chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Epstein-Barr virus test negative, Haematuria, Hepatic enzyme increased, Imaging procedure, Malaise
Clinical narrative: This spontaneous report was received from a physician regarding a 17 year old male patient. The patient's pertinent medical conditions and concomitant medications were not reported. On 18-JUN-2018, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly, lot # N028567, expiry date: 17-MAY-2020 for prophylaxis. Approximately on 28-JUN-2018, 10 days after vaccination, the patient experienced fever, malaise, gross hematuria and back pain. On an unknown date in 2018, the patient's white blood cell count was dropped from 6.7 to 2.1 (unknown units) and liver enzymes were elevated. On an unknown date in 2018, the patient underwent Epstein-Barr count, urine culture and urologic imaging which was negative, and alanine transaminase was 78, aspartate transaminase was 48 and alkaline phosphatase was 73 (unknown units). The event fever was resolved on 01-JUL-2018 (reported as 3 days after) and on an unknown date in 2018, the liver enzymes returned to normal. On 31-JUL-2018, the white blood cell count was 5 (unknown units). Outcome of the other events was considered to be recovered (reported as patient was doing fine) on an unknown date in 2018. Causality assessment was not provided. No product quality complaint was involved.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, White blood cell count decreased
Clinical narrative: This spontaneous report was received from a physician regarding a 17 year old male patient. The patient's pertinent medical conditions and concomitant medications were not reported. On 18-JUN-2018, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly, lot # N028567, expiry date: 17-MAY-2020 for prophylaxis. Approximately on 28-JUN-2018, 10 days after vaccination, the patient experienced fever, malaise, gross hematuria and back pain. On an unknown date in 2018, the patient's white blood cell count was dropped from 6.7 to 2.1 (unknown units) and liver enzymes were elevated. On an unknown date in 2018, the patient underwent Epstein-Barr count, urine culture and urologic imaging which was negative, and alanine transaminase was 78, aspartate transaminase was 48 and alkaline phosphatase was 73 (unknown units). The event fever was resolved on 01-JUL-2018 (reported as 3 days after) and on an unknown date in 2018, the liver enzymes returned to normal. On 31-JUL-2018, the white blood cell count was 5 (unknown units). Outcome of the other events was considered to be recovered (reported as patient was doing fine) on an unknown date in 2018. Causality assessment was not provided. No product quality complaint was involved.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 67 years old female patient. The patient had a history of unspecified reactions to penicillin, codeine, hydrocodone, ceftriaxone and moxifloxacin. The patient had no pertinent medical history. Information about concurrent condition was not reported. On 18-SEP-2018, the patient was in the office and was administered a dose of PNEUMOVAX 23 (lot # N024717, expiration date 06-APR-2019 and intramuscular; strength, dose and frequency were not reported) and a dose of influenza vaccine concomitantly in the left arm for prophylaxis. On the same day, within a few hours of the vaccine administration, the patient experienced swelling, erythema and tenderness at the injection site. On 20-SEP-2018, the patient returned to the office for treatment. Physician treated the patient with cold compresses, unspecified anti-inflammatories, and unspecified antihistamines. No lab diagnostics or studies were performed. The outcome of the events was reported as not recovered. The causality for the event was not reported.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Hypersensitivity, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. It was reported that the patient had a severe allergic reaction to ADACEL. The reporter did not know if the patient was ever vaccinated with M-M-R II for prophylaxis. On an unknown date, the patient just after the patient gave birth, she had a low titer for rubella.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 21-SEP-2018 and 26-SEP-2018, the patient was vaccinated with improperly stored doses of PROQUAD subcutaneously, for prophylaxis, lot number R014354, albumin status rHA and expiration date reported as 18-NOV-2019 (strength, dose and frequency were not reported), and improperly doses of VARIVAX subcutaneously, for prophylaxis, lot number reported as R008794 and expiration date reported as 20-DEC-2020 (strength, dose and frequency were not reported). The vaccines were reconstituted with a properly stored sterile diluent (MERCK). No adverse effects were reported. The temperature excursion was reported as from 15°F to 46°F (33.9°F) during a time frame of 2 hours and 32 minutes. There was no previous temperature excursion. A Digital Data Logger was involved. Lot number R008794 not valid for varicella virus vaccine live (oka/merck). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA002355: US-009507513-1810USA002356: US-009507513-1810USA002357: US-009507513-1810USA002354: US-009507513-1810USA002358: US-009507513-1810USA002352: US-009507513-1810USA002353.
Age: 26.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 26 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-SEP-2018, the patient was vaccinated with Oka-Merck PROQUAD, therapy type: recombinant human albumin (rHA), for prophylaxis, lot # R008196, expiration date on 16-SEP-2019 (dose, site and route of administration were not reported) and Oka/Merck VARIVAX for prophylaxis, lot # R009409, expiration date on 29-MAR-2020 (dose, site and route of administration were not reported). The vaccines were injected to the patient of inappropriate age as she was 26 year old. Also it was considered as inappropriate schedule of drug administration as both suspects were varicella-containing vaccines. No adverse reactions were reported.
Sex: U
Vaccine: MMR, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a Registered nurse concerning to multiple unspecified patients (age and genders not reported). No medical history, concomitant medications nor concurrent conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored dosages of PNEUMOVAX 23 (Lot number R012497, exp. date 08-JAN-2020; Lot number R012976, exp. 25-JAN-2020) for prophylaxis and M-M-R II (Lot number N032752, exp. date 20-NOV-2019 and lot number N025898, exp. date 19-SEP-2019) (rHA both lot numbers) for prophylaxis. All lots of M-M-R II were reconstituted with properly stored diluent (lot number N029877, exp. date 18-MAY-2020 and lot number M041689, exp. date 29-JUN-2019). No adverse effects were reported. Excursion information: PNEUMOVAX 23 (Lot R12976 and lot R012497); Temperature: at or above 32°F up to 35°F; Time frame: 36 minutes. Previous temperature excursion: Yes, 47°F to 77°F for 37 minutes. Was call made of "data logger": Yes. M-M-R II (Lot N025898 and lot N032752); Temperature: -58°F and +46°F; Time frame: 36 minutes. Previous temperature excursion: Yes, 47°F to 77°F for 37 minutes. Was call made of "data logger": Yes.
Sex: F
Vaccine: HIBV
Symptoms: Blood test, Food allergy, Growth retardation, Immune system disorder, Laboratory test
Clinical narrative: This spontaneous report was received from the patient's mother referring to a 11 month old female patient. The patient had no pertinent medical history, concomitant medications, or drug reactions/allergies. The patient's concurrent conditions were not reported. In December 2017, the patient was vaccinated with LIQUID PEDVAXHIB 1 x 0.5 ml dose via intramuscular (dose, concentration, dose number, frequency,and anatomical location were unknown), with lot # N024569 and expiration date on 07-FEB-2020, as vaccination against Haemophilus influenzae type b (HIB). In February 2018, the patient experienced severe hives and rashes, vomiting and developed food allergies to almost everything. It was also reported that she was not growing and something was wrong with her immune system. The patient had sought medical attention and had visited an Immunologist, a Gastroenterologist Specialist, and Allergist, a Nutritionist in addition to her Pediatrician and a second Nurse Practitioner. No treatment was given to the patient for the events. A blood work and numerous other unspecified lab tests were performed, however the results were not provided. At the time of the report, the outcome of the events growth retardation, vomiting, rash, urticaria, food allergy and immune system disorder was not resolved. The reporter did not mention the causality assessment between the events and haemophilus b conjugate vaccine LIQUID PEDVAXHIB. Upon internal review, growth retardation was determined to be a medically significant event.
Sex: F
Vaccine: HIBV
Symptoms: Rash, Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from the patient's mother referring to a 11 month old female patient. The patient had no pertinent medical history, concomitant medications, or drug reactions/allergies. The patient's concurrent conditions were not reported. In December 2017, the patient was vaccinated with LIQUID PEDVAXHIB 1 x 0.5 ml dose via intramuscular (dose, concentration, dose number, frequency,and anatomical location were unknown), with lot # N024569 and expiration date on 07-FEB-2020, as vaccination against Haemophilus influenzae type b (HIB). In February 2018, the patient experienced severe hives and rashes, vomiting and developed food allergies to almost everything. It was also reported that she was not growing and something was wrong with her immune system. The patient had sought medical attention and had visited an Immunologist, a Gastroenterologist Specialist, and Allergist, a Nutritionist in addition to her Pediatrician and a second Nurse Practitioner. No treatment was given to the patient for the events. A blood work and numerous other unspecified lab tests were performed, however the results were not provided. At the time of the report, the outcome of the events growth retardation, vomiting, rash, urticaria, food allergy and immune system disorder was not resolved. The reporter did not mention the causality assessment between the events and haemophilus b conjugate vaccine LIQUID PEDVAXHIB. Upon internal review, growth retardation was determined to be a medically significant event.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72-year-old female patient. The patient's concurrent conditions, concomitant medications and drug reactions/ allergies were not reported. The patient had lymph nodes removed in her left arm. On 29-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the right arm (lot # R002084, expiry date: 26-OCT-2019, dose not reported) for prophylaxis (reported as to complete the pneumococcal series). On the same day, the patient was also vaccinated with the high dose of FLUZONE (manufacturer unknown) on the right arm (dose, route, lot # and expiry date were not reported) for prophylaxis. Subsequently, the patient developed redness and swelling in her right arm. The pharmacist stated that, the patient saw her physician and she was diagnosed with the cellulitis in her right arm (cellulitis). Product quality issues was not involved. The outcome of cellulitis was reported as recovering. The reporter's causality assessment was not provided. Upon internal review, cellulitis was determined to be medically significant.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician and refers to a 15-year-old male patient. The patient's concurrent condition included environmental allergy and fatigue. His medical history included nasal congestion. Historical medications included MOTRIN PM for allergy and MOTRIN IB SINUS for nasal congestion. The patient had several FLUZONE vaccinations in past flu seasons. The patient did not take any concomitant medications. On 11-JUN-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, lot# R003245, expiration date: 16-NOV-2020 and with FLUZONE lot# UT6258NA, both into left arm (doses and routes of administration were not provided). On the same day, the patient experienced syncope after receiving the vaccinations. No drug treatment prescription was required for the event. The outcome of syncope was reported as recovered on an unknown date in 2018. The relatedness between the events and GARDASIL 9 was not provided. This is one of two reports received from the same source. Sender's Comments: US-009507513-1809USA005320.
Age: 1.17
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner (Prescriber) referring to a 14-months-old patient. The patient's historical conditions, concurrent conditions, historical drugs or allergies were not reported. The patient's concomitant therapies included sterile diluent. On 07-SEP-2018, the patient was vaccinated with M-M-R II (strength, dose, frequency, lot # and expiration date were not provided) dose 1 for prophylaxis, and on 03-OCT-2018, the patient was vaccinated with M-M-R II dose (Inappropriate schedule of drug administration). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-OCT-2018, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # M039904, expiration date 26-SEP-2018, subcutaneously, (dose and frequency were not reported) for prophylaxis. The vaccine was administered along with a sterlie diluent, Lot # N008379, expiration date 14-NOV-2019. No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 97.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Product use in unapproved indication
Clinical narrative: This spontaneous report was received from an office manager via a social media regarding to a 97 years old female patient with warts. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, strength, anatomical location or route of administration were not provided) for prophylaxis. On an unknown date, the patient experienced drug administered to patient of inappropriate age and product use in unapproved indication. Furthermore, the patient had been free and clear of the warts.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 29-JAN-2018 the patient was vaccinated with improperly stored PROQUAD lot # N020620, expiration date: 23-AUG-2019, dose 1 for prophylaxis. Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 127 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA002332: Original Case: 1810USA001739; US-009507513-1810USA002333: Original Case: 1810USA001739; US-009507513-1810USA002335: Original Case: 1810USA001739; US-009507513-1810USA002336: Original Case: 1810USA001739; US-009507513-1810USA002337: Original Case: 1810USA001739; US-009507513-1810USA002338: Original Case: 1810USA001739; US-009507513-1810USA002331: Original Case: 1810USA001739; US-009507513-1810USA002330: Original Case: 1810USA001739; US-009507513-1810USA002329: Original Case: 1810USA001739; US-009507513-1810USA002334: Original Case: 1810USA001739.
Sex: F
Vaccine: HPV9
Symptoms: Menstruation irregular
Clinical narrative: This spontaneous report was received from a female patient over 26 years old, referring to herself. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 05-JUN-2018, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml, for prophylaxis (strength, route, lot number and expiration date were not reported). On 31-JUL-2018, the patient received the second dose of GARDASIL 9. Since an unknown date, the patient's period became irregular, skipping a month and then had two within the same month (menstruation irregular). The outcome of menstruation irregular was unknown. Causality assessment was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: 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-OCT-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # N013885 (expiration date: 09-DEC-2018), for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 9-25 Celsius degrees for a timeframe of 1 hour and 9 minutes. It was found because of a digital data logger. There were no previous excursions.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 01-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (route, dose, frequency, and anatomical location were unknown) with lot # R018741, and expiration date 06-APR-2020 for prophylaxis. The pharmacist reported that since the vaccination, the patient experienced swollen arms and hands, and also developed tingling in his hands, and consulted the pharmacist. It was unknown if the patient had seen a physician regarding this issue. At the time of the report, the outcome of tingling hands and swollen arms and hands was reported as not resolved. The pharmacist did not mention the causality assessment between the events and PNEUMOVAX 23 vaccination.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Paraesthesia, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 01-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (route, dose, frequency, and anatomical location were unknown) with lot # R018741, and expiration date 06-APR-2020 for prophylaxis. The pharmacist reported that since the vaccination, the patient experienced swollen arms and hands, and also developed tingling in his hands, and consulted the pharmacist. It was unknown if the patient had seen a physician regarding this issue. At the time of the report, the outcome of tingling hands and swollen arms and hands was reported as not resolved. The pharmacist did not mention the causality assessment between the events and PNEUMOVAX 23 vaccination.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 04-SEP-2018, the patient was vaccinated with improperly stored VARIVAX lot # N022981, expiration date: 23-AUG-2019, dose 1 for prophylaxis. Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 135 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001739.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 08-JAN-2018, the patient was vaccinated with improperly stored VARIVAX lot # N022981, expiration date: 23-AUG-2019, dose 1 for prophylaxis. Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 135 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001739.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 26-FEB-2018, the patient was vaccinated with improperly stored VARIVAX lot # N022981, expiration date: 23-AUG-2019, dose 1 for prophylaxis. Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 135 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001739.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 05-FEB-2018 the patient was vaccinated with improperly stored PROQUAD lot # N020620, expiration date: 23-AUG-2019, dose 1 for prophylaxis (product storage error). Concomitant therapies included sterile diluent(STERILE DILUENT). The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 127 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1810USA001739.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 05-FEB-2018 the patient was vaccinated with improperly stored PROQUAD lot # N020620, expiration date: 23-AUG-2019, dose 1 for prophylaxis. Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 127 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001739.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 04-SEP-2018, the patient was vaccinated with improperly stored VARIVAX lot # N022981, expiration date: 23-AUG-2019, dose 1 for prophylaxis (product storage error). Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 135 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001739.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 04-SEP-2018, the patient was vaccinated with improperly stored PROQUAD lot # N020620, expiration date: 23-AUG-2019, dose 1 for prophylaxis. Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 127 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001739.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 08-JAN-2018, the patient was vaccinated with improperly stored Oka/Merck VARIVAX lot # N022981, expiration date: 23-AUG-2019, dose 1 for prophylaxis (product storage error). Concomitant therapies included STERILE DILUENT. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 135 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001739.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Herpes zoster, Hypoaesthesia, Injection site pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-SEP-2016, the patient was inoculated in her right arm with ZOSTAVAX (lot #, dosage and route of administration not provided) at a pharmacy, for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient presented to a physician with complaints of headaches and a raised, painful injection site, in conjunction with feelings of numbness and tingling in her right arm. The patient's complaints did not improve. Accordingly, on 12-DEC-2016, the patient returned to the physician with complaints of decreased strength, weakness, and numbness/paresthesias in her right arm. She was evaluated and diagnosed as suffering from neuralgia and neuritis of an unspecified origin. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Neuralgia, Neuritis, Paraesthesia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-SEP-2016, the patient was inoculated in her right arm with ZOSTAVAX (lot #, dosage and route of administration not provided) at a pharmacy, for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient presented to a physician with complaints of headaches and a raised, painful injection site, in conjunction with feelings of numbness and tingling in her right arm. The patient's complaints did not improve. Accordingly, on 12-DEC-2016, the patient returned to the physician with complaints of decreased strength, weakness, and numbness/paresthesias in her right arm. She was evaluated and diagnosed as suffering from neuralgia and neuritis of an unspecified origin. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 21-SEP-2018 and 26-SEP-2018, the patient was vaccinated with improperly stored doses of PROQUAD subcutaneously, for prophylaxis, lot number R014354, albumin status rHA and expiration date reported as 18-NOV-2019 (strength, dose and frequency were not reported), and improperly doses of VARIVAX subcutaneously, for prophylaxis, lot number reported as R008794 and expiration date reported as 20-DEC-2020 (strength, dose and frequency were not reported). The vaccines were reconstituted with a properly stored sterile diluent (MERCK). No adverse effects were reported. The temperature excursion was reported as from 15°F to 46°F (33.9°F) during a time frame of 2 hours and 32 minutes. There was no previous temperature excursion. A Digital Data Logger was involved. Lot number R008794 not valid for varicella virus vaccine live (oka/merck). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA012813.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 21-SEP-2018 and 26-SEP-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD subcutaneously, for prophylaxis, lot number R014354, albumin status rHA and expiration date reported as 18-NOV-2019 (strength, dose and frequency were not reported), and improperly doses of Oka/Merck VARIVAX subcutaneously, for prophylaxis, lot number reported as R008794 and expiration date reported as 20-DEC-2020 (strength, dose and frequency were not reported). The vaccines were reconstituted with a properly stored MERCK STERILE DILUENT. No adverse effects were reported. The temperature excursion was reported as from 15°F to 46°F (33.9°F) during a time frame of 2 hours and 32 minutes. There was no previous temperature excursion. A Digital Data Logger was involved. Lot number R008794 not valid for Oka/Merck. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA012813.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 21-SEP-2018 and 26-SEP-2018, the patient was vaccinated with improperly stored doses of PROQUAD subcutaneously, for prophylaxis, lot number R014354, albumin status rHA and expiration date reported as 18-NOV-2019 (strength, dose and frequency were not reported), and improperly doses of VARIVAX subcutaneously, for prophylaxis, lot number reported as R008794 and expiration date reported as 20-DEC-2020 (strength, dose and frequency were not reported). The vaccines were reconstituted with a properly stored Merck sterile diluent. No adverse effects were reported. The temperature excursion was reported as from 15 degrees F to 46 degrees F (33.9 degrees F) during a time frame of 2 hours and 32 minutes. There was no previous temperature excursion. A Digital Data Logger was involved. Lot number R008794 not valid for varicella virus vaccine live (oka/merck). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA012813.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Bone pain, Condition aggravated, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included systemic lupus erythematosus. In July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 21st September 2018, less than a week after receiving SHINGRIX, the patient experienced cold. On an unknown date, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), muscle pain, sleepiness, joint pain, bone pain and arthritis. The patient was treated with Aspirin. On an unknown date, the outcome of the systemic lupus erythematosus, muscle pain, sleepiness, joint pain, bone pain and arthritis were recovered/resolved and the outcome of the cold was unknown. It was unknown if the reporter considered the systemic lupus erythematosus, muscle pain, cold, sleepiness, joint pain, bone pain and arthritis to be related to SHINGRIX. Additional information was reported as follows: The patient experienced muscle aches, sore bones, sore joints and slept for a period of 2 days after vaccination with the first dose of SHINGRIX. The patient stated that the pain experienced by her was so bad that taking Aspirin did not help. The pain experienced by the patient was similar to when she had lupus flare up, which typically manifested as arthritis like pain. The events resolved 2 days post vaccination with SHINGRIX.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Somnolence, Systemic lupus erythematosus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included systemic lupus erythematosus. In July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 21st September 2018, less than a week after receiving SHINGRIX, the patient experienced cold. On an unknown date, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), muscle pain, sleepiness, joint pain, bone pain and arthritis. The patient was treated with Aspirin. On an unknown date, the outcome of the systemic lupus erythematosus, muscle pain, sleepiness, joint pain, bone pain and arthritis were recovered/resolved and the outcome of the cold was unknown. It was unknown if the reporter considered the systemic lupus erythematosus, muscle pain, cold, sleepiness, joint pain, bone pain and arthritis to be related to SHINGRIX. Additional information was reported as follows: The patient experienced muscle aches, sore bones, sore joints and slept for a period of 2 days after vaccination with the first dose of SHINGRIX. The patient stated that the pain experienced by her was so bad that taking Aspirin did not help. The pain experienced by the patient was similar to when she had lupus flare up, which typically manifested as arthritis like pain. The events resolved 2 days post vaccination with SHINGRIX.
Sex: M
Vaccine: TD
Symptoms: Anaphylactic reaction, Skin discolouration, Vaccination complication
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid serious case received from a consumer. This case involves male patient (age unknown) who experienced bad reaction to TD, he was fighting for his life, it was an anaphylactic reaction, sort of and turning grey, while he received vaccine DIPHTHERIA AND TETANUS TOXOIDS. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, back in the 90s, the patient received injection of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious bad reaction to td, he was fighting for his life, it was an anaphylactic reaction, sort of (anaphylactic reaction) and was turning grey with Unknown latency following the administration of DIPHTHERIA AND TETANUS TOXOIDS. This event was assessed as life-threatening. Lab data was not provided. Final diagnosis was (Life-threatening) bad reaction to TD, he was fighting for his life, it was an anaphylactic reaction, sort of and turning grey. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for bad reaction to TD, he was fighting for his life, it was an anaphylactic reaction, sort of and turning grey. List of the documents held by sender- none. Sender's Comments: This is a poorly documented case in which male patient was reported to have bad unspecified reaction to TD vaccine in 1990's, patient was fighting for his life, it was a sort of (anaphylactic reaction) and was turning grey after vaccination with DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer. The time to onset is unknown. No information regarding medical history and tolerance to previous vaccinations was reported. Laboratory tests for alternative diagnoses were not reported. Based upon reported information, the role of one vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient of an unknown demographics who received a dose of FLUZONE QUADRIVALENT lot UJ023AA expiry date: 25-Apr-2019 via unknown route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to vaccine underdose. It was reported that the vaccine seemed to leak at the bottom where the needle attaches to. Pharmacist stated that there was not issues or anything out of the ordinary that she noticed when attaching the needle to the pen and felt that she tightened it down as she always did. Pharmacist stated that she was unsure if the patient received the full dose or not. It was also a case of syringe issue. It was not reported that if any adverse reaction occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Wheezing
Clinical narrative: Trouble breathing. Sharp pain in chest. WHEEZING.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling noted around site of vaccine one day after administration. Redness and swelling were worse the second day after vaccine given. Mother reports yellow drainage from vaccine site.  Mother gave pt Benadryl. Mother brought pt to clinic 3 days after vaccine given. Mild swelling and redness around site to right thigh. Tender to touch. Mother reports pt had a fever after vaccines were given. Fever for one day.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Patient walked out of the office with her mother after receiving the vaccines. They had stopped at the front desk to ask for a note for school and a clerical staff called to report that the client ''passed out''. When I saw her she was standing, and her mother was holding her tight in a hug. When asked what happened, she said she got dizzy and fell on the floor. She denied hitting her head. Placed her on a chair. She admitted that she did not eat any breakfast. The mother stated that she was planning to treat her to a breakfast at a restaurant after getting the shots. A pouch of juice was given. No other problem noted. The client verbalized feeling better and got up, went out via the elevator with a steady gait.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gingival bleeding, Gingival erythema, Gingival pain, Glossodynia
Clinical narrative: 9/15 Slight discomfort at injections site, chills, headache, body aches. Lasted 24 hours. 9/17 Developed first cold sore ever. 9/20 Developed white, painful sores on tongue, gums, oral mucosa inside of cheeks, chills, bleeding, red sore gums. Resolved completely on 10/6/2018.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site discomfort, Oral herpes, Pain, Stomatitis
Clinical narrative: 9/15 Slight discomfort at injections site, chills, headache, body aches. Lasted 24 hours. 9/17 Developed first cold sore ever. 9/20 Developed white, painful sores on tongue, gums, oral mucosa inside of cheeks, chills, bleeding, red sore gums. Resolved completely on 10/6/2018.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Tongue disorder
Clinical narrative: 9/15 Slight discomfort at injections site, chills, headache, body aches. Lasted 24 hours. 9/17 Developed first cold sore ever. 9/20 Developed white, painful sores on tongue, gums, oral mucosa inside of cheeks, chills, bleeding, red sore gums. Resolved completely on 10/6/2018.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling noted around site of vaccination one day after administration. Redness and swelling were worse the second day after vaccine given. Mother reports yellow drainage from vaccine site. Mother gave pt BENADRYL. Mother brought pt to clinic 3 days after vaccine given.  Mild swelling and redness around site to right thigh, Tender to touch. Mother states pt had a fever after vaccines were given. Fever for one day.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Fatigue, headache, weakness, fever, sore throat.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site warmth
Clinical narrative: Patient called me today, Monday, 10-8-18. She said on Friday, (10/5/18), the day after she got the shot, she had one of the worst headaches she's ever had, she said she can't remember ever having such a bad headache. She also had about a 3" circle around where the shot was given, that was painful and hot to touch. She said when she had her 1st SHINGRIX shot (2 months ago) she didn't have any reactions. She said on Saturday her headache was gone.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Received flu shot at a workplace clinic event on Wed, 9/25/18. Woke up 2am Thurs, 9/26 with hives on both inner thighs, took BENADRYL. Raised hives and itching got worse as day went on, took BENADRYL every 4 hours. Pain and itching continued as hives spread to both buttocks, all over thighs, back and stomach. Kept taking BENADRYL with no relief entire weekend. Went to emergency room on Mon 10/01. ER doctor gave me shot of steroid and sent me home with BENADRYL, PEPCID. Relief for 1.5 days. Hives flared up again Wed, 10/03 all over body, continued to take BENADRYL. Hives continued through Thurs, 10/04 and I had to return to Emergency Room Fri 10/05, where they gave me IV DECADRON, BENADRYL and other meds. Today is Monday, 10/08 and I continue to have horrible red raised hives on both legs, torso, back, chest and arms. Doctors at hospital agree adverse reaction to flu shot but no one can figure out how to clear it up. PLEASE HELP.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: Symptoms started the night after he received PNEUMOVAX and flu vaccine. Has had flu vaccine in past. Has noticed overall aches, thinks maybe he might have had some wheezing one night. Symptoms seem worse at night. Has been taking over the counter antipyretics for fever. Denies any cough or congestion.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Chills, Diarrhoea, Dyspnoea
Clinical narrative: Received shot 1040AM about 45min later had elevated heart rate, chest discomfort, then chills, body aches, tiredness, sinus congestion, went home got into bed and over the next 30 hrs. Had previous symptoms along with fever 101.5, sinus congestion, diaphoretic, nausea, diarrhea, headache, scalp tenderness, sob, pain on R side of chest with inhalation.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Headache, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: Received shot 1040AM about 45min later had elevated heart rate, chest discomfort, then chills, body aches, tiredness, sinus congestion, went home got into bed and over the next 30 hrs. Had previous symptoms along with fever 101.5, sinus congestion, diaphoretic, nausea, diarrhea, headache, scalp tenderness, sob, pain on R side of chest with inhalation.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain of skin, Pyrexia, Sinus congestion
Clinical narrative: Received shot 1040AM about 45min later had elevated heart rate, chest discomfort, then chills, body aches, tiredness, sinus congestion, went home got into bed and over the next 30 hrs. Had previous symptoms along with fever 101.5, sinus congestion, diaphoretic, nausea, diarrhea, headache, scalp tenderness, sob, pain on R side of chest with inhalation.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Rash, Hives, swelling of face.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Erythema, Skin warm
Clinical narrative: Large warm red area on arm.