chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Tachycardia
Clinical narrative: facial flushing; tachycardia; blood pressure went 140 over 85; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (facial flushing), TACHYCARDIA (tachycardia), BLOOD PRESSURE INCREASED (blood pressure went 140 over 85) and HYPERSENSITIVITY (allergic reaction) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy, Hypertension in 2019 and Depression since 1997. Concomitant products included MODAFINIL and LAMOTRIGINE for Depression, CHLORTALIDONE (CHLORTHALIDONE) for Hypertension.    On 22-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Sep-2022, the patient experienced FLUSHING (facial flushing), TACHYCARDIA (tachycardia), BLOOD PRESSURE INCREASED (blood pressure went 140 over 85) and HYPERSENSITIVITY (allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) on 22-Sep-2022 at a dose of 50 milligram. On 22-Sep-2022, FLUSHING (facial flushing), TACHYCARDIA (tachycardia), BLOOD PRESSURE INCREASED (blood pressure went 140 over 85) and HYPERSENSITIVITY (allergic reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2022, Blood pressure measurement: 140/85. On 22-Sep-2022, Heart rate: 94.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was physician working in pharmacovigilance had several leadership positions in Drug Safety/ PV organizations at multiple companies.   This case was linked to MOD-2022-651090 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Significant follow up was received.
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 , on 18Sep2022 at 11:45 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pacemaker" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022); MALAISE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "feeling unwell"; PYREXIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "fever"; HEADACHE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022); VACCINATION SITE PAIN (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "injection site pain"; ARTHRALGIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "joint pain"; MYALGIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "muscle pain"; FATIGUE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, headache, myalgia, chills, arthralgia, pyrexia, malaise.  Additional information: the patient did not receive other vaccine in four weeks. No covid-19 prior vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 , on 18Sep2022 at 11:45 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pacemaker" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022); MALAISE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "feeling unwell"; PYREXIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "fever"; HEADACHE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022); VACCINATION SITE PAIN (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "injection site pain"; ARTHRALGIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "joint pain"; MYALGIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "muscle pain"; FATIGUE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, headache, myalgia, chills, arthralgia, pyrexia, malaise.  Additional information: the patient did not receive other vaccine in four weeks. No covid-19 prior vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 , on 18Sep2022 at 11:45 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pacemaker" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022); MALAISE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "feeling unwell"; PYREXIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "fever"; HEADACHE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022); VACCINATION SITE PAIN (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "injection site pain"; ARTHRALGIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "joint pain"; MYALGIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "muscle pain"; FATIGUE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, headache, myalgia, chills, arthralgia, pyrexia, malaise.  Additional information: the patient did not receive other vaccine in four weeks. No covid-19 prior vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 , on 18Sep2022 at 11:45 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pacemaker" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022); MALAISE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "feeling unwell"; PYREXIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "fever"; HEADACHE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022); VACCINATION SITE PAIN (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "injection site pain"; ARTHRALGIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "joint pain"; MYALGIA (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "muscle pain"; FATIGUE (non-serious) with onset 24Sep2022 at 16:00, outcome "recovered" (26Sep2022), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, headache, myalgia, chills, arthralgia, pyrexia, malaise.  Additional information: the patient did not receive other vaccine in four weeks. No covid-19 prior vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: No adverse event; not sure if he received the original vaccine or the new Bivalent shot. He states that they texted him a different lot number; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (not sure if he received the original vaccine or the new Bivalent shot. He states that they texted him a different lot number) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (not sure if he received the original vaccine or the new Bivalent shot. He states that they texted him a different lot number). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (not sure if he received the original vaccine or the new Bivalent shot. He states that they texted him a different lot number) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant drug was reported. Patient was not sure if he received the original vaccine or the new Bivalent shot. Patient stated that he was concerned that they might have given him the wrong shot, the original (Monovalent ) booster shot. No treatment drug was reported.   Reporter did not allow further contact
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No adverse event; not sure if he received the original vaccine or the new Bivalent shot. He states that they texted him a different lot number; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (not sure if he received the original vaccine or the new Bivalent shot. He states that they texted him a different lot number) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (not sure if he received the original vaccine or the new Bivalent shot. He states that they texted him a different lot number). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (not sure if he received the original vaccine or the new Bivalent shot. He states that they texted him a different lot number) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant drug was reported. Patient was not sure if he received the original vaccine or the new Bivalent shot. Patient stated that he was concerned that they might have given him the wrong shot, the original (Monovalent ) booster shot. No treatment drug was reported.   Reporter did not allow further contact
Age: 19.0
Sex: M
Vaccine: SMALLMNK, UNK
Symptoms: Blister, Erythema, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 4 d after receiving vaccine, patient developed 4 pruritic macular lesions, one on the L wrist, one on the dorsal left foreamr (vaccine administered on the left volar forearm), and 2 on the left leg
Age: 19.0
Sex: M
Vaccine: SMALLMNK, UNK
Symptoms: Polymerase chain reaction
Clinical narrative: 4 d after receiving vaccine, patient developed 4 pruritic macular lesions, one on the L wrist, one on the dorsal left foreamr (vaccine administered on the left volar forearm), and 2 on the left leg
Age: 19.0
Sex: M
Vaccine: SMALLMNK, UNK
Symptoms: Injection site reaction, Rash, Rash macular, Rash pruritic, Viral test negative
Clinical narrative: 4 d after receiving vaccine, patient developed 4 pruritic macular lesions, one on the L wrist, one on the dorsal left foreamr (vaccine administered on the left volar forearm), and 2 on the left leg
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Constipation, Defaecation urgency, Feeling abnormal, Sleep disorder
Clinical narrative: Approximately 45 hours after the COVID Bivalent injection I felt poorly and started to shiver. Was not cold and did not have a fever; just needed to shiver. This continued even as I got into bed about 11:30pm. About 3:15am I was awake attempting to satisfy a perceived need for a bowel movement without success; at that time the shivering had stopped. At 3:45am I went back to bed and slept until 9:15am when I got up and the event had apparently ended.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Hypotension, Injection site cellulitis, Sepsis
Clinical narrative: Patient developed cellulitis at injection site. Patient subsequently was hypotensive/septic and had to be hospitalized.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Impaired work ability, Lymphadenopathy, Myalgia
Clinical narrative: Large painful swelling of the lymph nodes on the lower anterior throat beginning the morning after the vaccination (approx 16hrs) and significantly getting worse until treatment in the ED that evening, extreme fatigue, and general soreness of muscles in arms and wrists.   Events resolved after 5 days of high-dose steroids and rest which involved time off work.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: Large painful swelling of the lymph nodes on the lower anterior throat beginning the morning after the vaccination (approx 16hrs) and significantly getting worse until treatment in the ED that evening, extreme fatigue, and general soreness of muscles in arms and wrists.   Events resolved after 5 days of high-dose steroids and rest which involved time off work.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal distension, Atrial fibrillation, Blood test, Computerised tomogram, Constipation
Clinical narrative: 9.27.2022 PATIENT STARTED FEELING BLOATED AND CONSTIPATED. HE WENT TO AN URGENT CARE WHERE HE WAS PRESCRIBED REGLAN. HE THEN STARTED HAVING DIARRHEA, NAUSEA AND VOMITING. THEN HE CAME TO OUR ER FOR EVALUATION AND WAS FOUND TO HAVE NEW ONSET OF AFIB WITH RVR.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diarrhoea, Electrocardiogram abnormal, Nausea, Vomiting
Clinical narrative: 9.27.2022 PATIENT STARTED FEELING BLOATED AND CONSTIPATED. HE WENT TO AN URGENT CARE WHERE HE WAS PRESCRIBED REGLAN. HE THEN STARTED HAVING DIARRHEA, NAUSEA AND VOMITING. THEN HE CAME TO OUR ER FOR EVALUATION AND WAS FOUND TO HAVE NEW ONSET OF AFIB WITH RVR.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph node - size of softball
Age: 79.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Chest discomfort, Dysphonia, Dyspnoea, Pneumonitis
Clinical narrative: The first 3 Covid vaccines were from Moderna. The 4th was Pfizer.  Within 24 hours after vaccination, my breathing began to be a little more difficult. The 5th day after vaccination, I am having considerable trouble breathing and have begun Amoxicillin 875 to stop inflammation in my lungs. I hope that works. The tightness in lungs feels like bronchitis without the cough. My voice is weak and different from normal.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Implantable cardiac monitor insertion, Implantable defibrillator insertion, Sinus arrest
Clinical narrative: PATIENT HAD A 12-13 SECOND PAUSE ON HER LOOP RECORDER AND WEAKNESS
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Mild symptoms started at 5pm: body aches, headache Chills started at 7pm Fever started at 9pm and continued to rise, currently 101.8F oral, HR 105 bpm, o2 sat 95%
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Arthralgia, Axillary pain, Chills, Diarrhoea
Clinical narrative: Heavier longer period, period came early again with every shot, fever, chills, abdominal to hip pain, muscle aches, pain at injection site, soreness in arm pit, headaches, nausea, diarrhea, vomit (once), hoarse felt like vocal chords straining for 4 days.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphonia, Extra dose administered, Headache, Heavy menstrual bleeding, Injection site pain
Clinical narrative: Heavier longer period, period came early again with every shot, fever, chills, abdominal to hip pain, muscle aches, pain at injection site, soreness in arm pit, headaches, nausea, diarrhea, vomit (once), hoarse felt like vocal chords straining for 4 days.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Menstruation irregular, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Heavier longer period, period came early again with every shot, fever, chills, abdominal to hip pain, muscle aches, pain at injection site, soreness in arm pit, headaches, nausea, diarrhea, vomit (once), hoarse felt like vocal chords straining for 4 days.
Age: 32.0
Sex: F
Vaccine: ANTH, TD
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: SWELLING AT THE SITE, SORENESS, HOT TO THE TOUCH, ITCHING AT SITE, BODY ACHES, SORENESS TO ENTIRE ARM
Age: 32.0
Sex: F
Vaccine: ANTH, TD
Symptoms: Pain in extremity
Clinical narrative: SWELLING AT THE SITE, SORENESS, HOT TO THE TOUCH, ITCHING AT SITE, BODY ACHES, SORENESS TO ENTIRE ARM
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Gambling disorder
Clinical narrative: After receiving one dose of the Moderna Covid 19 vaccine on May2021, patient immediately started to compulsively gambling; This spontaneous case was reported by a patient and describes the occurrence of GAMBLING DISORDER (After receiving one dose of the Moderna Covid 19 vaccine on May2021, patient immediately started to compulsively gambling) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced GAMBLING DISORDER (After receiving one dose of the Moderna Covid 19 vaccine on May2021, patient immediately started to compulsively gambling). At the time of the report, GAMBLING DISORDER (After receiving one dose of the Moderna Covid 19 vaccine on May2021, patient immediately started to compulsively gambling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  It was reported that patient wants to play and go to the facility constantly.  No treatment was given to the patient.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired GARDASIL 9 on 09/06/2022.; This spontaneous report has been received from a pharmacist, concerning to a patient of an unknown age and gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 06-SEP-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dosage, strength, vaccination scheme frequency, anatomical site of application and route of administration were not provided; lot number T007035 that was verified to be valid for syringe formulation with expiration date reported and established as 01-MAY-2022) for prophylaxis (expired product administered).   No additional adverse event (AE) (no adverse event) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 26-JUL-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller reported patient received 1st dose of VARIVAX in 2017 and did not receive a second dose.; No additional AEs; This spontaneous report has been received from a pharmacist concerning a currently 53-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On an unspecified date in 2017, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, anatomical location, route of administration, lot# and expiration date were not reported) for prophylaxis. At the reporting time, the patient had not received a second dose (Routine immunization schedule incomplete).  No additional adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: No additional AE information provided.; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted; HCP states that the personadministering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering it; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-AUG-2022, the patient was vaccinated with the second dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 mL (route of administration was not provided) lot #U039951, expiration date: 22-JUN-2024, administered as prophylaxis which was accidentally diluted with 0.5 mL of normal saline (Incorrect dose administered) (Product preparation error). No additional adverse event (AE) information provided.  This is one of several cases received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported; Caller explained VARIVAX was administered after a temperature excursion; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # U025204 and expiration date 13-AUG-2023, administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 26.6 degree fahrenheit (F) for 1 hour, and 7.9 F for 30 minutes on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported.
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Blood immunoglobulin G normal, Body temperature increased, CSF glucose increased, CSF lymphocyte count increased
Clinical narrative: vaccine-strain varicella zoster virus (vVZV) meningoencephalitis; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a 10-year-old male patient with attention-deficit hyperactivity disorder (ADHD). His medical history and concomitant medications were not reported.  On unknown dates, the patient was vaccinated with the first and the second dose of varicella virus vaccine live (manufacturer unknown) subcutaneous injection (dose, site and route of administration, lot#, and expiration date were not reported) for prophylaxis and he completed the two-dose series.  On an unknown date, he presented to a emergency department (ED) with headache and rash. Symptoms started five days prior to presentation with left upper extremity (LUE) pain, followed by the appearance of multiple blisters on the LUE. His doctor diagnosed him with shingles and recommended supportive care. The rash worsened and he developed severe frontal headache. In the ED, his temperature was 38.1 degree Celsius (C). All other vitals were normal. Exam revealed LUE coalescing vesicles on an erythematous base, particularly in the C7 dermatome. Additional solitary lesions were noted on the left thigh and bilateral scapulae. While in the ED, he became confused, mistaking providers for school classmates. Head computed tomography (CT) was unremarkable. Cerebral spinal fluid (CSF) revealed lymphocytosis (red blood cells 4 (units not reported), white blood cells 26 (units not reported), 82% lymphocytes, glucose 53 (units not reported), protein 32). Ultimately, LUE vesicles and CSF were varicella zoster virus (VZV) polymerase chain reaction (PCR) positive. Genotyping showed vaccine-strain VZV (vVZV) rather than wild-type (wtVZV). On an unknown date, he was diagnosed with vVZV meningoencephalitis. Initial immune workup was normal, including total immunoglobulin G (IgG) and subclasses, varicella IgG, human immunodeficiency virus (HIV), and pneumococcal titers. The patient completed a 10-day course of intravenous acyclovir and a 14-day course of oral acyclovir. At 4-month follow-up, he was asymptomatic. Outcome of the event was unknown.  The event of vaccine-strain VZV meningoencephalitis was considered to be related to varicella virus vaccine live (manufacturer unknown).  Upon internal review, the event of vaccine-strain VZV meningoencephalitis was considered to be medically significant.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience
Sex: M
Vaccine: VARCEL
Symptoms: CSF protein increased, CSF red blood cell count positive, CSF test abnormal, CSF white blood cell count increased, Computerised tomogram head normal
Clinical narrative: vaccine-strain varicella zoster virus (vVZV) meningoencephalitis; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a 10-year-old male patient with attention-deficit hyperactivity disorder (ADHD). His medical history and concomitant medications were not reported.  On unknown dates, the patient was vaccinated with the first and the second dose of varicella virus vaccine live (manufacturer unknown) subcutaneous injection (dose, site and route of administration, lot#, and expiration date were not reported) for prophylaxis and he completed the two-dose series.  On an unknown date, he presented to a emergency department (ED) with headache and rash. Symptoms started five days prior to presentation with left upper extremity (LUE) pain, followed by the appearance of multiple blisters on the LUE. His doctor diagnosed him with shingles and recommended supportive care. The rash worsened and he developed severe frontal headache. In the ED, his temperature was 38.1 degree Celsius (C). All other vitals were normal. Exam revealed LUE coalescing vesicles on an erythematous base, particularly in the C7 dermatome. Additional solitary lesions were noted on the left thigh and bilateral scapulae. While in the ED, he became confused, mistaking providers for school classmates. Head computed tomography (CT) was unremarkable. Cerebral spinal fluid (CSF) revealed lymphocytosis (red blood cells 4 (units not reported), white blood cells 26 (units not reported), 82% lymphocytes, glucose 53 (units not reported), protein 32). Ultimately, LUE vesicles and CSF were varicella zoster virus (VZV) polymerase chain reaction (PCR) positive. Genotyping showed vaccine-strain VZV (vVZV) rather than wild-type (wtVZV). On an unknown date, he was diagnosed with vVZV meningoencephalitis. Initial immune workup was normal, including total immunoglobulin G (IgG) and subclasses, varicella IgG, human immunodeficiency virus (HIV), and pneumococcal titers. The patient completed a 10-day course of intravenous acyclovir and a 14-day course of oral acyclovir. At 4-month follow-up, he was asymptomatic. Outcome of the event was unknown.  The event of vaccine-strain VZV meningoencephalitis was considered to be related to varicella virus vaccine live (manufacturer unknown).  Upon internal review, the event of vaccine-strain VZV meningoencephalitis was considered to be medically significant.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience
Sex: M
Vaccine: VARCEL
Symptoms: Confusional state, Encephalitis, HIV test negative, Headache, Herpes zoster
Clinical narrative: vaccine-strain varicella zoster virus (vVZV) meningoencephalitis; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a 10-year-old male patient with attention-deficit hyperactivity disorder (ADHD). His medical history and concomitant medications were not reported.  On unknown dates, the patient was vaccinated with the first and the second dose of varicella virus vaccine live (manufacturer unknown) subcutaneous injection (dose, site and route of administration, lot#, and expiration date were not reported) for prophylaxis and he completed the two-dose series.  On an unknown date, he presented to a emergency department (ED) with headache and rash. Symptoms started five days prior to presentation with left upper extremity (LUE) pain, followed by the appearance of multiple blisters on the LUE. His doctor diagnosed him with shingles and recommended supportive care. The rash worsened and he developed severe frontal headache. In the ED, his temperature was 38.1 degree Celsius (C). All other vitals were normal. Exam revealed LUE coalescing vesicles on an erythematous base, particularly in the C7 dermatome. Additional solitary lesions were noted on the left thigh and bilateral scapulae. While in the ED, he became confused, mistaking providers for school classmates. Head computed tomography (CT) was unremarkable. Cerebral spinal fluid (CSF) revealed lymphocytosis (red blood cells 4 (units not reported), white blood cells 26 (units not reported), 82% lymphocytes, glucose 53 (units not reported), protein 32). Ultimately, LUE vesicles and CSF were varicella zoster virus (VZV) polymerase chain reaction (PCR) positive. Genotyping showed vaccine-strain VZV (vVZV) rather than wild-type (wtVZV). On an unknown date, he was diagnosed with vVZV meningoencephalitis. Initial immune workup was normal, including total immunoglobulin G (IgG) and subclasses, varicella IgG, human immunodeficiency virus (HIV), and pneumococcal titers. The patient completed a 10-day course of intravenous acyclovir and a 14-day course of oral acyclovir. At 4-month follow-up, he was asymptomatic. Outcome of the event was unknown.  The event of vaccine-strain VZV meningoencephalitis was considered to be related to varicella virus vaccine live (manufacturer unknown).  Upon internal review, the event of vaccine-strain VZV meningoencephalitis was considered to be medically significant.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience
Sex: M
Vaccine: VARCEL
Symptoms: Immunology test, Laboratory test normal, Lymphocytosis, Pain in extremity, Rash
Clinical narrative: vaccine-strain varicella zoster virus (vVZV) meningoencephalitis; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a 10-year-old male patient with attention-deficit hyperactivity disorder (ADHD). His medical history and concomitant medications were not reported.  On unknown dates, the patient was vaccinated with the first and the second dose of varicella virus vaccine live (manufacturer unknown) subcutaneous injection (dose, site and route of administration, lot#, and expiration date were not reported) for prophylaxis and he completed the two-dose series.  On an unknown date, he presented to a emergency department (ED) with headache and rash. Symptoms started five days prior to presentation with left upper extremity (LUE) pain, followed by the appearance of multiple blisters on the LUE. His doctor diagnosed him with shingles and recommended supportive care. The rash worsened and he developed severe frontal headache. In the ED, his temperature was 38.1 degree Celsius (C). All other vitals were normal. Exam revealed LUE coalescing vesicles on an erythematous base, particularly in the C7 dermatome. Additional solitary lesions were noted on the left thigh and bilateral scapulae. While in the ED, he became confused, mistaking providers for school classmates. Head computed tomography (CT) was unremarkable. Cerebral spinal fluid (CSF) revealed lymphocytosis (red blood cells 4 (units not reported), white blood cells 26 (units not reported), 82% lymphocytes, glucose 53 (units not reported), protein 32). Ultimately, LUE vesicles and CSF were varicella zoster virus (VZV) polymerase chain reaction (PCR) positive. Genotyping showed vaccine-strain VZV (vVZV) rather than wild-type (wtVZV). On an unknown date, he was diagnosed with vVZV meningoencephalitis. Initial immune workup was normal, including total immunoglobulin G (IgG) and subclasses, varicella IgG, human immunodeficiency virus (HIV), and pneumococcal titers. The patient completed a 10-day course of intravenous acyclovir and a 14-day course of oral acyclovir. At 4-month follow-up, he was asymptomatic. Outcome of the event was unknown.  The event of vaccine-strain VZV meningoencephalitis was considered to be related to varicella virus vaccine live (manufacturer unknown).  Upon internal review, the event of vaccine-strain VZV meningoencephalitis was considered to be medically significant.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Skin lesion, Varicella virus test positive
Clinical narrative: vaccine-strain varicella zoster virus (vVZV) meningoencephalitis; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a 10-year-old male patient with attention-deficit hyperactivity disorder (ADHD). His medical history and concomitant medications were not reported.  On unknown dates, the patient was vaccinated with the first and the second dose of varicella virus vaccine live (manufacturer unknown) subcutaneous injection (dose, site and route of administration, lot#, and expiration date were not reported) for prophylaxis and he completed the two-dose series.  On an unknown date, he presented to a emergency department (ED) with headache and rash. Symptoms started five days prior to presentation with left upper extremity (LUE) pain, followed by the appearance of multiple blisters on the LUE. His doctor diagnosed him with shingles and recommended supportive care. The rash worsened and he developed severe frontal headache. In the ED, his temperature was 38.1 degree Celsius (C). All other vitals were normal. Exam revealed LUE coalescing vesicles on an erythematous base, particularly in the C7 dermatome. Additional solitary lesions were noted on the left thigh and bilateral scapulae. While in the ED, he became confused, mistaking providers for school classmates. Head computed tomography (CT) was unremarkable. Cerebral spinal fluid (CSF) revealed lymphocytosis (red blood cells 4 (units not reported), white blood cells 26 (units not reported), 82% lymphocytes, glucose 53 (units not reported), protein 32). Ultimately, LUE vesicles and CSF were varicella zoster virus (VZV) polymerase chain reaction (PCR) positive. Genotyping showed vaccine-strain VZV (vVZV) rather than wild-type (wtVZV). On an unknown date, he was diagnosed with vVZV meningoencephalitis. Initial immune workup was normal, including total immunoglobulin G (IgG) and subclasses, varicella IgG, human immunodeficiency virus (HIV), and pneumococcal titers. The patient completed a 10-day course of intravenous acyclovir and a 14-day course of oral acyclovir. At 4-month follow-up, he was asymptomatic. Outcome of the event was unknown.  The event of vaccine-strain VZV meningoencephalitis was considered to be related to varicella virus vaccine live (manufacturer unknown).  Upon internal review, the event of vaccine-strain VZV meningoencephalitis was considered to be medically significant.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from medical assistant and refers to a 1 year-old female patient.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W003819, expiration date: 24-FEB-2022, administered subcutaneously on the left thigh as prophylaxis (strength was not provided) following a temperature excursion of  14 degrees Fahrenheit (F) up to 46 F for 1 hour 30 minutes data logger involved (product storage error), it was mentioned that no previous temperature excursion occurred. No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008720: US-009507513-2209USA008838: US-009507513-2209USA008836: US-009507513-2209USA008837: US-009507513-2209USA008835:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; expired dose of GARDASIL 9  was administered to an adolescent patient; This spontaneous report was received from a physician via a company representative and referred to an adolescent patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-SEP-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, quantity: 1, to prevent human papilloma virus infection (lot #1659422, expiration date: 04-SEP-2022, strength, dose, and route of administration were not provided) (expired product administered). No additional adverse event was reported (no adverse event).
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram thorax abnormal, Malaise, Pneumonia, Pyrexia, Scan with contrast abnormal
Clinical narrative: Patient was diagnosed with Pneumonia; This spontaneous report was received from an 81-year-old female patient who was reporting on herself. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Historical drugs included pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) received around June - August 2021. She stated she was in good health and never had pneumonia or lung issues in her life.  On 08-SEP-2022, the patient received one dose of booster vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, frequency, route of administration, lot number and expiration date were not reported) as prophylaxis.  On 19-SEP-2022 (also reported as 11 days after the vaccination), she became very sick and had a fever. She stated that she had never been so sick like this. On 21-SEP-2022, the patient was admitted to the hospital due to the event. White blood cell count level was 12,000 (unit not provided). A computerized tomography (CT) of the chest with contrast was performed, and the patient was diagnosed with pneumonia and placed on intravenous (IV) medications. IV medications brought their white blood cell count to normal levels. The patient stated that she hoped to be discharged on 23-SEP-2022 (reported as tomorrow) and sent home with oral medications. She stated that she found it 'very fishy' that less than two weeks after receiving the vaccine, she was diagnosed with pneumonia. At the reporting time, the outcome of the event was recovering as the patient stated that she was doing better, but not completely well.  The causality between the event of pneumonia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 was not reported.  Upon internal review, the event of pneumonia was considered to be medically significant.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Patient was diagnosed with Pneumonia; This spontaneous report was received from an 81-year-old female patient who was reporting on herself. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Historical drugs included pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) received around June - August 2021. She stated she was in good health and never had pneumonia or lung issues in her life.  On 08-SEP-2022, the patient received one dose of booster vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, frequency, route of administration, lot number and expiration date were not reported) as prophylaxis.  On 19-SEP-2022 (also reported as 11 days after the vaccination), she became very sick and had a fever. She stated that she had never been so sick like this. On 21-SEP-2022, the patient was admitted to the hospital due to the event. White blood cell count level was 12,000 (unit not provided). A computerized tomography (CT) of the chest with contrast was performed, and the patient was diagnosed with pneumonia and placed on intravenous (IV) medications. IV medications brought their white blood cell count to normal levels. The patient stated that she hoped to be discharged on 23-SEP-2022 (reported as tomorrow) and sent home with oral medications. She stated that she found it 'very fishy' that less than two weeks after receiving the vaccine, she was diagnosed with pneumonia. At the reporting time, the outcome of the event was recovering as the patient stated that she was doing better, but not completely well.  The causality between the event of pneumonia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 was not reported.  Upon internal review, the event of pneumonia was considered to be medically significant.
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: patient did not receive a full dose of VARIVAX due to "user error."; patient did not receive a full dose of VARIVAX due to "user error."; no aditional AE reported; This spontaneous report was received from a nurse and refers to a 17-month-old patient.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with less than full dose as first dose of varicella virus vaccine live (oka/merck) (VARIVAX)due to "user error" (Unevaluable event) lot #W002601, expiration date: 24-JAN-2024 (dose description, route of administration were not provided) as prophylaxis (Inappropriate dose of vaccine administered). No additional adverse event was reported.