chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L039141, expiration date 16-AUG-2017, oral (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 28.4 degrees Fahrenheit for 46 hours. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M009764, expiration date 23-FEB-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.3 degrees Fahrenheit for 25 hours. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of an unknown age (reported date of birth was later that adverse event's onset date) and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L016429, expiration date: 09-AUG-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017; lot # M005714, expiration date 03-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 28.4 degrees Fahrenheit for 46 hours. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: H1N1 influenza, Pneumonia
Clinical narrative: Case PHEH2016US022328, is an initial report received from a consumer via patient oriented program on 31 Aug 2016. This report refers to a 62 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, batch number: not reported) on an unknown date. The patient stated that, while on HUMIRA she took the flu vaccine and ended up getting the flu, the H1N1 strain. She ended up in the hospital with pneumonia and her healthcare professional decided not to use HUMIRA any longer. Her healthcare professional would start her on COSENTYX hoping that she may not get any secondary infections as she was infection prone. The outcome and causality of the events was not reported.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Case number PHEH2016US022905, is an initial spontaneous report received from a pharmacist on 08 Sep 2016. This report refers to a 27 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 168723) intramuscularly at a dose of 0.5 ml on 03 Sep 2016. On the same day after vaccination, the patient experienced Stevens Johnson syndrome. The outcome of the event was unknown. The seriousness and causality of the event was not reported. The seriousness assessment of the event Stevens Johnson syndrome was upgraded based on the Novartis Important Medical Events list.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 18-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L027282, expiration date: 21-SEP-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reported as received from a medical assistant refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-MAR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # L031601, expiration date: 18-FEB-2017 (therapy type, exact dose, route of administration and anatomical location were not provided). There were no adverse events reported. This is one of several reports received from the same reporter. This is one of two reports concerning the same patient. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 15-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 29-MAR-2016, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. Information on the pertinent medical history, concurrent conditions and drug allergies of the patient were not reported. On 29-AUG-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # J013394, expiry date25-AUG-2016. via intramuscular route. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: Approximately two days after receiving FLUZONE HD and PREVNAR 13 in the same arm the patient has throbbing, redness and pain. This occurred in the left arm. Slight itching.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 3 patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On an unknown date, the patients were vaccinated with PROQUAD (dose and route of administration were not reported, lot# reported as M021729, expiry date on 29-OCT-2017) that was not delivered to the office on time due to a hurricane. No adverse symptoms were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Patient's pertinent medical history, concurrent condition and concomitant medication were unknown. No previous drug reactions/allergies were reported. On an unknown date in DEC-2015, the patient was vaccinated with first dose of GARDASIL 9 in the three dose series, (strength, dosing details, anatomical location, lot# and expiration date were unknown). On an unknown date in JUN-2016, she received the second dose and on an unknown date in DEC-2016, she received the third dose in the series of GARDASIL 9 (inappropriate schedule of drug administration). Lab diagnostic tests performed was not known. The patient did not sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 12-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 17-OCT-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Allergy status to serum and vaccine status on 2016-06-14.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-03-03.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Lethargy, Myalgia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Intense muscle aches, sore throat runny nose lethargy.
Age: 0.5
Sex: M
Vaccine: PNC13, UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, subs on 2016-04-05, Advrs effect of pertuss vaccine, inc combin w pertuss, sqla on 2016-04-06.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Adverse event
Clinical narrative: Adverse effect of other viral vaccines, initial encounter on 2016-08-10.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization, NEC, unit on 2016-06-19.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biolg substances, sequela on 2016-04-15.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Blepharospasm, Drooling, Dysphagia, Facial paralysis, Hypoaesthesia
Clinical narrative: Client reported left sided facial numbness/paralysis/droop, diminished taste, drooling, left eye twitch, difficulty swallowing. Client seen in PCP office on 09/14/16 for symptoms. Advised client have CT of head, be seen in emergency department for evaluation. Client seen in health department office 09/15/16, symptoms remain as described above. Client alert, oriented x3, tongue center without deviation, gaze/vision normal, no extremity weakness/motor loss noted, skin normal without rash/hives, respirations normal, vital signs normal/afebrile. Mother states that no CT of head has been completed, advised client to be seen in ER for evaluation. Mother and client in route to emergency department.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Hypogeusia
Clinical narrative: Client reported left sided facial numbness/paralysis/droop, diminished taste, drooling, left eye twitch, difficulty swallowing. Client seen in PCP office on 09/14/16 for symptoms. Advised client have CT of head, be seen in emergency department for evaluation. Client seen in health department office 09/15/16, symptoms remain as described above. Client alert, oriented x3, tongue center without deviation, gaze/vision normal, no extremity weakness/motor loss noted, skin normal without rash/hives, respirations normal, vital signs normal/afebrile. Mother states that no CT of head has been completed, advised client to be seen in ER for evaluation. Mother and client in route to emergency department.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, unit on 2016-04-17
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Depressed mood, Irritability, Personality change, Screaming
Clinical narrative: Inconsolable crying, shrieking scream, unable to be soothed, completely uncharacteristic (had never happened before). Happened again 2 days later 10/07/2013 in evening- same inconsolable cry. 10/8/2013 baby began staring, unresponsive, despondent. Personality changes lasted a week, less smiling, less interaction.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Social avoidant behaviour, Staring, Unresponsive to stimuli
Clinical narrative: Inconsolable crying, shrieking scream, unable to be soothed, completely uncharacteristic (had never happened before). Happened again 2 days later 10/07/2013 in evening- same inconsolable cry. 10/8/2013 baby began staring, unresponsive, despondent. Personality changes lasted a week, less smiling, less interaction.
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-05-05.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-MAR-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # K004540, expiration date 03-DEC-2016 (exact dose, route of administration and anatomical location were not provided). There were no adverse events reported. This is one of several reports received from the same reporter. This is one of two reports concerning the same patient. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Client received PNEUMOVAX 23 on 08/22/16 at 10:24 am. At 3:27 pm client reported to the emergency room complaining of pain, swelling, and redness at injection site; and she "had a hard time breathing for a little bit". Client was given Prednisone 40 mg 1 tab PO, PEPCID 20mg 1 tab PO and BENADRYL 25mg 1 tab PO. Client was discharged home. Per client swelling resolved on its own in 1-2 days.
Age: 0.42
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 71.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Mass, Pruritus, Rash erythematous, Swelling
Clinical narrative: "Red tomato color" rash, swelling, itchy, lump.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Epistaxis, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Pt. received flu sot on 9/11/16 and 15 mins. later (L) arm started to swell, she reports that 3 hours later had body aches. By midnight she had fever, coughing and a runny nose. States later on had a bloody nose x 4 hours. Didn't get medical care was feeling better by 9/13/16,
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea
Clinical narrative: Pt. received flu sot on 9/11/16 and 15 mins. later (L) arm started to swell, she reports that 3 hours later had body aches. By midnight she had fever, coughing and a runny nose. States later on had a bloody nose x 4 hours. Didn't get medical care was feeling better by 9/13/16,
Age: 32.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Cellulitis, Erythema, Injection site pain, Pain, Swelling
Clinical narrative: Redness, swelling and pain after receiving TDAP and PNEUMOVAX. Vaccines given on 9/7/16. Pt. seen in ED 9/8/16 for pain at injection site. Seen in ED again on 9/10/16 for development of red raised stripes across deltoid. Given abx for cellulitis improving.
Age: 32.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Redness, swelling and pain after receiving TDAP and PNEUMOVAX. Vaccines given on 9/7/16. Pt. seen in ED 9/8/16 for pain at injection site. Seen in ED again on 9/10/16 for development of red raised stripes across deltoid. Given abx for cellulitis improving.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 13-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L016429, expiration date: 09-AUG-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 20-year-old patient of unknown gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. On 14-MAR-2016 and on 11-MAY-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot number: L037339, expiration date: 09-FEB-2018 and lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided) respectively. The vaccines underwent temperature excursion of either +1 or -1 Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD lot # L042818, expiration date 26-APR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.3 degrees Fahrenheit for 25 hours. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Body temperature increased, Rash erythematous, Rash pruritic
Clinical narrative: Temp of 99.2 and red raised itchy rash on neck and upper back.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-MAR-2016, the patient received improperly stored GARDASIL 9 (lot number L026602 and expiration date 19-OCT-2017, dose, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either plus 1 or minus 1 Celsius degrees for 255.5 total cumulative hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effect were 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: 1.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Abdominal discomfort, Abnormal behaviour, Abnormal faeces, Balance disorder, Dyskinesia
Clinical narrative: Toxic, chemical smelling diapers that lasted for 2 months.  Upset digestive system for 3 months. Behavioral changes: biting her arms, walking on tip toes, waving arms, legs buckling/unsteady, spinning in circles.
Age: 1.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Inappropriate schedule of drug administration, Intentional self-injury, Muscular weakness, Toe walking
Clinical narrative: Toxic, chemical smelling diapers that lasted for 2 months.  Upset digestive system for 3 months. Behavioral changes: biting her arms, walking on tip toes, waving arms, legs buckling/unsteady, spinning in circles.
Age: 36.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient reports awakening on 9/8/16 with an area of hot redness at site of varicella vaccine. Treated with ice, Advil and Benadryl on the advice of her sister who is a nurse. States area of redness/heat doubled overnight and on the morning of 9/9/16 was also swollen. On 9/10/16, reports the effected area was less bright red and hot, but was a darker shade of red and her arm was achy from shoulder to hand. By the afternoon of 9/10/16 the condition was not improved and her sister advised her to go to Urgent Care. Urgent Care provider told her she had "a staph infection" and gave her Rx for antibiotics which she started on 9/12/16. When I spoke to her today, she says she feels fine, but a small area on her arm remains slightly red/warm. States she never felt swelling of throat or shortness of breath during the entire incident.
Age: 36.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Staphylococcal infection
Clinical narrative: Patient reports awakening on 9/8/16 with an area of hot redness at site of varicella vaccine. Treated with ice, Advil and Benadryl on the advice of her sister who is a nurse. States area of redness/heat doubled overnight and on the morning of 9/9/16 was also swollen. On 9/10/16, reports the effected area was less bright red and hot, but was a darker shade of red and her arm was achy from shoulder to hand. By the afternoon of 9/10/16 the condition was not improved and her sister advised her to go to Urgent Care. Urgent Care provider told her she had "a staph infection" and gave her Rx for antibiotics which she started on 9/12/16. When I spoke to her today, she says she feels fine, but a small area on her arm remains slightly red/warm. States she never felt swelling of throat or shortness of breath during the entire incident.
Age: 83.0
Sex: M
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Erythema, Joint swelling, Local swelling, Pain
Clinical narrative: Red line from mid upper arm extending to wrist. Swelling in elbow and posterior forearm. Saw PA, she said shot was given in wrong place.  Saw Dr and he said it was a reaction.  1 week later, I still have redness, pain and swelling.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: On 9/15/16, patient had redness on left upper arm, fever of 99.9.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt says injection site hurts and right arm difficult in raising arm. Pt did go to ER.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, warm, pink area at injection site sore pain /10 on 10/10 scale treat with TYLENOL orally; use cool to warm compresses next few days.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Feeling hot, Hyperhidrosis, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Immediately after immunizations, patient became nauseated, pale, diaphoretic and c/o being hot. Emesis. Small amount of clear phlegm. Cool cloth applied. Denies dizziness or light headedness. Mother in room Dr and H2O. Stayed x 20 min for evaluation with no further issues. Left facility without issues. Starting Hep B series over Dr dif negative titer.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Productive cough, Vomiting
Clinical narrative: Immediately after immunizations, patient became nauseated, pale, diaphoretic and c/o being hot. Emesis. Small amount of clear phlegm. Cool cloth applied. Denies dizziness or light headedness. Mother in room Dr and H2O. Stayed x 20 min for evaluation with no further issues. Left facility without issues. Starting Hep B series over Dr dif negative titer.
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a 40 year old male patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 29-AUG-2016, the patient was vaccinated with VARIVAX lot # L029472 with expiration date 06-AUG-2017, subcutaneously (dose was not reported). The patient had no concomitant medications. On an unknown date in 2016, following the administration of VARIVAX, the patient developed sore throat and chicken pox. The patient was seen by the physician and did not receive treatment for the events. None laboratory diagnostic studies were performed. The outcome of the events was reported as recovering. The relatedness between the events and VARIVAX was not provided. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered
Clinical narrative: PROQUAD was administered and vaccine had expired 4 days ago. RN did not see this prior to administration.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Malaise, Peripheral swelling
Clinical narrative: Pt reported feeling hot, sick and swelling in her arm from deltoid to elbow. She slept all day on 9/14/16. Patient gets swelling every in her deltoid for 2-4 days. She thought this was normal after a flu shot.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patients' medical history, concurrent conditions and drug reaction/allergies were not reported. On 24-AUG-2016 or 25-AUG-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M020103, expiration date: 15-FEB-2018, (dose and route of administration were not reported). The administered doses of Gardasil 9 underwent temperature excursion at 55 Fahrenheit degrees, for 28 hours and 20 minutes. No previous temperature excursions were reported. Patients' concomitant medication was not reported. No adverse effects reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Red, raised welt at injection site that is warm to touch. About the size 2"x2" (ZOSTAVAX site).
Age: 66.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Hot, redness and swollen arm.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Administration site joint pain
Clinical narrative: Joint pain at administration site.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Urticaria
Clinical narrative: Began as "hot muscle aches" moving around to various parts of the body. Several days later, she developed hives on her torso.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Body temperature increased, Fatigue, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Patient woke up with all over body aches, stiffness, fatigue, Raised temp (99.5F), lasting 12 hours, then developed headache. Fully asymptomatic after 48hrs.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Myalgia
Clinical narrative: Within 24 hours, patient experienced "hot muscle aches" that moved around to various areas of the body. Now resolved. Patient has been getting influenza vaccines for 40+ years. This was his first time receiving the High Dose vaccine.
Age: 4.0
Sex: F
Vaccine: DTPIPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, warm to touch. Redness was 10cm across at widest point.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Fatigue, Injection site urticaria, Pyrexia
Clinical narrative: Per mom, the patient has had a 101.9 fever, been very tired and a large welt the size of a softball at the injection site.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Arthralgia, Chills, Dyspnoea, Feeling abnormal
Clinical narrative: Chills (with shaking) and hot spells; muscle and joint pain, arms and legs bilaterally; upset stomach; difficulty breathing (lasted about 10 minutes): felt bad for about 18 hours.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Myalgia, Tremor
Clinical narrative: Chills (with shaking) and hot spells; muscle and joint pain, arms and legs bilaterally; upset stomach; difficulty breathing (lasted about 10 minutes): felt bad for about 18 hours.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy, Injection site pain, Rash erythematous, Skin discolouration
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 06 September 2016. This case involves a 67-year-old female patient who was vaccinated with a second dose of IFLUZONE HD (batch number, expiry date, site of administrated was not reported) intramuscularly on 2015. It was reported that, the patient was allergic to formaldehyde and balsam of teru. Medical history of patient revealed that she was multiple allergists (unspecified). Illness at time of vaccination and any other vaccinations within 4 weeks of vaccinations was reported as none. On an unspecified date, following the vaccination, the patient had experienced red raised bumps on hands to her elbows (lasted almost a year), arms were purplish in color and pain at the injection site (resolved). Patient also received Fluzone HD previously on an unspecified date in 2014, after which patient experienced red raised bumps on hands to her elbows (lasted almost a year), arms were purplish in color and pain at the injection site (resolved). Patient required ER or doctor visit. Lab data includes multiple allergy tests including biopsy and scrapings. Corrective treatment was received for rash (unspecified) (reported as no treatments worked to resolve the rash). The patient was recovered from the events. Also reported as rash was almost gone. List of documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site inflammation, Peripheral swelling
Clinical narrative: Injection site discoloration/ inflammation, and abnormal leg swelling.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Clusters of bumps appeared on legs, hips and lower abdomen.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, IPV, MEA, PNC13, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received a polio vaccine 3 years early.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema
Clinical narrative: Redness at around arm that was injected.
Age: 0.19
Sex: F
Vaccine: FLU4, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: 2 month old was given sisters 0.5 flu vaccine. Patient did not show any signs and symptoms of adverse reaction.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Dizziness, Epistaxis, Fatigue
Clinical narrative: Sudden onset of body aches, fever of 102, sore throat, dizziness, headache, chills, fatigue, lethargy and cough. 3 days alter it hit again symptoms 10x worse, last night nosebleed that took 30 minutes to stop.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Influenza, Lethargy, Mononucleosis heterophile test negative, Oropharyngeal pain
Clinical narrative: Sudden onset of body aches, fever of 102, sore throat, dizziness, headache, chills, fatigue, lethargy and cough. 3 days alter it hit again symptoms 10x worse, last night nosebleed that took 30 minutes to stop.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Streptococcus test negative
Clinical narrative: Sudden onset of body aches, fever of 102, sore throat, dizziness, headache, chills, fatigue, lethargy and cough. 3 days alter it hit again symptoms 10x worse, last night nosebleed that took 30 minutes to stop.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: REDNESS, SWELLING, AND WARM TO TOUCH IN LEFT ARM.
Age: 9.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness and swelling at site, approx size little bigger than a quarter, pt reports painful, area was marked and recommended TYLENOL and ice to site. Patient to report back if gets worse.
Age: 4.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Wrong immunization was given by mistake.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Maculopathy, Visual impairment
Clinical narrative: Patient complained of difficulty seeing from right eye. Seen by ophthalmologist who diagnosed him with maculopathy of right eye. Recommended observation.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Peripheral swelling, Rash erythematous, Tenderness
Clinical narrative: Left arm very swollen and tender to touch, red rash and numbness in the arm and fingers.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Patient's wife reported that patient was feverish, had chills and malaise.  Also, patient complained of leg pain for 1 day.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Arthralgia, Injection site reaction, Rash macular
Clinical narrative: Left hip joint pain, painless, non-pruritic macular rash at site of injection.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site joint pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Left hip joint pain, painless, non-pruritic macular rash at site of injection.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Arthralgia, Injection site reaction, Rash macular
Clinical narrative: It's been 8 days and patient still has a rash at the injection site that swells and itches.  She has complained about chronic joint pain in the left leg (injection site) at her hip socket. I finally gave her an antihistamine orally and cortisone topically.  Both over the counter.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site joint pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: It's been 8 days and patient still has a rash at the injection site that swells and itches.  She has complained about chronic joint pain in the left leg (injection site) at her hip socket. I finally gave her an antihistamine orally and cortisone topically.  Both over the counter.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Pallor, Tremor
Clinical narrative: Pt given Tdap and MENACTRA vaccines in right upper leg. Pt tolerated that well. Then pt was given HPV #1 vaccine in left upper leg. Immediately after receiving HPV vaccine, pt fell forward into nurse and father as if she had passed out but then she had whole body shaking and loss of bladder control. Episode lasted several seconds. She was pale. Once lying down and given juice, she recovered nicely.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urinary incontinence
Clinical narrative: Pt given Tdap and MENACTRA vaccines in right upper leg. Pt tolerated that well. Then pt was given HPV #1 vaccine in left upper leg. Immediately after receiving HPV vaccine, pt fell forward into nurse and father as if she had passed out but then she had whole body shaking and loss of bladder control. Episode lasted several seconds. She was pale. Once lying down and given juice, she recovered nicely.
Age: 0.76
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Haematochezia, Ultrasound abdomen normal, Vomiting
Clinical narrative: VOMITING, DIARRHEA WITHIN 15 MINUTES OF VACCINE. ABOUT 30 MINUTES AFTER VACCINE BLOODY STOOLS OCCURRED...2 FULL DIAPERS OF BLOOD.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient stated when she got home she got sweaty and passed out.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dermatitis, Erythema, Pyrexia
Clinical narrative: Red inflamed skin, fever of 101 degrees.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Balance disorder, Dizziness, Lymphadenopathy, Movement disorder, Pain in extremity
Clinical narrative: Dizziness, difficultly with balance, lightheaded (contacted the Dr and she suggested fluids and rest) arm and lymph nodes swelled and become very hot difficulty lifting arm and painful.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: Fever and chills day of vaccine, red arm starting and swelling starting 9/15/16.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: A warm, itchy, and red patch 10cmx7cm appeared 4 cm below PREVNAR-13 injection site.
Age: 77.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at site of injection - also redness and pain approximately 2 inches from site of injection.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Sudden onset of severe chills, for at least 90 minutes. Followed by aches and fever(102).
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Oral herpes, Peripheral swelling, Pyrexia, Rhinorrhoea
Clinical narrative: FEVER, RUNNY NOSE, COUGHING, COLD SORE AND ARM SWOLLEN TO SIZE OF PINEAPPLE OR SOFTBALL.
Age: 51.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Pt felt dizzy, hot and sweaty for about 5-10 minutes after the shot. Then the pt felt better after 10 minutes.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Chest X-ray normal, Chest pain, Chills, Culture throat negative
Clinical narrative: Malaise, fever, chills, severe chest pain (pleurodynia), tremors, shortness of breath, anxiety.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Electrocardiogram normal, Influenza virus test negative, Laboratory test normal, Malaise
Clinical narrative: Malaise, fever, chills, severe chest pain (pleurodynia), tremors, shortness of breath, anxiety.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Pleuritic pain, Pyrexia, Streptococcus test negative, Tremor, Viral infection
Clinical narrative: Malaise, fever, chills, severe chest pain (pleurodynia), tremors, shortness of breath, anxiety.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Aphonia, Dizziness, Heart rate increased, Throat irritation
Clinical narrative: Very scratchy throat, lost my voice, fast heartbeat light headed.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: SEVERE PAIN IN THE SHOULDER AND DIFFICULTY MOVING ARM WHERE SHOT WAS GIVEN.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a molecular biology student, who obtained the information from a Vaccine Adverse Event Reporting System (VAERS) report, concerning 235 patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with unspecified doses of GARDASIL (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On unknown dates, the patients died. The causes of death were unknown, and it was also unknown whether autopsies were performed. The reporter indicated that he read the deaths were related to GARDASIL and he was concerned about the number of deaths reported for GARDASIL products. Upon internal review, death was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 02-SEP-2016, the patient was vaccinated with  an expired dose of PROQUAD (Concentration, dose and route of administration were not reported), lot # L006388, expiration date 25-AUG-2016. Patient's concomitant medication was not provided. No adverse effect was reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Patient started with soreness and pain on right arm later in the day after receiving vaccine. Patient with trump of 103. Mom then gave 4 tabs of ibuprofen.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Blood glucose normal, Seizure
Clinical narrative: Seizure 10 minutes following administration of influenza vaccine, Tdap, and MENCTRA.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abscess
Clinical narrative: 1 inch x 1 inch abscess on left arm, currently being treated with cephalexin, may need I and D if doesn't clear up with antibiotic. Cephalexin dispensed 9/15/16.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: R arm swollen. Hot to touch pain-17cm top of shoulder to right above elbow.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Muscle spasms, Peripheral swelling, Pyrexia, Retching
Clinical narrative: Immunizations given approximately 215 pm. Around midnight, patient experienced severe shaking, spasms, fever of 102 degree and dry heaves. Symptoms continued throughout the night. Arm was red and swollen for 1 week.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Immunizations given approximately 215 pm. Around midnight, patient experienced severe shaking, spasms, fever of 102 degree and dry heaves. Symptoms continued throughout the night. Arm was red and swollen for 1 week.
Age: 100.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient received FLUZONE HD and PNEUMOVAX, one in each arm on 9/8/16. Patient called pharmacy on 9/9/16 spoke with clerk. Patient stated she her arm was swollen and red. Clerk told patient to use ice, BENADRYL and follow up with MD if necessary. On 9/10/16 patient arrived at the pharmacy from the urgent care. Urgent care had diagnosed her with cellulitis in her right arm. Patient was prescribed an antibiotic. I filled prescription and went over instructions. Patient had new RX today for cream for pain.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient received FLUVIRIN in left arm and PREVNAR in right arm on 8/23/16. On 9/15/16, patient called to say her arm was sore since date of vaccinations. Patient reported to doctor on 9/14/16.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: For reference only-no adverse events reported by patient. During extremely busy period, forgot to remove blue collar from PREVNAR syringe prior to administering the vaccination. As collar had removed from other syringes in past without difficulty, I attempted to remove the collar while stabilizing the syringe. When the collar came off the syringe, it felt like the syringe shifted. I administered the PREVNAR. There was not reaction from the patient. I called the patient 9/15/16 2:29 PM to follow-up. She denied having any soreness and said she was not having any adverse events.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Large red area approximately 4 " long 1 1/2" wide oval, hot to the touch, painful. Injected SC into back Left arm (upper) on 9/15 Rx'd ->cephalexin 500 mg bid 7 days to treat possible infection.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On 02-NOV-2016, the patient was vaccinated with the first dose of Gardasil 9 (exact dose, route of administration, lot # and expiration date were not provided). On 15-AUG-2016, the patient received the second dose of GARDASIL 9 (lot # M009116, expiration date: 13-JUN-2018), which was outside the recommendations per the Gardasil 9 prescribing information. No adverse effects were reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of generalized rash in a female patient who received Seasonal flu vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received a GlaxoSmithKline flu vaccine (didn't know which one) and had a generalized fine rash all over her body.