chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-MAR-2016, the patient was inadvertently vaccinated with expired doses of MMR II lot # K001997, expiration date: 10-FEB-2016 (dose and route of administration were not reported) and (Oka/Merck) VARIVAX lot# K002918, expiration date: 26-FEB-2016 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC)) was not involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness/swelling/pain at injection site. Oval shape size of a plum tomato.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) referring to an unspecified number of patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with and improperly stored dose of ROTATEQ oral (strength, dose, were not provided) (lot # L037924 expiry date 22-JUN-2017, lot # L023870 expiry date 02-APR-2017 and reported lot # L029618 expiry date 20-MAY-2017). The Certified Medical Assistant (C.M.A) stated that oral ROTATEQ was exposed to the following temperature conditions: -7 C for 36 hours. There was no a previous temperature excursion. No adverse effects was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and unknown gender. There was no information abut concurrent condition, medical history or concomitant medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored PNEUMVOVAX 23 (lot # L019835 and expiry date 23-MAR-2017) (dosing details unspecified) (also reported nurse was unsure of which vaccine was administered). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 64.9F. Time frame: 4 hours and 19 minutes. Previous temperature excursion: No. Data logger: Yes. This is one of the several 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 as received from a registered nurse refers to a multiple unspecified patients of unknown age and unknown gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored MMR II (lot # L011528 and expiration date 03-APR-2017; lot # L012482 and expiration date 10-APR-2017 and lot # L024265 and expiration date 01-JUL-2017) (dosing details unspecified) (also reported nurse was unsure of which vaccine was administered). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 4 hours and 19 minutes. Previous temperature excursion: No. Data logger: Yes. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored LIQUID PEDVAXHIB (lot # L033690 and expiry date 14-JUN-2018) (dosing details unspecified) (also reported nurse was unsure of which vaccine was administered). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 64.9F. Time frame: 4 hours and 19 minutes. Previous temperature excursion: No. Data logger: Yes. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles, Mumps
Clinical narrative: This spontaneous report was received a female patient of unknown age reporting on herself. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date (when she was 18 months old), the patient was vaccinated  with M-M-R II (dose, lot #, expiry date, anatomical location and route of administration were not specified). However, on an unknown date, after the vaccination with M-M-R II, the patient developed mumps and measles. The patient stated that she did not develop these diseases at the same time. Product quality complaint (PQC) was not involved. The outcome of the events was not reported. The reporter did not provide the causality assessment between the events and M-M-R II. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 59 year old male patient with no drug allergies/reactions or medical history. On 20-FEB-2016 the patient was vaccinated with ZOSTAVAX (Lot# reported as L034727, unspecified expiration date), 0.65 ml, once, subcutaneously. No concomitant medication was taken. In February 2016 the patient developed an unspecified rash underneath both arms on the trunk of the body. The patient also experienced difficulty breathing for about 1 hour after the administration of ZOSTAVAX (onset date and stop date: unspecified date in February 2016), but the breathing difficulty was not severe. The patient called his primary physician, on an unspecified date, and the physician advised the patient to use an unspecified over the counter hydrocortisone (manufacturer unknown) cream as treatment of the rash, but the cream made the patient feel worse (capture into MARRS#1603USA001502). Lab diagnostics study was not performed. The outcome of rash was unknown. Action taken with ZOSTAVAX was not applicable. The relationship between the ZOSTAVAX and the two events was not reported. This is one of the two reports received from the same patient. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) rHA (strength, dose and route of administration were not provided) (lot # L030592 expiry date 12-FEB-2017, L034931 expiry date 03-MAR-2017, L041628 expiry date 20-APR-2017 and reported lot number L044058 expiry date 02-MAY-2017). The Certified Medical Assistant (C.M.A) stated that PROQUAD (Merck) was exposed to the following temperature conditions: -14 degree C for 93 hours. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported). On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (strength, dose and route of administration were not provided) (lot # L023588 expiry date 26-JUN-2017, L023594 expiry date 26-JUN-2016 and L027287 expiry date 27-JUL-2017). The Certified Medical Assistant (C.M.A) stated that VARIVAX (Merck) was exposed to the following temperature conditions: -14 degrees C for 93 hours. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. This is one of several 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 Certified Medical Assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VAQTA (strength, dose and route of administration were not provided) (lot # L015460 expiration date 20-JUL-2017 and L045713 expiry date 14-JAN-2017). The Certified Medical Assistant (C.M.A) stated that VAQTA was exposed to the following temperature conditions: -7 degrees C for 36 hours. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. 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 Certified Medical Assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, dose and route of administration were not provided) (lot # L027733 expiry date 13-SEP-2017, L029631 expiry date 17-AUG-2017). The Certified Medical Assistant (C.M.A) stated that RECOMBIVAX HB was exposed to the following temperature conditions: -7 degrees C for 36 hours. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. This is one of several 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 Certified Medical Assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported.  On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (strength, dose and route of administration were not provided) (lot # K010215 expiry date 05-MAY-2017, K011562 expiry date 08-MAR-2017 and L040459 expiry date 06-MAR-2017). The Certified Medical Assistant (C.M.A) stated that GARDASIL was exposed to the following temperature conditions: -7 degrees C for 36 hours. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. This is one of several 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 Certified Medical Assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose and route of administration were not provided) (lot # L020015 expiry 16-AUG-2017 and L045711 expiry date 08-MAY-2017). The Certified Medical Assistant (C.M.A) stated that GARDASIL 9 was exposed to the following temperature conditions: -7 degree C for 36 hours. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Muscle twitching, Skin warm, Urticaria
Clinical narrative: Large hot welt, swelling, pt has reported muscle twitching and spasms in arm (left).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L029631, expiration date 14-AUG-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown dates the unspecified patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (incorrect product storage) (lot # L027733, expiry date 13-SEP-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the vaccines were exposed to a temperature of 53 degrees Fahrenheit, for a time frame of 3 hours and 15 minutes. It was also reported that these vaccines were administered. No adverse effect was reported. No product quality complaint was reported. The action taken with the therapy with RECOMBIHAX HB was unknown. The outcome of the event was unknown. It was reported that this case was reported due to a data logger. This case is related to case numbers 1603USA005893 and 1603USA006320 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown dates the unspecified patients were vaccinated with an improperly stored dose of VAQTA (incorrect product storage) (lot # L034381, expiry date 21-DEC-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the vaccines were exposed to a temperature of 53 degrees Fahrenheit, for a time frame of 3 hours and 15 minutes. It was also reported that these vaccines were administered. No adverse effect was reported. No product quality complaint was reported. The action taken with the therapy with VAQTA was unknown. The outcome of the event was unknown. It was reported that this case was reported due to a data logger. This case is related to case numbers 1603USA005893 and 1603USA006319 via same reporter link. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report was received from a 59 year old female patient reporting on herself. The patient's medical history included shingles before December 2015. The patient's concurrent conditions were not provided. On 22-DEC-2015, the patient was vaccinated with ZOSTAVAX injection (dose, lot #, expiration date and route of administration were not reported). There were no concomitant medication provided. On 22-DEC-2015, after ZOSTAVAX administration, the patient experienced pain and rash and on early January 2016, she was diagnosed with shingles by the physician. The patient was treated with prednisone (manufacturer unknown). It was also reported that the patient seemed to be recovered. On 14-FEB-2016, the patient experienced another rash. On 20-FEB-2016 (also reported as "on Saturday"), when she woke up she saw unspecified spots. It was also reported, that on an unknown date the patient experienced "fire and temperature". The patient sought medical attention- contacted her physician. The outcome of shingles was reported as recovered on an unknown date in 2016. The outcome of rash and spots was reported as not recovered/not resolved. The outcome of fire and temperature was unknown. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test negative, Body temperature increased, Herpes zoster, Injection site rash, Pain
Clinical narrative: This spontaneous report was received from a 59 year old female patient reporting on herself. The patient's medical history included shingles before December 2015. The patient's concurrent conditions were not provided. On 22-DEC-2015, the patient was vaccinated with ZOSTAVAX injection (dose, lot #, expiration date and route of administration were not reported). There were no concomitant medication provided. On 22-DEC-2015, after ZOSTAVAX administration, the patient experienced pain and rash and on early January 2016, she was diagnosed with shingles by the physician. The patient was treated with prednisone (manufacturer unknown). It was also reported that the patient seemed to be recovered. On 14-FEB-2016, the patient experienced another rash. On 20-FEB-2016 (also reported as "on Saturday"), when she woke up she saw unspecified spots. It was also reported, that on an unknown date the patient experienced "fire and temperature". The patient sought medical attention- contacted her physician. The outcome of shingles was reported as recovered on an unknown date in 2016. The outcome of rash and spots was reported as not recovered/not resolved. The outcome of fire and temperature was unknown. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Skin lesion, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a 59 year old female patient reporting on herself. The patient's medical history included shingles before December 2015. The patient's concurrent conditions were not provided. On 22-DEC-2015, the patient was vaccinated with ZOSTAVAX injection (dose, lot #, expiration date and route of administration were not reported). There were no concomitant medication provided. On 22-DEC-2015, after ZOSTAVAX administration, the patient experienced pain and rash and on early January 2016, she was diagnosed with shingles by the physician. The patient was treated with prednisone (manufacturer unknown). It was also reported that the patient seemed to be recovered. On 14-FEB-2016, the patient experienced another rash. On 20-FEB-2016 (also reported as "on Saturday"), when she woke up she saw unspecified spots. It was also reported, that on an unknown date the patient experienced "fire and temperature". The patient sought medical attention- contacted her physician. The outcome of shingles was reported as recovered on an unknown date in 2016. The outcome of rash and spots was reported as not recovered/not resolved. The outcome of fire and temperature was unknown. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Fever of 102 degrees F the day after shots. PENTACEL. PREVNAR 13, ROTATEQ. Also has congestion and runny nose.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 22-FEB-2016, the patient was vaccinated with a dose of VARIVAX (Merck) lot # L035124, expiration date 14-SEP-2017 (route was not provided). Concomitant therapy information was not provided. On 22-FEB-2016, there was an incorrect product storage, the patient received an improperly stored dose of VARIVAX (Merck). No adverse event was reported. It was reported that the total cumulative excursions and time were 10.4 F for 7 hours and 20.4 F for 1 hour and 30 minutes. The patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with doses of GARDASIL 9 (dose and route not reported, lot number L020015 with expiration date 16-AUG-2017 and lot number L045711 with expiration date 08-MAY-2017) that were improperly stored (temperature: 12.3C and time frame: 4.5 hours). It was reported that there was a previous temperature excursion (9.6C for 2 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for follow up.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored GARDASIL (lot# K016966, expiration date 10-MAY-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (LPN) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored ROTATEQ (lot # L010837 with expire date of 06-FEB-2017 or L013192 with expire date of 19-JAN-2017, dose and dose number not reported) orally. The vaccines had been exposed to temperature of 48.4 F for 50 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 (lot# L045711, expiration date 07-MAY-2017, dose and route were unknown). 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: Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (incorrect product storage) (dose and route not reported, lot # L027287 and Exp. date 21-JUL-2017). The vaccinates were exposed to 13.8F for 43 hours. There was no previous temperature excursion reported. 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: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB (Lot# L019298, expiration date 22-JUN-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017, dose and route were unknown). Other suspect therapy included improperly stored GARDASIL 9 (lot# L045711, expiration date 07-MAY-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored VAQTA (lot # L036300, expiration date 04-NOV-2016, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored RECOMIBVAX HB (Lot# L029631, expiration date 14-AUG-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients was vaccinated with improperly stored doses of PROQUAD (Merck) (dose and route not reported, lot # L033698 an Exp. date 28-FEB-2017). The vaccinates were exposed to 13.8F for 43 hours. There was no previous temperature excursion reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (lot # L029615, expiration date 15-MAY-2017, dose was unknown) orally. Other suspect therapy included improperly stored RECOMIBVAX HB (lot # L029615, expiration date 15-MAY-2017, dose and route were unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report was received from a physician regarding a 5 year old female patient. Pertinent medical history and drug allergies or reaction was reported as none. On 10-MAR-2016, the patient was vaccinated with PROQUAD (Merck) lot # L034930, expiration date- 03-MAR-2017, intramuscular instead of the intended subcutaneous route. Concomitant medication was reported as none. On 10-MAR-2016, a few hours later after vaccination patient experienced soreness at the injection site. Patient was treated with MOTRIN and a warm compress to the injection site. No laboratory diagnostic studies were performed. Patient seek medical attention from office clinic. The outcome of soreness at the injection site was reported as not resolved. The outcome of intramuscular instead of the intended subcutaneous route was unknown. Causality between PROQUAD (Merck) and soreness at the injection site was unknown. Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Chills, Pneumonia, Pyrexia
Clinical narrative: This spontaneous report as received from a male patient of unknown age (who was also a company representative) via company representative, refers to himself. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 05-FEB-2016, the patient was vaccinated with M-M-R II (lot#, therapy type, expiration date, dose and anatomical location were not reported; subcutaneously) and with VARIVAX (Merck) (lot#, expiration date, dose and anatomical location were not reported; subcutaneously). On 08-FEB-2016, the patient experienced chills and a fever. On 27-FEB-2016, he was diagnosed with pneumonia. The treatment was given and included antibiotic quinolone and an unspecified steroid. The physician also suggested bed rest. The outcome of the events was reported as recovering. The patient sought medical attention and visited physician and emergency room (name or location were unknown). The relatedness between the events and vaccination with M-M-R II and VARIVAX (Merck) was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown dates the unspecified patients were vaccinated with an improperly stored dose of ROTATEQ (incorrect product storage) (lot # L013204, expiry date 28-JAN-2017) (Lot # L026067, expiry date 13-SEP-2017) (Lot # L029617, 19-MAY-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that these vaccines were exposed to a temperature of 53 degrees Fahrenheit, for a time frame of 3 hours and 15 minutes. It was also reported that these vaccines were administered. No adverse effect was reported. No product quality complaint was reported. The action taken with the therapy with ROTATEQ was unknown. The outcome of the event was unknown. It was reported that this case was reported due to a data logger. This case is related to case numbers 1603USA006320 and 1603USA006319 via same reporter link. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling and tenderness 5 days later after vaccination.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Swelling and tenderness 5 days later after vaccination.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Hyperacusis, Vomiting
Clinical narrative: Swelling and tenderness 5 days later after vaccination.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Cellulitis
Clinical narrative: (L) arm cellulitis 2 days post 3rd HPV.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain of skin
Clinical narrative: Patient's arm was red and she stated that it was tender. Her physician said to keep an eye on it - no other treatment at this time.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Anger, Asthenia, Blood iron decreased, Depression, Lethargy
Clinical narrative: Mother of patient stated that symptoms started after 1st shot with cold like symptoms, fever, no tiredness after 2nd shot symptoms were weakness, lethargy and fever. After 3rd shot symptoms were depression, anger, lethargy and vomiting. Mom stated that patient has lost 15 lbs in lost 3 months. Her dr now saying cause is HPV shots.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Nasopharyngitis, Pyrexia, Vitamin B12 decreased, Vomiting, Weight decreased
Clinical narrative: Mother of patient stated that symptoms started after 1st shot with cold like symptoms, fever, no tiredness after 2nd shot symptoms were weakness, lethargy and fever. After 3rd shot symptoms were depression, anger, lethargy and vomiting. Mom stated that patient has lost 15 lbs in lost 3 months. Her dr now saying cause is HPV shots.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased
Clinical narrative: Temp 105 to ER about 12 hours after vaccine.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site scab, Injection site vesicles
Clinical narrative: 5 x 6 cm area erythema (L) thigh at site of injection 4 crusted vesicles lower back.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Lethargy, Pallor, Tonic clonic movements
Clinical narrative: Tonic clonic tremors after vaccines, 20 seconds, pale, lethargic x 10 minutes.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Fatigue, Presyncope, Syncope
Clinical narrative: 12 hours post vaccine developed extreme fatigue, difficulty completing routine tasks, intermittent syncope and pre-syncope. (Lasted x 2 months).
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states he is still experiencing pain in the arm and is unable to lift his arm above his head.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Irritability, Lip dry, Pain, Vomiting
Clinical narrative: Vomiting and diarrhea, dry lips, body aches, irritable.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient's Rt arm became red, hot to touch, with some swelling, painful when pushed on.
Age: 21.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: Employee c/o fever on 3/1/16, as well as rash and itchy bumps on arm. 3/2/16 she had increased bumps to torso, hips. Sent to medical for work comp evaluation. Determined to be adverse reaction to varicella vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash
Clinical narrative: Rash, aches, pain, required visit to urgent care.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Fatigue, Headache, Induration, Nausea
Clinical narrative: Within 24 hrs nausea, temps between 100 degrees - 101 degrees for 3 days, arm sore and hard, arm blotchy looking, diarrhea, headache. Now at day 6, fever gone, but arm still sore and blotchy Evening of day 1 slept 12 hours. Still tired.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Within 24 hrs nausea, temps between 100 degrees - 101 degrees for 3 days, arm sore and hard, arm blotchy looking, diarrhea, headache. Now at day 6, fever gone, but arm still sore and blotchy Evening of day 1 slept 12 hours. Still tired.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash that was painful, goes around arm, almost looks like a burn
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient noted with both upper deltoids with 4 inch by 4 inch erythema with warmth. Advised cold compress as needed.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates the patient was vaccinated with improperly stored M-M-R II (lot # L012480 with expiration date 10-APR-2017, lot # L010488 with expiration date 26-MAR-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Pruritis in area of left deltoid in the evening after receiving vaccine. Next day redness and swelling of deltoid extending down to elbow. No difficulty breathing or mouth tingling. Some Myalgia.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Mouth ulceration, Oral pain, Rash generalised, Rash pruritic, Tongue ulceration
Clinical narrative: Injection Fri March 4, 2016 at 11AM at pharmacy. Pt noticed generalized rash that afternoon starting on leg. (R) shoulder rash pruritic (L deltoid vaccine) Ulcerations noticed on tongue the next day, progressed with mod-severe ulcerations and pain in mouth at visit 3-8-16
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site discolouration, Injection site swelling, Middle insomnia, Neck pain
Clinical narrative: Information has been received from a 52 year old female consumer with penicillin and erythromycin allergies and no pertinent medical history, who on 14-NOV-2007 was vaccinated (route reported as injection) in left arm with a 1 ml dose of PNEUMOVAX 23 (lot #657042/1345U) Concomitant therapy included an influenza virus vaccine (unspecified). On 14-NOV-2007, post vaccination, the patient experienced pain and a burning sensation on the left arm which was the injection site right after receiving PNEUMOVAX 23. The patient reported that, on an unknown date in November 2007, the injection site became swollen up to half the size of an egg and turned purple, then green and later yellow, which lasted for a week or more. Then, on an unknown date in 2007, the patient reported that she woke up at night because her arm hurt and the pain was traveling up to her neck. Per patient, to date, the swelling was gone but the pain and burning were still there. The patient did not receive medical attention and no diagnostic lab test were performed. At the time of this report, the patient had not recovered. The relatedness between the events and PNEUMOVAX 23 was not provided. Follow up information has been received from the patient on 14-MAR-2016. The patient states she was considering another companies product as an alternative therapy for pneumococcal disease. No product quality complaint was involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 52 year old female consumer with penicillin and erythromycin allergies and no pertinent medical history, who on 14-NOV-2007 was vaccinated (route reported as injection) in left arm with a 1 ml dose of PNEUMOVAX 23 (lot #657042/1345U) Concomitant therapy included an influenza virus vaccine (unspecified). On 14-NOV-2007, post vaccination, the patient experienced pain and a burning sensation on the left arm which was the injection site right after receiving PNEUMOVAX 23. The patient reported that, on an unknown date in November 2007, the injection site became swollen up to half the size of an egg and turned purple, then green and later yellow, which lasted for a week or more. Then, on an unknown date in 2007, the patient reported that she woke up at night because her arm hurt and the pain was traveling up to her neck. Per patient, to date, the swelling was gone but the pain and burning were still there. The patient did not receive medical attention and no diagnostic lab test were performed. At the time of this report, the patient had not recovered. The relatedness between the events and PNEUMOVAX 23 was not provided. Follow up information has been received from the patient on 14-MAR-2016. The patient states she was considering another companies product as an alternative therapy for pneumococcal disease. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Malaise, Vaccination failure
Clinical narrative: Initial unsolicited report received from non-healthcare professional on 29-Feb-2016. This case is linked to 2016SA041761 (same reporter). This case involves a 7-8 patients who were vaccinated with an intramuscular dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number and site of administration were not reported) on an unspecified date in 2015. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On an unspecified date in 2015, after vaccination, patient's tested positive for an A virus and had become sick with flu. Lab tests and corrective treatments were not reported. Outcome was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: influenza A virus infection, sickness and vaccination failure. Documents held by sender: none. Sender's Comments: As with any vaccine, vaccination with influenza vaccine may not protect 100% of susceptible individuals. However, additional information on the patient's immune status at the time of vaccination (medical history, concomitant medication), the time to event onset, previous vaccinations, infectious work-up results and details of tests used to identify the influenza strain (e.g. PCR, nasal swab, etc.) are needed to further assess this case.
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, "a long time ago", the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiry date were not reported), at unspecified location. Concomitant therapy was not reported. On an unknown date, after receiving ZOSTAVAX, the patient experienced pneumonia and was hospitalized due to this event. The outcome of pneumonia was not reported. The relatedness between pneumonia and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Injection site rash, Nausea, Rash
Clinical narrative: 03/10/2016-bumps started around the injection site on the left upper arm, then spread to his neck, chest, and back, had headache and nausea.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Impaired work ability, Paraesthesia
Clinical narrative: Dizziness reported 15 minutes after HEP B Vaccine injection given to employee. Employee monitored for 1 hour for additional signs and symptoms and vital signs. Employee continued to feel dizzy with some light headedness and tingling in jaws. Epi-pen was not administered per assessment of Medical Doctor who validated order not to give.  Employee unable to continue working due to symptoms and was sent home with instructions if symptoms worsen to seek emergency care at local Hospital Emergency Room.  Employee to be followed by Workers Comp. Doctor on 3/15/2016.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Laboratory test, Pneumonia, X-ray
Clinical narrative: PREVNAR 13. The patient developed pneumonia within 1 month of the vaccine. This is my 2nd (of 4 patients) to develop pneumonia within 1 month.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Tenderness and redness at injection site.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tremor
Clinical narrative: Fainted with shaking.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood culture, Culture urine, Differential white blood cell count, Feeling hot, Full blood count
Clinical narrative: Patient started to feel warm at 7:30 pm.  Patient had a generalized tonic seizure at 8:50 pm.  Fever in ER at 2102 was 101.5.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Generalised tonic-clonic seizure, Influenza A virus test, Influenza B virus test, Pyrexia
Clinical narrative: Patient started to feel warm at 7:30 pm.  Patient had a generalized tonic seizure at 8:50 pm.  Fever in ER at 2102 was 101.5.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Chest pain, Feeling cold, Insomnia, Pain
Clinical narrative: 1. Cramping below waist all the way down. 2. Intense Arm pain, swelling (evening) 3. Whole body hurt. 4. Rash on arm. 5. Next 2 days extreme cold, body pain. Skin sensitive to touch felt like burning. 6. 1st & 2nd night very little sleep. 7. Evening different rash on both arms. Some itchiness. 8. 3rd day chest hurt like being beat up. Still dealing with symptoms.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash, Skin burning sensation
Clinical narrative: 1. Cramping below waist all the way down. 2. Intense Arm pain, swelling (evening) 3. Whole body hurt. 4. Rash on arm. 5. Next 2 days extreme cold, body pain. Skin sensitive to touch felt like burning. 6. 1st & 2nd night very little sleep. 7. Evening different rash on both arms. Some itchiness. 8. 3rd day chest hurt like being beat up. Still dealing with symptoms.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Crying, Emotional distress, Injection site erythema, Injection site rash, Pruritus
Clinical narrative: More distress, crying, scratching leg.  Awoke on 3/14 in distress, crying, leg injection site red, 4 pox at injection site.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Anaphylactic reaction
Clinical narrative: Anaplyaxis.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Influenza B virus test positive, Malaise, Vaccination failure
Clinical narrative: Initial unsolicited report received from a non-health care professional on 29 February 2016. This case is linked to case 2016SA041775. This case involves a (age and gender not reported) three patients who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (FLUZONE QIV) (batch number, expiry date and site of administration were not reported) intramuscularly on an unspecified date of 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was not provided. Concomitant medications was not reported. On an unspecified date of 2015, following the vaccination patient experienced sick with the flu and tested positive for a B virus. It was also vaccination failure case. Other laboratory investigation and corrective treatment were not reported. The outcome of event was unknown. Upon internal review, the company decided to consider the events sick with the flu and employees were tested and 3 tested positive for a B virus and suspected vaccination failure serious because of important medical event. List of documents held by sender: none. Sender's Comments: As with any vaccine, vaccination with influenza vaccine may not protect 100% of susceptible individuals. However, additional information on the patient's immune status at the time of vaccination (medical history, concomitant medication), the time to event onset, previous vaccinations, infectious work-up results and details of tests used to identify the influenza strain (e.g. PCR, nasal swab, etc.) are needed to further assess this case.
Sex: U
Vaccine: FLUN4
Symptoms: Endotracheal intubation, Malaise, Viral infection
Clinical narrative: A spontaneous report received from a health professional, concerns a patient of unknown gender. No information regarding concomitant disease and concomitant medications was provided. On an unknown date, patient was given FLUMIST (intranasal) 0.2 millilitres, yearly, unknown time prior to hospitalization. Patient hospitalized with viral infection and critical illness and was intubated. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of viral infection and critical illness was unknown. Company physician assessed viral infection and critical illness as serious due to hospitalization.