chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 08-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L016428, expiration date 30-JUL-2017 (strength, dose and route of administration were not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 28-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (route and site of administration, dose, lot number and expiration date were not reported) and on 21-DEC-2015, received second dose of GARDASIL dose: 0.5 ml, intramuscular, lot # K006960, expiration date: 19-FEB-2017 (coded as inappropriate schedule of vaccine administered). There was no adverse effects reported. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
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. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored MMR II (lot# K006141 (rHA), expiry date 29-APR-2016; lot# K006396 (rHA), expiry date 04-MAY-2016, lot# K014833 (rHA), expiry date 17-FEB-2017, lot# L012479 (rHA), expiry date 10-APR-2017) (dose, route unspecified). Concomitant therapies were 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: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to two unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, two doses of improperly stored ZOSTAVAX 19400 PFU, lot # L011529 and expiration 03-JUL-2016, were administered to 2 unspecified patients (dose and route were not provided). No adverse effects reported and no PQC involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Induration, Injection site erythema, Injection site pain, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a 65 year old female patient refers to herself. The patient's medical history included "cold which tends to develop into bronchitis because of asthma". The patient was allergic to ragweed, mold, dust, dill, cat dander and grass. On an unknown date in December 2015 (reported as about a week ago) the patient was vaccinated with PNEUMOVAX 23, 25/0.5 ml/one shot (lot number not provided). No concomitant medications were reported. On the same evening, on an unknown date in December 2015, the patient noticed that her shoulder felt sore and "was hot to the touch". The patient mentioned the arm she received the vaccination in also "felt hard" and appeared red around the injection site area. The patient had a huge bruise that was 3 to 4 inches in diameter and she recalls that the vaccine "shot hurt" when she first got it. The patient did not seek medical attention and no treatment was given for the adverse events. No laboratory diagnostics were performed. No product quality complaint was involved. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a 65 year old female patient refers to herself. The patient's medical history included "cold which tends to develop into bronchitis because of asthma". The patient was allergic to ragweed, mold, dust, dill, cat dander and grass. On an unknown date in December 2015 (reported as about a week ago) the patient was vaccinated with PNEUMOVAX 23, 25/0.5 ml/one shot (lot number not provided). No concomitant medications were reported. On the same evening, on an unknown date in December 2015, the patient noticed that her shoulder felt sore and "was hot to the touch". The patient mentioned the arm she received the vaccination in also "felt hard" and appeared red around the injection site area. The patient had a huge bruise that was 3 to 4 inches in diameter and she recalls that the vaccine "shot hurt" when she first got it. The patient did not seek medical attention and no treatment was given for the adverse events. No laboratory diagnostics were performed. No product quality complaint was involved. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an unspecified dates in July 2015, the patients were vaccinated with improperly stored doses of MMR II injection (dose, lot# and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a other reporter, only two doses of VARIVAX (Merck) were used on two patients. This case refers to a 4 year old female patient. On 06-NOV-2015 at 10 AM, the patient was vaccinated with first dose of improperly stored dose of VARIVAX (Merck) lot # K005428, expiry date 15-APR-2016, in the right leg (thigh), at private doctor's office using private funds. Other vaccines given within four weeks were PENTACEL, lot # C4877AA, fourth dose, in the left thigh, on 06-NOV-2015 at 10 AM; PREVENAR 13, lot # L99262, third dose, in the left thigh, on 06-NOV-2015 at 10 AM; Hepatitis A virus vaccine (unspecified), lot # L023936, first dose, in the left thigh, on 06-NOV-2015 at 10 AM; influenza virus vaccine (unspecified), lot # UI450AD, second dose, in the right thigh, on 06-NOV-2015 at 10 AM; and M-M-R II, lot # K005431, first dose, in the right thigh, on 06-NOV-2015 at 10 AM. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The medical history and concurrent conditions of the patient were not provided. On 14-JAN-2013 and 22-AUG-2013, the patient was vaccinated with GARDASIL (lot # and expiration date unknown). On 04-DEC-2015, the patient was vaccinated with GARDASIL 9 (lot # and expiration date unknown) and an unspecified image of GARDASIL (unknown if it was GARDASIL or GARDASIL 9). No adverse symptoms reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received form a 53 year old female patient, who was reporting on herself. The patient's medical history and concurrent conditions were not reported. On 21-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX 1 injection given in the left arm (lot # and route were not provided). Concomitant therapies included primula vulgaris (reported as "primrose"). On 22-DEC-2015, the patient experienced swelling, redness and warmth at the ZOSTAVAX injection site. She also reported a "low grade fever". No treatment for the events was given. The outcome of the injection site swelling, injection site warmth and injection site redness was reported as recovering/resolving. Since the onset, her arm had reduced in swelling and seemed to be getting better. The outcome of low grade fever was unknown. The patient did not seek medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a licensed nurse practitioner referring to a 65 year old male patient. On 17-MAR-2015, the patient was vaccinated with the first dose of ZOSTAVAX (dose, frequency, route and lot number not provided). On 31-OCT-2015, the patient was vaccinated with the second dose of ZOSTAVAX (dose, frequency, route and lot number not provided) (extra dose administered). No adverse effects were reported. There was no product quality issue (PQC). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 16-DEC2015, the patient was vaccinated with the first dose of MMR II (lot #, expiration date, exact dose and route of administration were not reported). On 18-DEC-2015, the patient accidentally received the second dose of MMR II (lot #, expiration date, exact dose and route of administration were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 form the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received on 14-DEC-2015. This case concerns a 14 year old patient. On 08-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 16 year old patient. On 09-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the nurse on 14-DEC-2015. This case concerns a 15 year old patient. On 11-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the nurse on 14-DEC-2015. This case concerns a 16 year old patient. On 15-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the nurse on 14-DEC-2015. This case concerns a 16 year old patient. On 04-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the nurse on 14-DEC-2015. This case concerns a 15 year old patient. On 15-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information as received 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 15 year old patient. On 09-SEP-2015, the patient was vaccinated with VARIVAX (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Menorrhagia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Information has been received from a 49 year old female consumer referring to herself. The patient had no pertinent medical history or drug reactions/allergies. "2 years ago", in approximately December 2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose and route not reported, indication reported as respiratory asthma). Concomitant therapies included ZYRTEC. On an unspecified date the patient was tested for immunity to pneumococcal disease and did not show immunity after receiving PNEUMOVAX 23. Her allergist recommended that she got revaccinated. After revaccination of PNEUMOVAX 23 (lot#, dose and route not reported) on 18-DEC-2015, she experienced severe arm pain which woke her from her sleep on the same day. She also stated that she could not lift or move her arm at night (on 18-DEC-2015). She experienced pain from the tip of her toes and throughout her body (on 18-DEC-2015) which lasted three days. She stated that the pain had improved significantly but was still mild. The patient also stated that since receiving the revaccination, she had experienced heavier than usual menstrual bleeding which appeared to get worse every day (started on 18-DEC-2015). The bleeding was so heavy that, "it felt like peeing". She also noticed clotting in her menstruation (started on 18-DEC-2015). The patient had sought medical attention from physical therapist for arm pain. She was treated with MOTRIN. At time of this reporting, outcome of the events "arm pain" and "pain from the tip of her toes and throughout her body" was considered as recovering (improved but still mild). Outcome of the other events was unknown. The causality was not provided. Additional information is not expected because the physician did not want to be contacted.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Poor quality sleep
Clinical narrative: Information has been received from a 49 year old female consumer referring to herself. The patient had no pertinent medical history or drug reactions/allergies. "2 years ago", in approximately December 2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose and route not reported, indication reported as respiratory asthma). Concomitant therapies included ZYRTEC. On an unspecified date the patient was tested for immunity to pneumococcal disease and did not show immunity after receiving PNEUMOVAX 23. Her allergist recommended that she got revaccinated. After revaccination of PNEUMOVAX 23 (lot#, dose and route not reported) on 18-DEC-2015, she experienced severe arm pain which woke her from her sleep on the same day. She also stated that she could not lift or move her arm at night (on 18-DEC-2015). She experienced pain from the tip of her toes and throughout her body (on 18-DEC-2015) which lasted three days. She stated that the pain had improved significantly but was still mild. The patient also stated that since receiving the revaccination, she had experienced heavier than usual menstrual bleeding which appeared to get worse every day (started on 18-DEC-2015). The bleeding was so heavy that, "it felt like peeing". She also noticed clotting in her menstruation (started on 18-DEC-2015). The patient had sought medical attention from physical therapist for arm pain. She was treated with MOTRIN. At time of this reporting, outcome of the events "arm pain" and "pain from the tip of her toes and throughout her body" was considered as recovering (improved but still mild). Outcome of the other events was unknown. The causality was not provided. Additional information is not expected because the physician did not want to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Retinopathy
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX (dose, route of administration and lot# were not reported). On an unknown date, two days after receiving the ZOSTAVAX, the patient developed retinopathy in an unspecified eye. No product quality complaint (PQC) was involved. The outcome of the event of retinopathy was not reported. The causality assessment between the event of retinopathy and ZOSTAVAX was not provided. Additional information is not expected as the reporting physician did not want to be contacted.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 14 year old patient. On 08-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to four patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 17 year old patient. On 08-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 16 year old patient. On 11-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 16 year old patient. On 01-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 3 unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On 06-SEP-2015, one unspecified patient was vaccinated with improperly MMRII lot # L001336, expiry date 13-JAN-2017 (route and site of administration, dose were not reported). On 11-SEP-2015, two unspecified patients were vaccinated with doses of improperly stored MMRII lot #L001336, expiry date 13-JAN-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. Therapy type of MMRII was determined to be rHA (recombinant human albumin). Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 16 year old patient of unknown gender. On 11-SEP-2015, the patient was vaccinated with MMRII. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 3 unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history provided. On 06-SEP-2015, one unspecified patient was  vaccinated with a dose of improperly stored MMRII lot # L001336, expiry date 13-JAN-2017 (route and site of administration, dose were not reported). On 11-SEP-2015, two unspecified patients were vaccinated with doses of improperly stored MMRII lot # L001336, expiry date 13-JAN-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. Therapy type of MMRII was determined to be rHA (recombinant human albumin). Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 15 year old patient of unknown gender. On 11-SEP-2015, the patient was vaccinated with MMRII. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician refers to a 66 year old female patient. The patient had a history of anaphylactic reaction to unspecified tetanus toxoid vaccine on an unspecified date. The patient did not have any other pertinent medical history. On 16-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (strength, lot# and expiry date were not reported) in the arm (reported as further down the arm where someone might get an allergy shot). Concomitant therapies included ZYRTEC, pramipexole, CRESTOR, PREMARIN, ESTRACE, vitamin D, AMITIZA, AUGMENTIN, guaifenesin, albuterol, sertraline hydrochloride, NORCO, NUVIGIL, DALIRESP, liothyronine sodium, clonazepam, ziprasidone, NEXIUM, potassium chloride and simethicone. On 16-DEC-2015, the patient developed 6x4 centimeter red, raised area around the injection site that was warm to touch following the administration of ZOSTAVAX. The patient received treatment with ice and BENADRYL. At the time of this report, the patient had not recovered from the event. The patient sought medical attention via calling the office. The causality assessment between adverse events and the ZOSTAVAX was not provided. 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/certified medical assistant refers to five patients of unspecified demographics. The patients received improperly stored VARIVAX with possible lot/expiration dates as follows: L019124/27-MAY-2017, reported as L027288/21-JUL-2017, L013064/14-APR-2017, and/or L025209/07-JUL-2017 on multiple unspecified dates ranging from 20-NOV-2015 through 30-NOV-2015. No adverse effects were reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
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. The patient's medical history and concurrent condition were unknown. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L019835 with expiration date 23-MAR-2017, dose and route unknown). No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 03-DEC-2015, the patient was accidentally vaccinated with an expired dose of PNEUMOVAX 23 lot # K007824, expiration date 05-NOV-2015, (dose number, route, and anatomical location were unspecified). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist concerning a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-JUN-2015, the patient was vaccinated with the first dose of GARDASIL injection (dose, route, anatomical location or lot# were unknown). Then, on 21-DEC-2015, the patient was vaccinated with the second dose of GARDASIL injection (dose, route, anatomical location or lot# were unknown). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: RV5, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were no provided. On an unspecified dates, in 2015, reported as "between 02-SEP-2015 and 09-OCT-2015", the patients were vaccinated with unspecified improperly stored doses of VARIVAX, lot# L017146 and expiration date 13-MAY-2017, as part of the immunization series (dose, route of administration and anatomical location were not provided). There were no concomitant medications provided. No adverse effects reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L014876, expiration date 13-JAN-2017; lot # L021367, expiration date 05-NOV-2016) (dose and route of administration were not reported). No adverse effect reported. There was no product quality involved. This is one of two reports from the same reporter (1512USA013616). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 3 patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 12-MAY-2015, the patients were vaccinated with doses of improperly stored (exposed to 47 degrees F for 34.5 hours on 07-MAY-2015) MMRII (dose and route were not reported) lot # J008533, expiration date: 12-JUL-2015. There was no adverse reactions report or PQC involved. There was no concomitant medication provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were no provided. On an unspecified dates, in 2015, reported as "between 02-SEP-2015 and 09-OCT-2015", the patients were vaccinated with unspecified improperly stored doses of ROTATEQ, lot # L008053 and expiration date 30-NOV-2016, orally, as part of the immunization series (dose, route of administration and anatomical location were not provided). There were no concomitant medications provided. No adverse effects reported. There was no product quality issue involved. This is one of several cases 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 pharmacist referring to multiple unspecified patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of MMRII (lot # L004656, expiration date 11-FEB-2017) (dose and route of administration were not reported). No adverse effect reported. There was no product quality involved. This is one of two reports from the same reporter (1512USA011947). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report received from a health care worker refers to a patient of unknown demographics. No medical history was reported. On 09-SEP-2015 the patient was vaccinated with VARIVAX (lot # K016127, route, dose and frequency: unknown) instead of PROQUAD due to a human error. No adverse effect was reported. No Product Quality Complaints (PQCs) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 15 year old male patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, lot number L016429, expiration date 09-AUG-2017, (dose, route, anatomical location were not reported) after temperature excursion (incorrect product storage). There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report received from a health care worker refers to a patient of unknown demographics. No medical history was reported. On 01-SEP-2015 the patient was inadvertently vaccinated with VARIVAX (lot # K016127, route, dose and frequency: unknown) instead of PROQUAD due to a human error. No adverse event reported. No Product Quality Complaints (PQCs) was involved. This is one of the several reports 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 received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 12 year old female patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, lot number L016429, expiration date 09-AUG-2017, (dose, route, anatomical location were not reported) after temperature excursion. There was no concomitant medication reported. This is one of several reports 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 Registered Nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # K009182, expiry date 26-APR-2016, dose and route were unspecified). No adverse effects were reported. Additional information is not expected because there was no consent to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patient were vaccinated with improperly stored VARIVAX lot # L008270, expiry date: 11-MAR-2017 (dose, route and frequency: unknown). No adverse effects were reported. No Product Quality Complaints (PQCs) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Local swelling, Pain, Pruritus, Rash
Clinical narrative: Pain, aching, itching. Gradual increased swelling. Rash-erythema 4cm x 11cm warm raised. Possible secondary cellulitis. 12/9/15 Treatment: oral antihistamine (BENADRYL), KEFLEX 500mg one tid x10 days. 12/11/15 Added: ZYRTEC 10mg one qid, topical hydrocortisone.
Age: 36.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Pain, aching, itching. Gradual increased swelling. Rash-erythema 4cm x 11cm warm raised. Possible secondary cellulitis. 12/9/15 Treatment: oral antihistamine (BENADRYL), KEFLEX 500mg one tid x10 days. 12/11/15 Added: ZYRTEC 10mg one qid, topical hydrocortisone.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous case report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 11-DEC-2015, the patient was vaccinated with a dose of PROQUAD (Merck) (lot number # K025759 and expiry date 08-JUN-2016) and VARIVAX (Merck) (lot number K007982 and expiry date: 06-MAR-2016) (overdose). Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Nausea, Skin warm
Clinical narrative: This spontaneous report was received from a 57 year old female patient who reported for self. The patient has allergy to red dye and the patient's pertinent medical history was none. On 22-SEP-2015, the patient was vaccinated with ZOSTAVAX (unknown dose, strength and lot#). Concomitant therapies included tramadol and FLEXERIL. On 23-SEP-2015, developed redness and warmth which was traveling down her arm after receiving ZOSTAVAX. The patient also reported that she also felt nauseous on 23-SEP-2015. No lab diagnostic studies were performed. The patient did not seek medical attention and no treatment was received in response to the events. The patient was not hospitalized. The outcome of the events was reported as not resolved. Causality assessment was not provided. There was no product quality complaint involved. Follow up information was received from an unspecified reporter on 29-DEC-2015, regarding on the female patient. The patient's medical history also included allergy to unspecified nonsteroidal anti-inflammatory drug (NSAIDS), statins, valsartan and warfarin. The reporter stated that the patient was vaccinated on 22-SEP-2015 at 14:45, with the first dose of ZOSTAVAX (lot # L021602, expiration date not reported) by subcutaneous route in the left deltoid. On 22-SEP-2015 (previously reported as 23-SEP-2015), the patient experienced erythema reported as redness moved towards to elbow, headache reported as "HA", mild pain, blistering of skin below injection site, injection site redness, nausea and feeling hot. The reporter stated that the patient required medical intervention (unspecified). At the reporting time, the outcome of erythema, headache, injection site erythema, mild pain, injection site vesicles, nausea and feeling hot was reported as recovered on an unspecified date in 2015. Erythema, headache, injection site erythema, mild pain, injection site vesicles, nausea and feeling hot was considered to be medically significant by the reporter. Additional information is not expected as all information has been collected. General information, patient information, products, events and narrative were updated.