chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Pain, Pruritus
Clinical narrative: My arm hurt tremendously at the injection site and muscle for days after the shot. On the evening of March 29, I decided to look to see what was causing the itching on the inside of my left shoulder blade. I thought it might have been spider bites. They looked like volcanos that have lost their tops, and had a liquid center. Over the weekend the itching increased, and was accompanied by a burning pain. On Tuesday I went to see a doctor, and she said that it appeared to be an adverse reaction to the SHINGRIX vaccine--which had caused a small shingles rash. She gave me a prescription for Valacyclovir, and topical Lidocaine. My pharmacist was unable to fill the Lidocaine prescription due to my insurance--so she gave me an over the counter version instead. The pharmacist at pharmacy said that there was a chance that the Valacyclovir could lesson the effectiveness of the SHINGRIX vaccine. This was vaccine #1 in a two part series. Since the 29th, I have also been applying apple cider vinegar which I read would lesson the itching and pain. The rash has been scabbed over for days (today is April 7), yet the itching and pain has not gone away.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: My arm hurt tremendously at the injection site and muscle for days after the shot. On the evening of March 29, I decided to look to see what was causing the itching on the inside of my left shoulder blade. I thought it might have been spider bites. They looked like volcanos that have lost their tops, and had a liquid center. Over the weekend the itching increased, and was accompanied by a burning pain. On Tuesday I went to see a doctor, and she said that it appeared to be an adverse reaction to the SHINGRIX vaccine--which had caused a small shingles rash. She gave me a prescription for Valacyclovir, and topical Lidocaine. My pharmacist was unable to fill the Lidocaine prescription due to my insurance--so she gave me an over the counter version instead. The pharmacist at pharmacy said that there was a chance that the Valacyclovir could lesson the effectiveness of the SHINGRIX vaccine. This was vaccine #1 in a two part series. Since the 29th, I have also been applying apple cider vinegar which I read would lesson the itching and pain. The rash has been scabbed over for days (today is April 7), yet the itching and pain has not gone away.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Raised red bump, about 2 inches wide. Warm and tender to touch. Not itchy.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Biopsy skin abnormal, Blister, Condition aggravated, Culture wound negative
Clinical narrative: Sheets of blisters on mid back extremely itchy, sores formed, early on 3/1 by 3/8, spread to arms, legs, buttock, as of today I still have numerous pox type sores on arms legs and back 4/7/2019.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Pruritus, Skin ulcer, Varicella virus test positive, Viral test negative
Clinical narrative: Sheets of blisters on mid back extremely itchy, sores formed, early on 3/1 by 3/8, spread to arms, legs, buttock, as of today I still have numerous pox type sores on arms legs and back 4/7/2019.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Chills, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: Severe flu-like symptoms, shaking, sweating then chills. Joint and muscle pain.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: Severe flu-like symptoms, shaking, sweating then chills. Joint and muscle pain.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, X-ray limb
Clinical narrative: got the shot on Sunday and on Monday I could not walk without a lot of pain in my knees
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Decreased appetite, Peripheral swelling, Platelet count, Swelling face, Urticaria
Clinical narrative: Decreased appetite followed by hives and swelling of face, legs, and feet.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Blood thyroid stimulating hormone decreased, Cardiac stress test normal, Chest pain
Clinical narrative: Shortness of breath, chest pain, abdominal pain, nausea, vomiting, weakness, body malaise, tachycardia, flu-like symptoms, generalized itchiness, congestion, loss of appetite. First or second week of March - rashes on the right side of body.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dyspnoea, Electrocardiogram abnormal, Full blood count normal, Influenza like illness
Clinical narrative: Shortness of breath, chest pain, abdominal pain, nausea, vomiting, weakness, body malaise, tachycardia, flu-like symptoms, generalized itchiness, congestion, loss of appetite. First or second week of March - rashes on the right side of body.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pruritus, Rash, Respiratory tract congestion
Clinical narrative: Shortness of breath, chest pain, abdominal pain, nausea, vomiting, weakness, body malaise, tachycardia, flu-like symptoms, generalized itchiness, congestion, loss of appetite. First or second week of March - rashes on the right side of body.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Serum ferritin increased, Tachycardia, Vomiting
Clinical narrative: Shortness of breath, chest pain, abdominal pain, nausea, vomiting, weakness, body malaise, tachycardia, flu-like symptoms, generalized itchiness, congestion, loss of appetite. First or second week of March - rashes on the right side of body.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain
Clinical narrative: Patient is stating that he is still having arm soreness and discomfort at the injection site as of 04/05/2019. He states that he cannot lift his arm any higher than the height of his shoulder.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Muscular weakness
Clinical narrative: Fever, chills, muscle weakness, joint pain, pain at site of injection, fatigue.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, muscle weakness, joint pain, pain at site of injection, fatigue.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Left upper arm, area of redness/swelling/warm to touch. Area is round and approx. 3.5 inches in size. Patient complains of sore arm and some itching at site of injection. Patient reports that symptoms began appearing on 04/03/2019 in the morning. Patient reported symptoms on 04/05/2019, stating symptoms have improved slightly. Recommended patient to take ibuprofen, oral Benadryl, and cold compress to affected area.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: may have received second dose of PNEUMOVAX 23 one month after receiving first dose of PNEUMOVAX 23; No adverse effects reported; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's current conditions, concomitant medication and medical history were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the nurse reported that the patient might have received second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) one month after receiving first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Extra dose administered). No adverse effects reported. The outcome of the events was unknown.
Age: 16.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; a 16 year old female inadvertently administered one separate dose each of ZOSTAVAX; ZOSTAVAX administered were expired; Information has been received from a pharmacist referring to a 16 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent.  On 22-MAR-2019, the patient was inadvertently administered one dose of zoster vaccine live(ZOSTAVAX) 19400 plaque-forming unit (PFU) (lot # N025568, expiration date 08-DEC-2018; dose and frequency were not reported) subcutaneously for prophylaxis (inappropriate schedule of vaccine administered and expired product administered). No adverse effects were reported in patient.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-1904USA003352:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effects; the patient was inadvertently administered a dose of MMR II via the intramuscular route rather than the recommended subcutaneous route; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 25-MAR-2019, the patient was inadvertently vaccinated wit a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA)(lot # N020926 with an expiration date in 01-AUG-2019), via intramuscular route rather than the recommended subcutaneous, for prophylaxis (strength, dose and frequency were no provided). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Stored improperly; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On an unknown date the patient was vaccinated with one improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) (lot # R028531, expiry date: 02-APR-2020) (dose and frequency were not reported) subcutaneously for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK INJ).  The vaccine was stored in temperature of -9 degree Celsius (C) to 8 C (-1.7 C) for 51 hours and 9 minutes and -14 degree Celsius (C) to -10 C (-9.8 C) for 3 hours and 40 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: the patient was inadvertenlty administered a dose of ZOSTAVAX instead of the scheduled second dose of VARIVAX.; Dose/Frequency: 0.5 ml/ once; No adverse effects were reported; Information has been received from a nurse referring to a 28 years old female patient. Information of drug reactions/allergies was not reported. Concomitant therapy included sterile diluent. On an unspecified date, the patient received her first dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, frequency, route, lot# and expiration date were unknown) for prophylaxis.   On 29-MAR-2019, the patient was inadvertenlty administered a dose of zoster vaccine live (ZOSTAVAX)(0.5 ml, once, subcutaneous, lot # R023356, expiration date: 28-JUN-2019) for prophylaxis instead of the scheduled second dose of varicella virus vaccine live (oka/merck)(VARIVAX)(wrong vaccine administered, inappropriate dose of vaccine administered). Properly stored sterile diluent was used to reconstitute the zoster vaccine live(ZOSTAVAX). No adverse effects were reported.
Sex: M
Vaccine: PPV
Symptoms: Renal transplant
Clinical narrative: This spontaneous report as received from a health professional via Pfizer (manufacturer control #2019137878) refers to a 64 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, lot# and route of administration were not reported) for prophylaxis. On an unknown date, the patient underwent kidney transplant. The consumer wanted to know how soon a patient can receive PREVNAR 13 after receiving PNEUMOVAX 23. The outcome of kidney transplant and causality assessment were unknown. Upon internal review kidney transplant was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored VARIVAX; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant therapy were not reported.   On 20-MAR-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were not reported) (lot # R018143 and expiry date: 25-JUN-2020, lot # R026715 and expiry date: 18-SEP-2020) for prophylaxis. The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored diluent(DILUENT MRK INJ). It was reported that, the nurse did not know which lot number was administered to the patient therefore 2 lot numbers are documented.  The vaccine was stored in temperature 47 degree Fahrenheit (F) to 77 F (66.5 F) for 943 Minutes. No previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of two reports received from the same reporter.
Sex: M
Vaccine: HPV9
Symptoms: Congenital ureterovesical junction anomaly, Foetal exposure during pregnancy, Hydronephrosis
Clinical narrative: This spontaneous report was received from a physician regarding a male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. The mother of the patient was a female. On an unspecified date, the mother of the patient was vaccinated with the first two doses of GARDASIL 9 (frequency, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 06-JUL-2018, the mother of the patient was vaccinated with third dose of GARDASIL 9 intramuscularly, lot # R000301 with expiration date 29-AUG-2020 (frequency and anatomical location were not provided) for prophylaxis. On 13-JUL-2018, the mother of the patient returned for intrauterine device (IUD) placement and the nurse discovered that the mother of the patient was pregnant (foetal exposure during pregnancy). The mother of the patient's last menstrual period was on 10-JUN-2018. The estimated date of delivery (EDD) was on 17-MAR-2019. On an unknown date, the mother of the patient had motor vehicle accident (MVA) (road traffic accident) and developed brain aneurysm from MVA and the mother of the patient underwent to clipping of brain aneurysm (intra-cerebral aneurysm operation). On 19-OCT-2018, the mother of the patient underwent Ultrasound examination and the result showed fetal abnormality, Ureterovesical junction (UVJ) abnormality and renal concerns at normal measurements. The quad screen and Prenatal panel test were performed, and the result showed as Trisomy 18 was at risk of 1/65. On 27-DEC-2018, the mother of the patient was vaccinated with another suspect product diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (strength 0.5 ml), (dose, lot number, expiry date not provided) for prophylaxis. Other therapy taken by the mother of the patient included prenatal vitamin. On an unknown date, the patient experienced hydronephrosis. The outcome of the events was unknown. The causality assessment was not provided by the reporter. Upon internal review, the events hydronephrosis and ureterovesical (UVJ) junction abnormality were determined to be medically significant. This case has been cross linked to 1808USA003635 (mother case).; Sender's Comments:  US-009507513-1808USA003635:
Sex: M
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: mumps; This spontaneous report was received from a medical assistant via a company representative regarding a male child of unknown age (also reported as 9 or 10-year old). The patient's concurrent condition, medical history and concomitant therapy details were unknown.  On an unknown date, the patient was vaccinated with unspecified dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route of administration, lot# and expiry date were not reported) for prophylaxis. On an unknown date in 2019 (also reported as within last two weeks), the patient developed mums. The outcome of the events was unknown. Causality assessment was unknown.  There was no product quality complaints associated with this report.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX was stored improperly. Unknown if MERCK STERILE DILUENT that was used to reconstitute VARIVAX was properly stored; No adverse effects reported; This spontaneous report was received from a registered nurse referring 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 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R024144 with a expiration date on 23-AUG-2020, subcutaneous for prophylaxis (dose was not reported) that was reconstitute with a sterile diluent(MERCK STERILE DILUENT) that was unknown if it was properly stored. The administered dose of the vaccine experienced a temperature excursion of -13 degrees Celsius for 5 minutes. There was no adverse effect reported.  This call was because of a data logger.   No product quality complaint was involved.
Sex: F
Vaccine: HPV9
Symptoms: Multiple sclerosis, Neuralgia
Clinical narrative: This spontaneous report was received from a Pharmacist via company representative refers to a female patient of age between 14 and 16 years old at the time of vaccination. The patient's medical history, concurrent condition and concomitant medications were unknown. On an unknown date in 2017 (reported as 2 years ago), the patient was vaccinated with GARDASIL 9 (strength, formulation, dose, unit, frequency, route of administration unknown) as "routine vaccination" (prophylaxis). On an unknown date, the patient experienced neurological pain and symptoms similar to multiple sclerosis (Multiple sclerosis). It was reported that the patient sought unspecified medial attention. No Product quality complaints involved. Outcome and causality of the events were not reported. Upon internal review, the event "Multiple sclerosis" was determined to be medically significant.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician regarding a 33 year old Adult female patient. Patient's pertinent medical history included pulmonary embolism and pre-diabetics. No concomitant medications were mentioned and she had no known drug allergies. On 25-MAR-2019 the patient was vaccinated with GARDASIL 9, intramuscular for hpv pre (prophylaxis). Other suspect therapies included tinidazole (TINDAMAX) administered for bacterial vaginosis on 25-MAR-2019. On an unknown date in 2019, the patient complained of urticaria. Patient went to an unspecified emergency room and was given diphenhydramine hydrochloride (BENADRYL) and was sent home. Patient seek medical attention. No laboratory diagnostics were done. The outcome of urticaria was unknown. Causality assessment was not reported.
Age: 0.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a physician refers to a 1-month old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 04-MAR-2019, about a month ago the patient was inadvertently administered a dose of GARDASIL 9 (lot # R017249 and expiration date 20-APR-2021 (also reported as 04-MAY-2021)) (wrong product administered) instead of RECOMBIVAX HB. The physician did not elaborate on the possible reason for the error. No adverse effects were reported. No PQC (product quality complaint) was reported.
Age: 4.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4-year-old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the four year old patient was possibly vaccinated with one dose of GARDASIL 9 (lot# and expiration date unknown) (product administered to patient of inappropriate age). This was not a product confusion. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Administered Improperly stored vaccine; This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 02-APR-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R024265,expiry date: 26-AUG-2020) via subcutaneous route for prophylaxis. Concomitant drugs included sterile diluent. The vaccine administered was not properly stored and was administered after reconstituting with properly stored sterile diluent. The temperature at the time of administration was 11.8 Fahrenheit with time frame of 2 hours and 20 minutes. The vaccine had previous temperature excursion at 6.8 Fahrenheit for 2 hours 40 minutes. No adverse effects reported. No product quality complaint involved in this case. Digital data logger was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On 26-MAR-2019, the improperly stored and administered GARDASIL 9 intramuscularly, lot number R008163, expiry date 18-NOV-2020 (anatomical location, strength, dose and frequency were not reported) for prophylaxis, underwent a temperature excursion prior to being administered to the patient on 29-MAR-2019. The administered dose of the GARDASIL 9 experienced a temperature excursion of -28.94 degrees Celsius (C) for 30 minutes, as recorded by a data logger. With no previous reported temperature excursion. There were no known adverse effects reported. No product quality complaint was involved.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 month old patient was received VAQTA; No adverse effect; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided.  It was reported that on an unspecified date when the patient was 2months-old, was vaccinated with a dose of hepatitis a vaccine, inactivated(VAQTA) (dosing details, route of administration, anatomical location, lot number and expiration date not reported) (Inappropriate age at vaccine administration). No adverse effects reported.   .
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; An expired dose of VAQTA was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 04-APR-2019, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) lot # R009952 (expiration date: 17-MAR-2019) (the dosage regimen information was not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effects reported; the patient inadvertently received a dose of VARIVAX via intramuscular route; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about patient's concurrent conditions or pertinent medical history. Concomitant therapy included sterile diluent(MERCK STERILE DILUENT).     On 29-MAR-2019, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) via intramuscularly, lot number N034559, expiration date 05-DEC-2019, for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; a baby girl received improperly stored ROTATEQ; This spontaneous report was received from a registered nurse, referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications.  On 01-APR-2019, a baby girl received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot # R002516 (expiration date: 13-SEP-2019) for prophylaxis (strength, dose and frequency were not reported). The highest temperature excursion was in total, temperature above 9°C (9.1 C) for 17 minutes as recorded by a data logger. No adverse effects were reported.
Sex: F
Vaccine: HIBV
Symptoms: Exposure via skin contact, Product container issue, Skin laceration
Clinical narrative: cut her right index finger on PedVax vial which was broken at the neck of vial and broken at the bottom of vial.; cut her right index finger on PedVax vial which was broken at the neck of vial and broken at the bottom of vial.; cut her right index finger on PedVax vial which was broken at the neck of vial and broken at the bottom of vial.; This spontaneous report was received from an other health professional referring to a 30-year-old female patient who is also a healthcare worker. Her concurrent condition included immunisation. She did not have any pertinent medical history, concomitant medications and drug reactions/allergies.  On 04-APR-2019, it was reported that the patient cut her right index finger on haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) vial which was broken at the neck and bottom of the vial (skin laceration, accidental exposure to product, product container issue). The patient sought medical attention and was treated by physician. Her wound was cleaned and band aid was applied. No lab diagnostics/studies were performed. The outcome of skin laceration was reported to be recovered/resolved. Outcome of accidental exposure to product and product container issue was unknown. Causality of the events skin laceration and product container issue  were not reported. Product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored VARIVAX; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant therapy were not reported.   On 26-FEB-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were not reported) (lot # R018143 and expiry date: 25-JUN-2020, lot # R026715 and expiry date: 18-SEP-2020) for prophylaxis. The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored diluent(DILUENT MRK INJ). It was reported that, the nurse did not know which lot number was administered to the patient therefore 2 lot numbers are documented.  The vaccines were stored in temperature 47 degree Fahrenheit (F) to 77 F (66.5 F) for 943 Minutes. No previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of two reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: He erroneously administered 2 doses of M-M-R II; He erroneously administered 2 doses of M-M-R II; No adverse symptoms reported; This spontaneous report was received from an other health professional via company representative referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported). The reporter stated that he erroneously administered two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to the patient with an unknown vaccination history, because he thought that the dose listed in the prescribing information was the dose for pediatric patients and he also mentioned that he thought two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) needed to be administered, based on other unspecified vaccines having a pediatric and adult formulation (incorrect dose administered and extra dose administered). No adverse symptoms were reported. No product quality complaint (PQC) was involved.
Age: 16.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; a 16 year old male inadvertently administered one separate dose each of ZOSTAVAX; ZOSTAVAX administered were expired; Information has been received from a pharmacist referring to a 16 year old male patient. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent.  On 22-MAR-2019, the patient was inadvertently administered one dose of zoster vaccine live(ZOSTAVAX) 19400 plaque-forming unit (PFU) (lot # N025568, expiration date 08-DEC-2018; dose and frequency were not reported) subcutaneously for prophylaxis (inappropriate schedule of vaccine administered and expired product administered). No adverse effects were reported in patient.  This is one of two reports from the same reporter.; Sender's Comments:  US-1009507513-1903USA011073:
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning leg in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 23rd March 2019, the patient received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced burning leg and pain burning. On an unknown date, the outcome of the burning leg and pain burning were unknown. It was unknown if the reporter considered the burning leg and pain burning to be related to SHINGRIX. Additional details were provided as follows: The patient received shot of SHINGRIX in the left arm. Twenty four hours after vaccination with SHINGRIX, the patient experienced burning sensation 2 inch forward to hip bone. The patient stated that this actually felt like shingles pain but no welt or blister was present.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient asked that how long to do the side effects last after shingle's shot. The patient was enquiring about taking BENADRYL to help with side effects.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 23rd February 2019, the patient received the 1st dose of SHINGRIX. On 23rd February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were unknown. It was unknown if the reporter considered the injection site pain and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The reporter was made aware of injection site pain from the patient previous night before the day of reporting. The patient had been experiencing pain and rash in the injected arm since receiving the vaccine. The reporter said they knew that this need to report and take all adverse events very seriously. The reporter would like to know if there was need of any additional information and she would be happy to share what they have.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was reported. The case was reported by the patient for themselves. The patient experienced bad muscle pain after receiving SHINGRIX vaccine. The patient inquired whether how long this side effect would last.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced rash in the armpits located in lymph node area. The reporter did not give consent to follow up.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: sweating; diarrhea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included chemotherapy (1 and half years before the date of reporting).   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Shingrix and Influenza vaccine, the patient experienced diarrhea, vomiting and sweating. The patient was treated with sodium chloride (Intravenous Normal Saline). On an unknown date, the outcome of the diarrhea, vomiting and sweating were unknown.   It was unknown if the reporter considered the diarrhea, vomiting and sweating to be related to Shingrix and Influenza vaccine.  Additional details were reported as follows: The patient was was due for their 2nd dose in the week of reporting. The patient had the flu shot at the same time and had a horrid reaction like diarrhea, vomiting and severe sweating. The patient had to go to the urgent care for an intravenous 1000 saline for hydration.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and 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 age at vaccination was not reported. The patient got a case of the shingles after 2 doses of SHINGRIX. This case was considered as suspected vaccination failure as time to onset for the event was unknown. The reporter agree to follow up from GlaxoSmithKline.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chest pain, Computerised tomogram, Eyelid ptosis, Headache, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chest pain in a 16-year-old female patient who received MENVEO (batch number X17098, expiry date unknown) for prophylaxis. Co-suspect products included BEXSERO (batch number ABX752BA, expiry date unknown) for prophylaxis. On 11th March 2019, the patient received MENVEO and BEXSERO. On 18th March 2019, 7 days after receiving MENVEO and BEXSERO, the patient experienced eye muscle paralysis (serious criteria GSK medically significant), swelling of eyelid and eyelid ptosis. On 19th March 2019, the patient experienced headache and myalgia. On 25th March 2019, the patient experienced chest pain (serious criteria hospitalization). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the chest pain, eye muscle paralysis, swelling of eyelid, eyelid ptosis, headache and myalgia were unknown. It was unknown if the reporter considered the chest pain, eye muscle paralysis, swelling of eyelid, eyelid ptosis, headache and myalgia to be related to MENVEO and BEXSERO. Additional details were reported as follows: The patient's mother brought the patient to physician due to having headache and muscle ache. The day prior to that the patient's eyelid looked swollen and droppy. No fever and redness presented. The physician thought it might be a palsy type illness and administered steroids. The patient again visited emergency room complaining of chest pain On 25th March 2019, the patient had computerised tomogram (CT scan) but results were unknown then transfer to another facility for eye concern.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Ophthalmoplegia, Swelling of eyelid
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chest pain in a 16-year-old female patient who received MENVEO (batch number X17098, expiry date unknown) for prophylaxis. Co-suspect products included BEXSERO (batch number ABX752BA, expiry date unknown) for prophylaxis. On 11th March 2019, the patient received MENVEO and BEXSERO. On 18th March 2019, 7 days after receiving MENVEO and BEXSERO, the patient experienced eye muscle paralysis (serious criteria GSK medically significant), swelling of eyelid and eyelid ptosis. On 19th March 2019, the patient experienced headache and myalgia. On 25th March 2019, the patient experienced chest pain (serious criteria hospitalization). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the chest pain, eye muscle paralysis, swelling of eyelid, eyelid ptosis, headache and myalgia were unknown. It was unknown if the reporter considered the chest pain, eye muscle paralysis, swelling of eyelid, eyelid ptosis, headache and myalgia to be related to MENVEO and BEXSERO. Additional details were reported as follows: The patient's mother brought the patient to physician due to having headache and muscle ache. The day prior to that the patient's eyelid looked swollen and droppy. No fever and redness presented. The physician thought it might be a palsy type illness and administered steroids. The patient again visited emergency room complaining of chest pain On 25th March 2019, the patient had computerised tomogram (CT scan) but results were unknown then transfer to another facility for eye concern.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received SHINGRIX for prophylaxis. On 26th March 2019, the patient received SHINGRIX. On 26th March 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got SHINGRIX shot and experienced arm sore. The patient asked whether it was fine to take Tylenol or Advil.
Age: 61.0
Sex: F
Vaccine: FLU4, HEPA, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX vaccine. Concurrent medical conditions included shingles. Concomitant products included Influenza vaccine Quadrivalent (2018-2019 season) and Hepatitis A vaccine. In October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, Influenza vaccine Quadrivalent 2018-2019 season and Hepatitis A vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX vaccine on unknown arm at her physician office and experienced arm soreness. The patient also received either a flu shot or a Hepatitis A shot at the same time in the opposite arm. The patient could not recall that which arm the patient received the SHINGRIX. This case has been linked to US2019056486 by same reporter for the second dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (after receiving 1st dose on 21st September 2018, see case US2019GSK027100). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient said the fever also happened with the 2nd booster shot in other facility.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received on 8th January 2019, refer linked case US2019056538). Concomitant products included NAPROSYN. On 13th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain. Rechallenge with SHINGRIX was positive. On 15th March 2019, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left deltoid. Before receiving the 2nd dose of the SHINGRIX the patient pre-medicated herself with BENADRYL and NAPROSYN. The next day after having the 2nd dose, she felt a little achy and that lasted for one day. The patient took NAPROSYN to help with the achy feeling. All symptoms were resolved. The reporter gave permission for her physician to be contacted.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Malaise, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX vaccine, SHINGRIX with an associated reaction of injection site pain (for tolerance refer the first dose US2019GSK060272), Hepatitis A (received the dose of Hepatitis A on October 2018 in the opposite arm) and flu shot (received the flu shot on October 2018 in the opposite arm). Concurrent medical conditions included shingles. Concomitant products included acyclovir. On 27th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain, tiredness and feeling unwell. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, tiredness and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, tiredness and feeling unwell to be related to SHINGRIX. Additional case details were provided as follows: The day before reporting, the patient received the dose of SHINGRIX in left arm and experienced some of the side effects since last night and on the day of reporting. The patient had no lot number information. The patient stated that her left arm, the site she had the vaccine in, was sorer than the first shot, fatigue and feels like she was getting a virus. Overall kind of virally feeling as expected but nothing was alarming, but enough to cause the patient to stop and lie down. The patient has been referred to her physician and provided the median duration of events from the prescribing information. The patient was wondering and enquiry that how long the side effects normally last was one or two days.