chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling abnormal, Haematochezia
Clinical narrative: He got his vaccine, started becoming extremely tired around 4:00 PM.  Around 5-6 he was quite dizzy and within 1/2 hour he was vomiting.  He continued with the vomiting until he had nothing left.  His girlfriend arrived and he had to lie down and by 10:00 PM he was in bed and could not move.  When he was throwing up he was sweating profusely.  He felt like his whole body was trying to get out of him, had some sensation of diarrhea and this morning had blood in his stool, and decided to call us.  He has had a GI bleed in the past due to hemorrhoids.  He has not seen any blood in his stool since the two episodes, but is going to get a suppository to help his hemorrhoids.  He is now tired and took a nap.  When he got up today he feels a little out of sorts, is about 90% back, and has a sensation that he could become dizzy.  He is still not back to his normal self.   He called office and they told him to go to the UC.  He felt better/safer once the nausea stopped.  His girlfriend took care of him until he felt better this morning.   He did have COVID in November and has not recovered his sense of smell and has episodes of fatigue due to long-haul COVID.  His girlfriend said she sees different things since having COVID.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Vomiting
Clinical narrative: He got his vaccine, started becoming extremely tired around 4:00 PM.  Around 5-6 he was quite dizzy and within 1/2 hour he was vomiting.  He continued with the vomiting until he had nothing left.  His girlfriend arrived and he had to lie down and by 10:00 PM he was in bed and could not move.  When he was throwing up he was sweating profusely.  He felt like his whole body was trying to get out of him, had some sensation of diarrhea and this morning had blood in his stool, and decided to call us.  He has had a GI bleed in the past due to hemorrhoids.  He has not seen any blood in his stool since the two episodes, but is going to get a suppository to help his hemorrhoids.  He is now tired and took a nap.  When he got up today he feels a little out of sorts, is about 90% back, and has a sensation that he could become dizzy.  He is still not back to his normal self.   He called office and they told him to go to the UC.  He felt better/safer once the nausea stopped.  His girlfriend took care of him until he felt better this morning.   He did have COVID in November and has not recovered his sense of smell and has episodes of fatigue due to long-haul COVID.  His girlfriend said she sees different things since having COVID.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: red itchy patch on the right thigh
Age: 70.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Fatigue, Headache
Clinical narrative: Patient started having side affects the day after she got the vaccines.  These include dizziness, weakness, hypotension SBP 95, Nausea Vomiting, headache, fatigue, and lower grade fever 95.  These symptoms lasted about about and is still shaking 10 days after.  She felt weak and could not every stand for awhile after getting the vaccine.  Most side affects have gotten better but her hands still shake a little.
Age: 70.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Hypotension, Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: Patient started having side affects the day after she got the vaccines.  These include dizziness, weakness, hypotension SBP 95, Nausea Vomiting, headache, fatigue, and lower grade fever 95.  These symptoms lasted about about and is still shaking 10 days after.  She felt weak and could not every stand for awhile after getting the vaccine.  Most side affects have gotten better but her hands still shake a little.
Age: 70.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Fatigue, Gait disturbance
Clinical narrative: Patient started having side affects the day after she got the vaccines.  These include dizziness, weakness, hypotension SBP 95, Nausea Vomiting, headache, fatigue, and lower grade fever 95.  These symptoms lasted about about and is still shaking 10 days after.  She felt weak and could not every stand for awhile after getting the vaccine.  Most side affects have gotten better but her hands still shake a little.
Age: 70.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Hypotension, Nausea, Vomiting
Clinical narrative: Patient started having side affects the day after she got the vaccines.  These include dizziness, weakness, hypotension SBP 95, Nausea Vomiting, headache, fatigue, and lower grade fever 95.  These symptoms lasted about about and is still shaking 10 days after.  She felt weak and could not every stand for awhile after getting the vaccine.  Most side affects have gotten better but her hands still shake a little.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called for TE evaluation of VAQTA. Caller stated that product was admAinistered after a not supported excursion.; This spontaneous report was received from an other health professional, referring to a patient of unknown age and gender.  The patient's pertinent medical history was not reported, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 29-APR-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X025342 has been verified to be a valid lot number, expiration date was reported and validated as 12-MAY-2025, administered for prophylaxis (strength, dose and route of administration were not provided) after a not supported excursion (product storage error). There was no reported signs/symptoms of adverse effects. No additional adverse event (AE)/no product quality concern (PQC) (no adverse event).
Age: 1.17
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HCP calling to report expired 1st dose of MMR II vaccine was inadvertently given to 14-month-old child on 5/6/2024.; This spontaneous report was received from a medical assistant, referring to a 14-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 06-MAY-2024, the patient was inadvertently vaccinated with expired first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, lot #W001519, expiration date: 13-JAN-2024, 1 dose, administered for prophylaxis by health professional (strength, and route of administration were not provided) (expired product administered). Healthcare professional (HCP) confirmed there was no temperature excursion (T/E) had occurred. No side effects were reported (no adverse event).
Age: 1.67
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No other AE; inadvertent administration of PROQUAD and VARIVAX; Patient was supposed to receive the MMR II and VARIVAX Vaccines; This spontaneous report was received from medical assistant and refers to a 20-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-MAY-2024, the patient was inadvertently administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection (lot #X020565, expiration date: 03-FEB-2025, exact dose, route of administration and anatomical location were not provided) and first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #X018952, expiration date: 13-JUL-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Accidental overdose). The patient was supposed to be vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Wrong vaccine administered). No symptoms reported. No Additional details provided. No other AE and no PQC reported (No adverse event).
Age: 11.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report RECOMBIVAX HB that was administered to one patient on 5/17/2024 and expired on 2/26/2024; This spontaneous report was received from a medical assistant and refers to an 11-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-MAY-2024, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #W002452, expiration date reported as and upon internal review confirmed as: 26-FEB-2024 (exact dose, route of administration and vaccination site were not provided) administered for prophylaxis.  On 17-MAY-2024, expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was administered to one patient. No adverse side effects were reported. No additional information was available at the time of report. No additional adverse event (AE) and no product quality complaint (PQC) were noted (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reported signs/symptoms of adverse effects./ No additional AE/no PQC; HCP called regarding MMR II that was administered post expiry.; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 21-MAY-2024, the patient was vaccinated with an expired second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, as prophylaxis (lot number: W023071, which as determined to be valid, with an expiration date on 05-APR-2024. Therapy type: rHA) (strength, dose, route and anatomical location of administration were not reported) (Expired product administered).  Limited information provided.   No additional reported signs/symptoms of adverse effects.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shots and still got them /Suspected vaccination failure; I got the shots and still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shots and still got them /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shots and still got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-APR-2024 This case was reported by patient via interactive digital media. The patient received the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Herpes zoster, Mobility decreased, Nerve injury, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; Deep nerve damage; body can't function; Covid sucks even with the Shingles vaccination; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included the patient was married and dated for 5 years.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), nerve damage (Verbatim: Deep nerve damage), mobility decreased (Verbatim: body can't function) and covid-19 (Verbatim: Covid sucks even with the Shingles vaccination). The outcome of the vaccination failure was unknown and the outcome of the shingles, nerve damage, mobility decreased and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage, mobility decreased and covid-19 to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, nerve damage, mobility decreased and covid-19 to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2024 The case was received from the patient via interactive digital media. The patient reported about shingles during Covid that even after the double Shingix shot gave such deep nerve damage that the body cannot function and become one of the long haulers Covid statistics.  That happened after 3 years of deep nerve damage. The reporter reported that covid sucked even with the Shingles vaccination. It was sometimes just a crap shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got the first one more than a year ago/gave him the second one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient got the first one more than a year ago (like 1 to 2 years).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: got the first one more than a year ago/gave him the second one). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-MAY-2024 The patient came in for his second Shingrix vaccine, so the reporter gave him the second one. The patient told the reporter that his doctor told him to start again. The reporter did not thought that it was correct. The reporter asked if he/she was correct. No further details were available on form were reported. Medical Information submitted all available details per form. No further information available and due to submission via web form, specialist was unable to ask permission for safety follow up. The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Experience arm soreness at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Experience arm soreness at injection site) in a 20-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031707) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-May-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 14-May-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced VACCINATION SITE PAIN (Experience arm soreness at injection site). On 14-May-2024, VACCINATION SITE PAIN (Experience arm soreness at injection site) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The PFS was initially stored in the fridge or thawed on 17-Apr-2024. The PFS did not underwent any temperature excursions. Patient was given an expired vaccine and called Moderna, which looked at the lot analysis and concluded it was still useable. She only experienced arm soreness at injection site for 24 hours after injection. No lasting effects other than that was reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2024: Follow-up received and added Patient details, updated dose and units, of suspect, added new event of vaccination site pain, removed event of expired vaccine, no adverse effect and updated narrative.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test, Vaccination site rash
Clinical narrative: on 5/16 I became sick suddenly tested positive for Covid; large oval red rash on my arm near the site of the vaccine; My arm was very sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (My arm was very sore), COVID-19 (on 5/16 I became sick suddenly tested positive for Covid) and VACCINATION SITE RASH (large oval red rash on my arm near the site of the vaccine) in a 75-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-May-2024, the patient received tenth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 12-May-2024, the patient experienced PAIN IN EXTREMITY (My arm was very sore) and VACCINATION SITE RASH (large oval red rash on my arm near the site of the vaccine). On 16-May-2024, the patient experienced COVID-19 (on 5/16 I became sick suddenly tested positive for Covid). At the time of the report, PAIN IN EXTREMITY (My arm was very sore), COVID-19 (on 5/16 I became sick suddenly tested positive for Covid) and VACCINATION SITE RASH (large oval red rash on my arm near the site of the vaccine) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2024, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter causality was not reported.   Patient wears a mask everywhere. Patient never had COVID before, not aware of being exposed to anyone who has had it. It was unknown if the patient experienced any additional symptoms/events.   No treatment medication was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling fatigue; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feeling fatigue) in a 66-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 204H23-2A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (He had COVID twice, that he has recovered: "no long term effects) in January 2023 and COVID-19 (he has recovered: "no long term effects) in January 2024. Previously administered products included for Product used for unknown indication: Pfizer (Lot ER8732, dose 1) on 29-Mar-2021, Pfizer (Lot EW0170, dose 2) on 19-Apr-2021, Pfizer (Lot  FW0185, dose 3) on 07-Oct-2021, Pfizer (Lot FM9992, dose 4) on 12-May-2022, Pfizer (Lot GJ5342, dose 5) on 20-Sep-2022, Pfizer (Lot GL2042 and dose 6) on 01-May-2023. Past adverse reactions to the above products included No adverse effect with Pfizer, Pfizer, Pfizer, Pfizer, Pfizer and Pfizer.    On 30-Apr-2024, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 02-May-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced FATIGUE (feeling fatigue). At the time of the report, FATIGUE (feeling fatigue) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Reporter stated that all doses previously received were Pfizer; this was his first from Moderna. Reporter stated that shortly thereafter, a couple of days, he started feeling fatigue and added that "it hasn't gone away, and he had been really tired having to nap in the afternoon, which was unusual. He was also, going to be bed really early. At the time of the report, reporter noted that he was still experiencing these symptoms. The reporter noted that this was his first dose of Moderna, 7th overall dose of COVID vaccine. No treatment medication was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site discharge
Clinical narrative: some of the vaccines leaked out of patient's injection site; some of the vaccines leaked out of patient's injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE DISCHARGE (some of the vaccines leaked out of patient's injection site) and INCORRECT DOSE ADMINISTERED (some of the vaccines leaked out of patient's injection site) in a 61-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 208H23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-May-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 18-May-2024, the patient experienced INJECTION SITE DISCHARGE (some of the vaccines leaked out of patient's injection site) and INCORRECT DOSE ADMINISTERED (some of the vaccines leaked out of patient's injection site). At the time of the report, INJECTION SITE DISCHARGE (some of the vaccines leaked out of patient's injection site) and INCORRECT DOSE ADMINISTERED (some of the vaccines leaked out of patient's injection site) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No information provided by the HCP for relevant medical history/conditions, allergy, concomitant diseases and risk factor. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.
Sex: U
Vaccine: PNC20
Symptoms: Device physical property issue
Clinical narrative: Damaged Prevnar (Prevnar 20) vaccine vial; Screw top kind of just snapped away from the vaccine; Damaged Prevnar (Prevnar 20) vaccine vial; Screw top kind of just snapped away from the vaccine; The initial case was missing the following minimum  criteria: product complaint only. Upon receipt of follow-up information on 13May2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Nurse from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HH9323) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE PHYSICAL PROPERTY ISSUE (non-serious), DEVICE ISSUE (non-serious) and all described as "Damaged Prevnar (Prevnar 20) vaccine vial; Screw top kind of just snapped away from the vaccine".  Additional information: Packaging sealed and intact: Reporter stated, "Not that I know of this one was closer to the bottom of the box and then when we went to go take it out and place it on the basket that is when we notice that the screw top kind of just snapped away from the vaccine."  The reporter considered "damaged prevnar (prevnar 20) vaccine vial; screw top kind of just snapped away from the vaccine" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "damaged prevnar (prevnar 20) vaccine vial; screw top kind of just snapped away from the vaccine" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm and on 02Apr2024 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08May2024, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (08May2024) positive. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 08May2024 to 12May2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: just about pass out; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "just about pass out". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: TDAP
Symptoms: Injection site discharge, Underdose
Clinical narrative: patient didn't receive the full dose of adacel with no reported adverse event; Initial information received on 13-May-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age/gender patient who didn't receive the full dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] 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 didn't receive the full dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection (incorrect dose administered, latency same day) (dose, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  Reportedly: pharmacist reports that a nurse was administering ADACEL to a patient, and the patient didn't receive the full dose because they had leakage after the injection.   A Product Technical Complaint (PTC) was initiated on 13-May-2024 for Adacel (lot/batch number: unknown) with Global PTC number:  COMPLAINT-004529. Main investigation ID: CP-004562  The sample status of the PTC was in investigation.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 13-May-2024 from quality department via other healthcare professional: PTC details added. Text amended accordingly.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Skin laceration
Clinical narrative: expired tenivac vaccine was given to a patient with no reported adverse event; Initial information received on 17-May-2024 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 31 years old male patient who was administered expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult [Tenivac] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  'List concomitant or no other vaccines: No other vaccines and Treatment: No  On 17-May-2024, the patient received an expired 0.5 ml dose (dose 1) (frequency: once; strength: standard) of suspect Diphtheria-2/Tetanus-5 Adsorbed toxoids no Preservative adult Suspension for injection of lot U7183AA and expiry: 24-sep-2023 via intramuscular route in the left deltoid for immunization, with no reported adverse event (expired product administered) (latency: same day).  Reportedly, an expired TENIVAC vaccine was given to a patient who accidentally cut himself.  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: 0.17
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MENQUADFI administered to a 2 month old baby, with no adverse event; Initial information received on 20-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old baby of an unknown gender who was administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (with an unknown strength, expiry date, lot number) via unknown route in unknown administration site for immunization.  On an unknown date,  the patient was administered Meningococcal A-C-Y-W135 (T Conj) Vaccine with no adverse event (product administered to patient of inappropriate age) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: received a dose of Pentacel in which the diluent, DTAP/IPV, was not administered, only the HIB portion was administered and reconstituted with sterile water with no reported adverse event; Initial information received on 21-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old and unknown gender patient who had received a dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] in which the diluent, dtap/ipv, was not administered, only the hib portion was administered and reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-May-2024, the patient received a 0.5 ml (millimeter) dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 25-Nov-2024 and lot UJ974AC via intramuscular route in the left thigh as immunization and received a dose of pentacel in which the diluent, dtap/ipv, was not administered, only the hib portion was administered and reconstituted with sterile water with no reported adverse event (single component of a two-component product administered) (latency: same day)   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4, FLUA4, FLUC3
Symptoms: Deafness unilateral
Clinical narrative: Acute hearing loss in right ear; This spontaneous case, initially received on 16-May-2024, was reported by a health professional and concerns a patient of unknown age and gender.  Administration of company suspect drug(s): On an unknown date, the patient received Fluad Quadrivalent for Influenza immunization., Lot number: No batch number available. On an unknown date, the patient received Flucelvax Quadrivalent for Influenza immunization., Lot number: No batch number available. On an unknown date, the patient received Afluria Quadrivalent for Influenza immunization., Lot number: No batch number available.   No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, an unknown amount of time after receiving Afluria Quadrivalent, Fluad Quadrivalent, and Flucelvax Quadrivalent, the patient experienced acute hearing loss in right ear (Medically Significant, outcome: Not Reported).  Non-drug treatment/Other action taken:  Fluad Quadrivalent action taken: Not Applicable Flucelvax Quadrivalent action taken: Not Applicable Afluria Quadrivalent action taken: Not Applicable  Reporter's assessment: The event of 'hearing loss unilateral' was considered serious due to seriousness criterion of medical significance, and the reporter did not provide a causality assessment.; Reporter's Comments: Due to a lack of information and unclear temporal relationship causality between suspect vaccines Afluria Quadrivalent, Fluad Quadrivalent and Flucelvax Quadrivalent and event deafness unilateral is unassessable.
Age: 1.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant referring to a 12 month-old-patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 20-MAY-2024, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) Albumin status rHA lot # W036939 with expiration date 19-MAY-2024, for prophylaxis(strength, dose, route of administration and anatomical location were not reported).  Other suspect therapies included sterile diluent(STERILE DILUENT) (strength, dose, route of administration, Lot #, expiration date and indication were not reported). No additional adverse event (AE) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse practitioner reported VARIVAX was administered after a temperature excursion to patient.; This spontaneous report was received from a Nurse practitioner and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 20-MAY-2024, the patient was vaccinated with improperly stored vaccines of varicella virus vaccine live (oka/merck) (VARIVAX) injection, once, lot #X024543, expiration date reported and confirmed as 10-OCT-2025, (strength, exact dose and route of administration were not provided) administered for prophylaxis (Product storage error).  The vaccine was involved in a temperature excursion of 9.3 F during a time frame of 2 minutes and 30 seconds. There was not previous temperature excursion. Operator of device was a health professional. No further information provided. No additional adverse event or product quality complaint reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing), notes: DM; "Peripheral vascular DZ" (unspecified if ongoing), notes: Peripheral vascular DZ. Concomitant medication(s) included: METFORMIN, start date: 01Apr2023; GABAPENTIN, start date: 01Dec2023. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 immunization; Moderna (Dose 4, vaccine location=Left arm), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid as treatment from 12May2024 to 16May2024.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and COvid-19 are related to BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)) cannot be excluded. This case will be reassessed should additional information become available.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: patient reported that she has had trouble with her arm since having the injection
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Decreased appetite, Night sweats, Weight decreased
Clinical narrative: Appox 1 week after vaccine, I overall body weakness, night sweats, lost weight and no appetite. These symptoms continue to today'4 months later
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother of child called today to report, child woke up with redness and swelling on left lower arm. Advised MOC to apply ice pack to area, may give Benadryl  PRN and to call back if child develops more symptoms or has more questions/concerns.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal pain upper, Back pain, Cough
Clinical narrative: Pt called stating that he is having stomach pains, coughing, and back pain. Advised pt to take some Tylenol.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting patients likely received PROQUAD during TE.; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender.  The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with an improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, lot #X024655, which had been verified to be a valid lot number, expiration date reported and confirmed as 09-APR-2025, administered for prophylaxis (strength, dose, route of administration and anatomical location were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X018952, which had been verified to be a valid lot number, expiration date reported and confirmed as 13-JUL-2025, administered for prophylaxis (strength, dose, route of administration and anatomical location were not provided) (product storage error). The temperature excursion was unknown with a time frame of 17 minutes (the most recent excursion was reported on 28-MAR-2024). No previous temperature excursion for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reported, while for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as 14.1 degree Celsius for 19 minutes. No additional adverse event reported (no adverse event). No other information at that time was provided.  Follow-up information has been received from the medical assistant referring to the 4-year-old male patient, on 15-MAY-2024.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 01-APR-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (rHA), lot #X024655, expiration date: 09-APR-2025, administered in the left arm for prophylaxis (strength and route of administration were not provided) that experienced a temperature excursion (freezer) on 28-MAR-2024.  This is one of several reports received from the same source.  This case was previously considered non-valid, but upon receipt of follow-up, the patient identifiers were received.; Sender's Comments:  US-009507513-2405USA004944: US-009507513-2405USA004945: US-009507513-2405USA004946: US-009507513-2405USA004947: US-009507513-2405USA004948:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting patient likely received PROQUAD during temperature excursion.; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 01-APR-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (rHA), lot #X024655, expiration date: 09-APR-2025, administered subcutaneously in the left arm for prophylaxis (strength was not provided) that was improperly stored. The temperature excursion (freezer) was unknown with a time frame of 17 minutes (the most recent excursion was reported on 28-MAR-2024). No previous temperature excursion for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reported. No additional adverse event was reported (no adverse event). No other information at that time was provided.; Sender's Comments:  US-009507513-2404USA009834: US-009507513-2405USA004945: US-009507513-2405USA004946: US-009507513-2405USA004947: US-009507513-2405USA004948:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting patient likely received PROQUAD  during temperature excursion.; This spontaneous report was received from a medical assistant referring to a 4-year-old male patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 01-APR-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (rHA), lot #X024655, expiration date: 09-APR-2025, administered subcutaneously in the left arm for prophylaxis (strength was not provided) that was improperly stored. The temperature excursion (freezer) was unknown with a time frame of 17 minutes (the most recent excursion was reported on 28-MAR-2024). No previous temperature excursion for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reported. No additional adverse event was reported (no adverse event). No other information at that time was provided.; Sender's Comments:  US-009507513-2404USA009834: US-009507513-2405USA004944: US-009507513-2405USA004946: US-009507513-2405USA004947: US-009507513-2405USA004948:
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting patient likely received VARIVAX during temperature excursion; This spontaneous report was received from a medical assistant referring to a 14-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-MAR-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X018952, expiration date: 13-JUL-2025, administered subcutaneously in the left tight for prophylaxis (strength was not provided) that was improperly stored. The temperature excursion (freezer) was unknown with a time frame of 17 minutes (the most recent excursion was reported on 28-MAR-2024). A previous temperature excursion was reported as 14.1 degrees Celsius for 19 minutes. No additional adverse event was reported (no adverse event). No other information at that time was provided.; Sender's Comments:  US-009507513-2404USA009834: US-009507513-2405USA004944: US-009507513-2405USA004945: US-009507513-2405USA004947: US-009507513-2405USA004948:
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Fall, Hyperhidrosis, Loss of consciousness, Nausea, Syncope
Clinical narrative: The patient experienced fainting within 5 minutes of receiving the vaccine. He was seated at the time, and immediately started to fall over losing consciousness. After about 1 minute, he became fully alert and asked what happened. He said he "blacked out." He was sweating. After another 5 minutes, he became nauseous and started vomiting. EMS arrived shortly after and checked his vitals. His pulse was around 50, and blood pressure was around 80/60. They waited a few minutes and rechecked vitals which stayed about the same. They wanted to take him to the hospital, but the patient was unwilling. They stayed a bit longer to recheck the vitals - his vitals improved to around 98/70, the patient was able to stand at this point and said he was feeling much better. We gave him some water. I checked in with the patient later that night and he did get home okay and said he was doing fine.