chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FF2584), in left arm and on 16Jun2022 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (not ongoing); "Anxiety" (not ongoing); "sleep apnea" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (start date: 10May2023 and stop date: 15May2023.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 90-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm and on 25Apr2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 90 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL1686), in right arm, on 30Jan2021 as dose 2, single (Lot number: EL9261), in right arm, on 20Sep2021 as dose 3 (booster), single (Lot number: FC3181), in right arm and on 30Mar2022 as dose 4 (booster), single (Lot number: FK0895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering", described as "COVID 19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment with Paxlovid with onset date 15May2023 and stop date as 19May2023, no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300202471 Same patient/different product, different dose/event;US-PFIZER INC-202300202805 Same patient/different product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she contracted COVID in September of last year (2022) in spite of being vaccinated; she contracted COVID in September of last year (2022) in spite of being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "she contracted COVID in September of last year (2022) in spite of being vaccinated". Clinical course: She further reported that she contracted COVID in September of last year (2022) in spite of being vaccinated. She knew that she received all Pfizer COVID-22 vaccines but could not recall the dates. It was so funny because, you know she got all of my COVID vaccines, and this was kind of a side discussion, but she had gotten her COVID vaccines but then last September she had to go to  and she should have taken a third booster shot, and she did not, and patient got COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19. Clinical course: Treatment start date=19May2023; Treatment stop date=23May2023  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300203787 Same reporter/patient, different drug, different AE.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchitis, COVID-19, Chest X-ray, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Also being treated for bronchitis; Had 5 Pfizer COVID shots before testing positive for Covid, last shot was Oct2022; Had 5 Pfizer COVID shots before testing positive for Covid, last shot was Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Had 5 Pfizer COVID shots before testing positive for Covid, last shot was Oct2022"; BRONCHITIS (non-serious), outcome "unknown", described as "Also being treated for bronchitis". The events "had 5 pfizer covid shots before testing positive for covid, last shot was oct2022" and "also being treated for bronchitis" required physician office visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (unspecified date) unknown result; SARS-CoV-2 test: (unspecified date) negative, notes: after testing negative at home 2 times for Covid; (unspecified date) negative, notes: after testing negative at home 2 times for Covid; (May2023) positive, notes: but the urgent care test came back positive Monday. Therapeutic measures were taken as a result of drug ineffective, covid-19, bronchitis. Clinical course: Paxlovid was prescribed for caller on Monday, after testing negative at home 2 times for Covid, then tested positive last Saturday at urgent care, clarified the test was sent away, not sure if there was a difference in the home tests and the other test, but the urgent care test came back positive Monday. Had drainage that led to coughing, could be part of Covid-19 since patient had never had before. Patient was also being treated for bronchitis and was given a chest x-ray at that time, had horrible cough, bronchitis was no surprise, didn't have pneumonia. Monday night doctor got word and told patient to try Paxlovid. Patient started Paxlovid first dose Monday night.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300203791 same patient, different drug, different event;
Age: 78.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 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: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of Drug ineffective, covid-19 which included Paxlovid from 13May2023 to 18May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300203866 Same patient, different product, different event;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; 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 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), outcome "unknown", described as "Drug ineffective "; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300203962 same patient/product, different dose/event;
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in right 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: "Chronic atherosclerosis" (unspecified if ongoing); "Multiple stents" (not ongoing); "Triple bypass", start date: 2014 (not ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 13May2023 to 18May2023. Clinical course: The patient did not receive other medication in 2weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300203955 same reporter/patient, different product/AE;
Sex: U
Vaccine: PNC13
Symptoms: Illness, Malaise
Clinical narrative: not getting high enough IG and requiring boosting as they get sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP)\.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for 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 "not getting high enough IG and requiring boosting as they get sick".  Additional information: Some kids [5 over the last few years] not getting high enough IG and requiring boosting as they get sick.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300092588 same drug and event with different patient.;
Sex: U
Vaccine: PNC13
Symptoms: Illness, Malaise
Clinical narrative: not getting high enough and requiring boosting as they get sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for 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 "not getting high enough and requiring boosting as they get sick".  Additional information: Some kids [5 over the last few years] not getting high enough and requiring boosting as they get sick.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300092588 same drug and event with different patient.;
Sex: U
Vaccine: PNC13
Symptoms: Illness, Malaise
Clinical narrative: not getting high enough IG and requiring boosting as they get sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for 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 "not getting high enough IG and requiring boosting as they get sick".  Additional information: Some kids [5 over the last few years] not getting high enough IG and requiring boosting as they get sick.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300202763 same drug and event with different patient.;US-PFIZER INC-202300204702 same drug and event with different patient.;US-PFIZER INC-202300204700 same drug and event with different patient.;US-PFIZER INC-202300204701 same drug and event with different patient.;
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy in each arm and both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy in each arm and both hands". Clinical course: After receiving a Pfizer vaccine in each arm patient now had neuropathy in each arm and both hands and don't have diabetes or any other issues. Patient thought the need to be compensated for this horrible heath issue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300201418 same patient, same vaccine, different doses, same events;
Sex: F
Vaccine: COVID19
Symptoms: Delusion, Encephalitis, Rapid eye movement sleep behaviour disorder
Clinical narrative: Lower lyphatic encephalitis; delusional rem disorder; delusional rem disorder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD-2023-717862 (MODERNA).  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: ENCEPHALITIS (medically significant), outcome "unknown", described as "Lower lyphatic encephalitis"; RAPID EYE MOVEMENT SLEEP BEHAVIOUR DISORDER (non-serious), DELUSION (non-serious), outcome "unknown" and all described as "delusional rem disorder".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: there was an excursion where the temperature rise to 49.6f for 12 minutes and administered to patient post excursion with no reported adverse event; there was an excursion where the temperature rise to 49.6f for 12 minutes and administered to patient post excursion with no reported adverse event; Initial information received on 23-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient (26 cm and 7.75 kg) and there was an excursion for the vaccine IPV (VERO) [IPOL] and the temperature rise to 49.6f for 12 minutes and administered to patient post excursion with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   Concomitant medications included Hib Vaccine Conj (Tet Tox) (Acthib) and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) both for Immunisation.  On 09-May-2023, the there was an excursion where the temperature of IPOL rise to 49.6 f for 12 minutes and administered to patient post excursion (product storage error) followed by the administration of suspect IPV (VERO) suspension for injection of dose 0.5 ml (lot: V1A022M, Expiry date: 17-Feb-2024) with unknown strength via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation) with no reported adverse event (poor quality product administered) (latency: same day).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   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 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.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: YF-Vax was administered with a different diluent with no reported adverse event; Initial information was received on 25-May-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and gender patient who was administered with a different diluent with no reported adverse event after receiving yellow fever vaccine [Yf-Vax].  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 yellow fever vaccine Solution for injection (lot: UJ81AAA, expiry date: 18-Apr-2024, strength: unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient was administered with a different diluent with no reported adverse event (product preparation error) (unknown latency) following the administration of yellow fever vaccine.  Caller asked if the 0.7 ml Sterile water that they used as diluent was compatible to YF-VAX.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 23.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose given to patient with no reported adverse event; Initial information received on 25-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 23 years old female patient and IPV (VERO) [IPOL] expired dose given to 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 Hepatitis A Vaccine for Prophylactic vaccination.  On 25-May-2023, the patient received a dose 1 dose 0.5 ml of suspect IPV (VERO) Suspension for injection lot T1E871M expiry date: 10-oct-2022 via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  On 25-MAY-2023 the patient developed a non-serious expired dose given to patient with no reported adverse event (expired product administered) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose given to patient 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 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.
Sex: U
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: quadracel vaccine was accidentally mixed with a sterile diluent and administered to a patient with no reported adverse event; Initial information received on 26-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics and diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was accidentally mixed with a sterile diluent and 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.   On an unknown date, the patient received a dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination(immunization).Information on the batch number was requested.  On an unknown date the patient developed a non-serious quadracel vaccine was accidentally mixed with a sterile diluent and administered to a patient with no reported adverse event (product preparation error) (unknown latency) following the administration of vaccine.  It was reported "She wants to find out if the vaccine would need to be readministered".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event quadracel vaccine was accidentally mixed with a sterile diluent and administered to a patient 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 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I have been experiencing chronic head-to-toe hives for the past year.  Hives started two weeks after my second Moderna booster.
Sex: F
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: Patient with an unspecified autoimmune disease was vaccinated with PNEUMOVAX 23/ Patient had recent blood work done that did not show an immune response/resistance to pneumococcal disease; This spontaneous report has been received from a company representative and refers to a 45-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies were not reported. The patient's concurrent conditions included and autoimmune disorder. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and anatomical site of administration were not provided).  On an unknown date, the patient had recent blood work done that did not show an immune response/resistance to pneumococcal disease (vaccination failure). The patient received treatment for the adverse event.  The outcome of the event was not provided.  The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Pain in biceps area/Pain in fingers; Can't rising right arm in the morning; Pain in right elbow/Pain in right shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 28-APR-2023, the patient received the 2nd dose of Shingrix. In MAY-2023, 1 week after receiving Shingrix, the patient experienced pain in extremity (Verbatim: Pain in biceps area/Pain in fingers), mobility decreased (Verbatim: Can't rising right arm in the morning) and arthralgia (Verbatim: Pain in right elbow/Pain in right shoulder). The outcome of the pain in extremity, mobility decreased and arthralgia were not resolved.   It was unknown if the reporter considered the pain in extremity, mobility decreased and arthralgia to be related to Shingrix.     It was unknown if the company considered the pain in extremity, mobility decreased and arthralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023 The reporter was the patient who stated that a week after second dose the patient started with pain in right shoulder and right elbow, also pain in fingers.  The reporter also complained of inability to rising right arm in the morning and also pain in biceps area.  All the symptoms were persist until the date of reporting. The reporter did not consent to follow-up.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event; administered earlier than minimal interval of 4 weeks after 1st dose; This spontaneous report was received from a nurse, referring to a 28-year-old female patient. The patient's pertinent medical history, concurrent condition and concomitant medication were not provided.  On 29-MAR-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; strength and route were not provided) for prophylaxis. On 04-APR-2023, the patient vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; strength and route were unknown), which was administered earlier than minimal interval of 4 weeks after the first dose. (Inappropriate schedule of product administration). The Lot# was reported as 0121342 with expiration date 14-DEC-2024, but unsure it was for the first dose or second dose or both. No additional adverse events or product quality complaints (PQC).
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: GARDASIL-9 was administered to a 46 year old female patient; No additional AE/PQC; This spontaneous report has been received from an unspecified reporter and refers to a 46-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the 46-year-old patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (Product administered to patient of inappropriate age), administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; Caller reports that improperly stored vaccines were administered.; This spontaneous report has been received from an administrator and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 30-MAR-2023, the patient was vaccinated with the first dose of an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product storage error) injection (lot number U031056 has been determined to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Expiration date has been established as 16-JUN-2024), administered for prophylaxis (strength, and route of administration were not provided). No other adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/PQC reported; administered the second dose too early/ First dose was adminitered on 17-JAN-2023 and the second dose was given 2 months early on 22-MAY-2023.; This spontaneous report has been received from a consumer and refers to a patient of unknown age and gender.  The patient's pertinent medical, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2023, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, and had the second dose of hepatitis a vaccine, inactivated (VAQTA) administered  two months early, on 22-MAY-2023 (inappropriate schedule of product administration); both doses administered for prophylaxis (strength, lot #, expiry date, and anatomical route of administration were not provided). No other adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm) and headache (Verbatim: headache). The outcome of the pain in arm and headache were unknown.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.     It was unknown if the company considered the pain in arm and headache to be related to Shingrix.   Linked case(s) involving the same patient:  US2023072482   Additional Information: GSK Receipt Date: 22-MAY-2023 The consumer was the reporter. The consumer reported that after first dose of Shingrix she had sore arm and headache. The reporter consented to follow up. For tolerance to the 2nd dose refer case US2023072482.; Sender's Comments:  US-GSK-US2023072482:Same reporter, Other dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus
Clinical narrative: Rash since she got the vaccine in 2021 the rash name is Lichen planus rash; This spontaneous case was reported by a patient and describes the occurrence of LICHEN PLANUS (Rash since she got the vaccine in 2021 the rash name is Lichen planus rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LICHEN PLANUS (Rash since she got the vaccine in 2021 the rash name is Lichen planus rash). At the time of the report, LICHEN PLANUS (Rash since she got the vaccine in 2021 the rash name is Lichen planus rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was reported that the rash comes and goes. Patient was seeing skin doctor and was on medication.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: patient reported having severe pain at the site of injection. Her arm was swollen, hot to touch, have severe pain. She said the arm was really swollen that her sweater would not fit. she came in on 05/26/23 to show us and it was still red, still swollen, and still very warm to the touch. She did say the swelling went down a little from before but it was still swollen. We advised her to reach out to her doctor right away to alert them of the reaction as well.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Systemic: hives, mainly to legs & inner elbows-Medium
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough event  all Moderna dose 1   3/1/21 010A21A dose 2   3/29/21 018B21A dose 3   11/9/21 049C21A dose 4   4/18/22 065K21A
Age: 66.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Patient returned from the restroom and reported feelings of dizziness and nausea. During 15 minutes of observation, patient was in a seated position and was provided water. Syncope reaction was observed.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypovolaemic shock
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOVOLEMIC SHOCK
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE PERICARDITIS, UNSPECIFIED MYOCARDITIS 12/22/2021 -- RECURRENCE OF SAME SYMPTOMS
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute coronary syndrome, Acute myocardial infarction, Hypoxia, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED HYPOXIA 6/7/2022 -- RECURRENCE OF SAME SYMPTOMS
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXEMIA
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI 5/21/2022 -- RECURRENCE OF SAME SYMPTOMS
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOXIA
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS GIVEN 2 DAYS PAST BY USE DATE. BY USE DATE WAS 5/23/2023, GIVEN 5/25/2023
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Hypotension
Clinical narrative: ACUTE NON ST ELEVATION MI HYPOTENSION
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Hypoxic respiratory failure, COVID + 5/14/2023
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Neuropathy peripheral, Symptom recurrence
Clinical narrative: PERIPHERAL NEUROPATHY ACUTE HYPERCAPNIC RESPIRATORY FAILURE 2/2/2023  --  RECURRENCE OF SAME SYMPTOMS
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angina unstable, Neuropathy peripheral, Symptom recurrence
Clinical narrative: NEUROPATHY UNSTABLE ANGINA ACUTE NON ST ELEVATION MI 10/3/2022 - RECURRENCE OF SAME SYMPTOMS
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Pt inadvertently received an inadequate dose of COVID vaccine, no signs or symptoms of adverse reaction noted.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Partial seizures
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE FOCAL MOTOR SEIZURE
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ALLERGIC REACTION, INIT
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever of 102F 12 days post vaccination. Unsure duration, because it is only 12 hours since the fever started but it is still present. Ranges from 100.8-102
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Death
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE EPILEPSY, INTRACTABLE
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Had syncopal episode and lost control of bladder approx 5 minutes after vaccines were administered.  Pt was lowered to the ground.  Lay on the ground for a few minutes.  Nurse reoriented pt and brought to exam room.   Lay in quiet exam room and drank juice until pt was feeling better.  Nurse and Doctor both checked on patient multiple times and pt and mother left office approx 15 minutes after syncopal episode.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Feeling cold, Paranasal sinus discomfort, Paranasal sinus hypersecretion
Clinical narrative: I woke up shivering and was cold. My sinus passages were stinging and when wakinfg up in the morning I felt like I had a temperature and it was two degrees higher than normal at nintey nine point eight. I took Tylenol which reduced the fever and remained low . My sinus es began to drain down my throat and the next morning I stillhad a fever and so I tested myself for COVID -19.  My fever was gone by 12MAY2023 and by 20MAY2023 I was tetsing negative for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I woke up shivering and was cold. My sinus passages were stinging and when wakinfg up in the morning I felt like I had a temperature and it was two degrees higher than normal at nintey nine point eight. I took Tylenol which reduced the fever and remained low . My sinus es began to drain down my throat and the next morning I stillhad a fever and so I tested myself for COVID -19.  My fever was gone by 12MAY2023 and by 20MAY2023 I was tetsing negative for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC DISORDER, INIT
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebral small vessel ischaemic disease, Chest X-ray normal, Computerised tomogram abdomen abnormal, Computerised tomogram head abnormal
Clinical narrative: BREAKTHROUGTH COVID: PT FULLY VACCINATED WITH J&J VACCINE: This is a 62 year old female Admitted for Fever, COVID19, Hepatomegaly with Splenomegaly, UTI, Left Flank Pain, Kidney Stones, Pyelonephritis, Thrombocytopenia, Positive Troponin, Sleep Apena, Diabetes Mellitus, Diabetic Neuropathy, and Leukopenia.  I Consulted Dr for COVID19 and Dr for Recurrent UTI and Kidney Stones.  Patient does complain of left flank pain prior to coming in.  Does complain of some coughing spells.  Patient was found to be COVID positive in the emergency room.  Apparently son was found to be positive2 days ago.  Denies any shortness of breath.  No nausea vomiting.  No abdominal pain.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Diabetes mellitus, Diabetic neuropathy, Flank pain
Clinical narrative: BREAKTHROUGTH COVID: PT FULLY VACCINATED WITH J&J VACCINE: This is a 62 year old female Admitted for Fever, COVID19, Hepatomegaly with Splenomegaly, UTI, Left Flank Pain, Kidney Stones, Pyelonephritis, Thrombocytopenia, Positive Troponin, Sleep Apena, Diabetes Mellitus, Diabetic Neuropathy, and Leukopenia.  I Consulted Dr for COVID19 and Dr for Recurrent UTI and Kidney Stones.  Patient does complain of left flank pain prior to coming in.  Does complain of some coughing spells.  Patient was found to be COVID positive in the emergency room.  Apparently son was found to be positive2 days ago.  Denies any shortness of breath.  No nausea vomiting.  No abdominal pain.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatomegaly, Hydronephrosis, Leukopenia, Nephrolithiasis, Pyelonephritis
Clinical narrative: BREAKTHROUGTH COVID: PT FULLY VACCINATED WITH J&J VACCINE: This is a 62 year old female Admitted for Fever, COVID19, Hepatomegaly with Splenomegaly, UTI, Left Flank Pain, Kidney Stones, Pyelonephritis, Thrombocytopenia, Positive Troponin, Sleep Apena, Diabetes Mellitus, Diabetic Neuropathy, and Leukopenia.  I Consulted Dr for COVID19 and Dr for Recurrent UTI and Kidney Stones.  Patient does complain of left flank pain prior to coming in.  Does complain of some coughing spells.  Patient was found to be COVID positive in the emergency room.  Apparently son was found to be positive2 days ago.  Denies any shortness of breath.  No nausea vomiting.  No abdominal pain.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Sleep apnoea syndrome, Splenomegaly, Thrombocytopenia
Clinical narrative: BREAKTHROUGTH COVID: PT FULLY VACCINATED WITH J&J VACCINE: This is a 62 year old female Admitted for Fever, COVID19, Hepatomegaly with Splenomegaly, UTI, Left Flank Pain, Kidney Stones, Pyelonephritis, Thrombocytopenia, Positive Troponin, Sleep Apena, Diabetes Mellitus, Diabetic Neuropathy, and Leukopenia.  I Consulted Dr for COVID19 and Dr for Recurrent UTI and Kidney Stones.  Patient does complain of left flank pain prior to coming in.  Does complain of some coughing spells.  Patient was found to be COVID positive in the emergency room.  Apparently son was found to be positive2 days ago.  Denies any shortness of breath.  No nausea vomiting.  No abdominal pain.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased, Urinary tract infection, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGTH COVID: PT FULLY VACCINATED WITH J&J VACCINE: This is a 62 year old female Admitted for Fever, COVID19, Hepatomegaly with Splenomegaly, UTI, Left Flank Pain, Kidney Stones, Pyelonephritis, Thrombocytopenia, Positive Troponin, Sleep Apena, Diabetes Mellitus, Diabetic Neuropathy, and Leukopenia.  I Consulted Dr for COVID19 and Dr for Recurrent UTI and Kidney Stones.  Patient does complain of left flank pain prior to coming in.  Does complain of some coughing spells.  Patient was found to be COVID positive in the emergency room.  Apparently son was found to be positive2 days ago.  Denies any shortness of breath.  No nausea vomiting.  No abdominal pain.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Symptom recurrence, Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA 12/5/2021 -- RECURRENCE OF SAME SYMPTOMS