chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Palpitations, Pyrexia
Clinical narrative: Within a few hours of receiving the vaccination I started to feel dizzy and light headed, my arms and legs also began to feel weak which was accompanied by a severe headache later that evening. The following day my symptoms seemed to have gotten worst I had a fever along with joint pain and muscle spasms by mid afternoon I started to have chest pains and heart palpitations within next few hours my symptoms continued to get worst they were accompanied with swelling of my lips and an even more rapid heartbeat. I remember going upstairs to sit down and before I made it to the couch I had passed out, I do not recall the length of time but by the time I came to the ambulance was at our home. They completed the regular first responders assessment and advised me that If I continue have cheat pain, to feel light headed or weak that I should go to the hospital. I then made an initial appointment with hospital which at that point I was scheduled for follow up x-rays and examinations. I had never received the flu shot prior, and I had never had any medical issues, on any medication and neither does my family have any history of any medical complications. I exercise 4 to 5 times per week and live and maintain a healthy lifestyle and diet, I do not consume alcohol or smoke. In the months that followed I continue to have unexplained frequently occurring chest pains, shortness of breath and heart palpitations.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Chest pain, Chills, Dizziness
Clinical narrative: Within hours after receiving the flu shot I started to have soreness and bruising around the injection sight that lasted for almost 10 days. Within 48 hours I had a high fever, chills, muscle aches accompanied with joint pain, weakness and dizziness. At around 3 days after the flu shot I had hives, a bright red rash all along my arms, which was then followed by severe chest pains, shortness of breathe and heart palpitations.  In the months that followed I continue to have unexplained frequently occurring chest pains, shortness of breath and heart palpitations.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Injection site bruising, Injection site pain, Myalgia, Palpitations
Clinical narrative: Within hours after receiving the flu shot I started to have soreness and bruising around the injection sight that lasted for almost 10 days. Within 48 hours I had a high fever, chills, muscle aches accompanied with joint pain, weakness and dizziness. At around 3 days after the flu shot I had hives, a bright red rash all along my arms, which was then followed by severe chest pains, shortness of breathe and heart palpitations.  In the months that followed I continue to have unexplained frequently occurring chest pains, shortness of breath and heart palpitations.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash, Rash erythematous, Urticaria
Clinical narrative: Within hours after receiving the flu shot I started to have soreness and bruising around the injection sight that lasted for almost 10 days. Within 48 hours I had a high fever, chills, muscle aches accompanied with joint pain, weakness and dizziness. At around 3 days after the flu shot I had hives, a bright red rash all along my arms, which was then followed by severe chest pains, shortness of breathe and heart palpitations.  In the months that followed I continue to have unexplained frequently occurring chest pains, shortness of breath and heart palpitations.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Paraesthesia, Paralysis
Clinical narrative: Patient experienced guillain barre syndrome.  Her symptoms started with tingling in toes on 9/30/2020. She went to the ER on 10/4/2020 with numbness in Arms and legs thinking it was a stroke.  Hospital sent her home since it was not a stroke.  She went to hospital on 10/16/2020 with paralysis and started IVIG treatment for 3 days. She was Discharged 10/20/2020.  The family has applied for help with paying for the treatments.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash, Rash papular
Clinical narrative: Swelling and erythema at site, next day the arm in which vaccine was administered had a papular rash.  The following day the rash was gone from the administered arm and had appeared on the other arm.  The third day, the rash had spread to the trunk and legs and looked more like large hives.  Rash remains 7 days past administration.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site swelling, Pain
Clinical narrative: The patient presented to Doctor on 10/16/2020 at 4:20 PM, Patient stated that she started to get achiness the evening of the vaccination, and then next day she noticed redness around the injection site moving down her arm with swelling.  The patient is to follow up with her PCP as scheduled, and if the condition worsens the patient should receive another evaluation at the emergency room immediately or contact the primary medical clinic to discuss further concerns.  The patient is diagnosed with cellulitis. The patient should take Cipro 500 mg oral tablets as 1 tablet by mouth every 12 hours for 7 days, and should apply topical hydrocortisone to the site of inflammation twice daily.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: slight rash, still a little sore
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: Hives with swelling and redness on left arm
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Pyrexia, Rash
Clinical narrative: rash, arm pain, fever, fatigue
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Cheilitis, Cough, Pharyngeal swelling, Rash
Clinical narrative: Patient had cough, throat swelling, rash on the lip and face 4 hours after received vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Arm and body aches and tiredness at night Fever, 101, shivering, headache all night in bed
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Arm and body aches and tiredness at night Fever, 101, shivering, headache all night in bed
Age: 80.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Blindness unilateral, Gait inability, Laboratory test normal, Muscular weakness
Clinical narrative: About 20-30 minutes after receiving the vaccine, the patient began feeling weakness in the legs/saying unable to walk. We checked all vitals and those were normal. 911 was called and ambulance came. The patient was able to walk out to the ambulance  saying his symptoms had subsided and get checked by emergency personal. After being checked by emergency personal and all vitals being good/symptoms subsiding the patient decided he was fine to go home.  After being home for sometime, the patient's wife stated that he started losing vision in left eye. They consulted with a doctor and were told to go to the hospital. The patient's wife stated that he was admitted and several tests were done to check for blockage/or stroke. All tests are coming back normal. The patient is remaining in hospital for more tests to be done. Unknown if this was caused by either vaccine.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: the male patient received the MMR and Varivax immunizations IM not SQ; This spontaneous report was received from an other health professional and refers to an adult male patient of unknown age (reported as between 30-40 years old). The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 30-SEP-2020, the patient was vaccinated with a doses of: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S005251, expiration date 20-FEB-2021 and varicella virus vaccine live (oka/merck)(VARIVAX) lot # S024364, expiration date 06-AUG-2021 both for prophylaxis (exact doses, doses # and anatomical locations were not provided). Both vaccines were administered intramuscularly (IM) instead of subcutaneously (SQ). It was reported, that the patient was not aware of the incorrect route of administration. The reported asked for some information about giving these vaccines IM instead of SQ.
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 04-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 02-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 05-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 05-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. Combination product report: Yes; brand name: RECOMBIVAX HB SYRINGE (DEVICE); common device name: Hepatitis B Vaccine (Recombinant); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp.; device lot number: S022583; expiration date: 31-OCT-2021; device age and unit: 0; malfunction: Unknown; device usage: Initial; evaluated by mfr: Not returned to manufacturer; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp rep rationale: Case information does not meet the criteria for Reportability: Sender's Comments: US-009507513-2010USA001083.
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 07-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 07-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 10-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 12-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 12-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 13-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 07-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 02-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 03-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2020; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. No information regarding current condition, historical condition and concomitant medication was provided. In 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the use of the zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Snoring, Vomiting
Clinical narrative: passed out cold and was snoring; passed out cold and was snoring; vomiting; This spontaneous report was received from a vaccine coordinator/nurse via a field representative and refers to a 15-year-old female patient. She was in good health and had no significant medical history. Her concomitant therapies included influenza virus vaccine (unspecified) (reported as flu vaccine). There was no information about patient's drug reactions and allergies.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, lot#, expiration date anatomical location and route of administration were not reported). No problems were noted after the first vaccination. On 12-OCT-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter, via intramuscular route (frequency, lot #, expiration date and anatomical location were not reported) as vaccination against human papilloma virus (HPV). On the same day, within 5 minutes after vaccination, the patient passed out cold and was snoring. It was stated that when the patient came to, she started vomiting. The patient had not eaten anything prior to coming to the office. She did not seek medical attention and did not receive any treatment for the events. The nurse stated that they followed up with the patient later that day and after some sleep, she felt much better.  The patient recovered from the events on the same day (12-OCT-2020). The causality assessment was not provided.  Upon internal review, the event of passed out cold was determined to be medically significant.
Sex: F
Vaccine: FLU4, MENB
Symptoms: Musculoskeletal stiffness
Clinical narrative: neck stiffness; This case was reported by a nurse via sales rep and described the occurrence of stiff neck in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On 7th October 2020, the patient received Bexsero and FluLaval Tetra 2020-2021 season. On 10th October 2020, 3 days after receiving Bexsero and FluLaval Tetra 2020-2021 season, the patient experienced stiff neck. The patient was treated with ibuprofen. On an unknown date, the outcome of the stiff neck was recovering/resolving.   It was unknown if the reporter considered the stiff neck to be related to Bexsero and FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Bexsero in one arm and FluLaval in the other on same day. Patient experienced neck stiffness on the side that the FluLaval was given. The patient was advised to take Ibuprofen. The patient reported that event was resolving.
Sex: U
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: developed itchy rashes on my body; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: This case reported by patient himself/herself. The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient was wondering, as reported reactions to 2nd shingles vaccination. The patient developed several itchy rashes on body.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: 2 doses of Boostrix received; Pregnant patient / 2 doses of Boostrix / 2-10/8/2020; Pregnant patient recdived 2 doses of Boostrix, first dose on  9/182020; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number Z59N7, expiry date 8th October 2022) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Boostrix. On 8th October 2020, the patient received the 2nd dose of Boostrix (intramuscular). The patient's last menstrual period was on 29th March 2020 and estimated date of delivery was 23rd December 2020. The patient received Boostrix at week 24 of the pregnancy. On 18th September 2020, not applicable after receiving Boostrix and unknown after receiving Boostrix, the patient experienced vaccine exposure during pregnancy. In October 2020, the patient experienced vaccine exposure during pregnancy. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. The pregnancy was ongoing.   Additional details were provided as follows: The age at vaccination was not reported. A nurse reported a pregnant patient came and received 2 doses of Boostrix one month apart which led to extra dose administered.  No symptoms reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like aches; This case was reported by a consumer via call center representative and described the occurrence of flu-like aching in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced flu-like aching. On an unknown date, the outcome of the flu-like aching was recovered/resolved.   It was unknown if the reporter considered the flu-like aching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 3 or 4 months ago and had flu like aches for 2 days. The reporter did not consent to follow up. The reporter did not had any additional details regarding patient experience with Shingrix. This case linked with US2020208335, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020208335:same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats
Clinical narrative: Night Sweats; This case was reported by a pharmacist via call center representative and described the occurrence of night sweat in a 69-year-old female patient who received Herpes zoster SHINGRIX for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of SHINGRIX. On 27th September 2020, 5 days after receiving SHINGRIX, the patient experienced night sweat. On an unknown date, the outcome of the night sweat was not recovered/not resolved.   It was unknown if the reporter considered the night sweat to be related to SHINGRIX.  Additional details were provided as follows: The patient was vaccinated with dose of SHINGRIX. 5 days after vaccination patient started to experience Night Sweats that occur every night and were ongoing. All information was not available. The reporter consent to follow up.