chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: COVID19, MMRV
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient given 0.25mL covid dose instead of 0.5mL dose. Action corrected by later giving 0.5mL dose.  Patient was also administered MMRV. She should have received MMR and Varicella separately. No adverse reactions to vaccination. Patient's mother notified.
Age: 24.0
Sex: M
Vaccine: FLUC4, HEPA, HPV9, MNQ, TDAP
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of the Havrix instead of the adult dose
Age: 8.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Fatigue, Myalgia
Clinical narrative: Stomach pain, painful arm, general weakness and fatigue, muscle and joint pain
Age: 8.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pain in extremity
Clinical narrative: Stomach pain, painful arm, general weakness and fatigue, muscle and joint pain
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: At 10:50 am today I was told by MA that an incorrect vaccine was given. Beyfortus 50mg was given to the patient instead of Abrysvo. Second person verification check was done with Dr. and was given to patient. Dr. was informed of this as well as the patient. No monitoring required, no harm was done.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Dyspnoea, Fatigue, Gait disturbance, Lymphoedema
Clinical narrative: cellulitis; sepsis; lower extremity lymphedema; shortness of breath; inability to exercise or walk for any very long period; fatigue; This spontaneous case was reported by a patient and describes the occurrence of CELLULITIS (cellulitis) and SEPSIS (sepsis) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016j21-2a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 17-Oct-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant), SEPSIS (sepsis) (seriousness criterion medically significant), LYMPHOEDEMA (lower extremity lymphedema), DYSPNOEA (shortness of breath), GAIT DISTURBANCE (inability to exercise or walk for any very long period) and FATIGUE (fatigue). At the time of the report, CELLULITIS (cellulitis), SEPSIS (sepsis), LYMPHOEDEMA (lower extremity lymphedema), DYSPNOEA (shortness of breath), GAIT DISTURBANCE (inability to exercise or walk for any very long period) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It is unknown if the patient experienced any additional symptoms/events.  Treatment medications were not reported.  Company comment:  This is a regulatory authority case concerning a 59-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant) events of Cellulitis, Sepsis and the non-serious events of Lymphoedema, dyspnoea, gait disturbance and fatigue. The events occurred 5 months after the administration of an unknown dose of mRNA-1273 vaccine.  No further information on clinical course, investigations and treatment received was available in the report. The causality for the events is assessed as not related due to nature of the events, localization of infection, lack of temporal association (latency too long) and inconsistency with the safety profile of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: cellulitis; sepsis; lower extremity lymphedema; shortness of breath; inability to exercise or walk for any very long period; fatigue; This spontaneous case was reported by a patient and describes the occurrence of CELLULITIS (cellulitis) and SEPSIS (sepsis) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016j21-2a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 17-Oct-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant), SEPSIS (sepsis) (seriousness criterion medically significant), LYMPHOEDEMA (lower extremity lymphedema), DYSPNOEA (shortness of breath), GAIT DISTURBANCE (inability to exercise or walk for any very long period) and FATIGUE (fatigue). At the time of the report, CELLULITIS (cellulitis), SEPSIS (sepsis), LYMPHOEDEMA (lower extremity lymphedema), DYSPNOEA (shortness of breath), GAIT DISTURBANCE (inability to exercise or walk for any very long period) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It is unknown if the patient experienced any additional symptoms/events.  Treatment medications were not reported.  Company comment:  This is a regulatory authority case concerning a 59-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant) events of Cellulitis, Sepsis and the non-serious events of Lymphoedema, dyspnoea, gait disturbance and fatigue. The events occurred 5 months after the administration of an unknown dose of mRNA-1273 vaccine.  No further information on clinical course, investigations and treatment received was available in the report. The causality for the events is assessed as not related due to nature of the events, localization of infection, lack of temporal association (latency too long) and inconsistency with the safety profile of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 17.0
Sex: U
Vaccine: HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 17-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 30-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1957405, expiration date: 11-NOV-2025, administered intramuscularly for prophylaxis (strength and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA016206:
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: rotavirus vaccine administered on 14-MAY-2008 and 22-JUL-2008; This spontaneous report has been received from a physician, via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (MARRS # 2402USA009921), concerning a 4-month-old female patient.   The patient's medical history and concurrent conditions were not reported. Historical vaccines included hepatitis b vaccine (HEP B). Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), hib vaccine (HIB PRP-T), pneumococcal conjugate vaccine 13-valent (PCV13), and polio vaccine inact (IPV).  On 14-MAY-2008, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered for prophylaxis (oral, strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). On 22-JUL-2008, the patient received second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  This is one of several reports regarding the same patient.; Sender's Comments:  US-009507513-2402USA009921:
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: received a full bottle and also vomited formula; vomited immediately; accidental underdose; vomited immediately afterwards; This spontaneous report was received from a consumer and refers to her 4-month-old daughter. The patient had no know drug allergies. Medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-APR-2024, the patient received her second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, administered orally (strength, lot #, expiry date were not provided) for prevention of rotavirus gastroenteritis and vomited immediately afterwards (accidental underdose). The patient sought medical attention but no treatment was given. The outcome of event was reported as recovered in approximately April 2024.  On 03-APR-2024, the patient received a full bottle and also vomited formula. No treatment was given. The outcome of vomiting was reported as recovered in approximately April 2024. No laboratory diagnostics were performed.  The causal relationship between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.  Lot # is being requested and will be submitted if received.
Age: 0.5
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse effects were reported; HCP called to report an AE regarding GARDASIL 9.  HCP reported that GARDASIL was inadvertently administered today (4/4/2024) instead of VAXNEUVANCE to a 6 month old infant.; HCP called to report an AE regarding GARDASIL 9.  HCP reported that GARDASIL was inadvertently administered today (4/4/2024) instead of VAXNEUVANCE to a 6 month old infant.; This spontaneous report was received from a medical assistant referring to a 6-month-old female patient. The patient's concurrent condition, medical history and concomitant therapies were not reported.  On 04-APR-2024, the 6-month-old patient (product administered to patient of inappropriate age) was inadvertently vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 mL, lot # 1957404, which had been confirmed to be a valid lot number, expiration date reported and confirmed as 05-OCT-2025 (strength, route of administration and anatomical location not provided) instead of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection as prophylaxis (wrong product administered). Operator of device was an other health care professional. It was reported that the nurse simply grabbed the wrong medication out of the refrigerator, and it was a situation that did not involve product confusion. No additional adverse effects were reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No reported signs/symptoms of adverse effects; PNEUMOVAX 23. It was inadvertently administered to an infant instead of PREVNAR 20.; PNEUMOVAX 23. It was inadvertently administered to an infant instead of PREVNAR 20.; This spontaneous report was received from a nurse and refers to an infant patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-APR-2024, the patient was inadvertently administered with vaccinated with the 3rd in series dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot number x018278 with expiration date 24-NOV-2024, that was verified to be valid, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) instead of pneumococcal vaccine conj 7v (crm197) (PREVENAR) (Wrong product administered and Product confusion). No reported signs/symptoms of adverse effects. No additional AE/no PQC.
Age: 3.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; Administered after Temperature Excursion; This spontaneous report has been received from a nurse practitioner and refers to a 3-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 23-OCT-2023, the patient was vaccinated haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #X003664, expiration date: 10-NOV-2025, administered for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided) after temperature excursion.  No additional adverse event (AE).  This is one of several reports received from the same reporter.
Age: 3.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; Administered after Temperature Excursion; This spontaneous report has been received from a nurse practitioner and refers to a 3-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 25-OCT-2023, the patient was vaccinated haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #X003664, expiration date: 10-NOV-2025, administered for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided) after temperature excursion.  No additional adverse event (AE).  This is one of several reports received from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: getting shingles again/suspected vaccination failure; shingles again; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 57-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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: getting shingles again/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles again). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   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: 31-MAR-2024 The patient was self-reported. The patient stated that it worked for several years but now he/she was getting shingles again. The patient wanted to like to be vaccinated again if possible. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Insomnia, Pain
Clinical narrative: Very painful/2 months with a lot of pain; Blisters on the left side of the back and on the left side of abdomen; Could not sleep at night; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: Very painful/2 months with a lot of pain), blister (Verbatim: Blisters on the left side of the back and on the left side of abdomen) and sleeplessness (Verbatim: Could not sleep at night). The outcome of the pain, blister and sleeplessness were not reported.   It was unknown if the reporter considered the pain, blister and sleeplessness to be related to Shingles vaccine.     It was unknown if the company considered the pain, blister and sleeplessness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that it was very painful, 2 months with a lot of pain. The patient got blisters on the left side of the back and on the left side of the abdomen.  The patient could not sleep at night and the doctor recommended patient to get the vaccine and patient had already got it.  The patient stated he/she needed another one because it might happen again.
Sex: F
Vaccine: RSV
Symptoms: Burning sensation, Injection site pain, Injection site pruritus, Rash, Rash pruritic
Clinical narrative: Experienced itchy from injection site; experienced burning from injection site; itchy rash going up to her neck; burning going up to her neck; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site itching in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site itching (Verbatim: Experienced itchy from injection site), injection site burning (Verbatim: experienced burning from injection site), itchy rash (Verbatim: itchy rash going up to her neck) and burning sensation (Verbatim: burning going up to her neck). The outcome of the injection site itching, injection site burning, itchy rash and burning sensation were unknown.   It was unknown if the reporter considered the injection site itching, injection site burning, itchy rash and burning sensation to be related to Arexvy.     It was unknown if the company considered the injection site itching, injection site burning, itchy rash and burning sensation to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-MAR-2024 The caller was a representative stating that he was just called by a reporter and wanted to report an adverse event.  He stated the reporter reported about a female patient in her late 70's was given Arexvy and experienced burning and itchy from injection site, and has a burning, itchy rash going up to her neck.  No other information was provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not had the second dose yet and it has been over years; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 04-NOV-2022).   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: not had the second dose yet and it has been over years). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-MAR-2024 The RPH (registered pharmacist) reported that a patient who received their first dose of Shingrix and has not had his second dose yet and it had been over years. The reporter wanted to know how long patient need to wait to get the second dose and do the patient had to start over on the Shingrix series. Till the time of reporting the patient did not receive the second dose of Shingrix, which led to an incomplete course of vaccination. This was 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024038680:Different patient US-GSK-US2024038678:Different patient US-GSK-US2024038679:Different patient US-GSK-US2024038682:Different patient
Age: 5.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered
Clinical narrative: Administration of Kinrix with a Sanofi IPV vaccine on the same day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 5-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included Polio vaccine inact (Ipv) for prophylaxis.   Previously administered products included IPV (received IPV vaccine on an Unknown date) and Dtap (received Dtap vaccine on an Unknown date).   On 29-MAR-2024, the patient received Kinrix (unknown arm) and Ipv (unknown arm). On 29-MAR-2024, an unknown time after receiving Kinrix, the patient experienced overdose (Verbatim: Administration of Kinrix with a Sanofi IPV vaccine on the same day). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-MAR-2024 The pharmacist reported that the patient received the Kinrix vaccine and single IPV Sanofi vaccine were administered at the same time, same arm but separated injection sites, which led to overdose. The patient had now 5 IPV doses and 5 Dtap doses, so was fully vaccinated.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: I do not have the conjugate component; I just have the powder. Indicating a possible administration of only the adjuvant to a patient; I do not have the conjugate component; I just have the powder. Indicating a possible administration of only the adjuvant to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: I do not have the conjugate component; I just have the powder. Indicating a possible administration of only the adjuvant to a patient) and inappropriate dose of vaccine administered (Verbatim: I do not have the conjugate component; I just have the powder. Indicating a possible administration of only the adjuvant to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-MAR-2024 A healthcare provider called from pharmacy and informed that the following about Menveo, the patient did not have the conjugate component, he/she just had the powder. Indicating a possible administration of only the adjuvant to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The connection was lost after that, so no more data could be collected from the caller.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient reports to NP that after dose one of vaccine she had redness and itching at the injection site; Patient reports to NP that after dose one of vaccine she had redness and itching at the injection site; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Patient reports to NP that after dose one of vaccine she had redness and itching at the injection site) and injection site itching (Verbatim: Patient reports to NP that after dose one of vaccine she had redness and itching at the injection site). The outcome of the injection site erythema and injection site itching were resolved (duration 7 days).   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.     It was unknown if the company considered the injection site erythema and injection site itching to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-MAR-2024 The reporter was a sales representative reported on behalf of a nurse practitioner. The reporter stated that the patient came in office two months after dose one to receive dose two of vaccine series. The patient reported to nurse practitioner that after dose one of vaccine she had redness and itching at the injection site.(Symptomatic AE). It was reported that both symptoms spread over a seven day period then resolved. The patient did not receive dose two of series. The nurse practitioner(NP) was seeking further guidance from the medical information department before dose two was given. The patient's initials, date of birth, date of vaccination and lot number of product was not available at the time of call. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, Surgery
Clinical narrative: Unknown surgical procedure; Patient had covid; This serious case was reported by a consumer via call center representative and described the occurrence of surgical procedure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included nirmatrelvir;ritonavir (Paxlovid).   On 21-AUG-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced surgical procedure (Verbatim: Unknown surgical procedure) (serious criteria clinically significant/intervention required) and covid-19 (Verbatim: Patient had covid). The outcome of the surgical procedure was unknown and the outcome of the covid-19 was not reported.   It was unknown if the reporter considered the surgical procedure and covid-19 to be related to Shingrix.     It was unknown if the company considered the surgical procedure and covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-APR-2024 The reporter received his first dose of a vaccine series in August of last year.   During the time frame of when second vaccine of series was scheduled; patient had Covid and an unknown surgical procedure.   Second dose was not given as scheduled and approved in the package insert instruction section Dosage and Administration. Location of injection and lot number of first dose were not available at the time of call.   The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Electric shock sensation, Herpes zoster, Pain in extremity, Skin ulcer, Vaccination failure
Clinical narrative: diagnosed him with Shingles once again; his right arm started having severe pains like electrical shock; 5 little sores on his right arm; electrical shock; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had Shingles 1.5 years ago). Previously administered products included Shingrix (received 1st dose on OCT-2023).   On 20-FEB-2024, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid). In MAR-2024, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: diagnosed him with Shingles once again), pain in arm (Verbatim: his right arm started having severe pains like electrical shock), ulcer of upper extremity (Verbatim: 5 little sores on his right arm) and electric shock sensation (Verbatim: electrical shock). The outcome of the shingles, pain in arm, ulcer of upper extremity and electric shock sensation were not resolved.   It was unknown if the reporter considered the shingles, pain in arm, ulcer of upper extremity and electric shock sensation to be related to Shingrix.     It was unknown if the company considered the shingles, pain in arm, ulcer of upper extremity and electric shock sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-APR-2024. The reporter was the patient. Reporter stated that approximately 2 weeks ago his right arm started having severe pains like electrical shock for lasting about 60 seconds and this had not recovered.  Reporter also stated he had 5 little sores that showed up on his right arm that looked like something bit him. Reporter stated he did have Shingles 1.5 years ago and went to his healthcare provider on 28-MAR-2024 and he diagnosed him with Shingles once again.  All adverse events were not resolved. This case was considered as confirm vaccination failure as detail regarding diagnosis of shingles, time to onset and primary schedule were reported at the time of reporting.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GL0446), in left arm and on 25Oct2023 at 12:00 as dose 6 (booster), single (Lot number: GL2042) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 at 12:00 as dose 1, single (Lot number: EL3302), in right arm, on 10Feb2021 at 12:00 as dose 2, single (Lot number: EN6201), in left arm, on 14Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FP7218), in left arm and on 22Jun2022 at 12:00 as dose 4 (booster), single (Lot number: FN2908), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Jan2024 at 12:00 as dose 7 (booster), single (Lot number: 8058877), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 18Mar2024 to 22Mar2024.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: massive heart attack; This is a spontaneous report received from a Consumer or other non HCP.  A male patient in his 30's received BNT162b2 (BNT162B2 NOS), 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "massive heart attack". Customer stated a friend's son had a massive heart attack in his 30's which they attribute to the covid vaccine. It was unknown if therapeutic measures were taken as a result of myocardial infarction.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Afib; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown, I have had adverse effects from the intial 2 part covid 19 vaccine), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown, Fatigue started the day after the second injection), for Covid-19 immunization, reaction(s): "fatigue". The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Afib". Therapeutic measures were taken as a result of atrial fibrillation.  Clinical information: The Reporter stated that "I have had adverse effects from the intial 2 part covid 19 vaccine. Fatigue started the day after the second injection. Since then fatigue progressed untill i was told i was in Afib. After heart Ablation Surgery I have not felt the same. Illnesses are different now."  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired act-hib is given to a patient with no reported adverse event; Initial information received on 03-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who was administered expired HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) and Pneumococcal Vaccine CONJ 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination.  On 02-Apr-2024, the patient received 0.5 ml (dose 4) of expired HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) with no reported adverse event (expired product administered) (Latency: same day) (lot UJ858AB) (expiry: 29-Mar-2024) (strength: standard) (frequency: once) via intramuscular route in the thigh nos right vastus lateralis (not otherwise specified) for Immunization.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 55.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired typhim vi was inadvertently administered to a patient with no reported adverse event; Initial information received on 03-Apr-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 55-year-old female patient and expired typhoid VI polysaccharide vaccine [Typhim VI] was inadvertently administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 29-Mar-2024, the patient received a 0.5 ml dose of suspect typhoid VI polysaccharide vaccine, Solution for injection (strength: unknown) (lot: VA121M, expiry date: 26-MAR-2024) via intramuscular route in the left deltoid for Immunization and expired typhim vi was inadvertently administered to a patient with no reported adverse event (expired product administered) (latency: same day).    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was nine days past the expiration date when administered (with no reported adverse event); Initial information received on 03-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old female patient for whom vaccine HIB (PRP/T) VACCINE [ACT-HIB] was nine days past the expiration date when administered (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Apr-2024, the patient received suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection, expiry- 25-MAR-2024 via unknown route in unknown administration site for immunization (strength, dose, batch number-unknown), vaccine was nine days past the expiration date when administered (with no reported adverse event) (expired product administered) (latency same day). Information on the batch number was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACTHIB was administered to patient with no reported adverse event; Initial information received on 03-Apr-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 1 years old male patient to whom expired HIB (PRP/T) vaccine [ACT-HIB] was administered to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot- UJ863AA and expiry date- 25-Mar-2024) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (expired product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACTHIB was administered to the patient, with no adverse event; Initial information received on 03-Apr-2024 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 1 years old female patient who was administered expired HIB (PRP/T) Vaccine [ACT-HIB] 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 was administered expired dose of HIB (PRP/T) Vaccine [ACT-HIB](Powder and solvent for solution for injection)(lot UJ863AA, expiry date: 25-Mar-2024, strength, dose not reported) via unknown route in unknown administration site for Immunization with no adverse event (expired product administered) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: DTAPIPV, MEN
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Quadracel was mistakenly administered to a patient in the left deltoid instead of the intended meningococcal vaccine with no reported adverse event; Initial information received on 04-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 11 years old female patient to whom diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)] was mistakenly administered in the left deltoid instead of the intended meningococcal vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Immunisation.  On 03-Apr-2024, the patient received an 0.5 ml (once, total) dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine (Suspension for injection) (lot U7931AB, expiry date: 09-Nov-2025, strength: unknown) via unknown route in the left deltoid for Immunization and quadracel was mistakenly administered to a patient in the left deltoid instead of the intended meningococcal vaccine with no reported adverse event (wrong product administered) (Latency:same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Hand-foot-and-mouth disease
Clinical narrative: The day after the vaccine, he woke up with blister-like on the palms of his 2 hands and the bottom of his 2 feet. He never complained nor was ever itchy. I was constantly checking the rest of his body and thankfully it didn't spread elsewhere.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: PT HAD INCREASED HEART RATE OVER 100
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia, Rash pruritic
Clinical narrative: Swelling to right thigh and warmth starting 2 days post vaccination.  No prior vaccine reactions. Low grade fever. No severe symptoms. No hives or difficulty breathing. Administered Benadryl 11.2mg and acetaminophen 160mg in ED. Discharged w/ Benadryl 12.5mg/5mL, 4mL TID PRN itching rash & ibuprofen 100mg/5mL, 5mL Q6H PRN fever/pain.
Age: 24.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Dyskinesia, Muscle twitching, Posture abnormal, Unresponsive to stimuli
Clinical narrative: After both covid and flu vaccines were given to pt, one in each arm, I told the pt to sit in the chair outside vaccine room for 15 minutes. After couple minutes, pt reported to us that he feels dizzy. I walked to where pt is sitting down and asked if he's allergic to anything or have anxieties with needles, to which he said no to both. As we were speaking, I noticed the pt started closing his eyes and dropping his head. I ran to him and caught his head and body so he doesn't fall to ground and hit himself. At the same time I tried calling him, pt was already unresponsive. Pt was slightly twitching, and hands scrunching up into fist. I tried holding his head and arms so he's not huring himself. In the mean time I screamed at my technician to call EMS. She immediately called them and told me that they are on their way. I settled pt to the ground, ran to the vaccine room and grabbed the crash bag. I retrieved a 0.3mg epinephrine pen, and when I was about to use it, pt opened his eyes and said he's feeling better, so I did not give the pen. I asked if he's having any rashes or difficulty breathing, pt said no to both and said hes just feeling dizzy and slowly feeling better. I sat on the ground with him while he's laying flat and waited for EMS to arrive. I used his phone and called his parents, told them what happend and EMS is coming. EMS came and they had him sit up, checked all his vitals, asked questions, and told me that pt is doing okay now, pt will just wait for his parents to come and pick him up. EMS left, pt remained sitting in the lobby while I constantly checked on him to see if he's still doing okay. Later his parents showed up, I explained to them what happened, answered some of their questions, then they all left together. Afterwards I went back and double checked the VAR form and vaccines I have to the pt. Confrimed pt had marked no to allergies and major health conditions, vaccines given were correct, and none were expired or left outside the right temperature.