chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: NYQUIL, start date: 10Jul2023, stop date: 12Jul2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given from 12Jul2023 to 16Jul2023.   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: Back pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Pain in arm pit; swollen lymph nodes; pain in upper back left side; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GK0928), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN (E.C.); VITAMIN C [ASCORBIC ACID]; SLOW FE; B COMPLEX (B50). Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: FJ8762, Vaccine location=Left arm), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Jul2023 at 06:30, outcome "not recovered", described as "Pain in arm pit"; BACK PAIN (non-serious) with onset 24Jul2023 at 06:30, outcome "not recovered", described as "pain in upper back left side"; LYMPHADENOPATHY (non-serious) with onset 24Jul2023 at 06:30, outcome "not recovered", described as "swollen lymph nodes". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy, back pain.  Additional information: Patient doesn't have covid prior or after vaccination. Vaccination date of third and fourth dose of vaccine was reported as 24Jul2023 (discrepant information).
Sex: F
Vaccine: COVID19
Symptoms: Burning mouth syndrome
Clinical narrative: painful burning in her mouth and tongue, known as burning mouth syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 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: BURNING MOUTH SYNDROME (non-serious) with onset 06Feb2021, outcome "not recovered", described as "painful burning in her mouth and tongue, known as burning mouth syndrome". The events "painful burning in her mouth and tongue, known as burning mouth syndrome" required physician office visit. Therapeutic measures were taken as a result of burning mouth syndrome. Additional information: The patient is active, working, keeping up with grandkids, and very healthy. The next morning following vaccination, the patient awoke to painful burning in her mouth and tongue, known as burning mouth syndrome. The patient had seen 3 neurologists, 3 ENT, 2 dentists with no relief, also gabapentin 900mg/day does nothing, she is in pain 24/7. Lidocaine does not help; the only relief was chewing with Trident sugarless gum all day and sleep with a wad of gum in her mouth at night. She mentioned that she might have it the rest of her life, the patient is asking for help.   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: Death
Clinical narrative: killing millions already with their covid vaccine including my wife; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  An elderly (age reported as "60-99") female (also reported as male) patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "killing millions already with their covid vaccine including my wife". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: The reporter stated that Pfizer is not very trustworthy with more people killed by their COVID vaccine including the reporter's wife than any previous new vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: killing millions already with their covid vaccine including my wife
Sex: F
Vaccine: RSV
Symptoms: Illness
Clinical narrative: When I take vaccine most the time I was sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An adult female patient received PF-06928316 (ABRYSVO), 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 "When I take vaccine most the time I was sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 0.58
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired pentacel vaccine to a patient today with no reported adverse event; Initial information was received on 20-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional. Live follow up information was processed together.  This case involves a 7 months old female patient who received an expired diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] vaccine to a patient today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar) for Prophylactic vaccination (immunisation); and hepatitis b vaccine for Prophylactic vaccination (immunisation).  On 20-Jul-2023, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (strength: standard) at dose of  0.5 ml once (1x) (lot number: UJ671AAA, expiration date: 13-May-2023, administration site: Unknown) via intramuscular route for Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired pentacel vaccine to a patient today with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event, Product dose omission issue
Clinical narrative: missed their 2nd dose of IMOVAX RABIES for pre-exposure prophylaxis. They missed Day 07 and has come in at Day 10 with no reported adverse event; Initial information received on 20-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient who missed their 2nd dose of imovax rabies for pre-exposure prophylaxis. they missed day 07 and has come in at day 10 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 RABIES (HDC) VACCINE, Powder and solvent for suspension for injection via unknown route in unknown administration site for pre-exposure prophylaxis (strength, dose, batch number and expiry date: unknown) and missed their 2nd dose of imovax rabies for pre-exposure prophylaxis. they missed day 07 and has come in at day 10 with no reported adverse event (product dose omission issue) (unknown latency).   Information on the batch number was requested  Action taken: not applicable.  Outcome was Unknown for the event (product dose omission issue).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: accidentally administered PENTACEL to a patient without reconstituting it; reports that they only administered the liquid part of PENTACEL; the patient did not receive the powder HIB part with no reported adverse event; Initial information received on 20-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old female patient who was accidentally administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] to the patient without reconstituting it; reports that they only administered the liquid part of pentacel; the patient did not receive the powder hib part with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE for Prophylactic vaccination.  On 23-Jun-2023, the patient received a dose 3 with dosage 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ851AA, expiry date: 01-Apr-2024 with unknown strength) via intramuscular route in the left vastus lateralis for immunization.  On 23-Jun-2023 the patient developed a non-serious "accidentally administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine to a patient without reconstituting it; reports that they only administered the liquid part of pentacel; the patient did not receive the powder hib part with no reported adverse event (Single component of a two-component 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an expired daptacel with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA225761.  This case involves a 4 years old female patient who received an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR); polio vaccine inact 3V (vero) (IPOL); and varicella zoster vaccine (Varicella Vaccine) all for Prophylactic vaccination.  On 14-Jul-2023, the patient received an expired 0.5 mL dose 5 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: C5893AA; expiry date: 21-Jun-2023) via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion for IPV (VERO) [IPOL] as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event; administration of vaccine post excursion with no reported adverse event; Initial information received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 4 years old female patient and reporter reported temperature excursion for IPV (VERO) [IPOL] as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event and administration of vaccine post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  Caller reported that opened IPV (VERO) [IPOL] Suspension for injection (lot V1A021M, expiry date- 27-FEB-2024) at a dose of 0.5mL once via intramuscular route in unknown administration site for Immunization was exposed to temperature excursion as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event (product storage error) (unknown latency) and On 26-May-2023, the patient had administration of vaccine post excursion with no reported adverse event (poor quality product administered) (latency- same day). Human error was involved.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: ipol (opened) was exposed to a temperature excursion ,total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes with no reported adverse event; was administered to the patient post excursion with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from physician.  This case involves a 4 years old male patient who was administered vaccine IPV (VERO) [IPOL] (opened) that was exposed to a temperature excursion, (total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 30-May-2023, the patient received 0.5 mL dose of suspect IPV (VERO), Suspension for injection (batch number: V1A021M; expiry date: 27-Feb-2024) via intramuscular route in unknown administration site for Immunization that was exposed to a temperature excursion, (total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes) with no reported adverse event (poor quality product administered) (same day latency) (product storage error) (unknown latency) following the administration of IPV (vero).  Human error: Yes  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Ipol exposed to a temperature excursion was administered to the patient with no reported adverse event; Initial information was received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a poliomyelitis vaccine (inactivated) (IPV) (vero) [Ipol] which was exposed to a temperature excursion was administered to a 4 years old male patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination (immunisation).  On 05-Jun-2023, the patient received a dose of suspect poliomyelitis vaccine (inactivated) (IPV) (vero) Suspension for injection (strength: standard) at dose of 0.5 ml once (lot number: V1A021M, expiration date: 27-Feb-2023, administration site: unknown) via intramuscular route for Immunization (immunisation) which was exposed to a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  It was reported that "Products involved: IPOL opened Reason of the excursion: accidentally left the refrigerator door open too long. Did excursion occur due to a human error: Yes Conditions of the excursion: 3 separate excursions with the same vaccines. Total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes."  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event ipol exposed to a temperature excursion was administered to the patient with no reported adverse event
Age: 0.92
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: accidentally left refrigerator door open too long; due to human error,low of 1.85C for 30 min with no reported adverse event; opened ipol was administered to patient with no reported adverse event; Initial information was received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 11 months old male patient who reported that accidentally left refrigerator door open too long; due to human error,low of 1.85c for 30 min with no reported adverse event and opened ipol was administered to patient with no reported adverse event after receiving ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Jul-2023, the patient received a dose of 0.5 ml of suspect ipv (VERO) (Suspension for injection) (lot V1A021M, Expiry date: 27-Feb-2024) (strength was unknown) via intramuscular route in unknown administration site for and developed a non-serious event of accidentally left refrigerator door open too long; due to human error,low of 1.85c for 30 min with no reported adverse event (product storage error) and opened ipol was administered to patient with no reported adverse event (poor quality product administered) (latency : same day) following the administration of ipv (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event accidentally left refrigerator door open too long; due to human error,low of 1.85c for 30 min with no reported adverse event and was Unknown for the event opened ipol was administered 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site discharge, Underdose, Vaccination site extravasation
Clinical narrative: approximately 1/2 of the dose leaking at the site of administration at needle; a dose of MENQUADFI leaked at the injection site during administration; Initial information was received on 25-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 18 years old male patient who reported that a dose of menquadfi leaked at the injection site during administration and approximately 1/2 of the dose leaking at the site of administration at needle after receiving meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  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 0.5 ml of suspect meningococcal a-c-y-w135 (t conj) vaccine (Solution for injection) lot U7632BB (strength, expiry date unknown) via unknown route in unknown administration site for Immunization.  On 25-Jul-2023 the patient developed a non-serious event of a dose of menquadfi leaked at the injection site during administration (vaccination site extravasation) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine. On an unknown date the patient developed a non-serious event of approximately 1/2 of the dose leaking at the site of administration at needle (incorrect dose administered) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  It was not reported if the patient received a corrective treatment for the events (a dose of Menquadfi leaked at the injection site during administration).  At time of reporting, the outcome was Unknown for the event a dose of menquadfi leaked at the injection site during administration and was Unknown for the event approximately 1/2 of the dose leaking at the site of administration at needle.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.92
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: pt previously received one moderna monovalent vaccine 12/27/22 for first dose in series.  then received moderna bivalent vaccine on 4/18/23 (10mcg, pink cap).  should have received higher dose of moderna bivalent vaccine (25mcg, blue cap) instead.  no symptoms reported (mother did call office and report pt was fussy on 4/19/23).  error noted on 7/18/23 after chart review.   I called moderna for guidance, and was directed to call the CDC.  CDC recommended pt receive a dose of the moderna bivalent vaccine (25mcg, blue cap) since lower than recommended bivalent dose previously received.  no minimum time interval required. family notified on 7/21/23
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Disorientation, Dizziness, Vomiting
Clinical narrative: patient reported vomiting starting at 5pm on day of vaccine. at time of report to triage phone nurse on 7/27/23 at 12:50pm, patient had vomited 4 times. he felt dizzy, disoriented, and had an elevated blood pressure. the phone nurse advised his daughter to give him a benadryl and go to the er. phone nurse then called to report to us.
Age: 0.75
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: pt previously received one moderna monovalent vaccine 3/28/23 for first dose in series.  then received moderna bivalent vaccine on 4/25/23 (10mcg, pink cap).  should have received higher dose of moderna bivalent vaccine (25mcg, blue cap) instead.  no symptoms reported.  error noted on 7/18/23 after chart review.   I called moderna for guidance, and was directed to call the CDC.  CDC recommended pt receive a dose of the moderna bivalent vaccine (25mcg, blue cap) since lower than recommended bivalent dose previously received.  no minimum time interval required. family notified by PMD on 7/24/23
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 77.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient came in to get the 2nd dose of shingles vaccine. Upon registering the patient, we noticed that we gave the Varivax vaccine instead of shingles. No adverse reaction reported.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Reaction started with soreness and by day 2, there was significant redness and swelling. The redness continued to increase to cover much of my upper arm. I was scheduled to see my primary care doctor on day three anyway, so I used OTC antihistamines and steroid cream until then.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Contusion, Fall, Headache, Hypoglycaemia
Clinical narrative: Patient's initial symptoms started in March 2020 with unexplained headaches. Those symptoms worsened after COVID-19 vaccination in February 2021. Patient fell in her bathroom in March 2021 and presented the emergency room. She was treated for finger dislocation, hip contusion and notably hypoglycemia. Headaches worsened from March through June and eventually became daily headaches. She was seen by local neurologist in June 2021 and recommended for MRI. She completed MRI on 6/25/21 with multiple nonenhancing T2/FLAIR hyperintense lesions in juxtacortical, deep, periventricular white matter, as well as lesions along the septal callosal interface suspicious for multiple sclerosis. She was referred to our clinic and ultimately diagnosed with primary progressive MS in November 2021. Patient noted they had worsening in balance that started late 2020 to early 2021. While symptoms clearly started before COVID-19 vaccination, the worsening in MS symptoms appears to correlate at least temporarily with initial COVID-19 vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Joint dislocation, Magnetic resonance imaging head abnormal, Multiple sclerosis, Primary progressive multiple sclerosis, Scan with contrast abnormal
Clinical narrative: Patient's initial symptoms started in March 2020 with unexplained headaches. Those symptoms worsened after COVID-19 vaccination in February 2021. Patient fell in her bathroom in March 2021 and presented the emergency room. She was treated for finger dislocation, hip contusion and notably hypoglycemia. Headaches worsened from March through June and eventually became daily headaches. She was seen by local neurologist in June 2021 and recommended for MRI. She completed MRI on 6/25/21 with multiple nonenhancing T2/FLAIR hyperintense lesions in juxtacortical, deep, periventricular white matter, as well as lesions along the septal callosal interface suspicious for multiple sclerosis. She was referred to our clinic and ultimately diagnosed with primary progressive MS in November 2021. Patient noted they had worsening in balance that started late 2020 to early 2021. While symptoms clearly started before COVID-19 vaccination, the worsening in MS symptoms appears to correlate at least temporarily with initial COVID-19 vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: White matter lesion
Clinical narrative: Patient's initial symptoms started in March 2020 with unexplained headaches. Those symptoms worsened after COVID-19 vaccination in February 2021. Patient fell in her bathroom in March 2021 and presented the emergency room. She was treated for finger dislocation, hip contusion and notably hypoglycemia. Headaches worsened from March through June and eventually became daily headaches. She was seen by local neurologist in June 2021 and recommended for MRI. She completed MRI on 6/25/21 with multiple nonenhancing T2/FLAIR hyperintense lesions in juxtacortical, deep, periventricular white matter, as well as lesions along the septal callosal interface suspicious for multiple sclerosis. She was referred to our clinic and ultimately diagnosed with primary progressive MS in November 2021. Patient noted they had worsening in balance that started late 2020 to early 2021. While symptoms clearly started before COVID-19 vaccination, the worsening in MS symptoms appears to correlate at least temporarily with initial COVID-19 vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, B-lymphocyte count decreased, Blood test abnormal, Diarrhoea, Full blood count
Clinical narrative: At some time after my 3rd injection, I would say about 4 months afterwards, I got very weak and I did not want to get out of bed. My blood tests show a decrease in B Lymphocytes.  I am sick with colds and other viral illnesses frequently. In fact, I believe that if a virus is 10-miles away, It knows to contact RN first. Basically, I am often sick. I also began having trouble with my bowels.  I have uncontrolled diarrhea and am now incontinent of urine at times. Of course I do understand that there exists a genetic component to my health problems;  the decline in my general health and overall weakness began to accelerate after getting this vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gastrointestinal disorder, General physical health deterioration, Haemoglobin decreased, Illness, Laboratory test
Clinical narrative: At some time after my 3rd injection, I would say about 4 months afterwards, I got very weak and I did not want to get out of bed. My blood tests show a decrease in B Lymphocytes.  I am sick with colds and other viral illnesses frequently. In fact, I believe that if a virus is 10-miles away, It knows to contact RN first. Basically, I am often sick. I also began having trouble with my bowels.  I have uncontrolled diarrhea and am now incontinent of urine at times. Of course I do understand that there exists a genetic component to my health problems;  the decline in my general health and overall weakness began to accelerate after getting this vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Mineral supplementation, Nasopharyngitis, Thyroid function test, Urinary incontinence
Clinical narrative: At some time after my 3rd injection, I would say about 4 months afterwards, I got very weak and I did not want to get out of bed. My blood tests show a decrease in B Lymphocytes.  I am sick with colds and other viral illnesses frequently. In fact, I believe that if a virus is 10-miles away, It knows to contact RN first. Basically, I am often sick. I also began having trouble with my bowels.  I have uncontrolled diarrhea and am now incontinent of urine at times. Of course I do understand that there exists a genetic component to my health problems;  the decline in my general health and overall weakness began to accelerate after getting this vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Viral infection
Clinical narrative: At some time after my 3rd injection, I would say about 4 months afterwards, I got very weak and I did not want to get out of bed. My blood tests show a decrease in B Lymphocytes.  I am sick with colds and other viral illnesses frequently. In fact, I believe that if a virus is 10-miles away, It knows to contact RN first. Basically, I am often sick. I also began having trouble with my bowels.  I have uncontrolled diarrhea and am now incontinent of urine at times. Of course I do understand that there exists a genetic component to my health problems;  the decline in my general health and overall weakness began to accelerate after getting this vaccination.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event occurred; The caller said the patient inadvertently received PROQUAD on the same day as VARIVAX, on 7/12/2023; This spontaneous report was received from other health professional concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported.  On 12-JUL-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot number w031810 has been verified to be a valid lot number, expiration date reported and validated as 05-OCT-2024), and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (therapy type recombinant Human albumin [rHA]; lot number X011979 has been verified to be a valid lot number, expiration date reported and validated as 18-JUL-2024), both as prophylaxis (Accidental overdose) (Strengths, doses, route of administration, vaccination schemes and anatomical locations were not reported). Nevertheless, it was confirmed that no adverse event (AE) occurred.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2023-099919 . Information was received from a Consumer/other non-health professional concerning an 82 Year(s) old Male patient, who received Suspect product APIXABAN (Tablet) via Oral (5 milligram(s) 2 every 1 Day) for prophylaxis stroke, lot number: Unknown; Suspect product COVID-19 VACCINE for Product used for unknown indication, lot number: Unknown. The patient received apixaban with strength of 5 mg. On 06-Sep-2022, the patient had covid-19 (covid-19), which was considered non-serious. Treatment was not provided. The outcome of the covid-19 was unknown. The patient died on 01-Oct-2022. It is unknown if an autopsy was performed. The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Medical history and concurrent conditions included clot blood, fall, neck injury and atrial fibrillation. Past therapy included Warfarin. Concomitant medications were not reported. Relevant Laboratory and amp; other Diagnostic Tests On an unknown date, EKG: Diagnosed blood clots, MRI: Diagnosed blood clots. The reporter did not provide a causality assessment for event covid-19 to APIXABAN. The reporter did not provide a causality assessment for event covid-19 to COVID-19 VACCINE. The following Case IDs are linked to this patient: 2022-129212. Tracking of Changes: 10-Jul-2023: Initial information was received.   Eliquis is under agreement. Sender's Comments:Causality Assessment: COVID-19 was related to Apixaban and COVID-19 VACCINE..  Pfizer Comment: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Linked Report(s) : US-PFIZER INC-202201273191 Same reporter, Same patient, different events. Reported Cause(s) of Death: Clot blood.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of received on 2nd November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-Jul-2023 The health care professional (HCP) did not have the lot and expiry date. Till the date of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up via email.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, SARS-CoV-2 test, Tongue disorder
Clinical narrative: extreme burning mouth; tongue syndrome; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 15:00 as dose 1, single (batch/lot number: EN6202) at the age of 75 years, in left arm for covid-19 immunization. The vaccine was administered in a public health clinic/veterans administration facility. The patient's relevant medical history was not reported. Concomitant medications included: LOVASTATIN. The following information was reported: ORAL DISCOMFORT (disability), outcome "not recovered", described as "extreme burning mouth"; TONGUE DISORDER (disability), outcome "not recovered", described as "tongue syndrome". The patient informed that the events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. The patient underwent the following laboratory tests and procedures: I Health Covid-19 antigen rapid test: (12Apr2023) negative, notes: nasal swab. Therapeutic measures were taken as a result of oral discomfort, tongue disorder which included gabapentin 300 mg, 3 times a day.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported events oral discomfort, tongue disorder and BNT162B2 is considered possible. 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: Patient stated that she developed swelling and that her veins started to protrude and she felt a slight pain in her arms.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient recevied vaccine after BUD
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient recevied vaccine after BUD
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Raynaud's phenomenon
Clinical narrative: raynauds symptoms began the same month
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient recevied vaccine after BUD
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient recevied vaccine after BUD
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: Patients arm is very red. she says she has been experiencing pain in her body on the side that the vaccine was administered and she her arm is very sore
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD