chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to an unknown number of patients of unspecified ages and genders. There was no pertinent medical history or drug allergies/drug reactions. The reporter stated that on unspecified dates, the patients were inadvertently administered with improperly stored PROQUAD (Merck) (Lot# L009210, expiration date 17-SEP-2016, dose and route not provided). There was no concomitant medication described. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 28-JUL-2015, the patient was inadvertently vaccinated with improperly stored VARIVAX (Merck) lot # K006133, expiry date 29-APR-2016 (site, route and dose was not reported). Additional information is not expected as the reporter did not wish the further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report has been received from a pharmacist via a company representative concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On an unknown date, unspecified patients were vaccinated with ZOSTAVAX, (lot #, exp. date, strength, route of administration and dose were not provided). There was not concomitant medication reported. The pharmacist reported that an article in a magazine, summarized VAERS data that patients who received ZOSTAVAX may have a higher incidence, 2 to 2.7 percent risk of developing alopecia or arthritis, on an unknown date. At the reporting time, the outcome of alopecia or arthritis was not reported. The causal relationship of alopecia or arthritis to ZOSTAVAX was not reported. Additional information is not expected due the reporter did not want to be contacted.
Age: 2.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pyrexia, Vaccination error, Vomiting
Clinical narrative: This spontaneous report as received from a consumer, who was the patient's father, refers to a 2 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated in error with a dose of ZOSTAVAX (dose and frequency reported as 1 injection, once; strength, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On an unknown date, the patient experienced fever, was throwing up and "felt stiff". The patient sought medical attention (spoke with an unspecified medical professional on an unspecified date). The outcome of the events was reported as not recovered. There was no product quality complaint (PQC) involved. The relatedness between ZOSTAVAX and the events was not provided. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 23-JUL-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (strength, dose, route of administration were not reported; lot# L007227, expiry date 03-MAR-2017), which had been improperly stored. There were no concomitant therapies reported. No adverse experience was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB injection (lot # L001626, expiry date: 06-OCT-2016) (dose, strength and route were not reported). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, unspecified number of patients were vaccinated with improperly stored COMVAX injection (lot # J009691, expiry date: 29-NOV-2015) (dose, strength and route were not reported). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unkonwn. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, unspecified number of patients were vaccinated with improperly stored PEDVAXHIB injection (lot # K011078, expiry date: 31-MAR-2017) (dose, strength and route were not reported). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Pt has small bumps (red) that itch on shoulder, both arms, both legs, and back.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient who was indicated for a dose of ZOSTAVAX was accidentally with VARIVAX (Merck). No adverse effect was reported. The outcome of the events were unkonwn. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.43
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 17 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Information has been received from a physician via company representative referring to a female patient of unknown age. In 2013 and in 2014, the patient was vaccinated with a dose of GARDASIL (dose, route and lot number not provided) respectively. On an unknown date, the patient experienced dizziness, stomach pain, headache, episodes of nearly passing out (causing the patient to need to pull over while driving), tingling in extremities, weakness and fatigue. The outcome of events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician via company representative referring to a female patient of unknown age. In 2013 and in 2014, the patient was vaccinated with a dose of GARDASIL (dose, route and lot number not provided) respectively. On an unknown date, the patient experienced dizziness, stomach pain, headache, episodes of nearly passing out (causing the patient to need to pull over while driving), tingling in extremities, weakness and fatigue. The outcome of events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# K021444, expiration date 17-SEP-2016, dose, frequency and route of administration were not reported). Concomitant medication was not provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patient were vaccinated with improperly stored doses of GARDASIL 9, lot # K026247, expiration date 29-JAN-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reprots received from the same source. Additional information is not expected as there was no consent to contact any physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot # K002527, expiration date 18-FEB-2016 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as there was no consent to contact any physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on multiple unspecified dates, 5 unspecified patients were each administered improperly stored VARIVAX (Merck) injection, all from the same lot number and expiration date (lot # K016129, exp. date: 23-SEP-2016) (dose, strength, route and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Initial report received from healthcare professional on 15 January 2013. A 53-year-old female patient, who had no medical history and concomitant medication was not reported, received first dose of FLUZONE ID (batch number: UT4466BA, route of administration was not reported) in left arm on 10 January 2013. On 11 January 2013, it was reported that the patient experienced pain in her arm, throbbing, achy, uncomfortable lifting the arm and it was swollen. The patient lab details and corrective treatments were not reported. At the time of this report, the patient had not recovered from the events. Follow up information received from a healthcare professional on 10 April 2013. The patient had no illness at the time of vaccination and no risk factors. The patient had received first dose of FLUZONE in deltoid (side not specified). The patient had not received any corrective treatment and no laboratory tests were performed. The patient did not report any continued adverse event and hence had recovered from the events on an unspecified date. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported. No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Herpes zoster, Pain, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 22 months old female patient with no current conditions, medical history, drug reactions or allergies. On 04-SEP-2014 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX lot # K002924 (expiration date was not provided), 0.5 ml/once, subcutaneous injection as routine vaccination. The patient was not taken any concomitant medication. On 04-JUL-2015, the patient experienced a red rash on her left hand which progressed to a rash and blisters from the fingers and palm of her left hand up to her shoulder. The patient sought medical care on 05-JUL-2015 from an unspecified healthcare provider at an Urgent Care facility and from a physician on 07-JUL-2015. The patient was diagnosed with shingles. The patient was prescribed with acyclovir liquid. Laboratory tests were not performed. At the time of the report the outcome of shingles was reported as not recovered. The reporter did not assess the relatedness of shingles with (Oka/Merck) VARIVAX. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Herpes zoster, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 22 months old female patient with no current conditions, medical history, drug reactions or allergies. On 04-SEP-2014 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX lot # K002924 (expiration date was not provided), 0.5 ml/once, subcutaneous injection as routine vaccination. The patient was not taken any concomitant medication. On 04-JUL-2015, the patient experienced a red rash on her left hand which progressed to a rash and blisters from the fingers and palm of her left hand up to her shoulder. The patient sought medical care on 05-JUL-2015 from an unspecified healthcare provider at an Urgent Care facility and from a physician on 07-JUL-2015. The patient was diagnosed with shingles. The patient was prescribed with acyclovir liquid. Laboratory tests were not performed. At the time of the report the outcome of shingles was reported as not recovered. The reporter did not assess the relatedness of shingles with (Oka/Merck) VARIVAX. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: My Daughter is breaking out in hives I have pictures of it. First she started with a low grade fever then around 9pm she complained of itching. I told her to come here and see her breaking out in hives like she does when she is allergic to something. I am giving her Benadryl and taking her to the DR in the am. If the Benadryl wasn't going to work I was going to take her to the ER. I have told the people at the county before she had an allergic reaction to the chicken pox shot it couldn't be the Dtap or TDAP she just had the Tdap as well she had the DTaP before no problem. Well here we are again this time the reaction was worse.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: My Daughter is breaking out in hives I have pictures of it. First she started with a low grade fever then around 9pm she complained of itching. I told her to come here and see her breaking out in hives like she does when she is allergic to something. I am giving her Benadryl and taking her to the DR in the am. If the Benadryl wasn't going to work I was going to take her to the ER. I have told the people at the county before she had an allergic reaction to the chicken pox shot it couldn't be the Dtap or TDAP she just had the Tdap as well she had the DTaP before no problem. Well here we are again this time the reaction was worse.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Mother presented no documentation of allergy. Vaccines administered as noted below Kw/no adverse event noted while child still at clinic (mother had indicated "mild reaction" in 2009 to Varicella) so observed for longer time. Mother notified HD today of reaction that began at 10 PM yesterday including hives and mild fever. Mother took child to urgent care today. Prescribed Prednisone (15mg x 5 days)-taking BENADRYL.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Mother presented no documentation of allergy. Vaccines administered as noted below Kw/no adverse event noted while child still at clinic (mother had indicated "mild reaction" in 2009 to Varicella) so observed for longer time. Mother notified HD today of reaction that began at 10 PM yesterday including hives and mild fever. Mother took child to urgent care today. Prescribed Prednisone (15mg x 5 days)-taking BENADRYL.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Gait disturbance, Injection site pain, Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: Started complaining of some soreness at the injection site that evening. Spiked a fever of 102.4 at bedtime (7/31/15) Fever 99 Sat-Mon pt taking Acetaminophen or Ibuprofen to help with pain and fever. Does not want to move arm due to discomfort. Feet are hurting and he is walking with an odd gait.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Electrocardiogram normal, Full blood count normal, Metabolic function test normal, Syncope
Clinical narrative: Vasovagal syncope.
Age: 36.0
Sex: F
Vaccine: DTAP, HEP, HEPA, PPV
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Nodule
Clinical narrative: Large, red swollen knot. Tender, swollen, painful lymph nodes under arm.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Body temperature fluctuation, Body temperature increased, Rash erythematous, Rash generalised
Clinical narrative: Temperature of 102.0 started around 9am on Friday. Tylenol was given and temperature decreased to 101.1. The temperature continued to fluctuate over the next day ending Saturday afternoon. Saturday night around 8PM he developed small red dots not raised, non blanchable over his trunk and leading out his limbs with some around his neck and ears. The small red dots continued until Wednesday without apparent pain or itching. Each day the dots began to fade.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: Woke up with strong headache, which is very unusual for patient.  Headache lasted all day and was not eased with ibuprofen.  Headache was accompanied with tiredness and lack of energy.  Headache present at bedtime at 9:30 pm.  Headache gone the next morning.
Age: 39.0
Sex: F
Vaccine: TTOX
Symptoms: Discomfort, Injection site pain, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Pain to injection site, tenderness and pain, swelling to Rt. Axillary nodes. mild fever, discomfort.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 77-year-old female patient of an unspecified ethnicity received PREVNAR 13 via intramuscular route on 24Jul2015 at 0.5 ml single. Medical history and concomitant medications were not reported. The patient came back to her doctor's office after the injection site became very red and hot to the touch. The anatomical location of the injection site was unknown. The patient was given unknown antibiotics in the doctor's office on an unknown date and was then sent to the hospital on 30Jul2015 in response to the events. The outcome of the events was unknown. The patient's hospitalization was ongoing at the time of this report.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased, Chest X-ray normal, Culture urine negative, Eye movement disorder, Full blood count normal
Clinical narrative: Based on the additional information received on 27-Jul-2015, this case initially considered as non-serious was upgraded to serious as the patient was hospitalized on an unspecified date. Initial unsolicited report received from a nurse on 30-Jun-2015. A four months old patient (gender not reported), had received a dose of PENTACEL (batch number: C4759AA, expiry date: 22-Mar-2016, dose details, route of administration and site of administration were not provided) and a dose of PREVNAR (dose details, batch number, route of administration and site of administration were not provided) both on an unspecified date. The patient had received PENTACEL and PREVNAR vaccines previously at 2 months of age. There were no issues. On an unspecified date, one hour post-vaccination, the patient went limp and eyes rolled back. Laboratory investigations and corrective treatment were not provided. At the time of this report, the outcome of the event was not reported. Documents held by sender: none. Follow up information received from a nurse on 27-Jul-2015. The gender of the patient was reported as female. The patient was approximately nine months of age at the time of this report and was in good health. The lot number for PENTACEL vaccine was 4759AA and the vaccine was administered in the right thigh. It was reported that on an unspecified date, the patient had a possible seizure in the evening hours after receiving the PENTACEL vaccine. She also had 102 temperature (units not provided) prior to the seizure. On an unspecified date, she was admitted overnight for observation in the hospital. Laboratory tests included RSV (Respiratory Syncytial Virus), Flu, UA (Urinalysis) and Chest X-ray, the results of which were negative for all the tests. Results of CBC (Complete Blood Count) and urine culture also showed no abnormalities. She was discharged home and had no further events after that time. It was reported that the future doses of vaccine were given individually to avoid PENTACEL. At the time of this report, the patient had recovered from the above mentioned events. Documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Hypotonia, Influenza virus test negative, Respiratory syncytial virus test negative, Urine analysis normal
Clinical narrative: Based on the additional information received on 27-Jul-2015, this case initially considered as non-serious was upgraded to serious as the patient was hospitalized on an unspecified date. Initial unsolicited report received from a nurse on 30-Jun-2015. A four months old patient (gender not reported), had received a dose of PENTACEL (batch number: C4759AA, expiry date: 22-Mar-2016, dose details, route of administration and site of administration were not provided) and a dose of PREVNAR (dose details, batch number, route of administration and site of administration were not provided) both on an unspecified date. The patient had received PENTACEL and PREVNAR vaccines previously at 2 months of age. There were no issues. On an unspecified date, one hour post-vaccination, the patient went limp and eyes rolled back. Laboratory investigations and corrective treatment were not provided. At the time of this report, the outcome of the event was not reported. Documents held by sender: none. Follow up information received from a nurse on 27-Jul-2015. The gender of the patient was reported as female. The patient was approximately nine months of age at the time of this report and was in good health. The lot number for PENTACEL vaccine was 4759AA and the vaccine was administered in the right thigh. It was reported that on an unspecified date, the patient had a possible seizure in the evening hours after receiving the PENTACEL vaccine. She also had 102 temperature (units not provided) prior to the seizure. On an unspecified date, she was admitted overnight for observation in the hospital. Laboratory tests included RSV (Respiratory Syncytial Virus), Flu, UA (Urinalysis) and Chest X-ray, the results of which were negative for all the tests. Results of CBC (Complete Blood Count) and urine culture also showed no abnormalities. She was discharged home and had no further events after that time. It was reported that the future doses of vaccine were given individually to avoid PENTACEL. At the time of this report, the patient had recovered from the above mentioned events. Documents held by sender: none.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 65 year old patient of an unspecified gender and ethnicity received, on 22Jul2015, PREVNAR 13 single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Jul2015, the patient experienced fever and cellulitis. The patient was treated with KEFLEX. Clinical outcome of the events was unknown at time of this report. The nurse believed that the patient got cellulitis from PREVNAR 13.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Confusional state, Crying, Dyspnoea, Headache
Clinical narrative: Mother states patient cried 4 hours after vaccine administered on 8/4/15 patient had swelling of (R) deltoid, arm, and hand with alterations of warm/cold to touch. Patient complained her throat felt tight and she couldn't breathe. Patient also said "felt like something was sitting on her chest". Then mom noticed patient seemed lethargic and confused. Today patient is having headache and neck pain.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Lethargy, Neck pain, Peripheral coldness, Peripheral swelling
Clinical narrative: Mother states patient cried 4 hours after vaccine administered on 8/4/15 patient had swelling of (R) deltoid, arm, and hand with alterations of warm/cold to touch. Patient complained her throat felt tight and she couldn't breathe. Patient also said "felt like something was sitting on her chest". Then mom noticed patient seemed lethargic and confused. Today patient is having headache and neck pain.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Skin warm, Throat tightness
Clinical narrative: Mother states patient cried 4 hours after vaccine administered on 8/4/15 patient had swelling of (R) deltoid, arm, and hand with alterations of warm/cold to touch. Patient complained her throat felt tight and she couldn't breathe. Patient also said "felt like something was sitting on her chest". Then mom noticed patient seemed lethargic and confused. Today patient is having headache and neck pain.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING & REDNESS AT SITE. INCREASED IN SEVERITY UNTIL PATIENT WAS BROUGHT IN BY MOTHER TODAY. MOTHER STATED SHE HAD BEEN PLACING WARM COMPRESSES WHICH COULD HAVE INCREASED THE REACTION. PATIENT GIVEN AN ICE PACK & AN RX OF BENADRYL. ADVISED TO RETURN TOMORROW FOR FOLLOW UP.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Swelling
Clinical narrative: Call received from child's mother on 7/29/2015 stating that child had developed extensive redness and taut edema to upper R arm (site of injection of varicella and TDaP vaccines on 7/28/2015) from acromian process to lower biceps region). Child's mother is a RN.  No other SE's reported.  I checked with her again on 8/4/15.  She stated the swelling had about resolved but that there was still an area of deep red discoloration at one of the injection sites.  No other adverse effects were reported.  Did not seek medical attention.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Gait disturbance, Headache, Laboratory test normal, Lymphadenopathy
Clinical narrative: Severe body pain. Started with swollen lymphnodes and severe headache. Now the pain is transient and moves all over her body. Swollen feet and hands. Dizzy, excruciating pain. Can't walk more than 15 steps. Veins swell up and become blue when it is about to start hurting or is hurting. Treated with Gabapentin and Amitriptyline.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Peripheral swelling, Vasodilatation, Vein discolouration, White blood cell count increased
Clinical narrative: Severe body pain. Started with swollen lymphnodes and severe headache. Now the pain is transient and moves all over her body. Swollen feet and hands. Dizzy, excruciating pain. Can't walk more than 15 steps. Veins swell up and become blue when it is about to start hurting or is hurting. Treated with Gabapentin and Amitriptyline.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Chest discomfort, Hypoaesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal oedema, Sensation of foreign body
Clinical narrative: 44 year old female, who is otherwise healthy, required emergency medical care within 15-30 minutes after the administration of the MMR Vaccine. The patient noticed a lump/swollen feeling in her throat that progressively got worse. She developed swelling and numbness of her tongue and throat, along with chest tightness. The patient required 2 epinephrine doses initially as well as a third dose of epinephrine when symptoms relapsed. Then she received 125mg of Solu-Medrol, 20mg of famotidine, and 50mg of Benadryl intravenously. She was admitted to the hospital for observation overnight.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Swollen tongue
Clinical narrative: 44 year old female, who is otherwise healthy, required emergency medical care within 15-30 minutes after the administration of the MMR Vaccine. The patient noticed a lump/swollen feeling in her throat that progressively got worse. She developed swelling and numbness of her tongue and throat, along with chest tightness. The patient required 2 epinephrine doses initially as well as a third dose of epinephrine when symptoms relapsed. Then she received 125mg of Solu-Medrol, 20mg of famotidine, and 50mg of Benadryl intravenously. She was admitted to the hospital for observation overnight.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, minor swelling and itching at injection site.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Patient reported "lymph node under clavicle on the side of the injection is enlarged".
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: RASH AND ITCHING ON THE BODY.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Neuralgia
Clinical narrative: Large area of redness at injection site, neuropathic pain, large blisters.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Arm swelling and redness at site of injection, myalgia at injection site, fever, headache, and vomiting throughout the entire night following the injection of Prevnar 13. Still experiencing arm redness and headache on 8/6/15.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Arm swelling and redness at site of injection, myalgia at injection site, fever, headache, and vomiting throughout the entire night following the injection of Prevnar 13. Still experiencing arm redness and headache on 8/6/15.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Nausea, Skin warm, Vomiting
Clinical narrative: Large red area about the size of a small grapefruit.  In the center it was hard like when you get a mosquito bite and it was hot.  This lasted about 2 weeks.  She also vomited the night of the injection and felt nauseous the next day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever 100.0, redness & swelling at site location on left arm. 8/6/2015 redness & swelling radiating to left elbow.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling abnormal, Immediate post-injection reaction, Lip swelling, Tongue disorder
Clinical narrative: Immediately after receiving immunization, pt states she felt "funny". 5 minutes after receiving Varicella immunization, pt's lips swelled and her tongue felt thick. Pt brought back to exam room and given subcutaneous epinephrine.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen spot below injection site. Diameter started out about 1/2"  and by the next day was almost 2" in diameter and was hot to the touch. It feels hard to the touch, like a knot under the skin.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Burning sensation, Chills, Diarrhoea, Neuralgia, Pain
Clinical narrative: Diarrhea, low grade fever, chills, aches and pain in lower body. As of Aug 5 diarrhea continued now stopped. Pain and burning in legs to pelvic are continues. This is a strong neuro pain, taking Neurontin from Dr. Problem continues now for 7 days.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Diarrhea, low grade fever, chills, aches and pain in lower body. As of Aug 5 diarrhea continued now stopped. Pain and burning in legs to pelvic are continues. This is a strong neuro pain, taking Neurontin from Dr. Problem continues now for 7 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Skin warm, Urticaria
Clinical narrative: Large welt formed (covered most of upper arm), had heat to it, small knot. Patient took Benadryl per pharmacist recommendation. Welt and knot had resolved within 5 days.
Age: 58.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Cold sweat, Injection site cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt stated he had redness in the area of injection, swelling at injection, fever of 103 degrees F, and clammy.
Age: 12.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on face and trunk, no difficulty breathing. Benadryl given, improved significantly within 10 minutes, oberved and discharged.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Client states she developed a raised rash with little bumps of her left deltoid.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: PT PRESENTED 6 DAYS AFTER INJECTION WITH RED RAISED RASH APROX 7 INCHES IN DIAMETER SURROUNDING THE INJECTION SITE, PT COMPLAINS OF PAIN AND HEAT AT INJECTION SITE AS WELL.  PT WAS REFERRED TO PRIMARY CARE PHYSICIAN, WAITING FOR RESULTS.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abasia, Gait disturbance, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Lower extremity pain, limping, then moderate to severe R thigh and knee swelling and warmth, unable to walk/bear weight due to pain.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Weight bearing difficulty
Clinical narrative: Lower extremity pain, limping, then moderate to severe R thigh and knee swelling and warmth, unable to walk/bear weight due to pain.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Type III immune complex mediated reaction, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain, marked swelling area of vaccine and throughout upper arm - suggestive of Arthus phenomenon.
Age: 25.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site rash, Myalgia, Pain, Pyrexia
Clinical narrative: Patient has injection site reaction with red raised rash.  Patient also had a low fever and muscle and body aches.  Patient states fever and muscle/body aches lasted one day, but rash remains.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Agitation, Emotional distress, Restlessness
Clinical narrative: Inconsolable. Clingy. Wouldn't let me put him down. Restless. Agitated.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Injection site pain, Joint range of motion decreased, Muscular weakness, Myalgia
Clinical narrative: Intense burning sensation just below rotator cuff.  Severe soreness at injection site for about 3 weeks.  Thereafter, muscle weakness and intense soreness when lifting arm, effectively limiting motion.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: ON 8/6/15 PATIENT DESCRIBED SORENESS AND TROUBLE SLEEPING DUE TO PAIN FOR 3 DAYS AFTER RECEIVING VACCCINE.  SHE REPORTED THIS BECAUSE ON 8/5/15 SHE FELT A SIMILAR PAIN IN HER ARM AND ASSUMES THIS IS DUE TO THE VACCINE RECEIVED ON 1/25/15 ALTHOUGH SHE HAS HAD NO SYMPTOMS BETWEEN 1/28/15 AND 8/5/15.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Initial information received from a health care professional on 25 October 2012. A female patient (age and date of birth were unknown), had received an intradermal dose 1 of FLUZONE ID (Batch number: UT4466BA) on left deltoid on 24 October 2012. The patient had no illness at the time of vaccination. The patient's concomitant medications included Ibuprofen and Aspirin. The reporter stated that on 24 October 2012, after vaccination, the patient experienced immediate redness. On 25 October 2012, 1 day after vaccination, the patient developed 6 cm diameter area at injection site with some hardness, induration and hot to touch which was very painful. Laboratory details included none. Corrective treatment included cold packs, TYLENOL and BENADRYL on unspecified dates. At the time of this report, the patient had not recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Initial report received from a healthcare professional on 18 October 2012. A female patient whose age, medical history and concomitant medications were not reported had received a dose of FLUZONE (batch number, dose, number in series and site of administration were not reported) intradermally on an unspecified date. On an unspecified date after receiving the FLUZONE shot, the patient's arm was swelled so much for which patient received corrective treatment with steroids to quell swelling. Laboratory details were not reported. The outcome of the event was not reported. List of documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site pain, Insomnia, Pain
Clinical narrative: Initial report received from a healthcare professional on 22 October 2012. A 31-year-old pregnant female patient, whose medical history was unknown and concomitant medications were not reported, received an intradermal dose of FLUZONE ID (Lot number UT4470AA) in the left deltoid area on 04 October 2012. The last menstrual period was unknown. The patient's estimated date of delivery was reported as 01 May 2013. On 4 October 2012, same day after vaccination, the patient experienced left arm site sore, painful to move and had difficulty in sleeping. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. As of 22 October 2012, the patient's outcome was not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial misuse report received from a health care professional on 11 September 2013. A patient, whose demographics details including initials, age and date of birth was declined, received a dose of FLUZONE vaccine (lot number U4717AA, dose number not reported, subcutaneously in the left deltoid) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was reported that, not sure whether the patient had received the vaccine intramuscularly, may have been administered subcutaneously. It was reported that after receiving FLUZONE vaccine, on an unspecified date the patient had large red, swollen, warm to touch and itchy area at the injection site. Laboratory details and corrective medication was not reported. At the time of this report, the patient was not recovered. Documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Drug administration error, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial report received from a consumer (patient) on 20 September 2012. A 39-year-old female patient, with no illness at the time of vaccination and no known allergies whose concomitant medications were not reported, received first dose of FLUZONE ID (lot number: unknown) intradermally in the left deltoid area on 19 September 2012. On 19 September 2012, approximately 6 hours after vaccination, patient's arm became sore, warm to touch, red at site with a dime sized bump surrounded by a larger bump half dollar sized, and area was itching to underarm. The patient had returned to pharmacist on 20 September 2012; however the pharmacist did not offer any corrective treatment. As of 20 September 2012, the patient had not recovered from the events. List of documents held by sender: none. The follow-up information received from a healthcare professional on 22 October 2012. The pharmacist stated that the vaccine administered incorrectly so the nature of the report was considered as misuse. The patient received the FLUZONE ID vaccine with lot number UT4470AA. Corrective treatment was not offered. It was reported that, the patient received 2 intradermal injection and both caused patient more pain and discomfort than the prefilled and syringe.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Initial report received from a consumer (patient) on 20 September 2012. A 39-year-old female patient, with no illness at the time of vaccination and no known allergies whose concomitant medications were not reported, received first dose of FLUZONE ID (lot number: unknown) intradermally in the left deltoid area on 19 September 2012. On 19 September 2012, approximately 6 hours after vaccination, patient's arm became sore, warm to touch, red at site with a dime sized bump surrounded by a larger bump half dollar sized, and area was itching to underarm. The patient had returned to pharmacist on 20 September 2012; however the pharmacist did not offer any corrective treatment. As of 20 September 2012, the patient had not recovered from the events. List of documents held by sender: none. The follow-up information received from a healthcare professional on 22 October 2012. The pharmacist stated that the vaccine administered incorrectly so the nature of the report was considered as misuse. The patient received the FLUZONE ID vaccine with lot number UT4470AA. Corrective treatment was not offered. It was reported that, the patient received 2 intradermal injection and both caused patient more pain and discomfort than the prefilled and syringe.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dyspnoea, Feeling hot, Influenza like illness, Injection site erythema
Clinical narrative: Initial report received from a consumer on 24 September 2012. A 42-year-old female patient with no medical history and concomitant medications had received FLUZONE (batch number UT4475AA) through intradermal route in the right deltoid region on 20 September 2012. At the time of vaccination on 20 September 2012, the patient had difficulty breathing, felt hot and was "shakey". The patient's whole arm became hot and a red area developed at the injection site. She experienced warm feeling throughout her body, felt like she was going to get sick to her stomach and vomit. She now felt like that she was coming down with the flu and her muscles and joints ache and just doesn't feel well. Laboratory investigations and corrective treatment was not reported. The patient was not recovered from the events; at the time of report. Documents held by sender: None. Follow-up information received on 19 November 2012. Details of patient address was updated. As of on 19 November 2012, it was reported that the patient was had hard time breathing and the patient was sick for 10 days after vaccination. Documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Nausea, Nervousness, Skin warm
Clinical narrative: Initial report received from a consumer on 24 September 2012. A 42-year-old female patient with no medical history and concomitant medications had received FLUZONE (batch number UT4475AA) through intradermal route in the right deltoid region on 20 September 2012. At the time of vaccination on 20 September 2012, the patient had difficulty breathing, felt hot and was "shakey". The patient's whole arm became hot and a red area developed at the injection site. She experienced warm feeling throughout her body, felt like she was going to get sick to her stomach and vomit. She now felt like that she was coming down with the flu and her muscles and joints ache and just doesn't feel well. Laboratory investigations and corrective treatment was not reported. The patient was not recovered from the events; at the time of report. Documents held by sender: None. Follow-up information received on 19 November 2012. Details of patient address was updated. As of on 19 November 2012, it was reported that the patient was had hard time breathing and the patient was sick for 10 days after vaccination. Documents held by sender: none.