chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Induration, Injection site erythema, Mobility decreased, Pain in extremity
Clinical narrative: The arm was very painful after leaving office. It had a hard red area. Tingling in arm and hand and lost most use of shoulder. Patient had PT, and use of shoulder now present. Continues to have arm pain. Erythema at injection site and area.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Paraesthesia
Clinical narrative: The arm was very painful after leaving office. It had a hard red area. Tingling in arm and hand and lost most use of shoulder. Patient had PT, and use of shoulder now present. Continues to have arm pain. Erythema at injection site and area.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: On 04/26/16, 65 yo F was seen in clinic for annual wellness exam. During this visit, pt was ordered to receive Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13) [IMM78 Custom]. At 1118, pt was administered 0.5 mL IM in right deltoid (Mfg: Wyeth-Ayerst, NDC #0005-1971-01, lot #M51194, exp: 5/1/2017). Pt tolerated injection without incident and was discharged home. On 05/03, pt returned to clinic for an unrelated complaint. During this visit, the pt was noted to have a rash on her right upper arm. Pt denied any pain and there was no warmth to the area. Pt reported that the rash was "getting better". Pt was evaluated by MD and rash was diagnosed as an "Injection site reaction....secondary to Prevnar - resolving reaction". The pt was advised to apply cool compresses, take benadryl prn and return to clinic for any worsening symptoms. Pt was then discharged in stable condition.
Age: 42.0
Sex: F
Vaccine: DTP
Symptoms: Pain
Clinical narrative: Pain
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema multiforme, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Patient called in on 3/21/12 to report having redness and swelling at site of pneumonia vaccine administered 3/20/12. Patient was advised to come in but later canceled visit and went to local ED for these symptoms. Patient states site is swollen and warm. Patient was diagnosed with cellulitis infection at local ED and was given IV antibiotics, Cephalexin 500 mg QID X 10 days, BENADRYL 25-50 mg q 6 hr and taking ibuprofen for pain. Symptoms: Erythema multiform and erythema, edema, pain at injection site.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient called in on 3/21/12 to report having redness and swelling at site of pneumonia vaccine administered 3/20/12. Patient was advised to come in but later canceled visit and went to local ED for these symptoms. Patient states site is swollen and warm. Patient was diagnosed with cellulitis infection at local ED and was given IV antibiotics, Cephalexin 500 mg QID X 10 days, BENADRYL 25-50 mg q 6 hr and taking ibuprofen for pain. Symptoms: Erythema multiform and erythema, edema, pain at injection site.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported right arm swollen from shoulder to elbow (about 1.5 the size of other arm). Erythema Multiform and erythema, edema, pain at injection site. ETODOLAC.
Age: 54.0
Sex: M
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Induration
Clinical narrative: (R) upper extremity erythema, firm/indurated.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Left thigh swelling at inj site no hardness, no warm to touch.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Myalgia, Sedation
Clinical narrative: Headache, sedation and myalgia.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 14 year old female patient. The patient was allergic to AMOXIL. The patient had no pertinent medical history. On 21-JUL-2015 the patient was vaccinated with GARDASIL 9 (dose 1, dose, route and lot # not reported). On the same day, the patient was also vaccinated with HAVRIX. There was no other concomitant medication. Since then the patent had a rash for "last 9 months". The patient sought medical attention by calling the office. ZYRTE was given as treatment. No lab diagnostics studies were performed. The outcome of rash was reported as not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV4
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 14 year old female patient. The patient was allergic to AMOXIL. The patient had no pertinent medical history. On 21-JUL-2015 the patient was vaccinated with GARDASIL 9 (dose 1, dose, route and lot # not reported). On the same day, the patient was also vaccinated with HAVRIX. There was no other concomitant medication. Since then the patent had a rash for "last 9 months". The patient sought medical attention by calling the office. ZYRTE was given as treatment. No lab diagnostics studies were performed. The outcome of rash was reported as not recovered. 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 registered nurse (also reported as medical assistant) refers to unspecified multiple patients of unknown age. The concurrent condition, medical history and concomitant medication was not reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# L033343 and Expiry: 13-SEP-2017; lot # L027733 and Expiry: 13-SEP-2017; lot# L039660 and Expiry: 04-FEB-2018). The vaccines were stored at a temperature of 9.5 degrees Celsius for an hour. There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Age: 0.59
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site haemorrhage, Injection site reaction, Petechiae, Rash erythematous
Clinical narrative: Faint pin point reddish spots on shoulder and legs, (petechiae on arms and legs).
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth, Lymphangitis
Clinical narrative: Deltoid swollen, red, hot to touch with streaking to axilla. Seen at urgent care. Dx lymphangitis. Tx'd with BENADRYL given Rx KEFLEX but did not end up needing.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to 23 patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9, dose and route were not reported. Improperly stored doses of GARDASIL 9 with lot # L044475 and expiration date: 12-MAY-2017 were administered to 20 patients, whereas doses with lot# M004116 and expiration date: 12-OCT-2017 were administered to 3 patients. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Irritability, Oral mucosal eruption, Pyrexia, Rash erythematous
Clinical narrative: Red bumpy rash developed on legs, fever of 101, rash continued to spread through next few days, even in mouth, fussy, irritable.
Sex: U
Vaccine: MMRV
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. The patient did not experience temperature excursion previously. On 26-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger (also reported as rHA) (incorrect product storage). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case was one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. The patient did not experience temperature excursion previously. On 26-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit for 1 hour and 20 minutes. No adverse events were reported. This case was one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. The patient did not experience temperature excursion previously. On 26-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case was one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. The patient did not experience temperature excursion previously. On 26-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot # L050910, expiration date: 14-JUN-3017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hours and 20 minutes. No adverse events were reported. This case was one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. The patient did not experience temperature excursion previously. On 19-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case was one of several cases 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 registered nurse referring to a patient of unknown age and gender. The patient did not experience temperature excursion previously. On 21-APR-2016 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (dose and route were unknown, lot #: L044524, expiration date: 09-NOV-2017, therapy type: digital data logger) (incorrect product storage). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case was one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. The patient did not experience temperature excursion previously. On 28-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case was one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. The patient did not experience temperature excursion previously. On 27-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case was one of several case received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot # L020162, expiration date: 23-JUL-2017), dose and route were not provided. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On multiple unspecified dates, the patients were vaccinated with improperly stored (temperature 23.7 Fahrenheit degrees (F), time frame reported as cumulative total of 14 hours and 45 minutes, also reported as vaccine temperature excursion) doses of VARIVAX (Merck) injection (lot# L027288 with expiration date 21-JUL-2017, lot# L026411 with expiration date 15-FEB-2017, lot# L018001 with expiration date 19-MAY-2017, lot# L031065 with expiration date 18-AUG-2017, lot# L044526 with expiration date 09-NOV-2017 and lot# L020003 with expiration date 02-JUN-2017, dose and route of administration were not reported). No adverse effect was reported. There was no previous temperature excursion. The call was made because of data logger. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. The patient did not experience temperature excursion previously. On 19-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L50910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case as one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. The patient did not experience temperature excursion previously. On 21-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (dose and route were unknown, lot #: K050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case as one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On multiple unspecified dates, the patients were vaccinated with improperly stored (temperature 23.7 Fahrenheit degrees (F), time frame reported as cumulative total of 14 hours and 45 minutes, also reported as vaccine temperature excursion) doses of PROQUAD (Merck) injection (lot# L014405 with expiration date 23-OCT-2016, lot# L033698 with expiration date 28-FEB-2017, lot# L023112 with expiration date 24-DEC-2016, lot# L034931 with expiration date 03-MAR-2017, lot# L046507 with expiration date 17-MAY-2017 and lot# L051098 with expiration date 16-JUN-2017, therapy type, dose and route of administration were not reported). No adverse effect was reported. There was no previous temperature excursion. The call was made because of data logger. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored (temperature: 31 F for 16 hours) doses of PNEUMOVAX 23 (lot # L013428, expiration date: 13-FEB-2017), dose and route were not provided. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Injection site induration, Injection site nodule, Injection site rash, Insomnia
Clinical narrative: Within 24 hours large swelling at injection and hard ball under skin. Swelling proceeded to grow larger and larger over the next 7 days taking over top part of leg and thigh. Behavior was irritable, constant crying, screaming for 3-4 day straight. Not sleeping. Swelling went down on 7th day but additional rash broke out all over leg on 7th day.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Screaming, Vaccination complication
Clinical narrative: Within 24 hours large swelling at injection and hard ball under skin. Swelling proceeded to grow larger and larger over the next 7 days taking over top part of leg and thigh. Behavior was irritable, constant crying, screaming for 3-4 day straight. Not sleeping. Swelling went down on 7th day but additional rash broke out all over leg on 7th day.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to 12 patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored (temperature: 34 F for a total time of 65 hours) doses of ROTATEQ (lot# reported as L033543, expiration date: 30-MAY-2017) orally, dose was not reported. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Rash
Clinical narrative: Cellulitis, pt had a rash on left arm.
Age: 1.84
Sex: M
Vaccine: DTP, FLU3, HEPA, HIBV, PNC13
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: 1 week post vaccines, pt experience swollenness, itchiness, and rash. Mother applied hydrocortisone. No relief.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Skin lesion, Urticaria
Clinical narrative: Urticarial lesion, > 10 measured 30-10mm currently resolving, using hydrocortisone for symptomatic treatment.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Full blood count, Injection site discolouration, Injection site rash, Metabolic function test, Reticulocyte count
Clinical narrative: Non-blanchable purple rash on left lower leg noted in afternoon of 5/4/16.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Dyskinesia, Eye movement disorder, Tension, Tremor
Clinical narrative: The patient had a tactile temperature and the mother gave her ibuprofen. Hours later, patient started to cry and then she had an episode described as "body jerking/shaking/tense" movements, eye rolling that lasted a few seconds.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal chest pain, Peripheral swelling
Clinical narrative: Swelling and joint pain in lower legs from knees down and full left side. Progression to joint pain in arms chest... ribcage headache and extreme exhaustion. Low grade fever.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Swelling and joint pain in lower legs from knees down and full left side. Progression to joint pain in arms chest... ribcage headache and extreme exhaustion. Low grade fever.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning multiple patients of unknown age and gender. Unspecified number of patients were vaccinated with improperly stored doses (-3.1 degree Celsius for 1632 hours) of GARDASIL 9 lot number L019297 (expiry date 18-AUG-2017) on the following dates: 21-JAN-2016, 22-JAN-2016, 25-JAN-2016, 26-JAN-2016, 27-JAN-2016, 02-FEB-2016, 03-FEB-2016, 05-FEB-2016, 09-FEB-2016, 10-FEB-2016, 11-FEB-2016, 12-FEB-2016, 23-FEB-2016, 24-FEB-2016, 25-FEB-2016, 26-FEB-2016, 29-FEB-2016 and 03-MAR-2016. Improperly stored dosages of Lot L044475 (expiry date: 12-MAY-2017) were administered to the unspecified patients on the following dates: 27-JAN-2016, 07-MAR-2016, 08-MAR-2016, 11-MAR-2016, 14-MAR-2016, 17-MAR-2016, 18-MAR-2016 and 22-MAR-2016. Unspecified number of patients received improperly doses of lot number L016428 (expiry date: 30-JUL-2017) since an unknown date in January 2016. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from registered nurse referring to a 14 year old male patient. No concurrent condition, medical history or concomitant therapy was reported. On 13-APR-2016 (reported as "today"), the patient was inadvertently vaccinated with a 0.5 ml dose of PROQUAD (Merck) (lot # L044055 with expiration date 02-MAY-2017, therapy type: RHA, subcutaneous) in the left arm (inappropriate schedule of drug administration), instead of VARIVAX (Merck) and M-M-R II (wrong drug administered). No adverse effects were reported. Additional information is not expected due to no consent to do follow-up.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Chills for 2 days, low grade fever, headache, pain and tenderness and a large area of redness by the injection site as well as all the way down my arm. Joint pain and fatigue.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Chills for 2 days, low grade fever, headache, pain and tenderness and a large area of redness by the injection site as well as all the way down my arm. Joint pain and fatigue.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Malaise, Pharyngeal oedema
Clinical narrative: 1700 throat swollen, malaise, numbness on left side. Seen in ER, given BENADRYL and steroids.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored RECOMBIVAX HB (Lot # L048849 and expiration date: 04-FEB-2018; Lot# L039660 and expiration date: 04-FEB-2018) (dose and route not provided). Concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 31.5 F for 3.5 hours. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (route, dose, dose number, lot number, expiration date and frequency were not reported). Concomitant medications were not provided. On an unknown date, the patient experienced herpes zoster. The outcome of herpes zoster was unknown. No product quality complaint (PQC) was involved. The primary reporter did not provide the causal relationship between ZOSTAVAX and herpes zoster. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Approx 8 hrs after receiving vaccine, pt developed redness, swelling and warm to touch at site. Also had fatigue and body aches the following day - now improved. Pt in office now.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Plasmapheresis, Sensory loss
Clinical narrative: Guillain-Barre. Loss of feeling all over body. Plasma treatment and therapy.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On unspecified dates in 2016 (reported as started on or after 09-FEB-2016), the patients were vaccinated with improperly stored doses of VAQTA (lot # l015460, expiry date: 20-JUL-2017; lot # L022259, expiry date: 06-APR-2017). Nurse stated tha the mentioned lot numbers of the vaccine underwent temperature excursion at 22.7 and -1.2 degree Celsius for 10 hours 8 minutes and 37 hours 6 minutes, respectively. She also reported the details of unsupported vaccine administered to unspecified patients: lot # L041676 (expiry date: 15-MAR-2016, lot # L041676 (temperature excursion of -1.2 degree Celsius for 18 hours 34 minutes) on 22-MAR-2016, lot # L041676 (temperature excursion at -1.2 degree Celsius for 23 hours 20 minutes) on 23-MAR-2016, lot # L041676 (temperature excursion at -1.2 degree Celsius for 24 hours 33 minutes) on 24-MAR-2016, lot # L041676 (temperature excursion at -1.2 degree Celsius for 25 hours 40 minutes) on 28-MAR-2016, lot # L015460 (temperature excursion at -1.2 degree Celsius for 26 hours 58 minutes) on 29-MAR-2016. No adverse effect was reported.  This is one of five reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient with drug allergy to BIAXIN, Doxycycline and CECLOR. On 19-APR-2016, the patient was vaccinated with ZOSTAVAX with lot # L034726 and expiration date 09-DEC-2016 (unspecified dose and route), in the left deltoid. There were no concomitant medications. The pharmacist reported that since 25-APR-2016, the patient had had a swollen gland in her left axillary area, as well as another swollen gland on the left side of her neck (Lymphadenopathy). There were no laboratory diagnostic studies performed and no treatment was given for the adverse event. At the reporting time, the patient was not recovered from Lymphadenopathy. The causality assessment was not provided. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling and erythema at injection site that worsened after 24 hours. Was seen in clinic diagnosed with cellulitis by me. Treated with KEFLEX. Patient called back later that day stating erythema had spread beyond outline borders. At which point I directed her to one of our ERs for further eval and possible IV antibiotics. However, ER reports erythema same as I measured. She fully recovered on oral antibiotics.
Age: 0.58
Sex: F
Vaccine: FLU4, HIBV, PNC13, FLUX, HIBV, MNQ
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hypotonia
Clinical narrative: Progressive hypotonia, Guillain Barre Syndrome.
Age: 0.58
Sex: F
Vaccine: FLU4, HIBV, PNC13, FLUX, HIBV, MNQ
Symptoms: Blood test, Electromyogram, Fatigue, Guillain-Barre syndrome, Lethargy
Clinical narrative: Progressive hypotonia, Guillain Barre Syndrome.
Age: 0.58
Sex: F
Vaccine: FLU4, HIBV, PNC13, FLUX, HIBV, MNQ
Symptoms: Lumbar puncture, Mobility decreased, Nuclear magnetic resonance imaging, Posture abnormal, Scan brain
Clinical narrative: Progressive hypotonia, Guillain Barre Syndrome.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain, Pyrexia, Rash
Clinical narrative: MUSCLE PAIN IN ARM OF INJECTION AND PECTORAL MUSCLE ON RIGHT SIDE. REDNESS AND RASH ON INJECTION ARM DOWN TO ELBOW. SORENESS, FEVER.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO ADVERSE EFFECTS. NO TREATMENT NEEDED.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Administration site swelling, Injection site swelling
Clinical narrative: Redness and swelling at the administer site of the arm.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient received pneumococcal polysaccharide PPV23 on 5/4/16. She reported swelling and redness of left arm. Came to the urgent care dept on 5/5/16 diagnosed with cellulitis and given PO antibiotics and NSAIDS.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Computerised tomogram head normal, Seizure, Sleep apnoea syndrome
Clinical narrative: Seizure vs sleep apneic episode 5/3/16 while napping at daycare. Seen at ED immed after.
Age: 1.43
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Severe swelling on left thigh and it feels hot when touched.
Age: 34.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Blepharospasm, Muscle twitching
Clinical narrative: Grad student states that she continues to experience daily muscle twitches (brief- lasting 2 to 3 seconds) mainly noticed when she is still; she feels this on various muscles of her body- more lower than upper(calf, left foot, thighs, buttock, cheek, scalp, eyelids from 5 to 25 times/day; She first noticed this about 5 weeks after she got her first Hep B vaccine (also given MMR and Tdap that same day); She then received her 2nd Hep B vaccine on 11/13/2015.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Soreness of left deltoid Saturday morning then numbness and tingling in left arm from shoulder to fingertips beginning around 10:00 pm lasting about 45 minutes. Reports she "did not feel like herself from Saturday through Monday". Began feeling better on Tuesday 5/3/16.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Feeling abnormal, Heart rate increased
Clinical narrative: FELT TERRIBLE, WEAK, FAST HEARTBEAT, DIZZY.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Blood test, Computerised tomogram, Deafness, Hyperacusis
Clinical narrative: Arm Swollen for several days, Sudden Hearing Loss/Deafness (ongoing), tinnitus, hypercusis.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Peripheral swelling, Sudden hearing loss, Tinnitus
Clinical narrative: Arm Swollen for several days, Sudden Hearing Loss/Deafness (ongoing), tinnitus, hypercusis.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Induration, Pain, Peripheral swelling, Skin warm
Clinical narrative: HEPATITIS B IMMUNIZATION. AROUSED WITH RT ARM SWOLLEN, WARM, FIRM, SORE. ICE PACK PLACE TO ARM.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Swelling, Urticaria
Clinical narrative: Received only the MMR vaccine. Swelling and hives near injection site. Occurred within less than 5 minutes of administration of the MRR injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid is swollen, hard to the touch, skin is warm and red, no complaints of itching or pain.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Fall, Seizure
Clinical narrative: Mother reported seizure occurred during school, patient dropped pencil and fell to floor from desk, had 4 convulsions, teacher let him rest for 1.5 minutes, then called his name while rubbing his back and he responded, was taken to school office where he rested and his parents were contacted. Mother called clinic at 2:54 PM to report incident, per provider I instructed patient's mother to take him to the local emergency department.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Pt's hand got swollen (hand that he received vaccine on) and is having fever.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Pain, Skin discolouration, Swelling
Clinical narrative: Swelling, bruising,black and blue, pain. Patient went to ER and was told to put ice pack on arm.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Nausea, Pruritus
Clinical narrative: Pt had mild itching and redness on both arms from elbow up about 3-4 inches. The reaction started about 20 minutes after the injection and continued for about 30-45 min. There was no redness around the injection site. The patient also reported mild nausea. I recommended a cold compress and that helped with redness. Nausea resolved on its own.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: Erythema, induration and itchy rash surrounding injection site.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Erythema, induration and itchy rash surrounding injection site.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, body aches, dizziness and sore arm.
Age: 0.11
Sex: M
Vaccine: HEP
Symptoms: Crying, Eating disorder, Rash, Screaming, Sleep disorder
Clinical narrative: Baby has not been eating well, sleepy, but not sleeping like she usually does, high pitched screams & crying that is inconsolable, patchy rashes on legs, arms and face, still currently being affected.
Age: 0.11
Sex: M
Vaccine: HEP
Symptoms: Somnolence
Clinical narrative: Baby has not been eating well, sleepy, but not sleeping like she usually does, high pitched screams & crying that is inconsolable, patchy rashes on legs, arms and face, still currently being affected.
Age: 0.52
Sex: F
Vaccine: DTPIHI
Symptoms: Vomiting
Clinical narrative: Vomiting for 2 hours.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Discomfort, Eye irritation, Headache, Hypersensitivity, Injection site pain
Clinical narrative: SHE CAME TO MY PHARMACY TODAY 5/5/16 AT 6:30 PM AND TOLD ME SHE HAS ALL THIS ADVERSE REACTION, HAS PAIN ON INJECTION SITE LEFT ARM, HOT, RED, SORES, HAS LOW {FEVER,HEADACHE AND EYE BURNING (ONLY LAST NIGHT 5/4/16 pm),},SHE STILL HAS LITTLE PAIN FROM LEFT SHOULDER TO NECK (BELOW HAIR LINE), AND RASH AND LITTLE SWELLING ON INJECTION SITE TODAY. I GIVE HER 25MG BENADRYL AND AN ICE PACK IMMEDIATELY, AND TOLD HER TO CONTINUE TAKE BENADRYL 25 MG EVERY 8 HRS AS NEEDED FOR ALLEGIC REACTION, ALSO APPLY ICE PACK FOR PAIN AND HOT AND SWELLING. TOLD HER TO CALL DOCTOR, AND ALSO CALL US BACK IF GET WORSE. -- SHE HAS NO BREATHING PROBLEM, ONLY COMPLAIN LOCALIZED DISCOMFORT TODAY.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site ulcer, Injection site warmth, Neck pain
Clinical narrative: SHE CAME TO MY PHARMACY TODAY 5/5/16 AT 6:30 PM AND TOLD ME SHE HAS ALL THIS ADVERSE REACTION, HAS PAIN ON INJECTION SITE LEFT ARM, HOT, RED, SORES, HAS LOW {FEVER,HEADACHE AND EYE BURNING (ONLY LAST NIGHT 5/4/16 pm),},SHE STILL HAS LITTLE PAIN FROM LEFT SHOULDER TO NECK (BELOW HAIR LINE), AND RASH AND LITTLE SWELLING ON INJECTION SITE TODAY. I GIVE HER 25MG BENADRYL AND AN ICE PACK IMMEDIATELY, AND TOLD HER TO CONTINUE TAKE BENADRYL 25 MG EVERY 8 HRS AS NEEDED FOR ALLEGIC REACTION, ALSO APPLY ICE PACK FOR PAIN AND HOT AND SWELLING. TOLD HER TO CALL DOCTOR, AND ALSO CALL US BACK IF GET WORSE. -- SHE HAS NO BREATHING PROBLEM, ONLY COMPLAIN LOCALIZED DISCOMFORT TODAY.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: SHE CAME TO MY PHARMACY TODAY 5/5/16 AT 6:30 PM AND TOLD ME SHE HAS ALL THIS ADVERSE REACTION, HAS PAIN ON INJECTION SITE LEFT ARM, HOT, RED, SORES, HAS LOW {FEVER,HEADACHE AND EYE BURNING (ONLY LAST NIGHT 5/4/16 pm),},SHE STILL HAS LITTLE PAIN FROM LEFT SHOULDER TO NECK (BELOW HAIR LINE), AND RASH AND LITTLE SWELLING ON INJECTION SITE TODAY. I GIVE HER 25MG BENADRYL AND AN ICE PACK IMMEDIATELY, AND TOLD HER TO CONTINUE TAKE BENADRYL 25 MG EVERY 8 HRS AS NEEDED FOR ALLEGIC REACTION, ALSO APPLY ICE PACK FOR PAIN AND HOT AND SWELLING. TOLD HER TO CALL DOCTOR, AND ALSO CALL US BACK IF GET WORSE. -- SHE HAS NO BREATHING PROBLEM, ONLY COMPLAIN LOCALIZED DISCOMFORT TODAY.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Bursitis, Immediate post-injection reaction, Vaccination site swelling
Clinical narrative: Immediate swelling below site of vaccination followed by olecranon bursitis which has persisted now 2 weeks.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, CSF test normal, Guillain-Barre syndrome, Muscular weakness, Weight bearing difficulty
Clinical narrative: 5/3/16 - received vaccine. Began getting weak starting with lower extremity weakness on 5/3/16 afternoon. 5/5/16 muscular weakness progressing upward to neck and worsening weakness overall. 5/4 brought to ER due to unable to bear weight and transferred to hospital.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 29-FEB-2016, the patient was vaccinated with an improperly stored (Temperature:32F - Time frame: 5 minutes) dose of VAQTA (lot # L023232 and expiration date: 25-FEB-2017) (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Facial paralysis
Clinical narrative: This spontaneous report was received from a physician referring to a 20 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patient was vaccinated with the 1st and 2nd dose of GARDASIL (anatomical route of vaccination, lot number and expiration date were not provided). Furthermore, on 21-MAR-2016, the patient was vaccinated with the 3rd dose of GARDASIL. The patient's concomitant medications were not reported. On 05-APR-2016, (reported as "about"), the patient experienced Bell's Palsy. The patient sought for medical attention, but it was unspecified if treatment was provided for the adverse event. Furthermore, no product quality issue was involved. At the time of the report, the outcome of VIIth nerve paralysis was unknown. Also, relatedness between the adverse event and vaccination with GARDASIL was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unspecified dates in 2016 (reported as starting on or after 09-FEB-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L020015, expiry date: 16-AUG-2017). Nurse stated that the mentioned lot number of the vaccine underwent temperature excursion at 22.7 and -1.2 degree Celsius for 10 hours 8 minutes and 37 hours 6 minutes, respectively. She also reported the details of unsupported vaccine administered to unspecified patients: lot # L016428 (expiry date: 30-JUL-2017; underwent a temperature excursion at -1.2 degree Celsius for 25 hours 40 minutes) was administered on 28-MAR-2016, lot # L020015 (temperature excursion at -1.2 degree Celsius for 26 hours 58 minutes) was administered on 29-MAR-2016. No adverse effect was reported. This is one of the five reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reaction/allergies and concomitant thereapy were not reported. On unspecified dates in 2016 (reported as starting on or after 08-FEB-2016) the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L010595, expiry date: 12-NOV-2016; lot # L016959, expiry date: 12-MAR-2018). Nurse stated that the mentioned lot numbers of the vaccine underwent temperature excursion at 22.7 and -1.2 degree Celsius for 10 hours 8 minutes and 37 hours 6 minutes, respectively. Nurse also reported the details of unspecified vaccine administered to unspecified patients: lot # L040458 (expiry date: 04-FEB-2016, lot # L048236 (expiry date 31-MAR-2018; temperature excursion at -1.2 degree Celsius for 23 hours 20 minutes) on 23-MAR-2016, lot # L040458 (temperature excursion at -1.2 degree Celsius for 22 hours 33 minutes) on 24-MAR-2016, lot # L048236 (temperature excursion at -1.2 degree Celsius for 25 hours 40 minutes) on 25-MAR-2016 and 28-MAR-2016, lot # L048236 (temperature excursion at -1.2 degree Celsius for 25 hours 40 minutes on 24-MAR-2016 and 28-MAR-2016, lot # L048236 (temperature excursion at -1.2 degree Celsius for 26 hours 58 minutes) on 29-MAR-2016. No adverse effect was reported. This is one of the five reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local redness and swelling at injection site 1 inch, mildly tender 36 hrs after shot.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Condition aggravated, Crying, Diet refusal, Gastrooesophageal reflux disease, Immediate post-injection reaction
Clinical narrative: Immediately after receiving his 2 mo vaccines PENTACEL, PCV, ROTARIX he refused to eat and was taking only 1 oz at a time and crying increased fussiness increased GERD sx. H/O GERD and already on ZANTAC.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Skin rash. Prednisone 40 mg every day, hydroxyzine 25 mg TID.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous  report was received from a nurse refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unspecified dates in 2016 (reported as starting on or after 09-FEB-2016), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013203, expiry date: 28-JAN-2017). Nurse reported that the vaccine underwent temperature excursion at 22.7 and -1.2 degree Celsius for 10 hours 8 minutes and 37 hours 6 minutes, respectively. No adverse effects were reported. This is one of the five reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Came to office 2 days after immunization, 3.5 x 3.14 red swollen deltoid site. C/o itching, discomfort warmth.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L005301 with an expiration date of 17-FEB-2017, lot # L023594 with an expiration date of 26-JUN-2017, lot # L026405 with an expiration date of 15-JUL-2017 and lot # L041204 with an expiration date of 20-OCT-2017 (dosage number and route of administration were not provided) after following a temperature excursion on 02-MAR-2016. Nonetheless, no adverse effects were reported. The registered nurse, stated that the vaccines had the following temperature excursion: -1.3 for a time frame of 3 hours and 21 minutes. A previous temperature excursion was reported for the aforementioned vaccine on 22-FEB-2016. Temperature excursion of -1.9C for 4  hours and 43 minutes; -4.1C for 3 hours and 21 minutes and -5.5C for 2 hours and 42 minutes. Furthermore, on 29-FEB-2016, the temperature excursion was -2.3C for 6 hours and 19 minutes and on 01-MAR-2016 of -0.7 for 4 hours and 5 minutes. No product quality issued was involved. Additional information has been requested.
Age: 0.25
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 3 month old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 24-APR-2016, the patient was vaccinated with PNEUMOVAX23 (lot # reported as 1045710, expiry date 25-APR-2017, dose, route and anatomical site of injection were not reported. No adverse events were reported. NO product quality complaint (PQC) was involved. Lot number 1045710 is an invalid lot number for PNEUMOVAX23. Additional information has been requested.