chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Metabolic function test, Parvovirus B19 test negative, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: 4/25 Rash on arms and legs, fever, ecchymosis at injection site. 4/29 Fever to 103.5, joint pain, limp. Urticarial rash symptoms continued through 5/3 when she was treated with oral steroids for presumed serum sickness with rapid resolution of symptoms. 4/20: MMR, Varicella, DTaP, Polio. 4/22: Hive-like maculopapular rash develops on extremities (including hands). Vaccination site looks particularly bad - large red/dark patch. 4/23: Rash starts itching. 4/24: Fever of 102.5, rash is itchy. 4/25: Seen by Dr. who suggests there is one reaction at the vaccination site and the rest is a viral rash. 4/25-4/28: Rash continues and keeps itching. Does not respond to BENADRYL. Spreads to face. 4/29: Preschool director calls to say that patient is having right knee pain, possibly due to stumbling. She won't put weight on it and limps (although she can put weight on it). Won't let us go near it or ice it. 4/30: Wakes up screaming at dawn with 103 fever and extreme knee pain. Seen by Dr. who orders blood work. Blood work shows elevated Sed rate (28) and CRP, but otherwise normal. Joint pain spreads to arms and legs. 5/1: Fever continues, spikes to 104.9 at night. Joint pain is severe, rash is back - both seem to come and go with fever. 5/2: Fever breaks in the morning and then rises through the day. Starts complaining of non-specific abdominal pain (has barely eaten since Friday but is taking in some liquids). Joint pain and rash come and go with the fever. Fever spikes again in the evening at 104.9. Sees Drs. for follow up. Has enlarged lymph nodes. 5/3: Dr. - after consulting with colleagues - suggest serum sickness after vaccines. Fever is gone during the day (along with rash for the most part and joint pain) but then spikes again in the afternoon. First dose of prednisone at 6:00pm as treatment if serum sickness theory is correct. Still waiting on parvovirus and Lyme results. 5/4: (After starting prednisone the evening of 5/3) - rash is back without the fever and is very itchy again for the first time since 4/28. Joint pain is gone although in the middle of the night she was complaining of leg pain (but pointing to her quads not her joints). 5/6: No fever, no joint pain, itchy rash is gone. Returns to school. Develops rash that looks (perhaps) like varicella, but it resolves within a day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash pruritic, Red blood cell sedimentation rate increased, Screaming, Streptococcus test negative, Urine analysis
Clinical narrative: 4/25 Rash on arms and legs, fever, ecchymosis at injection site. 4/29 Fever to 103.5, joint pain, limp. Urticarial rash symptoms continued through 5/3 when she was treated with oral steroids for presumed serum sickness with rapid resolution of symptoms. 4/20: MMR, Varicella, DTaP, Polio. 4/22: Hive-like maculopapular rash develops on extremities (including hands). Vaccination site looks particularly bad - large red/dark patch. 4/23: Rash starts itching. 4/24: Fever of 102.5, rash is itchy. 4/25: Seen by Dr. who suggests there is one reaction at the vaccination site and the rest is a viral rash. 4/25-4/28: Rash continues and keeps itching. Does not respond to BENADRYL. Spreads to face. 4/29: Preschool director calls to say that patient is having right knee pain, possibly due to stumbling. She won't put weight on it and limps (although she can put weight on it). Won't let us go near it or ice it. 4/30: Wakes up screaming at dawn with 103 fever and extreme knee pain. Seen by Dr. who orders blood work. Blood work shows elevated Sed rate (28) and CRP, but otherwise normal. Joint pain spreads to arms and legs. 5/1: Fever continues, spikes to 104.9 at night. Joint pain is severe, rash is back - both seem to come and go with fever. 5/2: Fever breaks in the morning and then rises through the day. Starts complaining of non-specific abdominal pain (has barely eaten since Friday but is taking in some liquids). Joint pain and rash come and go with the fever. Fever spikes again in the evening at 104.9. Sees Drs. for follow up. Has enlarged lymph nodes. 5/3: Dr. - after consulting with colleagues - suggest serum sickness after vaccines. Fever is gone during the day (along with rash for the most part and joint pain) but then spikes again in the afternoon. First dose of prednisone at 6:00pm as treatment if serum sickness theory is correct. Still waiting on parvovirus and Lyme results. 5/4: (After starting prednisone the evening of 5/3) - rash is back without the fever and is very itchy again for the first time since 4/28. Joint pain is gone although in the middle of the night she was complaining of leg pain (but pointing to her quads not her joints). 5/6: No fever, no joint pain, itchy rash is gone. Returns to school. Develops rash that looks (perhaps) like varicella, but it resolves within a day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria, Weight bearing difficulty
Clinical narrative: 4/25 Rash on arms and legs, fever, ecchymosis at injection site. 4/29 Fever to 103.5, joint pain, limp. Urticarial rash symptoms continued through 5/3 when she was treated with oral steroids for presumed serum sickness with rapid resolution of symptoms. 4/20: MMR, Varicella, DTaP, Polio. 4/22: Hive-like maculopapular rash develops on extremities (including hands). Vaccination site looks particularly bad - large red/dark patch. 4/23: Rash starts itching. 4/24: Fever of 102.5, rash is itchy. 4/25: Seen by Dr. who suggests there is one reaction at the vaccination site and the rest is a viral rash. 4/25-4/28: Rash continues and keeps itching. Does not respond to BENADRYL. Spreads to face. 4/29: Preschool director calls to say that patient is having right knee pain, possibly due to stumbling. She won't put weight on it and limps (although she can put weight on it). Won't let us go near it or ice it. 4/30: Wakes up screaming at dawn with 103 fever and extreme knee pain. Seen by Dr. who orders blood work. Blood work shows elevated Sed rate (28) and CRP, but otherwise normal. Joint pain spreads to arms and legs. 5/1: Fever continues, spikes to 104.9 at night. Joint pain is severe, rash is back - both seem to come and go with fever. 5/2: Fever breaks in the morning and then rises through the day. Starts complaining of non-specific abdominal pain (has barely eaten since Friday but is taking in some liquids). Joint pain and rash come and go with the fever. Fever spikes again in the evening at 104.9. Sees Drs. for follow up. Has enlarged lymph nodes. 5/3: Dr. - after consulting with colleagues - suggest serum sickness after vaccines. Fever is gone during the day (along with rash for the most part and joint pain) but then spikes again in the afternoon. First dose of prednisone at 6:00pm as treatment if serum sickness theory is correct. Still waiting on parvovirus and Lyme results. 5/4: (After starting prednisone the evening of 5/3) - rash is back without the fever and is very itchy again for the first time since 4/28. Joint pain is gone although in the middle of the night she was complaining of leg pain (but pointing to her quads not her joints). 5/6: No fever, no joint pain, itchy rash is gone. Returns to school. Develops rash that looks (perhaps) like varicella, but it resolves within a day.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 12-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042264 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 10-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 05-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 02-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 09-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 02-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Urticaria
Clinical narrative: This spontaneous report concerning a 57 year old male patient, was received from the patient himself. His concurrent conditions included high blood pressure. However, he had no drug reactions/allergies and his medical history was not reported. On an unknown date (reported as "over two years ago"), the patient was vaccinated with ZOSTAVAX (dose, dosage number, route of administration, anatomical location, lot # and expiration date were not reported). His concomitant medications included an unspecified medication. Subsequently, in approximately 2014 (reported as "about two years ago"), the patient started to experience hives and about a year ago, in approximately 2015, the patient experienced muscle aches. A routine blood work had been performed but the results were not provided. The patient sought medical attention from various physicians and received an unspecified treatment. However, at the time of reporting, the events of hives and muscle aches had not resolved. Additionally, no product quality complaint was involved and the patient failed to provide a causal relationship between the events and the vaccination with ZOSTAVAX. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: YF
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: 5-1-16 noticed left tricep sore. Bilateral legs tingling sensation intermittently. Feels as if "rain hitting" legs.
Sex: F
Vaccine: HEP
Symptoms: Protein C deficiency
Clinical narrative: This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient did not have any concurrent conditions, medical history or drug reactions/allergies. On an unknown date, the patient was vaccinated with either one or two doses of the series of RECOMBIVAX HB intramuscularly, (lot number, dose and frequency were not reported). Concomitant therapies were not provided. In early March 2016, after the patient had started the RECOMBIVAX HB series, she was diagnosed with protein C deficiency. It was reported that the patient visited a different unspecified provider and then she received an unspecified treatment. No laboratory studies were performed. No product quality complain (PQC) was involved. At the time of reporting, the outcome of protein C deficiency was reported as not recovered. The reporter did not provide a causality assessment between the reported event and the RECOMBIVAX HB. This is one of two reports from the same source. Additional information has been requested.
Age: 1.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Child came in to have a check-up and received the PENTACEL vaccine in the left leg around 6:30 pm on Monday night. On Tuesday night around 7:00 pm Mom was giving the child a bath when she noticed that the area around the injection site - had a red rash around it with several scratches where child had been scratching at it. By the next morning on Wednesday it appeared to have doubled in size and was warm to touch. Area is red, bumpy (rash), swollen, and warm to touch and appears to be slightly larger than a softball. There is a history of MRSA in the family so originally treated as a cellulitis with cephalexin and BACTROBAN. When rechecked on Thursday - reddened area was only the size of a baseball, cool to touch, slightly reddened but fading not swollen. Child was acting as if this area was not bothering him throughout the reaction. Determined it was a large, local reaction but continued the cellulitis treatment as precautionary.
Age: 1.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site warmth, Local reaction, Rash erythematous, Scratch
Clinical narrative: Child came in to have a check-up and received the PENTACEL vaccine in the left leg around 6:30 pm on Monday night. On Tuesday night around 7:00 pm Mom was giving the child a bath when she noticed that the area around the injection site - had a red rash around it with several scratches where child had been scratching at it. By the next morning on Wednesday it appeared to have doubled in size and was warm to touch. Area is red, bumpy (rash), swollen, and warm to touch and appears to be slightly larger than a softball. There is a history of MRSA in the family so originally treated as a cellulitis with cephalexin and BACTROBAN. When rechecked on Thursday - reddened area was only the size of a baseball, cool to touch, slightly reddened but fading not swollen. Child was acting as if this area was not bothering him throughout the reaction. Determined it was a large, local reaction but continued the cellulitis treatment as precautionary.
Age: 0.58
Sex: M
Vaccine: IPV, PNC13
Symptoms: Injection site rash, Peripheral swelling, Skin discolouration
Clinical narrative: Less than 5 minutes after vaccine given - rash to bilateral thighs, within 10 min. swelling of hands and feet with mottling of hands, arms. No swelling of lips, no respiratory difficulty given BENADRYL, TYLENOL and dexamethasone.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash generalised
Clinical narrative: Itching, rash all over body.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse via office manager referring to a 14 year old female patient. The patient's relevant medical history, concomitant medications and past drug history were unknown. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (lot number, dose and route unknown). On 28-APR-2016 the patient was vaccinated with her second dose of GARDASIL 9 (lot # L018351, expiration date 11-AUG-2017, dose and route unknown) which had previously undergone a supported temperature excursion. It was unknown if there was any relevant laboratory data. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: HEP, FLUX
Symptoms: Herpes zoster, Seroconversion test negative
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old female patient. On an unknown date approximately in 1986 (also reported as over 30 years ago), the patient was vaccinated with unspecified flu vaccine 'influenza virus vaccine (unspecified)' and an unspecified time after receiving the flu vaccine the patient developed a rash on an unspecified area of the body and experienced unspecified high temperature and nausea and vomiting which lasted for an unspecified amount of time. The patient's other medical history and concurrent conditions were not reported. The pharmacist also reported that the patient has been administered "5 - three dose series" of RECOMBIVAX HB on multiple unspecified dates, lot, dosing details unknown as a part of routine vaccination for employment. The pharmacist reported that the last RECOMBIVAX HB was completed approximately in 2002 (also reported as 14 years ago) and the patient "was not seroconverted". The pharmacist also reported that since unknown date approximately in 2002 (also reported as for the last 14 years), the patient took acyclovir (manufacturer unknown) 400 milligram (mg) twice daily) for the prevention of shingles. The pharmacist stated that patient has developed shingles multiple times on unspecified dates and when the patient has had an exacerbation of shingles, the patient took acyclovir (manufacturer unknown) 800 mg twice daily for 10 days then goes back down to 400 mg twice daily after the shingles resolves. The pharmacist also reported that the patient was also taking TOPAMAX since unspecified start dates for an unspecified reason. The patient sought medical attention to the events by consulting physician. The outcome of event the patient was not seroconverted and shingles was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: HEP, FLUX
Symptoms: Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old female patient. On an unknown date approximately in 1986 (also reported as over 30 years ago), the patient was vaccinated with unspecified flu vaccine 'influenza virus vaccine (unspecified)' and an unspecified time after receiving the flu vaccine the patient developed a rash on an unspecified area of the body and experienced unspecified high temperature and nausea and vomiting which lasted for an unspecified amount of time. The patient's other medical history and concurrent conditions were not reported. The pharmacist also reported that the patient has been administered "5 - three dose series" of RECOMBIVAX HB on multiple unspecified dates, lot, dosing details unknown as a part of routine vaccination for employment. The pharmacist reported that the last RECOMBIVAX HB was completed approximately in 2002 (also reported as 14 years ago) and the patient "was not seroconverted". The pharmacist also reported that since unknown date approximately in 2002 (also reported as for the last 14 years), the patient took acyclovir (manufacturer unknown) 400 milligram (mg) twice daily) for the prevention of shingles. The pharmacist stated that patient has developed shingles multiple times on unspecified dates and when the patient has had an exacerbation of shingles, the patient took acyclovir (manufacturer unknown) 800 mg twice daily for 10 days then goes back down to 400 mg twice daily after the shingles resolves. The pharmacist also reported that the patient was also taking TOPAMAX since unspecified start dates for an unspecified reason. The patient sought medical attention to the events by consulting physician. The outcome of event the patient was not seroconverted and shingles was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose (temperature 52F, for 1 hour 15 minutes, not because of data logger), of VAQTA, 25/0.5 ml, lot # L046953, expiry date 14-JAN-2017, (dose, frequency and route of administration not reported). There was no previous temperature excursion. No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L033343, expiry date: 13-SEP-2017; lot # L040458, expiry date: 04-FEB-2018; lot # L048236, expiry date: 31-MAR-2018; lot # L045117, expiry date: 06-OCT-2018; lot # L027733, expiry date: 13-SEP-2017). Nurse reported that the vaccine underwent a temperature excursion at 11 degree Celsius in a large refrigerator for a time frame of 1 hour 18 minutes which came back to its temperature range. She reported that the vaccine also underwent 2 temperature excursions previously on an unknown date: at 0.2C as minimum for 96 hours plus a second exposure at 1.5C for 7 hours 22 minutes (evaluating 0.2C for cumulative time of 103 hours, 22 minutes). No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L038534, expiry date: 19-AUG-2017; lot # L039297, expiry date: 19-JUN-2017; lot # L047185, expiry date: 17-SEP-2017; lot # L038536, expiry date: 19-AUG-2017; lot # L027719, expiry date: 28-APR-2017; lot # L037921, expiry date: 31-MAY-2017). Nurse reported that the vaccine underwent a temperature excursion at 11 degree Celsius in a large refrigerator for a time frame of 1 hour 18 minutes which came back to its temperature range. She reported that the vaccine also underwent 2 temperature excursions previously on an unknown date: at 0.2C as minimum for 96 hours plus a second exposure at 1.5C for 7 hours 22 minutes (evaluating 0.2C for cumulative time of 103 hours, 22 minutes). No adverse events were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of M-M-R II (lot # K006396, expiry date: 04-MAY-2016 and lot # K008202, expiry date: 05-JUN-2016). Nurse reported that the vaccine underwent a temperature excursion in a large refrigerator at an unspecified temperature for an unknown time frame. No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Chills, Headache, Muscle tightness, Photophobia, Pyrexia
Clinical narrative: Approximately 45 minutes after receiving vaccines pt started with muscle tightness in his neck and shoulders then a severe headache with light sensitivity and vomiting, then the chills, and a slight fever (max temp 100.1 orally). Symptoms lasted 12 hrs.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Vomiting
Clinical narrative: Approximately 45 minutes after receiving vaccines pt started with muscle tightness in his neck and shoulders then a severe headache with light sensitivity and vomiting, then the chills, and a slight fever (max temp 100.1 orally). Symptoms lasted 12 hrs.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Allergy test, Blood pressure increased, Chills, Migraine, Myalgia
Clinical narrative: Approximately 45 minutes after receiving vaccines pt started with muscle tightness in his neck and shoulders then a severe headache with light sensitivity and vomiting, then the chills, and a slight fever (max temp 100.1 orally). Symptoms lasted 12 hrs.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L051099, expiry date: 17-JUN-2017; lot # M002058, expiry date: 11-JUL-2017; lot # L046510, expiry date: 19-MAY-2017; lot # L044058, expiry date: 02-MAY-2017). Nurse reported that the vaccine underwent a temperature excursion in a freezer at -3.2 degree Celsius for 2 hours 13 minutes, which came back to its temperature range. No adverse events were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 12-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 06-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly store vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concomitant conditions were reported. On 04-MAY-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical locations were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 13-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042264 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016(reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of VARIVAX (lot # K010437, expiry date: 22-JUL-2016). Nurse reported that the vaccine underwent a temperature excursion in a freezer at -3.2 degrees Celsius for 2 hours and 13 minutes, which came back to its temperature range. No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On specified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of VAQTA (lot # L046953, expiry date: 14-JAN-2017; lot # L015460, expiry date: 02-JUL-2017; lot # L045713, expiry date: 14-JAN-2017; lot # L018498, expiry date: 28-APR-2016; lot # L043209, expiry date: 17-SEP-2017; lot # L023936, expiry date: 15-MAR-2017). Nurse reported that the vaccine underwent a temperature excursion at 11 degree Celsius in a large refrigerator for a time frame of 1 hour 18 minutes which came back to its temperature range. She reported that the vaccine also underwent 2 temperature excursions previously on an unknown date: at 0.2C as minimum for 96 hours plus a second exposure at 1.5C for 7 hours 22 minutes (evaluating 0.2C for cumulative time of 103 hours, 22 minutes). No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L044475, expiry date 12-MAY-2017; lot # L019297, expiry date: 18-AUG-2017; lot # L026602, expiry date: 19-OCT-2017; lot # L043213, expiry date: 28-AUG-2017; lot # L019297, expiry date: 08-AUG-2017). Nurse reported that the vaccine underwent a temperature excursion at 11 degree Celsius in a large refrigerator for a time frame of 1 hour 18 minutes which came back to its temperature range. She reported that the vaccine also underwent 2 temperature excursions previously on an unknown date: at 0.2C as minimum for 96 hours plus a second exposure at 1.5C for 7 hours 22 minutes (evaluating 0.2C for cumulative time of 103 hours, 22 minutes). No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006960, expiry date: 19-FEB-2017). Nurse reported that the vaccine underwent a temperature excursion in a large refrigerator at an unspecified temperature for an unknown time frame. No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Age: 0.55
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given 1st dose at age 6 1/2 months today 5/17/16.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-MAY-2016, the patient was vaccinated with an expired dose of VAQTA (lot # J000366, expiration date 22-AUG-2015; dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Blister, Erythema, Rash
Clinical narrative: Rash occurring for 2 days. Rash described as vesicles with red rim in various stages of healing. PT instructed to use NEOSPORIN TID.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to six different unspecified patients of an unknown age and gender. The relevant medical history, concurrent condition and concomitant medication of the patients were not reported. On an unknown dates, six different unspecified patients were vaccinated with six doses of improperly stored VARIVAX (Merck) lot # L048465 (expiry date: 02-DEC-2017) (dosage not reported). The temperature excursions were 3C for 1 hour 54 minutes and 3.8C for 2 hours 11 minutes. No previous temperature excursion involved. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: DTAPIPV, MMRV, MMRV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 5 year old patient of unknown gender. No medical history or concomitant medications were reported. The patient was vaccinated with first dose of PROQUAD on 26-JUN-2012 and received the second dose of PROQUAD on 23-APR-2015. On 22-APR-2016, the patient was inadvertently vaccinated with the third extra dose of PROQUAD (lot # M001152, expiry:05-JUL-2017). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # K021487, expiry date: 03-NOV-2016; lot# L024250, expiry date: 30-JUN-2017; lot# L019128, expiry date: 27-MAY-2017 and lot# L042266, expiry date: 27-OCT-2017 (route, dose# and site of administration not reported). Concomitant medication was not mentioned by the nurse. The vaccine was started at -2.0 degree centigrade for a time frame of 12 hours and 10 minutes. There was no previous temperature excursion. The call was a result of a "data logger". No adverse effects were reported. No additional information was provided. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the three reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On multiple unspecified dates, unspecified doses of PROQUAD (Merck) (lot # L030591 with expiration date 10-FEB-2017, dosage and route not reported) which were improperly stored under 12.5 F for 20 hours were administered to multiple unspecified patients. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown gender and age. Information regarding her medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with RECOMBIVAX HB. Nurse reported that the patient had negative titers on an unspecified date. It was unspecified if the patient required medical attention or not. Outcome of the event was unknown. Reporting nurse had not assessed the causality of the event with respect to vaccination with RECOMBIVAX HB. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concurrent conditions were not reported. On 06-SEP-1991, the patient was vaccinated with MMR II dose 1, subcutaneous (dose, lot # and expiration date unknown) and again on 06-JUN-1995, the patient received vaccination with MMR II dose 2, subcutaneous (dose, lot # and expiration date unknown) to prevent MMR II. On an unspecified date after the vaccination, a blood titer was drawn and the patient was found to be negative for rubella antibodies. The patient's status at the time of this report was not specified. The outcome of the event was unknown. Causality was not provided by the reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis. Seen at an urgent care. And was given Clindamycin on May 15. Called May 16 for status report per patient doing well with no current concerns.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-DEC-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: June 2017, dose reported as 1 mg, intramuscularly, in left deltoid (dose number was not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Anion gap, C-reactive protein normal, Febrile convulsion, Full blood count normal, Metabolic function test normal
Clinical narrative: 2 hours after administration of vaccine developed fever up to 103 F. Was taken to hospital where fever was documented at 104.9 F and patient had febrile seizure, simple lasting 1 minute. Admitted for observation.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Streptococcus test negative, Urine analysis normal
Clinical narrative: 2 hours after administration of vaccine developed fever up to 103 F. Was taken to hospital where fever was documented at 104.9 F and patient had febrile seizure, simple lasting 1 minute. Admitted for observation.
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: 9 x 3 red area - warm to touch - tx: ice PRN and OTC allergy med.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 12-APR-2016 the patient was vaccinated with an improperly stored dose of MMR II (lot#I023386, expiration date 25-JUN-2017, dose and route unknown) and an improperly stored dose of (Oka/Merck) VARIVAX (lot# reported as I04688, expiration date 23-NOV-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. Lot number I04688 is an invalid lot number for (Oka/Merck) VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-APR-2016 the patient was vaccinated with an improperly stored dose of MMR II (lot#I023386, expiration date 25-JUN-2017, dose and route unknown) and an improperly stored dose of (Oka/Merck) VARIVAX (lot# reported as I04688, expiration date 23-NOV-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. Lot number I04688 is an invalid lot number for (Oka/Merck) VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 18-APR-2016 the patient was vaccinated with an improperly stored dose of MMR II (lot#I023386, expiration date 25-JUN-2017, dose and route unknown) and an improperly stored dose of (Oka/Merck) VARIVAX (lot# reported as I04688, expiration date 23-NOV-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. Lot number I04688 is an invalid lot number for (Oka/Merck) VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.