chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Allergy test negative, Anaphylactic reaction, Antibody test positive, Measles antibody positive, Mumps antibody test positive
Clinical narrative: Eyelids and facial swelling, cough, wheezing.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Rubella antibody positive
Clinical narrative: Eyelids and facial swelling, cough, wheezing.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: Blurred Vision. Hep B vaccine (Merck & Co Inc.).
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site inflammation, Injection site pain, Injection site urticaria
Clinical narrative: Time of onset is approximate. Generalized hives inflammation and pain at the injection site. Treated with oral Benadryl. Patient denied: dyspnea or difficulty swallowing.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-JAN-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J006236, expiration date: 25-FEB-2016) dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This spontaneous report was received from a registered nurse regarding her daughter a 20 year old female patient. No medical history was reported. The patient was vaccinated with VARIVAX dose 1 on 17-OCT-1995 and dose 2 on 23-OCT-2008 subcutaneously (lot# and expiry not reported). The patient also received RECOMBIVAX HB dose 1 and dose 2 respectively on 17-NOV-1994 and 21-JUL-1995 (lot# and expiry not reported). The reporter stated that it was unknown which hepatitis-B vaccine the patient received but RECOMBIVAX HB cannot be ruled out. No concomitant therapy was reported. On 01-JUL-2015, the patient had routine titers drawn as required by the patient's nursing school which she attends. The patient's results returned showing negative immunity to both varicella zoster virus and hepatitis B. The hepatitis B surface antibody results as <5mIU/ml and the varicella zoster (IgG) antibody resulted as 1.05 liters in the equivocal range. The nurse reported that the patient's report stated that, the patient might not have immunity or adequate response to chicken pox and revaccination was recommended. The outcome of the events were unknown. The causality of the events were unknown. 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 refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-JAN-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J006236, expiration date: 25-FEB-2016), dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cardiovascular disorder, Syncope
Clinical narrative: This spontaneous report as received on 10-JUL-2015 from a healthcare worker via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency and route were not reported). On an unknown date, the patient experienced serious cardiovascular effects. The reporter stated that the patient was an athlete and runs track and on an unknown date, experienced fainting and collapses. On an unknown date, the patient sought medical attention and was currently taking treatment in clinic. Action taken with GARDASIL was unknown. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Upon internal review, the events cardiovascular effects and collapse were determined to be medically significant. Additional information is not expected as the reported does not wish to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-FEB-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J006236, expiration date: 25-FEB-2016) dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medial history, concurrent conditions and concomitant medications were not reported. On 10-FEB-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB lot # reported as J005672, expiration date reported as 05-DEC-2015 (dose and route were not reported). No adverse experiences were reported. This is one of several repots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 20-MAR-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB lot # reported as J005672, expiration date reported as of 05-DEC-2015 (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 07-APR-2015, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number reported as K001124, Expiry Date: 16-OCT-2016) (dose and route were not reported). No adverse experiences were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Within the past months (from 13-MAY-2015 to 13-JUL-2015), the patients were vaccinated with improperly stored doses of VAQTA (lot # K019560, expiration date 02-JUN-2017; lot # K010579, expiration date 12-FEB-2017, dose and route were unknown). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (unknown strength) both subcutaneously and intramuscularly. Concomitant medications were not reported. The nurse could not confirm if intramuscular injections were standard practice for administering these vaccines at the facility. No adverse effects were reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored ZOSTAVAX (unknown strength) both subcutaneously and intramuscularly. Concomitant medications were not reported. The nurse could not confirm if intramuscular injections were standard practice for administering these vaccines at the facility. No adverse effects were reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a consumer (patient's mother) referring to her daughter, a 19 year old female patient. Information about patient's concurrent conditions and medical history was not reported. "Last year", in 2014 the patient was vaccinated with three doses of GARDASIL (lot#, dose, route not reported). On an unspecified date the patient was given a dose of GARDASIL 9 (lot#, dose not reported, intramuscular injection) by accident (extra dose administered). No adverse event was being reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient states that arm became red and swollen below the injection site.  She was prescribed a Steroid pak by her physician, but did not take it because the reaction improved. The response resolved after 10 days.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local redness, pain, swelling at site of injection.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Cough, Exposure during pregnancy, Injected limb mobility decreased, Injection site induration
Clinical narrative: Pt described an increasing soreness at injection site which advanced to not being able to move arm by the end of the day 7/11.  By 7/12 pt states the discomfort started moving up her neck to her jaw.  Jaw very sore to touch and when she bent forward the pressure was extremely painful.  All joints began to become painful, difficulty making a fist with her hands, ankles, knees sore.  Persistent dry cough developed.  No fever.  Injection site with large area of induration but no advancing erythema.  Went to see PCP who recommended OTC antihistamine.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal discomfort, Pain in jaw, Tenderness
Clinical narrative: Pt described an increasing soreness at injection site which advanced to not being able to move arm by the end of the day 7/11.  By 7/12 pt states the discomfort started moving up her neck to her jaw.  Jaw very sore to touch and when she bent forward the pressure was extremely painful.  All joints began to become painful, difficulty making a fist with her hands, ankles, knees sore.  Persistent dry cough developed.  No fever.  Injection site with large area of induration but no advancing erythema.  Went to see PCP who recommended OTC antihistamine.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Mobility decreased, Urinary incontinence
Clinical narrative: FELT THAT THE VACCINE WAS "ALMOST DEADLY" BECAUSE SHE HAD EXTREME WEAKNESS AND FATIGUE AFTER PCV13, SHE COULD NOT MOVE OUT OF BED AFTER THE VACCINE, HAD AN EPISODE OF MILD URINARY INCONTINENCE IN THE BED.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Immunology test, Mononeuropathy, Nerve root compression
Clinical narrative: Radial neuropathy vs C6 impingement vaccinated in RUE.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood pressure increased, Chills, Flushing, Nausea
Clinical narrative: Patient felt nauseated and felt her heart was racing. Blood pressured was checked and was slightly elevated based on what the patient reported was normal. Chills/felt flushed/ weak.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Patient felt nauseated and felt her heart was racing. Blood pressured was checked and was slightly elevated based on what the patient reported was normal. Chills/felt flushed/ weak.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Eye pruritus, Eye swelling, Eyelid oedema, Hypersensitivity, Urticaria
Clinical narrative: Hives slowly started showing and the allergic reaction peaked around 6:00 PM with hives all over back, shoulders and neck and swollen, puffy, itchy eyes.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Pain, Rash generalised
Clinical narrative: Full body rash, achiness, lethargy.
Age: 54.0
Sex: F
Vaccine: HEPA, MMR, MNQ
Symptoms: Chills, Headache, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: Local redness, swelling (Right deltoid); Body ache; chills; headache; sweating.
Age: 54.0
Sex: F
Vaccine: HEPA, MMR, MNQ
Symptoms: Pain
Clinical narrative: Local redness, swelling (Right deltoid); Body ache; chills; headache; sweating.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Marked redness and swelling upper anterior and medial L arm.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Rash
Clinical narrative: RASH ON FACE WITH REDNESS AROUND THE EYES. WE GIVE PATIENT BENADRYL AND WE KEEP PATIENT FOR 30MIN. WE SEND PATIENT HOME AFTER. NO RASH NOTICED.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Pt said had pain in arm for a week following shot.
Age: 66.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Activities of daily living impaired, Inflammation, Injected limb mobility decreased, Insomnia, Nuclear magnetic resonance imaging abnormal
Clinical narrative: 2 Injections in Left Arm Boostrix -Diphtheria-Tetaus & Fluzone High Dose Flu vaccinations. Arm was sore after injections, by 4 couldn't move arm and had extreme pain. Checked internet & said to expect some pain. Arm didn't get better, couldn't sleep or move arm. Been six months still can't do much. Painful Physical Therapy twice a week. Major limited range of motion, can't hold or lift arm up. Impacted everyday activities and social life to the point I am a shut in. Before injection I had no problem with arm, shoulder, neck or side. MRI shows inflammation in arm, shoulder area. Now I can't function.
Age: 66.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity, Social problem, X-ray normal
Clinical narrative: 2 Injections in Left Arm Boostrix -Diphtheria-Tetaus & Fluzone High Dose Flu vaccinations. Arm was sore after injections, by 4 couldn't move arm and had extreme pain. Checked internet & said to expect some pain. Arm didn't get better, couldn't sleep or move arm. Been six months still can't do much. Painful Physical Therapy twice a week. Major limited range of motion, can't hold or lift arm up. Impacted everyday activities and social life to the point I am a shut in. Before injection I had no problem with arm, shoulder, neck or side. MRI shows inflammation in arm, shoulder area. Now I can't function.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history was not reported. On unknown dates the patients were vaccinated with VARIVAX (Merck) (strength, dose, route and lot # not reported) which was improperly stored. No adverse effect reported. This is one of the 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 registered nurse referring to unspecified patients of unknown age and gender. The patient's concurrent condition and medical history was not reported. On unknown dates the patients were vaccinated with PROQUAD (strength, dose, route and lot # not reported) which was improperly stored. No adverse effect 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 nurse 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 date, the patients were vaccinated orally with doses of ROTATEQ (lot # K006457, expiry date 03-SEP-2016; strength, dose, frequency were not reported), which were exposed to temperature outside of the recommended range. There were no concomitant therapies reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a health care worker and a nurse and refers to a 13-years-old female patient. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On 13-JUL-2015 (also reported as "today"), the patient was vaccinated with an expired dose of GARDASIL, lot # H020901, expiration date: 05-JUL-2015 (dose, route of administration and indication were not reported). It was the patient's first dose in the series. The patient had not reported an adverse experience. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a health care worker and a nurse and refers to a 15-years-old female patient. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On 13-JUL-2015 (also reported as "today"), the patient was vaccinated with an expired dose of GARDASIL, lot # H020901, expiration date: 05-JUL-2015 (dose, route of administration and indication were not reported). It was the patient's first dose in the series. The patient had not reported an adverse experience. This is one of several reports received form the same reporter. 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 Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2015, as reported since 20-APR-2015, the patient was vaccinated with improperly stored VARIVAX (Merck). 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. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 1 day old male patient. Information about concurrent conditions and medical history was not provided. On 10-JUL-2015 the patient was vaccinated with RECOMBIVAX HB (lot # L007558, expire date 10-NOV-2016, 0.5 ml, intramuscular in the right lower extremity) which was improperly stored. No adverse effects reported at this time. The outcome of the events was not reported. Additional information is not expected because physician gave no consent to be contacted.
Age: 2.0
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a physician via a company representative and concerns a 2-year-old patient of unknown gender. No information about patient's concomitant medication, pertinent medical history, drug reactions or allergies was provided. The physician read, on an unspecified website, that the patient was administered GARDASIL (dose, route of administration, lot# and expiration date not reported) (date not specified). It was confirmed that the patient was not administered GARDASIL 9. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age. Concomitant medication, medical history and concurrent condition were not reported. The reporter stated that expired VARIVAX (Merck) (lot # J004164, Exp 8-APR-2015) was administered to patient on 09-JUL-2015. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy, HIV test negative, Human chorionic gonadotropin positive, Nasopharyngitis
Clinical narrative: This spontaneous retrospective pregnancy report was received from a current 26 year old female patient, reporting on herself. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date in "2012 or 2013", the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# were not provided). The patient reported that she completed a three-dose series of GARDASIL on unspecified dates. The patient also reported that she suspected she may have been inadvertently administered doses of an unspecified "birth control shot" instead of the intended doses of GARDASIL, because she became pregnant an unspecified number of times after completing the GARDASIL series on unspecified dates, but each pregnancy resulted in miscarriage (MARRS # 1507USA005633). The patient reported that she had two positive pregnancy tests on unspecified dates which confirmed her most recent pregnancy (exposure during pregnancy). The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known. The patient reported that she then experienced vaginal bleeding which was considered as a vaginal haemorrhage and another miscarriage "5 months ago" in approximately February 2015; as a result, the patient went to an unspecified local and was given unspecified "pain pills" as treatment. The patient reported that in order to determine why all of her pregnancies had been resulting in miscarriages, she had Human Immunodeficiency Virus (HIV)/ Acquired immune deficiency syndrome (AIDS) testing on an unspecified date which was negative. Patient also reported that her "human chorionic gonadotropin (HCG) level was 57 (units not provided)" on an unspecified date; the significance of this result or relationship to the patient's event was unspecified. The patient also reported that she was taking unspecified vitamins (since on an unspecified date), and also was taking unspecified pain medication (manufacturer unspecified) "whenever she had pain" on unspecified dates and unspecified antibiotic (manufacturer unspecified) "whenever she had a cold" on unspecified dates. It was additionally reported that it could not be confirmed whether patient experienced unspecified pain or developed a cold after receiving GARDASIL. No product confusion was reported. At the time of the report, the patient's outcome from abortion spontaneous, pain and cold was unknown. Upon internal review the event of abortion spontaneous was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Pregnancy test positive, Vaginal haemorrhage
Clinical narrative: This spontaneous retrospective pregnancy report was received from a current 26 year old female patient, reporting on herself. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date in "2012 or 2013", the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# were not provided). The patient reported that she completed a three-dose series of GARDASIL on unspecified dates. The patient also reported that she suspected she may have been inadvertently administered doses of an unspecified "birth control shot" instead of the intended doses of GARDASIL, because she became pregnant an unspecified number of times after completing the GARDASIL series on unspecified dates, but each pregnancy resulted in miscarriage (MARRS # 1507USA005633). The patient reported that she had two positive pregnancy tests on unspecified dates which confirmed her most recent pregnancy (exposure during pregnancy). The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known. The patient reported that she then experienced vaginal bleeding which was considered as a vaginal haemorrhage and another miscarriage "5 months ago" in approximately February 2015; as a result, the patient went to an unspecified local and was given unspecified "pain pills" as treatment. The patient reported that in order to determine why all of her pregnancies had been resulting in miscarriages, she had Human Immunodeficiency Virus (HIV)/ Acquired immune deficiency syndrome (AIDS) testing on an unspecified date which was negative. Patient also reported that her "human chorionic gonadotropin (HCG) level was 57 (units not provided)" on an unspecified date; the significance of this result or relationship to the patient's event was unspecified. The patient also reported that she was taking unspecified vitamins (since on an unspecified date), and also was taking unspecified pain medication (manufacturer unspecified) "whenever she had pain" on unspecified dates and unspecified antibiotic (manufacturer unspecified) "whenever she had a cold" on unspecified dates. It was additionally reported that it could not be confirmed whether patient experienced unspecified pain or developed a cold after receiving GARDASIL. No product confusion was reported. At the time of the report, the patient's outcome from abortion spontaneous, pain and cold was unknown. Upon internal review the event of abortion spontaneous was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Accidental exposure to product, Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a current 26 year old female patient, reporting on herself. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date in "2012 or 2013", the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# were not provided). The patient reported that she completed a three-dose series of GARDASIL on unspecified dates. The patient also reported that she suspected she may have been inadvertently administered doses of an unspecified "birth control shot" instead of the intended doses of GARDASIL, because she became pregnant an unspecified number of times after completing the GARDASIL series on unspecified dates, but each pregnancy resulted in miscarriage (MARRS # 1507USA005633). The patient reported that she had two positive pregnancy tests on unspecified dates which confirmed her most recent pregnancy (exposure during pregnancy). The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known. The patient reported that she then experienced vaginal bleeding which was considered as a vaginal haemorrhage and another miscarriage "5 months ago" in approximately February 2015; as a result, the patient went to an unspecified local and was given unspecified "pain pills" as treatment. The patient reported that in order to determine why all of her pregnancies had been resulting in miscarriages, she had Human Immunodeficiency Virus (HIV)/ Acquired immune deficiency syndrome (AIDS) testing on an unspecified date which was negative. Patient also reported that her "human chorionic gonadotropin (HCG) level was 57 (units not provided)" on an unspecified date; the significance of this result or relationship to the patient's event was unspecified. The patient also reported that she was taking unspecified vitamins (since on an unspecified date), and also was taking unspecified pain medication (manufacturer unspecified) "whenever she had pain" on unspecified dates and unspecified antibiotic (manufacturer unspecified) "whenever she had a cold" on unspecified dates. It was additionally reported that it could not be confirmed whether patient experienced unspecified pain or developed a cold after receiving GARDASIL. No product confusion was reported. At the time of the report, the patient's outcome from abortion spontaneous, pain and cold was unknown. Upon internal review the event of abortion spontaneous was considered to be medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy, HIV test negative, Human chorionic gonadotropin positive, Nasopharyngitis
Clinical narrative: This spontaneous retrospective pregnancy report was received from a current 26 year old female patient, reporting on herself. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date in "2012 or 2013", the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # were not provided). The patient reported that she completed a three-dose series of GARDASIL on unspecified dates. The patient also reported that she suspected she may had been inadvertently administered doses of an unspecified "birth control shot" instead of the intended doses of GARDASIL, because she became pregnant an unspecified number of times after completing the GARDASIL series on unspecified dates. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known. It was reported that each pregnancy resulted in miscarriage on unspecified dates. The patient also reported she had a recent pregnancy on an unspecified date but she then experienced another miscarriage "5 months ago" in February 2015 (MARRS # 1507USA006213). At the time of the report, the patient's outcome from abortion spontaneous was unknown. It was unknown if the patient sought medical attention. Upon internal review the event of abortion spontaneous was considered to be medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Pregnancy test positive, Vaginal haemorrhage
Clinical narrative: This spontaneous retrospective pregnancy report was received from a current 26 year old female patient, reporting on herself. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date in "2012 or 2013", the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # were not provided). The patient reported that she completed a three-dose series of GARDASIL on unspecified dates. The patient also reported that she suspected she may had been inadvertently administered doses of an unspecified "birth control shot" instead of the intended doses of GARDASIL, because she became pregnant an unspecified number of times after completing the GARDASIL series on unspecified dates. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known. It was reported that each pregnancy resulted in miscarriage on unspecified dates. The patient also reported she had a recent pregnancy on an unspecified date but she then experienced another miscarriage "5 months ago" in February 2015 (MARRS # 1507USA006213). At the time of the report, the patient's outcome from abortion spontaneous was unknown. It was unknown if the patient sought medical attention. Upon internal review the event of abortion spontaneous was considered to be medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Accidental exposure to product, Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a current 26 year old female patient, reporting on herself. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date in "2012 or 2013", the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # were not provided). The patient reported that she completed a three-dose series of GARDASIL on unspecified dates. The patient also reported that she suspected she may had been inadvertently administered doses of an unspecified "birth control shot" instead of the intended doses of GARDASIL, because she became pregnant an unspecified number of times after completing the GARDASIL series on unspecified dates. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known. It was reported that each pregnancy resulted in miscarriage on unspecified dates. The patient also reported she had a recent pregnancy on an unspecified date but she then experienced another miscarriage "5 months ago" in February 2015 (MARRS # 1507USA006213). At the time of the report, the patient's outcome from abortion spontaneous was unknown. It was unknown if the patient sought medical attention. Upon internal review the event of abortion spontaneous was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 17-MAR-2015, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number reported as K001124, Expiry date: 16-OCT-2016) (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 03-JAN-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number: J000360, Expiry date: 25-OCT-2015) (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 10-JAN-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number reported as J005672, Expiry date: 05-DEC-2015) (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Pain in extremity
Clinical narrative: 10/14/2013 Received Tdap and Typhoid Vi (IM (L) deltoid on 10/14/13. 11/4/13 Called c/o (L) arm pain. Recommended Ibuprofen prn reassurance given and advised to follow up with PCP if symptoms continue.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 03-FEB-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB lot # reported as J005672, expiration date reported as 05-DEC-2015 (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness unilateral, Lumbar puncture, Nuclear magnetic resonance imaging, Visual impairment
Clinical narrative: Pt experienced usual difficulties in Oct, 2014 - continues to have significant (R) sided visual loss.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient' concurrent conditions and medical history were not reported. On 05-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J006236, expiration date: 25-FEB-2016) dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Injection site reaction-erythema, warmth, induration, pain. GI upset-nausea, loose stools.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea
Clinical narrative: Injection site reaction-erythema, warmth, induration, pain. GI upset-nausea, loose stools.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: HPV-4 given on 7/9/15. Pregnant test same day resulted positive. She had her 1st prenatal appt done 7/14/15.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood glucose normal, Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope
Clinical narrative: Vaccine administered-Tdap-LD, HPV, MCV4-RD immediately started to lose consciousness, became pale, not diaphoretic, no salivary excretions, no eye movement, pt. fainted no loss of consciousness. Pt responded to directions and opened eyes.
Age: 60.0
Sex: U
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: Generalized joint pain. Home measures as per phone call to telephone advice line, today.
Age: 82.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling abnormal
Clinical narrative: My father received a Tdap on 7-2-15. On 7-3-15, he reported feeling "out of it" and vision changes. He says these possible side effects were listed on his VIS. They are not on the VIS I have. Regardless, he said a cold shower and nap resolved the sx.
Age: 1.14
Sex: F
Vaccine: PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 09-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences 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 certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 12-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 44 years old female patient. The patient had no pertinent medical history nor drug reactions or allergies. On 28-MAY-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB, intramuscular, (dose was not reported), lot # K010216, expiration date 17-SEP-2016. The patient was taking no concomitant medication. On 09-JUN-2015, the patient experienced systemic arthralgia in all of her joints that developed into muscle pain following the administration of RECOMBIVAX HB. The reporter stated that the patient sought medical attention by visited an unspecified primary care physician's office on an unspecified date where an unspecified blood test was performed, and treatment was given to the patient in the form of an unspecified dose of nonsteroidal anti-inflammatory drugs (NSAIDS). The reporter also stated that the patient was currently experiencing residual muscle pain that is localized in the patient's calves on 16-JUN-2015. At the time of the report, the outcome of currently experiencing residual muscle pain that is localized in the patient's calves, the patient experienced systemic arthralgia and developed into muscle pain was reported as recovering/resolving. The relatedness between the events and therapy with RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medical history and drug reactions and allergies. On unspecified dates in July 2015, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot#, expiration date, dose, frequency, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer Inc. (Manufacturer Control No. 201503126) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and Lot number were not reported). No concomitant therapy was provided. On an unknown date, the patient experienced injection site reaction to PNEUMOVAX23. The outcome of injection site reaction was 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 nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medical history and drug reactions and allergies. On unspecified dates in July 2015, the patients were vaccinated with improperly stored PROQUAD (lot#, expiration date, dose, frequency, route and site of administration were not reported). No adverse events 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 reprot as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # H020901, expiration date: 05-JUL-2015), dose and route were not reported. No adverse experiences were 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 as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 15-MAY-2015 was vaccinated with a dose of ROTATEQ (lot No. K016313) (dose and route not reported) that was 87 hours temperature excursion. This lot was received on 08-APR-2015. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PNEUMOVAX23 single dose (dose strength, route and lot number was unknown). 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 form the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Insomnia
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 66 year old male patient. No concurrent conditions or medical history were reported. On 24-JAN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot No. H009826 Expiration date: 11-FEB-2014) (dose, dose number and route were not reported). There was no concomitant medication reported. On the same date of administration, the patient experienced injection site pain for several days, painful enough that he couldn't sleep for that period of time. The pharmacist stated that the patient did not report any redness or any other adverse effects. The patient did not seek medical attention. No treatment was given for the adverse events. Also, she stated that the patient came to her pharmacy only for his vaccinations. The outcome of injection site pain was reported as recovered on an unknown date. 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 medical assistant and refers to an unknown number of patients (age and gender were not reported). Pertinent medical history or drug allergy/drug reactions were not reported. On an unknown date, the patients were inadvertently vaccinated with improperly stored GARDASIL (confirmed not GARDASIL 9) (lot number, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of three reports from the same reporter. Additional information has been requested.