chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Blood test, Brain fog, Computerised tomogram
Clinical narrative: loss of sense of smell/taste; loss of sense of smell/taste; ongoing headaches; brain fog; feeling fatigued; difficulties focusing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 2, single (Lot number: FF2593) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FE3590), administration date: 12Oct2021, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: BRAIN FOG (non-serious) with onset 02Nov2021, outcome "not recovered"; DISTRACTIBILITY (non-serious) with onset 02Nov2021, outcome "not recovered", described as "difficulties focusing"; FATIGUE (non-serious) with onset 02Nov2021, outcome "not recovered", described as "feeling fatigued"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 02Nov2021, outcome "not recovered" and all described as "loss of sense of smell/taste"; HEADACHE (non-serious) with onset 02Nov2021, outcome "not recovered", described as "ongoing headaches". The events "loss of sense of smell/taste", "ongoing headaches", "brain fog", "feeling fatigued" and "difficulties focusing" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia, ageusia, headache, brain fog, fatigue, distractibility.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Distractibility, Fatigue, Headache
Clinical narrative: loss of sense of smell/taste; loss of sense of smell/taste; ongoing headaches; brain fog; feeling fatigued; difficulties focusing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 2, single (Lot number: FF2593) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FE3590), administration date: 12Oct2021, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: BRAIN FOG (non-serious) with onset 02Nov2021, outcome "not recovered"; DISTRACTIBILITY (non-serious) with onset 02Nov2021, outcome "not recovered", described as "difficulties focusing"; FATIGUE (non-serious) with onset 02Nov2021, outcome "not recovered", described as "feeling fatigued"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 02Nov2021, outcome "not recovered" and all described as "loss of sense of smell/taste"; HEADACHE (non-serious) with onset 02Nov2021, outcome "not recovered", described as "ongoing headaches". The events "loss of sense of smell/taste", "ongoing headaches", "brain fog", "feeling fatigued" and "difficulties focusing" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia, ageusia, headache, brain fog, fatigue, distractibility.
Sex: U
Vaccine: HIBV, MMRV, PNC13, VARCEL, UNK, UNK, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: HCP called to report VARIVAX was inadvertently administered with PROQUAD. No signs/symptoms of adverse effects have been reported; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-AUG-2023, the patient was inadvertently vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # w021743, expiry date: 10-JUL-2024 for prophylaxis (dose and route of administration were not provided) and with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # w026316, expiry date: 18-FEB-2024, albumin status: recombinant Human albumin (rHA) for prophylaxis ((dose and route of administration were not provided) (accidental overdose). No signs/symptoms of adverse effects have been reported.
Sex: U
Vaccine: HIBV, MMRV, PNC13, VARCEL, UNK, UNK, MMRV, VARCEL
Symptoms: Rash
Clinical narrative: HCP called to report VARIVAX was inadvertently administered with PROQUAD. No signs/symptoms of adverse effects have been reported; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-AUG-2023, the patient was inadvertently vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # w021743, expiry date: 10-JUL-2024 for prophylaxis (dose and route of administration were not provided) and with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # w026316, expiry date: 18-FEB-2024, albumin status: recombinant Human albumin (rHA) for prophylaxis ((dose and route of administration were not provided) (accidental overdose). No signs/symptoms of adverse effects have been reported.
Sex: U
Vaccine: HIBV, MMRV, PNC13, VARCEL, UNK, UNK, MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: HCP called to report VARIVAX was inadvertently administered with PROQUAD. No signs/symptoms of adverse effects have been reported; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-AUG-2023, the patient was inadvertently vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # w021743, expiry date: 10-JUL-2024 for prophylaxis (dose and route of administration were not provided) and with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # w026316, expiry date: 18-FEB-2024, albumin status: recombinant Human albumin (rHA) for prophylaxis ((dose and route of administration were not provided) (accidental overdose). No signs/symptoms of adverse effects have been reported.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Heart arrhythmia requiring an ablation procedure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 at 15:30 as dose 2, single (Lot number: FF2583) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EE3590, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 11Oct2021, when the patient was 65-year-old, for COVID-19 Immunization. No known allergy. No COVID prior vaccination. The following information was reported: ARRHYTHMIA (disability) with onset 27Nov2021 at 22:00, outcome "not recovered", described as "Heart arrhythmia requiring an ablation procedure". The event "heart arrhythmia requiring an ablation procedure" required physician office visit. Therapeutic measures were not taken as a result of arrhythmia.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia
Clinical narrative: Heart arrhythmia requiring an ablation procedure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 at 15:30 as dose 2, single (Lot number: FF2583) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EE3590, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 11Oct2021, when the patient was 65-year-old, for COVID-19 Immunization. No known allergy. No COVID prior vaccination. The following information was reported: ARRHYTHMIA (disability) with onset 27Nov2021 at 22:00, outcome "not recovered", described as "Heart arrhythmia requiring an ablation procedure". The event "heart arrhythmia requiring an ablation procedure" required physician office visit. Therapeutic measures were not taken as a result of arrhythmia.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Kind of mimic allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Lot number: GH9703) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Kind of mimic allergies". Additional information: patient said that she does have allergies. No allergy to the vaccine, just the new strain that's out, kind of mimic allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300278629 same patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: Kind of mimic allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Lot number: GH9703) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Kind of mimic allergies". Additional information: patient said that she does have allergies. No allergy to the vaccine, just the new strain that's out, kind of mimic allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300278629 same patient, different dose/event;
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Abdominal pain, Chills, Confusional state, Diarrhoea, Headache
Clinical narrative: On the evening of the day that I was given the booster vaccine, out of no where I started feeling very foggy. I was experiencing dizziness, vertigo, fever, confustion and headache. I took some aleve to help subside the symptoms hoping it would make me feel normal. That evening I had extreme night sweats, chills, headache, stomach ache, heart palpitations, confusion, and vertigo still going on. The next day I went from having a fever to the chills, then back to fever and then chills on and off for a few days while still experiencing headache, confusion, and vertigo. On August 17, 2023 I went into Urgent Care. The Nurse Practitioner that seen me said that there is nothing she can do and I just needed to sleep it off.  She suggested I take Benadryl to make me sleep and Zofran for the stomach pain. I already had all of these medications at home so when I went home that evening, I took the medication and tried to just sleep it off.  I then went the next  days still miserable and made an appointment to see my primary doctor on Monday. She told me that there is nothing she could do and was trying to help me feel better. I then went back to see my primary doctor on Tuesday to run some tests to make sure I did not have  an underlying condition. All of the tests she ran: Covid, Strep, RSV,  and many more all came back negative.  It has now been a week and  2 days and I am still having night sweats, heart palpitations, extreme confusion, headaches, feeling foggy, stomach pain, chills and vertio.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Night sweats, Pain in extremity, Pyrexia
Clinical narrative: On the evening of the day that I was given the booster vaccine, out of no where I started feeling very foggy. I was experiencing dizziness, vertigo, fever, confustion and headache. I took some aleve to help subside the symptoms hoping it would make me feel normal. That evening I had extreme night sweats, chills, headache, stomach ache, heart palpitations, confusion, and vertigo still going on. The next day I went from having a fever to the chills, then back to fever and then chills on and off for a few days while still experiencing headache, confusion, and vertigo. On August 17, 2023 I went into Urgent Care. The Nurse Practitioner that seen me said that there is nothing she can do and I just needed to sleep it off.  She suggested I take Benadryl to make me sleep and Zofran for the stomach pain. I already had all of these medications at home so when I went home that evening, I took the medication and tried to just sleep it off.  I then went the next  days still miserable and made an appointment to see my primary doctor on Monday. She told me that there is nothing she could do and was trying to help me feel better. I then went back to see my primary doctor on Tuesday to run some tests to make sure I did not have  an underlying condition. All of the tests she ran: Covid, Strep, RSV,  and many more all came back negative.  It has now been a week and  2 days and I am still having night sweats, heart palpitations, extreme confusion, headaches, feeling foggy, stomach pain, chills and vertio.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Abdominal pain upper, Brain fog, Chills, Confusional state, Dizziness
Clinical narrative: On the evening of the day that I was given the booster vaccine, out of no where I started feeling very foggy. I was experiencing dizziness, vertigo, fever, confustion and headache. I took some aleve to help subside the symptoms hoping it would make me feel normal. That evening I had extreme night sweats, chills, headache, stomach ache, heart palpitations, confusion, and vertigo still going on. The next day I went from having a fever to the chills, then back to fever and then chills on and off for a few days while still experiencing headache, confusion, and vertigo. On August 17, 2023 I went into Urgent Care. The Nurse Practitioner that seen me said that there is nothing she can do and I just needed to sleep it off.  She suggested I take Benadryl to make me sleep and Zofran for the stomach pain. I already had all of these medications at home so when I went home that evening, I took the medication and tried to just sleep it off.  I then went the next  days still miserable and made an appointment to see my primary doctor on Monday. She told me that there is nothing she could do and was trying to help me feel better. I then went back to see my primary doctor on Tuesday to run some tests to make sure I did not have  an underlying condition. All of the tests she ran: Covid, Strep, RSV,  and many more all came back negative.  It has now been a week and  2 days and I am still having night sweats, heart palpitations, extreme confusion, headaches, feeling foggy, stomach pain, chills and vertio.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Feeling abnormal, Headache, Laboratory test normal, Night sweats, Palpitations
Clinical narrative: On the evening of the day that I was given the booster vaccine, out of no where I started feeling very foggy. I was experiencing dizziness, vertigo, fever, confustion and headache. I took some aleve to help subside the symptoms hoping it would make me feel normal. That evening I had extreme night sweats, chills, headache, stomach ache, heart palpitations, confusion, and vertigo still going on. The next day I went from having a fever to the chills, then back to fever and then chills on and off for a few days while still experiencing headache, confusion, and vertigo. On August 17, 2023 I went into Urgent Care. The Nurse Practitioner that seen me said that there is nothing she can do and I just needed to sleep it off.  She suggested I take Benadryl to make me sleep and Zofran for the stomach pain. I already had all of these medications at home so when I went home that evening, I took the medication and tried to just sleep it off.  I then went the next  days still miserable and made an appointment to see my primary doctor on Monday. She told me that there is nothing she could do and was trying to help me feel better. I then went back to see my primary doctor on Tuesday to run some tests to make sure I did not have  an underlying condition. All of the tests she ran: Covid, Strep, RSV,  and many more all came back negative.  It has now been a week and  2 days and I am still having night sweats, heart palpitations, extreme confusion, headaches, feeling foggy, stomach pain, chills and vertio.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative, Vertigo
Clinical narrative: On the evening of the day that I was given the booster vaccine, out of no where I started feeling very foggy. I was experiencing dizziness, vertigo, fever, confustion and headache. I took some aleve to help subside the symptoms hoping it would make me feel normal. That evening I had extreme night sweats, chills, headache, stomach ache, heart palpitations, confusion, and vertigo still going on. The next day I went from having a fever to the chills, then back to fever and then chills on and off for a few days while still experiencing headache, confusion, and vertigo. On August 17, 2023 I went into Urgent Care. The Nurse Practitioner that seen me said that there is nothing she can do and I just needed to sleep it off.  She suggested I take Benadryl to make me sleep and Zofran for the stomach pain. I already had all of these medications at home so when I went home that evening, I took the medication and tried to just sleep it off.  I then went the next  days still miserable and made an appointment to see my primary doctor on Monday. She told me that there is nothing she could do and was trying to help me feel better. I then went back to see my primary doctor on Tuesday to run some tests to make sure I did not have  an underlying condition. All of the tests she ran: Covid, Strep, RSV,  and many more all came back negative.  It has now been a week and  2 days and I am still having night sweats, heart palpitations, extreme confusion, headaches, feeling foggy, stomach pain, chills and vertio.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid; had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller reports he began having flu symptoms last week. His Covid test was positive. He has had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid. He states his symptoms are mild and his nose is stuffed up every so often.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300281467 same reporter and drug; different events;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid; had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller reports he began having flu symptoms last week. His Covid test was positive. He has had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid. He states his symptoms are mild and his nose is stuffed up every so often.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300281467 same reporter and drug; different events;
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed that no symptomatic adverse events were reported; nurse calling to report temperature excursion. HCP states that MMR-II may have been administered to patient; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 31-JUL-2023, the patient was vaccinated with a measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection that had suffered a temperature excursion (product storage error), at a dose of 0.5 milliliters  (ml) / once (lot #W022640 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), with an expiration date established as 15-APR-2024), administered for prophylaxis (strength, and route of administration were not provided). No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE/no PQC; Product had undergone a TE in July and not reported. PROQUAD was administered after the not supported TE; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 17-JUL-2023, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection that had undergone a temperature excursion (product storage error) (lot number w038812 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 04-JUN-2024), administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion had a timeframe of 120 hours at a temperature of 11 degrees Celsius. No adverse events were reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2308USA003164:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: ROTATEQ that experienced a temperature excursion and was administered.; No side effects reported.; This spontaneous report was received from a medical assistant regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (strength, dosage regimen, lot #, and expiry date were not provided) (Product storage error). Lot number W0291190 is an invalid lot number for pentavalent (ROTATEQ) (expiration date was reported as 28-JAN-2024, conflicting information).  The improperly stored vaccine underwent a temperature excursion of 9.3 degrees Celsius (C) for 11 minutes with a previous excursion of 18.8 degrees Celsius (C) for 2 hours and 55 minutes. No side effects reported.  This is one of three cases received from the same reporter.; Sender's Comments:  US-009507513-2308USA005021: US-009507513-2308USA005116:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No adverse effects reported/No additional AE; TE with ROTATEQ, which was supported and also administered; This spontaneous report was received from physician and referred to a 3-year-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot number W026137 has been verified to be a valid lot number, expiration date reported and validated as 05-FEB-2024), 2 ml, administered as prophylaxis (strength, frequency, vaccination scheme were not provided) after a temperature excursion (TE) (product storage error).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptomatic adverse events; GARDASIL-9 that was expired.; This spontaneous report was received from other health professional (medical assistant) and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with the first expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, once (lot #1780867, expiration date: 08-AUG-2023) for prophylaxis (strength, and route of administration were not provided) (expired product administered). It was confirmed no symptomatic adverse events were reported (no adverse event). It was confirmed product did not have any temperature excursions.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Accidentally Gave a Pregnant Woman a HEPLISAV-B Vaccine; Accidentally Gave a Pregnant Woman a HEPLISAV-B Vaccine; Initial report received on 31-May-2023.  A healthcare professional reported that a 28-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and that the patient is pregnant.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date (approximate date of Apr-2023), the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported) from a pharmacist.   On an unspecified date, after having been vaccinated with HEPLISAV-B, the patient was noted to having been pregnant. The event outcome was not reported.  No additional information was reported.    Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Lethargy
Clinical narrative: Flu-like symptoms; felt lethargic; This non-serious case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu-like symptoms) and lethargy (Verbatim: felt lethargic). The outcome of the influenza-like symptoms and lethargy were resolved (duration 1 week).   The reporter considered the influenza-like symptoms and lethargy to be related to Shingrix.     The company considered the influenza-like symptoms and lethargy to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-AUG-2023 The patient age was reported as 6 decades. The reporter stated that the patient had 1 dose of Shingrix and felt lethargic and had flu-like symptoms for a week after. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Shingles; sore arm/arm still hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-AUG-2023, the patient received the 1st dose of Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) and pain in arm (Verbatim: sore arm/arm still hurt). The outcome of the shingles was not reported and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the shingles and pain in arm to be related to Shingrix.     It was unknown if the company considered the shingles and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-AUG-2023 The case was received from the patient via interactive digital media. The patient yesterday (06August2023) just received one of two shots. The reporter stated that after receiving the one shot of Shingrix vaccine, he had sore arm and his arm still hurts. He also had shingles. The insurance company was paying for it. The follow-up would not required per process
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Loss of motor skills; Loss of appetite/ Could not eat or drink; vomiting; bad diarrhea; Soreness at injection site; Swelling at injection site; not able to sleep and did not sleep for 7 to 8 days; not feeling well; This serious case was reported by a consumer via call center representative and described the occurrence of motor dysfunction in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 2nd dose of Shingrix. In AUG-2023, less than a day after receiving Shingrix, the patient experienced motor dysfunction (Verbatim: Loss of motor skills) (serious criteria hospitalization), appetite lost (Verbatim: Loss of appetite/ Could not eat or drink) (serious criteria hospitalization), vomiting (Verbatim: vomiting) (serious criteria hospitalization), diarrhea (Verbatim: bad diarrhea) (serious criteria hospitalization), injection site pain (Verbatim: Soreness at injection site), injection site swelling (Verbatim: Swelling at injection site), insomnia (Verbatim: not able to sleep and did not sleep for 7 to 8 days) and feeling unwell (Verbatim: not feeling well). The patient was treated with intravenous fluid (nos) (Intravenous Fluids). In AUG-2023, the outcome of the injection site pain, injection site swelling and insomnia were resolved. The outcome of the motor dysfunction, appetite lost, vomiting and diarrhea were unknown and the outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the motor dysfunction, appetite lost, vomiting, diarrhea, injection site pain, injection site swelling, insomnia and feeling unwell to be related to Shingrix.     It was unknown if the company considered the motor dysfunction, appetite lost, vomiting, diarrhea, injection site pain, injection site swelling, insomnia and feeling unwell to be related to Shingrix.   Additional Information: Receipt date: 10-Aug-2023 Patient's husband called to say his wife was hospitalized after the 2nd Shingrix Vaccine.  He said that she had swelling and soreness at the injection site for a few days, swelling and soreness had been resolved.   This vaccine was given approximately one week ago.  Patient was not feeling well after the vaccine and went to lay down.  She was not able to sleep and did not sleep for 7 to 8 days, then patient was taken to the emergency room and had multiple tests with no result.  Patient was given IV fluids.   Patient was released the same day but was readmitted yesterday (day before reporting) with a loss of motor skills, loss of  appetite, bad diarrhea and vomiting.  Patient was currently in the hospital.  Husband said the symptoms started within hours of the second vaccine.  Husband did not have a lot number or expiration date. The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Motor dysfunction, Vomiting
Clinical narrative: Loss of motor skills; Loss of appetite/ Could not eat or drink; vomiting; bad diarrhea; Soreness at injection site; Swelling at injection site; not able to sleep and did not sleep for 7 to 8 days; not feeling well; This serious case was reported by a consumer via call center representative and described the occurrence of motor dysfunction in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 2nd dose of Shingrix. In AUG-2023, less than a day after receiving Shingrix, the patient experienced motor dysfunction (Verbatim: Loss of motor skills) (serious criteria hospitalization), appetite lost (Verbatim: Loss of appetite/ Could not eat or drink) (serious criteria hospitalization), vomiting (Verbatim: vomiting) (serious criteria hospitalization), diarrhea (Verbatim: bad diarrhea) (serious criteria hospitalization), injection site pain (Verbatim: Soreness at injection site), injection site swelling (Verbatim: Swelling at injection site), insomnia (Verbatim: not able to sleep and did not sleep for 7 to 8 days) and feeling unwell (Verbatim: not feeling well). The patient was treated with intravenous fluid (nos) (Intravenous Fluids). In AUG-2023, the outcome of the injection site pain, injection site swelling and insomnia were resolved. The outcome of the motor dysfunction, appetite lost, vomiting and diarrhea were unknown and the outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the motor dysfunction, appetite lost, vomiting, diarrhea, injection site pain, injection site swelling, insomnia and feeling unwell to be related to Shingrix.     It was unknown if the company considered the motor dysfunction, appetite lost, vomiting, diarrhea, injection site pain, injection site swelling, insomnia and feeling unwell to be related to Shingrix.   Additional Information: Receipt date: 10-Aug-2023 Patient's husband called to say his wife was hospitalized after the 2nd Shingrix Vaccine.  He said that she had swelling and soreness at the injection site for a few days, swelling and soreness had been resolved.   This vaccine was given approximately one week ago.  Patient was not feeling well after the vaccine and went to lay down.  She was not able to sleep and did not sleep for 7 to 8 days, then patient was taken to the emergency room and had multiple tests with no result.  Patient was given IV fluids.   Patient was released the same day but was readmitted yesterday (day before reporting) with a loss of motor skills, loss of  appetite, bad diarrhea and vomiting.  Patient was currently in the hospital.  Husband said the symptoms started within hours of the second vaccine.  Husband did not have a lot number or expiration date. The reporter consented to follow up
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: patient had a shingles episode last year/suspected vaccination failure; patient had a shingles episode last year; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 64-year-old male 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: patient had a shingles episode last year/suspected vaccination failure) (serious criteria medically significant) and shingles (Verbatim: patient had a shingles episode last year). The outcome of the vaccination failure and shingles were unknown.   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: Receipt date: 17-AUG-2023 A pharmacist reported that information about a patient who received the 2 doses of Shingrix back in 2020.  The pharmacist mentioned that the patient had a shingles episode last year and asked if it was recommended to repeat the series.  The reporter did not provide any information about the 2 Shingrix doses. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Permission to follow up was not requested.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: received last week a dose of Shingrix but the intended vaccine was Varivax; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: received last week a dose of Shingrix but the intended vaccine was Varivax). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt date: 18-AUG-2023 A pharmacist reported that a patient who received last week a dose of Shingrix but the intended vaccine was Varivax which led to wrong vaccine administered.  The HCP wanted to know what was the recommended interval to administer Varivax after Shingirx.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of Twinrix that had expired; 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 patient who received HAB (Twinrix) (expiry date 20-MAY-2023) for prophylaxis.   On 04-AUG-2023, the patient received Twinrix. On 04-AUG-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Patient received a dose of Twinrix that had 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: 18-AUG-2023 The reporter was a pharmacy student. The vaccine administration facility was the same as primary reporter. The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: infanrix vaccine instead of the boostrix vaccine inadvertently; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis.   On 05-AUG-2023, the patient received the 5th dose of Infanrix. On 05-AUG-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: infanrix vaccine instead of the boostrix vaccine inadvertently) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 21-AUG-2023 The reporter was clinic manager. The reporter reported that a patient was administered an infanrix vaccine instead of the Boostrix vaccine inadvertently, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Device connection issue, Incorrect dose administered, Syringe issue
Clinical narrative: vaccine leaked out during administration; connecting piece on the syringe loosened/ vaccine leaked out; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   On 17-AUG-2023, the patient received Kinrix. On 17-AUG-2023, an unknown time after receiving Kinrix, the patient experienced incomplete dose administered (Verbatim: vaccine leaked out during administration) and syringe leak (Verbatim: connecting piece on the syringe loosened/ vaccine leaked out ). The outcome of the incomplete dose administered and syringe leak were 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: 21-Aug-2023 Nurse reported that a patient was administered a Kinrix vaccine.   Looking at advise to see if and when the patient should be revaccinated. The reporter consented to follow-up via email. The connecting piece on the syringe loosened and the majority of the vaccine leaked out during administration, which led to incomplete dose administered and syringe leak.
Sex: U
Vaccine: COVID19
Symptoms: Tooth loss
Clinical narrative: TEETH FELL OUT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced teeth fell out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of teeth fell out was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Awoke forcefully for 19 days; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Awoke forcefully for 19 days) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 immunization.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient received dose of NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INSOMNIA (Awoke forcefully for 19 days). At the time of the report, INSOMNIA (Awoke forcefully for 19 days) outcome was unknown.            No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2023: Follow up received with significant information Moderna product added as suspect
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was administered post expiration date 13-JUL-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Patient did not describe any medical history or conditions.     On 21-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022).    It was unknown if the patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine. No previous doses were reported.  No concomitant medication was reported.   The expiration date was reported as 13-JUL-2022. Caller wanted to know what the stability of the vaccine after 13-Jun-2022.  No treatment information was reported.  This case contains information for patient 3 out of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-737010 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737010:Master, Patient 1