chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. Pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients received an unspecified dose of (Oka/Merck) VARIVAX (Lot # L024256; expiration date: 01-JUL-2017) (route not reported), which was improperly stored. Concomitant therapies were not provided. No adverse effects were reported. This is one of two reports from the same source (MARRS # 1602USA001373). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unspecified date in December 2015 the patient was inadvertently administered with an expired dose of RECOMBIVAX HB (dose and lot# unspecified, exp unspecified date in October 2015) (expired product administered). No adverse effect was reported. No product quality complaint was involved. 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. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of oral, ROTATEQ (lot# L008578, exp. date: 14-DEC-2016) (strength, dose and frequency were not reported). The doses of oral ROTATEQ were in temperature minus 1.2 Celsius degree for 18 hours and 32 minutes. There was no previous temperature available. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, PPV
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Patient is being treated at this time. Child received vaccines 4 days ago. Developed fever 101-1-4 3 days ago. Has also developed area of erythema and induration over place of injection that is getting worse.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot #: K026533, expiration date on 07-AUG-2017 and lot #: L012837, expiration date on 11-MAR-2018 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Client came to clinic for zoster vaccine had prescription from doctor on 1-26-16 stated she felt some soreness that evening on the 1-27-16. Had small area quarter size redness and swelling - 1-28-16 - large area of redness noted - warm to touch may use cool compress.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from two physicians via a company representative referring to an approximately 18 year old (reported as college age, around 18 years old) patient (unspecified gender). The patient's medical history and concurrent conditions were not provided. On unspecified dates, the patient was vaccinated with two doses off (Oka/Merck) VARIVAX (doses, lot numbers and expiration dates not reported). Both doses for prophylaxis. Concomitant therapies were not provided. On an unknown date, the patient had titers drawn which were negative for immunity to varicella (antibody test negative). The outcome of antibody test negative was unknown. There was no product quality complaint (PQC) reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from two physicians via a company representative referring to an unspecified referring to an unspecified number of patients (unspecified age and gender). The patient's medical histories and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with two doses of VARIVAX (Merck) (doses, lot numbers and expiration dates not reported). Concomitant therapies were not provided. On an unknown date, the patients had titers drawn which were negative for immunity to varicella (antibody test negative). The outcome of antibody test negative was unknown. There was no product quality complain (PQC) reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received MENVEO. On 9th January 2016, the patient received MENVEO. On 27th January 2016, 18 days after receiving MENVEO, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. The reporter considered the headache to be unrelated to MENVEO. Additional details provided were as follows: This case was reported by the patient herself. The patient was in her 30s and did not have weakened immune system or diabetes.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse refers to a patients with unknown demographics. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On 08-JAN-2016, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB; dose, route and frequency: unknown) (lot # L030870, expiry date: 11-JUN-2018). The temperature excursion details for vaccine were as follows: temperature 33.6 degrees Fahrenheit (F), time frame: 6 hours, 4 minutes. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 7 days after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were received as follows: The reporter stated that, 2 patients experienced soreness one week out after the vaccination with BEXSERO. The reporter stated that, very little information was known about the event was known and all other information included as batch number of vaccine, age of patient, date of vaccination, initials of patients and expiry date of vaccine were unknown. This case has been linked with the case US2016GSK015440 for the 1st patient reported by the same reporter.
Age: 23.0
Sex: M
Vaccine: ANTH, JEV, SMALL
Symptoms: Erythema, Pain, Papule, Pruritus, Rash
Clinical narrative: Began to notice a rash on 30 Jan. He went to his local clinic and was given BENADRYL. During the weekend he noticed the onset of new lesions appearing on both of his hands, fingers and elbows. There was slight itching but he reported that the lesions were very painful and it hurt for him to bend his fingers. Multiple red papules noted on both elbows, bilateral hands with concentration of lesions noted over PIP joints. Few lesions noted on dorsal surface of fingers. No drainage, no swelling of surrounding tissue. No central clearing.
Age: 23.0
Sex: M
Vaccine: ANTH, JEV, SMALL
Symptoms: Skin lesion
Clinical narrative: Began to notice a rash on 30 Jan. He went to his local clinic and was given BENADRYL. During the weekend he noticed the onset of new lesions appearing on both of his hands, fingers and elbows. There was slight itching but he reported that the lesions were very painful and it hurt for him to bend his fingers. Multiple red papules noted on both elbows, bilateral hands with concentration of lesions noted over PIP joints. Few lesions noted on dorsal surface of fingers. No drainage, no swelling of surrounding tissue. No central clearing.
Age: 25.0
Sex: M
Vaccine: TTOX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Soreness on shoulder, limited mobility, when I'm very active as standing for 8 hours it begins to feel like it's hanging off my body.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with the unspecified number of improperly stored doses of VAQTA (lot# K018181, exp. date: 04-JUN-2017) (strength, dose and frequency were not reported). The doses of VAQTA were in temperature minus 1.2 Celsius degree for 18 hours and 32 minutes. There was no previous temperature excursion available. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with the unspecified number of improperly stored doses of GARDASIL (lot# K008931, exp. date: 04-MAR-2017) (strength, dose and frequency were not reported). The doses of GARDASIL were in temperature minus 1.2 Celsius degree for 18 hours and 32 minutes. There was no previous temperature excursion available. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored RECOMBIVAX HB (dose, route of administration, injection site, lot# and expiration date were not reported). Administered doses of RECOMBIVAX HB (dose, route of administration, injection site, lot# and expiration date were not reported). Administered doses of RECOMBIVAX HB underwent temperature excursions at 47 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a healthcare professional (medical assistant) and refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 02-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L034724, expiration date 09-DEC-2016, exact dose and route of administration were not reported) in error. The patient was indicated to receive VARIVAX (Merck) (lot # and expiration date were not reported). The reporter did not know why the error occurred, but she stated that the ZOSTAVAX vials were in the freezer beside the VARIVAX (Merck). The patient had not reported an adverse experience. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not provided. On 29-JAN-2016, the patient was vaccinated with a dose of MMR II lot # K000255, expiration date 08-JAN-2016 (route was not provided). Concomitant therapy information was not provided. On 29-JAN-2016, an expired product was administered as the patient accidentally received an expired dose of MMR II. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patients with unknown demographics. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (dose, route and frequency: unknown) (lot # L030870, expiry date: 11-JUN-2018). The temperature excursion details for vaccine were as follows: temperature 31.3 degrees Fahrenheit (F), time frame: 3 hours, 5 minutes. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored VAQTA (dose, route of administration , injection site, lot# and expiration date were not reported). Administered doses of VAQTA underwent temperature excursions at 47 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unknown doses of VAQTA (lot # L042631 with expiry date 16-DEC-2016; route was not reported), which were exposed to the temperature of 1.5 degree Celsius for 265 hours and 19 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Nodule, Swelling
Clinical narrative: Some swelling, no redness, warmth reported on 1/14/16. Seen on 1/15/16 and no redness or warmth on examination. Was told to do MOTRIN, BENADRYL, cool compress. Given AUGMENTIN on 1/18/16. Still with a knot and mild swelling after completing medication on 2/1/16.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unknown doses of GARDASIL 9 (lot # L020015 with expiry date 16-AUG-2014, lot # L011846 with expiry date 16-JUN-2017 and lot # reported as L040459 with expiry date 06-APR-2014), which were exposed to the temperature of 1.5 degree Celsius for 265 hours and 19 minutes. There was no previous temperature excursion. No adverse effects were reported. Lot number L040459 is an invalid lot number for GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Ovarian failure
Clinical narrative: Information was received from a physician via a field employee. The physician reported that on a social media physician's group, there is an article that associated GARDASIL with ovarian failure. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information of prospective pregnancy report has received from a nurse referring to a female patient of unknown age. On 27-JAN-2016 the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) (lot# L037562, expiration 29-SEP-2017, dose, frequency and route were not reported) (vaccine exposure during pregnancy). The patient was unaware of pregnancy at time of administration; patient took a home pregnancy test which came up positive on 31-JAN-2016. Patient's last menstrual period (LMP) was 22-DEC-2015 and estimated due date (EDD) of 27-SEP-2016. No adverse effect was reported. The pregnancy outcome was outcome pending. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse refers to a patient with unknown demographics. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On 07-JAN-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (dose, route and frequency: unknown) (lot # L030870, expiry date: 11-JUN-2018). The temperature excursion details for vaccine were as follows: temperature 30.1 degrees Fahrenheit (F), time frame: 6 hours, 36 minutes. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 1 month old patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 24-SEP-2015, the patient was inadvertently administered an adult dose of RECOMBIVAX HB, first dose, injection, 10/1.0 microgram/ml, 1.0ml, lot # L016427 and expiration date 13-APR-2017. There were no concomitant medications provided. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: Information has been received from a 67 year old female patient with epinephrine allergy referring to herself. Sometime in 2008 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route were unknown). On 23-JAN-2016 the patient experienced severe pain on her head. On 24-JAN-2016 a rash formed on her face, head and around her eye. The patient sought medical attention. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 01-FEB-2016 the patient was inadvertently received an expired dose of M-M-R II (lot K001231, expiry date 27-JAN-2016, dose, route and dose number were unspecified). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical Assistant referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On unknown dates the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # K008679, expiration date 05-MAR-2017; lot # L009649, expiration date 29-NOV-2017; dose and route were unknown). The vaccines were stored under 33 F for 24 hours, and were cumulative 33 F for 48 hours. There was no previous temperature excursion. It was not called because of a "data logger". No adverse effects were reported. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Feeling hot, Headache, Myalgia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 23-Jan-2015. A 40 years old male patient, had received a dose of MENACTRA via intramuscular route in the right deltoid (batch number: U4798AA, expiry date not provided) and ADACEL via intramuscular route in the left deltoid (batch number: U4971AA, expiry date not provided) on 22-Jan-2015 at 08:30 a.m. There was no pre-existing physician diagnosed allergies, birth defects, medical conditions and no illness at the time of vaccination. The concomitant medications were not reported. On 22-Jan-2015, at about 09:00 p.m., the patient experienced chills, felt hot and his deltoid muscles were hurting. That morning the patient felt better. Chills had gone but the patient had headache. It was reported that the patient did not take any "ADVIL". Laboratory investigations were not reported. The patient had recovered from chills on an unknown date however he still had headache. The patient outcome was unknown. Documents held by sender: none. Follow up information received from a healthcare professional on 23 April 2015. It was reported that, patient had received a second dose of MENACTRA and ADACEL on 22-Jan-2015 at 08:30 a.m. Patient had no other prior vaccination within four weeks and laboratory investigations. On an unspecified date, patient had recovered. Documents held by sender: none. Addendum on 15 July 2015: Upon second medical examination of the case during internal review, a significant correction was performed on 15 July 2015 to change the reporter from non-healthcare professional to health care professional in the reporter screen and narrative, to change 'administered by' from unknown to blank, to correct lot numbers in narrative and product screen, to leave the medically confirmed field blank, to mention about the event 'headache' in narrative, to add onset time of events and to enter full name of the reporter in the reporter screen.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Abdominal pain, Bacterial test negative, Basophil count normal, Basophil percentage, Chest X-ray normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Chest pain, Confusional state, Constipation, Crying, Dermatitis atopic
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Dysarthria, Dyspnoea, Eosinophil count normal, Eosinophil percentage, Flatulence
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Full blood count, Glucose urine absent, Granulocyte percentage, Haematocrit normal, Haemoglobin normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Lip oedema, Lip swelling, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Mental status changes, Monocyte count normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Monocyte percentage, Nervousness, Neutrophil count normal, Neutrophil percentage, Nitrite urine absent
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Platelet count normal, Protein urine absent, Red blood cell count normal, Red blood cells urine positive, Red cell distribution width normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Specific gravity urine normal, Speech disorder, Tachypnoea, Urinary sediment present, Urine analysis
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Urine bilirubin decreased, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, White blood cell count normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: White blood cells urine negative, pH urine normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Dysarthria, Dyspnoea, Full blood count, Mental status changes, Urine analysis
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 May 2015. This case is link to AE15-0151 (2015SA052364) (same patient same vaccine at different time). A 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL (batch number- U5081AE) and first dose of MENACTRA (batch number- U5058AA), (route of administration, site of administration were not reported for both the vaccine) on 16 April 2015. On 16 April 2015, within 20 minute after vaccination, the patient experienced altered mental status, shortness of breath and slurred speech. Other laboratory investigations were reported as UA (u Urinalysis) and CBC (Complete Blood Count). The patient was treated in the emergency room with lab work (vs) initiated with monitoring. The patient was released without treatment. At the time of this report the patient was recovered. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse refers to a patients with unknown demographics. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB; dose, route and frequency: unknown) (lot # L030870, expiry date: 11-JUN-2018. The temperature excursion details for vaccine were as follows: temperature 31.3 degrees Fahrenheit (F), time frame: 3 hours, 5 minutes. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 6-April-2015. A female patient, whose medical history and concomitant medications were not reported, had received a intramuscular dose of MENACTRA (batch number, expiry date, dose number and site of administration were not reported) and a intramuscular dose of ADACEL (batch number, expiry date, dose number and site of administration were not reported) on an unspecified date (about four years ago). Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were not provided. On an unspecified date after vaccination, the patient experienced arm became swollen from the deltoid to the elbow. Laboratory investigations and corrective treatment were not provided. On an unspecified date, the patient had recovered from the above mentioned event. Documents held by sender: none. Follow up information received from a Physician on 04-May-2015. The physician reported that he did not report any information about the event. There was no additional information provided.
Age: 45.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site mass, Limb discomfort, Local reaction, Wrong technique in product usage process
Clinical narrative: Initial unsolicited report received from pharmacist on 06 February 2015. A 45-year-old patient (gender was not reported), whose medical history and concomitant medication were not reported, had received a dose of MENACTRA (Batch number, expiry date was not reported) via intramuscular in deltoid left on 04 February 2015. On 06 February 2015, 2 days after vaccination, the patient had experienced arm feels heavy and lump at injection site and no redness at site. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. The laboratory investigation and corrective treatment was not reported. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none. Follow-up report received from a physician on 01 May 2015. Gender of patient was reported as male and the patient did not have any known drug allergy. Documents held by sender: none. Follow-up misuse information received from physician on 14 May 2015. The patient had not received any vaccine within four weeks prior to vaccination. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions, illness at the time of vaccination, relevant diagnostic test or laboratory data, other medication and adverse event following prior vaccination were reported as none. Number of previous doses was reported as more than three years ago. The patient was vaccinated at pharmacy and vaccine was purchased with private funds. Physician further reported that patient apparently had a local reaction at the site of injection which according to the patient was related to the technique rather than the vaccine itself. Patient claimed, the pharmacist injected the vaccine which was too deep, hit the bone. Patient noticed that the needle was bent. It was a wrong injection technique as the patient was injected the vaccine too deep that hit the bone. At the time of this report, patient had recovered from the events on an unspecified date. List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Adverse event
Clinical narrative: Initial unsolicited report received from a patient on 05 August 2015. A male patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of MENACTRA (batch number, expiry date, route and site of administration were not reported) on an unspecified date. On an unspecified date; after vaccination, the patient presented an adverse event. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of event was not reported. Documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Adverse event
Clinical narrative: Initial solicited report received on 04 August 2015 from a partner performing market research for Sanofi Pasteur for the below mentioned study. This case involves a female child subject (date of birth or age not reported) who developed a reaction to the last dose administered during the study participation. The subject's medical history and concomitant therapies were not reported. On an unknown date, after receiving a dose Meningococcal A-C-Y-W135 vaccine on an unspecified date (batch number, route and site of administration not reported), the subject developed a reaction. It was reported that the subject would not receive the booster vaccine as she had a reaction to the last dose administered. The subject's lab investigations and corrective treatment were not reported. Outcome of the event was unknown. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. It was not reported if the event led to the termination of the subject. List of documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Headache, Pain, Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited report received from a health care professional on 31 July 2015. A 50-year-old female patient, had received first dose of MENACTRA (batch number U4847BA, expiry date 03 March 2016, dose, dose number were not reported) intramuscularly in right deltoid on 27 July 2015 (08:00 Am). Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as diabetes type 1, anemia, hypertension and penicillin allergy. Patient had no illness at time of vaccination. Any other vaccine within four week prior vaccinations were reported as none. Concomitant medications were Norvasc, lisinopril, PROTONIX, vitamin d and apidra. On 29 July 20155 (12:00 Pm); post vaccination, the patient experienced pain, headache and redness, swelling right arm and it was hot to touch. Patient had no laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of event was unknown. Documents held by sender: none. Follow-up information received from a health care professional on 19 August 2015. It was reported that no further treatment was given to the patient. As of 05 Aug 2015 the patient had recovered from the events "actual recovery date was not reported".
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal discomfort, Pain in extremity, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 29 July 2015. A 12-year-old male patient, whose pre-existing physician diagnosed allergies, birth defects, medical conditions included asthma and illness at the time of vaccination was reported as none and concomitant medication were not reported, had received an intramuscular dose of MENACTRA (batch number U5058AA) in left deltoid and also received an intramuscular dose of BOOSTRIX (batch number 5SR2L, manufacturer GSK) in left deltoid on 28 July 2015. On 29 July 2015, one day after vaccination the patient experienced fever of 100, then later at 2 PM the patient experienced fever of 102 along with leg pain and upset stomach. The patient required ER visit following the events. The patient was given TYLENOL as corrective treatment. Laboratory investigations was not reported. At the time of reporting final outcome of the event was not reported. List of documents held by sender: none. Follow up information received from nurse on 24 August 2015. It was reported that the patient was vaccinated at private physician office/hospital. The event outcome was recovered on an unspecified time.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Injection site swelling, Nausea
Clinical narrative: Initial unsolicited report received from a nurse on 02 July 2015. A 20-year-old male patient, had received a second dose of MENACTRA (batch number U4846BA, expiry date 01 March 2016) intramuscularly in left deltoid on 29 June 2015 (16:50 hours). Patient had no other vaccine within four weeks of vaccinations. It was also reported that, patient had no illness at the time of vaccination and pre-existing physician allergies, birth defect, medical conditions. On 30 Jun 2015, i.e. after twelve hour forty minutes post vaccination patient felt light headed and it got worse during day and was sick to stomach. On 01 July 2015, i.e. two days after vaccination patient experienced some swelling at left site. Patient had no laboratory investigations. The patient had too ADVIL for lightheadedness. At the time of this report, outcome of event was unknown. Documents held by sender: none. Follow up information received from a health care professional on 22 July 2015. It was reported that on an unspecified date the patient was completely recovered and no corrective treatments were given to patient. Documents held by sender: none.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Migraine, Postural orthostatic tachycardia syndrome
Clinical narrative: Initial unsolicited report received from a consumer on 21 May 2015. A 13-year-old male patient, whose concomitant medication were not reported, had received a first dose of MENACTRA (batch number and site of administration were not reported) intramuscularly on an unspecified date in October 2010. Patient medical history included Mono + Epstein Barr (Infectious mononucleosis and Epstein-Barr Virus) Virus Infection since 2008 and it was ongoing at the time of report. On an unspecified date within a week after vaccination, patient developed fatigue and within another week, patient had developed migraines and postural orthostatic tachycardia syndrome. Patient visited a neurologist but, it was an ongoing issue and they were unsure if it was related to the vaccine or coincidental. It was reported that patient did not disclose any laboratory investigations during call. Corrective treatments were not reported. At the time of this report, patient was not recovered from the event. Documents held by sender: none.