chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse concerning a 36 year old female patient. The patient's concurrent conditions included type 1 Diabetes Mellitus (DM), gastroesophageal reflux disease (GERD), asthma, osteopenia, rheumatoid arthritis, malabsorption and vitamin deficiency. The patient had no concomitant medication or drug reactions or allergies. On 25-JAN-2018, the patient was vaccinated with the first dose of PNEUMOVAX 23 with lot number N027624 and expiration date on 11-MAY-2019 (anatomical location was not provided) administered intramuscularly for prophylaxis at a public health clinic/hospital. It was reported that the patient received the vaccine due to diabetes. It was also reported that there was none illness at the time of vaccination. On 25-JAN-2018, the patient experienced excruciating pain above the injection site, down to elbow. The patient's mother stated that the patient had severe pain and swelling (pain in extremity). It was also reported that she was unable to dress herself. The nurse reported that the patient was advised to apply warm compresses and move her arm around. The nurse also recommended to visit the emergency room and they did not find anything wrong though assessment or labs. It was reported that drug treatment was required. The patient received acetaminophen, NORCO for other diagnosis but she needed to take it for the experience. At the time of reporting, the patient was recovering from pain in extremity and peripheral swelling and the causal relationship between the events and PNEUMOVAX 23 was unknown.
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse concerning a 36 year old female patient. The patient's concurrent conditions included type 1 Diabetes Mellitus (DM), gastroesophageal reflux disease (GERD), asthma, osteopenia, rheumatoid arthritis, malabsorption and vitamin deficiency. The patient had no concomitant medication or drug reactions or allergies. On 25-JAN-2018, the patient was vaccinated with the first dose of PNEUMOVAX 23 with lot number N027624 and expiration date on 11-MAY-2019 (anatomical location was not provided) administered intramuscularly for prophylaxis at a public health clinic/hospital. It was reported that the patient received the vaccine due to diabetes. It was also reported that there was none illness at the time of vaccination. On 25-JAN-2018, the patient experienced excruciating pain above the injection site, down to elbow. The patient's mother stated that the patient had severe pain and swelling (pain in extremity). It was also reported that she was unable to dress herself. The nurse reported that the patient was advised to apply warm compresses and move her arm around. The nurse also recommended to visit the emergency room and they did not find anything wrong though assessment or labs. It was reported that drug treatment was required. The patient received acetaminophen, NORCO for other diagnosis but she needed to take it for the experience. At the time of reporting, the patient was recovering from pain in extremity and peripheral swelling and the causal relationship between the events and PNEUMOVAX 23 was unknown.
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse concerning a 36 year old female patient. The patient's concurrent conditions included type 1 Diabetes Mellitus (DM), gastroesophageal reflux disease (GERD), asthma, osteopenia, rheumatoid arthritis, malabsorption and vitamin deficiency. The patient had no concomitant medication or drug reactions or allergies. On 25-JAN-2018, the patient was vaccinated with the first dose of PNEUMOVAX 23 with lot number N027624 and expiration date on 11-MAY-2019 (anatomical location was not provided) administered intramuscularly for prophylaxis at a public health clinic/hospital. It was reported that the patient received the vaccine due to diabetes. It was also reported that there was none illness at the time of vaccination. On 25-JAN-2018, the patient experienced excruciating pain above the injection site, down to elbow. The patient's mother stated that the patient had severe pain and swelling (pain in extremity). It was also reported that she was unable to dress herself. The nurse reported that the patient was advised to apply warm compresses and move her arm around. The nurse also recommended to visit the emergency room and they did not find anything wrong though assessment or labs. It was reported that drug treatment was required. The patient received acetaminophen, NORCO for other diagnosis but she needed to take it for the experience. At the time of reporting, the patient was recovering from pain in extremity and peripheral swelling and the causal relationship between the events and PNEUMOVAX 23 was unknown.
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pain, Swelling, Urticaria
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse concerning a 36 year old female patient. The patient's concurrent conditions included type 1 Diabetes Mellitus (DM), gastroesophageal reflux disease (GERD), asthma, osteopenia, rheumatoid arthritis, malabsorption and vitamin deficiency. The patient had no concomitant medication or drug reactions or allergies. On 25-JAN-2018, the patient was vaccinated with the first dose of PNEUMOVAX 23 with lot number N027624 and expiration date on 11-MAY-2019 (anatomical location was not provided) administered intramuscularly for prophylaxis at a public health clinic/hospital. It was reported that the patient received the vaccine due to diabetes. It was also reported that there was none illness at the time of vaccination. On 25-JAN-2018, the patient experienced excruciating pain above the injection site, down to elbow. The patient's mother stated that the patient had severe pain and swelling (pain in extremity). It was also reported that she was unable to dress herself. The nurse reported that the patient was advised to apply warm compresses and move her arm around. The nurse also recommended to visit the emergency room and they did not find anything wrong though assessment or labs. It was reported that drug treatment was required. The patient received acetaminophen, NORCO for other diagnosis but she needed to take it for the experience. At the time of reporting, the patient was recovering from pain in extremity and peripheral swelling and the causal relationship between the events and PNEUMOVAX 23 was unknown.
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from pharmacy technician and refers to a 36 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the right deltoid, lot # N027624 and expiration date 11-MAY-2019 for prophylaxis (strength, dose and frequency were not reported). On 25-JAN-2018, the patient experienced severe pain, swelling and hives. It was reported that the patient was advised by the clinic to go to the emergency department. At the reporting time, the patient was recovering from the events swelling, urticaria and pain. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) and the aforementioned events. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007512.
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report was received from pharmacy technician and refers to a 36 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the right deltoid, lot # N027624 and expiration date 11-MAY-2019 for prophylaxis (strength, dose and frequency were not reported). On 25-JAN-2018, the patient experienced severe pain, swelling and hives. It was reported that the patient was advised by the clinic to go to the emergency department. At the reporting time, the patient was recovering from the events swelling, urticaria and pain. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) and the aforementioned events. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007512.
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from pharmacy technician and refers to a 36 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the right deltoid, lot # N027624 and expiration date 11-MAY-2019 for prophylaxis (strength, dose and frequency were not reported). On 25-JAN-2018, the patient experienced severe pain, swelling and hives. It was reported that the patient was advised by the clinic to go to the emergency department. At the reporting time, the patient was recovering from the events swelling, urticaria and pain. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) and the aforementioned events. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007512.
Age: 36.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pain, Swelling, Urticaria
Clinical narrative: This spontaneous report was received from pharmacy technician and refers to a 36 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the right deltoid, lot # N027624 and expiration date 11-MAY-2019 for prophylaxis (strength, dose and frequency were not reported). On 25-JAN-2018, the patient experienced severe pain, swelling and hives. It was reported that the patient was advised by the clinic to go to the emergency department. At the reporting time, the patient was recovering from the events swelling, urticaria and pain. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) and the aforementioned events. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007512.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Sensory loss
Clinical narrative: This is a spontaneous report from a contactable physician. A 16-years-old male patient of an unspecified ethnicity received the first dose of TRUMENBA, via an unspecified route of administration in the arm on 03Feb2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lost feeling in the arm where the vaccine was injected and that limb was completely paralized, but has good pulses. The outcome of the events was unknown. Information on the batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Injection site hypoaesthesia, Monoplegia
Clinical narrative: This is a spontaneous report from a contactable physician. A 16-years-old male patient of an unspecified ethnicity received the first dose of TRUMENBA, via an unspecified route of administration in the arm on 03Feb2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lost feeling in the arm where the vaccine was injected and that limb was completely paralized, but has good pulses. The outcome of the events was unknown. Information on the batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient's current condition included penicillin allergy and erythromycin allergy. On 11-FEB-2018, the patient was vaccinated with PNEUMOVAX 23, (lot # N013541, Exp date: 23-JAN-2019), dose 1, 1 DF, intramuscularly for vaccination. On the same day, the patient experienced pain, swelling and her arm severely swelled to twice its normal size several hours after receiving the vaccine (extensive swelling of vaccinated limb). She obtained treatment at an urgent care clinic where she was given prednisone, NORCO, ALLEGRA, cephalexin. The outcome of events were unknown (also reported as not recovered). No other information was available. Sought to medical attention was yes. No product quality compliant (PQC) was found. Lab diagnostics/ Studies performed were reported as none. Pharmacist requested that a lot check needed to be performed. The reporter did not report the causal relation of events with respect to PNEUMOVAX 23. This case is cross linked with 1802USA009106 (same reporter).
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient's current condition included penicillin allergy and erythromycin allergy. On 11-FEB-2018, the patient was vaccinated with PNEUMOVAX 23, (lot # N013541, Exp date: 23-JAN-2019), dose 1, 1 DF, intramuscularly for vaccination. On the same day, the patient experienced pain, swelling and her arm severely swelled to twice its normal size several hours after receiving the vaccine (extensive swelling of vaccinated limb). She obtained treatment at an urgent care clinic where she was given prednisone, NORCO, ALLEGRA, cephalexin. The outcome of events were unknown (also reported as not recovered). No other information was available. Sought to medical attention was yes. No product quality compliant (PQC) was found. Lab diagnostics/ Studies performed were reported as none. Pharmacist requested that a lot check needed to be performed. The reporter did not report the causal relation of events with respect to PNEUMOVAX 23. This case is cross linked with 1802USA009106 (same reporter).
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's concurrent condition included hypertension. Concomitant therapy included losartan. The patient did not have any drug allergy. On an unknown date, the patient was vaccinated with two doses of PNEUMOVAX 23 lot # N025656 expiry date: 19-APR-2019 within a week (strength, frequency and route of administration were not reported) for immunization. Pharmacist was not able to clarify if lot number and expiration were same for both the doses. On an unknown date, the patient reported that his arm was hurting. Pharmacist reported that his second vaccination should have been BOOSTRIX. The patient did not sought medical attention. The patient did not received any treatment for the event and did not underwent any laboratory tests. The outcome of limb injury was unknown. Causality assessment of the event was not reported. No product quality compliant was reported.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Eczema, Erythema, Inflammation, Pruritus, Quality of life decreased
Clinical narrative: My child (born completely healthy) suffers from severe and unbearable itching/chronic inflammation (with redness and discoloration under the skin's surface) - likely referred to as eczema (doctor indicated it is likely eczema and recommended topical treatments which have not provided relief because it does not treat the cause). This severe and unbearable itching around the clock with flair ups occurring particularly during the evening hours intereferes with normal function, sleep and quality of life. These symptoms were reported as early as the two week visit (and also noticed in pictures). At six months old now, she has suffered since then. I believe this is an adverse reaction to ingredients in the vaccine (i.e. aluminum, etc.) and the manifestation of a disruption in her extremely immature immune system. Either way, I regret having allowed this as my child, who was born perfectly healthy, suffers tremendously as a result.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Skin discolouration, Sleep disorder
Clinical narrative: My child (born completely healthy) suffers from severe and unbearable itching/chronic inflammation (with redness and discoloration under the skin's surface) - likely referred to as eczema (doctor indicated it is likely eczema and recommended topical treatments which have not provided relief because it does not treat the cause). This severe and unbearable itching around the clock with flair ups occurring particularly during the evening hours intereferes with normal function, sleep and quality of life. These symptoms were reported as early as the two week visit (and also noticed in pictures). At six months old now, she has suffered since then. I believe this is an adverse reaction to ingredients in the vaccine (i.e. aluminum, etc.) and the manifestation of a disruption in her extremely immature immune system. Either way, I regret having allowed this as my child, who was born perfectly healthy, suffers tremendously as a result.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a 83 year old male consumer, reporting on himself. The patient's medical history included pneumonia in 2015 and bundle branch block left. The consumer stated that on an unspecified date in 2017, he was vaccinated with the first dose of PNEUMOVAX 23 one injection, in the arm, for prophylaxis (strength, frequency, lot # and expiration date were not provided. Then, on an unknown date, (reported as "9 months apart"), at the recommendation of his physician, the patient received the second dose of PNEUMOVAX 23 one injection, for prophylaxis (strength, lot # and expiration date were not provided). Concomitant therapy included unspecified "Flu vaccine". No adverse effects were reported.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Injection site oedema, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse via a company representative referring to a 42 year old female patient. The patient's concurrent conditions included hereditary spherocytosis and autoimmune thyroiditis. The patient's medical history included splenectomy. The patient's concomitant therapies and past drug reactions/allergies were not reported. On 22-JAN-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N027770 with expiration date: 02-FEB-2019 in her left arm (strength, dose and route were not reported) for post-splenectomy (prophylaxis). On 23-JAN-2018, 24 hours after the vaccination, the patient developed symptoms of severe chills, fever, arthralgia and edema of the left arm at the site of the injection. On 25-JAN-2018, the patient went to see the reporting physician and was treated with MEDROL DOSE PAK for her symptoms, and was instructed to follow up with her primary care physician within one week. The outcome of severe chills, fever, arthralgia and edema of the left arm at the site of the injection was unknown at the time of the report. The reporter did not assess a causal relationship between the aforementioned events and PNEUMOVAX 23.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Arthralgia, Contusion, Rash, Tenderness
Clinical narrative: This spontaneous report as received from a other health professional refers to a 20 year old patient. The patient's medical history included tonsillitis. Her concurrent conditions and concomitant therapy were not provided. On 14-DEC-2017, the patient was vaccinated with GARDASIL 9 (dose, frequency, lot# and expiration date were not provided) for prophylaxis. On an unspecified date in January 2018, the patient had bruising, some tenderness and unspecified rash on both knees. However, it was clarified that the rash did not appear at the injection site. On 20-JAN-2018, the patient complaint of pain when bending both knees (arthralgia). On an unspecified date, the patient visited the urgent clinic and was prescribed with unspecified antibiotic which helped with the joint pain in her knees. However, the outcome of contusion, arthralgia, rash and tenderness was unknown. The causal relationship between GARDASIL 9 and the above mentioned events was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of VARIVAX (dosage, frequency and route of administration were not reported), lot#: N025933 (expiration date: 19-SEP-2019), lot#: N020686 (expiration date: 27-JUL-2019,) lot # N014630 (expiration date: 11-AUG-2019 "also reported on 11-MAY-2019", for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from the office manager and refers to a 13 month old male patient. The patient's medical history, drug reactions and allergies were not provided. On 29-JAN-2018, the patient was vaccinated with an expired dose of properly stored M-M-R II 0.5 ml once, lot# M004305, expiration date on 25-JAN-2018, for prophylaxis, (route was not provided); reconstituted with properly store sterile diluent lot #M045717, expiration date: 31-MAY-2019. No adverse effects were reported.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This prospective pregnancy report was initially received from a 25 year old female patient referring to herself and follow-up information was received from a registered nurse. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions, and allergies were not reported. On 23-JUN-2017, the patient was vaccinated with her first dose of GARDASIL 9 for human papillomavirus prevention (route, lot number, and expiration date were not reported). On an unspecified date in August 2017, the patient had her last menstrual period (LMP). On an unspecified date in 2017, the patient had pregnancy test and blood tests and on 16-SEP-2017, she found out that she was pregnant since an unspecified date (maternal exposure during pregnancy). On 25-SEP-2017, the patient received her second dose of GARDASIL 9 lot # N010497 and expiration date of 15-JAN-2020. On an unspecified date, the patient experienced ''normal pregnancy symptoms''. The nurse also stated that she did not have any information regarding the patient's pregnancy. The outcome of normal pregnancy symptoms and maternal exposure during pregnancy was unknown and no causality assessment was reported.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a pharmacist referring to a female patient of unknown age. The patient did not have medical history, concurrent conditions or drug reactions/allergies. On 18-JAN-2018, the patient was vaccinated with a dose of VARIVAX, subcutaneous (strength, dose number, lot number and expiration date were not provided) for prophylaxis. Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins. It was reported that on 18-JAN-2018, the patient was in her "first trimester of pregnancy." The patient was still currently pregnant. The LMP (last menstrual period) was unknown (also reported as: "first trimester". The pregnancy outcome was outcome pending. No laboratory diagnostics or studies were performed.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 12 year old male patient. His medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 01-FEB-2018, the patient was accidentally vaccinated with 2 doses of GARDASIL 9 (lot # M044717 and expiration date: 19-JUL-2019) for prophylaxis. No adverse events were reported. No product quality complaint was involved.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Vaccination failure, Varicella post vaccine
Clinical narrative: This literature marketed report was received from the authors in a published literature article,  concerning a 12-year-old girl with a history of relapsed acute myeloid leukaemia (AML) presented 2 years status post-unrelated haematopoietic cell transplantation (HCT) for immune evaluation and assessment of readiness to receive live vaccinations. At the age of 10 years, she received a matched unrelated bone marrow transplant. She received myeloablative conditioning with busulfan and cyclophosphamide along with immunosuppression with alemtuzumab, tacrolimus and methotrexate for prevention of graft versus host disease (GVHD). Alemtuzumab was discontinued shortly thereafter because of rash and fever thought to be due to it. She received three total doses of methotrexate (5.6 mg). She had a complicated immediate post-transplant course, which included infections with Clostridium difficile and adenovirus. She also developed GVHD that manifested first as diarrhoea with mild GVHD on duodenal biopsy and was initially treated with ongoing tacrolimus and oral budesonide. Complete donor chimerism was achieved by 100 days post-HCT. Seven months post-transplant, she developed chronic GVHD with maculopapular rash involving <50% of skin surface and was treated with oral prednisone and subsequently briefly with rituximab. Tacrolimus was also continued at varying doses with a maximum of 1 mg twice daily, tapered down over several months and discontinued for the final time 573 days after transplant. Prednisone was started 207 days after transplant at a dose of 20 mg twice daily and was tapered down and discontinued 323 days after transplant. She had mild hypogammaglobulinaemia treated briefly with intravenous immunoglobulin. She was off of all immunosuppression at the time of her vaccination-readiness immune evaluation. On an unknown date, the patient was given live vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and VARIVAX, 0.5 mL for prophylaxis (route, lot# and the expiration date were not reported). She returned to an outside facility 10 days later with localized rash consistent with Varicella infection, subsequently confirmed to be vaccine strain (oka/ Merck strain) (varicella post vaccine). This patient had an initial immune evaluation 2 years after transplant, which was reassuring for apparently normal immune reconstitution. However, she developed localized Varicella infection soon after vaccination (vaccination failure). Serial assessment 7 months later demonstrated improvement in T-cell function, and subsequent vaccination was without incident or further infection. At the time of reporting, the outcome of varicella post vaccine and vaccination failure was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to an unspecified patient of unknown age and gender. On 30-JAN-2018, the patient was vaccinated with a improperly stored dose of VARIVAX (dose, frequency and route of administration were not reported) (lot # N023961 and expiration date 01-SEP-2019) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # N015479 and expiration date 23-JUL-2019). The vaccine was stored in between -50 degrees Celsius (C) to -15 C for 5 minutes and 18 seconds. The previous temperature excursion was between -14 C to -10 C for 11 minutes and 55 seconds. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality compliant (PQC) was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017), the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, on 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, on 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects reported. No product quality complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005084: US-009507513-1802USA005086: US-009507513-1802USA005085: US-009507513-1802USA005087: US-009507513-1802USA005089: US-009507513-1802USA005090.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). On 01-NOV-2017 or 21-NOV-2017 the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N017700 and expiration date: 09-JUN-2019). Reporter informed that, the lot# N017700 had multiple temperature excursion as follows, on 27-NOV-2017, temperature excursion was at 5.60 F for the duration of 1 hour, on 29-NOV-2017 at 16.50 F for 1 hour, on 30-NOV-2017 at 6.00 F for 1 hour, on 04-DEC-2017 at 22.80 F for 1 hour, on 05-DEC-2017 at 19.00 F for 2 hours, on 06-DEC-2017 at 16.70 F for 1 hour, on 07-DEC-2017 at 18.70 F for 1 hour, on 11-DEC-2017 at 20.10 F for 1 hour, on 12-DEC-2017 at 11.80 F for 1 hour, on 13-DEC-2017 at 19.80 F for 1 hour, on 14-DEC-2017 at 16.00 F for 2 hours, on 18-DEC-2017 at 14.50 F for 1 hour, on 20-DEC-2017 at 19.90 F for 1 hour, on 21-DEC-2017 at 19.00 F for 1 hour, on 27-DEC-2017 at 19.00 F for 1 hour and on 28-DEC-2017 at 7.70 F for 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects (no adverse event) reported. No product quality Complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link).; Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005088: US-009507513-1802USA005084: US-009507513-1802USA005089: US-009507513-1802USA005087: US-009507513-1802USA005086: US-009507513-1802USA005085.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-JAN-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, units, frequency, route, lot number, expiration date not reported), on 09-MAY-2016 with the second dose of GARDASIL 9 ((dose, units, frequency, route, lot number, expiration date not reported) and on 08-FEB-2018 with the third dose of GARDASIL 9 ((dose, units, frequency, route, lot number, expiration date not reported)(inappropriate schedule of drug administration). No adverse effects were reported (no adverse event). No further information was provided. There was no product quality complaint (PQC).
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a Medical assistant via field representative and refers to a female patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9, dose 1, 1 DF for prophylaxis. Two days later, she came back to office and complained of headache. The outcome of headache was unknown. The reporter did not provide the causal relation of event with respect to GARDASIL 9. No product quality compliant (PQC) was present. No further details were noted.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 10-JAN-2008, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) which was administered by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-FEB-2016, the patient was treated by (unspecified healthcare professional) at the community medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. 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, pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial test negative, Condition aggravated, Mental status changes
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 67 year old female patient. The patient's medical history included mental status changes approximately on 02-JAN-2018 (reported as "symptoms of alternate mental status one month prior to admission to the hospital on 02-FEB-2018"). The patient did not have any known allergies. No information was provided regarding the patient's concurrent conditions or concomitant medications. On 18-JAN-2018, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The physician reported that on 02-FEB-2018, the patient was admitted to a hospital complaining of alternate mental status and was tested for meningitis infection which was negative. It was also stated that the patient received treatment for the adverse event (unspecified treatment). The outcome of mental status changes was unknown. The physician considered mental status changes to be not related to ZOSTAVAX. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the ZOSTAVAX vaccine and the remaining reported event of Mental Status changes cannot be established. Missing important information includes medical history, comorbid conditions, concomitant medications and clinical course. Company Comment- No changes to the Zostavax product safety information are warranted at this time.  Merck and Co., Inc., continues to monitor the safety profile of the product.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 13-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX, subcutaneously, in the left arm, (lot # M041085 with an expiration date in 03-JAN-2018), for prophylaxis, (dose and frequency were not provided). No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 02-JUL-2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (lot #, route, and dose not provided). The vaccine was administered by a Registered Nurse at a physician's office. At the time of her vaccination, the patient relied on the warning label affixed to ZOSTAVAX, and the information relayed through her healthcare provider that ZOSTAVAX was effective in preventing shingles on a permanent basis, and did not carry significant risk of adverse effect, which induced her to be vaccinated. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 15-JAN-2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. She was prescribed gabapentin and valacyclovir for the management of her painful symptoms. 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of VARIVAX (dosage, frequency and route of administration were not reported), lot#: N025933 (expiration date: 19-SEP-2019), lot#: N020686 (expiration date: 27-JUL-2019,) lot # N014630 (expiration date: 11-AUG-2019 "also reported on 11-MAY-2019", for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Sender's Comments: US-009507513-1802USA008842: US-009507513-1802USA008838: US-009507513-1802USA008839: US-009507513-1802USA008840: US-009507513-1802USA008841: US-009507513-1802USA008836: US-009507513-1801USA014257: US-009507513-1802USA008837.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of PROQUAD (dosage, frequency and route of administration were not reported), lot#: N013295 (expiration date: 28-APR-2019), lot#: N012489 (expiration date: 17-OCT-2018) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Lot number N013295 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of four reports received from the same source. Sender's Comments: US-009507513-1802USA008842: US-009507513-1802USA008838: US-009507513-1802USA008839: US-009507513-1802USA008840: US-009507513-1802USA008841: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of PROQUAD (dosage, frequency and route of administration were not reported), lot#: N013295 (expiration date: 28-APR-2019), lot#: N012489 (expiration date: 17-OCT-2018) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. Lot number N013295 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of four reports received from the same source. Sender's Comments: US-009507513-1802USA008842: US-009507513-1802USA008839: US-009507513-1802USA008840: US-009507513-1802USA008841: US-009507513-1802USA008836: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of PROQUAD (dosage, frequency and route of administration were not reported), lot#: N013295 (expiration date: 28-APR-2019), lot#: N012489 (expiration date: 17-OCT-2018) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Lot number N013295 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of four reports received from the same source. Sender's Comments: US-009507513-1802USA008842: US-009507513-1802USA008838: US-009507513-1802USA008840: US-009507513-1802USA008841: US-009507513-1802USA008836: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of PROQUAD (dosage, frequency and route of administration were not reported), lot#: N013295 (expiration date: 28-APR-2019), lot#: N012489 (expiration date: 17-OCT-2018) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Lot number N013295 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of four reports received from the same source. Sender's Comments: US-009507513-1802USA008842: US-009507513-1802USA008838: US-009507513-1802USA008839: US-009507513-1802USA008841: US-009507513-1802USA008836: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.