moderna Booster 1 year after getting my two Pfizer vaccines. Approximately 6 weeks later I began losing a small patch of hair on the back of my head. Over the course of the next year, it grew larger and larger. I was diagnosed with Alopecia. I am currently undergoing steroid injections monthly in my scalp. They have not helped and my hair is continuing to fall out. The back of my head is now 3/4 bald.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 22Sep2022, 2nd on 30Jan2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 22th September 2022).   On 30-JAN-2023, the patient received the 2nd dose of Twinrix. On 30-JAN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 22Sep2022, 2nd on 30Jan2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 27-Mar-2023 Pharmacist stated that a patient did not get her 2nd dose of Twinrix on schedule and would like to know how to proceed with dosing. The reporter did not consent to follow-up. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain, Pyrexia
Clinical narrative: FELT ACHY; LOW GRADE FEVER; TIRED; COVID-19; This spontaneous report received from a consumer via other manufacturer concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On unspecified date in JUL-2022, the patient experienced covid-19 (dose number in series 2). On an unspecified date, the patient experienced felt achy, low grade fever, and tired which lasted just for a day and a half (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt achy, low grade fever, and tired, and the outcome of covid-19 was not reported. This report was non-serious.