chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Blister, Chills, Pain in extremity, Pyrexia, Rash
Clinical narrative: My daughter took Bexsero vaccine at the pediatrician's office on Aug 12, 2019 and went off to college. Next morning she woke up with a fever, chills and a big rash on her arm, looked like a burn and she was c/o of arm pain. Told her to take Benadryl and Tylenol. The next day she was able to move her arm and eventually swelling went down and then her skin started peeling. After the bubbling/redness of the skin there appeared like small tiny veins that were where the blister was and were blue/purplish in color. Those eventually darkened and her skin peeled. She has skin  discoloration over that area now. I need to know what to do about giving her the booster. I have pictures, if that helps, that I mail email somewhere.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Skin discolouration, Skin disorder, Skin exfoliation
Clinical narrative: My daughter took Bexsero vaccine at the pediatrician's office on Aug 12, 2019 and went off to college. Next morning she woke up with a fever, chills and a big rash on her arm, looked like a burn and she was c/o of arm pain. Told her to take Benadryl and Tylenol. The next day she was able to move her arm and eventually swelling went down and then her skin started peeling. After the bubbling/redness of the skin there appeared like small tiny veins that were where the blister was and were blue/purplish in color. Those eventually darkened and her skin peeled. She has skin  discoloration over that area now. I need to know what to do about giving her the booster. I have pictures, if that helps, that I mail email somewhere.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pain
Clinical narrative: Delayed onset of redness, lump over site were vaccine was given. tender to palpation indurated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms both times - I had two shots within the six months and got very sick both times.
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Pt received Proquad, Pentacel, Hep A, Hep B and PCV13 vaccines on Aug. 29, 2019 and pt broke out in a rash on Sept. 9, 2019. Pt did see Dr. and doctor wants a VAERS report filled out.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: No adverse event, Unevaluable event
Clinical narrative: Pt received ProQuad and Varicella at the same office visit along with the other 1 yr immunizations. Pt is doing well
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received PedVax Hib (third dose) at his 6 mos. WCC visit. This dose should have not been given until his 1 year birthday or after.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness, Tremor
Clinical narrative: Patient received the flu vaccine walked out of the immunization room and had a seat. All of a sudden, he felt dizzy and lost consciousness for about a minute and then regained consciousness and started shaking Paramedics were called
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injected limb mobility decreased, Nausea, Pain, Pain in extremity
Clinical narrative: Received Trumenba vaccine in R arm and complained of shooting pain radiating down the arm to her fingers, about 1 hr after she got the shot. Then she started complaining of nausea and dizziness which lasted until the next morning. Pt was unable to move her arm due to the pain, which resulted in the mom calling the office. All symptoms had subsided about 36 hours later.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Redness & soreness around injection site. Pt. stated it was very painful & she couldn't move her arm.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: rash/ rash progressed around and down his both arms; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of blistery rash in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 37K12, expiry date 12th February 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received in May 2018, for tolerance refer case US2019156608).   In June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was recovering/resolving and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received dose of Shingrix in a right arm at a other Clinic since the previous clinic had concerns due to reactions experienced by the patient after 1st dose. The patient experienced a same rash with blisters just below the injection site on right arm that progressed around and down his arm and that it also occurred on his other arm as well. The patient stated, it was resolved but that the clinic declined to give him 2nd dose due to concerns about the reaction. The patient stated that, rash had improved and was 90 percent cleared up now. The patient consented to follow up and provided contact details of clinic.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Rash vesicular
Clinical narrative: rash/ rash progressed around and down his both arms; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of blistery rash in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 37K12, expiry date 12th February 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received in May 2018, for tolerance refer case US2019156608).   In June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was recovering/resolving and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received dose of Shingrix in a right arm at a other Clinic since the previous clinic had concerns due to reactions experienced by the patient after 1st dose. The patient experienced a same rash with blisters just below the injection site on right arm that progressed around and down his arm and that it also occurred on his other arm as well. The patient stated, it was resolved but that the clinic declined to give him 2nd dose due to concerns about the reaction. The patient stated that, rash had improved and was 90 percent cleared up now. The patient consented to follow up and provided contact details of clinic.
Age: 31.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Erythema, Granuloma annulare, Loss of personal independence in daily activities, Skin lesion
Clinical narrative: I saw my PCP on on August 26th who thought my condition might be granuloma annulare; The left side of my face is swollen; my lip is swollen; calmed the inflammation about 80%; woke up on August 22nd with red lesions all over my body/patient's rash.; This spontaneous report was received from a 31 years old female patient referring to herself who had no drug reactions or allergies. Information about concomitant therapies was not provided. Concurrent condition included 4 months postpartum. The patient was not pregnant.  On 14-AUG-2019 (reported as Wednesday in the morning), the patient was vaccinated with the first dose hepatitis a vaccine, inactivated (VAQTA) Injection (single dose; strength, route, lot # and expiration date were not reported) for prophylaxis (reported as prevention of Hepatitis A) in left arm. On 22-AUG-2019, the patient woke up with red lesions all over her body and had rash. The patient saw dermatologist and started taking fexofenadine hydrochloride (ALLEGRA).  On 26-AUG-2019 the patient saw primary care physician (PCP) who thought her condition might be granuloma annulare.  But neither dermatologist nor primary care physician had come up with a diagnosis. On 28-AUG-2019 the patient took cetirizine hydrochloride (ZYRTEC), which calmed the inflammation about 80%, but she did not think her condition was actually improving.  On 29-AUG-2019 morning the patient started taking prednisone, but this was the eighth day of this. The left side of her face was swollen, and her lip was swollen. Blood work was performed.  The outcome of all the events was not recovered.  The causality was not reported.
Age: 31.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Lip swelling, Rash erythematous, Swelling face
Clinical narrative: I saw my PCP on on August 26th who thought my condition might be granuloma annulare; The left side of my face is swollen; my lip is swollen; calmed the inflammation about 80%; woke up on August 22nd with red lesions all over my body/patient's rash.; This spontaneous report was received from a 31 years old female patient referring to herself who had no drug reactions or allergies. Information about concomitant therapies was not provided. Concurrent condition included 4 months postpartum. The patient was not pregnant.  On 14-AUG-2019 (reported as Wednesday in the morning), the patient was vaccinated with the first dose hepatitis a vaccine, inactivated (VAQTA) Injection (single dose; strength, route, lot # and expiration date were not reported) for prophylaxis (reported as prevention of Hepatitis A) in left arm. On 22-AUG-2019, the patient woke up with red lesions all over her body and had rash. The patient saw dermatologist and started taking fexofenadine hydrochloride (ALLEGRA).  On 26-AUG-2019 the patient saw primary care physician (PCP) who thought her condition might be granuloma annulare.  But neither dermatologist nor primary care physician had come up with a diagnosis. On 28-AUG-2019 the patient took cetirizine hydrochloride (ZYRTEC), which calmed the inflammation about 80%, but she did not think her condition was actually improving.  On 29-AUG-2019 morning the patient started taking prednisone, but this was the eighth day of this. The left side of her face was swollen, and her lip was swollen. Blood work was performed.  The outcome of all the events was not recovered.  The causality was not reported.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paralysis, Pyrexia, Quadriplegia, Sensory loss, Walking aid user
Clinical narrative: Complete paralysis at 5:00 a.m. 3 1/2 days in ICU Transfered to a Rehabilitation Center to learn how to walk and learn actities of daily living. Total Hospitalization 8-19-19 thru 9-4-19 Now in outpatient P.T.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait inability, Intensive care, Loss of personal independence in daily activities, Paralysis
Clinical narrative: Complete paralysis at 5:00 a.m. 3 1/2 days in ICU Transfered to a Rehabilitation Center to learn how to walk and learn actities of daily living. Total Hospitalization 8-19-19 thru 9-4-19 Now in outpatient P.T.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Blood pressure abnormal, Herpes zoster, Nausea, Nervousness
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received Shingrix. On 5th September 2019, 4 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: On 5th September 2019 , the patient woke up on that morning with the shingles.  She saw her physician on 6th September 2019 and he confirmed that it was the shingles.   The physician placed her on Valacyclovir. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Night sweats
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received Shingrix. On 5th September 2019, 4 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: On 5th September 2019 , the patient woke up on that morning with the shingles.  She saw her physician on 6th September 2019 and he confirmed that it was the shingles.   The physician placed her on Valacyclovir. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received Shingrix. On 5th September 2019, 4 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: On 5th September 2019 , the patient woke up on that morning with the shingles.  She saw her physician on 6th September 2019 and he confirmed that it was the shingles.   The physician placed her on Valacyclovir. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Blood test, Dysstasia, Gait inability, Guillain-Barre syndrome, Immediate post-injection reaction
Clinical narrative: My son was vaccinated and immediately started showing symptoms of stiffness in his lower extremities. Over the course of a month my son started experiencing paralysis until he was no longer able to walk. Multiple trips to his pediatrician over the course of the month. His pediatrician was perplexed as to patient's condition. My son went from active 2 1/2 year old to paralyzed with no use of his legs.  We were told by our pediatrician to go to the emergency room. We were checked into Hospital. After a spinal tap, multiple blood tests, MRI, X-rays a Neurologist diagnosed patient with Guillain-Barré syndrome.  We stayed in the hospital so my son could receive the IGIV treatment for a week and monitoring by doctors. He then endured months of physical therapy to regain his ability to stand/walk. This diagnosis of Guillain Barre was directly linked to the HepB vaccine.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging, Monoplegia, Musculoskeletal stiffness
Clinical narrative: My son was vaccinated and immediately started showing symptoms of stiffness in his lower extremities. Over the course of a month my son started experiencing paralysis until he was no longer able to walk. Multiple trips to his pediatrician over the course of the month. His pediatrician was perplexed as to patient's condition. My son went from active 2 1/2 year old to paralyzed with no use of his legs.  We were told by our pediatrician to go to the emergency room. We were checked into Hospital. After a spinal tap, multiple blood tests, MRI, X-rays a Neurologist diagnosed patient with Guillain-Barré syndrome.  We stayed in the hospital so my son could receive the IGIV treatment for a week and monitoring by doctors. He then endured months of physical therapy to regain his ability to stand/walk. This diagnosis of Guillain Barre was directly linked to the HepB vaccine.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: X-ray
Clinical narrative: My son was vaccinated and immediately started showing symptoms of stiffness in his lower extremities. Over the course of a month my son started experiencing paralysis until he was no longer able to walk. Multiple trips to his pediatrician over the course of the month. His pediatrician was perplexed as to patient's condition. My son went from active 2 1/2 year old to paralyzed with no use of his legs.  We were told by our pediatrician to go to the emergency room. We were checked into Hospital. After a spinal tap, multiple blood tests, MRI, X-rays a Neurologist diagnosed patient with Guillain-Barré syndrome.  We stayed in the hospital so my son could receive the IGIV treatment for a week and monitoring by doctors. He then endured months of physical therapy to regain his ability to stand/walk. This diagnosis of Guillain Barre was directly linked to the HepB vaccine.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal discomfort, Diarrhoea, Skin discolouration
Clinical narrative: Diarrhea,  mucus in stool, gastrointestinal discomfort, splotches on skin that come and go beginning the next day and continuing through current date (9/17)
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Very red, swollen, warm, size of palm of adult hand at injection site - still there, red and warm 4 days later. Entire body felt run down, achy and as if had a fever
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Peripheral swelling
Clinical narrative: The arm was red and swollen adn has a small bruise
Age: 39.0
Sex: M
Vaccine: UNK
Symptoms: Biopsy, Lichen planus, Pruritus, Rash
Clinical narrative: New onset of rash, had bx 26 Oct 17 consistent with Lichen Planus. Per record review did have a rash prior to influenza vaccine with Lichen Planus listed in differential. Post vaccine had a increase in number of lesions.  Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21), PRURITUS, UNSPECIFIED(L299).
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Hallucination
Clinical narrative: patient claims she had hallucinations at night
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: negative varicella titers; received 2 doses of VARIVAX on unspecified dates "approximately 20 years ago" and one dose of VARIVAX on an unspecified date "approximately 10 years ago"/after receiving 3 doses of VARIVAX; This spontaneous report was received from a physician assistant referring to an approximately 52 years old female patient. She had no pertinent medical history, or drug reactions/allergies. The patient received unspecified medications for diabetes.  In approximately 1999 (reported as approximately 20 years ago), the patient received 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, unit, route, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in approximately 2009 (reported as approximately 10 years ago), she received one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, unit, route, lot number and expiration date were not reported) (extra dose administered).  After receiving 3 doses of varicella virus vaccine live (oka/merck) (VARIVAX), on 20-MAY-2019, the patient had blood work which showed negative varicella titers. No treatment was given. The patient had sought medical attention. The outcome of the event negative varicella titers was reported as not recovered. The causality between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient received one dose of improperly stored ROTATEQ; Information has been received from an office manager referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 08-AUG-2019, the patient received one dose of improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot # R025713, expiration date: 20-JUN-2020, strength and dose were unknown) orally for prophylaxis (product storage error). The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was exposed to lowest temperature below 36 Fahrenheit degrees (33.9F) for 40 minutes. There were previous temperature excursions of lowest temperature below 36 Fahrenheit degrees (30.3F) for 90 hours and 7 minutes, lowest temperature below 36 Fahrenheit degrees (30.5F) for 1 hour and 45 minutes and lowest temperature below 36 Fahrenheit degrees (35.2F) for 2 hour and 5 minutes. The data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; a improperly stored dose of MMRII was administered; This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S006647,  expiration date on 05-MAR-2021, for prophylaxis  (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 50 degrees Fahrenheit for 49 minutes. Data logger was involved. There were no previous excursions reported.
Age: 1.08
Sex: M
Vaccine: MMR, MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: the patient was inadvertently administered one dose of PROQUAD on 17-JUL-2019; The titers for varicella were less than 0.9, which the nurse reported as being negative titers to those diseases; The titers for rubeola were less than 0.6, which the nurse reported as being negative titers to those diseases; Information has been received from a registered nurse referring to a 19 years old male patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 01-SEP-2000, the patient received one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (batch/lot #, expiration date, strength, dose and route were unknown) for prophylaxis. On 10-NOV-2000, he received one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (batch/lot #, expiration date, strength, dose and route were unknown) for prophylaxis. On 12-JUL-2004, he received another dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (batch/lot #, expiration date, strength, dose and route were unknown). On 24-MAY-2010, he received another of varicella virus vaccine live (Oka/Merck) (VARIVAX) (batch/lot #, expiration date, strength, dose and route were unknown).  On 12-JUN-2019, the patient had titers drawn because he was going to school to be a certified medical assistant, and titers were required. The titers for rubeola were less than 0.6 (unit not provided), and for varicella were less than 0.9 (unit not provided), which the nurse reported as being negative titers to those diseases (measles antibody negative, antibody test negative). Because of that, on 17-JUL-2019, the patient was inadvertently administered one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (1 dose, batch/lot # S003173, expiration date: 30-JUL-2020, strength and route were unknown) for prophylaxis (inappropriate age at vaccine administration). Medical attention was sought to the physician. The outcome of the events was unknown.  The causality between the vaccines and the events was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was administered an improperly stored ROTATEQ.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 23-AUG-2019 the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S010702, expiration date 16-JAN-2021; strength, dose, frequency and route were not reported) for prophylaxis (improper storage of product in use). No adverse effects were reported. The temperature and time frame were unknown. The previous excursion was not reported. The call was not because of a data logger.
Sex: F
Vaccine: PPV
Symptoms: Dry mouth, Oropharyngeal pain, Taste disorder
Clinical narrative: Patient developed a sore throat, was unable to taste and smell normally and had a dry mouth; Patient developed a sore throat, was unable to taste and smell normally and had a dry mouth; Patient developed a sore throat, was unable to taste and smell normally and had a dry mouth; Patient developed a sore throat, was unable to taste and smell normally and had a dry mouth; Information has been received from a medical assistant, concerning a 69-years-old female patient. The patient's concurrent conditions included liver sclerosis, osteoporosis, thrombocytopenia, hypertension, osteoarthritis and electrocardiography abnormalities. The patient was allergic to depomedrol, penicillin, cortisone, levofloxacin (LEVAQUIN), red dye and sulfa. Patient's concomitant medications included calcium (+) vitamin D supplement, alprazolam (XANAX), desmopressin, escitalopram oxalate (LEXAPRO), lansoprazole (PREVACID), loperamide hydrochloride (IMODIUM), multivitamin, tramadol hydrochloride and ursodiol (ACTIGALL).  On 21-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly in her right arm to prevent pneumonia (lot number: R033342 with expiration date: 03-AUG-2020) (strength and dose was not provided).  On the same date later than night, the patient experienced a sore throat (oropharyngeal pain), was unable to taste (ageusia), and smell normally (parosmia) and had a dry mouth. The patient sought for medical attention and there was no lab diagnostics or studies performed. There was no treatment given for the adverse events.  It was unknown if the abovementioned adverse events were resolved at the time of this report.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the abovementioned adverse events were not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient received an improperly stored PROQUAD; This spontaneous report was received from a registered nurse referring to a 4 year old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided.  On 12-AUG-2019 and 13-AUG-2019, therapy of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) experienced two temperature excursions which were stored in the range of -14°C to -10°C (-11.91°C, multiple) for 8 hours.   On 21-AUG-2019, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R026722, expiration date on 17-MAR-2020 and R023499, expiration date on 13-FEB-2020 (strength, dose number, route and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No previous temperature excursion was reported. No adverse effects were reported.   Digital data logger was involved.
Age: 4.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; Proquad experienced two temperature excursions; This spontaneous report was received from a registered nurse and refers to an 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.   On 27-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) lot # R026722, expiration date 17-MAR-2020 (dose, route of administration and anatomical location were not reported) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) lot # R023499, expiration date 13-FEB-2020 (dose, route of administration and anatomical location were not reported) for prophylaxis. Concomitant therapies included sterile diluent. Administered dose of vaccine experienced the temperature excursion from -14 degrees Celsius to -10 degrees Celcius for 8 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Cellulitis, Diarrhoea, Injection site warmth, Loss of personal independence in daily activities
Clinical narrative: Was diagnosed with Cellulitis/ "cellulitis or staff infection"/fever; She has experienced diarrhea; Severe adverse reaction/Unable to do anything for more than a week; Nausea; Injection site hot to touch; Information has been received from a 77 year old female patient. No medical history, concurrent conditions nor concomitant medications were reported. On 08-SEP-2019 (also reported as "unknown date"), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (route, strength, lot number and expiration date not reported) for prophylaxis. In September 2019, the patient experienced a severe adverse reaction (adverse event), fever and the injection site was "hot to touch" (injection site warmth). On 09-SEP-2019 (also reported as "24 hours after vaccination"), the patient was seen by a registered nurse who diagnosed her with cellulitis (also reported as "cellulitis/staff infection"). The patient received treated with ondansentron hydrochloride (ZOFRAN) 8 mg and an unidentified "strong antibiotic". In September 2019, the patient experienced diarrhea and nausea but didn't know if it was due to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or the antibiotic. The patient reported she was "unable to do anything for more than a week" (adverse event) (conflicting information as report was received the same day of onset date). In September 2019, the patient saw a physician and was told to stop the antibiotic. The outcome of cellulitis, nausea, adverse event, injection site warmth and diarrhea was unknown.  The relationship between cellulitis, nausea, adverse event, diarrhea, injection site warmth and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, cellulitis was considered to be a medically significant event.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Was diagnosed with Cellulitis/ "cellulitis or staff infection"/fever; She has experienced diarrhea; Severe adverse reaction/Unable to do anything for more than a week; Nausea; Injection site hot to touch; Information has been received from a 77 year old female patient. No medical history, concurrent conditions nor concomitant medications were reported. On 08-SEP-2019 (also reported as "unknown date"), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (route, strength, lot number and expiration date not reported) for prophylaxis. In September 2019, the patient experienced a severe adverse reaction (adverse event), fever and the injection site was "hot to touch" (injection site warmth). On 09-SEP-2019 (also reported as "24 hours after vaccination"), the patient was seen by a registered nurse who diagnosed her with cellulitis (also reported as "cellulitis/staff infection"). The patient received treated with ondansentron hydrochloride (ZOFRAN) 8 mg and an unidentified "strong antibiotic". In September 2019, the patient experienced diarrhea and nausea but didn't know if it was due to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or the antibiotic. The patient reported she was "unable to do anything for more than a week" (adverse event) (conflicting information as report was received the same day of onset date). In September 2019, the patient saw a physician and was told to stop the antibiotic. The outcome of cellulitis, nausea, adverse event, injection site warmth and diarrhea was unknown.  The relationship between cellulitis, nausea, adverse event, diarrhea, injection site warmth and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, cellulitis was considered to be a medically significant event.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: cellulitis; This spontaneous report was received from a consumer who was referring to herself, a female patient of unknown age, via Pfizer (manufacturer control #2019391227). There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported).        On an unknown date, the patient experienced side effects from pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) such as cellulitis and wanted unspecified medical information.  The outcome of cellulitis was unknown.    The reporter considered cellulitis to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).     Upon internal review, cellulitis was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient; the physician reports that a patient received a dose of PROQUAD following a temperature excursion; 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, concomitant medications, drug reactions and allergies.  On 09-SEP-2019, the patient received a dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot number S012535 and expiration date on 20-OCT-2020 (dose, dose number, route of administration, anatomical injection site were not reported) for prophylaxis; following a temperature excursion (product storage error).  It was reported that on an unknown date, the vaccines were exposed to a temperature excursion between 15 Fahrenheit (F) degrees to 16 F degrees (-9 Celsius (C) degrees to 8 C degrees) (30 F degrees) for 60 minutes. There were no previous temperature excursions and the Digital Data logger report. was not involved. No adverse effects were reported in the patient.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: syncope; This spontaneous report was received from a physician assistant, via company representative, concerning a female patient of currently 12 years old. The patient had no pertinent medical history or concomitant medications; concurrent conditions, previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with first dosage of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly into the left deltoid (no concentration or dose reported; lot # N007931 expiration date reported as 17-NOV-2019 and upon internal validation stablished as the same) indicated for prophylaxis.  On an unknown date, 5 minutes after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced a syncope.  The outcome of the syncope was not reported. The relatedness between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the syncope was not reported.  Upon internal review, the event of syncope was determined to be medically significant.
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects reported; One dose of VAQTA was accidentally administered to the patient in place of Recombivax; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 08-NOV-2018, the nurse reported that one dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot # R013859 has been verified to be a valid lot number for hepatitis a vaccine, inactivated, expiration date reported and establish as 14-JUN-2019) (strength, dose, frequency and route of administration were not reported); was accidentally administered to patient in place of hepatitis b virus vaccine rhbsag (yeast) (RECOMBIVAX) (wrong product administered).         No adverse effects reported.
Age: 1.92
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; a patient received improperly stored PROQUAD; This spontaneous report was received from a medical assistant regarding a 23 month old patient of unknown gender. Information on pertinent medical history and drug reactions/allergies was not reported. Concomitant medications included sterile diluent.  On 05-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # S002494, expiration date: 23-JUL-2020, albumin status: rha) (dose, dose number, route, location of administration and frequency were not reported) administered for prophylaxis.  The vaccine was exposed to temperature of 6 to 14 degree Fahrenheit (F) (10.2 F, multiple) for 50 minutes as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; improperly stored vaccine administration; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient with unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.      On 10-SEP-2019, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, frequency and route were not reported) (lot # S002874, Expiration Date: 29-JAN-2021) for prophylaxis. There was no adverse effect. The stored temperature was 6 Fahrenheit (F) to 14 F (10.2 F, multiple) for 50 minutes and the data logger was involved. There was no previous temperature excursion. It was used to reconstitute sterile diluent (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The storage of sterile diluent was properly.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005223: US-009507513-1909USA005220:
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: After all the girls were given the vaccine, many were becoming disabled and/or terminal; After all the girls were given the vaccine, many were becoming disabled and/or terminal; This spontaneous report was received from a consumer refers to unknown number of female patients of unknown age. The patients' medical history, concurrent conditions, historical dugs and concomitant medications were not reported. On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, frequency, route, lot # and expiration date not reported) for prophylaxis. It was reported that, after all the girls were given the vaccine, many were becoming disabled (adverse event) and/or terminal (terminal state). The outcome of the events was unknown. The causality assessment was not provided by the reporter.  The reporter considered the adverse event to be disabling.  Upon internal review, terminal state was determined to be medically significant.  This is one of several reports received from the same reporter (1909USA004907).; Sender's Comments:  US-009507513-1909USA004907:
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: reported ROTATEQ was given past 32 weeks of age to a patient. No adverse symptoms reported.; reported ROTATEQ was given past 32 weeks of age to a patient. No adverse symptoms reported.; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 13-SEP-2019, the patient, who was past 32 weeks of age, was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, for prophylaxis (lot/batch # and expiration date were not reported). No adverse symptoms reported. No further information provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored vaccine administered intramuscularly; confirmed route of administartation was intramuscular; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 10-SEP-2019 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S002736 dose 1, .5 milliliter, intramuscular for prophylaxis.    Concomitant therapies included sterile diluent (STERILE DILUENT) (possible lot # S000130, expiry date: 23-AUG-2021).   On 10-SEP-2019, 1 day after onset of therapy the patient experienced product storage error and incorrect route of product administration.  On an unknown date the patient experienced no adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; one dose of an improperly stored vaccine, VARIVAX, was administered; route of adminsitration was intramuscular; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/ allergies were not reported. Concomitant therapies included sterile diluent which was used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored in the correct storage temperature range. On 10-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot # S002877 and expiration date 29-JAN-2021, at a dose of 0.5 milliliter once via intramuscular route for prophylaxis (product storage error) and (incorrect route of product administration). The storage temperature was reported as 8.1 Fahrenheit (F) for time frame of 20 minutes. Previous temperature excursions included 8.1 F for 17 minutes and 9.5 F for 21 minutes. The call was because of a data logger. No adverse effects reported. No product quality complaint (PQC) present.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Feel achy all over; Chills; Low grade fever; Feels tired; This case was reported by a consumer and described the occurrence of pain in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of heart rate increased (1st dose received on 1st March 2019 and experienced fever and other events, refer case US2019052626).   On 9th September 2019, the patient received the 2nd dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix, the patient experienced pain, chills, low grade fever and tiredness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain, chills, low grade fever and tiredness were unknown.   It was unknown if the reporter considered the pain, chills, low grade fever and tiredness to be related to Shingrix.  Additional details were received as follows:  In the morning, the patient received Shingrix at around 8 am. The patient noted it was a little under 6 months from his first dose. Later in the day he began to feel achy all over, chills, low grade fever of 98.8 to 99 (which he also had with the first dose) and he feels tired. He has treated the fever with Tylenol. He continued to have the symptoms today.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.  Additional details were received as follows: The age at vaccination was not was reported. The age group selected as per vaccine specification.  The patient reported flu like symptoms after receiving a dose of shingrix. This case was linked with cases US2019AMR165395 and US2019AMR165390, reported by the same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular, Tinea infection
Clinical narrative: ringworm infection; rash/ rash progressed around and down his arm; This case was reported by a consumer via call center representative and described the occurrence of tinea in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tinea and blistery rash. The patient was treated with antifungals for topical use (Antifungal Cream). On an unknown date, the outcome of the tinea and blistery rash were recovered/resolved.   It was unknown if the reporter considered the tinea and blistery rash to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received dose of Shingrix in anunknown arm at a Clinic. The patient experienced a rash with blisters just below the injection site on left arm that progressed around and down his arm. The patient was treated with an antifungal cream in case it was a ringworm infection. The patient stated, it was resolved but that the clinic declined to give him 2nd dose due to concerns about the reaction. The patient then changed clinics in 2019 and received 2nd dose of Shingrix. For tolerance of 2nd dose, refer case US2019AMR162633. The patient consented to follow up and provided contact details of clinic.