chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity, Periarthritis
Clinical narrative: "Free" flu shot administered by pharmacist in January 2014. Very painful shot. Given very high up on my arm. Being a teacher (retired now) I've received numerous flu shots thru school and have never had any problems. Upper arm/shoulder became very painful when moved. Went to Dr. in March 2014, diagnosed it as "frozen shoulder" and ordered X-rays which did not indicate major concerns. Physical therapy followed from March 18 to June 16, 2014. Still had problems over ensuing months. Went to chiropractor for a couple of weeks. Some relief but still ongoing pain. Decided to try an orthopedic doctor in June 23 of 2015. Cortisone shot given in shoulder - physical therapy ordered from June 24 to August 14, 2015. Found the most relief - however - I now live with shoulder/upper arm pain frequently.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray normal
Clinical narrative: "Free" flu shot administered by pharmacist in January 2014. Very painful shot. Given very high up on my arm. Being a teacher (retired now) I've received numerous flu shots thru school and have never had any problems. Upper arm/shoulder became very painful when moved. Went to Dr. in March 2014, diagnosed it as "frozen shoulder" and ordered X-rays which did not indicate major concerns. Physical therapy followed from March 18 to June 16, 2014. Still had problems over ensuing months. Went to chiropractor for a couple of weeks. Some relief but still ongoing pain. Decided to try an orthopedic doctor in June 23 of 2015. Cortisone shot given in shoulder - physical therapy ordered from June 24 to August 14, 2015. Found the most relief - however - I now live with shoulder/upper arm pain frequently.
Age: 22.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, HEPA, MNQ, TDAP, VARCEL
Symptoms: CSF protein increased, Electromyogram abnormal, Facial paresis, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Progressive muscle weakness in upper and lower extremities starting 11 days after receiving mass immunizations. Also associated with facial weakness. Admitted to hospital on Dec. 22, 2015 - underwent workup including imaging, LP, EMG, lab work with diagnosis of GBS - treated with 5 day course of IVIG.
Age: 22.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, HEPA, MNQ, TDAP, VARCEL
Symptoms: Muscular weakness, Nerve conduction studies abnormal, Pleocytosis
Clinical narrative: Progressive muscle weakness in upper and lower extremities starting 11 days after receiving mass immunizations. Also associated with facial weakness. Admitted to hospital on Dec. 22, 2015 - underwent workup including imaging, LP, EMG, lab work with diagnosis of GBS - treated with 5 day course of IVIG.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Half left arm was very red. (all around) after 3 days of vaccine redness-showed to my pharmacy on 3/11/16 she called doctor same day. Went to see my provider (given cephalexin 500 mg).
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Injection site pruritus, Rash, Sleep apnoea syndrome
Clinical narrative: I am 60. According to my medical chart I saw the lot # for shot given is one given below my chart said manuf GlaxoSmithKline debilitating itching flu shot site LA and spreading. Rash forearms today.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy test negative, Autoimmune disorder, Injection site pruritus, Laboratory test normal, Skin test negative
Clinical narrative: I am 60. According to my medical chart I saw the lot # for shot given is one given below my chart said manuf GlaxoSmithKline debilitating itching flu shot site LA and spreading. Rash forearms today.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pruritus
Clinical narrative: Large red itchy localized reaction that continued to spread down arm. Relieved somewhat with BENADRYL.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL, VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Patient received VARIVAX 3/14/16 at 12 month physical. Rash erupted 3/16/16 involving the extremities and trunk. Progressed from 10-12 lesions to 200 + lesions before it started to resolve. Now resolving and getting better, but has taken some time.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL, VARCEL
Symptoms: Rash
Clinical narrative: Patient received VARIVAX 3/14/16 at 12 month physical. Rash erupted 3/16/16 involving the extremities and trunk. Progressed from 10-12 lesions to 200 + lesions before it started to resolve. Now resolving and getting better, but has taken some time.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL, VARCEL
Symptoms: Varicella
Clinical narrative: Patient received VARIVAX 3/14/16 at 12 month physical. Rash erupted 3/16/16 involving the extremities and trunk. Progressed from 10-12 lesions to 200 + lesions before it started to resolve. Now resolving and getting better, but has taken some time.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PPV, DTAPIPVHIB, FLUX, PPV
Symptoms: Rash generalised
Clinical narrative: Started with a small rash on the back and then spread all over the body. It took 1 month of antihistamines to counteract it.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PPV, DTAPIPVHIB, FLUX, PPV
Symptoms: Drug administered to patient of inappropriate age, Rash generalised
Clinical narrative: Started with a small rash on the back and then spread all over the body. It took 1 month of antihistamines to counteract it.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site reaction, Rash macular, Rash pruritic
Clinical narrative: Splotchy, itchy rash on left upper leg near MMRV injection site but not at same area. Gave Benadryl and monitored for 30 minutes. Rash and itching resolved.
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Injection site mass, Lethargy
Clinical narrative: Fever, lump in leg, lethargy, bumps on face and body, diarrhea, dehydration, lack of appetite.
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Mass, Pyrexia, Rash, Rash generalised
Clinical narrative: Fever, lump in leg, lethargy, bumps on face and body, diarrhea, dehydration, lack of appetite.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, hot to the touch (warm). A little itching. All at the site of injection and spread downwards.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via field employee refers to a multiple unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # L019297 (expiry date: 18-AUg-2017) and lot # K026247 (expiry date: 29-JAN-2017) (dosage not reported). No adverse effects reported. The GARDASIL 9 with lot # L019297 was stored at temperature 31.3F, time frame was 211.45 hours and no previous temperature was reported. The GARDASIL 9 with lot # K026247 was stored at temperature 31.1F, time frame was 598 hours and no previous temperature excursion was reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Left leg swelling after immunizations on 3/18/16 fever. Came in to Dr's office on 3/21/16.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Left leg swelling after immunizations on 3/18/16 fever. Came in to Dr's office on 3/21/16.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified number of patients of unknown age and gender. Patient demographics were not reported. Information on concurrent conditions, pertinent medical history and drug allergies of the patients were not reported. On an unknown date (multiple unspecified dates), the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L025210, expiry date 07-JUL-2017 (dose, #, route, anatomical location and dose units were not reported). Concomitant medication included MMR II, which was the product tab but did not experience a temperature excursion. There were no adverse effects reported. There was no Product Quality Concern (PQC) involved. Temperature at which the product was stored was: a minute of 14.2 Fahrenheit (F) and a maximum of 21.4F, for a time frame of 1 hour. There were no previous temperature excursions reported. Additional information has been requested.
Age: 23.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product name confusion, Wrong drug administered
Clinical narrative: Information has been received from a health professional referring to a 23 year old patient of unknown gender. Information about medical history and concurrent condition was unspecified. On 24-MAR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # L034930, expiration date 03-MAR-2017, dose and route unknown) in error. The person who administered the dose of PROQUAD (Merck) consumed it with M-M-R II. The patient had not reported an adverse effect. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were administered improperly stored oral ROTATEQ (lot # L027719 with expiration date of 28-APR-2017, dose and strength unknown) orally. The vaccines were exposed to 8.5 degree C for 15 minutes. There was no previous temperature excursion. No adverse event reported. This is one of the 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: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were administered improperly stored GARDASIL 9 (lot # L007560 with expiration date 15-JUN-2017, lot # L019297 with an expiration date of 18-AUG-2017, lot # L043213 with expiration date of 28-AUG-2017, dose, strength and route unknown). The vaccines were exposed at 8.5 degree Celsius for 15 minutes. There was no previous temperature excursion. No adverse event reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were administered improperly stored M-M-R II (lot # K014833 with expiration date of 14-SEP-2016, lot # L020188 with expiration date of L020188, dose, strength and route unknown). The vaccines were exposed to 8.5 degree Celsius for 15 minutes. There was no previous temperature excursion. No adverse event reported. 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: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were administered improperly stored LIQUID PEDVAXHIB (lot # L030872 with expiration date 11-JUN-2018, dose, strength and route unknown). The vaccines were exposed at 8.5 degree Celsius for 15 minutes. There was no previous temperature excursion. No adverse event reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Injection site pain, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: This spontaneous report was received from a 61 year old female patient regarding herself. The patient has concurrent condition of gastrointestinal disease. The patient is allergic to BACTRIM and most narcotics. On 25-FEB-2016 the patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported). She explained that she did not have blisters or any rash at the injection site, but has been experiencing other adverse reactions. Approximately on an unknown date in 2016, the patient experienced unspecified tingling in the right arm (the same arm in which the patient was vaccinated). She also experienced a low grade fever for four days approximately on an unknown date in 2016 since the injection. On two unspecified nights approximately in 2016, the patient was awakened by a terrible itching on the bottom of unspecified foot that felt like bugs crawling on it. On 07-MAR-2016, the area near the injection site felt like someone hit her in the arm, but it was not swollen. The patient did not seek medical attention. No lab tests were performed and the patient was not treated. The patient reported still having the low grade fever and tingling on the day of report. The outcome of other events were unknown. Causality assessment was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: This spontaneous report was received from a 61 year old female patient regarding herself. The patient has concurrent condition of gastrointestinal disease. The patient is allergic to BACTRIM and most narcotics. On 25-FEB-2016 the patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported). She explained that she did not have blisters or any rash at the injection site, but has been experiencing other adverse reactions. Approximately on an unknown date in 2016, the patient experienced unspecified tingling in the right arm (the same arm in which the patient was vaccinated). She also experienced a low grade fever for four days approximately on an unknown date in 2016 since the injection. On two unspecified nights approximately in 2016, the patient was awakened by a terrible itching on the bottom of unspecified foot that felt like bugs crawling on it. On 07-MAR-2016, the area near the injection site felt like someone hit her in the arm, but it was not swollen. The patient did not seek medical attention. No lab tests were performed and the patient was not treated. The patient reported still having the low grade fever and tingling on the day of report. The outcome of other events were unknown. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to 3 unspecified patients of an unknown age and gender. The patients' relevant medical history, concurrent condition and concomitant medication were not reported. On 17-FEB-2016, 2 unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030587 (10-FEB-2017) (dosage not reported). It was stored at 20F temperature and time frame was 599 hours. There was no previous temperature excursion. No product quality complaint reported. No adverse events reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. No patient's concurrent conditions or medical history were provided. On 15-MAR-2016, the patient was vaccinated with a dose of improperly stored (temperature: 12 degree Celsius, time frame: 8.5 hours) MMR II (lot# L012482, expiry date: 10-APR-2017, dose, route and site of administration were unspecified). There was no temperature excursion issues previously. Concomitant medication was not reported. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. No patient's concurrent conditions or medical history were provided. On 17-MAR-2016, the patient was vaccinated with dose of improperly stored (temperature: 12 degrees Celsius, time frame: 8.5 hours) MMR II (lot# L012482, expiry date: 10-APR-2017, dose, route and site of administration were unspecified). There was no temperature excursion issues previously. Concomitant medication was not reported. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via field employee refers to a multiple unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored MMR II lot # L020188 (expiry date: 03-JUN-2017), L012481 (expiry date: 10-APR-2017) and K018990 (expiry date: 15-OCT-2016) (dosage not reported). No adverse effects reported. The vaccine was stored at temperature 57.4F, time frame was 7.25 hours and no previous temperature excursion was reported. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Information has been received via field representative from an unknown age male physician referring to himself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, once, subcutaneously, (lot # and expiration date were unknown) for prevention of herpes zoster. On an unknown date, Six months after receipt of the vaccine, the patient diagnosed himself with shingles (rash and blisters). The rash was treated (topical cream administered unknown) and had since abated (recovering). The patient didn't seek medical attention. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The pharmacist called to report that the multiple patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # I027321 with expiration date: 21-OCT-2016; dose and route not reported) on unspecified dates since 04-DEC-2015. The vaccine was stored in 42F for 5 hours. No adverse effects were reported. It was unspecified if the patients sought medical attention or not. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Erythema, Malaise, Pain, Swelling
Clinical narrative: Sore after administration but by Saturday it was really red, swollen all the way to elbow. Called pharmacy and doctor on call who advised ice and BENADRYL. Also felt sick and did not have much appetite. Treatment doctor advised helped; the swelling decreased. There still is redness but hoping it will go away in a couple of days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to 3 patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route were not reported; lot # L033343, expiration date 13-SEP-2017; Temperature: 34 Fahrenheit (F), Time frame: 14 hours; no previous excursion). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to 3 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 02-MAR-2016, 1 unspecified patient was vaccinated with improperly stored PROQUAD (Merck) lot # L030587 (10-FEB-2017) (dosage not reported). It was stored at 20F temperature and time frame was 599 hours. There was no previous temperature excursion. No adverse events reported. No product quality complaint reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's drug reactions/allergies, concurrent conditions and historical conditions were not provided. On an unknown date in 2014, the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reported). The patient's concomitant medications were not provided. On an unknown date the "patient had an unspecified titer drawn which resulted low" (antibody test negative). The outcome of the event was unknown. The causality assessment was not provided. No further information was provided. Additional information is not expected since the pharmacist declined to provide any further information.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Urticaria
Clinical narrative: Warm to touch, raised itchy red welt.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Pain where shot was given, pain and swelling where shot was given, chills and sore joints and body aches, lump where shot was given, has resolved.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Pain where shot was given, pain and swelling where shot was given, chills and sore joints and body aches, lump where shot was given, has resolved.
Age: 19.0
Sex: M
Vaccine: HEPAB, TD
Symptoms: Dizziness
Clinical narrative: Patient felt light headed and dizzy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: Body aches, fatigue - The next morning there were blisters present near the site of injection and low grade fever.  Area was sore, red, and warm to touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches, fatigue - The next morning there were blisters present near the site of injection and low grade fever.  Area was sore, red, and warm to touch.
Age: 58.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine, Influenza like illness, Myalgia, Nausea, Vomiting
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) on 29 February 2016. Manufacturer Report Number: 2014326408. This case involves a 58-years-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu Vaccine) (batch number, dose, dose in series, route and site of administration was not reported) on an unspecified date. The patient had a medical history of allergy to ACE inhibitors which caused angioedema, swelling and allergy to Enalapril which caused angioedema. Concomitant medications were not reported. On 19 February 2016, following the vaccination, the patient experienced flu like syndrome, nausea, vomiting, myalgia, allergies to flu vaccine. Lab data was not reported. Corrective treatment was not reported. It was reported that patient was treated outpatient. Outcome of patient was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (manufacturer report number- 2016116108) on 07 March 2016. This case involves a female (age not reported) patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu vaccine) (batch number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced allergy to flu vaccine. Laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Skin test negative
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (manufacturer report number- 2016116108) on 07 March 2016. This case involves a female (age not reported) patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu vaccine) (batch number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced allergy to flu vaccine. Laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Pt had reaction to PNEUMOVAX 23 after receiving vaccine in office. Pt "could not move" arm that injection was given in. There was no redness, swelling or warmth. Pt reports severe pain.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 21-MAR-2016, the patient was vaccinated with an expired dose of oral, ROTATEQ (lot # K017572, expiration date: 18-MAR-2016) (dose was not provided). Concomitant medication was not reported. No adverse symptoms were reported and there was not product quality complaint involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Axillary pain
Clinical narrative: C/O (L) armpit pain. No redness. No fever.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Broke out in hives, urticaria (4 hours post injection of PREVNAR 13). Urgent care tx 3/19/16 eval w/PCP on 3/23/16 for continuing symptoms.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Discomfort, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Immediate tingling = arm and numbness in fingers, resolved after 24h. Residual discomfort. Transient weakness 10 days later.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Expired product administered
Clinical narrative: Staff pulled 2 vaccines from the frig and asked me to give them. I checked the date of 1 part of the Hib vaccine (the diluent) and it was not expired. I didn't know that the other part could have a different exp. date.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Anger, Asthenia, Confusional state, Constipation, Dizziness
Clinical narrative: Extreme vertigo (dizziness, unsteady when standing, floating when laying), weakness, confusion (fuzzy brain), un-well feeling, constipation, shortened temper, for 7 days after injection. After 12 days; occasional dizziness and no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Dizziness postural, Feeling abnormal, Malaise, Vertigo
Clinical narrative: Extreme vertigo (dizziness, unsteady when standing, floating when laying), weakness, confusion (fuzzy brain), un-well feeling, constipation, shortened temper, for 7 days after injection. After 12 days; occasional dizziness and no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Asthenia, Balance disorder, Dizziness, Nausea
Clinical narrative: Extreme vertigo (dizziness, unsteady when standing, floating when laying), weakness, confusion (fuzzy brain), un-well feeling, constipation, shortened temper, for 7 days after injection. After 12 days; occasional dizziness and no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Asthenia, Confusional state, Constipation, Dizziness, Injection site pain
Clinical narrative: Extreme vertigo (dizziness, unsteady when standing, floating when laying), weakness, confusion (fuzzy brain), un-well feeling, constipation, shortened temper, for 7 days after injection. After 12 days; occasional dizziness and no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Malaise, Nausea, Vertigo
Clinical narrative: Extreme vertigo (dizziness, unsteady when standing, floating when laying), weakness, confusion (fuzzy brain), un-well feeling, constipation, shortened temper, for 7 days after injection. After 12 days; occasional dizziness and no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Asthenia, Balance disorder, Blood chloride increased, Blood creatinine normal, Blood glucose normal
Clinical narrative: Extreme vertigo (dizziness, unsteady when standing, floating when laying), weakness, confusion (fuzzy brain), un-well feeling, constipation, shortened temper, for 7 days after injection. After 12 days; occasional dizziness and no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide decreased, Dizziness
Clinical narrative: Extreme vertigo (dizziness, unsteady when standing, floating when laying), weakness, confusion (fuzzy brain), un-well feeling, constipation, shortened temper, for 7 days after injection. After 12 days; occasional dizziness and no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphadenopathy, Nausea, Neurological examination abnormal
Clinical narrative: Extreme vertigo (dizziness, unsteady when standing, floating when laying), weakness, confusion (fuzzy brain), un-well feeling, constipation, shortened temper, for 7 days after injection. After 12 days; occasional dizziness and no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Nystagmus, Vertigo
Clinical narrative: Extreme vertigo (dizziness, unsteady when standing, floating when laying), weakness, confusion (fuzzy brain), un-well feeling, constipation, shortened temper, for 7 days after injection. After 12 days; occasional dizziness and no energy.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen from injection site down to elbow.  Patient used ice packs and took Tylenol and didn't get much better so went to urgent care on 3/26/16.  She was given rx for prednisone and cephalexin.
Age: 1.03
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Haemorrhage, Vomiting
Clinical narrative: Febrile Seizure - lasted 25-30 mins - double dosage of Ativan to stop it only to have another at 6:25 PM lasting over 40 mins with vomit and bleeding.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Skin irritation
Clinical narrative: Skin irritation.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Limb discomfort, Pain in extremity, Skin warm
Clinical narrative: Heaviness, aching, large hardened area under the skin, warm to touch (Left Arm).
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Exposure during pregnancy, Feeling hot, Pyrexia, Swelling
Clinical narrative: Initial unsolicited pregnancy report received from a nurse on 10 March 2016. This case is linked to 2016SA051134 (same reporter and same vaccine). This case involves female patient (age not reported) who was vaccinated with first dose of ADACEL (batch number- U5298AA, expiry date- 27 March 2018, site of administration not reported) intramuscularly on an unspecified date. Pregnancy information included last menstrual period, estimated delivery date, pregnancy trimester was not provided. The patient's medical history and concomitant medications were not reported. Illness at the time of vaccination was reported as none. On an unspecified date, same day following the vaccination, the patient had developed redness, swelling, warmth and fever. Relevant laboratory test was reported as none. The patient's corrective treatment included compresses and over the counter medications. The pregnancy outcome was not reported. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Headache
Clinical narrative: Initial unsolicited report received from a nurse on 11 March 2016. This case involves a 45-year-old male patient who was vaccinated with a dose of ADACEL (batch number U4804AA, expiry date 22 May 2016) intramuscularly in left deltoid on 09 March 2016. Patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as diabetic. Concomitant medications were not reported. On 10 March 2016, one day following the vaccination patient experienced headache. Pain is not as bad as a migraine and is located at the top of his head. On 11 March 2016, two days following the vaccination patient experienced stomach pain (intermittently). Laboratory investigation was not reported. Corrective treatment was Aleve. The outcome of event was not recovered. List of documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Swelling
Clinical narrative: She was given Prevnar-13 on 3/25/16. She says that later that evening or the next day, her left upper arm became pink, mildly tender, and mildly itchy at the injection site. No fever. The pink color was faint but extended to her elbow. She initially had some swelling but that resolved by the time she was seen in office on Monday 3/28/16.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Alanine aminotransferase increased, Chills, Diarrhoea, Fatigue, Full blood count normal
Clinical narrative: Patient noted diarrhea, fever, chills, fatigue and felt mildly forgetful.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Memory impairment, Pyrexia
Clinical narrative: Patient noted diarrhea, fever, chills, fatigue and felt mildly forgetful.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Aphthous ulcer, Fatigue, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Developed congestion, a sore throat and many canker sores in his mouth, fatigue reported.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: After clinic visit, patient had swelling and warmth to Hep A injection site. No systemic symptoms of trouble breathing, facial/tongue swelling, or itching. Given 50 mg Benadryl in clinic, mom will continue to watch at least for 1 hour after injection, then patient to call if having new symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash, Rash pruritic
Clinical narrative: Patient reported having a red line stemming from the injection site, it has now faded and was present the day off administration. The patient is also reporting a small rash that is present on right rib cage.  The rash is not burning, but is a little bit itchy. There are no systemic adverse effects reported (ie fever, malaise, etc.).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Pt. returned to administering pharmacy complaining of a possible reaction. She indicated a large "goose egg" welp had appeared at injection site. The area was red and a little warm. Pt. also had red, rash on arms, feet, and calves. Pt. reported she is allergic to a lot of things (seasonal, aspirin). Pt. reported she had been using hydrocortisone cream.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient received GARDASIL #1 on 2/24/16 and two weeks later developed an itchy red rash and on both hands. Rash still present on 3/7/16. Patient otherwise well, but hands are red with rash and itchy.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Diplopia, Nuclear magnetic resonance imaging brain, Ophthalmoplegia
Clinical narrative: After 15 minutes of administration of PREVNAR (PCV-13) given by the pharmacist (I wrote the Rx). Pt developed diplopia and his intermittent ophthalmoplegia.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram, Loss of consciousness
Clinical narrative: This spontaneous report was received from a certified medical assistant, via company representative, concerning an 11 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were unspecified by reporter. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, 0.5 ml (dose number, route, anatomical location, lot number and expiration date were unspecified). The patient was concomitantly vaccinated with TDAP and MENACTRA. On an unknown date in March 2016 (reported as "within the last two weeks"), the patient was "out for about 30 seconds". Then, the patient was taken to the emergency room (ER) of an unspecified hospital where a computerized axial tomography (CAT) scan was performed. The reporter did not discuss the results of the CAT scan. It was not reported if the patient was admitted to the hospital or not. The outcome of the passed out was unknown. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ (lot # K023532, expiration 21-JUN-2016, dose was not reported) orally (incorrect product storage). The vaccines were stored in temperature of 33F for 9 hours and 50 minutes. GARDASIL 9 appeared in the product list, however no improperly stored doses of GARDASIL 9 were administered. No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with an unspecified number of improperly stored doses of VAQTA (lot # L030442, expiration 19-DEC-2016, dose and route were not reported) (incorrect product storage). The vaccines were stored in temperature of 33F for 9 hours and 50 minutes. No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter stated that on unknown dates improperly stored doses of VARIVAX (Merck) (lot # L023594, expiration date 26-JUN-2017; lot # L034372, expiration date 08-SEP-2017; lot # L028277, expiration date 28-JUL-2017 and lot # L037562, expiration date 29-SEP-2017) (dosage, strength and route unknown) were administered to an unspecified number of unspecified patients. No adverse effect was reported. Temperature: VARIVAX (Merck) (lot # L037562 and L028277) was 6.1 degree F. Time frame: undetermined. Previous excursion: VARIVAX (Merck) (lot # L037562 and L028277) 6 degree F for 45 minutes. 6.1 degree F for 1 hour, 14 degree F for 8 hours and 9 degree F 1 hour. Administered: yes, since the last previously reported excursion. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the improperly stored GARDASIL was administered to the patients. No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information has been received from a registered nurse during a phone call on 18-MAR-2016. The registered nurse reported that the original reporter Medical Assistant was no longer at the facility. The registered nurse did not have the requested information (patient identifiers, dates of vaccination, lot numbers or reason for temperature excursion) available at the time of the call. 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: Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unspecified. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L037565, expiration date 29-SEP-2017, dose and route unknown). The vaccine was stored under 22.6 F for 44 hours and supported until labeled expiry. There was no previous excursion. It was reported due to data logger. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unspecified. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L005295, expiration date 17-AUG-2016; lot # L014401, expiration date 23-OCT-2016, dose and route unknown). The vaccine was supported until labeled expiry. There was no previous excursion. It was reported due to data logger. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a pharmacist referring to a currently 22 years old female patient. On unknown dates the patient received a full 3-dose series of unspecified hepatitis b vaccine (recombinant) (manufacturer unknown) (dose and route were not reported). In March 2016 (reported as currently) the patient had a titer of 3. The desired level was 10. The outcome of the event was unknown. Causality was not reported. The patient was "healthy" and had not experienced any other adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red swollen "bump" at injection site approx. 5" long. Painful and swollen for 4 days before resolving on its own.
Sex: U
Vaccine: PPV, HEP, MMRV, HIBV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the improperly stored PNEUMOVAX 23 was administered to the unspecified patients. No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information has been received from a registered nurse during a phone call on 18-MAR-2016. The registered nurse reported that the original reporter Medical Assistant was no longer at the facility. The registered nurse did not have the requested information (patient identifiers, dates of vaccination, lot numbers or reason for temperature excursion) available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, HEP, MMRV, HIBV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the improperly stored RECOMBIVAX HB was administered to the unspecified patients. No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information has been received from a registered nurse during a phone call on 18-MAR-2016. The registered nurse reported that the original reporter Medical Assistant was no longer at the facility. The registered nurse did not have the requested information (patient identifiers, dates of vaccination, lot numbers or reason for temperature excursion) available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, HEP, MMRV, HIBV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the improperly stored PROQUAD (Merck) was administered to unspecified patients. No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information has been received from a registered nurse during a phone call on 18-MAR-2016. The registered nurse reported that the original reporter Medical Assistant was no longer at the facility. The registered nurse did not have the requested information (patient identifiers, dates of vaccination, lot numbers or reason for temperature excursion) available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, HEP, MMRV, HIBV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the improperly stored PEDVAXHIB was administered to the unspecified patients. No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information has been received from a registered nurse during a phone call on 18-MAR-2016. The registered nurse reported that the original reporter Medical Assistant was no longer at the facility. The registered nurse did not have the registered information (patient identifiers, dates of vaccination, lot numbers or reason for temperature excursion) available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, HEP, MMRV, HIBV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the improperly stored VARIVAX was administered to the unspecified patients. No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information has been received from a registered nurse during a phone call on 18-Mar-2016. The registered nurse reported that the original reporter Medical Assistant was no longer at the facility. The registered nurse did not have the requested information (patient identifiers, dates of vaccination, lot numbers or reason for temperature excursion) available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.