chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Neisseria test positive, Vomiting
Clinical narrative: She received meningococcal vaccine MenB dose#1 and Men ACWY dose #2 on 4/3/24, approx 2 weeks before symptom onset.   Diagnosed with meningococcal disease on 4/15/24. Symptom onset 4/14/24 of nausea, vomiting, headaches, back/neck pain, but no fever.  She was treated with ceftriaxone.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, C-reactive protein increased, Condition aggravated, Depression, Fatigue
Clinical narrative: psoriasis, psoriatic arthritis, chronic fatigue, unspecified leukocytosis, PCOS, insulin resistance, depression, anxiety
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Insulin resistance, Leukocytosis, Polycystic ovarian syndrome, Psoriasis, Psoriatic arthropathy
Clinical narrative: psoriasis, psoriatic arthritis, chronic fatigue, unspecified leukocytosis, PCOS, insulin resistance, depression, anxiety
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: psoriasis, psoriatic arthritis, chronic fatigue, unspecified leukocytosis, PCOS, insulin resistance, depression, anxiety
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received pediatric dose.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Middle ear effusion, Rash
Clinical narrative: rash on torso, back and arms. Also, plugged up right ear. (Rash went away by April 20).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received pediatric vaccine
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received a pediatric vaccine dose
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received a pediatric dose
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received pediatric dose
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Vaccines given on 11/01/2023 weren't documented. Patient received same vaccines on 12/12/2023.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received pediatric dose
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received pediatric dose
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Irritability, Skin warm
Clinical narrative: RN, with patient parent and stated patient was a little fussy yesterday on 4/24/24, has been not eating too much and was a little warm but it went away and patient is running around.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: I have pictures showing my hair falling out severely as a side effect of getting this shot!  Since taking the shot, my hair has thinned and is completely fallen out in the crown and back of my scalp.  I was diagnosed with having alopecia.
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Erroneous dose- gave 4th dose
Age: 0.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia
Clinical narrative: 04/25/24 RN, called patient parent today and asking how the patient is doing. Mom was saying that patient did have a fever but now is doing good.
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4/25/24 RN, called patient parent and to see how patient is doing. Mom stated that patient is doing well.
Age: 63.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient received and 3rd dose of Hepatitis A
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient administered a full vial (2.5ml) of Novavax Vaccine by the pharmacist intern.  Patient has had no physical issues as of now, however given excess vaccine.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, Brain natriuretic peptide increased, Diuretic therapy, Electrocardiogram
Clinical narrative: PFIZER #1 1/26/2021 PFIZER #2 2/19/2021 BY 2022 DEVELOPED ARTHRALIGIAS, SWOLLEN JOINTS, WITH ANA POSITIVE, TROPONIN  BNP ELEVATED  AND 2023 DEVELOPED LARGYNGEAL CANCER REQUIRING XRT AS PRIMARY FORM OF TREATMENT. DIAGNOSED WITH SUBCLINICAL VACCINE MYOCARDITIS AND VACCINE-ACCELERATED ENT CANCER.  TREATED WITH BETA BLOCKERS ACE INHIBITOR DIURETICS WITH IMPROVEMENT.   ALSO TREATED WITH EMPIRIC HYDROXYCHLOROQUINE.  RECEIVED PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Imaging procedure abnormal, Immunisation reaction, Joint swelling, Laboratory test, Laryngeal cancer
Clinical narrative: PFIZER #1 1/26/2021 PFIZER #2 2/19/2021 BY 2022 DEVELOPED ARTHRALIGIAS, SWOLLEN JOINTS, WITH ANA POSITIVE, TROPONIN  BNP ELEVATED  AND 2023 DEVELOPED LARGYNGEAL CANCER REQUIRING XRT AS PRIMARY FORM OF TREATMENT. DIAGNOSED WITH SUBCLINICAL VACCINE MYOCARDITIS AND VACCINE-ACCELERATED ENT CANCER.  TREATED WITH BETA BLOCKERS ACE INHIBITOR DIURETICS WITH IMPROVEMENT.   ALSO TREATED WITH EMPIRIC HYDROXYCHLOROQUINE.  RECEIVED PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Radiotherapy, Troponin increased
Clinical narrative: PFIZER #1 1/26/2021 PFIZER #2 2/19/2021 BY 2022 DEVELOPED ARTHRALIGIAS, SWOLLEN JOINTS, WITH ANA POSITIVE, TROPONIN  BNP ELEVATED  AND 2023 DEVELOPED LARGYNGEAL CANCER REQUIRING XRT AS PRIMARY FORM OF TREATMENT. DIAGNOSED WITH SUBCLINICAL VACCINE MYOCARDITIS AND VACCINE-ACCELERATED ENT CANCER.  TREATED WITH BETA BLOCKERS ACE INHIBITOR DIURETICS WITH IMPROVEMENT.   ALSO TREATED WITH EMPIRIC HYDROXYCHLOROQUINE.  RECEIVED PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypertension, No adverse event
Clinical narrative: The patient was inadvertently administered an expired vaccination. The vaccine expired on 04/16/2024, and this was administered on 04/18/2024. This was reported to Moderna and their lab responded with the following, "The vaccines administered [on April 17, 2024 and April 18, 2024] from log number 206E23A maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration." The patient was notified, but reported no additional adverse effects outside of what they normally experience.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Crying, Eye movement disorder, Unresponsive to stimuli
Clinical narrative: After patient received her second vaccine, her eyes rolled to the back of her head and she went unresponsive. I picked her up immediately, she took a deep breath, and started to cry. Pt was evaluated for about 30 minutes and was good to go home.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was inadvertently administered an expired vaccination. The vaccine expired on 04/16/2024, and this was administered on 04/17/2024. This was reported to Moderna and their lab responded with the following, "The vaccines administered [on April 17, 2024 and April 18, 2024] from lot number 206E23A maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration." Have attempted to reach patient multiple times, but patient has not answered phone calls. Patient has not called complaining of any additional adverse effects.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Diarrhoea, Echocardiogram, Electrocardiogram, Headache
Clinical narrative: MODERNA #1 1/5/2021 MODERNA #2 2/1/2021 MODERNA #3 11/17/2021 PATIENT DEVELOPED WORSENED HEADACHES EFFORT INTOLERANCE AND FREQUENT DAILY 4-5 TIMES DIARRHEA.  FOUND TO HAVE A SMALL PERICARDIAL EFFUSION ON ULTRASOUND.    HAD EXTENSIVE WORK UP WHICH REVEALED NO OBVIOUS ETIOLOGY.  TREATED WITH COSEVELAM AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Pericardial effusion, Physical deconditioning
Clinical narrative: MODERNA #1 1/5/2021 MODERNA #2 2/1/2021 MODERNA #3 11/17/2021 PATIENT DEVELOPED WORSENED HEADACHES EFFORT INTOLERANCE AND FREQUENT DAILY 4-5 TIMES DIARRHEA.  FOUND TO HAVE A SMALL PERICARDIAL EFFUSION ON ULTRASOUND.    HAD EXTENSIVE WORK UP WHICH REVEALED NO OBVIOUS ETIOLOGY.  TREATED WITH COSEVELAM AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 0.17
Sex: M
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called and reported that VAXNEUVANCE and ROTATEQ involved in a temperature excursion were administered to 1 patient; This spontaneous report was received from a nurse concerning a 3-months-old male patient. Patient's concurrent conditions included mild cradle cap of frontal scalp and small umbilical hernia. Patient's concomitant therapies included diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (PEDIARIX) and hib vaccine conj (tet tox) (HIBERIX). Patient's pertinent medical history was not provided.  On 29-MAR-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose in left leg, lot #X019438, expiration date: 07-NOV-2025, administered intramuscularly in the left leg for prophylaxis (strength was not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1979985, expiration date: 30-NOV-2024, administered orally for prophylaxis (strength was not provided).  On that date, a temperature excursion occurred out of recommended range, seeking a minimum temperature of 35.2 degrees Fahrenheit for a total of 45 minutes. There was a previous temperature excursion of 35.1 Fahrenheit for 50 minutes.  No patient's symptoms were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller stated the patient has not had any symptoms.; an expired dose of MMR II was administered to a patient; This spontaneous report was received from a nurse and referring to a patient with unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-APR-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) subcutaneous injection, 1 dose, lot #W023071 has been verified to be a valid lot number, expiration date reported and established as 05-APR-2024 (strength, route of administration, and indication were not provided) (Expired product administered). The patient had not had any symptoms. The product was not involved in any temperature excursions. There was no additional adverse event.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AEs were reported; Pharmacist reported that an 18 year old patient received 2 pediatric RECOMBIVAX doses for the first and the second dose in a series but received an adult dose for the third dose on 4/1/2024.; Pharmacist reported that an 18 year old patient received 2 pediatric RECOMBIVAX doses for the first and the second dose in a series but received an adult dose for the third dose on 4/1/2024.; This spontaneous report was received from a pharmacist and refers to an 18-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date (when the patient was 18 years old), the patient was vaccinated with the first and the second doses in a series of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, pediatric formulation, administered for prophylaxis (exact dose, lot #, expiry date, and route of administration were not provided). On 01-APR-2024, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 dose; adult formulation, lot #X021830 (lot was validated as valid for vial formulation) with established expiration date of 03-FEB-2026, administered for prophylaxis (exact dose and route of administration were not provided) (overdose, product administered to patient of inappropriate age). No additional adverse events (AEs) were reported (no adverse event).  Lot # (for first and second doses) is being requested and will be submitted if received.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient received his second dose of GARDASIL-9 3 months late; No additional AE; This spontaneous report was received from a pharmacy representative and refers to a male patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, lot #, expiration date, site and route of administration were not provided) administered for prophylaxis. On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, lot #, expiration date, site and route of administration were not provided) administered for prophylaxis. The reporter stated that the patient received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) three months late (inappropriate schedule of product administration). There was no additional adverse event reported.   Additional information is not expected.
Sex: F
Vaccine: HPV9
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: had miscarriage; patient received GARDASIL 9 while pregnant; This spontaneous report was received from Other Health Professional and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) while pregnant (Exposure during pregnancy).  On an unknown date, the patient experienced miscarriage. At the time of reporting, the outcome of the event had miscarriage was not known.   The causal relationship between miscarriage and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. Upon internal review, the event had miscarriage was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Varicella-type rash; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On 16-JUN-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection (dose, strength, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for long-term prevention of shingles and zoster-related conditions. It has been reported that, on an unknown date, the pt was treated by providers for multiple outbreaks of a varicella-type rash, resulting from pt's zoster vaccine live (ZOSTAVAX) use. The pt had sustained and will continue to sustain severe physical injuries, emotional distress, mental anguish, economic losses, and other damages. At the time of reporting, the pt had not recovered from the events. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event was considered as disabling by reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On 29-JAN-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection (dose, strength, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for long-term prevention of shingles and zoster-related conditions. It has been reported that, on an unknown date, the pt was treated by providers for Bell's palsy, resulting from pt's zoster vaccine live (ZOSTAVAX) use. The pt had sustained and will continue to sustain severe physical injuries, emotional distress, mental anguish, economic losses, and other damages. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned event to be related to zoster vaccine live (ZOSTAVAX).  The event was considered as disabling by reporter.  Upon internal review, the event Bell's palsy was determined to be medically significant.
Sex: U
Vaccine: RVX
Symptoms: Bedridden, Extra dose administered
Clinical narrative: spending my second week in bed; I got both vaccines; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bedridden in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included COVID-19 vaccine (received on an unknown date) and RSV vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced bedridden (Verbatim: spending my second week in bed) and extra dose administered (Verbatim: I got both vaccines). The patient was treated with salbutamol (Albuterol), guaifenesin (Mucinex), codeine and amoxicillin trihydrate, clavulanate potassium (Augment). The outcome of the bedridden was not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the bedridden to be related to RSV vaccine.     It was unknown if the company considered the bedridden to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 16-APR-2024 This case was reported by a patient via interactive digital media. The patient got both RSV vaccines and was spending his/her second week in bed, which led to extra dose administered. The patient was using augmenten anti biotic,vaporizer and hot tea with honey. The patient got all covid shots and ended up in hospital. The patient would never get another government shot again.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Tremor
Clinical narrative: made me really sick; shaking in my arms and hands; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: made me really sick) and tremor (Verbatim: shaking in my arms and hands). The outcome of the sickness and tremor were not reported.   It was unknown if the reporter considered the sickness and tremor to be related to Shingles vaccine.     It was unknown if the company considered the sickness and tremor to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-APR-2024 This case was reported by a patient via interactive digital media. The reporter reported that he/she finally got the Shingles vaccine shot last year (73). The reporter mentioned that the 1st shot was tolerated well. The reporter stated that he/she had received second dose Shingles vaccine and made him/her sick and the shaking in his/her arms and hands almost sent him/her to the ER (Emergency Room). The reporter reported that he/she glad to get the Shingles shot regardless.  He/she stated that it was a bit scary but again it passed.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: she got sick; sick from shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced sickness (Verbatim: she got sick) and shingles (Verbatim: sick from shingles). The outcome of the sickness was resolved and the outcome of the shingles was not reported.   It was unknown if the reporter considered the sickness and shingles to be related to Shingles vaccine.     It was unknown if the company considered the sickness and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-APR-2024 This case was received via interactive digital media. The reporter's mother-in-law (patient) got vaccinated with Shingles vaccine. Two days after the vaccine she got sick from shingles, and she was sick more than ten days from having been vaccinated. The reporter stated that do not play and leave elderly people alone, do not lie to them just to had clients to the doctors.
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration
Clinical narrative: had her second dose of Shingrix administered later than 6 months after the first dose/ late dose; vaccine documented as being given in the left arm when it was given in the right arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: had her second dose of Shingrix administered later than 6 months after the first dose/ late dose) and incorrect information in patient's record (Verbatim: vaccine documented as being given in the left arm when it was given in the right arm). The outcome of the drug dose administration interval too long and incorrect information in patient's record were unknown.   Additional Information: GSK Receipt Date: 11-APR-2024 The patient self-reported this case for herself. The patient had her second dose of Shingrix administered later than 6 months after the first dose (late dose) which led to lengthening of the vaccine scheduled. The reporter also reported that, the vaccine was documented as administered in the left arm when she had the injection in her right arm, which led to an incorrect information in patient's record. The reporter did not receive a vaccination information statement (VIS) from the pharmacy. The reporter did not consent to follow up.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: patient received Bexsero vaccine and then they found vaccine was expired; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   In APR-2024, the patient received Bexsero. In APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: patient received Bexsero vaccine and then they found vaccine was expired). The outcome of the expired vaccine used 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: 15-APR-2024 The reporter was a pharmacy student who stated a patient received Bexsero vaccine and then they found vaccine was expired on 31st March 2024.  Reporter didn't know any patient demographics and denied to provide consent to contact HCP.  Reporter stated vaccine was administered between 1st April 2024 and 15th April 2024 not knowing the exact vaccination day.  No other information provided. Transferred to medical information for advise. The reporter did not consent to follow-up.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: overdose; A dose for 19 years and up of Havrix was given to a 1 year old patient, instead of the 11 month dose./Medical Assistant gave HAVRIX to a 12 month old patient.; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix adult) (batch number 3S54K, expiry date 18-DEC-2025) for prophylaxis.   On 15-APR-2024, the patient received Havrix adult. On 15-APR-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: overdose) and inappropriate age at vaccine administration (Verbatim: A dose for 19 years and up of Havrix was given to a 1 year old patient, instead of the 11 month dose./Medical Assistant gave HAVRIX to a 12 month old patient.). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 15-APR-2024 Physician reported that a Medical Assistant gave HAVRIX to a 12 month old patient. A dose for 19 years and up of Havrix was given to a 1 year old patient, instead of the 11 month dose, which led overdose and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-day-old female patient who received HBV (Engerix B) (batch number X9FT7, expiry date 31-MAR-2024) for prophylaxis.   On 11-APR-2024, the patient received Engerix B. On 11-APR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used 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: 15-APR-2024 It was reported that a patient that was given a Hepatitis B vaccine that was expired by about a week which led to expired vaccine used.
Sex: F
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: deathly ill; This serious case was reported by a physician via sales rep and described the occurrence of unwell in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced unwell (Verbatim: deathly ill) (serious criteria other: serious as per reporter). The outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Arexvy.     It was unknown if the company considered the unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-APR-2024 GlaxoSmithKline field representative was the reporter who stated that she was informed of a patient in her 60's that had the Arexvy vaccine administered and in 1 or 2 days the patient became deathly ill and went to the emergency room two weeks after the vaccination with Arexvy.  No further information was available such as patient date of birth, date of vaccination, lot number for vaccination, date of emergency room visit, diagnosis or treatment at emergency room.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received full 2 dose series of Shingrix but still experiencing Shingles/suspected vaccination failure; received full 2 dose series of Shingrix but still experiencing Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   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: received full 2 dose series of Shingrix but still experiencing Shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: received full 2 dose series of Shingrix but still experiencing Shingles). 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 Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2024 The reporter contacted to GlaxoSmithKline through a field representative to ask about information on how to proceed after a patient received a full 2 dose series of Shingrix. The patient was still experiencing Shingles after 2 full doses. Not other information was given and medical information was provided. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Overdose, Pain, Pain in extremity, Pyrexia
Clinical narrative: Achy; Sore arm; Terrible HA; Fever like sx's; 16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Achy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Terrible HA), PYREXIA (Fever like sx's) and OVERDOSE (16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.) in an 11-year-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5556B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2024, the patient received third dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced PAIN (Achy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Terrible HA), PYREXIA (Fever like sx's) and OVERDOSE (16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.). At the time of the report, PAIN (Achy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Terrible HA) and PYREXIA (Fever like sx's) had resolved and OVERDOSE (16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter considered PAIN (Achy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Terrible HA) and PYREXIA (Fever like sx's) to be related. No further causality assessment was provided for OVERDOSE (16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.).    This case contains information for the 3rd patient out of 16 patients as described by the reporter.  No concomitant medication information was reported.  The patient had significant reaction to the vaccine as compared to the previous doses.  Patient had no acute illnesses at the time of vaccination and upto one month before. Patient had no chronic or long-standing health conditions.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-760906 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2024: Significant follow up received included : added new reporter, updated patient details, updated suspect product details, added new events of headache, pyrexia, pain in extremity, and pain and updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760906:Patient 3 out of 16
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for Covid-19 on 11-Apr-2024; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for Covid-19 on 11-Apr-2024) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood cholesterol increased and Hypertension. Concomitant products included ATORVASTATIN from an unknown date to 11-Apr-2024, AMLODIPINE, UBIDECARENONE (QUNOL COQ10), CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]), VITAMIN K2 [MENAQUINONE], MAGNESIUM, CENTRUM SILVER WOMEN 50+ and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 07-Mar-2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Apr-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (Patient tested positive for Covid-19 on 11-Apr-2024). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-Apr-2024 to 16-Apr-2024 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient tested positive for Covid-19 on 11-Apr-2024) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2024, SARS-CoV-2 test: Positive. On 17-Apr-2024, SARS-CoV-2 test: Negative. On 18-Apr-2024, SARS-CoV-2 test: Negative. On 21-Apr-2024, SARS-CoV-2 test: Positive.         Concomitant medication included Probiotic.  Patient tested positive for Covid-19 on 11-Apr-2024, started Paxlovid therapy on 12-Apr-2024 and finished 5-day course on 16-Apr-2024. The patient tested negative on 17-Apr-2024 and 18-Apr-2024. Began experiencing symptoms of stuffy nose and lethargy on 20-Apr-2024, the patient had undergone Covid test on 21-Apr-2024 which was positive.
Sex: U
Vaccine: RSV
Symptoms: Product container issue
Clinical narrative: Had issue for constituting it and then the vial broke; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 16Apr2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, 0.5ml single (Lot number: HL9687, Expiration Date: May2025) for immunisation, Device Lot Number: F660, Device Expiration Date: 01Jun2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Had issue for constituting it and then the vial broke".  The reporter considered "had issue for constituting it and then the vial broke" not related to rsv vaccine prot.subunit pref 2v. Causality for "had issue for constituting it and then the vial broke" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Headache
Clinical narrative: Headache; Received the expired Comirnaty; vaccine expired on April-16th and she received it or was administered it on the 17-April, 2024; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Apr2024 as dose 1, single (Lot number: Unknown, Expiration Date: 16Apr2024) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 17Apr2024, outcome "unknown", described as "Received the expired Comirnaty; vaccine expired on April-16th and she received it or was administered it on the 17-April, 2024"; HEADACHE (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of headache. Additional information: Patient reported to have got a Pfizer booster shot. Patient was given a call by Pharmacist and about an expiration date of a COVID shot (Pfizer COVID-19 Vaccine) that she took it on the 17th (April 17th 2024), and it expired on the 16th (April 16th 2024). They said it was safe after the expiration date for something like 5 days but she wanted to check with the company. Confirming Comirnaty presentation received (glass PFS). Patient reported "It was intravenous, yes. What I am saying, they gave me vaccination in my arm. An injection, it was an injection." Patient had nothing but headaches and was not taking any medication for headache; trying to withstand them because she was thinking that was basically best way to, okay well.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: In between each one when I have a flare, I take a Prednisolone/ still have flares in between; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 26Aug2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Batch\lot number: EZ9266, Route of administration: Intramuscular, Anatomical location: left arm), administration date: 21Feb2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "Developed rheumatoid arthritis"; BNT162b2 (DOSE 2, SINGLE , Batch\lot number: EN6207), administration date: 14Mar2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "In between each one when I have a flare, I take a Prednisolone/still have flares in between". The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "In between each one when I have a flare, I take a Prednisolone/ still have flares in between". Therapeutic measures were taken as a result of rheumatoid arthritis. Clinical course: This (Unclear voice) she started out with taking Hydroxychloroquine (Plaquenil) and that didn't do much good, so they started her on tablets of Methotrexate and Injections didn't do her much good. In between each one when she had a flare, she took a Prednisolone. Now she was taking Leflunomide (taking one time a day and 20 milligrams) and Plaquenil, Hydroxychloroquine. They helped her a bit, she still had flares in between. Most recent Hydroxychloroquine. She had been on it for 3 years. She had an RX. She had another one for the RA that was taking along with the Plaquenil for the rheumatoid arthritis and it was Leflunomide. Hydroxychloroquine and Methotrexate handy: She hadn't been taking the Methotrexate since Oct of last year. She had one vial of, a partial vial left that she need to take. When probed for any medication of heart disease: Consumer stated, Yes.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400091998 Same Patient/reporter/product, different dose;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old male patient received BNT162b2 (BNT162B2 NOS), in Sep2023 as dose number unknown, single (Lot number: 6215019), in left 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 2024, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient reported that he did not receive other medication in 2weeks of Paxlovid treatment which was administered from 03Apr2024 to 08Apr2024 for the treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid anyway; got covid anyway; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 74-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "cancer patient" (ongoing); "heart patient" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got covid anyway". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient informed that she took all of the covid shots (she believed they were Pfizer but didn't know for sure) and got covid anyway. The patient has a sore throat. The patient wanted to know why did she got covid. The patient informed that she was prescribed Paxlovid and also takes Pravastatin and levothyroxine (a generic) and wanted to be sure it was okay to take them together. The patient wanted to know if it was okay to take Pravastatin and Levothyroxine since she was a cancer patient and a heart patient.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2024, outcome "recovered" (Apr2024); DRUG INEFFECTIVE (medically significant), outcome "recovered" (Apr2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2024) positive; (Apr2024) negative; (Apr2024) negative, notes: 24 hrs apart. Therapeutic measures were taken as a result of drug ineffective, covid-19 with which included from 09Apr2024 to 14Apr2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose number known, single (Lot number: FE3594), in right arm for covid-19 immunisation. The patient's relevant medical history included: "T2 controlled diabetes" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 13Apr2024 to 17Apr2024.  No follow-up attempts are possible.