chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cyst ruptured, SARS-CoV-2 test
Clinical narrative: Ovarian cyst ruptured; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: ER8730) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Beta-thalassemia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "COVID-19", start date: 11Dec2020 (unspecified if ongoing), notes: Patient had COVID-19 prior to vaccination. Concomitant medication(s) included: CLONAZEPAM; ESCITALOPRAM; MUSHROOM COMPLEX [ALLIUM SATIVUM;GANODERMA LUCIDUM;HERICIUM ERINACEUS;INONOTUS OBLIQUUS;LENTINUS EDODES]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: ER2613, Anatomical location: Left arm), administration date: 17Mar2021, when the patient was 45-year-old, for COVID-19 immunization. The following information was reported: OVARIAN CYST RUPTURED (medically significant) with onset Aug2021, 5 months after the suspect product(s) administration, outcome "not recovered". The event "ovarian cyst ruptured" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Dec2020) Positive, notes: Other. Therapeutic measures were taken as a result of ovarian cyst ruptured.  Clinical Course: Clinical Course: It was reported that the event occurred approximately 5 months after first Pfizer vaccination series and the patient did not have any cysts prior. The patient did not have nay known allergies and did not receive any vaccines four weeks prior to Covid vaccination. It was also reported that Tramadol was taken as treatment for the event Ovarian Cyst Ruptured.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event OVARIAN CYST RUPTURED and the suspect drug  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.  ,Linked Report(s) : US-PFIZER INC-202300185261 Same reporter, patient, product, different doses and events;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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.  A 93-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid ( tart date: 21Apr2023, stop date: 26Apr2023). Clinical course: Had positive COVID test 2 weeks after completing Paxlovid Course. Ptient was somewhat symptomatic.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Hand, finger and wrist pain. Initially a little bit of pain and now it has increased to very little strength in both hands.; Hand, finger and wrist pain. Initially a little bit of pain and now it has increased to very little strength in both hands.; Hand, finger and wrist pain. Initially a little bit of pain and now it has increased to very little strength in both hands.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (PFIZER COVID-19 VACCINE), as dose 1, 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: PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "Hand, finger and wrist pain. Initially a little bit of pain and now it has increased to very little strength in both hands.". The events "hand, finger and wrist pain. initially a little bit of pain and now it has increased to very little strength in both hands." required physician office visit.  Additional information: No Covid prior vaccination. Unknown if Covid tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Born with one kidney but fully functional" (unspecified if ongoing). There were no concomitant medications. 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.  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-202300186341 Same patient, different drug, different event;
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Obesity" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "cad" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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. Clinical course: Patient was treated from 29Apr2023 to 04May2023 with Paxlovid (Batch/lot number: GK2847). Patient had 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.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: my lymph node under my right arm is still swollen; my arm is still hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "my lymph node under my right arm is still swollen"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "my arm is still hurting".  Additional information: After 3 months, the patient's lymph node under her right arm was still swollen, and her arm was still hurting.  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.
Sex: F
Vaccine: PNC13
Symptoms: Blood cholesterol increased, Incorrect route of product administration, Pain in extremity
Clinical narrative: Inappropriate route of vaccination; she had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Jan2023 as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "elevated cholesterol reported" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset Jan2023, outcome "unknown", described as "Inappropriate route of vaccination"; PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "recovered", described as "she had a sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter considered the event as caused by suspect product. A patient reported in market research that she had a sore arm for about one day after her pneumococcal pneumonia vaccine in Jan2023.   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.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Illness
Clinical narrative: got ill; she started to feel her heart properly, and she got burning all over; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing), notes: she used to have migraines years ago. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got ill"; BURNING SENSATION (non-serious), outcome "unknown", described as "she started to feel her heart properly, and she got burning all over".  Additional information: Reporter who was calling on behalf of his wife, mentioned that his wife got ill when she took the Pfizer COVID vaccines 2 years ago. Reporter reported that a week after his wife took the Pfizer COVID-19 vaccine, she got ill, and he would like to speak to someone regarding legal matters regarding what happened. He also said that his wife has been sick for more than two years, and his wife writes everything down because she used to have migraines years ago, and all of a sudden, a week after she took that COVID shot, she started to feel her heart properly, and she got burning all over. Also stated his wife has been sick for two years after taking the Pfizer covid-19 vaccine.  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-202201020700 same reporter/patient, different dose/event;
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: no taste; no smell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262) at the age of 75 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious) with onset 2021, outcome "unknown", described as "no smell"; AGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "no taste".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300037577 same patient/vaccine, diff dose/event;
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, White blood cell count, White blood cell disorder
Clinical narrative: no taste; no smell; WBC was 3.66; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old patient received BNT162b2 (BNT162B2), on 20Jul2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE, start date: 04Jun2022. Vaccination history included: BNT162b2 (Dose 1, Pfizer Lot# EL9262), administration date: 22Jan2021, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "no taste", "no smell"; BNT162b2 (Dose 2, Pfizer Lot# EN6201), administration date: 12Feb2021, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "no taste", "no smell", "WBC was 3.4 and has been dropping since"; BNT162b2 (Dose 3 booster, Lot 30125BA), administration date: 11Oct2021, when the patient was 76-year-old, for Covid-19 immunization, reaction(s): "WBC was 2.0", "no taste", "no smell". The following information was reported: WHITE BLOOD CELL DISORDER (non-serious) with onset 04Aug2022, outcome "unknown", described as "WBC was 3.66"; AGEUSIA (non-serious), outcome "unknown", described as "no taste"; ANOSMIA (non-serious), outcome "unknown", described as "no smell". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300037577 same patient/vaccine, diff dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Encephalomyelitis
Clinical narrative: Acute encephalomyelitis; This is a literature report for the following literature source(s):  A 52-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: ENCEPHALOMYELITIS (medically significant), outcome "unknown", described as "Acute encephalomyelitis".; Sender's Comments: The Company cannot completely exclude the possibel causality between the reported Acute encephalomyelitis and the administration of the suspect, BNT162b2, considering the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: received Act-Hib after the expiration date printed on the carton 07Apr2023 but the powder vial that they scanned had an expiration date of 28May2023 with no reported adverse event; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1 years old male patient who received HIB (prp/t) vaccine [act-HIB] after the expiration date printed on the carton 07apr2023 but the powder vial that they scanned had an expiration date of 28may2023 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 (Daptacel) for Prophylactic vaccination.  On 10-Apr-2023, the patient received 0.5 ml total dose 4 of suspect HIB (prp/t) vaccine Powder and solvent for solution for injection (batch number- UJ679AAA/UJ667ABA and expiration dates- 07-Apr-2023/28-May-2023/15-May-2023) via intramuscular route in the left thigh (strength: not provided) for Immunization.  On 10-Apr-2023 the patient received act-hib after the expiration date printed on the carton 07apr2023 but the powder vial that they scanned had an expiration date of 28may2023 with no reported adverse event (expired product administered) (latency- same day) following the administration of hib (prp/t) vaccine.  It was reported that they have 2 boxes of ACT-HIB where the lot numbers on the carton and powder vials match, but the expiration dates on the carton and powder vials do not match. The office manager also reports that due to this, 1 patient received ACT-HIB after the expiration date on the box; asks what they should do.  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: 0.5
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered expired doses, with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient for whom inadvertently expired dose of IPV (Vero) [IPOL] was administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Mar-2023, the patient received a dose of suspect IPV (VERO) at dose 0.5 ml (1x) suspension for injection of standard strength (lot: U1A601M, expiry date: 27-Feb-2023) via intramuscular route in the right thigh for prophylactic vaccination (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired DAPTACEL was administered to a patient, with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1 years old female patient and it was reported expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administered to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 06-MAY-2023, expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] Suspension for injection (batch/lot number: C5828AA; expiry date: 30-MAR-2023) was administered to a patient via intramuscular route in the left thigh for immunization, with no reported adverse event (expired product administered) (latency: same day)  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: 2.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: they had administered an expired vaccine to a patient, with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 27 months old male patient administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] vaccine, 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/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection  (strength, dose: unknown) (lot: UJ662AA, Expiry date: 04-May-2023) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, with no reported adverse event (expired product administered) (latency: same day).  It was reported, "Medical assistant called to report that they had administered an expired vaccine to a patient."  Action taken with Diphtheria, Tetanus, Ac Pertussis, Ipv And Hib Vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  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: 2.0
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Dad brought pt into clinic and this nurse was summoned to lobby. Pt was asleep on dads chest. Pt breathing normally with 02 sat=98% RA, afebrile and HR=89. Pt aroused with physical touch. Pt has pink firm round area 3"X2.5" to R thigh where vaccine was administered. Area is warm to the touch and didn't seem to be painful when palpated. Dad states he has given pt Tylenol for comfort but pt does not complain of pain to area. Dad is not familiar with vaccines so he felt the need to have a nurse visualize area. This RN recommended cold pack to area, Pediatric Benadryl 12.5mg per bottle instructions and Tylenol for pain. Alert placed in chart for future immunization administration. Dad and pt left clinic without s/sx's distress.
Age: 2.0
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Dad brought pt into clinic and this nurse was summoned to lobby. Pt was asleep on dads chest. Pt breathing normally with 02 sat=98% RA, afebrile and HR=89. Pt aroused with physical touch. Pt has pink firm round area 3"X2.5" to R thigh where vaccine was administered. Area is warm to the touch and didn't seem to be painful when palpated. Dad states he has given pt Tylenol for comfort but pt does not complain of pain to area. Dad is not familiar with vaccines so he felt the need to have a nurse visualize area. This RN recommended cold pack to area, Pediatric Benadryl 12.5mg per bottle instructions and Tylenol for pain. Alert placed in chart for future immunization administration. Dad and pt left clinic without s/sx's distress.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Body temperature increased, Chills, Decreased appetite, Headache
Clinical narrative: general aching and chilling with 100.4 temperature,lack of appetite, headache, no energy.  Minimal after 24 hours and only headache after 40 hours.  Dull headache for 3 or 4 days.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: general aching and chilling with 100.4 temperature,lack of appetite, headache, no energy.  Minimal after 24 hours and only headache after 40 hours.  Dull headache for 3 or 4 days.
Age: 1.17
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13, DTPPVHBHPB, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Subcutaneous haematoma
Clinical narrative: Initial redness and swelling at injection site, transitioned into 1.3cm subq hematoma
Age: 1.17
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13, DTPPVHBHPB, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: Initial redness and swelling at injection site, transitioned into 1.3cm subq hematoma
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received the Pfizer Covid vaccine for his first dose on 09/22/2022. He received the Moderna Bivalent Covid vaccine as his second dose on 05/05/23. He SHOULD HAVE received the Pfizer vaccine instead of the Moderna. No adverse reactions occured as a result.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Brain fog, Burning sensation, Chills, Disturbance in attention, Dizziness
Clinical narrative: day 1 after vaccine felt foggy, unable to focus. Day 2 after injection had nausea/vomiting, swelling and redness at injection site, pulsating  and burning sensation, chills but no fever.  Developed tingling in lips. No SOB or wheezes.  Took Benadryl which helped.  Day 3 vomiting resolved, but still with nausea and lightheaded.  Exam here  5/11: Arm less red, 7x5cm raised injection site reaction, brownish color, no fluctuance.  Plan to continue benadryl, add ibuprofen for inflammatory reaction.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Inflammation, Injection site discolouration, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: day 1 after vaccine felt foggy, unable to focus. Day 2 after injection had nausea/vomiting, swelling and redness at injection site, pulsating  and burning sensation, chills but no fever.  Developed tingling in lips. No SOB or wheezes.  Took Benadryl which helped.  Day 3 vomiting resolved, but still with nausea and lightheaded.  Exam here  5/11: Arm less red, 7x5cm raised injection site reaction, brownish color, no fluctuance.  Plan to continue benadryl, add ibuprofen for inflammatory reaction.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Nausea, Paraesthesia oral, Sensory disturbance, Vomiting
Clinical narrative: day 1 after vaccine felt foggy, unable to focus. Day 2 after injection had nausea/vomiting, swelling and redness at injection site, pulsating  and burning sensation, chills but no fever.  Developed tingling in lips. No SOB or wheezes.  Took Benadryl which helped.  Day 3 vomiting resolved, but still with nausea and lightheaded.  Exam here  5/11: Arm less red, 7x5cm raised injection site reaction, brownish color, no fluctuance.  Plan to continue benadryl, add ibuprofen for inflammatory reaction.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administration error, Wrong product administered
Clinical narrative: My two month old came in for her wellness visit. Both parents acknowledged wanting to receive Pentacel because patient had already received HepB at birth and 1 month. Nurse practitioner and tech both acknowledged and agreed. Mother received a phone call after the appointment saying the wrong vaccine had been given. This was a medial error from the practice after being told by the parents they didn't want this vaccine at the time. No severe reactions, but reporting the medical error per instructions from the CDC.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Death.  The patient went to bed the night he was given vaccine and died during the night.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Impaired work ability, SARS-CoV-2 test positive
Clinical narrative: On about 4/18/2022, I developed a dry cough. The dry cough continued through the end of the week. On 4/22/2022, I saw my doctor for a routine visit. I mentioned the dry cough to her, but she didn't seem concerned. The cough neither improved nor worsened that weekend or on Monday, 4/25/2022. I asked my doctors if I should get another dose of COVID-19 vaccine, and they told me I should, so I got one that afternoon. I went to work on 4/26/2022, and I was told that half our employees were out sick with COVID-19. I was thus instructed to test myself for COVID-19 at the worksite, and I got a positive result when I did. I was then instructed to go home and self-isolate. I never developed any symptoms besides dry cough and a bit of fatigue. I was eventually prescribed the medication another person was given, though I don't remember the name of it. The medication helped, and the cough diminished in severity. I was finally over the cough maybe around mid-May 2022. If I remember correctly, I don't think I was out of work for over a week.
Age: 0.75
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Administered undiluted dosage, no symptoms reported during observation.
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Death
Clinical narrative: Patient death. Unknown if related to vaccine.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Pt was given pediatric primary series Moderna (6mo-5 year) instead of Adult dose Moderna bivalent. No adverse reaction was noted by Pt after notification of med error.
Age: 35.0
Sex: M
Vaccine: YF
Symptoms: Erythema, Injection site pain, Injection site pruritus, Peripheral swelling, Pyrexia
Clinical narrative: Swelling and redness to back of left arm. Patient states he has had fever after receiving vaccine but took OTC Tylenol and symptoms resolved. Patient states swelling has increased to left arm and complains of soreness and itching to site.  Patient advised to be seen at Emergency Department. Patient states he has appointment with PCM and will have site examined.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: deltoid pain intermittent since administration
Age: 3.0
Sex: M
Vaccine: COVID19-2, DTAP, HEPA
Symptoms: Underdose
Clinical narrative: vaccine given on 05/01/2023 pt waited in clinic for 15 min after vaccine was administered  by, CMA -Vaccine given was not the correct covid dose. 05/11/2023 T/C with mom and explained that patient was administered a lower Moderna dose than the CDC recommends. Recommendation is to have this dose re-peated appt schedule on 05/18/2023 with nurse to have this done. Mom reports no concerns after vaccine was given.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient received second COVID-19 Bivalent dose before it was approved to be given.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Magnetic resonance imaging, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received vaccine of Menquadfi on 4/4/23 on the Lt deltoid. Patient reports; following that appointment her arm became sore and swollen. This was expected from the patient. Patient reports that the pain never went away. She also had fever for the first two days. She reports pain in his left shoulder radiating down her arm
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Patient received vaccine of Menquadfi on 4/4/23 on the Lt deltoid. Patient reports; following that appointment her arm became sore and swollen. This was expected from the patient. Patient reports that the pain never went away. She also had fever for the first two days. She reports pain in his left shoulder radiating down her arm
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Herpes ophthalmic, SARS-CoV-2 test positive
Clinical narrative: Ocular HSV and Covid infection following vaccinations
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer
Clinical narrative: Elevated D-dimer over 35
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: N/A, Client receive Pfizer dose 6m-4y instead of 5m-11y
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event, Product preparation issue, Wrong product administered
Clinical narrative: I was doing a double physical (sibling) when checking out the orders I accidentally prepared HPV ordered 08-05-22 that was already given. Overlooking date as usually given on physicals. he was given a 3rd dose  12 days after his 2nd dose. I verified prior to administration and it wasn't caught until after administration.  ***no adverse/side effects to report
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient received 3 doses of covid pfizer vaccination prior to admission.  Patient is under hospice services. 8-9-21 at 9:30pm, he expired in house
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufacturer dates on box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: Reporting administration error as per immunization system. WE contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufacturer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactaurer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Age: 0.33
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Incorrect vaccines ordered and administered to patient.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufatuarer dates on the box and vials. Therefore we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from patietn at the time of the vaccination and no adverse reaction reported since vaccine given.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: patient came to office for booster dose of Pfizer Covid-19 vaccine. Instead of getting .2ml of Pfizer Covid-19 5-11 dose she received .2ml of Pfizer Covid19 6m-4yr. Mother notified immed
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erectile dysfunction
Clinical narrative: onset of erectile dysfunction,
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Anticoagulant therapy, Cardiac telemetry normal, Cerebral atrophy, Cerebrovascular accident
Clinical narrative: Posterior circulation CVA, elevated D-Dimer, no afib, no carotid dz . Acute posterior cerebellar CVA initially eval and airlift transfer to Hospital admission on 7/15/22 to 7/18/22, and tx within 74 minutes with alteplase and CT and CTA showed basilar artery CVA and left splenium left corpus collosum and left posterior cerebral and left parieto-occipital CA s/p thrombectomy. He has right homonomous hemianopsia, but no residual weakness or expressive aphasia. His TEE and carotid and telemetry showed no source and he had LINQ placed, follows with cardiology and neurology. His d-dimer was elevated again at 5.35,  Previously following his covid vax his d-dimer was high and we used eliquis for 6 weeks and in 12/21 d-dimer had normalized to 0.33 so we had stopped his Eliquis.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Echocardiogram, Fibrin D dimer increased, Hemianopia homonymous, Implantable cardiac monitor insertion
Clinical narrative: Posterior circulation CVA, elevated D-Dimer, no afib, no carotid dz . Acute posterior cerebellar CVA initially eval and airlift transfer to Hospital admission on 7/15/22 to 7/18/22, and tx within 74 minutes with alteplase and CT and CTA showed basilar artery CVA and left splenium left corpus collosum and left posterior cerebral and left parieto-occipital CA s/p thrombectomy. He has right homonomous hemianopsia, but no residual weakness or expressive aphasia. His TEE and carotid and telemetry showed no source and he had LINQ placed, follows with cardiology and neurology. His d-dimer was elevated again at 5.35,  Previously following his covid vax his d-dimer was high and we used eliquis for 6 weeks and in 12/21 d-dimer had normalized to 0.33 so we had stopped his Eliquis.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test normal, Posterior cortical atrophy, Thrombectomy
Clinical narrative: Posterior circulation CVA, elevated D-Dimer, no afib, no carotid dz . Acute posterior cerebellar CVA initially eval and airlift transfer to Hospital admission on 7/15/22 to 7/18/22, and tx within 74 minutes with alteplase and CT and CTA showed basilar artery CVA and left splenium left corpus collosum and left posterior cerebral and left parieto-occipital CA s/p thrombectomy. He has right homonomous hemianopsia, but no residual weakness or expressive aphasia. His TEE and carotid and telemetry showed no source and he had LINQ placed, follows with cardiology and neurology. His d-dimer was elevated again at 5.35,  Previously following his covid vax his d-dimer was high and we used eliquis for 6 weeks and in 12/21 d-dimer had normalized to 0.33 so we had stopped his Eliquis.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: Reporting administration error as per state immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Age: 1.25
Sex: U
Vaccine: HEPA, HIBV, MMR, PNC15, VARCEL
Symptoms: Cough, Ear infection, Pyrexia, Rash, Rash erythematous
Clinical narrative: 16 month-old here with mother for follow-up on ear infection. Had completed antibiotics x 10 days and no issues at this time.  (+) MMR, varicella - given on 4/19/2023 4 days ago, had fever x 2 days and then on third day, had erythematous rash that started on the face and spread to the trunk and extremities. (+) cough and congestion.
Age: 1.25
Sex: U
Vaccine: HEPA, HIBV, MMR, PNC15, VARCEL
Symptoms: Respiratory tract congestion
Clinical narrative: 16 month-old here with mother for follow-up on ear infection. Had completed antibiotics x 10 days and no issues at this time.  (+) MMR, varicella - given on 4/19/2023 4 days ago, had fever x 2 days and then on third day, had erythematous rash that started on the face and spread to the trunk and extremities. (+) cough and congestion.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Feeding disorder, Impaired work ability, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states she began having right arm pain and swelling once she was home after receiving PCV-20 vaccine on 05/08/23. Patient complains of being unable to work and eat since vaccine administered.
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist calling to report 2 patients received a vaccine pass 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report 2 patients received a vaccine pass 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 08-May-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report 2 patients received a vaccine pass 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report 2 patients received a vaccine pass 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was unknown if patient had any diseases and had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant information was reported. Suspect product dosage text was reported as additional booster. It was reported that the vaccine was punctured around 12:15 pm yesterday (07-May-2023) and was administered to 2 patients at 9:58 am and 10:02 am the following day (08-May-2023). This case is reported for patient 1 out of 2 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723414 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723414:Patient 2