chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Somnolence
Clinical narrative: This spontaneous report was received from the patient's mother and refers to currently 23 years old male patient. The patient's medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route of administration, lot number and expire date were not reported). No concomitant therapy was reported. On an unknown date, after receiving RECOMBIVAX HB, the patient experienced fatigue, muscle ache, stiffness in the back and neck, constipation, drowsiness, and sleeplessness. The patient sought medical attention (call physician). The patient's outcome was not reported. The relatedness between the vaccination with RECOMBIVAX HB and the adverse events was not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site nodule
Clinical narrative: Grape-sized deep nodule formed at injection site 5 days after HPV-9.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On 03-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) injection (lot # L005292 and expiry date: 17-AUG-2016) (dose, frequency, route and site of administration not reported). No concomitant medications were reported. No adverse symptoms were reported. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of 3 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 medical assistant (MA) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot#K011562, expiration date 08-APR-2017), dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (MA) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 07-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K011562, expiration date 08-APR-201, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (MA) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K011562, expiration date 08-APR-201, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (MA) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K011562, expiration date 08-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. Patient's concurrent conditions and medical history were not reported. On an unknown dates, the patients received doses of improperly stored GARDASIL (lot #K004205, expiration date: 12-JAN-2017, lot#K001631, expiration date: 06-NOV-2016 and lot#K009482, expiration date: 06-MAR-2017), dose and route were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 28 year old female patient with no drug reactions or allergies. The patient had no pertinent medical history. On 07-AUG-2015, the patient was vaccinated with a dose of VARIVAX (Merck), subcutaneously, lot # K016127, expiration date 23-SEP-2016 (dose and frequency were not provided). The patient took no concomitant medication. On 12-AUG-2015, the patient developed a "rash on both of her feet". The patient did not receive the treatment for the event. On 14-AUG-2015, the patient recovered from the event. No lab diagnostics studies were performed. The patient sought medical attention via seeing the pharmacist. The relatedness between the event and VARIVAX (Merck) was not reported. 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 certified medical assistant (CMA) refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and concomitant therapies were not reported. In approximately 2015 (reported as on unspecified dates since 18-AUG-2015), the patients were vaccinated with improperly stored does of GARDASIL (lot #L001442, expiration date 04-NOV-2016, dose and route of administration were not reported). No adverse reactions were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Current conditions, medical history and concomitant therapies were not reported. In approximately 2015 (reported as on unspecified dates since 18-AUG-2015), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (lot# K007262 with expiration date 19-MAR-2016 and lot# K007262 with expiration date 24-NOV-2015, dose and route of administration were not reported). No adverse reactions were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: This spontaneous report was received from an unknown reporter via Baxter Health Care Corp (reference # 2015BAX047291) refers to a patient of an unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient felt nauseous after the vaccination with Pneumococcal vaccine(Manufacturer unknown). The outcome of nausea was unknown. The reporter did not provide the relatedness of the event with Pneumococcal vaccine (Manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 04-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # K008185, expiration date was reported as "52-DEC-2015", dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site reaction, Rash, Rash erythematous, Urticaria
Clinical narrative: Onset 5 hrs ago. Erythematous and urticarial rash; location is abdomen, both arms and both legs. Denies cough, diarrhea, fever, painful rash and vomiting. No treatment at this time.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis left upper arm. Cllindamycin 300 mg IM, TMP/SMZ DS BID x 10 D, DURICEF 1 gm BID x 10 D.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Arthralgia, Henoch-Schonlein purpura, Laboratory test, Purpura
Clinical narrative: Patient presented with purpura 5 days after imms. given. Had arthralgias and treated with NAPROSYN. Needs monthly renal function tests x 6 mo. Diagnosis: Henoch-Schonlein purpura.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Extreme pain, swelling and warmth at injection site, accompanied by a headache. Patient received KEFLEX 500mg BID x 7 days and triamcinolone cream from Dr.
Age: 35.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site pruritus, Pyrexia, Tuberculin test
Clinical narrative: MENACTRA administered by ID route inadvertently in (R) forearm approximately 9 AM. MENACTRA IM (L) deltoid; TB skin test ID left forearm - called Sanofi - advised to observe in 48 hours - awakened at 2 AM on 8/20/15 with fever 101, itchy (R) forearm at admin. site.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Neuralgic amyotrophy, Pain, Paraesthesia
Clinical narrative: Weakeness, loss of strength, some pain, tingling. DX; Parsonage-Aldren Turner Syndrome.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported arm was red, swollen, tender and painful. Also raised and became hard as a rock and did not feel well. MD prescribed antibiotic but patient did not take any - reported on f/u that rxn is almost all gone and just a little sore.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient reported arm was red, swollen, tender and painful. Also raised and became hard as a rock and did not feel well. MD prescribed antibiotic but patient did not take any - reported on f/u that rxn is almost all gone and just a little sore.
Age: 1.0
Sex: F
Vaccine: MMR, MMR
Symptoms: C-reactive protein, Full blood count, Nausea, Pyrexia, Viral test
Clinical narrative: MMR 8/27/15. 9-1-15 phone call - fever - T=107 - to ER. 9-2-15 office visit - f/u ER - fever poss roseola. 9-3-15 phone call - fever and N/V (T=105). 9-4-15 OV - fever - labs CBC/CRP. 9-4-15 phone calls - CBC -> viral.
Age: 1.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Vomiting
Clinical narrative: MMR 8/27/15. 9-1-15 phone call - fever - T=107 - to ER. 9-2-15 office visit - f/u ER - fever poss roseola. 9-3-15 phone call - fever and N/V (T=105). 9-4-15 OV - fever - labs CBC/CRP. 9-4-15 phone calls - CBC -> viral.
Age: 1.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Laboratory test, Pyrexia
Clinical narrative: MMR 8/27/15. 9-1-15 phone call - fever - T=107 - to ER. 9-2-15 office visit - f/u ER - fever poss roseola. 9-3-15 phone call - fever and N/V (T=105). 9-4-15 OV - fever - labs CBC/CRP. 9-4-15 phone calls - CBC -> viral.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tension
Clinical narrative: Mother brought child experienced tense, redness, swelling left arm with warmth, no fever/chills, child otherwise well; given antihistamine with improvement.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, hot to touch, swelling around injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to touch, increase in symptoms over 3 days.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: No adverse event, Product preparation error
Clinical narrative: Hib/DTaP/IPV (PENTACEL) reconstituted incorrectly and administered. No adverse event noted.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Pruritus
Clinical narrative: Pt came back to MD office today complaining of pain at injection site and swelling of the area. Has large reddened area on upper right arm. States has looked this way for 2 days. Complaining of itchy skin also. MD diagnosed today as local reaction to PREVNAR 13 vaccine.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from   a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. The patient received the first dose of the series of three of GARDASIL on an unspecified day in November 2014, and the second dose of GARDASIL was administered on an unspecified day in AUGUST 2015 (inappropriate schedule of drug administration). Also, it was confirmed that the third dose of GARDASIL was not administered to the patient. No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare student referring to a patient of unknown age and gender. On 26-AUG-2015 the patient was inadvertently vaccinated with an expired dose of VARIVAX (Merck) injection (lot # J008652, expiration date 10-JUL-2015) (dose and route were not reported). No adverse effects reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red, tender, warm annular rash at site of injection. Began 1 day after injection was received. This was the #4 injection in the series. Treatment was supportive.
Sex: U
Vaccine: MMRV
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 pertinent medical history and concurrent condition were not reported. On 11-AUG-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K021548, expiration date 06-MAY-2016, dose, frequency and route were unknown). No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with unspecified doses of ZOSTAVAX (lot # L002423 and expiration date 23-APR-2016)(dose and route were not reported) which was improperly stored. No Product Quality Complaint (PQC) was involved. Additional information is not expected as the reporter did not wish further contact.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Information has been received from a pharmacist referring to a 78 year old female patient. Concurrent condition and medical history were not reported. On 13-AUG-2015 ("yesterday"), the patient was administered with a dose of expired ZOSTAVAX (lot # K000325, expiration date 27-FEB-2015 0.65 ml) subcutaneously on left arm. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B virus test positive
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hepatitis b virus test positive in a patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, several weeks after receiving Hepatitis B vaccine, the patient experienced hepatitis b virus test positive. On an unknown date, the outcome of the hepatitis b virus test positive was unknown. It was unknown if the reporter considered the hepatitis b virus test positive to be related to Hepatitis B vaccine. Additional details were received as follows: On an unknown date, 2 patients had received a dose of Hepatitis B vaccine. The number doses the patient received were unknown. After few weeks the patient underwent the hepatitis B vaccine test which was revealed to be positive. The reporter did not know the name of the test. Refer case US2015GSK126722, for the details of another patient vaccinated with Hepatitis B vaccine.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B virus test positive
Clinical narrative: This case was reported by a other health professional and described the occurrence of hepatitis b virus test positive in a patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, several weeks after receiving Hepatitis B vaccine, the patient experienced hepatitis b virus test positive. On an unknown date, the outcome of the hepatitis b virus test positive was unknown. It was unknown if the reporter considered the hepatitis b virus test positive to be related to Hepatitis B vaccine. Additional details were received a dose of Hepatitis B vaccine. The number doses the patient received were unknown. After few weeks the patient underwent the hepatitis B vaccine test which was revealed to be positive. The reporter did not know the name of the test. Refer case US2015GSK1267616, for the details of another patient vaccinated with Hepatitis vaccine.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 17-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L017140, expiration date 13-NOV-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a physician and refers to an over 75 year old male patient enrolled in message testing. No information regarding the patient's medical history, concurrent conditions and concomitant medication was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose, lot # and expiration date were not provided). On an unknown date (in last 4 years), the patient had very mild case of shingles even after having ZOSTAVAX. The physician attributed that this case was mild because of the vaccination and would have expected much worse without having it. The patient recovered from the shingles on an unknown date. The outcome of vaccination failure was unknown. The reporter considered the shingles to be not related to ZOSTAVAX. The relatedness between vaccination failure and ZOSTAVAX was not reported. This is one of two reports received from the same source. Additional information is not expected as there was no consent to contact the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a physician and refers to three over 75 year old female patients enrolled in ZOSTAVAX testing. No information regarding the patients' medical history, concurrent conditions and concomitant medication was reported. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX, subcutaneous (dose, lot # and expiration date were not provided). On unknown dates (in last 4 years), the patients had very mild cases of shingles even after having ZOSTAVAX. The physician attributed that these cases were mild because of the vaccination and would have expected much worse without having it. The patients recovered from the from the shingles on unknown dates. The outcome of vaccination failure was unknown. The reporter considered the shingles to be not related to ZOSTAVAX. The relatedness between vaccination failure and ZOSTAVAX was unknown. This is one of two reports received from the same source. Additional information is not expected as there was no consent to contact the physician.
Sex: U
Vaccine: MMRV
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 pertinent medical history and concurrent condition were not reported. On 13-AUG-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K021548, expiration date 06-MAY-2016, dose, frequency and route were unkonwn). No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-SEP-2015, the patient was vaccinated intramuscularly with an expired 0.5 ml dose of PNEUMOVAX23 injection (lot # J013344, expiry date 22-JAN-2015). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age. Starting from 06-AUG-2015, the patients were inadvertently vaccinated with an improperly stored dose of ROTATEQ, LOT #K013411, 19-MAR-2016, K010325, 10-MAY-2016, K014826, 28-MAY-2016, L004466, 02-AUG-2016. No adverse reactions were reported. The outcome of the events were unknown. This is one of the 4 linked cases received from the.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 12-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 11-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L017140, expiration date 13-NOV-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, MMRV
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 pertinent medical history and concurrent condition were not reported. On 03-AUG-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K021548, expiration date 06-MAY-2016, dose, frequency and route were unknown). No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 03-AUG-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K021548, expiration date 06-MAY-2016, dose, frequency and route were unknown). No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several 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 was received from a registered nurse refers to an unspecified number of patients of unknown age. Starting from 06-AUG-2015, the patients were inadvertently vaccinated with an improperly stored dose of GARDASIL, lot # K011325, 08-APR-2017, K011562, 08-APR-2017. No advers reactions were reported. The outcome of the events were unknown. This is one of the 4 linked cases received from the same reporter. Additonal information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also a medical assistant) referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # K012457 with expired date 04-JUN-2017, lot# L018499 with expired date 25-FEB-2017, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also a medical assistant) referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # K023363 with expired date 20-MAY-2016, lot# L010142 with expired date 24-SEP-2016, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also a medical assistant) referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K003407 with expired date 06-MAR-2016, lot# L011082 with expired date 01-APR-2017, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age. Starting from 06-AUG-2015, the patients were inadvertently vaccinated with an improperly stored dose of RECOMBIVAX HB lot #K006682, expiry date 17-DEC-2015, J004700, expiry date 26-NOV-2015, K020126, expiry date 17-SEP-2016. No adverse reactions were reported. The outcome of the events were unknown. This is one of the 4 linked cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 5 unspecified patients of unknown age. On an unknown date, the patients were vaccinated with doses of improperly stored PROQUAD (Merck), lot# 1010141, expiry date 24-SEP-2016 and no adverse effects were reported. The outcome of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with unspecified number of improperly stored doses of ROTATEQ lot # L008034, expiry date 05-AUG-2016 and lot # K016263, expiry date 26-JUN-2016, (dose, frequency and route of administration were not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of 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 was received from a licensed nurse practitioner refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with unspecified number of improperly stored doses of GARDASIL lot#K010215, expiry date 05-MAY-2017, (dose, frequency and route of administration were not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Thi sis one of two reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Feeling abnormal, Malaise, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered nurse (patient's mother) refers to a 16 year old female patient. Information regarding medical history and current condition was not reported. On 01-SEP-2015 the patient was vaccinated with GARDASIL 9, of dose 0.5 ml via intramuscular route. Other co-suspects were not reported and concomitant therapies included GILDESS FE. On 01-SEP-2015 (reported as later that day) the patient arm "hurt" (unspecified arm). The nurse stated that approximately on an unknown date in September 2015 (also reported as the days have gone), the patient arm hurt gotten worse. On an unknown date in September 2015, the patient overall feels bad, has general malaise and fatigue and is achy all over her body. On an unknown date in September 2015, the patient took TYLENOL (manufacturer unspecified) and ADVIL (manufacturer unspecified) for treatment. The patient did not visited the doctor since she received GARDASIL 9. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. 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 multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot#K005083, expiration date 04-NOV-2016 or lot #K006117, expiration date: 14-JAN-2017, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of COMVAX injection (lot # J013884, expiry date 19-AUG-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality compliant (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. Patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients received doses of improperly stored VAQTA (lot# K012457, expiration date: 04-JUN-2017 or lot# L004742, expiration date: 18-AUG-2016), dose and route were not reported. No adverse effects 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 as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On 03-SEP-2015, the patients were vaccinated with improperly stored ZOSTAVAX (lot # L000449 and expiry date: 08-MAR-2016) (dose, frequency, route and site of administration not reported). No concomitant medications were reported. No adverse symptoms were reported. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 3 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On 03-SEP-2015, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K007784 and expiry date: 28-MAY-2016) (dose, frequency, route and site of administration not reported). No concomitant medications were reported. No adverse symptoms were reported. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 3 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection (lot # K010338, expiry date 22-JUL-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. 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 refers to an unspecified number of patients of unknown age and gender. The patients concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (Lot # L017142, expiry date 13-MAY-2017). No adverse events reported. This is one of the two reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of an unknown age and gender. The patients concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck) (Lot # L023111, expiry date 24-DEC-2016). No adverse events reported. This is one of the two reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern refers to a patient of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with first dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported). On 01-SEP-2015, the patient was vaccinated with second dose of ZOSTAVAX (lot # K019388 and expiration date 20-JAN-2016) (dose and route were not reported). The two doses of ZOSTAVAX were administered to a patient, less than one year from one another. No adverse reactions were reported. No Product Quality Complaint (PQ) was involved. 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 (also reported as office manager) refers to multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with  improperly stored (incorrect product storage) VARIVAX (Merck) (lot # L012034, 06-APR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the events was unknown. No product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Thiss spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. Patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients received doses of improperly stored RECOMBIVAX HB (lot# K006682, expiration date: 17-DEC-2015, lot# J013394, expiration date: 25-AUG-2016 or lot# J014855, expiration date: 16-APR-2016), dose and route were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. Patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients received doses of improperly stored PNEUMOVAX 23 (lot# K006681, expiration date: 21-OCT-2015 or lot# K008409, expiration date: 04-MAR-2016), dose and route were not reported. No adverse effects reported. This is one of several reports received from the same source. 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 administrator and refers to two patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unspecified date, the patients were vaccinated with doses of improperly stored ROTATEQ, orally, lot # K002991, expiration date 12-DEC-2015 (strength, dose and frequency were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 11 year old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 28-AUG-2013, the patient was vaccinated with the first dose of VAQTA, pediatric (route and dose were not reported, strength reported as 25/0.5 (unit not provided), lot # J003719, expiry date: 27-SEP-2015). On 29-AUG-2014, the patient was vaccinated with the second doe of VAQTA, pediatric (route and dose were not reported, strength reported as 25/0.5 (unit not provided), lot # K007791, expiry date: 22-AUG-2016). On 02-SEP-2015, the patient was vaccinated with the third dose of VAQTA, pediatric (route and dose were not reported, strength reported as 25/0.5 (unit not provided), lot # K007791, expiry date: 22-AUG-2016). On 02-SEP-2015, the patient was vaccinated with the third dose of VAQTA, pediatric (route and dose were not reported, strength reported as 25/0.5 (unit not provided), lot # L009445, expiry date: 01-JUN-2017. Concomitant medications were not reported. No adverse effects were reported. 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 multiple patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K010215, expiry date: 05-MAY-2017). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route were not reported, lot # K008334, expiry date: 09-JUN-2016). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K023532, expiry date 21-JUN-2016; exact dose was not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # reported as L016428, expiry date 30-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. Patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients received doses of improperly stored M-M-R II (lot# K000174, expiration date: 08-JAN-2016, lot# reported as 1002873, expiration date: 27-JAN-2017 or lot# J014876, expiration date: 21-NOV-2015), dose and route were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer referring to a 74 year old female patient. The patient's pertinent medical history included high blood pressure and "afiv". Drug allergies included Sulfa and penicillin. On 28-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#/expiration date, dose, strength and route unknown, one time injection). Concomitant medication included Diltiazem XR and XARELTO. On 11-NOV-2013 (reported as two weeks after) the patient broke out shingles. The patient also reported getting outbreaks of shingles every six to seven months. The patient did not seek medical attention. No lab diagnostics study was performed. Acyclovir was given for the treatment of the event and the event was improved on the therapy. At present the patient recovered from the event. Additional information is not expected as no contact details were provided.
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. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L000453, expiration date 06-JAN-2007, dose and route unspecified). No adverse effect reported. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a 66 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 08-SEP-2015 the patient was vaccinated with an expired dose PNEUMOVAX23 lot # K010016 with expiration date 05-AUG-2015 (dose, dose number and route were not reported). Information regarding concomitant medication was not reported. No adverse effect had been reported. 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 pharmacist regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL lot # K006960, expiration date 19-FEB-2017 and lot # K010215, expiration date 05-MAY-2017 Incorrect product storage). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter.