chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical Assistant referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On 26-OCT-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M026306 with expiration date 30-APR-2018, lot # M007728 with expiration date 21-MAR-2018, lot # M021407 with expiration date 30-APR-2018, lot # M023169 with expiration date 13-JUN-2018; dose and route were not provided) for prophylaxis, which were exposed to 49.1 Fahrenheit (F) for 55 minutes. No adverse effects were reported. The data logger was involved. Additional information was received on 11-NOV-2016: Lot number M021407 and M026306 have been verified to be valid for GARDASIL 9. Follow up information was received on 05-JAN-2017. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Narrative were updated. Sender's Comments: US-009507513-1611USA000084: US-009507513-1611USA001748: US-009507513-1611USA001779: US-009507513-1611USA001825: MERCK 1611USA001731:Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates in October 2016 (reported as "at the beginning of October 2016"), the patients were vaccinated with doses of improperly stored PROQUAD (lot # L045675 with expiration date 09-MAY-2017; dose and route were unknown), for prophylaxis. The vaccines were exposed under temperature of 14 degrees Fahrenheit for a short amount. The previous temperature excursions started at the beginning of October 2016. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. All telephone attempts to obtain to follow-up information on 05-JAN-2017 have been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1611USA002911: US-009507513-1611USA000085: MERCK 1611USA002910:Mfr number.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician via a company representative referring to an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug allergies/reactions were not reported. On unknown dates, the patients were vaccinated with two doses of PNEUMOVAX 23 (Lot#, dose and route were unknown) for prophylaxis in less than the five year recommended spacing. No adverse effects were reported. Additional information is not expected as there is no consent to contact the reporter.
Sex: F
Vaccine: HPVX
Symptoms: Drug administered at inappropriate site, Limb discomfort
Clinical narrative: This spontaneous report was received from a nurse referring to herself, a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-DEC-2016, the patient was vaccinated with a dose of GARDASIL or a dose of GARDASIL 9, the reporter could not specify which, for prophylaxis, intramuscularly, on her triceps instead of in her deltoid (dose, strength, lot/batch number and expiration date were not reported). On 15-DEC-2016, a few hours after vaccination with GARDASIL or GARDASIL 9, the patient arm felt weird (Limb discomfort) and then that feeling went away. The reporter could not specify the date when the weird feeling resolved. The outcome of arm felt weird (feeling abnormal) was reported as resolved on an unspecified date in December 2016.  The relationship between GARDASIL or GARDASIL 9 and limb discomfort was not reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, Injection site pain
Clinical narrative: This spontaneous report was received from  a medical assistant concerning a 46 year old female patient. The patient had no medical history and drug reactions or allergies. The patient's concurrent conditions were not reported. On 23-DEC-2016 ( reported as "today"), the patient was inadvertently vaccinated with an expired dose of M-M-R II injection, 0.5 ml-once, subcutaneous route in his left arm, expiration date: 02-DEC-2016 (also reported as "02-OCT-2016") (strength and lot number were not reported) for prophylaxis(reported as "for school"). The patient's concomitant medications included vitamin D, hydrochlorothiazide, venlafaxine hydrochloride (EFFEXOR), amphetamine aspartate (+) amphetamine sulfate(+)dextroamphetamine saccharate(+)dextroamphetamine sulfate (ADDERALL) and nicotine patches. On the same date, after vaccination, the patient experienced burning in his left arm  where she was injected. The medical assistant provided her treatment to the patient described as rubbing the site and the patient recovered from the burning, on the same date. No laboratory diagnostic studies were performed. The causality assessment between the Injection site burning and the was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 22-DEC-2016 the patient was inadvertently administered with ZOSTAVAX (unspecified lot/unspecified expiration) instead of VARIVAX. No adverse effect reported. Information of treatment was not provided.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unspecified dates during the time period of 06-DEC-2016 to 13-DEC-2016, the patients were vaccinated with improperly stored M-M-R II (lot # M016233, expiration date: 31-MAR-2018; lot # L040961, expiration date: 19-OCT-2017; lot # M002419, expiration date: 12-JAN-2018; lot # M022408, expiration date: 02-MAY-2018; dose and route were unknown) (rHA) for prophylaxis. The detail of the storage was a temperature excursion of 53.4 Fahrenheit for 2 hours 24 minutes for the refrigerated vaccine M-M-R II. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as follow up with the reporter is not permitted. Sender's Comments: US-009507513-1701USA001926: US-009507513-1701USA001927: US-009507513-1612USA007495.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unspecified dates during the time period of 06-DEC-2016 to 13-DEC-2016, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L035882, expiration date: 19-APR-2017; lot # M026317, expiration date: 11-JAN-2018; lot # L014458, expiration date: 11-FEB-2017; dose and route were unknown) for prophylaxis. The detail of the storage was a temperature excursion of 53.4 Fahrenheit for 2 hours 24 minutes for the refrigerated vaccine PNEUMOVAX 23. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as follow up with the reporter is not permitted. Sender's Comments: US-009507513-1701USA001925: US-009507513-1701USA001927: US-009507513-1612USA007495.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unspecified dates during the time period of 06-DEC-2016 to 13-DEC-2016, the patients were vaccinated with improperly stored ROTATEQ (lot # M025563, expiration date: 06-NOV-2017; lot # M006112, expiration date: 16-NOV-2017; lot # M007307, expiration date: 30-NOV-2017; lot # M034799, expiration date: 01-FEB-2018; oral, dose was unknown) for prophylaxis. The detail of the storage was a temperature excursion of 53.4 Fahrenheit for 2 hours 24 minutes for the refrigerated vaccine ROTATEQ. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as follow up with the reporter is not permitted. Sender's Comments: US-009507513-1701USA001925: US-009507513-1701USA001926: US-009507513-1612USA007495.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician concerning  an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, lot # L023592, expiration date 26-JUN-2016, for prophylaxis (dose number and route of administration were unknown). The temperature reported was -1 C and the time frame was 21 days. A digital data logger was involved.  No previous temperature excursions were performed and no adverse effects were reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Headache, Inflammation, Injected limb mobility decreased, Injection site pain
Clinical narrative: Soreness to left shoulder, and surrounding area to include left scapula and bicep. Unable to lift arm above shoulder. Called Drs office 11/23/2016, was directed to take Ibuprofen and return to quick care if symptoms persist. 11/25/2016, unable to lift arm over head for more then a few seconds, weakness, causing headaches from surrounding inflammation. Returned to quick care 11/27/2016, prescribed 800 mg motrin. Directed to call DR if not better in a week. Motrin helps alleviate the pain, while taking this med. This is not a long term solution however, and pain returns when I stop.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Soreness to left shoulder, and surrounding area to include left scapula and bicep. Unable to lift arm above shoulder. Called Drs office 11/23/2016, was directed to take Ibuprofen and return to quick care if symptoms persist. 11/25/2016, unable to lift arm over head for more then a few seconds, weakness, causing headaches from surrounding inflammation. Returned to quick care 11/27/2016, prescribed 800 mg motrin. Directed to call DR if not better in a week. Motrin helps alleviate the pain, while taking this med. This is not a long term solution however, and pain returns when I stop.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swelling at injection site the size of a tennis ball only ova.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a from a registered nurse who reported that four unspecified patients received improperly stored GARDASIL 9 (lot# M007764, expiration date 30-JAN-2018) on 21-SEP-2016 and one unspecified patient received improperly stored GARDASIL 9 (lot# M007764, expiration date 30-JAN-2018) on 14-OCT-2016. No adverse effects were reported. No further information was provided. Follow up information has been received on 05-JAN-2017. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: , MERCK 1610USA010829:Mfr number.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever after imms to 102.2.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Drug administered at inappropriate site
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque Forming Unit (PFU), subcutaneously, "one time vaccination" for prevention of herpes zoster. (lot # and expiration date were not reported). It was stated that the vaccine was administered incorrectly at the wrong injection site. The patient sought medical attention by visiting doctor's office and was diagnosed with cellulitis; which was treated with unspecified antibiotics.  There was not a product quality complaint (PQC) involved. At the time of reporting the outcome of cellulitis was reported as unknown. The causality assessment between cellulitis and ZOSTAVAX was not reported. Upon internal review cellulitis was determined to be a medically significant event. As of 30-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: , MERCK 1611USA009008:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 (lot # M017983 expiration date: 30-MAY-2018; lot # M024261 expiration date: 30-JUL-2018; lot # M034437 expiration date 03-FEB-2019; lot # M011840 expiration date: 01-FEB-2018). The vaccines were exposed to 68.7 degrees F for 5 hours, also vaccines with lot # M024261 expiration date: 30-JUL-2018 was exposed to 54.5 degrees F for 5 hours. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010201: US-009507513-1612USA010218: US-009507513-1612USA010219: US-009507513-1612USA010220.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PROQUAD (lot # M004889 expiration date: 25-JUL-2017; lot # M017337 expiration date: 05-OCT-2017; lot # M021731 expiration date 29-OCT-2017; lot # M032497 expiration date: 02-JAN-2018; lot # M035145 expiration date: 30-JAN-2018). The vaccines were exposed to 30.2 degrees F for 5 hours, 30 minutes. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010201: US-009507513-1612USA010217: US-009507513-1612USA010218: US-009507513-1612USA010220.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning a 35 year old female patient. The patient's pertinent medical history, drug reactions, allergies and concurrent conditions were not informed. The patient was not pregnant. The patient's concomitant therapies included a birth control medication and acetaminophen, hydrocodone bitartrate (NORCO). On 14-NOV-2016, the patient was vaccinated with the first dose of VARIVAX (lot #, expiration date and therapy route were not provided), for prophylaxis. On approximately 20-NOV-2016, reported as "1 week after received VARIVAX", the patient had complaints of tingling and pickling throughout her body, mainly in her hands and feet. The patient received her second dose of VARIVAX on 19-DEC-2016 and the pharmacist reported that the patient had complaints again of tingling and prickling within one week of received the VARIVAX. It was informed that the patient sought medical attention but no laboratory studies were performed and no treatment was given for the adverse events. The patient did not present any disability or incapacity. The outcome of tingling and prickling  was reported as not recovered at the time of the report. No product quality complaint (PQC) was involved.  Additional information has been requested.
Sex: F
Vaccine: FLUN4
Symptoms: Allergy to vaccine
Clinical narrative: A consumer report has been received concerning a female patient.  Patient's concurrent diseases, concomitant medications and relevant history was not provided. On an unknown date, the patient received  FLUMIST QUADRIVALENT (intranasal), 0.2 mL. Patient reported that she was allergic to the flu shot (preferred term: allergy to vaccine). At the time of reporting, the outcome of the event of allergic to the flu shot was reported as unknown. Company physician assessed the event of allergic to the flu shot to be non-serious.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Cerebral disorder, Encephalitis post immunisation, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection
Clinical narrative: A spontaneous report has been received from consumer concerning a 7 year old, female patient. No information regarding patient relevant history, concomitant medication and concomitant diseases were provided.  Patient had been received FLUMIST (intranasal), dose unknown which started on an unknown date. It was reported that the patient had post vaccine encephalitis (Preferred Term: Encephalitis post immunisation), pandas/immune system was thrown into a tizzy (unspecified)(Preferred Term: Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection) and her body was attacking her brain(Preferred Term: Cerebral disorder). The outcome of the events of post vaccine encephalitis, pandas/immune system was thrown into a tizzy (unspecified) and body is attacking her brain were unknown. Company physician identified and captured the event of post vaccine encephalitis and assessed it to be serious due to important medical event criteria and the reporter assessed the events of pandas/immune system was thrown into a tizzy (unspecified) and body is attacking her brain to be non-serious. Sender's Comments: Encephalitis post immunisation is not listed in company core data sheet of FLUMIST. Non-serious events such as cerebral disorder and paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection could be contributory risk factors for the event. However, there is limited information on patient's relevant medical history, concurrent diseases, concomitant medications, traumatic head injury and diagnostic workup (complete blood count, cerebrospinal fluid examination, computerized tomography) which makes the causal assessment difficult.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Crying, Depressed level of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: 0900 administered vaccines,  infant cried for approximately 30 seconds and fell asleep,  left room.  0902 entered exam room, infant lying in stroller with pale color to face and lips, attempted to wake up infant, unable to arouse infant. Immediately transferred child from stroller to exam table, unresponsive, breathing on his own and able to sustain own airway. Heart rate 98, SPO2 98%. Called provider to room immediately.
Age: 7.0
Sex: F
Vaccine: TD
Symptoms: Henoch-Schonlein purpura, Vasculitis
Clinical narrative: Patient's mother reported that she took daughter to a pediatrician who dismissed symptoms. Mother then took child to another Dr. Dr diagnosed HSP vasculitis and encouraged mother to call hospital and report reaction.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain, Anaemia, Arthralgia, Back pain, Fatigue
Clinical narrative: SEVERE ABDOMINAL PAIN, NECK AND BACK PAIN, SWOLLEN LYMPH NODES, MENSTRUAL PERIOD FOR 3 months now, Anemia, headaches, swollen and achy joints, heat intolerance, fatigue, weight gain.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Haemoglobin decreased, Headache, Hypertension, Inflammatory marker increased, Joint swelling
Clinical narrative: SEVERE ABDOMINAL PAIN, NECK AND BACK PAIN, SWOLLEN LYMPH NODES, MENSTRUAL PERIOD FOR 3 months now, Anemia, headaches, swollen and achy joints, heat intolerance, fatigue, weight gain.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lymphadenopathy, Menstrual disorder, Neck pain, Temperature intolerance, Weight increased
Clinical narrative: SEVERE ABDOMINAL PAIN, NECK AND BACK PAIN, SWOLLEN LYMPH NODES, MENSTRUAL PERIOD FOR 3 months now, Anemia, headaches, swollen and achy joints, heat intolerance, fatigue, weight gain.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain, Anaemia, Arthralgia, Back pain, Blood pressure increased
Clinical narrative: SEVERE ABDOMINAL PAIN, NECK AND BACK PAIN, SWOLLEN LYMPH NODES, MENSTRUAL PERIOD FOR 3 months now, Anemia, headaches, swollen and achy joints, heat intolerance, fatigue, weight gain.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fatigue, Haemoglobin decreased, Headache, Inflammatory marker increased, Joint swelling
Clinical narrative: SEVERE ABDOMINAL PAIN, NECK AND BACK PAIN, SWOLLEN LYMPH NODES, MENSTRUAL PERIOD FOR 3 months now, Anemia, headaches, swollen and achy joints, heat intolerance, fatigue, weight gain.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lymphadenopathy, Neck pain, Oligomenorrhoea, Temperature intolerance, Weight increased
Clinical narrative: SEVERE ABDOMINAL PAIN, NECK AND BACK PAIN, SWOLLEN LYMPH NODES, MENSTRUAL PERIOD FOR 3 months now, Anemia, headaches, swollen and achy joints, heat intolerance, fatigue, weight gain.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: On 10/18/16 reported persistent pain from shoulder to elbow in left arm and decreased range of motion in left arm since receiving influenza vaccine in left arm, required physical therapy for improvement of symptoms.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: HIV test positive
Clinical narrative: Initial unsolicited report received from a Nurse on 20 December 2016. This case involves male (age not reported) patient who was vaccinated with a dose of High Dose Flu Vaccine (batch number, expiration date, dose, site and route of administration was not reported) on 27 October 2016. Patient had medical history of Diabetes. Concomitant medications included insulin injection on an unknown date. On an unknown date, following the vaccination, the patient was tested positive to a recent HIV test. It was reported that "insulin injection was given to patient by a staff member at the facility recently and after the injection, the staff member accidentally stuck themselves with the needle." Both the patient and the staff members were tested for HIV and the patient had a positive result. The administrator had been told that false positive HIV test results were possible in patients who received a flu vaccine. Other Lab data was not reported. Corrective treatment was not reported. List of documents held by sender: none.
Age: 0.6
Sex: F
Vaccine: IPV
Symptoms: Paralysis
Clinical narrative: Initial unsolicited report received from a Pharmacist via other company, Merck (Reference number-00308614) on 03 January 2017. This case involves a 06-month-old female patient who was vaccinated with a dose of Ipol (lot number, expiration date, route of administration, site of administration, dose and dose in series were not reported) on an unknown day. The medical history and concomitant medications were not reported. On an unknown day, unspecified day following the vaccination, the patients suffered paralysis. The laboratory test and the corrective treatment were not reported. The outcome of the event was not reported. Upon internal review the company decided to consider the event serious because of important medical event as paralysis. List of the documents held by sender: none.; Sender's Comments: This case concerns 57 year old female patient who received IPV (VERO) VACCINE at age of 6 month and developed paralysis . Time to onset was not provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, reaction to previous vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case. Based upon available information role of vaccine cannot be ruled out
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Pain, Visual impairment
Clinical narrative: I noticed that my first adverse event a few days after the vaccine. If I had wine/alcohol the night before, the next day I would have facial numbness, visual disturbance and knife like jabbing pains throughout my body.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Acute, chronic pain in deltoid and tricep muscles of right arm.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Ear pain, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site very sore, warm to the touch, painful, red, and some swelling: patient experienced pain on the upper arm to the neck and to her ear.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Neck pain
Clinical narrative: Injection site very sore, warm to the touch, painful, red, and some swelling: patient experienced pain on the upper arm to the neck and to her ear.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Cough, Wheezing
Clinical narrative: Approximately 5 minutes after being given immunizations listed below pt started to cough and wheeze- was examined per RN and NP. Pt was given Abutenal Neb tx. Prior to Neb lungs were tight, bronchi and bilateral lobes and wheezing in right upper lobes. after neb tx. lungs were clear and patient was calm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: Patient experiencing extreme muscle pain in arms and legs. Started approximately 1 wk. after vaccine. Still ongoing.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Acanthosis nigricans, Amenorrhoea, Hirsutism, Skin discolouration
Clinical narrative: After 3rd HPV - within 2 months, developed darkening of skin of posterior neck and arm pit, had primary amenorrhea, hirsutism, Acanthosis nigricans.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Erythema, Fatigue, Headache, Heart rate increased
Clinical narrative: High fever, high heart rate, headache, dizziness, nausea, fatigue, stiffness and pain at injection site (4 hours after vaccine). Swollen, blotchy red area below injection site in arm (40 hours after vaccine).
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Local swelling, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: High fever, high heart rate, headache, dizziness, nausea, fatigue, stiffness and pain at injection site (4 hours after vaccine). Swollen, blotchy red area below injection site in arm (40 hours after vaccine).
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash macular
Clinical narrative: High fever, high heart rate, headache, dizziness, nausea, fatigue, stiffness and pain at injection site (4 hours after vaccine). Swollen, blotchy red area below injection site in arm (40 hours after vaccine).
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Patient received influenza vaccine that contained preservatives while pregnant.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: 2 minutes post immunization, pt experienced and seizure which lasted approx. 2 minutes. He required further medical attention and was treated by EMT and transported to E.R. Pt was treated there and released.
Age: 1.67
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On 18-MAR-2016, the patient was vaccinated with a dose of M-M-R II (route, dosage schedule, lot # and expiration date were not reported). Then, on 07-APR-2016, the patient was vaccinated with a dose of VARIVAX (route, dosage schedule, lot # and expiration date were not reported) both therapies for prophylaxis. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse refers to an unspecified patient of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On an unknown date, the patient was vaccinated with an improperly stored PEDVAXHIB, (route of administration, dose and frequency were not provided)  lot # M020101, and expiration date 07-MAR-2019 for prophylaxis. The reporter stated that the temperature range of the vaccine was 32F and 36F and the time frame was 24 hours, also she stated that there was not previous temperature excursion, this information was administered in a data logger. No adverse effect was reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA000713: US-009507513-1701USA000712.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse refers to an unspecified patient of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ, oral, (dose and frequency were not provided) with  lot # M002254, and expiration date 15-NOV-2017 for prophylaxis, or ROTATEQ with lot# M016238 and expiration date 07-DEC-2017. The reporter stated that the temperature range of the vaccine was 32F and 36F and the time frame was 24 hours, also she stated that there was not previous temperature excursion, this information was administered in a data logger. No adverse effect was reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA000713: US-009507513-1612USA014621.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse refers to an unspecified patient of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9 (route of administration, dose and frequency were not provided)  lot # M017983, and expiration date 30-MAY-2018 for prophylaxis. The reporter stated that the temperature range of the vaccine was 32F and 36F and the time frame was 24 hours, also she stated that there was not previous temperature excursion, this information was administered in a data logger. No adverse effect was reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014621:US-009507513-1701USA000712:
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient observed right arm red when waking up on 12/29/16; by the evening the area grew in size of red and swelling; today (12/30/16) at time of visit arm is warm to touch, red, raised and has spread from shoulder area down to elbow (right side only). Treated with Clindamycin 300 mg PO TID for 7-10 day and BENADRYL.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Nervousness, Paraesthesia
Clinical narrative: After 10 minutes, some tingling in fingers; feeling of nervousness.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Patient had stated he had passed out before because he doesn't like needles. Patient was given a flu shot and a PPD and patient did pass out but then had a seizure. No past history of seizure event. Patient came out of his seizure, was fine, did not require emergency room but we sent him to the emergency room for observation and precaution.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging, Rotator cuff syndrome
Clinical narrative: Pain and swelling to injection site affecting L shoulder/upper arm movement, diagnosed with multiple tears to shoulder and upper arm months later.
Age: 0.08
Sex: M
Vaccine: DPP, HEP, HIBV, IPV, RVX
Symptoms: Crying, Diarrhoea, Vomiting
Clinical narrative: Vomiting, diarrhea, uncontrollably crying.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling at the injection site, iced and asked to take benedryl watched her for 15 min.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Infantile back arching
Clinical narrative: 6 hours of inconsolable crying arching back no meds given.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on bilateral lower legs and on lower abdomen.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Tdap administered at 1:57pm. Patient checked out at clerk at 2:14pm and remained in building with no complications for uncertain time. Patient left building then returned at 4:00pm complaining of "lightheadedness, warmth and sweat". Patient taken to private room where vitals were monitored and juice and crackers were given. Eaten completely. Patient states "I had a blood glucose test at my OBGYN this morning and I haven't eaten since". Patient alert and oriented x 4, skin warm and dry. Patient encouraged to report incident to her OBGYN. She verbalized understanding. Patient reported feeling "much better", denied any lightheadedness nor other concerning symptoms at 4:40pm. Patient provided current contact information for RN follow-up. Patient left building at 4:43pm.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site induration, Migraine
Clinical narrative: First varicella vaccine 9/14/2016 local reaction - HA since first injection. #2 12/7/16 Varicella - Induration at site 4 cm. dizzy, lightheaded. Migraine HA.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received injection and complained about pain upon injection. Later that evening, patients arm swelled up and she complained of a burning pain that radiated to the tips of fingers. Pt. also complained of "dead arm" with lack of movement. Pt. was treated at ER.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received ROTARIX. On 28th December 2016, the patient received the 2nd dose of ROTARIX. On 28th December 2016, several minutes after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details were provided as follows: It was reported that the patient threw up, minutes after receiving a dose of ROTARIX.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: 16 y/o female received immunizations 1/4/17. Several hours later noticed redness at back of left arm with tenderness. She took ibuprofen, ok since that time. No cold compress applied. Yesterday more swollen, improving today.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Erythema, Inflammation, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site burning in a 56-year-old female patient who received BOOSTRIX. Concomitant products included Pneumococcal vaccine. On 16th December 2016, the patient received BOOSTRIX .5 ml. On 17th December 2016, 1 days after receiving BOOSTRIX, the patient experienced injection site burning. On 18th December 2016, the patient experienced injection site induration and back pain. On 19th December 2016, the patient experienced injection site inflammation, injection site erythema, inflammation localized and erythema. On an unknown date, the outcome of the injection site burning, injection site inflammation, injection site erythema, injection site induration, back pain, inflammation localized and erythema were unknown. It was unknown if the reporter considered the injection site burning, injection site inflammation, injection site erythema, injection site induration, back pain, inflammation localized and erythema to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received BOOSTRIX in his left deltoid. One month before the reporting date ago, the patient received Pneumococcal vaccination. The patient experienced burning and pain at injection site. Two days after vaccination, the patient experienced back and injection site pain with induration at injection site. Three days after vaccination, the patient experienced injection site and back inflammation and redness. Field representative reports doctor had previously contacted GSK regarding this event. Field representative was unable to provide doctor's complete address.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site burning in a 56-year-old female patient who received BOOSTRIX. Concomitant products included Pneumococcal vaccine. On 16th December 2016, the patient received BOOSTRIX .5 ml. On 17th December 2016, 1 days after receiving BOOSTRIX, the patient experienced injection site burning. On 18th December 2016, the patient experienced injection site induration and back pain. On 19th December 2016, the patient experienced injection site inflammation, injection site erythema, inflammation localized and erythema. On an unknown date, the outcome of the injection site burning, injection site inflammation, injection site erythema, injection site induration, back pain, inflammation localized and erythema were unknown. It was unknown if the reporter considered the injection site burning, injection site inflammation, injection site erythema, injection site induration, back pain, inflammation localized and erythema to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received BOOSTRIX in his left deltoid. One month before the reporting date ago, the patient received Pneumococcal vaccination. The patient experienced burning and pain at injection site. Two days after vaccination, the patient experienced back and injection site pain with induration at injection site. Three days after vaccination, the patient experienced injection site and back inflammation and redness. Field representative reports doctor had previously contacted GSK regarding this event. Field representative was unable to provide doctor's complete address.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Vaccine - PNEUMOVAX 23 admin. (R) deltoid 1/3/17. Pt. at office. 1/6/17 reports swelling and redness (R) anterior and posterior arm. Reports symptoms improved since 1/3/17.
Age: 4.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 4 year old female patient. It was reported that she was a healthy kid. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with a dose of M-M-R II for prophylaxis (dose, route, frequency, lot/batch number and expiration date were not reported) and a dose of PROQUAD for prophylaxis (dose, route, frequency, lot/batch number and expiration date were not reported). On 14-DEC-2016, the child was in for her second round of included M-M-R II and 0.5 ml, by unknown route, lot # L039613, expiration date 08-OCT-2017, for prophylaxis and that same day also received the second dose of PROQUAD 0.5 ml, 0.5 ml, by unknown route, lot # L031601, expiration date 18-FEB-2017, also for prophylaxis. At the time of this report the patient was fine and was unknown if she would continue to take M-M-R II or PROQUAD. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M016193, expiration date: 24-APR-2018, the medical assistant also reported lot # M026306 which was not valid for GARDASIL 9, however, lot # M026306 is valid for GARDASIL, expiration date: 30-APR-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 46.5 Fahrenheit degrees for 20 minutes. A previous excursion of 46.5 Fahrenheit degrees for 20 minutes and a total time out of range of 40 minutes were reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.  Sender's Comments: US-009507513-1612USA012399: US-009507513-1701USA001262: US-009507513-1701USA001263: US-009507513-1701USA001265: US-009507513-1701USA001266: US-009507513-1701USA001267.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discolouration, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Severe pain with movement 10/10 radiating from injection site up left side of neck & down to left thumb & wrist. Hardness/swollen at injection site & down, but not to elbow (Left shoulder/deltoid). Blotchy red discoloration injection site to elbow.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain, Pain, Pain in extremity, Rash macular
Clinical narrative: Severe pain with movement 10/10 radiating from injection site up left side of neck & down to left thumb & wrist. Hardness/swollen at injection site & down, but not to elbow (Left shoulder/deltoid). Blotchy red discoloration injection site to elbow.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Hypoaesthesia, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: Pain in left arm, numbness in fingers, difficulty breathing. Treated with Lyrica and Medrol Dose Pack thus far. Diagnosed as Parsonage Turner Syndrome.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: NAUSEA, DIZZINESS, INJECTION SITE SORENESS/PAIN, LOW GRADE FEVER, BODY ACHES.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Deafness unilateral, Pyrexia
Clinical narrative: Right sided hearing loss, fever.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying, Diarrhoea, Insomnia, Irritability, Pyrexia
Clinical narrative: Day of vaccinations: Excessive crying for hours with none of the usual comfort measures working, fever rising, would not sleep if set down. Day 2: Diarrhea, fever of 102, and excessive crying, Nursing more than usual. Day 3, Diarrhea and fussiness more than usual, still nursing more than usual. Currently on day 3.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Fist sized redness at injection site, mild pain.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray normal, Computerised tomogram normal, Dizziness, Headache, Heart rate increased
Clinical narrative: Patient had trouble seeing, high blood pressure and heart rate, dizziness, pain in back of head.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Hypertension, Visual impairment
Clinical narrative: Patient had trouble seeing, high blood pressure and heart rate, dizziness, pain in back of head.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Tendonitis, Vaccination complication
Clinical narrative: Soreness of shoulder, especially with use and movement.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Tendonitis
Clinical narrative: Soreness of shoulder, especially with use and movement.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Severe pain at injection sight. 5 by 3 inch swelling. Fever, chills, headaches, nausea.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Severe pain at injection sight. 5 by 3 inch swelling. Fever, chills, headaches, nausea.
Age: 22.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Lymphadenopathy
Clinical narrative: MMR given in (R) arm SQ. Client states: "swollen lymph nodes under arm".
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Rash erythematous
Clinical narrative: Very red 4" long 1" wide sub-derm rash U or V persisted 3 weeks. Area still sensitive to inadvertent touch.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient stated that she experienced a rash and swollen arm after getting PNEUMOVAX 23.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Dermatitis diaper, Diarrhoea, Infantile spitting up, Sleep disorder
Clinical narrative: Stooled a lot like diarrhea after the PEDIARIX and got a shot, disturbed sleep. She stooled a lot like diarrhea after the PEDIARIX and got a diaper rash. Diaper rash. Disturbed sleep. No fever, more spit up more. Now that is gone.
Age: 1.67
Sex: F
Vaccine: DTP, HEP, MMR, VARCEL
Symptoms: Erythema, Eye movement disorder, Foaming at mouth, Laboratory test, Tremor
Clinical narrative: Shaking, foaming at the mouth, turning red, eyes rolling in the back of head.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Product packaging quantity issue
Clinical narrative: PT MAY NOT HAVE RECEIVED IMMUNIZATION UPON INITIAL INJECTION. SYRINGE MAY HAVE BEEN EMPTY. TO ENSURE PT TRULY RECEIVED IMMUNZATION, THE VACCINE WAS READMINISTERED IN OTHER ARM.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Loss of consciousness, Nerve compression, Nerve conduction studies abnormal
Clinical narrative: Pain in left shoulder; tingling and numbness in left index finger; pain disrupted sleep during night; passed out because of the pain on 11/14/2016 and was rushed to emergency room; doctor attributed indicent to pain; no other likely causes found; pain responded to Gabapentin and Prednisone, but returned immediately after stopping Prednisone; nerve study on 11/28/2016 did not reveal cause of problems (althought slight entrapments of median nerve at wrist and of ulnar nerve at elbow were detected); X-ray on 12/14/2016 were negative; problems with left are persist until this day, although sleep disruption is not as bad as earlier on; tingling/slight pain persists.