chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with Chronic Obstructive Pulmonary Disease (COPD) -developed at an unspecified time prior to receiving the ZOSTAVAX. The patient did not have drug reaction. On 27-OCt-2014 the patient was vaccinated with ZOSTAVAX lot # K009198, exp. date 27-SEP-2015, 0.65 ml, subcutaneous. Concomitant therapies included fluticasone furoate, BREO ELLIPTA, diclofenac 75mg, Z-PAKK "occasionally" and albuterol. The patient has been experiencing tenderness at the injection site since receiving the ZOSTAVAX (27-OCT-2014). The reporter also reported that the patient developed what "looks like mosquito bite" at the injection site on 13-NOV-2014. No treatment was given for AE. No lab was performed. The patient sought medical attention and came into the pharmacy on 13-NOV-214. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates, since 23-OCT-2014, the patients were vaccinated with RECOMBIVAX HB (dose number, route, lot # and expiration date were not provided). In 2014, doses of RECOMBIVAX HB that were exposed to a supported temperature excursion (0.2 C for 55 hours) had been administered to unspecified patients on unspecified dates, since 23-OCT-2014. No adverse effects had been observed or reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 2 patients of unknown age. On an unspecified date, 2 unspecified patients received doses of (Merck) VARIVAX (strength, dose, frequency, route, lot # were not provided). (Merck) VARIVAX were exposed to temperatures outside of the proper storage range. No adverse effect reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received 27-OCT-2104 from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 11, units not reported) of unknown gender. On 10-NOV-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The nurse reported patient received dose of (unspecified) (Merck) VARIVAX (0.5 ml once, Subcutaneous, lot # J003534, exp 25-MAR-2015) that was stored at 10F for 264 hours. Nurse reported patient had (Merck) VARIVAX administered for an unspecified time in the last 2 weeks (between 03-NOV-2014 and 14-NOV-2014). No adverse effects reported. Additional information has been requested.
Age: 1.16
Sex: U
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a Licensed Practical  Nurse refers to a patient of 13 months old child patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with a dose of PROQUAD (lot K006771, expiration date 07-NOV-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Tuesday AM had red raised welts around where shot was given, soreness, pain in area. Continued thru Wed. night. Saw RPh recommended ice and Ibuprofen. Stopped in Thurs AM was better. Continued treatment. Called Friday night was back to normal.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report a received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an unspecified doses of GARDASIL (route, lot numbers and expirations dates not reported) which were improperly stored at 55.9 F for 2 hours. No adverse effects reported. This is one of several reports received  from the same reporter. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with MMR II (lot H020255, expiration date not reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with MMR II (lot H020255, expiration date not reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. 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 an unspecified number of patients of unknown age and gender. On an unknown date the patients may had been vaccinated with unspecified doses of RECOMBIVAX HB (route, lot numbers and expiration dates not reported) which were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 24-NOV-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot number J006082 and expiry date 12-APR-2014) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PNEUMOVAX 23 and the outcome of the event was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. No product quality issue was 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 an unspecified number of patients of unknown age and gender. On an unknown date the patients may had been vaccinated with unspecified dose of GARDASIL (route, lot numbers and expirations dates not reported) which were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, Off label use
Clinical narrative: This spontaneous report was received from a physician via field employee regarding unspecified number of children under age of 2. The patients had a compromised immune system. The historical drug included PREVNAR 13. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (strength, dose, frequency, product lot#, expiry date, route not reported). The physician stated that she only used the PNEUMOVAX 23 in the under 2 years of age group and only if the patients had a compromised immune system and if the patient did not respond to PREVNAR 13. There was no product quality complaint involved. The outcome of the events were unknown. The causality of the event, used the PNEUMOVAX 23 in the under 2 years of age group (off label use) was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. Medical history was not reported. The nurse practitioner informed that on 28-AUG-2014 the patient was vaccinated with PROQUAD injection, 0.5 ml, subcutaneous, which expired on 22-AUG-2014 (lot number were not reported). No adverse effects were reported. The outcome of the event was unknown.   Follow up information received with updates on 28-OCT-2014, regarding 5 year old female patient with known demographics. It was reported that on 25-AUG-2014 at 3:00 PM, the patient was vaccinated with second dose of PROQUAD injection, lot # J002306, expire date 22-AUG-2014 to the left arm.  No adverse effects were reported. This is one of the several report received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 08-SEP-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (lot K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. Medical history was not reported. The nurse practitioner informed that on 28-AUG-2014 the patient was vaccinated with PROQUAD injection, 0.5 ml, subcutaneous, which expired on 22-AUG-2014 (lot number were not reported). No adverse effects were reported. The outcome of the event was unknown.  Follow up information received with updates on 28-OCT-2014, regarding 5 year old male patient with know demographics. It was reported that on 25-AUG-2014 at 11:30 PM, the patient was vaccinated with second dose of PROQUAD injection, lot # J002306. expire date 22-AUG-2014 to the left arm. No adverse effects were reported. This is one of the several report received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV
Symptoms: Abdominal pain upper, Body temperature increased, Crying, Discomfort, Heart rate increased
Clinical narrative: This spontaneous report as received from a physician refers to a 6 year old male patient. The patient's pertinent medical history included eczema. The patient had not drug reactions/allergies. On 17-NOV-2014 the patient was vaccinated with a dose of (Oka/Merck) PROQUAD (lot # J007859, expiration date 28-DEC-2014, subcutaneous, dose and dose # not reported). Other suspect therapies included RECOMBIVAX HB (lot# J007298, expiration date 05-FEB-2016, intramuscular, dose and dose # not reported), a polio vaccine by Sanofi Pasteur and a hepatitis A vaccine by GlaxoSmithKline (both on 17-NOV-2014, lot#, dose, dose#, route and indication not reported). The reporter reported that his patient was pretreated with an unspecified dose of ibuprofen (unspecified manufacturer) before receipt of these vaccines. The physician reported that after receiving these vaccines, on 17-NOV-2014, the patient began crying, itching and complaining of a stomach ache. The patient's mother attempted to take the child home, but the child broke out into diffuse hives and the child was brought back to the office within minutes of leaving. The physician reported that upon assessment, the patient was very uncomfortable and had a mildly elevated temperature and elevated heart rate with a stable respiratory status - pulse oximetry above 94% throughout this episode. The patient was administered an unknown dose of BENADRYL as treatment and observed for one hour. It was noted that the patient's hives were almost completely resolved and his heart rate was down. The patient ws then sent home with his mother. The outcome of the events was reported as recovered on 17-NOV-2014. No product quality complaint PQC involved. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 6 year old male patient. The patient's pertinent medical history included eczema. The patient had not drug reactions/allergies. On 17-NOV-2014 the patient was vaccinated with a dose of (Oka/Merck) PROQUAD (lot # J007859, expiration date 28-DEC-2014, subcutaneous, dose and dose # not reported). Other suspect therapies included RECOMBIVAX HB (lot# J007298, expiration date 05-FEB-2016, intramuscular, dose and dose # not reported), a polio vaccine by Sanofi Pasteur and a hepatitis A vaccine by GlaxoSmithKline (both on 17-NOV-2014, lot#, dose, dose#, route and indication not reported). The reporter reported that his patient was pretreated with an unspecified dose of ibuprofen (unspecified manufacturer) before receipt of these vaccines. The physician reported that after receiving these vaccines, on 17-NOV-2014, the patient began crying, itching and complaining of a stomach ache. The patient's mother attempted to take the child home, but the child broke out into diffuse hives and the child was brought back to the office within minutes of leaving. The physician reported that upon assessment, the patient was very uncomfortable and had a mildly elevated temperature and elevated heart rate with a stable respiratory status - pulse oximetry above 94% throughout this episode. The patient was administered an unknown dose of BENADRYL as treatment and observed for one hour. It was noted that the patient's hives were almost completely resolved and his heart rate was down. The patient ws then sent home with his mother. The outcome of the events was reported as recovered on 17-NOV-2014. No product quality complaint PQC involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from an administrator refers to 3 unspecified adult patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, route of administration and lot # was not reported). On an unknown date (reported as recently), the patients had blood tests drawn to verify their immunity to hepatitis B and their titers came back negative. The outcome of the event was unknown. 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 an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an unspecified doses of RECOMBIVAX HB (route, lot numbers and expiration dates not reported) which were improperly stored at 55.9 degrees F for 2 hours. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with (Merck) VARIVAX dose 1 (route, dosage and lot number unknown). Six weeks later the patient received (Merck) VARIVAX dose 2 (route, dosage and lot number unknown). On an unspecified date, the patient had varicella titers drawn, which came back negative. The outcome of varicella titers negative was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect product formulation administered, No adverse event, Product packaging issue, Product quality issue
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. On an unknown date in 2013, reported as about a year ago, the patient was vaccinated with the adult formulation of RECOMBIVAX HB, 2 ml subcutaneous (lot number, expiry date and thimerosal content not reported), instead of the dialysis formulation of RECOMBIVAX HB 40 microgram per year, because there was a packaging error. No concomitant medications were reported. The adult formulation RECOMBIVAX HB was also administered in error as a 2 ml dose instead of a 1 ml dose. A product quality complaint was filed. The patient experienced no adverse effects. The outcome and causality was unknown. Additional information has been requested.
Age: 0.98
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 month old patient. On 23-MAY-2006 the patient was vaccinated with dose 1 of (Merck) VARIVAX (dose, route and lot# was not reported) and dose 1 of MMR II (dose, route and lot# was not reported), "which was before the minimum recommended age". No adverse effects reported. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a physician refers to a 68 year old female patient. Patient's medical history and concurrent condition was reported as none. On an unknown date in May 2013 (also reported as November 2013), the patient was vaccinated with ZOSTAVAX (strength, dose and route unknown). Patient's concomitant medication was not reported. The patient's diagnostic tests were reported as none. On an unknown date approximately 1.5 years ago (also reported as approximately 1 year ago) approximately in 2014 the patient experienced outbreak of a small rash like area about 3-4 inches around the immunization site. The reporter stated that it was not a big problem and it cleared up after 3-4 days. The outcome of the event was reported as recovered/resolved. The reporter considered the event to be related to ZOSTAVAX. Additional information is not expected since the reporter do not want to be contacted further.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. Medical history was not reported. The nurse practitioner informed that on 28-AUG-2014 the patient was vaccinated with PROQUAD (Merck) injection, 0.5 ml, subcutaneous, which expired on 22-AUG-2014 (lot number were not reported). No adverse effects were reported. The outcome of the event was unknown. Follow up information received with updates on 28-OCT-2014, regarding 4 year old female patient with known demographics. The patient has 3 sibling. It was reported that on 28-AUG-2014 at 3:00pm, the patient was vaccinated with second dose of PROQUAD (Merck) injection, lot#J002306, expire date 22-AUG-2014 to the left arm. No adverse effects were reported. This is one of the several report received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 54 year old male patient. On 10-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K008409, expiry date 04-MAR-2016, dose 0.5 ml, intramuscular). Concomitant medications were not reported. On 11-NOV-2014, the patient experienced rash and cellulitis at the injection site. Patient sought medical attention-he was assessed by a physician and no treatment was prescribed. No laboratory studies were performed. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. Product quality complaint was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 55 year old male patient. On 06-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K008409, expiry date 04-MAR-2016, dose 0.5 ml, intramuscular). Concomitant medications were not reported. In approximately November 2014, the patient experienced rash and cellulitis at the injection site. Patient sought medical attention-he was assessed by a physician on 11-NOV-2014 and no treatment was prescribed. No laboratory studies were performed. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. This is one of the several 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 refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2104, who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age range reported as 11, units not reported) of unknown gender. On 29-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 38 year old male patient with ankylosing spondylitis and DEMEROL allergy. On 18-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, intramuscular, in the arm, lot # K007262 with expiry date: 25-NOV-2015). Concomitant therapies included atorvastatin, baclofen, fluoxetine, HUMIRA and meloxicam. On 19-NOV-2014, the patient experienced severe muscle weakness and pain in the arm, redness and swelling from injection site, across the anterior arm to the axilla and difficulty moving the injection site, after receiving PNEUMOVAX 23. The patient was treated with an ice to site, KEFLEX and hydroxyzine. None lab diagnostics studies were performed. The patient sought medical attention via seeing the physician. The outcome of events was not reported. The relatedness between events and PNEUMOVAX 23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Urticaria
Clinical narrative: Pt had large hive/welt on back of arm 4 days after receiving ZOSTAVAX. Large inflamed area on arm where shot was given.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Bedridden, Injection site pain, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Severe pain at injection site - 4 days. Swelling, itching - 4 days. Bedridden x 3 days, pain in extremities.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Redness and itching at injection site and hard lump beneath skin.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information on medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of (Merck) VARIVAX (dose, route reported as in prescribing information, product lot#, expiry date not reported) that was improperly stored. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Incorrect product storage
Clinical narrative: This spontaneous report as received from a 66 year old female consumer refers to herself with chronic adult acne. The patient had no known drug allergies. On 24-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported, dose 0.65 ml, subcutaneously) in an unspecified pharmacy. Concomitant therapies included RETIN-A GEL. The patient stated that the vaccine was reconstituted and sat for 50 minutes at room temperature before she received ZOSTAVAX. The patient had been experiencing "bad diarrhea" today, 25-NOV-2014. The patient had not sought medical attention. No treatment was given for the event. At the time of reporting, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt given a ZOSTAVAX immunization. Pt not > 50 yrs old.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Foetal disorder, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 33 year old female patient refers to herself. The patient did not have drug reactions or pertinent medical history. On 27-MAR-2013 the patient received the first dose of vaccinated with GARDASIL (lot#, expiration date, dose were unknown) intramuscularly. Concomitant therapies included CELEXA. The patient found out that she was pregnant on 07-APR-2013. Last Menstrual Period (LMP) and Expected Delivery of Date (EDD) was unknown. After 31 weeks of pregnancy on an unspecified date, the patient delivered twins (MARRS#1411USA013058). On 07-APR-2014 (also reported as on an unknown date) the patient developed a urinary tract infection and bacterial vaginosis after receiving GARDASIL. Unspecified antibiotics were given for the adverse events. None lab diagnostics studies were performed. The patient had sought for unspecified medical attention. The outcome of the events was reported as recovered/resolved on an unspecified date. The patient had not receive any more doses of GARDASIL since receiving the first dose. Upon internal review, the event of the patient had twins that were born after 31 weeks of pregnancy were considered to be medically significant. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Foetal disorder, Foetal malformation
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 33 year old female patient refers to herself. The patient did not have drug reactions or pertinent medical history. On 27-MAR-2013 the patient received the first dose of vaccinated with GARDASIL (lot#, expiration date, dose were unknown) intramuscularly. Concomitant therapies included CELEXA. The patient found out that she was pregnant on 07-APR-2013. Last Menstrual Period (LMP) and Expected Delivery of Date (EDD) was unknown. After 31 weeks of pregnancy on an unspecified date, the patient delivered twins (MARRS#1411USA013058). On 07-APR-2014 (also reported as on an unknown date) the patient developed a urinary tract infection and bacterial vaginosis after receiving GARDASIL. Unspecified antibiotics were given for the adverse events. None lab diagnostics studies were performed. The patient had sought for unspecified medical attention. The outcome of the events was reported as recovered/resolved on an unspecified date. The patient had not receive any more doses of GARDASIL since receiving the first dose. Upon internal review, the event of the patient had twins that were born after 31 weeks of pregnancy were considered to be medically significant. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Progesterone decreased, Vaginitis bacterial
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 33 year old female patient refers to herself. The patient did not have drug reactions or pertinent medical history. On 27-MAR-2013 the patient received the first dose of vaccinated with GARDASIL (lot#, expiration date, dose were unknown) intramuscularly. Concomitant therapies included CELEXA. The patient found out that she was pregnant on 07-APR-2013. Last Menstrual Period (LMP) and Expected Delivery of Date (EDD) was unknown. After 31 weeks of pregnancy on an unspecified date, the patient delivered twins (MARRS#1411USA013058). On 07-APR-2014 (also reported as on an unknown date) the patient developed a urinary tract infection and bacterial vaginosis after receiving GARDASIL. Unspecified antibiotics were given for the adverse events. None lab diagnostics studies were performed. The patient had sought for unspecified medical attention. The outcome of the events was reported as recovered/resolved on an unspecified date. The patient had not receive any more doses of GARDASIL since receiving the first dose. Upon internal review, the event of the patient had twins that were born after 31 weeks of pregnancy were considered to be medically significant. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Premature delivery, Twin pregnancy, Urinary tract infection, Vaginitis bacterial
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 33 year old female patient refers to herself. The patient did not have drug reactions or pertinent medical history. On 27-MAR-2013 the patient received the first dose of vaccinated with GARDASIL (lot#, expiration date, dose were unknown) intramuscularly. Concomitant therapies included CELEXA. The patient found out that she was pregnant on 07-APR-2013. Last Menstrual Period (LMP) and Expected Delivery of Date (EDD) was unknown. After 31 weeks of pregnancy on an unspecified date, the patient delivered twins (MARRS#1411USA013058). On 07-APR-2014 (also reported as on an unknown date) the patient developed a urinary tract infection and bacterial vaginosis after receiving GARDASIL. Unspecified antibiotics were given for the adverse events. None lab diagnostics studies were performed. The patient had sought for unspecified medical attention. The outcome of the events was reported as recovered/resolved on an unspecified date. The patient had not receive any more doses of GARDASIL since receiving the first dose. Upon internal review, the event of the patient had twins that were born after 31 weeks of pregnancy were considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Dyskinesia, Ear pain, Insomnia, Middle insomnia, Pyrexia
Clinical narrative: Fever up to 105.5 with ear pain, difficulty sleeping, jerking awake from sleep.  Put on Cefdinir.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Dehydration, Vomiting
Clinical narrative: Acute onset of repeated emesis, up to 15 times.  Pulse was 160, and patient was moderately dehydrated at the doctor's office.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: I received a flu shot administered by pharmacy employees at the site of my employer (half the company got one), and had a one day strong flu-like reaction, however that resolved itself as expected and is not the main concern here.  The problem is that I have had persistent soreness and pain in the site of the injection (my shoulder) since the day it was administered. My shoulder has good days and bad days, but the pain has never completely gone away, and at the time of making this report, it's ad bad as it ever has been.  I never had any issues with my shoulder prior to receiving the injection. I have received no treatment yet, but I am going to go to the doctor soon.  It is very clear to me that something bad happened when I got this shot.  I should note that in past years when I got the flu shot the soreness would be gone in a couple days.  Not this time.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site mass, Injection site pain, Pyrexia, Varicella post vaccine
Clinical narrative: Large welt type lump at the location of the shot on the back of arm.  Present for 3+weeks now.  Gets bigger and smaller, painful to the pt when touched.  3 weeks after vaccine administration, pt developed mild case of chicken pox on body (stomach, back, etc).  Also had viral like symptoms such as mild fever and fatigue.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Large welt type lump at the location of the shot on the back of arm.  Present for 3+weeks now.  Gets bigger and smaller, painful to the pt when touched.  3 weeks after vaccine administration, pt developed mild case of chicken pox on body (stomach, back, etc).  Also had viral like symptoms such as mild fever and fatigue.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Bedridden, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Sudden fatigue and chills. By 6:30 bedridden, uncontrollable shaking with chills, body aches and 102.5'F fever. 600 mg Ibuprofen. Slept 9:30pm- 5:30am. Temp 98`F.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: Sudden fatigue and chills. By 6:30 bedridden, uncontrollable shaking with chills, body aches and 102.5'F fever. 600 mg Ibuprofen. Slept 9:30pm- 5:30am. Temp 98`F.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Bad pain whole right arm, real bad pain in right hand-couldn't use it for the rest of day and next day.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Fever, chills and total body aches. Felt terrible.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Fever, chills and total body aches. Felt terrible.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site pruritus
Clinical narrative: Developed soreness at injection site, followed by swelling and large red patch extending from just above elbow to just below armpit and nearly wrapping around bicep. Severe headache began next morning as well as extreme sensitivity and itching around injection site.  Ran low grade fever. Took ibuprofen (200 mg x 4) for soreness, fever and headache and Claritin for itching. No relief. Reported to doctor's office on 11/26/14. Advised to go to ER if temp reached 101.3.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Developed soreness at injection site, followed by swelling and large red patch extending from just above elbow to just below armpit and nearly wrapping around bicep. Severe headache began next morning as well as extreme sensitivity and itching around injection site.  Ran low grade fever. Took ibuprofen (200 mg x 4) for soreness, fever and headache and Claritin for itching. No relief. Reported to doctor's office on 11/26/14. Advised to go to ER if temp reached 101.3.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Drug administration error, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: After receiving flus hot, developed sharp pain in arm/shoulder when I moved it.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: After receiving flus hot, developed sharp pain in arm/shoulder when I moved it.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 81 year old female patient with allergy to penicillin. The patient had a history of shingles prior to receiving ZOSTAVAX. On 23-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K000327, expire date 05-MAR-2015) (dose and route not reported). The patient was hospitalized in an unspecified hospital on 14-NOV-2014. While the patient was in the hospital she was diagnosed with shingles on an unspecified date. It was unknown how long the patient was in the hospital. The patient was prescribed acyclovir as treatment of the shingles. The patient told the pharmacist that she suffered with just as much pain and discomfort with this last case of shingles as she had from the former outbreaks she had on unspecified dates prior to receiving ZOSTAVAX. The outcome was reported as recovering/resolving. According to the pharmacist, "the patient is almost completely recovered." It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV, VARZOS
Symptoms: Injection site pain, Lethargy
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a anonymous patient of unknown age and unknown gender. The patient's pertinent medical history and drug allergies were unspecified. On an unknown date the patient was concomitantly vaccinated with ZOSTAVAX, PNEUMOVAX 23 and unspecified flu vaccine (manufacturer unknown). Concomitant medications were unspecified. On an unknown date the patient experienced extreme lethargy and injection-site arm pain. The patient sought medical attention with the pharmacist. The outcome of extreme lethargy and injection-site arm pain was reported as recovered on an unknown date. The causality of the lethargy and injection-site arm pain was not reported. No product complaint was reported for ZOSTAVAX, PNEUMOVAX 23 and unspecified flu vaccine (manufacturer unknown). This case is linked to case # 1411USA006409 (same reporter link). 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 health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ, (dose, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: FLUX, PPV, VARZOS
Symptoms: Lethargy
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to two (2) anonymous patients of unknown age and unknown gender. The patients pertinent medical history was unspecified. On an unknown date, the anonymous patients were concomitantly vaccinated with ZOSTAVAX, PNEUMOVAX 23 and unspecified Flu vaccine (manufacturer unknown). Concomitant medications were unspecified. On an unknown date the patients experienced extreme lethargy. The patient sought medical attention with the pharmacist and the treatment given was unspecified. The outcome of extreme lethargy was reported as recovered on an unknown date. The causality of the lethargy was not reported. No product complaint was reported for ZOSTAVAX, PNEUMOVAX 23 and unspecified Flu vaccine (manufacturer unknown). This case is linked to case # 1411USA012872 (same reporter link). 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 licensed nurse practitioner refers to multiple unspecified patients of unknown age and gender. On 01-OCT-2014 the patients were vaccinated with ROTATEQ (dosing details unknown). The reporter stated that she had a supported temperature excursion that affected ROTATEQ. Reporter stated that she presumed she had administered to multiple unspecified patients since the first excursion date, on 01-OCT-2014, but had no patient or product specific information to offer. No adverse effects were noted. Outcome of the temperature excursion of ROTATEQ was unknown. No product quality complaint was involved. This is one of the several cases received from the same reporter. Additional information has been requested.
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 month old infant. It was reported that the patient received the first dose of ROTATEQ (2ml orally; lot number not reported) on 15-APR-2014, late dosing of 2nd dose administered on 16-JUL-2014 and third dose "after 8 months of age" on 18-NOV-2014. The patient did not experience any adverse events. Additional information has been requested.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is hot, swollen 4" long swollen 1 1/2" wide. At injection site and itchy at site of subcutaneous dose of ZOSTAVAX not FLUZONE.
Sex: F
Vaccine: FLUX, MMR
Symptoms: Erythema, Nausea, Pruritus, Pyrexia
Clinical narrative: This spontaneous report was received from a female consumer of an unknown age, who is also a company representative, via company representative. Medical history was not reported. On 17-NOV-2014 the patient was vaccinated with M-M-R II injection (strength, dosage, route, lot # and expiration were not reported). Other suspect therapies included influenza virus vaccine (Manufacturer unknown). (Strength, dosage, route, lot # and expiration were not reported). The consumer informed that on an unknown date in November 2014 she experienced itching, feeling feverish, nausea and redness. The outcome of feeling feverish, nausea, redness and the patient experienced itching was unknown. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 02-SEP-2014 the patient was vaccinated with (Merck) VARIVAX (lot J009002, expiration date 19-JUL-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 9 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 02-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (lot J009002, expiration date 19-JUL-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2914 they had 9 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with (Merck) VARIVAX (lot J009002, expiration date 19-JUL-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 9 does left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with (Merck) VARIVAX (lot J009002, expiration date 19-JUL-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 9 does left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, unspecified patients were administered VAQTA (strength, dose, route, lot# were not reported) which were exposed to temperatures of 10 degrees Celsius for 7 hours and 45 minutes. No adverse events were reported. This is one of the several reports from the same source. Additional information has been requested.