chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 26-OCT-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L006386 with expiration date 25-FEB-2017; dose and route were not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. 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 was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB (lot # K008879 and expiration date 30-MAR-2017) (dose and route were not reported). No adverse effects were reported. This is one of the several reports received from the same source. 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 nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unspecified date since 25-JUN-2015, the unspecified number of patients were vaccinated with VAQTA (lot# K012457 and expiry date: 04-JUN-2017) (dose and frequency were unknown), which were exposed to temperatures outside of the recommended range on 25-JUN-2015. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Paraesthesia, Swelling face
Clinical narrative: Light headed, sweaty (beaded on face), tingly across chest, arms, felt swollen in face/cheeks. Ambulance called and tended to pt. Pt walked out on own power. AAA x 3. No visual changes in arm.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Joint dislocation, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder/arm pian, limited ROM, numbness down arm, radiating pain up (L) side of neck and down (L) arm, "popping" in (L) shoulder. Tx: chiropractic adjustment, ultrasound therapy, steroid pack, ice, ibuprofen then ALEVE, GP care. Scheduled orthopedic Dr visit, scheduled nerve conduction study.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # L012034 and expiration date 07-APR-2017) (dose and route were not reported). No adverse effects were reported. This is one of the several reports received from the same source. 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 nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX (lot # L004653 and expiry date: 11-FEB-2017, dose and frequency were unknown), that were improperly stored. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date since 25-JUN-2015, the unspecified number of patients were vaccinated with doses of ROTATEQ (lot# K016261 and expiry date: 23-JUN-2016) (dose and frequency were unknown), which were exposed to temperatures outside of the recommend range on 25-JUN-2015. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored MMR II (lot # K024038 and expiration date 26-NOV-2016) (dose and route were not reported). No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 1.48
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site rash
Clinical narrative: Left thigh has area of small pink bumps, about a dozen spots the size of a pencil eraser. Afebrile, no swelling, itchiness or discomfort.
Age: 50.0
Sex: F
Vaccine: FLUR3
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Soreness, pain, stiffness, limited range of motion in the left deltoid/ shoulder area.
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain whole upper arm and shoulder. No redness or swelling. 11/11/2015 and 11/12/2015 - can not lift arm or move in certain positions - EXTREME pain. Made appointment with orthopedic specialist.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 16 years old patient of unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On 05-FEB-2015 the patient received PROQUAD (Merck) (lot # K014798, expiration date 12-MAR-2016, therapy type, route and dose were not reported) and another dose (lot# K010209, expiration date 17-JAN-2016) on 05-MAR-2015. Concomitant drug was not reported. The patient did not experience an adverse event. This is one of two reports 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 healthcare worker referring to a patient of unknown age and gender. On 19-OCT-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K022993, expiration 20-JUL-2016, dose was not reported) orally. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: 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 20-OCT-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K022993, expiration 20-JUL-2016, dose was not reported) orally. No adverse effects was reported. This is one of several cases received from the same source. 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 registered nurse refers to a patient of unknown age and gender. Medical history, current conditions and concomitant medications were not provided. On 11-NOV-2015, the patient was inadvertently vaccinated with improperly stored dose of VAQTA lot # L000718, expiration date 28-APR-2017 (dose and route were not provided). No adverse effects were reported. This is one of two 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 as received from a registered nurse refers to a patient of unknown age and gender. Medical history, current conditions and concomitant medications were not provided. On 11-NOV-2015, the patient was inadvertently vaccinated with improperly stored dose of VAQTA lot # L000718, expiration date 28-APR-20177 (dose and route were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug allergies were reported. On 28-OCT-2015 the patient was vaccinated with PNEUMOVAX 23 (strength, dose frequency were not reported) lot # K016294, with an expiry date of 28-APR-2016 intramuscularly. The reporter stated that patient received PREVNAR on 04-SEP-2015 and the patient inadvertently received dose of PNEUMOVAX 23 on 28-OCT-2015 which was too close in interval between recommended doses. The patient also received FLUZONE HD (manufacturer unspecified) in the opposite arm concomitantly with PNEUMOVAX 23. Patient did not seek any medical attention. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX. On 09-NOV-2015, via telephone call the nurse report that the patients received doses of improperly stored VARIVAX. No adverse event was reported. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, drug reactions or allergies and concomitant therapies reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dose and route were unknown). There were no adverse effects reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for (Oka/Merck) VARIVAX. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015. The reporting certified medical assistant would have to search the request made for patient's identifiers, lot numbers and expiration dates and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 1 year old patient of unknown gender. On 04-AUG-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # L003775). This is one of several reports received from the same source. Additional information has been requested. Patient's details, event information and narrative were upgraded.
Age: 1.03
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, drug reactions or allergies and concomitant therapies reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dose and route were unknown). There were no adverse effects reported. Lot number L003775 with expiry date 04-FEB-2017 (dose and route were unknown). There were no adverse effects reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for (Oka/Merck) VARIVAX. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015. The reporting certified medical assistant would have to search the request made for patients' identifiers, lot numbers and expiration dates and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12 months year old patient of unknown gender. On 17-JUL-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # L003775). This is one of several reports received from the same source. Additional information has been requested. Patient's details, event information and narrative were updated.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, drug reactions or allergies and concomitant therapies reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dose and route were unknown). There were no adverse effects reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for (Oka/Merck) VARIVAX. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015. The reporting certified medical assistant would have to search the request made for patients' identifiers, lot number and expiration dates and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 1 year old patient of unknown gender. On 30-JUL-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # L003775). This is one of several reports received from the same source. Additional information has been requested. Patient's details, event information and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients received improperly stored doses of ROTATEQ lot # K004432 with expiration date 27-JAN-2016, lot # K007243 with expiration date 13-DEC-2015, lot # K004921 with expiration date 25-FEB-2016 and lot # K006456 with expiration date 08-MAR-2016, route defaulted to oral (dose was not reported). No adverse effect reported. This is one of two reports 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 was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot # K007264 and expiration date 02-MAR-2017) (dose and route were not reported).  No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLUC3
Symptoms: Fall, Nausea, Vomiting
Clinical narrative: Patient picked up daughter's medication and received a flu shot. Was advised to wait seated for few minutes which she did. Patient went to purchase a soda about 10 minutes later, felt nausea and had a fall. 911 was called and was examined. She said she's okay; didn't want to go to hospital. She did throw up.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via field representative, refers to a patient of unknown demographics. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with an intramuscular injection of 0.5 ml PNEUMOVAX 23. The patient received this vaccination on the same day he/she was injected with another unspecified vaccine. Other co-suspect and concomitant medications were not reported. Reporting pharmacist stated that the patient went to an unknown emergency room for an unspecified treatment and an unspecified diagnosis. Outcome of the adverse event was unknown. Reporting pharmacist did not assessed the causality of the event with respect to vaccination with PNEUMOVAX 23. Additional information is not expected as the reporter did not wish further contact.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 13 years old patient of unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On 27-AUG-2015 the patient received PROQUAD (Merck) lot # L009210, expiration date 17-SEP-2016 (route and dose were not reported) (inappropriate schedule of drug administration). Concomitant drug was not reported. The patient did not experience an adverse event. This is one of two reports 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 as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unspecified date since 25-JUN-2015, the unspecified number of patients were vaccinated with GARDASIL (lot# K011562 and expiry date: 08-APR-2017) (dose and frequency were unknown), which were exposed to temperatures outside of the recommended range on 25-JUN-2015. No adverse effects were reported. This is one of the several reports 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 healthcare worker referring to a patient of unknown age and gender. On 19-OCT-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K020181, expiration 24-JUL-2016, dose was not reported) orally. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. Pertinent medical history and drug reactions/allergies were not reported. On 27-OCT-2015 (reported as 3 days ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and expiration date were not reported). Concomitant drug was not reported. On 29-OCT-2015, the patient felt pain all day at the injection site. And her arms hurt a lot on 30-OCT-2015 (reported as today). Outcome of the events and the causality were not reported. Additional information is not expected as there is no contact information.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of unspecified patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients received improperly stored does of GARDASIL lot # K006117 with expiration date 14-JAN-2017 and lot # K0096124 with expiration date 02-FEB-2017 (dose and route of administration were not reported). No adverse effect reported. No product quality complaint (PQC) involved. This is one of two reports 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 nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with PROQUAD (lot# L023112 and expiry date: 24-DEC-2016, dose and frequency were unknown), that were improperly stored. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Pruritus, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 61 year old female patient with an allergy to amoxicillin. The patient's pertinent medical history included chickenpox and pneumonia. On an unknown date in June 2014, the patient was vaccinated in the back of the arm with one dose of ZOSTAVAX (lot number J014812 and expiration date 20-FEB-2015, exact dose and route of administration were not reported). Concomitant therapies included ZYRTEC. On an unknown date in June 2014 (reported as on the day of vaccination), the patient experienced itching 6 inch diameter welt, joint pain, fever, chills, rash and a red arm from elbow to shoulder. The patient was given BENADRYL and ibuprofen as treatment for the events. There were no lab diagnostics studies performed. The patient recovered from the events of chills and rash on an unknown date in 2014 (reported as the chills lasted for a couple of days and the rash did not go away for one week). The patient recovered from the other events on an unknown date. The patient sought medical attention, she called the physician's office. The relatedness between the events and the ZOSTAVAX was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 61 year old female patient with an allergy to amoxicillin. The patient's pertinent medical history included chickenpox and pneumonia. On an unknown date in June 2014, the patient was vaccinated in the back of the arm with one dose of ZOSTAVAX (lot number J014812 and expiration date 20-FEB-2015, exact dose and route of administration were not reported). Concomitant therapies included ZYRTEC. On an unknown date in June 2014 (reported as on the day of vaccination), the patient experienced itching 6 inch diameter welt, joint pain, fever, chills, rash and a red arm from elbow to shoulder. The patient was given BENADRYL and ibuprofen as treatment for the events. There were no lab diagnostics studies performed. The patient recovered from the events of chills and rash on an unknown date in 2014 (reported as the chills lasted for a couple of days and the rash did not go away for one week). The patient recovered from the other events on an unknown date. The patient sought medical attention, she called the physician's office. The relatedness between the events and the ZOSTAVAX was not reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: This spontaneous report as received from nurse refers to a 45 year old female patient. There was no medical history for the patient. The patient was not allergic to any drugs. On 14-OCT-2015 the patient was vaccinated with MMR II (albumin status of rHA) (dosing details were not reported) lot# L009545 with an expiry date of 19-MAR-2017. Concomitant medications included unspecified birth control. On 28-OCT-2015, 15 days after vaccination patient broke out in a body wide measles like rash. Patient did not receive treatment for the event. Patient sought medical attention by making a call to physician's office. The outcome of event was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates in 2015 (reported as "starting on or after 13-OCT-2015"), the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # K011804 with expiry date 21-APR-2016, lot # L013068 with expiry date 14-APR-2017, lot # L017142 with expiry date 13-MAY-2017, lot # L017145 with expiry date 13-MAY-2017, lot # L019127 with expiry date 27-MAY-2017, lot # reported as L023594 with expiry date 22-JUN-2017 and lot # reported as L026408 with expiry date 15-JUL-2017; dose and route were not reported). The patients experienced no adverse event. This is one of two reports received from the same reporter. 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 healthcare worker refers to an unspecified number orf patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates in2015 (reported as "on or after 13-OCT-2015"), the patients were vaccinated with improperly stored doses of (Oka/Merck) PROQUAD (lot # L032761 with expiry date 30-DEC-2016, lot # L030586 with expiry date 10-FEB-2017, lot # L031602 with expiry date 18-FEB-2017, lot # L032421 with expiry date 24-FEB-2017 and lot # L032759 with expiry date 24-FEB-2017 and albumin status of recombinant human albumin (rHA); dose and route were not reported). The patient's experienced no adverse event. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date in November 2015 (reported as sometime during the period of 02-NOV-2015 through 06-NOV-2015), the patients might have been possibly vaccinated with improperly stored doses of ROTATEQ orally (dose was not reported, lot number reported as L004456 and expiration date 07-AUG-2016). Concomitant therapy was not reported. No symptoms were reported. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and route of administration were not reported, lot L013063 with expiration date 14-APR-2017). No adverse effect reported. 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 Licensed Practical Nurse refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (unknown strength and route) lot # K004541 and expiry date of 04-DEC-2016 or lot # K015463 and expiry date of 09-JUL-2017. No adverse effects were reported. This is one of the two 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 as received from a Licensed Practical Nurse refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (unknown strength and route) lot # K005881 and expiry date of 14-JAN-2017. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site nodule, Nausea, Pain
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a currently 51 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 injection, lot # L003188, expiration date 06-JUL-2016 in the arm (dose and route of administration were not reported). On the same day, the patient received FLUZONE (formulation, dose, lot #, expiration date and route of administration were not reported). On an unknown date, the patient experienced nausea, a headache, "terribly achy body" and fever. It was also reported that the patient's arm was red and she/he had a knot the size of a baseball at the injection site after being vaccinated with PNEUMOVAX23. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. The patient sought unspecified medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a currently 51 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 injection, lot # L003188, expiration date 06-JUL-2016 in the arm (dose and route of administration were not reported). On the same day, the patient received FLUZONE (formulation, dose, lot #, expiration date and route of administration were not reported). On an unknown date, the patient experienced nausea, a headache, "terribly achy body" and fever. It was also reported that the patient's arm was red and she/he had a knot the size of a baseball at the injection site after being vaccinated with PNEUMOVAX23. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. The patient sought unspecified medical attention. This is one of the 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 healthcare worker referring to a patient of unknown age and gender. On 20-OCT-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K020181, expiration 24-JUL-2016, dose was not reported) orally (incorrect product storage). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient had an unusual amount of swelling which extended past the elbow to the forearm.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Fatigue, Musculoskeletal pain, Pain
Clinical narrative: SHORT ASTHMA SYMPTOM, A FEW HIVES OVER WEEKEND. FATIGUE AND BODY ACHES PROGRESSING THROUGH TO 11/11 WITH THROBBING PAIN IN LEFT ARM (INJECTION ARM) AND DOWN INTO SHOULDER BLADE. STILL SOME BODY ACHES ON 11/12 BUT MUCH IMPROVED.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Urticaria
Clinical narrative: SHORT ASTHMA SYMPTOM, A FEW HIVES OVER WEEKEND. FATIGUE AND BODY ACHES PROGRESSING THROUGH TO 11/11 WITH THROBBING PAIN IN LEFT ARM (INJECTION ARM) AND DOWN INTO SHOULDER BLADE. STILL SOME BODY ACHES ON 11/12 BUT MUCH IMPROVED.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Bursitis, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Arm pain immediately following injection. "Feels like Tendonitis". Affecting daily activities. Advised on 10/29 to: take 600-800mg Motrin every 8 hours x 3 days. Cold compress to the affected area 1 hour 3-4 times per day. Avoid use of extremity x3 days.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Ataxia, Demyelination, Diplopia
Clinical narrative: Patient had severe demyelination in the brainstem following the vaccination and presented with weakness, parasthesia, paralysis of eye muscles, jaw clonus, double vision, severe ataxia and inability to swallow and trouble breathing.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Ophthalmoplegia, Paraesthesia, Trismus
Clinical narrative: Patient had severe demyelination in the brainstem following the vaccination and presented with weakness, parasthesia, paralysis of eye muscles, jaw clonus, double vision, severe ataxia and inability to swallow and trouble breathing.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Extreme soreness/pain in shoulder where vaccine was given, numbness throughout arm/hand.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Ppt states a pain when she has her arm in certain position. There is no swelling and no redness at site of injection.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat, nasal congestion, cough. This has happened every time I get hi-dose flu zone, this year and last year. Can we opt for regular flu vaccine instead?
Age: 0.41
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event occurred, however child will need additional dose.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a sales representative. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot # L36482, expiration date Oct2016), intramuscular at 0.5 ml, single in the left arm on 16Jun2015. Medical history included chronic obstructive pulmonary disease, type 2 diabetes mellitus (DM II), hypertension (HTN), hypercholesterolaemia. Concomitant medication included simvastatin 40 mg 1x/day for cholesterol, alendronate sodium 70 mg weekly for osteoporosis, metformin 500 mg 2x/day for DM II, metoprolol ER 25 mg 1x/day for HTN, PROAIR COPD as needed, lisinopril 5 mg 1x/day for HTN. On 17Jun2015, the patient went to Emergency Room (ER) for arm redness from deltoid to elbow. ER diagnosed it as cellulitis. Patient visited Primary Care Physician (PCP). PCP diagnosed redness as injection site reaction. The patient returned several weeks later to report resolution with no sequel. Follow-up (03Nov2015): New information obtained from a contactable pharmacist includes: details of vaccine administered, medical history, concomitant drugs, diagnosis, onset and outcome.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Albumin CSF increased, Areflexia, CSF protein increased, Coordination abnormal, Erythema
Clinical narrative: Soreness, myalgias for a few days then a red streak down his arm, then numbness in fingers and toes that progressed proximally. He lost coordination in his hands and decreased gag reflex. He received IVIG but couldn't tolerate this. His reflexes in lower extr are also absent.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Myalgia, Pain
Clinical narrative: Soreness, myalgias for a few days then a red streak down his arm, then numbness in fingers and toes that progressed proximally. He lost coordination in his hands and decreased gag reflex. He received IVIG but couldn't tolerate this. His reflexes in lower extr are also absent.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 4 hours after receiving PNEUMOVAX vaccine in right upper arm patient developed right upper arm swelling, pain and tenderness with diarrhea. Evaluated in the office 11/12/15, (+) fever.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 15-OCT-2015, the patient was vaccinated with improperly stored (Merck) VARIVAX (lot# L006386 with expiration date 25-FEB-2017; dose and route were not reported. No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No concurrent conditions, medical history, concomitant medications and drug allergies were reported. On 18-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD (lot number L005297, expiration date: 17-AUG-2016, albumin status HSA; 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: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema approx 4 cm at injection site - left upper arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received form a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 13-OCT-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L006386 with expiration date 25-FEB-2017; dose and route were not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Stiff neck and severe pain for several days.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No concurrent conditions, medical history, concomitant medications and drug allergies were reported. On 05-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot number L005297, expiration date: 17-AUG-2016, albumin status HSA; 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.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 22-OCT-2015, the patient was vaccinated with improperly stored (Merck) VARIVAX (lot # L006386 with expiration date 25-FEB-2017; dose and route were not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, IPV, MNQ, TD
Symptoms: Pallor, Visual impairment
Clinical narrative: Client had a systemic reaction immediately after last shot was given - HPV9. Became dizzy for 20 min. Explained that she had spots in front of her eyes. Became pale but was able to hear instructions. Client stated no respiratory or throat reaction. PHN suggested to family that it is important to see physician as soon as they can today to report what happened and to obtain physician feedback.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No concurrent conditions, medical history, concomitant medications and drug allergies were reported. On 13-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot number L005297, expiration date: 17-AUG-2016, albumin status HSA; 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.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The nurse reported that the patient received GARDASIL on a variation of the recommended dosing schedule, as the first dose was administered on an unknown date in February 2015, the second dose was administered on an unknown date in August 2015, and the third dose was administered on an unknown date in November 2015 (doses, routes, lot # and expiry dates were not reported). No adverse effect was reported. The patient did not seek medical attention. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Pyrexia, Rash macular, Vaccination site rash
Clinical narrative: Rash at vaccine site within approximately 30 min of administration. Erythematous maculo papular no systemic spread. No urticaria. No wheezing. Resolved in 2 days. Associated fever for 2 days.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pruritus
Clinical narrative: Itching, severe on going pain worse as days goes by. Lt arm limited movement.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm redness and swelling from shoulder down to elbow. Patient advised to use cold compress, give oral CLARITIN and local anti-itch cream.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Axillary pain, Lethargy, Lymphadenopathy, Myalgia, Swelling
Clinical narrative: Significant swelling of lymph nodes in arm that received injection. Whole body swelling including face, lethargy and muscle aches. Very painful armpit, treated with warm/cold compress. Missed day of work.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Swelling face
Clinical narrative: Significant swelling of lymph nodes in arm that received injection. Whole body swelling including face, lethargy and muscle aches. Very painful armpit, treated with warm/cold compress. Missed day of work.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2-year-old patient of unknown gender. No concurrent conditions, medical history, concomitant medications and drug allergies were reported. On 19-JUN-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021484 and expiry date on 03-NOV-2016; 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: 0.42
Sex: F
Vaccine: DTAP, FLUX, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Flu vaccine administered four days prior to age of 6 months. Attending physician aware. No side effects experienced. Plan to revaccinate at next visit.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reaction described. On 27-OCT-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L006386 with expiration date 25-FEB-2017; dose and route were not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. 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 initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 15-OCT-2015, the patient was vaccinated with improperly stored (Merck) VARIVAX (lot# L006386 with expiration date 25-FEB-2017; dose and route were not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: This spontaneous report was received from a physician (the patient's wife) and refers to a 50 year old male patient with multiple sclerosis (MS) from 2010 (reported as for 5 years). The patient's medical history included cerebrovascular accident (CVA) in 2014 (reported as 1 year ago) and unspecified morphine reaction. On 04-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX23 in the left upper deltoid (strength, dose, route of administration, lot # and expiration date were not provided). The patient was vaccinated at a military facility. Concomitant therapies included PLEGRIDY every 2 weeks, intravenously for multiple sclerosis (MS), gabapentin and baclofen. On 05-NOV-2015 (also reported as today), the patient experienced fever of 102.5 Fahrenheit degrees, was achy, had headache and had a localized reaction at the injection site of PNEUMOVAX23. The patient's left upper arm was red and hot, tender to touch. It was unspecified if the patient received any treatment or had diagnostic studies performed. The patient did not seek medical attention. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. This is one of two reports concerning the same patient. Additional information has been requested.