chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Fatigue, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: AT 1ST sore arm, lump, tired which continued then @8 days later became itchy with marks that look like bites near vaccinated arm elbow and then several days later dime size welts developed and site still has lump and is itchy and sore. advise a md visit , patient was advised by md to use Benadryl and triamcinolone cream on affected area. Md thought it was a result of bug bites because it has been so long since she got her shot but not sure md understood she had this is going on since she had the shot.  patient informed me today (7/16/20) and  just saw md today (7/16/20)
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: AT 1ST sore arm, lump, tired which continued then @8 days later became itchy with marks that look like bites near vaccinated arm elbow and then several days later dime size welts developed and site still has lump and is itchy and sore. advise a md visit , patient was advised by md to use Benadryl and triamcinolone cream on affected area. Md thought it was a result of bug bites because it has been so long since she got her shot but not sure md understood she had this is going on since she had the shot.  patient informed me today (7/16/20) and  just saw md today (7/16/20)
Age: 31.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Chills, rigors followed by fever to 101.9 with headache and fatigue.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Myalgia, Rhinorrhoea
Clinical narrative: chills, fatigue, runny nose, muscular aches
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event occured Patient was here for HPV & Menactra was given in error.  Patient came back & received the HPV vaccine.  Was instructed on adverse reactions to watch for with both vaccines.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: no painful  itchy rash on back  near left shoulder in straight line raised bumps, used Benadryl cream  last night mild relief
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Pain, Peripheral swelling
Clinical narrative: Extreme pain/discomfort x 2 weeks reported by patient. Left arm swelling x 2 weeks
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Depressed level of consciousness, Dyskinesia, Eye movement disorder, Malaise, Muscle rigidity
Clinical narrative: YOUTH HERE FOR TDAP IMMUNIZATION. TEMP 98.7 AT TIME OF VACCINATION. NO ALLERGIES, ILLNESS, OR PROBLEMS RECENT OR WITH PAST IMMUNIZATIONS. ADMINISTERED TDAP TO RIGHT DELTOID. WAS PREPARING FOR ADMINISTRATION OF MCV4 VACCINE WHEN YOUTH SAID SHE DIDNT FEEL WELL. SHE BECAME VERY PALE AND LEVEL OF CONSCIOUSNESS DELINED AND WOULD NOT RESPOND TO MY VERBAL. HER ARMS/TORSO BECAME VERY RIGID, SHE HAS SOME JERKING, AND HER EYES ROLLED BACK FAR. APPROXIMATELY LASTED 20 SECONDS. PLACED HER IN FRONT OF FAN, SUPPORTED HER FROM ANY INJURY. INSTRUCTED MOTHER TO CALL 9-1-1. STUDENTS LEVEL OF CONSCIOUSNESS IMPROVED AND BECAME RESPONSIVE.  SHE LEFT VIA EMS FOR FURTHER EVAL AND TREATMENT.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: YOUTH HERE FOR TDAP IMMUNIZATION. TEMP 98.7 AT TIME OF VACCINATION. NO ALLERGIES, ILLNESS, OR PROBLEMS RECENT OR WITH PAST IMMUNIZATIONS. ADMINISTERED TDAP TO RIGHT DELTOID. WAS PREPARING FOR ADMINISTRATION OF MCV4 VACCINE WHEN YOUTH SAID SHE DIDNT FEEL WELL. SHE BECAME VERY PALE AND LEVEL OF CONSCIOUSNESS DELINED AND WOULD NOT RESPOND TO MY VERBAL. HER ARMS/TORSO BECAME VERY RIGID, SHE HAS SOME JERKING, AND HER EYES ROLLED BACK FAR. APPROXIMATELY LASTED 20 SECONDS. PLACED HER IN FRONT OF FAN, SUPPORTED HER FROM ANY INJURY. INSTRUCTED MOTHER TO CALL 9-1-1. STUDENTS LEVEL OF CONSCIOUSNESS IMPROVED AND BECAME RESPONSIVE.  SHE LEFT VIA EMS FOR FURTHER EVAL AND TREATMENT.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Somnolence, Unresponsive to stimuli
Clinical narrative: Patients brother reported shortly after leaving office patient became unresponsive for five to ten seconds. Brother drove patient back to office. On exam patient was alert and oriented times three. Reports that she had remembered feeling sleepy prior to event and thought when she came to that she was at home.  911 was called to the scene. Patient/brother denied EMS transport to hospital.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient came back on 7-14-20 said she got rash at injection site  no pain
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Pyrexia, Specialist consultation
Clinical narrative: fever right facial droop
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient started with a headache, sore left arm, some nausea, low grade fever of 99.5 Friday evening. Patient is still having these issue when he came at this time. Site don't feel hot or warm to the touch. No change in color or site in his arm. we let him know to use cool packs on his arm for pain and Tylenol also for pain.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: & peripheral edema
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Areflexia, Asthenia, Paraesthesia
Clinical narrative: & weakness, praesthesias, areflexia
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Rash, UrticariaPruritus & ERYTHEMA FAMOTIDINE 20 MG ONCE ,DIPHENHYDRAMINE 25 MG ONCE
Age: 72.0
Sex: M
Vaccine: HEPA
Symptoms: Bradycardia, Hypotension, Syncope, Urinary incontinence, Vomiting
Clinical narrative: Shortly after receiving the vaccine, patient fainted, became hypotensive and bradycardic. Additionally he vomited and urinated. On recheck his blood pressure and HR had returned to a normal value. He declined going to the ED and left after feeling better NauseaVomiting, HYPOtension, Syncope, Bradycardia & urination
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Hypersomnia, Pollakiuria, Vomiting
Clinical narrative: pt had vomitting and sleeping a lot,  urinating frequently started the  day after vaccination
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Nausea
Clinical narrative: & nausea
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: NauseaVomiting
Age: 65.0
Sex: M
Vaccine: PNC
Symptoms: Myalgia
Clinical narrative: Per chart review. Allergy assessment was entered by resident physician: NOV 07, 2019@11:48:35 by ORIGINATOR  Patient complained for SEVERE myalgia of bilateral lower legs, shortly after Prevnar 13 injection in the shoulder. Myalgia. CELECOXIB 200 MG EVERY DAY ,BACLOFEN 10 MG TID
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Rash, Wheezing
Clinical narrative: SkinRash & CoughWheeze
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: & Guillain Barre
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient states that four days after receiving vaccine he started to get a rash that started on his arms and then progressed to his chest, back, legs. He stated the rash is itchy. He has tried no new soap, detergent, fabric softner or personal care products and no one else at home has the rash. The rash will calm for a few days but then comes back. Symptoms: SkinRash Treatment: DIPHENHYDRAMINE 50 MG QID, METHYLPREDNISOLONE use as directed per instructi
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: & Blisters
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: & Localized swelling and pain
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Herpes zoster, Pruritus
Clinical narrative: Headaches; Itching; Progressive eruption of shingles; Information has been downloaded from regulatory authority  (US-CHIRONMA-PHHY2014US171059).  This spontaneous report was received from two health professional, concerning a 63-year-old female patient. Her relevant medical history included shingles as a current condition. The patient's concomitant medications included escitalopram oxalate (LEXAPRO).   On 11-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), one dosage form, administered subcutaneously, (lot number K007548 has been verified to be a valid lot number for zoster vaccine live, the expiration date not reported but upon internal validation established as 23-AUG-2015; formulation was not reported), and influenza virus sag 3v vaccine inactivated (FLUVIRIN) 2014/2015 injection, one dosage form (1DF), administered by intramuscular route, (lot number 145204, expiration date was not provided), both vaccines were administered for immunisation (vaccination schemes frequency and anatomical location of vaccinations were not reported).  On 15-SEP-2014, the patient experienced a progressive eruption of shingles (herpes zoster), itching (pruritus) and headaches.     At the time of reporting, the outcome of headache, herpes zoster and pruritus was reported as not resolved.  The causal relationship between the aforementioned events and therapy with zoster vaccine live (ZOSTAVAX) was not reported. The causality assessment between the events of pruritus and herpes zoster and therapy with influenza virus sag 3v vaccine inactivated (FLUVIRIN) was suspected, while not provided for the headache.  The events were reported to be medically significant.; Sender's Comments:  545780:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: painful blistering rash which was diagnosed as shingles; Information has been received from a lawyer, regarding case in litigation, and refers to a currently approximately 69-year-old female patient (pt). No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On or about 09-JUN-2016, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) at her local medical provider's office for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a healthcare provider for painful blistering rash which was diagnosed as shingles, resulting from the pt's use of zoster vaccine live (ZOSTAVAX). The outcome of the event was not reported. The reporter considered the event of painful blistering rash which was diagnosed as shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cancer surgery, Condition aggravated, Herpes zoster, Neoplasm malignant, Stent placement
Clinical narrative: Shingles outbreak about 5 times; Shingles outbreaks are worse; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included open heart surgery (in 2017), shingles and stent placement (in 4th November 2019). Concomitant products included acyclovir and acyclovir (Zovirax Cream).   On 23rd October 2019, the patient received the 1st dose of Shingrix. On 27th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and less than 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported that she had both doses of the Shingrix (received on unknown top part of arm) and she would have gotten the second dose closer to the first dose but she had four carcinoma cancers removed from her face in December 2019. She also reported that she had a stent put in on 4th November 2019 after having open heart surgery in 2017. The patient had a history of shingles but she claims that her shingles outbreaks were worse after getting both doses of the Shingrix. The shingles were on her behind. After getting the first dose of Shingrix, two weeks later she got shingles again (refer case US2020126263). The patient had a shingles outbreak about 5 times since and they were worse than before. The patient now takes Acyclovir each night and uses the Zovirax cream. This case was considered as suspected vaccination failure, since the details regarding time to onset and laboratory confirmation for herpes zoster were not provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020126263:same patient
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Shingles outbreak about 5 times; Shingles outbreaks are worse; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included open heart surgery (in 2017), shingles and stent placement (in 4th November 2019). Concomitant products included acyclovir and acyclovir (Zovirax Cream).   On 23rd October 2019, the patient received the 1st dose of Shingrix. On 27th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and less than 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported that she had both doses of the Shingrix (received on unknown top part of arm) and she would have gotten the second dose closer to the first dose but she had four carcinoma cancers removed from her face in December 2019. She also reported that she had a stent put in on 4th November 2019 after having open heart surgery in 2017. The patient had a history of shingles but she claims that her shingles outbreaks were worse after getting both doses of the Shingrix. The shingles were on her behind. After getting the first dose of Shingrix, two weeks later she got shingles again (refer case US2020126263). The patient had a shingles outbreak about 5 times since and they were worse than before. The patient now takes Acyclovir each night and uses the Zovirax cream. This case was considered as suspected vaccination failure, since the details regarding time to onset and laboratory confirmation for herpes zoster were not provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020126263:same patient
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Flushing, Headache, Nausea
Clinical narrative: Headache, lightheadedness, flushing, nausea,
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Eating disorder, Erythema, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Left hand began itching end of February 2020 (approximately 1 month following 2nd dose), followed by itching on chin. Within days, a vivid rash developed on left hand and circling mouth. Rash on hand was typical of "shingles," with severe itch and pustules oozing, although pain was not as bad as itch. Rash around mouth extended over chin, with flat exuded areas. When I (patient) recognized this to be zoster, I began taking Valtrex, which I had been prescribed for HSVI outbreaks. The rash responded to Valtrex, confirming the presumed diagnosis. Despite taking large doses of Valtrex for a week, the itch and rash continued to expand, going up onto wrist, then up onto arm.  Both areas, hand and arm, continued to itch and have oozing for over a month. The rash around mouth was both very sore and very itchy. I consulted with dermatologist, who recommended continuing Valtrex 1000 mg x 3/day until symptoms subsided, which was another 2 months - end of May. Symptoms were better, but still present, but I was able to reduce Valtrex dosage gradually to 1000 mg/day. As I reduced dose of Valtrex, additional symptoms appeared in several areas on my forehead, with a large, red, swelling area with pustules over my left eyebrow, then over my right eyebrow, and last area (last week, early July) on right side of forehead near hairline.   The most effective "treatment" was continuing Valtrex, which made the symptoms more bearable. I also used a very thick cream made for "shingles," which greatly reduced itching for several hours.   By the first week of July, the rash on hand, wrist, and arm had cleared "active" itch, and all pustules had flattened and dried up. The rash around my mouth was mostly healed, but still required thick cream layers to reduce itch. At that time, the areas on my forehead were still active. Now, July 17, the forehead areas seem to be cleared, except for a small amount of redness and swelling above my left eyebrow.   The symptoms began and extended over a period of over four months. Most of this time I felt sick. I had great fatigue, headaches, difficulty eating, swollen lymph glands, and muscle soreness.
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Malaise, Myalgia, Oral mucosal eruption, Pruritus, Pustule
Clinical narrative: Left hand began itching end of February 2020 (approximately 1 month following 2nd dose), followed by itching on chin. Within days, a vivid rash developed on left hand and circling mouth. Rash on hand was typical of "shingles," with severe itch and pustules oozing, although pain was not as bad as itch. Rash around mouth extended over chin, with flat exuded areas. When I (patient) recognized this to be zoster, I began taking Valtrex, which I had been prescribed for HSVI outbreaks. The rash responded to Valtrex, confirming the presumed diagnosis. Despite taking large doses of Valtrex for a week, the itch and rash continued to expand, going up onto wrist, then up onto arm.  Both areas, hand and arm, continued to itch and have oozing for over a month. The rash around mouth was both very sore and very itchy. I consulted with dermatologist, who recommended continuing Valtrex 1000 mg x 3/day until symptoms subsided, which was another 2 months - end of May. Symptoms were better, but still present, but I was able to reduce Valtrex dosage gradually to 1000 mg/day. As I reduced dose of Valtrex, additional symptoms appeared in several areas on my forehead, with a large, red, swelling area with pustules over my left eyebrow, then over my right eyebrow, and last area (last week, early July) on right side of forehead near hairline.   The most effective "treatment" was continuing Valtrex, which made the symptoms more bearable. I also used a very thick cream made for "shingles," which greatly reduced itching for several hours.   By the first week of July, the rash on hand, wrist, and arm had cleared "active" itch, and all pustules had flattened and dried up. The rash around my mouth was mostly healed, but still required thick cream layers to reduce itch. At that time, the areas on my forehead were still active. Now, July 17, the forehead areas seem to be cleared, except for a small amount of redness and swelling above my left eyebrow.   The symptoms began and extended over a period of over four months. Most of this time I felt sick. I had great fatigue, headaches, difficulty eating, swollen lymph glands, and muscle soreness.
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Left hand began itching end of February 2020 (approximately 1 month following 2nd dose), followed by itching on chin. Within days, a vivid rash developed on left hand and circling mouth. Rash on hand was typical of "shingles," with severe itch and pustules oozing, although pain was not as bad as itch. Rash around mouth extended over chin, with flat exuded areas. When I (patient) recognized this to be zoster, I began taking Valtrex, which I had been prescribed for HSVI outbreaks. The rash responded to Valtrex, confirming the presumed diagnosis. Despite taking large doses of Valtrex for a week, the itch and rash continued to expand, going up onto wrist, then up onto arm.  Both areas, hand and arm, continued to itch and have oozing for over a month. The rash around mouth was both very sore and very itchy. I consulted with dermatologist, who recommended continuing Valtrex 1000 mg x 3/day until symptoms subsided, which was another 2 months - end of May. Symptoms were better, but still present, but I was able to reduce Valtrex dosage gradually to 1000 mg/day. As I reduced dose of Valtrex, additional symptoms appeared in several areas on my forehead, with a large, red, swelling area with pustules over my left eyebrow, then over my right eyebrow, and last area (last week, early July) on right side of forehead near hairline.   The most effective "treatment" was continuing Valtrex, which made the symptoms more bearable. I also used a very thick cream made for "shingles," which greatly reduced itching for several hours.   By the first week of July, the rash on hand, wrist, and arm had cleared "active" itch, and all pustules had flattened and dried up. The rash around my mouth was mostly healed, but still required thick cream layers to reduce itch. At that time, the areas on my forehead were still active. Now, July 17, the forehead areas seem to be cleared, except for a small amount of redness and swelling above my left eyebrow.   The symptoms began and extended over a period of over four months. Most of this time I felt sick. I had great fatigue, headaches, difficulty eating, swollen lymph glands, and muscle soreness.
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Asthenia, Erythema, Herpes ophthalmic, Herpes zoster cutaneous disseminated, Loss of personal independence in daily activities
Clinical narrative: Left hand began itching end of February 2020 (approximately 1 month following 2nd dose), followed by itching on chin. Within days, a vivid rash developed on left hand and circling mouth. Rash on hand was typical of "shingles," with severe itch and pustules oozing, although pain was not as bad as itch. Rash around mouth extended over chin, with flat exuded areas. When I (patient) recognized this to be zoster, I began taking Valtrex, which I had been prescribed for HSVI outbreaks. The rash responded to Valtrex, confirming the presumed diagnosis. Despite taking large doses of Valtrex for a week, the itch and rash continued to expand, going up onto wrist, then up onto arm.  Both areas, hand and arm, continued to itch and have oozing for over a month. The rash around mouth was both very sore and very itchy. I consulted with dermatologist, who recommended continuing Valtrex 1000 mg x 3/day until symptoms subsided, which was another 2 months - end of May. Symptoms were better, but still present, but I was able to reduce Valtrex dosage gradually to 1000 mg/day. As I reduced dose of Valtrex, additional symptoms appeared in several areas on my forehead, with a large, red, swelling area with pustules over my left eyebrow, then over my right eyebrow, and last area (last week, early July) on right side of forehead near hairline.   The most effective "treatment" was continuing Valtrex, which made the symptoms more bearable. I also used a very thick cream made for "shingles," which greatly reduced itching for several hours.   By the first week of July, the rash on hand, wrist, and arm had cleared "active" itch, and all pustules had flattened and dried up. The rash around my mouth was mostly healed, but still required thick cream layers to reduce itch. At that time, the areas on my forehead were still active. Now, July 17, the forehead areas seem to be cleared, except for a small amount of redness and swelling above my left eyebrow.   The symptoms began and extended over a period of over four months. Most of this time I felt sick. I had great fatigue, headaches, difficulty eating, swollen lymph glands, and muscle soreness.
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash, Swelling, Vaccination failure
Clinical narrative: Left hand began itching end of February 2020 (approximately 1 month following 2nd dose), followed by itching on chin. Within days, a vivid rash developed on left hand and circling mouth. Rash on hand was typical of "shingles," with severe itch and pustules oozing, although pain was not as bad as itch. Rash around mouth extended over chin, with flat exuded areas. When I (patient) recognized this to be zoster, I began taking Valtrex, which I had been prescribed for HSVI outbreaks. The rash responded to Valtrex, confirming the presumed diagnosis. Despite taking large doses of Valtrex for a week, the itch and rash continued to expand, going up onto wrist, then up onto arm.  Both areas, hand and arm, continued to itch and have oozing for over a month. The rash around mouth was both very sore and very itchy. I consulted with dermatologist, who recommended continuing Valtrex 1000 mg x 3/day until symptoms subsided, which was another 2 months - end of May. Symptoms were better, but still present, but I was able to reduce Valtrex dosage gradually to 1000 mg/day. As I reduced dose of Valtrex, additional symptoms appeared in several areas on my forehead, with a large, red, swelling area with pustules over my left eyebrow, then over my right eyebrow, and last area (last week, early July) on right side of forehead near hairline.   The most effective "treatment" was continuing Valtrex, which made the symptoms more bearable. I also used a very thick cream made for "shingles," which greatly reduced itching for several hours.   By the first week of July, the rash on hand, wrist, and arm had cleared "active" itch, and all pustules had flattened and dried up. The rash around my mouth was mostly healed, but still required thick cream layers to reduce itch. At that time, the areas on my forehead were still active. Now, July 17, the forehead areas seem to be cleared, except for a small amount of redness and swelling above my left eyebrow.   The symptoms began and extended over a period of over four months. Most of this time I felt sick. I had great fatigue, headaches, difficulty eating, swollen lymph glands, and muscle soreness.
Age: 1.08
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Acute respiratory failure, Akinesia, Dyskinesia, Gastrooesophageal reflux disease, Hypophagia
Clinical narrative: Akinesia-dyskinesia sequence; Akinesia-dyskinesia sequence; Myopathy; Gastroesophageal reflux; Poor oral intake; Acute respiratory decompensation; Vesicular rash; Information has been downloaded from Agency (HQ3513310NOV2000).  This spontaneous report was received from a healthcare professional concerning to a 13 month old male patient with a ventricular septal defect, cardiomegaly, bronchospasm, lung disorder, pneumonia, cryptorchism and developmental delay. The patient's medical history included cardiac arrest. Concomitant therapies included ipratropium bromide, lansoprazole, prednisone, albuterol and metoclopramide.     On 22-SEP-2000 the patient was vaccinated with a dose of varicella virus vaccine live (manufacturer unknown) (Lot No. reported as 0722J, upon internal validation determined to be valid for varicella virus vaccine live exp. date 24-OCT-2020), subcutaneous for immunisation. Other suspect therapies included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (Lot No. 474-718) intramuscular injection and measles, mumps, and rubella virus vaccine, live (manufacturer unknown) (Lot No. reported as 1720J, upon internal validation determined to be valid for  measles, mumps, and rubella virus vaccine, live) (HSA) subcutaneous.  On 23-SEP-2000, the patient experienced acute respiratory decompensation (respiratory failure), rash vesicular and was hospitalized on an unspecified date. On an unknown date, the patient experienced akinesia-dyskinesia sequence (akinesia), poor oral intake (poor feeding infant), gastrooesophageal reflux disease, myopathy and akinesia-dyskinesia sequence (dyskinesia) and was hospitalized on an unknown date. The outcome of respiratory failure, poor feeding infant, gastrooesophageal reflux disease, myopathy, dyskinesia, akinesia and rash vesicular was unknown.  The causal relationship between the aforementioned events and suspect therapies was not reported.
Age: 1.08
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Myopathy, Rash vesicular
Clinical narrative: Akinesia-dyskinesia sequence; Akinesia-dyskinesia sequence; Myopathy; Gastroesophageal reflux; Poor oral intake; Acute respiratory decompensation; Vesicular rash; Information has been downloaded from Agency (HQ3513310NOV2000).  This spontaneous report was received from a healthcare professional concerning to a 13 month old male patient with a ventricular septal defect, cardiomegaly, bronchospasm, lung disorder, pneumonia, cryptorchism and developmental delay. The patient's medical history included cardiac arrest. Concomitant therapies included ipratropium bromide, lansoprazole, prednisone, albuterol and metoclopramide.     On 22-SEP-2000 the patient was vaccinated with a dose of varicella virus vaccine live (manufacturer unknown) (Lot No. reported as 0722J, upon internal validation determined to be valid for varicella virus vaccine live exp. date 24-OCT-2020), subcutaneous for immunisation. Other suspect therapies included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (Lot No. 474-718) intramuscular injection and measles, mumps, and rubella virus vaccine, live (manufacturer unknown) (Lot No. reported as 1720J, upon internal validation determined to be valid for  measles, mumps, and rubella virus vaccine, live) (HSA) subcutaneous.  On 23-SEP-2000, the patient experienced acute respiratory decompensation (respiratory failure), rash vesicular and was hospitalized on an unspecified date. On an unknown date, the patient experienced akinesia-dyskinesia sequence (akinesia), poor oral intake (poor feeding infant), gastrooesophageal reflux disease, myopathy and akinesia-dyskinesia sequence (dyskinesia) and was hospitalized on an unknown date. The outcome of respiratory failure, poor feeding infant, gastrooesophageal reflux disease, myopathy, dyskinesia, akinesia and rash vesicular was unknown.  The causal relationship between the aforementioned events and suspect therapies was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; patient received improperly stored PROQUAD on 3/11/2020 which was administered via unspecified route.; This spontaneous report was received from an physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not provided.     On 11-MAR-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot number S027460, which has been verified to be valid, and expiration date reported and validated as 02-MAR-2020; (dose number, vaccination scheme, route of administration and anatomical site of vaccination were not provided), as prophylaxis (product storage error). The vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). Additionally, the reporter stated that the vaccine was exposed to a temperature between 6 degrees Fahrenheit (F) to 14 degrees F - 10.4 degress F, for a time frame of 15 minutes, as recorded by digital data logger. There was a previous temperature excursion reported at a temperature between 6 degrees F to 14 degrees F - 11.1 degrees F for a time frame of 15 minutes. No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001308: US-009507513-2007USA001370: US-009507513-2007USA001612: US-009507513-2007USA001668:
Sex: M
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; Vaccine administered via the intramuscular rather than subcutaneous route.; This spontaneous report was received from a pharmacist and refers to a 58-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-JUL-2020, the patient was vaccinated with properly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly, lot number reported as S031483, has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date was reported as 07-OCT-2021 (formulation, strength, dose, frequency were not reported) for prophylaxis.  Albumin status for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) has been verified as recombinant human albumin (rHA).  The vaccine was reconstituted in properly stored sterile diluent lot S033778, has been verified to be a valid lot number for sterile diluent, expiration date was reported as 27-AUG-2022. No additional adverse event was reported. The outcome of incorrect route of vaccine administration was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Patient received improperly stored PROQUAD on 7/7/2020 which was administered via unspecified route.; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and historical drug were not provided.  On 07-JUL-2020, the patient was vaccinated for prophylaxis with inappropriate storaged Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # S008570 (therapy type rha), expiration date 16-SEP-2020. Strength, dose, and routes of administration were not provided. The vaccine was reconstituted with a properly stored sterile diluent.   The temperatures involved were: -14 to -10 to -14 degrees Celsius in a timeframe of 50 minutes. It was not reported a previous temperature excursion and a data logger was involved. No additional adverse effect was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect reported; pediatric dose of VAQTA being administered to an adult patient; This spontaneous report as received from a Certified Medical Assisstant via company representative refers to an adult patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 09-JUL-2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. No adverse effects reported. Reporter would like to know the recommendations on whether that patient will need a re-peat dose, what precautionary steps they need to take, and how they should proceed.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 27-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.   This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA005030: US-009507513-2007USA005031: US-009507513-2007USA005032: US-009507513-2007USA005033: US-009507513-2007USA005034: US-009507513-2007USA005035: US-009507513-2007USA005036: US-009507513-2007USA005037: US-009507513-2007USA005038: US-009507513-2007USA005039: US-009507513-2007USA005040: US-009507513-2007USA005041: US-009507513-2007USA005042: US-009507513-2007USA005043: US-009507513-2007USA005044: US-009507513-2007USA005045: US-009507513-2007USA005046: US-009507513-2007USA005047: US-009507513-2007USA005048: US-009507513-2007USA005049: US-009507513-2007USA005050:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 02-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 05-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 12-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 15-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 17-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects; patient received first dose in 2015 and second dose on 20-JUN-2020; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On an unspecified date in 2015 and on 20-JUN-2020, the patient was vaccinated with first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), respectively, for prophylaxis (for dose 1, dose, route and site of administration, lot number and expiration date were not reported;  for dose 2, lot # R009615, expiration date not reported, but upon internal validation established as 07-DEC-2020, route intramuscular) (inappropriate schedule of product administration).  The patient had not experienced any adverse effects from any of the doses administered.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; temperature excursion on PROQUAD which was administered to one patient today; This spontaneous report was received from a medical assistant (also reported as nurse) referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not reported.     On 13-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant Human albumin)) (PROQUAD) (lot # S035109, expiration date 03-MAY-2021, 0.5 milliliter, route was not reported) which undergone a temperature excursion for prophylaxis (product storage error). Temperature excursion was 10.5 Fahrenheit degree for 1 hour 20 minutes. There was no previous temperature excursion. Data logger was involved. No additional adverse event (AE) and product quality compliant (PQC) was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or additional adverse effects reported.; patient received unspecified dose in PROQUAD that was improperly stored; This spontaneous report was received from a licensed practical nurse, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 06-JUL-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, as prophylaxis (lot number S021328 which has been verified to be valid, expiration date reported and validated as 05-JAN-2021) (dose, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). The administered dose of the vaccine was stored at a temperature of 67 degrees Fahrenheit, during a time frame of 17 hours, as recorded by a digital data logger. There was no previous temperature excursion. No symptoms or additional adverse effects were reported in the patient.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects were reported in the patient; A patient received an expired dose of VAQTA; Information has been received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 14-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) Vial 50 (units not provided), at a dose of 1 ml for prophylaxis, (lot number S001832 with expiration date in 12-MAY-2020) (route of administration and anatomical location were not reported) (expired vaccine used).  No additional adverse effects were reported in the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent