chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Allergies: Bactrim"; Ibuprofen, reaction(s): "Allergies: ibuprofen"; Codeine, reaction(s): "Allergies: codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid again less than a week after completing the Paxlovid and testing negative; Negative, notes: Tested positive for Covid again less than a week after completing the Paxlovid and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 18Mar2024 to 22Mar2024 as COVID-19 treatment.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: strawberries" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing); "Known allergies: wool" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3 (Booster), Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID". Clinical course: The patient received the vaccine in Oct2023 at 1400 hours. It was reported that the patient tested positive for COVID, the only symptom was a cold, symptom gone by day 5, symptom re-occurred on day 10. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown, DOSE 1, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (Manufacturer: Unknown, DOSE 2, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (Manufacturer: Unknown, DOSE 3, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (Manufacturer: Unknown, DOSE 4, SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 at 10:00 as dose 1, single (batch/lot number: unknown) at the age of 54 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Hashimoto's thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 4, manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: COVID-19 test: (24Mar2024) negative, notes: symptom-free; (29Mar2024) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Palovid with treatment start date 19Mar2024 and treatment stop date 24Mar2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (batch/lot number: unknown) at the age of 32 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "colitis ulcerative" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cefzil, reaction(s): "allergy"; Remicade, reaction(s): "allergy". Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3 (booster), manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 4 (booster), manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid with treatment start date 15Mar2024 and treatment stop date 19Mar2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a Nurse.  A 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "ankylosing spondylitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 4 (booster), manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3 (booster), manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy may vary from person to person and is subject to multiple factors. The possibility of an association between the event vaccination failure (COVID19) and the suspect drug BNT162B2 OMI XBB.1.5 cannot be fully excluded. This case will be reassessed when additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid with treatment start date 22Mar2024 and treatment stop date 26Mar2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "Mild Lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "allergies"; Macrodantin, reaction(s): "allergies". The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "allergies"; Macrodantin, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 13Feb2024 until 18Feb2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased
Clinical narrative: my eye dripping after 2nd vaccination; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 at 08:30 as dose 2, single (Lot number: ER8730) at the age of 71 years, in left arm for covid-19 immunisation. The patient's family history included: "high blood pressure" (ongoing). Concomitant medication(s) included: OLMESARTAN taken for hypertension; ALOPHEN [BISACODYL] taken for hypertension. Vaccination history included: comirnaty (DOSE 1, SINGLE, Lot number: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 03Mar2021, when the patient was 71-year-old, for covid-19 immunisation. The following information was reported: LACRIMATION INCREASED (non-serious) with onset 2021, outcome "unknown", described as "my eye dripping after 2nd vaccination". The event "my eye dripping after 2nd vaccination" required physician office visit. Therapeutic measures were taken as a result of lacrimation increased.  Additional information: She was convinced that this started with her eyes dripping after the 2nd vaccination sending her to see an eye doctor and he said to her what was going on with her eyes, they look like eyes of someone that had chemotherapy. She had pictures and doctors bills and medication that she was taking. This was such a devastating process that you can reach her and further discuss.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated, Decreased activity, Dyspnoea exertional, Migraine with aura
Clinical narrative: intractable migraines with Aura/right sided migraines; chronic pain syndrome; right sided neck pain; right arm pain, and right sided leg pain; edema; nausea; dyspnea on exertion; exacerbated pts Asthma; no longer able to play tennis daily which she was previously able to do; Based upon the follow up information, the case initially considered as non-valid was up-graded to Valid Case.  Initial information received on 22-Mar-2024 regarding an unsolicited non-valid  non-serious case received from a other health professional.  This case involves a 64 years old female patient  who experienced intractable migraines with aura/right sided migraines, chronic pain syndrome, right sided neck pain, right arm pain, and right sided leg pain, edema, nausea, dyspnea on exertion, exacerbated asthma and no longer able to play tennis daily which she was previously able to do after receiving Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Dec-2023, the patient had received (dose and units unknown) of suspect Influenza Quadrival A-B Vaccine (Suspension for injection) (lot UT8040KA; expiration date and strength not reported) via unknown route in right deltoid; for prophylactic vaccination (Immunisation).  On an unknown date (unknown latency) the patient had developed intractable migraines with aura/right sided migraines (migraine with aura), chronic pain syndrome (pain), right sided neck pain (neck pain), right arm pain, and right sided leg pain (pain in extremity), edema (oedema), nausea, dyspnea on exertion (dyspnoea exertional),  exacerbated asthma (asthma) and no longer able to play tennis daily which she was previously able to do (decreased activity) following the administration of Influenza Quadrival A-B Vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the event severe reaction and Not Recovered / Not Resolved for all other events.  Additional information was received on 26-Mar-2024: Age and Age group of patient was added, new events of (migraine with aura), (pain), (neck pain), (pain in extremity), (oedema), nausea, (dyspnoea exertional), (decreased activity) and (asthma) were added and Therapy onset date and administration site for the suspect was added. Clinical course updated. Text amended accordingly.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Near death experience, Oedema, Pain, Pain in extremity
Clinical narrative: intractable migraines with Aura/right sided migraines; chronic pain syndrome; right sided neck pain; right arm pain, and right sided leg pain; edema; nausea; dyspnea on exertion; exacerbated pts Asthma; no longer able to play tennis daily which she was previously able to do; Based upon the follow up information, the case initially considered as non-valid was up-graded to Valid Case.  Initial information received on 22-Mar-2024 regarding an unsolicited non-valid  non-serious case received from a other health professional.  This case involves a 64 years old female patient  who experienced intractable migraines with aura/right sided migraines, chronic pain syndrome, right sided neck pain, right arm pain, and right sided leg pain, edema, nausea, dyspnea on exertion, exacerbated asthma and no longer able to play tennis daily which she was previously able to do after receiving Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Dec-2023, the patient had received (dose and units unknown) of suspect Influenza Quadrival A-B Vaccine (Suspension for injection) (lot UT8040KA; expiration date and strength not reported) via unknown route in right deltoid; for prophylactic vaccination (Immunisation).  On an unknown date (unknown latency) the patient had developed intractable migraines with aura/right sided migraines (migraine with aura), chronic pain syndrome (pain), right sided neck pain (neck pain), right arm pain, and right sided leg pain (pain in extremity), edema (oedema), nausea, dyspnea on exertion (dyspnoea exertional),  exacerbated asthma (asthma) and no longer able to play tennis daily which she was previously able to do (decreased activity) following the administration of Influenza Quadrival A-B Vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the event severe reaction and Not Recovered / Not Resolved for all other events.  Additional information was received on 26-Mar-2024: Age and Age group of patient was added, new events of (migraine with aura), (pain), (neck pain), (pain in extremity), (oedema), nausea, (dyspnoea exertional), (decreased activity) and (asthma) were added and Therapy onset date and administration site for the suspect was added. Clinical course updated. Text amended accordingly.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: the product was mixed with sterile water instead of the diluent with no reported adverse event; Initial information received on 21-Mar-2024 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves an unknown age and unknown gender patient who experienced the Yellow fever vaccine [YF-VAX] was mixed with sterile water instead of the diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect yellow fever vaccine Solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation and product was mixed with sterile water instead of the diluent with no reported adverse event  (product preparation error) (latency- same day). There will be no information available on the batch number for this case.  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.  No follow up could be performed as Caller refused follow-up.
Age: 0.25
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL was administered post-excursion with no reported adverse event; Initial information received on 21-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old male patient and reporter reported Poliomyelitis Vaccine (Inactivated)  IPV (VERO) [IPOL] was 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.  Concomitant medications included rotavirus vaccine live oral 1v (rotarix) for prophylactic vaccination; pneumococcal vaccine conj (pneumococcal conjugate vaccine) for prophylactic vaccination; hib vaccine conj (hib vaccine conj) for prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) for prophylactic vaccination.  On 14-Mar-2024, the patient received 0.5 ml total (dose 1) of suspect Poliomyelitis Vaccine (Inactivated)  Suspension for injection (lot W1B511M) (Expiry date: 08-Sep-2025) (strength: standard) (Frequency: once) via intramuscular route in the right vastus lateralis for immunization.  On 14-Mar-2024, the patient was administered Poliomyelitis Vaccine (Inactivated) post-excursion  with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, Clinical coordinator states that IPOL was administered post-excursion. They related that the excursion happened on 05MAR2024 and the vaccine was administered on 14MAR2024. They are asking for guidelines, moving forward. This situation is pre-assessed as a medication error/an inappropriate use due to administration of IPOL post-excursion.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally administered an expired ACT-HIB with no reported adverse event; Initial information received on 26-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient who was accidentally administered an expired act-hib with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 26-Mar-2024, the patient received 0.5 ml of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection lot UJ856AB, expiry date-25-Mar-2024 via intramuscular route in the left thigh for immunization (strength unknown) with no reported adverse event (expired product administered) (latency same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: medication expired yesterday but was administered this morning, 27Mar2024 with no reported adverse event; Initial information received on 27-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 47 years old female patient who administered Typhoid VI Polysaccharide Vaccine [Typhim VI] medication that was expired yesterday but was administered this morning, 27-Mar-2024 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Elasomeran (Moderna COVID-19 Vaccine) and Hepatitis A Vaccine INACT, Hepatitis B Vaccine RHBSAG (YEAST) (Twinrix) both for Prophylactic vaccination.  On 27-Mar-2024, the patient received 0.5 ml dose of expired suspect Typhoid VI Polysaccharide Vaccine (Solution for injection) that was expired yesterday but was administered this morning, with no reported adverse event (expired product administered) (lot V2A121M) (expiry: 26-Mar-2024) (frequency: once) (strength: standard) via intramuscular route in the left deltoid for Immunization.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: received ACTHIB vaccine that was expired with no reported adverse event; Initial information received on 27-Mar-2024 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 15 months old male patient who received HIB (PRP/T) Vaccine [ACT-HIB] that was 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) for Prophylactic vaccination.  On 27-Mar-2024, the patient received 0.5 ml dose of expired suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) with no reported adverse event (expired product administered) (lot UJ863AA)(expiry: 25-Mar-2024) (Frequency: once) (Strength not reported) via intramuscular route via in unknown administration site. for Immunization.  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: 0.42
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered without using the correct diluent and sterile water was mistakenly used for the reconstitution with no adverse event; Initial information received on 27-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] without using the correct diluent and sterile water was mistakenly used for the reconstitution with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 27-Mar-2024, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (lot UJ975AA, Expiry: 23-Nov-2024 with unknown strength) via intramuscular route in the left thigh as Immunization which was administered without using the correct diluent and sterile water was mistakenly used for the reconstitution with no adverse event (product preparation error) (Latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: medication error/an inappropriate use due to administration of ADACEL intradermally with no reported adverse event; Initial information received on 28-Mar-2024 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 34 years old female patient who had medication error/an inappropriate use due to administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] intradermallywith no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 13-Mar-2024, the patient received a  dose of 0.5 ml of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (Suspension for injection) (lot U7904AA,Expiry date: 30-Oct-2025, strength was unknown) via intradermal route in right fore arm for Prophylactic vaccination (Immunization) and medication error/an inappropriate use due to administration of adacel intradermally with no reported adverse event (incorrect route of product administration) (latency : same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: they injected a patient with the expired PENTACEL with no reported adverse event.; Initial information received on 26-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who was injected with the expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant Medications Included Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar) and Rotavirus Vaccine Live Reassort Oral 5V (Rotateq) both for Prophylactic Vaccination  On 25-Mar-2024, the patient was injected with the expired 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (Suspension for injection) (lot UJ870AA, Expiry date: 24- Mar-2024, strength: standard, Frequency: once) via intramuscular route in the right thigh for Immunization (latency: same day) 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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: asking if they need to revaccinate a 1-year-old patient who was given ACTHIB that is expired for 2 days with no reported adverse event; Initial information received on 27-Mar-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 1 years old female patient and reporter was asking if they need to revaccinate patient who was given Haemophilus Type B (Hib) Vaccine (Act-Hib)  that is expired for 2 days with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Haemophilus Type B (Hib) Vaccine Powder and solvent for solution for injection (lot UJ862AA) (Expiry date: 24-Mar-2024) (with an unknown strength) via unknown route in unknown administration site for immunization.  On an unknown date, the reporter was asking if they need to revaccinate patient who was given Haemophilus Type B (Hib) Vaccine (Act-Hib)  that is expired for 2 days with no reported adverse event (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Onset of upper arm swelling, redness, and pruritis within 24 hours of vaccination. Pt also endorses full body aching.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Loss of personal independence in daily activities, Lymphadenopathy, Pain
Clinical narrative: I got the shingrix vaccine at pharmacy on 3/29/24 at about 1:15 p.m. The pharmacist who gave me the shot was completely apathetic and the injection was very painful. The area he chose for the injection was peculiar. It was given on the lower inner part of the deltoid in line with my armpit and not in the center. I went to bed with body aches and woke up with swollen lymph nodes. I'm reporting this since I read that lymph nodes swelling is a rare occurrence. I also feel strongly that this pharmacist should not be administering vaccine shots. When I told him I was needle phobic, he told me not to worry and that they use small needles yet I've never received a shot this painful. I told him that I'm very sensitive to drugs and he said that the only side effect to this vaccine is pain, which he repeated twice. Yet, I'm incapacitated with strong flu-like symptoms and swollen armpit lymph nodes.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: I got the shingrix vaccine at pharmacy on 3/29/24 at about 1:15 p.m. The pharmacist who gave me the shot was completely apathetic and the injection was very painful. The area he chose for the injection was peculiar. It was given on the lower inner part of the deltoid in line with my armpit and not in the center. I went to bed with body aches and woke up with swollen lymph nodes. I'm reporting this since I read that lymph nodes swelling is a rare occurrence. I also feel strongly that this pharmacist should not be administering vaccine shots. When I told him I was needle phobic, he told me not to worry and that they use small needles yet I've never received a shot this painful. I told him that I'm very sensitive to drugs and he said that the only side effect to this vaccine is pain, which he repeated twice. Yet, I'm incapacitated with strong flu-like symptoms and swollen armpit lymph nodes.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: 23 year old female inadvertently received an unnecessary dose of the 2023-2024 Flu vaccine on 4/1/2024, three months after she already received it on 10/18/2023 for the 2023-2024 Flu Season. She did not have any signs or symptoms of any adverse reaction at the time of administration. She reports no other signs or symptoms of any adverse reaction after vaccine administration, during a phone call 60 minutes after the time of administration.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Epistaxis, Headache, Oropharyngeal pain
Clinical narrative: Headaches, sore throat, blood from left nostril.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Simple febrile seizure, treated with antipyretics, hydration, went to ED. Monitored in ED without intervention. Discharged home
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy
Clinical narrative: persistent lymphadenopathy  over 6 months after vaccination
Age: 49.0
Sex: F
Vaccine: HEPA, PNC20, TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: PCP notified of error. Pt was notified of error and informed that the proper vaccination will be administered at her next visit. Event was VOICED in reporting system. Discussion with colleagues resulting in using different coloured labels to identify pediatric vaccines, and clearer visuals in our vaccines refrigerator for more selection accuracy.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site erythema, Injection site pain, Injection site vasculitis, Injection site warmth, Local reaction
Clinical narrative: Local reaction in deltoid, redness/warmth and soreness, also vasculitis on fingers on the side of shot administration that is intermittent and persistent. also , after the 1st injection of the series i developed a superficial blood clot in the left dorsal foot.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Injection site vasculitis, Skin discolouration
Clinical narrative: Local reaction in deltoid, redness/warmth and soreness, also vasculitis on fingers on the side of shot administration that is intermittent and persistent. also , after the 1st injection of the series i developed a superficial blood clot in the left dorsal foot.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Swelling, Vasculitis
Clinical narrative: Local reaction in deltoid, redness/warmth and soreness, also vasculitis on fingers on the side of shot administration that is intermittent and persistent. also , after the 1st injection of the series i developed a superficial blood clot in the left dorsal foot.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site erythema, Injection site pain, Injection site vasculitis, Injection site warmth, Local reaction
Clinical narrative: Incident report states the employee complained of redness, vasculitis at the injection site on her arm as well as fingers, swelling, discoloration and numbness. Employee is being sent to a physician for follow-up since symptoms have not improved.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Injection site vasculitis, Skin discolouration
Clinical narrative: Incident report states the employee complained of redness, vasculitis at the injection site on her arm as well as fingers, swelling, discoloration and numbness. Employee is being sent to a physician for follow-up since symptoms have not improved.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Swelling, Vasculitis
Clinical narrative: Incident report states the employee complained of redness, vasculitis at the injection site on her arm as well as fingers, swelling, discoloration and numbness. Employee is being sent to a physician for follow-up since symptoms have not improved.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No event just not correct vaccine. Should have been MMR and Varicella seperately
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: PATIENT RECEIVED GARDASIL, BEXSERO, AND MENQUADFI VACCINES AND IMMEDIATELY HAD A SEIZURE.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received COVID-19 vaccination on 3/6/2024. COVID-19 vaccine was received via shipment on 11/09/2023 and stored/maintained at refrigeration temperature. Based on the package storage requirements, the vials' beyond use date is 30 days from the date moved to the refrigerator: 12/09/2023. Vaccine was still being administered as pharmacists were going off of the beyond use date on the box, which is applicable to frozen temperatures: 03/31/2024. Upon discovering this error during inventory management, Moderna was immediately notified of the incident and they completed a LOT analysis on our behalf.  Moderna stated: "The vaccines administered on March 6, 2024 from lot number 8057456 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Use of an expired vaccine or a vaccine that has undergone a storage excursion that is determined to be invalid constitutes a vaccine administration error/deviation. Moderna does not provide any specific recommendations in the event of a vaccine administration error or deviation except to instruct vaccination providers to report these events to the Vaccine Adverse Event Reporting System (VAERS)." Our pharmacist called the patient to inform them of the error, passed on the information received from Moderna, and addressed any questions. They reported no adverse events as a result of the error.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Lipoatrophy, Skin indentation
Clinical narrative: Patient reported her arm formed an indentation following administration of the vaccine, and informed pharmacy on 4/1/24.  She was examined by her PCP who diagnosed her with lipoatrophy likely due to subcutaneous administration of the covid vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Mobility decreased
Clinical narrative: 11/16/2023 I had a Moderna Spikevax 3031900 covid vaccine in my left arm (all previous covid vaccines were Pfizer).  About 1:00 am on 11/17/2023 I awoke with a headache, 100.3 degree temp, body and joint aches which continued all day.  I stayed in bed.  On Saturday 11/18/2023 I was very tired and weak so rested all day.  On Sunday 11/19/2023 I was back to normal so started my post surgery home exercise program.  As I began a stretch exercise I had an excruciating pain in my arm and shoulder.  I stopped immediately and lowered my arm.  I could not raise it but a couple of inches.  I did see a physician on 11/21/2023 for xray and on 12/04/2023 for exam and treatment.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray
Clinical narrative: 11/16/2023 I had a Moderna Spikevax 3031900 covid vaccine in my left arm (all previous covid vaccines were Pfizer).  About 1:00 am on 11/17/2023 I awoke with a headache, 100.3 degree temp, body and joint aches which continued all day.  I stayed in bed.  On Saturday 11/18/2023 I was very tired and weak so rested all day.  On Sunday 11/19/2023 I was back to normal so started my post surgery home exercise program.  As I began a stretch exercise I had an excruciating pain in my arm and shoulder.  I stopped immediately and lowered my arm.  I could not raise it but a couple of inches.  I did see a physician on 11/21/2023 for xray and on 12/04/2023 for exam and treatment.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac abnormal, Chest pain, Electrocardiogram, Hypertension, Laboratory test
Clinical narrative: I received 3 Moderna shots from Feb 2021 to Dec 2021.  On Feb 2021, I was experience chest pain and couldn't sleep.  Proceeded to the hospital and Troponin levels were 1600 upon arriving at hospital (later increased to 3100).  I was giving medication to elevate the high blood pressure and was later transported to other hospital by ambulance for heart catheter.  It was reveled that I had Pericarditis with with swelling of the heart.  Since then, I was seen by several doctors and test and continue to have heart palpitations 2024.  Each Doctor I see indicates it was result of long covid / Moderna vaccine.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Myocardial oedema, Palpitations, Pericarditis, Post-acute COVID-19 syndrome
Clinical narrative: I received 3 Moderna shots from Feb 2021 to Dec 2021.  On Feb 2021, I was experience chest pain and couldn't sleep.  Proceeded to the hospital and Troponin levels were 1600 upon arriving at hospital (later increased to 3100).  I was giving medication to elevate the high blood pressure and was later transported to other hospital by ambulance for heart catheter.  It was reveled that I had Pericarditis with with swelling of the heart.  Since then, I was seen by several doctors and test and continue to have heart palpitations 2024.  Each Doctor I see indicates it was result of long covid / Moderna vaccine.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Troponin increased
Clinical narrative: I received 3 Moderna shots from Feb 2021 to Dec 2021.  On Feb 2021, I was experience chest pain and couldn't sleep.  Proceeded to the hospital and Troponin levels were 1600 upon arriving at hospital (later increased to 3100).  I was giving medication to elevate the high blood pressure and was later transported to other hospital by ambulance for heart catheter.  It was reveled that I had Pericarditis with with swelling of the heart.  Since then, I was seen by several doctors and test and continue to have heart palpitations 2024.  Each Doctor I see indicates it was result of long covid / Moderna vaccine.
Age: 1.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given NDC 58160-827-03. This is the liquid formulation intended for patients 10 years and older. We contacted CDC, they said this would not cause harm to patients less than 10 and would not require revaccination but that we should submit to VAERs.
Age: 59.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient came to pharmacy to complain of redness and itching at injections site. Area also warm to touch.
Age: 7.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given NDC 58160-827-03. This is the liquid formulation intended for patients 10 years and older. We contacted CDC, they said this would not cause harm to patients less than 10 and would not require revaccination but that we should submit to VAERs.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dizziness, Hypoaesthesia, Hypoaesthesia oral, Tinnitus
Clinical narrative: Immediate onset (minutes after vaccine administration) of ringing in the ears, dizziness that progressed to lip numbness, chest tightness and numbness into the bilateral upper extremities.  Patient given diphenhydramine 25 mg tablet in office.  EMS contacted and patient taken to the local ER via EMS.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Diarrhoea, Ear pain, Fatigue, Insomnia
Clinical narrative: ear pain, stomach pain, loose stool, fatigue, headache, rash on left arm, sore throat, runny nose, insomnia; applied heat and ice; took tylenol; all resolved as of now.