chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a registered nurse refers to multiple unspecified patients of unknown age. No information on their medical histories, concurrent conditions or concomitant therapies was provided. On unknown dates the patients were vaccinated with PROQUAD (Merck) (lot number, expiration date, dose, route of administration not specified). The reporter stated the vaccines were improperly stored. There was no adverse effect reported. This is one of 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 certified medical assistant refers to unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical histories or concomitant therapies reported. On an unknown date, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot number: L007227, expiration date: 03-MAR-2017), (lot number: L008272, expiration date: 11-MAR-2017), (lot number: L004650, expiration date: 11-FEB-2017) (dose, route of administration unspecified). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored GARDASIL (lot # J013324, expiration date 12-FEB-2016; dose, route and frequency not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On an unknown date in 2014, the patient was vaccinated with GARDASIL dose 1. On 29-JUL-2015, the patient was vaccinated with GARDASIL dose 2. No adverse effect was reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Fall, Head injury, Suture insertion, Syncope
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to an 18 year old male patient. The patient's concurrent conditions and medical history were not reported. On 27-JUL-2015, the patient was vaccinated with GARDASIL (unknown strength and route). Concomitant medications were not reported. On 27-JUL-2015, the patient fainted, fell off of the exam table and hit his head after he received his GARDASIL vaccination. He was then taken to an unspecified Emergency Room (ER) where he was given 12 stitches for his injury. It was unknown how long the patient was in the ER. The outcome of the events was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Computerised tomogram, Eyelid injury, Fall, Head injury, Laceration
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to an 18 year old male patient. The patient's concurrent conditions and medical history were not reported. On 27-JUL-2015, the patient was vaccinated with GARDASIL (unknown strength and route). Concomitant medications were not reported. On 27-JUL-2015, the patient fainted, fell off of the exam table and hit his head after he received his GARDASIL vaccination. He was then taken to an unspecified Emergency Room (ER) where he was given 12 stitches for his injury. It was unknown how long the patient was in the ER. The outcome of the events was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Loss of consciousness, Suture insertion, Syncope
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to an 18 year old male patient. The patient's concurrent conditions and medical history were not reported. On 27-JUL-2015, the patient was vaccinated with GARDASIL (unknown strength and route). Concomitant medications were not reported. On 27-JUL-2015, the patient fainted, fell off of the exam table and hit his head after he received his GARDASIL vaccination. He was then taken to an unspecified Emergency Room (ER) where he was given 12 stitches for his injury. It was unknown how long the patient was in the ER. The outcome of the events was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unspecified date in July 2014 the patient was administered the first dose of GARDASIL (dose, lot# and expiration date were not reported) intramuscularly. Then on 17-JUL-2015 the patient was administered the second dose. Concomitant drug was not reported. It was unknown whether the patient sought medical attention. No adverse effect 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 Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date between 12-JAN-2015 and 05-JUL-2015, the unspecified number of patients were vaccinated with GARDASIL lot# K007264 exp. 02-MAR-2017, lot# K008931 exp. 04-MAR-2017, K010574 exp. 08-APR-2017 (dose, route of administration not reported). The GARDASIL was improperly stored. There was no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to 3 patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored MMR II (lot# K022285, expiration date 22-NOV-2016, dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 11-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 11-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effects was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date between 12-JAN-2015 and 05-JUL-2015, the unspecified number of patients were vaccinated with ROTATEQ orally, lot # K006805 exp. 24-MAR-2016, lot # K009753 exp. 28-APR-2016, lot # K010222 exp. 12-MAY-2016, lot # K011948 exp. 07-JUN-2016 (dose, route of administration not reported). The ROTATEQ was improperly stored. There was no adverse effects reported. Additional information has been requested. This is one of several reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot# reported as L011085, expiration date 01-APR-2017, dose and route of administration were not reported). The patient's concomitant medication was not provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date between 12-JAN-2015 and 05-JUL-2015, the unspecified number of patients were vaccinated with GARDASIL 9 lot # K026246 exp. 28-JAN-2017 (dose, route of administration not reported). The GARDASIL 9 was improperly stored. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2008, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot#, expiration date were not reported). On 04-MAY-2015, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, lot#, expiration date were not reported) (Inappropriate schedule of drug administration). The physician thought that the second dose was quadrivalent. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 15-JUN-2015, the patient was vaccinated with unspecified number of improperly stored dose of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 16-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from healthcare worker referring to a 22 year old patient of unknown gender. Information about medical history and concurrent condition was not reported. The first dose of GARDASIL was administered on 08-OCT-2007; the second dose was on 19-SEP-2008 and the third dose was administered on 10-DEC-2008 (strength, dosage, frequency and route were all unspecified) (inappropriate schedule of vaccine administration). On 30-JUL-2015, the patient was vaccinated with the fourth dose of GARDASIL (lot # K010574 with expiration date of 30-JUL-2015; strength, dosage frequency and route unspecified) (extra dose administered). No adverse effects were reported. Additional information is not expected because the physician did not want to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 12-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Epstein-Barr virus test negative, Haematocrit decreased, Haemoglobin decreased, Lymphadenitis, Lymphadenopathy
Clinical narrative: Vaccine 7/23. 7/26-noticed lymph node (L) cervical enlargement. 7/30-started AUGMENTIN for cervical lymphadenitis. 8/3-Lymph enlarging (L) cervical.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Mononucleosis heterophile test negative
Clinical narrative: Vaccine 7/23. 7/26-noticed lymph node (L) cervical enlargement. 7/30-started AUGMENTIN for cervical lymphadenitis. 8/3-Lymph enlarging (L) cervical.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dry mouth, Dry throat, Headache, Migraine
Clinical narrative: C/O dry throat and mouth. C/O headache and nausea. C/O dizziness. C/O arm weakness. ER visit 8-3-15 said gave 3 injections for nausea, migraine and steroid. States rested a little and just feeling a little better 8-3-15 at 3:45 PM.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness, Nausea
Clinical narrative: C/O dry throat and mouth. C/O headache and nausea. C/O dizziness. C/O arm weakness. ER visit 8-3-15 said gave 3 injections for nausea, migraine and steroid. States rested a little and just feeling a little better 8-3-15 at 3:45 PM.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and healthcare student concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided. The pharmacist reported that the aforementioned patient received the first dose of GARDASIL (strength, dose, route of administration, lot number and expiration date were not provided) and subsequently, on 06-JUN-2015 the patient was vaccinated with the second dose of GARDASIL (strength, dose, route of administration, lot number and expiration date were not provided), leading to an inappropriate schedule of vaccine administered. No adverse events or product quality complaints were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product expiration date issue
Clinical narrative: This initial report was received from a certified medical assistant concerning to seven (7) anonymous patients of unknown age and gender. On an unknown date in 2015, the patients were vaccinated with the first dose of, at least, seven single-dose of MMR II 0.5 mL, intramuscular (lot # J007929, expire 28-JUL-2015). The reported also stated that no patients received any expired vaccine even though the unclear expire date in the carton was notice only the product had expired. The expired year in the carton was illegible in the way that the carton debussing was not clear whether the year was 2015 or 2016, but the product vials clearly showed the expired year as 2015, not 2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to an unspecified numbers of patient of unknown age and gender. On unspecified dates since 01-MAR-2015, the unspecified number of patients were vaccinated with an improperly stored dose of GARDASIL lot # K023432, expiration date 18-JUN-2016 (strength, dose #, dose, route of administration and anatomical location were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complaint involved. 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 was received from a licensed practical nurse, and refers to an unspecified numbers of patients of unknown age and gender. On unspecified dates since 01-MAR-2015, the unspecified number of patients were vaccinated with an improperly stored dose of ROTATEQ orally, lot # K004773, expiration date on 22-FEB-2015 (strength, dose # and dose were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complaint involved. This is one of several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to an unspecified numbers of patients of unknown age and gender. On unspecified dates since 01-MAR-2015, the unspecified number of patients received an improperly stored dose of RECOMBIVAX HB, lot # K007263, expiration date on 09-JUN-2016 (strength, dose #, dose, route of administration and anatomical location were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to an unspecified numbers of patient of unknown age and gender. On unspecified dates since 01-MAR-2015, the unspecified number of patients were vaccinated with an improperly stored dose of VAQTA lot # K005958; expiration date on 09-FEB-2017 (strength, dose #, dose, route of administration and anatomical location were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complaint involved. 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 was received from a healthcare worker and 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 (lot # K008140 with expiration date: 30-MAR-2016 and lot # L002048 with expiration date: 09-JUL-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Lot number L002048 has been verified to be a valid lot number for ROTATEQ. Follow up information has been received from the medical assistant on 21-JUL-2015. On 21-JUL-2015, a telephone call was placed to the physician who was not available at the time of the call. The call was transferred to the medical assistant, who confirmed the lot numbers and expiration dates for vaccines there were administered to multiple and unspecified patients from 05-JUN-2015 to 16-JUN-2015.  Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from 26 year old patient of unknown gender. Concurrent conditions and medical history were not reported. The patient stated that in June 2014, also reported as "had GARDASIL Dose 1 completed more than a year ago", the patient was vaccinated with the first dose of GARDASIL (Lot number, expiration date, dose and route were not reported). Concomitant medications were not reported. The reporter stated that the patient stopped continuing with the second dose and the third dose because the patient had an abnormal pap smear and the patient was told that had HPV. A gynecologist told her/him that once she/he had HPV, getting further GARDASIL treatments would be ineffective since she/he already had HPV. However, the patient read through the company web site that event if someone did have HPV, that person should still get GARDASIL. The patient wondered if he/she needed to restart the series and if she/he had to restart, the last dosage which would occur after the patient's 27th birthday in February 2015. The patient also query if that would affect the effectiveness of the series, also said that she/he had been traveling and would continue to travel, the patient wondered if it would be an issue to get the different dosages in different countries. The outcome of papilloma viral infection was unknown. The reporter did not assess the relatedness of GARDASIL to HPV. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: This spontaneous report was received from a pharmacist who was informed by the patient's husband, a currently 56 year old female patient. Concurrent conditions or pertinent medical history were not reported. On 13-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (lot # K020802, expiration date 31-JAN-2016) 0.65 ml, for the prevention of herpes zoster. Concomitant medications were not reported. On an unknown date in 2015 after receiving the vaccine, the patient experienced an unspecified reaction (adverse event following immunization), and it was started that at the time of the report, the patient still had 'discoloration" that looked like a bruise at the injection site. It was stated that the patient did not sought for medical attention, that no intervention to prevent serious criteria was necessary, that the patient did not die or was hospitalized, that there was not any significant disability or incapacity and that the events were not life threatening. At the time of the report, the outcome of the adverse event following immunization and administration site bruise was unknown. The relatedness of adverse event following immunization and administration site bruise with ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no concurrent condition or medical history. The patient had no drug reactions or allergies. The pharmacist reported that the patient received a dose of a tetanus vaccine (manufacturer unknown) on 11-JUN-2015 in her right arm. On 14-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot # L013546, expiration date 17-JUL-2015) 0.65 ml, subcutaneous in the posterior right arm (dose not reported). The pharmacist reported that on 16-JUL-2015, the patient consulted him to show her injection site where she received ZOSTAVAX. The pharmacist stated that site was red, swollen, and warm to the touch in a 4-inch diameter around the injection site. The patient reported that she noticed the symptoms developing "last night," (on 15-JUL-2015). The pharmacist stated that she had not notified her primary healthcare provider at this time, and that he cannot determine whether or not she was developing a rash. No treatment was given to the patient and on laboratory diagnostic studies were performed. The outcome of injection site erythema, rash, injection site warmth and injection site swelling was reported as not recovered/not resolved. The reporter did not assess the relatedness between ZOSTAVAX and the events above mentioned. 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 a patient of unknown age and gender who on 08-APR-2015 was vaccinated with a dose of ROTATEQ (lot # K011663 (expiration date, dose, route and site of administrations were not reported) that was exposed for 72 hours to temperatures outside of the recommended range. No adverse effects were observed or reported. This is one of several reports 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 Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date between 12-JAN-2015 and 05-JUL-2015, the unspecified number of patients were vaccinated with LIQUID PEDVAXHIB lot # K008879 exp. 30-MAR-2017, lot# K019701 exp. 17-JUL-2017, K026533 exp. 07-AUG-2017 (dose, route of administration not reported). The LIQUID PEDVAXHIB was improperly stored. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: M
Vaccine: HEP
Symptoms: Drug hypersensitivity
Clinical narrative: This case was reported by a other health professional via other manufacturer and described the occurrence of drug allergy in a male patient who received Hepatitis B vaccine. The patient's past medical history included depression, hypercholesterolemia, hypertension, atherosclerosis and peripheral vascular disease. Concurrent medical conditions included iodine allergy and penicillin allergy. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to Hepatitis B vaccine. Additional details were provided as follow: This case was received from Pfizer. It was reported in the medical history of the patient that he had a drug allergy to Hepatitis B vaccine.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medications was not reported. On 11-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reported received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 61 year old male patient with hypothyroidism, diabetes mellitus, chronic obstructive pulmonary disease (COPD), high cholesterol, hypertension, asthma, Graves' disease and with drug reaction/allergy to penicillin (MARRS # 1508USA000606) and ciprofloxacin (for both the reaction was anaphylaxis). On 24-MAR-2015, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # L001311, exp. date: 06-JUL-2016) (dose was not reported). On 30-JUL-2015, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # L002310, exp. date: 08-JUL-2016). Concomitant therapies included levothyroxine sodium (manufacturer unknown), LASIX, CHANTIX, NIASPAN, fenofibrate, lovastatin (manufacturer unknown), fluticasone propionate, ADVAIR, ZYRTEC, aspirin (manufacturer unknown), omeprazole (manufacturer unknown) and albuterol sulfate (manufacturer unknown). On 30-JUL-2015, the patient developed swelling at the PNEUMOVAX 23 injection site and slight fever. No lab diagnostic studies were performed. The patient sought medical attention via calling the healthcare worker. There was no treatment given for adverse events. The outcome of events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 16-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 18-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were not reported. Two months ago (approximately May 2015), the patient was vaccinated with GARDASIL (dose, frequency and route were not reported) and on 22-JUL-2015 the patient went to the office to received his second dose of HPV vaccine, but they would be administering GARDASIL 9 (dose, frequency, lot number and route were not provided) to complete the series. No adverse experience was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 19-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered
Clinical narrative: Information has been received from a female patient of unknown age via company representative, referring to herself. No relevant medical history or concurrent conditions were reported. In 2005 (reported as 10 years ago) the patient was vaccinated with three shots of GARDASIL (dose, frequency, lot# and expiration date not reported). In 2014 (reported as last year) the patient received a booster shot with the GARDASIL (dose, frequency, lot# and expiration date not reported) (Extra dose administered). The patient asked if she was able to booster again with GARDASIL 9 or if she was required to take the full 3-dose series of GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical research associate referring to an unspecified number of patients of unknown age and gender. On or about 23-JUN-2015 the patients were vaccinated with doses of PNEUMOVAX 23 (dose and route were unspecified, lot # K018528, expiration 14-APR-2016) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to an unspecified numbers of patient of unknown age and gender. On unspecified dates since 01-MAR-2015, the unspecified number of patients were vaccinated with an improperly stored dose of PROQUAD (Merck) lot # K018143; expiration date on 10-APR-2015 and Lot # L005297; expiration date on 17-AUG-2016 (strength, dose #, dose, anatomical location and route of administration were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, office manager who reported that doses of PROQUAD (Merck) (lot # L003221, expired date 30-JUN-2016; lot # L002421, expired date 23-JUL-2016; lot # K025763, expired date 08-JUN-2016; lot # reported as L009206, expired date 17-SEP-2016; lot # L002213, expired date 21-JUL-2016), which were exposed to temperatures outside of the recommended range, were administered to unspecified patients on unspecified dates since 30-JUN-2015 (dose, frequency and route were not provided). No adverse effects were reported. This is one of two reports received from the same source. Lot # L009206 is an invalid lot number for PROQUAD (Merck). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, office manager who reported that doses of VARIVAX (Merck) (lot # K010438, expired date 22-JUL-2016; lot # K021486, expired date 03-NOV-2016; lot # K003423, expired date 16-MAR-2016; lot # L004655, expired date 11-FEB-2017; lot # K026385, expired date 15-DEC-2016; lot # L010144, expired date 24-MAR_2017), which were exposed to temperature outside of the recommended range, were administered to unspecified patients on unspecified dates since 30-JUN-2015 (dose, frequency and route were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 83 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. Concomitant therapies included MACROBID, UTIRA C, ANTIVERT and MYRBETRIQ. On 22-JUL-2015, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX lot # K023624, expiration date: 19-FEB-2016, (dose not specified). In July 2015, after receipt of the ZOSTAVAX the patient's upper arm became extremely red with extreme swelling around the injection site and she had a headache. On 25-JUL-2015, patient reported that the redness and swelling had diminished but was still bothersome and there was an extensive redness area. The outcome of vaccination site redness and swelling was reported as recovering. The outcome of headache was unknown. The relatedness between the events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bone pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: HEADACHE, UPPER RIGHT ARM SWELLING AND HOT TO THE TOUCH. DAY 2- BODY ACHES MUSCLE AND JOINT, FEVER 100, CONSTANT HEADACHE MORE SWELLING.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Cellulitis, Headache, Injection site swelling, Injection site warmth
Clinical narrative: HEADACHE, UPPER RIGHT ARM SWELLING AND HOT TO THE TOUCH. DAY 2- BODY ACHES MUSCLE AND JOINT, FEVER 100, CONSTANT HEADACHE MORE SWELLING.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Swelling
Clinical narrative: HEADACHE, UPPER RIGHT ARM SWELLING AND HOT TO THE TOUCH. DAY 2- BODY ACHES MUSCLE AND JOINT, FEVER 100, CONSTANT HEADACHE MORE SWELLING.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: I was given a flu shot too high in my right shoulder joint instead of in the deltoid muscle. I had severe pain in the right shoulder for 3-4 months and continued mild pain for 8 months despite NSAIDS.
Age: 30.0
Sex: M
Vaccine: ANTH, HPV4, JEV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received HPV at age 30.  No adverse event.  Pt notified.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Confusional state, Crying, Febrile convulsion, Hyperhidrosis, Lethargy
Clinical narrative: Crying, sweats, loss of color in skin and lips, lethargic, confused. Febrile seizure.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Lip discolouration, Skin discolouration
Clinical narrative: Crying, sweats, loss of color in skin and lips, lethargic, confused. Febrile seizure.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test, Dizziness, Immediate post-injection reaction, Lethargy
Clinical narrative: Lightheaded, dizzy, weak, lethargic, nauseated, immediately following vaccine-symptoms lasting-1 yr later diagnosed with POTS syndrome-still has symptoms.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Postural orthostatic tachycardia syndrome, Tilt table test
Clinical narrative: Lightheaded, dizzy, weak, lethargic, nauseated, immediately following vaccine-symptoms lasting-1 yr later diagnosed with POTS syndrome-still has symptoms.
Sex: U
Vaccine: FLU3
Symptoms: Coeliac disease
Clinical narrative: This case was reported by a consumer and described the occurrence of gluten intolerance in a patient who received Flu vaccine. Previously administered products included flu vaccine. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced gluten intolerance (serious criteria GSK medically significant). On an unknown date, the outcome of the gluten intolerance was unknown. It was unknown if the reporter considered the gluten intolerance to be related to Flu vaccine. Additional details were provided as follow: An employee at a hospital received flu vaccinations through the hospital and was diagnosed with gluten intolerance. This is one of the three cases reported by the same reporter for the same vaccine.
Sex: F
Vaccine: FLU3
Symptoms: Coeliac disease, Impaired work ability, Quality of life decreased
Clinical narrative: This case was reported by a consumer and described the occurrence of gluten intolerance in a female patient who received FLUARIX. Previously administered products included FLUARIX and FLUARIX. In 2011, the patient received FLUARIX. In November 2011, an unknown time after receiving FLUARIX, the patient experienced gluten intolerance (serious criteria GSK medically significant). On an unknown date, the outcome of the gluten intolerance was not recovered/not resolved. It was unknown if the reporter considered the gluten intolerance to be related to FLUARIX. Additional details were provided as follow: The patient had no family history of gluten sensitivity, celiac disorder, nor any other chronic condition, autoimmune disorder, etc. She was an employee at a hospital and received FLUARIX in 2009, 2010, and 2011 distributed at the hospital as part of the hospital benefit/program. In November 2011, she was diagnosed with gluten sensitivity. Since being diagnosed with gluten sensitivity, her life had been turned upside down. Her health had continually deteriorated to the point where she was currently unable to work and she currently had zero quality of life. This is one of the three cases reported by the same reporter for the same vaccine.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Computerised tomogram head, Headache, Injection site reaction, Lymphadenopathy, Mobility decreased
Clinical narrative: Headache, Nausea, Swollen Arm, Shoulder blade. Swollen Lymph nodes Left Arm where vaccination was administered. Severe tenderness, reduced arm mobility Localized Arthus reaction, pain, swelling, edema. Treatment-7 day course of steroid 20mg. Day 8, Problem is 90% resolved.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea, Oedema, Pain, Peripheral swelling, Swelling
Clinical narrative: Headache, Nausea, Swollen Arm, Shoulder blade. Swollen Lymph nodes Left Arm where vaccination was administered. Severe tenderness, reduced arm mobility Localized Arthus reaction, pain, swelling, edema. Treatment-7 day course of steroid 20mg. Day 8, Problem is 90% resolved.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Tenderness, Type III immune complex mediated reaction
Clinical narrative: Headache, Nausea, Swollen Arm, Shoulder blade. Swollen Lymph nodes Left Arm where vaccination was administered. Severe tenderness, reduced arm mobility Localized Arthus reaction, pain, swelling, edema. Treatment-7 day course of steroid 20mg. Day 8, Problem is 90% resolved.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Confusional state, Feeling abnormal, Hypotension, Loss of consciousness, Pallor
Clinical narrative: Pt had episode of syncope in the lobby while leaving the office today. She was able to tell her family she did not feel good and sat herself in a chair. She then was pale and lost consciousness for less than 1 min. She had not injury with the loss of consciousness. VS at that time 109/65 HR 62 She did seem confused after the event. She was given apple juice and observed in the office and return to normal state within 30 min. Discussed with mom and pt that combination of HPV vaccine, no breakfast and baseline low BP probably contributed to the event.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Pt had episode of syncope in the lobby while leaving the office today. She was able to tell her family she did not feel good and sat herself in a chair. She then was pale and lost consciousness for less than 1 min. She had not injury with the loss of consciousness. VS at that time 109/65 HR 62 She did seem confused after the event. She was given apple juice and observed in the office and return to normal state within 30 min. Discussed with mom and pt that combination of HPV vaccine, no breakfast and baseline low BP probably contributed to the event.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Lg red hot to touch, itching of Rt arm from should to elbow.
Age: 1.9
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Urticarial rash of right thigh, persisted for about 24 hours.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Decreased appetite, Injection site rash, Rash generalised, Skin warm
Clinical narrative: Mom states she noticed rash around neck around 9:00 PM. Also noticed he was warm to touch. (does not have thermometer) States baby was crying and could not be consoled. Mom administered Tylenol and baby stopped crying after 30 min- 1 hour. Mom states baby usually doesn't cry much. She has been giving Tylenol every 4-6 hours. Mom also states baby has not been eating as well as usual. When baby was assessed here around 2:00 PM today, rash was noted on trunk- abdomen, and upper back, upper thighs, arms, and face. Referred to MD.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Neck pain, Pyrexia
Clinical narrative: Neck pain, fever.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Hypoaesthesia, Induration, Injection site hypoaesthesia
Clinical narrative: Mother describes a reddened area on upper arm, grew to the size of a "face cloth".  Had a hard center, numbness at site of injection and down the arm.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, fever, diffuse aching.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Depression, Insomnia, Labyrinthitis, Tinnitus
Clinical narrative: I developed tinnitus and had to call the employee hotline late in the evening because it was driving me crazy. I could not sleep for weeks until I got used to the sound, but I've never really gotten completely used to it and must avoid certain situations because of the associated labarynthitis.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Pallor
Clinical narrative: Approximately 5 minutes after IMZ the patient slouched in the chair.  I did not see any loss of consciousness.  He lost color but regained it.  He sat about 20 minutes in pharmacy area and I walked him, his mother and brother to their car.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Altered state of consciousness, Chills, Dizziness, Muscular weakness, Nausea
Clinical narrative: Client c/o dizziness and states "I'm going to pass out". Head lowered between legs, but client began to slump to side. FOC lowered client to the ground with RN assistance. Legs placed up on chair. Client's eyes remained open during episode and responded to his name after 3-5 seconds and client asked "what happened". Color beginning to return to face. Moved client from ground back up to chair at 10:15 and ice back applied to back of neck as cold compress. Water provided. Client c/o nausea. Continued to keep client's head between legs in chair. Client begins to shiver at 10:18. Granola bar offered and client takes 1 bite and vomits. 10:25 client continues to feel nauseous and states his legs feel weak. Moved to ground with legs elevated on chair. Pulse = 70. Client states he continues to go through periods where he "feels better" and then "feels nauseous". 10:40 911 called. RN comes into room. At 10:43, client c/o tightness in throat. 10:45- 0.4 cc epinephrine administered in left thigh by RN. Within 30 seconds of epinephrine, client states he "feels much better" and denies tightness in throat. Client continues to remain on ground with legs elevated and is conversing with FOC. 10:50 EMS arrives and evaluates. FOC declines transport to hospital. EMS instructs FOC to take client to PCP ASAP. FOC agrees. Client walked out of clinic on his own at 11:30am.