chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 26-JUN-2015, the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, dose, strength and route were not reported). The second dose of GARDASIL (lot#, expiration date, dose, strength and route were not reported) was vaccinated on 27-JUL-2015, and the third dose was vaccinated on 27-AUG-2015 (inappropriate schedule of vaccine administration). No adverse effects reported. It was unknown if the patient sought medical attention. Additional information is not expected since the reporter did not wish further contact.
Sex: M
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician assistant via company representative refers to a male patient of unknown age. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with GARDASIL 9 intramuscular (dose, lot number and expiration date were not reported). On an unknown date, the patient experienced bilateral rashes on both hands 48 hours after receiving GARDASIL 9. It was unknown if this was the first, second or third injection in the series. The patient seek medical attention via called physician and did not receive any treatment. The outcome of rash was unknown. The relatedness between the event and suspect therapy was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician referring to a 14 year old adolescent (also reported as adult) female patient. There was no medical history or concurrent condition reported. On an unknown date the physician reported the patient was vaccinated with GARDASIL 9 (dose, strength, route and lot # were not reported) too soon (inappropriate schedule of vaccine administered). There was no concomitant medication reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 24 days old male patient. No concurrent condition, medical history or allergy/drug reaction were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on unspecified date in August 2015, since 05-AUG-2015, the patients were vaccinated with improperly stored ZOSTAVAX # L003216, expiry date 30-APR-2016 (dose and route of administration unspecified). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 18-AUG-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot# K020186, expiration date 27-JAN-2016, dose, site and route of administration were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.9
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 months and 9 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This spontaneous report as received from a healthcare worker refers to her son: a 13-year-old male patient with atrioventricular block first degree. Healthcare worker reported the patient received GARDASIL on 15-AUG-2013, as the first dose, on 21-OCT-2013, as the second dose and in 03-MAR-2014 for the third dose of the vaccination series. The patient did not receive any concomitant medication and did not have any allergies.  On 28-JUL-2015, the patient was vaccinated with GARDASIL 9 0.5 ml (route of administration, lot number and expiration date were not reported) and experienced pain at the injection site, immediately following the injection. There was no lab diagnostics study performed. There was no Product Quality Complaints involved. The outcome of the event was reported as resolved within an unspecified time frame. The relatedness between the event and GARDASIL 9 was not 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 vocational nurse refers to patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on unspecified dates in August 2015, since 05-AUG-2015, the patients were vaccinated with improperly stored (Merck) VARIVAX (dose and route of administration unspecified). The following vaccines were improperly stored, however the nurse did not specify which exact lost were administered: lot # L010146 expiry date 24-MAR-2017, lot # K021486 expiry date 03-NOV-2016, lot # K010338 expiry date 22-JUL-2016, lot # K026386 expiry date 15-DEC-2016, lot # L013827 expiry date 21-APR-2017. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 22 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) referring to a 4 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-JUL-2015, the patient was vaccinated with a dose of VARIVAX (Merck), lot # K010440 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 11 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 5 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (dose, frequency and route not reported). The Lot number of PROQUAD (Merck) was reported as L011079, expiry 01-OCT-2016; L016394, expiry 08-NOV-2016 and K011311, expiry 14-FEB-2016. No adverse was reported at the time of this report. This case is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 months 12 days old female. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) referring to a 4 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 12-AUG-2015, the patient was vaccinated with a dose of (Merck) VARIVAX, lot # K026387 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on unspecified dates in August 2015, since 05-AUG-2015, the patients were vaccinated with improperly stored PROQUAD (dose and route of administration unspecified). The following vaccines were improperly stored, however the nurse did not specify which exact lots were administered: lot # L007230 expiry date 03-SEP-2016, lot # L011080 expiry date 01-OCT-2016, lot # K003818 expiry date 14-SEP-2015, lot # L009208 expiry date reported as 17-SEP-201. No adverse experiences 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 Licensed Practical Nurse refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, frequency and route not reported). The Lot number of VARIVAX (Merck) was reported as L011084, expiry 01-APR-2017 and L013395, expiry 16-APR-2016. No adverse event was reported at the time of this report. This case is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (unknown strength, route and lot#). Concomitant medications were not reported. On an unknown date, 8-9 months later, the patient was diagnosed with severe pneumonia. The outcome the event was unknown. There was no product quality complaint involved. 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 medical assistant refers to an unspecified number of patients of unknown age. On an unknown date, the patients may have been vaccinated with M-M-R II, lot # K022284, expiry date 12-NOV-2016, lot # K011188, expiry date 12-AUG-2016 that may have been exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician referring to a 2 month old patient of unknown gender. The patient's pertinent medical history and concurrent condition were not reported. On 16-AUG-2015, the patient was vaccinated with PNEUMOVAX 23 (strength, lot#, expired date, dose and frequency were unknown). No adverse effect reported. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 5 months 23 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.9
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 30 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 24 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Pt stated her arms were sore on Saturday morning. Her right arm became very swollen and reddened/hard. Pts mother took her to the ER on Sunday 8-30-15. She was given MOTRIN/KEFLEX and BENADRYL. No fever noted. On 9/2 pt arm was without swelling, redness, slightly sore. Only one dose of KEFLEX given, KEFLEX dc'd, arm was WNL.
Sex: M
Vaccine: MMR, TDAP
Symptoms: Abnormal behaviour, Psychomotor hyperactivity
Clinical narrative: This spontaneous report was received from a patient's mother refers to her son, a male patient of unknown age. There was no information about pertinent medical history, drug reactions and allergies. On an unknown date, the patient was vaccinated with M-M-R II (lot#, expiration date, dose, frequency, route and site of vaccination were not reported). The mother also specified that her son received the Tdap booster dose on an unspecified date. On an unknown date, the patient experienced a "behavioral reaction" and had become extremely hyperactive since getting the M-M-R II vaccine. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 30 hours of ZOSTAVAX administration, area around injection site became very sore, and red. Area about 4" around site very red and swollen.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with doses of GARDASIL 9 (lot# reported as L007560 with expiration date of 15-JUN-2017; strength, dosage, frequency and route unspecified), which were exposed to temperature outside of the recommended storage range. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.09
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Pt had reaction (rash) to bilateral arms post SQ.
Age: 87.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Asthenia, Injection site pain, Nuclear magnetic resonance imaging, Rotator cuff syndrome
Clinical narrative: Several days after PREVNAR shot--developed weakness (R) shoulder-now able to lift over her head only with help of her other hand shoulder initially was sore over (R) supraspinatus muscle-(R) hand is fine-not weak or numb. Concern re: rotator cuff tear.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event reported. Vaccine expired 5/24/15.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 60 year old female patient, who did not have chickenpox. There was no information about patient's concurrent conditions and concomitant therapy provided. On an unknown date, also reported as "20 years ago, in the early 1990's" the patient was vaccinated with (Merck) VARIVAX (lot#, expiration date, dose, were not reported) subcutaneously, the reporting nurse stated that it was possibly (but she was not sure) patient's 2 dose series. On 31-JUL-2015, the patient had titers drawn, which showed negative to varicella. There were no adverse effects beyond negative titers. The outcome of the event was unknown. The relatedness between the event and (Merck) VARIVAX was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: First sign was very sore arm, second day chills, low fever, then arm was hot to touch, fever went to 102.00 Used ice pack and ADVIL help.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered 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 12-AUG-2015, the patient was vaccinated with an expired dose of GARDASIL (lot # H020002 and expiration date on 08-AUG-2015 dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician who is the patient via a company representative. The patient was male and was around 60 plus years of age. The pertinent medical history was none. On 27-AUG-2015, the patient was vaccinated with PNEUMOVAX 23 (1 vial) (route and lot details unavailable) in the arm. The concomitant medication was not reported. On 28-AUG-2015 (also reported as the next day), the arm in which he received the vaccine was sore, he had achiness all over his body and he generally did not felt well. It was unspecified who administered the vaccine. The patient did not seek any medical attention and no treatment was rendered for the event. The action taken with PNEUMOVAX 23 was not applicable. The outcome of all the events was reported as not resolved. The causality was unspecified. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Fever and forearm swollen, red and developed chills and fever.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Between 18-AUG-2015 and 21-AUG-2015, unspecified number of patients were vaccinated with unspecified doses of GARDASIL 9 lot# L011846, expiry date 16-JUN-2017 (dose, site and route of administration were not reported). No adverse effect were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Arthralgia, Fatigue, Joint stiffness, Pain, Paraesthesia
Clinical narrative: Transient paresthesias after 3rd dose. The patient presents with body aches, onset gradually worsening since June. Pt had bat in her house and was advised to come to ED for vaccination against rabies. Following vaccination in June, pt began to experience increased fatigue, joint pain and body soreness. Pt states that in the past two weeks her pain has increased in her neck and she has experienced stiffness of joints such as her ankles. Pt denies any fever, shortness of breath, cough or any other associated symptoms. Pt states she thinks it may be a reaction to her vaccination. Hx of arthritis and IBS.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Arthralgia, Fatigue, Hypersensitivity, Inflammatory marker increased, Insomnia
Clinical narrative: Transient paresthesias after 3rd dose. The patient presents with body aches, onset gradually worsening since June. Pt had bat in her house and was advised to come to ED for vaccination against rabies. Following vaccination in June, pt began to experience increased fatigue, joint pain and body soreness. Pt states that in the past two weeks her pain has increased in her neck and she has experienced stiffness of joints such as her ankles. Pt denies any fever, shortness of breath, cough or any other associated symptoms. Pt states she thinks it may be a reaction to her vaccination. Hx of arthritis and IBS.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Joint swelling, Laboratory test abnormal, Mobility decreased, Muscle spasms, Muscle tightness
Clinical narrative: Transient paresthesias after 3rd dose. The patient presents with body aches, onset gradually worsening since June. Pt had bat in her house and was advised to come to ED for vaccination against rabies. Following vaccination in June, pt began to experience increased fatigue, joint pain and body soreness. Pt states that in the past two weeks her pain has increased in her neck and she has experienced stiffness of joints such as her ankles. Pt denies any fever, shortness of breath, cough or any other associated symptoms. Pt states she thinks it may be a reaction to her vaccination. Hx of arthritis and IBS.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Transient paresthesias after 3rd dose. The patient presents with body aches, onset gradually worsening since June. Pt had bat in her house and was advised to come to ED for vaccination against rabies. Following vaccination in June, pt began to experience increased fatigue, joint pain and body soreness. Pt states that in the past two weeks her pain has increased in her neck and she has experienced stiffness of joints such as her ankles. Pt denies any fever, shortness of breath, cough or any other associated symptoms. Pt states she thinks it may be a reaction to her vaccination. Hx of arthritis and IBS.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Peripheral swelling, Rheumatoid arthritis, Swelling, Vaccination complication
Clinical narrative: Transient paresthesias after 3rd dose. The patient presents with body aches, onset gradually worsening since June. Pt had bat in her house and was advised to come to ED for vaccination against rabies. Following vaccination in June, pt began to experience increased fatigue, joint pain and body soreness. Pt states that in the past two weeks her pain has increased in her neck and she has experienced stiffness of joints such as her ankles. Pt denies any fever, shortness of breath, cough or any other associated symptoms. Pt states she thinks it may be a reaction to her vaccination. Hx of arthritis and IBS.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Arthralgia, Arthritis, Condition aggravated, Discomfort, Fatigue
Clinical narrative: Transient paresthesias after 3rd dose. The patient presents with body aches, onset gradually worsening since June. Pt had bat in her house and was advised to come to ED for vaccination against rabies. Following vaccination in June, pt began to experience increased fatigue, joint pain and body soreness. Pt states that in the past two weeks her pain has increased in her neck and she has experienced stiffness of joints such as her ankles. Pt denies any fever, shortness of breath, cough or any other associated symptoms. Pt states she thinks it may be a reaction to her vaccination. Hx of arthritis and IBS.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Musculoskeletal stiffness
Clinical narrative: Transient paresthesias after 3rd dose. The patient presents with body aches, onset gradually worsening since June. Pt had bat in her house and was advised to come to ED for vaccination against rabies. Following vaccination in June, pt began to experience increased fatigue, joint pain and body soreness. Pt states that in the past two weeks her pain has increased in her neck and she has experienced stiffness of joints such as her ankles. Pt denies any fever, shortness of breath, cough or any other associated symptoms. Pt states she thinks it may be a reaction to her vaccination. Hx of arthritis and IBS.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from registered nurse via a company representative and refers to a 19 year old female patient. On an unknown date the patient was vaccinated with GARDASIL 9 (dose, frequency, route of administration, lot # and expiration date not reported). On an unknown date, after receiving GARDASIL 9, she had "sx". The reporter did not know what the "sx" represented. The outcome of adverse event was unknown. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 20-AUG-2015, the patient was vaccinated with an unspecified dose of improperly stored PROQUAD, injection, lot # L019996, expiration date 02-DEC-2016, (route of administration and anatomical location were not reported). There were not concomitant medications reported and any product quality issue involved. 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 registered nurse refers to 2 patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # K016263, expiration date: 26-JUN-2016) dose not reported, route defaulted to oral. No adverse effects reported. This is one of three reports received from the same source. Additional information is not expected, because there was no consent to contact the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored ZOSTAVAX (dose, route not reported, lot # L012478 with expiration date 10-JUL-2016). Concomitant medications were not provided. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 16-OCT-2014, the patient was vaccinated with MMR II (lot number, dose, route and site of administration was not reported) who was inadvertently administered with (Merck) VARIVAX vial 1350 U (lot number, dose, route and site of administration was not reported) on 30-OCT-2014 (inappropriate schedule of drug administration). No concomitant medications were reported. The outcome of inappropriate schedule of drug administration was unknown. No product quality complaint (PQC) was filed. No further information was provided. Additional information is not expected, because there was no consent for further contact.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from a pharmacist via Pfizer Inc (Manufacturer report # 2015266508), referring to a patient of unknown age and gender, with metastatic breast cancer and lupus. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, (dose, route of administration, lot # and expiration date were not provided), and subsequently developed an allergy to the vaccine. At the time of reporting, the outcome of the allergy to vaccine was unknown. Additional information is not expected because no consent for follow up was given by the reporter.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown ages and genders. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of MMR II, lot number K016153 expiration date 24-SEP-2016, lot number reported as L001336 expiration date 13-JAN-2017 and lot number K024038 expiration date 26-NOV-2016 (route of administration and anatomical location were not reported). There were not concomitant medications provided. No adverse effects were reported and there was no product quality issue involved. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a healthcare worker during a phone call concerning unspecified patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with "the series" of MMR II (dose, route, frequency and anatomical location of administration were not reported). No concomitant therapy was provided. On an unknown date, the patients had low titer levels after completing the series for MMR II. As treatment, the MMR II series were restarted. The event was resolved as titer was within therapeutic range. The outcome of viral titre decreased was reported as recovered on an unknown date. This is one several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 25-AUG-2015, the patient was vaccinated with a dose of GARDASIL intramuscular injection, lot # L012190, expiration date 13-APR-2017 (strength, dose series and route not reported), that was inappropriately stored. No adverse effects were reported. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 29-AUG-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX Lot number reported as "L000416", expiration date: 08-MAR-2016 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: This spontaneous report as received from a certified medical assistant (also reported as healthcare worker) refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with GARDASIL (unknown strength and dose) intramuscular. Concomitant medications were not reported. On an unknown date, the patient experienced shortness of breath after receiving a dose of GARDASIL. Therapy with GARDASIL was discontinued. The patient sought medical attention and went to an unspecified Emergency Room and had unspecified treatment. The outcome of the event was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Vaccination failure, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a healthcare worker during a phone call, concerning a coworker of the reporter, a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, when the patient was a child (unknown age) was vaccinated with (Merck) VARIVAX (Lot No. expiration date, dose, route and anatomical location were not reported). In approximately 2010, reported as "five years ago" the patient was exposed to a patient with active varicella. Despite being vaccinated with (Merck) VARIVAX, the patient developed varicella after this exposure (vaccination failure). The outcome of varicella and vaccination failure was unknown. The relatedness of (Merck) VARIVAX with the varicella and vaccination failure was not reported. This is one of three reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored MMR II (dose, route, lot # and expiration dates unspecified) and GARDASIL (dose, route, lot # and expiration dates unspecified). Concomitant medications were not reported. No adverse effects reported. No additional information to report. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 10-AUG-2015, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # K015464; expiration date 09-SEP-2017) dose and route of administration were not reported. Concomitant therapy was not reported. No adverse events have been 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: This spontaneous report was received from registered nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 31-JUL-2015 (also reported as 30-JUL-2015 by the same reporter), the patient was vaccinated with a incorrect storage of VAQTA, lot # J003719, expiration date: 27-SEP-2015, (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # K015464; expiration date 09-SEP-2017) dose and route of administration were not reported. Concomitant therapy was not reported. No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Delivery, Exposure during pregnancy, Injection site erythema, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer referring to her daughter, a 17 year old female patient. The patient had no history of previous pregnancies. Concurrent conditions included asthma. Concomitant therapies were not reported. On 12-APR-2012, the patient was vaccinated with the second dose of VARIVAX (lot# was not reported) 0.5 ml, subcutaneous, and subsequently, the patient learned that she was pregnant, with last menstrual period of 18-MAR-2012 and estimated date of delivery of 01-JAN-2013. Initial exposure to VARIVAX was at 3 week(s). The patient's mother stated that on an unknown date, when her daughter first got the VARIVAX, there was a red spot at the injection site that went away after two weeks. Follow up information was received from the reporting Registered Nurse on 05-AUG-2015. On 05-JAN-13, the patient delivered a male infant weighing 3495.5 gr (11.3 oz) via spontaneous vaginal delivery. The pregnancy outcome was live birth. It was stated that no abnormalities were noted and that the baby had good APGAR scores (unspecified), that the baby did well and was discharged home with his mother. It was also stated that the patient did not have herpes zoster symptoms post vaccination, and that she did not seek for medical attention. The relatedness of VARIVAX with the adverse events was not reported. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of PROQUAD, lot number L003221 expiration date 30-JUL-2016, lot number L007228 expiration date 03-SEP-2016 and lot number L014401 expiration date 23-OCT-2016 (route of administration and anatomical location were not reported). There were not concomitant medications provided. No adverse effects were reported and there was no product quality issue involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to 3 patients of unknown age and gender. The patients pertinent medical history, concurrent conditions and concomitant medications were not reported. The reporter stated that on an unknown date, the freezer went through another defrost cycle (11.5F with time frame 30 minutes), subsequently 3 doses of improperly stored ZOSTAVAX, lot # L013546 with expiration date 17-JUL-2016 were administered (dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of 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 was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 11-AUG-2015, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # K025006; expiration date 22-JUL-2017) dose and route of administration were not reported. Concomitant therapy was not reported. No adverse events have been 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 healthcare worker referring to unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored PROQUAD (dose, route not reported, lot # K009470 with expiration date 03-JAN-2016, lot # K010211 with expiration date 17-JAN-2015). Concomitant medications were not provided. 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 registered nurse refers to four patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# L004754, expiration date: 10-NOV-2016), dose and route not reported. No adverse effects reported. This is one of three reports received from the same source. Additional information is not expected, because there was no consent to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was receive from a medical assistant refers to an unknown number of patients of unknown ages and genders. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with unspecified improperly stored dose of (Oka/Merck) VARIVAX, lot number reported as L017145 expiration date 13-MAY-2017, lot number L001325 expiration date 13-JAN-2017 and lot number L009206 expiration date 17-MAR-2017 (route of administration and anatomical location were not reported). There were not concomitant medications provided. No adverse effects were reported and there was no product quality issue involved. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (dose, route not reported; lot # K005178 with expiration date 10-APR-2016, lot # K010437 with expiration date 22-JUL-2016. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.