chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 27-AUG-2014, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-APR-2016, the patient was treated by a physician at the medical group facility for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed acyclovir for management of her painful symptoms and chronic pain.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 27-JAN-2014, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical group office (by an unspecified health care professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-SEP-2016, the patient was treated by a nurse practitioner family health facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed acyclovir for management of her painful symptoms and pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 05-JAN-2012, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-SEP-2014, the patient was treated by a physician (site not specified) for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 17 year and 6 months old (reported as "17.5 year old") adolescent patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 09-MAY-2018, the patient was inadvertently vaccinated with an adult dose of VAQTA lot # N016805 with expiration date 04-SEP-2019,  for prophylaxis (route of administration was not reported). No adverse effects were reported.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Pyrexia, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician and refers to a 55 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications and it was stated that the patient did not have any allergies. On 20-APR-2018, the patient was vaccinated with an unspecified dose of VARIVAX injection, lot number N027627 with expiration date on 04-OCT-201, as the patient was a not immune healthcare worker (strength, dose, route of administration and anatomical location were not reported. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) injection (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). On 05-MAY-2018, the patient experienced 50 vesicular lesions on chest spreading over body with unspecified fever (rash vesicular and pyrexia), therefore, the patient was placed under an unspecified therapy treatment. On an unspecified date in May 2018, a varicella Immunoglobulin M (IGM) test was performed and the result was negative, 5/9 (units not provided) (antibody test negative). On approximately 08-MAY-2018, reported as "since last week", the patient's lesions were fading and there were no new outbreaks. The outcome of antibody test negative was not reported and the reporter did not assess the causal relationship between therapy with VARIVAX or sterile diluent (MERCK STERILE DILUENT) and the aforementioned events.
Age: 13.0
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 17-AUG-2015, when the patient was 13 years old, was vaccinated with GARDASIL (lot # K010215 with expiration date of 17-JAN-2016, for prophylaxis) (dose, route of administration, and anatomical location were not reported). On 06-SEP-2017, when the patient was 15 years old, was vaccinated with GARDASIL 9 (lot # N010497 with expiration date of 15-JAN-2020) (dose, route of administration, and anatomical location were not reported). No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash generalised
Clinical narrative: This spontaneous report was received from a physician via company representative concerning a 1 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient was also vaccinated with VARIVAX for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient experienced fever for 3 days (pyrexia) followed by prominent red rash covering legs, body and face (rash erythematous). The outcome of pyrexia and rash erythematous and the causal relationship between the events and therapy with M-M-R II and VARIVAX were not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 15-MAY-2018, the patient inadvertently received an expired dose of VAQTA (route, dose, frequency, and anatomical location were unknown) with lot # N005605 and expiration date 08-APR-2018 for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse refers to a 13-year old patient of unknown gender. The patient's medical History, concurrent conditions and concomitant therapies were not reported. On 01-SEP-2017, the 13-year old patient received the improperly stored dose of GARDASIL 9 (lot # N000326, expiration date 14-OCT-2017; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion was at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. Sender's Comments: US-009507513-1710USA004063.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse refers to an infant patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-SEP-2017, the patient received an improperly stored dose of RECOMBIVAX HB (lot # M031574, expiration date: 11-NOV-2018; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion occurred at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. Sender's Comments: US-009507513-1710USA004063.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse refers to a 12-year old patient of unknown gender. The patient's medical History, concurrent conditions and concomitant therapies were not reported. On 07-SEP-2017, the patient received an improperly stored dose of GARDASIL 9 (lot # N000326, expiration date 14-OCT-2019; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion was at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. Sender's Comments: US-009507513-1710USA004063.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse refers to a 16-year old patient of unknown gender. The patient's medical History, concurrent conditions and concomitant therapies were not reported. On 07-SEP-2017, the patient received an improperly stored dose of GARDASIL 9 (lot # N000326, expiration date 14-OCT-2019; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion was at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. Sender's Comments: US-009507513-1710USA004063.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse refers to an infant patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-SEP-2017, the patient received an improperly stored dose of RECOMBIVAX HB (lot # M031574, expiration date: 11-NOV-2018; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion occurred at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1710USA004063.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse refers to a 16-year old patient of unknown gender. The patient's medical History, concurrent conditions and concomitant therapies were not reported. On 26-SEP-2017, the 13-year old patient received the improperly stored dose of GARDASIL 9 (lot # N000326, expiration date 14-OCT-2019; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion was at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1710USA004063.
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of angioedema in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced angioedema (serious criteria GSK medically significant). On an unknown date, the outcome of the angioedema was unknown. It was unknown if the reporter considered the angioedema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 8.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Pruritus, Rash papular, Rash vesicular, Skin abrasion
Clinical narrative: Rash starting out as "water filled" bumps, then becoming papules. Itchy. No fever, no other sx.  Exam: scattered excoriated erythematous papules with central openings, one on back may be a tiny vescicle vs papule on erythematous background, no obvious vescicles, no crusted over papules. Treatment - supportive care. No testing done. Warning to avoid pregnant/immunocompromised people.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: PT REACTION WAS DUE TO MEDICAL ASSISTANT MISPLACING ON PATIENTS ARM THE VACCINE TO CLOSE TO SHOULDER INSTEAD OF MUSCLE.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Tremor
Clinical narrative: Patient felt shaky and faint post vaccine in car ride home. Parent called and stated that in the car ride on way home from receiving the Tdap that patient turned white and started shaking and sweating. Mom reported that once home, he stopped shaking. Patient states he was having trouble seeing in his peripheral vision. Mom declined a recheck appointment. No other complaints. Mom told to return to office is symptoms persisted.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient presented with redness, swelling, and pain at injection site. Red circle is the size of large grapefruit/small cantaloupe. He has also had a fever and chills last 2 nights. Pt has been applying ice pack at injection site and treating fever/ pain with APAP.
Age: 0.5
Sex: F
Vaccine: PNC13, RV1
Symptoms: Vomiting
Clinical narrative: My daughter has been vomiting nearly everything she takes in. Thick, foamy vomit. Began 2 hrs after vaccines, and still going this morning.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N013695 expiry date: 21-MAR-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N018273 expiry date: 17-JUN-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N019923 expiry date: 28-APR-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-OCT-2016, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-APR-2017, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-JUL-2012, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Myalgia, Rash
Clinical narrative: Fatigue, myalgia, rash.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Arm was very sore the evening of injection and lasted two days. Then redness appeared and continued to increase. Area is very warm to touch and the size of an orange.
Age: 48.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: Shivering, weakness, muscle soreness, fevered feeling but no heat.
Age: 0.83
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Both sites have redness, warmth, swelling, and hard knots underneath skin. Pt has been fussy and irritable and not sleeping well since vaccinations. Right side measured 2.5 by 2 inches. Left side measured 1.5 by 1 inch.
Age: 0.83
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Irritability, Poor quality sleep
Clinical narrative: Both sites have redness, warmth, swelling, and hard knots underneath skin. Pt has been fussy and irritable and not sleeping well since vaccinations. Right side measured 2.5 by 2 inches. Left side measured 1.5 by 1 inch.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Injection site erythema, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Next day, patient spent all day in bed because she felt feverish and weak. Took ADVIL and felt better; did not call doctor. On 5/16, noticed vaccination area red, warm, and swollen. Checked-in with pharmacist and told to take BENADRYL. Today, patient feels better and site of vaccination still is red, warm but not itchy.
Age: 1.08
Sex: U
Vaccine: HEPA, MMR
Symptoms: Aphasia, Brain stem auditory evoked response, Coordination abnormal, Nuclear magnetic resonance imaging brain, Social avoidant behaviour
Clinical narrative: Our son began to lose speech around the time of vaccinations and being treated for a croupe cough. He was given ORAPRED and clyndomycin. His eating became extremely restrictive. He then began to seclude himself frequently throughout the day and avoid eye contact and all forms of communication. Prior to this time, he ate a varied healthy diet and was a happy, verbal baby with no issues of any kind. He was diagnosed with speech delay to start.
Age: 1.08
Sex: U
Vaccine: HEPA, MMR
Symptoms: Speech disorder developmental
Clinical narrative: Our son began to lose speech around the time of vaccinations and being treated for a croupe cough. He was given ORAPRED and clyndomycin. His eating became extremely restrictive. He then began to seclude himself frequently throughout the day and avoid eye contact and all forms of communication. Prior to this time, he ate a varied healthy diet and was a happy, verbal baby with no issues of any kind. He was diagnosed with speech delay to start.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache
Clinical narrative: Headache, diarrhea.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: After receiving vaccination Friday afternoon patient awoke on Wednesday with redness and slight swelling on the arm of injection site. Redness was from just below shoulder to elbow.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Fatigue, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Pt is currently 28w4d gestation with an EDC: 8/5/2018, pt received TDAP inj in office, pt states that about a couple hours later her arm felt heavy and sore, then as the night went on she noticed a bump at the inj. site, over the next 4 days the injection site had a red wheel around it and increased up to about 4" in diameter, yesterday (Day 3) pt was very fatigued and nauseated, pt called today when she noticed her s/x getting worse a, pt states that the wheel is very hot to the touch, pt was advised to use topical OTC Benadryl cream and ice for relief, if she has trouble breathing pt to go to ER, if her rash cont. to spread pt to see her PCP or Walk-In Urgent care
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Limb discomfort, Nausea, Pain in extremity
Clinical narrative: Pt is currently 28w4d gestation with an EDC: 8/5/2018, pt received TDAP inj in office, pt states that about a couple hours later her arm felt heavy and sore, then as the night went on she noticed a bump at the inj. site, over the next 4 days the injection site had a red wheel around it and increased up to about 4" in diameter, yesterday (Day 3) pt was very fatigued and nauseated, pt called today when she noticed her s/x getting worse a, pt states that the wheel is very hot to the touch, pt was advised to use topical OTC Benadryl cream and ice for relief, if she has trouble breathing pt to go to ER, if her rash cont. to spread pt to see her PCP or Walk-In Urgent care
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: RASH THAT LOOKS LIKE RED DOTS AT THE SITE OF INJECTION, NO BLISTERS, NO EDEMA.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report Was received from a 28 year old, male patient and refer to himself refers. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-FEB-2018, the patient was vaccinated with GARDASIL 9 lot # N020138 (formulation, strength, dose, frequency, route of administration, were not reported) for prophylaxis. No adverse event was reported. The outcome of the event was unknown.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Analgesic drug level, Blood alcohol, Computerised tomogram head, Dizziness, Drug screen
Clinical narrative: Pt. fainted after given HPV and MENVEO vaccinations. Pt walked to waiting room accompanied by MDA. Felt faint--occurred at lunch time (his lunch not eaten yet-was in his car) when attempted to get pt up in W/C to take to treatment room pt fainted again--eyes rolled back-arms flailing. Sent to ER to R/O seizure. Will be following with neurologist.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dyskinesia, Eye movement disorder, Full blood count, Metabolic function test, Syncope
Clinical narrative: Pt. fainted after given HPV and MENVEO vaccinations. Pt walked to waiting room accompanied by MDA. Felt faint--occurred at lunch time (his lunch not eaten yet-was in his car) when attempted to get pt up in W/C to take to treatment room pt fainted again--eyes rolled back-arms flailing. Sent to ER to R/O seizure. Will be following with neurologist.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Urine analysis
Clinical narrative: Pt. fainted after given HPV and MENVEO vaccinations. Pt walked to waiting room accompanied by MDA. Felt faint--occurred at lunch time (his lunch not eaten yet-was in his car) when attempted to get pt up in W/C to take to treatment room pt fainted again--eyes rolled back-arms flailing. Sent to ER to R/O seizure. Will be following with neurologist.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 21-JUN-2016, the patient was treated by a physician for a persistent vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-OCT-2011, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-SEP-2013, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and carbamazepine for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-JUN-2016, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving zoster vaccine live ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 11-JUL-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-MAR-2018, the patient was treated by a nurse practitioner for a blistering vesicular outbreak which was then diagnosed as severe herpes zoster. The patient has been prescribed valacyclovir and oxycodone-acetaminophen for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 17-OCT-2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUN-2016, the patient was treated at a medical facility for a blistering vesicular outbreak which was then diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable consumer (an office manager, who is also a medical assistant) via a Pfizer sales representative. An adolescent male patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration on 14May2018 at a single dose as meningococcal B vaccine. The patient's medical history and concomitant medications were not reported. The adolescent fainted after administration of the vaccine on 14May2018 around 1200. The reporter stated that they monitored the patient's pulse and let him sit. The patient's blood pressure was also tested but results were not reported. The patient recovered from the event on the same day. The reporter did not have further details to provide. The batch/lot number for the vaccine, meningococcal group b rlp2086, was not provided and will be requested during follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling arm and erythema of extremities to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that multiple patients experienced mild to moderate soreness of the arm, redness and swelling. The adverse events lasted for a couple of days. The reporter did not wish to share any patient or vaccine information. The healthcare professional stated that all patients that reported these side effects did fully recover from them.
Sex: U
Vaccine: HEPA
Symptoms: Dizziness, Loss of consciousness, Vaccination complication
Clinical narrative: This case was reported by a nurse and described the occurrence of passed out in a patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 1 ml. On an unknown date, unknown after receiving HAVRIX 1440, the patient experienced passed out (serious criteria GSK medically significant) and dizziness. On an unknown date, the outcome of the passed out and dizziness were unknown. It was unknown if the reporter considered the passed out and dizziness to be related to HAVRIX 1440. Additional details were provided as follows: The age at vaccination was not reported. The patients had adverse reaction to medication. The customer also stated she contacted the vendor. The customer had been notified in writing that their complaint was forwarded to GlaxoSmithKline vaccines for investigation and said that to respond directly to the complainant in this matter and copy Health at provided address. This case is 1 of the 4 cases reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia, Rash, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 61-year-old female patient who received SHINGRIX (batch number EK279, expiry date March 2020). On 11th march 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, several weeks after receiving SHINGRIX, the patient experienced blistery rash (serious criteria other: as per reporter), influenza-like symptoms (serious criteria other: as per reporter), chills (serious criteria other: as per reporter), sores mouth (serious criteria other: as per reporter) and fever (serious criteria other: as per reporter). The patient was treated with acyclovir. On an unknown date, the outcome of the blistery rash was recovering/resolving and the outcome of the influenza-like symptoms, chills and fever were recovered/resolved and the outcome of the sores mouth was unknown. It was unknown if the reporter considered the blistery rash and sores mouth to be related to SHINGRIX. The reporter considered the influenza-like symptoms, chills and fever to be possibly related to SHINGRIX. Additional details were provided as follows: The healthcare professional was a retail pharmacist. The patient received SHINGRIX vaccine on the left arm. The healthcare professional (HCP) stated that the patient was due for 2nd dose. The HCP stated that the patient reported of having fever, chills, and flu like symptoms developed within a few days of 1st dose and recovered within a few days of onset. The HCP stated that the patient reported around 25th March 2018. The patient was unsure when the events occurred and had a gradual onset started to develop a blistered chest rash, sores in and around her mouth. The HCP stated that the patient went to on primary care doctor on 30th March 2018 and received Acyclovir to treat blister rash and sores. The HCP reported that all symptoms had resolved except for small chest rash. The only treatment was physician visit and Acyclovir and the patient had returned to normal daily activities.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 61-year-old female patient who received SHINGRIX (batch number EK279, expiry date March 2020). On 11th march 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, several weeks after receiving SHINGRIX, the patient experienced blistery rash (serious criteria other: as per reporter), influenza-like symptoms (serious criteria other: as per reporter), chills (serious criteria other: as per reporter), sores mouth (serious criteria other: as per reporter) and fever (serious criteria other: as per reporter). The patient was treated with acyclovir. On an unknown date, the outcome of the blistery rash was recovering/resolving and the outcome of the influenza-like symptoms, chills and fever were recovered/resolved and the outcome of the sores mouth was unknown. It was unknown if the reporter considered the blistery rash and sores mouth to be related to SHINGRIX. The reporter considered the influenza-like symptoms, chills and fever to be possibly related to SHINGRIX. Additional details were provided as follows: The healthcare professional was a retail pharmacist. The patient received SHINGRIX vaccine on the left arm. The healthcare professional (HCP) stated that the patient was due for 2nd dose. The HCP stated that the patient reported of having fever, chills, and flu like symptoms developed within a few days of 1st dose and recovered within a few days of onset. The HCP stated that the patient reported around 25th March 2018. The patient was unsure when the events occurred and had a gradual onset started to develop a blistered chest rash, sores in and around her mouth. The HCP stated that the patient went to on primary care doctor on 30th March 2018 and received Acyclovir to treat blister rash and sores. The HCP reported that all symptoms had resolved except for small chest rash. The only treatment was physician visit and Acyclovir and the patient had returned to normal daily activities.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: Redness, swelling from injection site to elbow. Reported increased confusion/lethargy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The vaccine was placed on right thigh, the reaction was red, raised bump around injection site.  The area was hot to the touch and painful to touch as well. The patient did not want anyone touching his leg.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia, Pyrexia
Clinical narrative: Myalgia x 3 days, Fatigue x 4 days, Shivering x 2 days, Fever x 2 days, Loss of appetite x 3 days.
Age: 28.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: There was no adverse event other than the fact that Hep A Dose #2 was administered 4 months after Dose #1, while the minimum interval is 6 months. Phone call with patient 4 days later revealed patient had no adverse reactions to the vaccine, and will return in 6 months to repeat Hep A dose #2.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache, Heart rate increased
Clinical narrative: Symptoms: hives, swelling of the face and throat. Difficulty breathing, fast heartbeat, weakness, no feelings in feet and hands, fatigue, fever, muscle aches, headache, nausea, shot area-swelling and redness at site of injection.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Myalgia, Nausea
Clinical narrative: Symptoms: hives, swelling of the face and throat. Difficulty breathing, fast heartbeat, weakness, no feelings in feet and hands, fatigue, fever, muscle aches, headache, nausea, shot area-swelling and redness at site of injection.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Pyrexia, Swelling face, Urticaria
Clinical narrative: Symptoms: hives, swelling of the face and throat. Difficulty breathing, fast heartbeat, weakness, no feelings in feet and hands, fatigue, fever, muscle aches, headache, nausea, shot area-swelling and redness at site of injection.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea and vomiting.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Oral mucosal blistering, Pain, Pyrexia
Clinical narrative: Pt complain feeling fever, sweats, body ache - blisters in mouth got antiviral from MD. Acyclovir from MD.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 48-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). On 1st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema and malaise. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and malaise were recovering/resolving. The reporter considered the injection site pain, injection site swelling, injection site erythema and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The nurse practitioner came to the pharmacy to inject the vaccine to the patient. The patient had SHINGRIX sometime in March 2018. The patient experienced injection site reactions consisting of redness, pain, swelling and bumps at site. For further tolerance to next dose, refer case US2018GSK087683. This case is also linked to cases US2018077566 and US2018GSK087683, reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Delirium, Dizziness, Epigastric discomfort, Fatigue
Clinical narrative: Within a few minutes felt dizzy (light headed). In 4 hours developed left arm pain - mild. Slept restless most of night, with moderate deltoid pain. Woke up at 7:00 AM feeling dizzy, had to sit in recliner. Woke up with moderate mid epigastric discomfort lasting 9 hours. Delirious x 8 hours - rested in recliner. Moderate shivering x 7 hours. Felt warm - did not take temp. Had generalized body aches x 20 hours. Ringing in both ears (moderate) x 30 hours. Fatigue x 24 hours. Lightheadedness lasted 24 hours. The worse symptom was the shivering and delirium. Woke up Wednesday AM feeling fine, no symptoms, no concerns. Question: Should I continue with the 2nd series of shot?