chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Heart rate increased, Nausea, Vomiting
Clinical narrative: Patient states that when she got home after receiving the vaccine, she had nausea, vomiting, and diarrhea. Patient states there is no reaction at the actual injection site. Patient states she also had a rapid heart rate. On 3/20/15 patient stated she felt fine, but that the symptoms lasted most of the night.
Age: 20.0
Sex: M
Vaccine: DTOX
Symptoms: Back pain, Headache, Nephrolithiasis, Tremor
Clinical narrative: Kidney stones, back pain, headaches, tremors.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MUR
Symptoms: Abasia, Decreased activity, Injection site pain, Irritability
Clinical narrative: Patient was very whiney, kept complaining his leg hurt, and then stopped walking on it. Just laid around all weekend and only would be active if he had Tylenol.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Muscular weakness, Myalgia
Clinical narrative: Weakness in upper left arm noticed within 1 hour of injection. Weakness remains. Soreness at the injection site lasting 4 days. Soreness in the muscle where the injection was given lasting 4 days.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: Patient experienced a 2 inch rash around injection site. The rash was raised with bumps and was itching.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Within 24 hrs of MCV vaccine, pt developed erythema and edema measuring 12cm x 9cm, hot to touch, 4 cm distal to injection site.
Age: 35.0
Sex: F
Vaccine: HEPA, MNQ, PPV, TDAP
Symptoms: Body temperature increased, Injection site erythema, Pain in extremity, Rash, Rash macular
Clinical narrative: To Right arm pt described redness at the site that developed 1 day after receiving the vaccine. 2 days later pt developed a rash/blotchy red area from the top of shoulder to mid upper arm. Pt stated it was sore. Pt developed a 101 degreee F temp.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness, Seizure
Clinical narrative: Patient passed out and fell to the ground; he then convulsed for 15 seconds before regaining consciousness. He was laid on an exam table under observation for 10 minutes. Pt recovered and walked out on his own accord without sequele.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Pt. states that she received the flu shot. Shot was placed in right upper  arm. Following the shot, pt. reports intermittent pain and numbness/tingling to right upper extremity. Reports a burning sensation to whole arm, which is intermittent. Also reports a "constant pain" from elbow radiating up to pinky and ring finger on right hand. Radial pulses 2+ bilaterally. Weakness noted to right hand.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Acoustic stimulation tests abnormal, Balance disorder, Blepharospasm, Blood pressure increased, Blood test abnormal
Clinical narrative: 12/9 woke up to Rt. ear deafness, dizziness, ringing in ear - numbness to Rt side of head and face, loss of balance, Rt. eye twitching and Rt side of head pressure went to PMD on 12/9. Then to ENT - 12/10 - put on po prednisone 40 mg. Hearing test 3/4 loss of hearing. On 12/12 received steroids by injection thru eardrum. Hearing test. Hearing declined further and increased pressure.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Deafness, Deafness unilateral, Dizziness, Head discomfort, Heart rate increased
Clinical narrative: 12/9 woke up to Rt. ear deafness, dizziness, ringing in ear - numbness to Rt side of head and face, loss of balance, Rt. eye twitching and Rt side of head pressure went to PMD on 12/9. Then to ENT - 12/10 - put on po prednisone 40 mg. Hearing test 3/4 loss of hearing. On 12/12 received steroids by injection thru eardrum. Hearing test. Hearing declined further and increased pressure.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging normal, Red blood cell sedimentation rate increased, Tinnitus
Clinical narrative: 12/9 woke up to Rt. ear deafness, dizziness, ringing in ear - numbness to Rt side of head and face, loss of balance, Rt. eye twitching and Rt side of head pressure went to PMD on 12/9. Then to ENT - 12/10 - put on po prednisone 40 mg. Hearing test 3/4 loss of hearing. On 12/12 received steroids by injection thru eardrum. Hearing test. Hearing declined further and increased pressure.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to an unspecified patient of unknown age and gender. On 20-MAR-2015, the patient was vaccinated with an expired dose of ROTATEQ (oral, expiration date 01-MAR-2015, dose, frequency and lot# were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (lot numbers, expiration dates and doses were not provided) oral. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old male patient. On an unknown date the patient was vaccinated with his first dose of ROTATEQ, (route of administration defaulted to oral, dose was not reported) at age 6 months (inappropriate age of vaccine administration). No adverse effect reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Flushing, Screaming, Skin warm, Urticaria
Clinical narrative: After the three vaccines were administered, she began screaming, and felt warm to her grandmother. She became flushed with small urticarial lesions on her cheeks. There was no stridor, or hypotension; no drooling. Lungs were clear. Benadryl was administered and the child was observed for thirty minutes.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Asthenia, Diarrhoea, Dizziness, Nausea
Clinical narrative: Client had dizziness, weakness, nausea, diarrhea after the administration of the following vaccines Gardasil, Hepatitis A and Meningitis.  Client was directed to the ER.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING, REDNESS AND WARMTH AT INJECTION SITE.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Feeling abnormal, Grip strength decreased, Nervousness, Tremor
Clinical narrative: Complaints of feeling like she was floating. At 9:10 AM complained of feeling shaky. visibly shaky. At 9:40 AM remains visibly shaky. Blood pressure - 117/58; Pulse - 80; Respiratory Rate - 22 - grip present but weak. Reported to have had breakfast.  Had a mint and water post vacination at about 9:10 AM.  Continued to remain supine with frequent checks.  Symptoms did not worsen but did not resolve.   9:50 AM - reported to Medical Director.  Medical Director concurred with followup - per medical evaluation.  Patient has no MD to folow up at an ER. Attempted to check with previous MD not seen in 5 years.  Office could not see her today. By 10:03 AM - discharged with Grandmother - ambulatory - No longer visibly shaky but continues ot complain of shakiness and dizziness.  Remained verbally responsive  and appropriate throughout. Grip remains weak. Vital signs at discharge - BP - 108/60; pulse- 80; respiratory rate = 22. Grandmother comfortable with leaving and will follow up with medical evaluation.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Herpes zoster, Injection site vesicles, PCO2 decreased, Rash, Varicella virus test positive
Clinical narrative: Herpes Zoster diagnosis on 11/4/2014 in two-dose varicella vaccine recipient. Seen by her PCP. Painful rash in one dermatome, blisters on right shoulder and arm.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash papular, Skin lesion, Varicella post vaccine
Clinical narrative: Thirteen days after receiving her second varicella vaccination, she developed a papular rash on her bottom and lower back. Mom reported less than 50 lesions. Rash lasted 5 days. Child was diagnosed with varicella over the phone. Rash was never observed by a healthcare provider.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymerase chain reaction, Rash, Varicella virus test positive
Clinical narrative: Herpes Zoster diagnosis on 9/30/2014 by Dermatologist at the Hospital. Painful rash in one dermatome. Treated with Valtrex x7 days.
Age: 15.0
Sex: F
Vaccine: DTAP
Symptoms: Allergy test, Chills, Cough, Pain, Pulmonary function test
Clinical narrative: Persistent cough, fever, chills, body aches.
Age: 15.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Persistent cough, fever, chills, body aches.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult Hep A vaccine dose administered to 18 yr old instead of pediatric Hep A vaccine dose.
Age: 5.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Rash
Clinical narrative: Rash of the thigh.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Right thigh with 2" urticarial lesion at injection site of Proquad at 24 hours after administration.  Urticaria spread to include both anterior lateral thighs and forearms bilaterally with 48 hours of Proquad administration.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Computerised tomogram normal, Electroencephalogram abnormal, Nuclear magnetic resonance imaging normal, Seizure, X-ray normal
Clinical narrative: Seizures.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain, Rash
Clinical narrative: Rash across left side-posterior back spreading to anterior front, following dermatone, erythematous vesicles, painful.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event. Expired Hep B vaccine was given.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Muscle in arm stated to hurt and has gotten worse throughout the last 4 months,  Went to Dr. on March 9, 2014. Was given prescription for Prednisone.  Has not helped. The pain moves up and down my left arm from top of arm (where injection site) to hand.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site pain, Injection site warmth
Clinical narrative: Sharp pain at injection site. Warm to touch, unable to move the arm. Patient did see Dr on 03/20/15 and Dr gave her Cipro 750mg and diagnose her with cellulitis of arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient presented to the pharmacy with complaints of stiffness and pain in the left arm. Patient spoke with assistance of interpretor. Patient stated she could not raise her arm due to pain. She was asked about fever, dizziness, rash, or change in color at injection site. Patient stated she did not have any of these other ADRs. Reporting pharmacist assured patient that pharmacy department would follow up with her on her progress. Pharmacist gave details to patient on ways to reduce effects of any pain she may be having which included applying a cold compress every 15 minutes and taking an Advil or Motrin to reduce pain and swelling. Pharmacist expressed concern for patient and well being for a quick recovery. Pharmacist inquired on patient's primary care physician and patient wrote down a name. Patient was given a complimentary bottled water and was reassured that symptoms would eventually subside. Patient was encouraged to contact pharmacy and physician's office if effects do not subside. Patient and daughter expressed gratitude for pharmacy's concern and was told pharmacy will contact her soon to see how well she is progressing. Patient and daughter thanked pharmacy and walked away.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: None stated.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, TDAP
Symptoms: Fall
Clinical narrative: Reaction noted at 3:34 pm, upon arrival of nurse to waiting room, mother stated that daughter "fell out" but, denies injury. Pt. was sitting in chair with mother standing beside her. She was alert and responsive. Denies discomfort. Phone call to mother on 3/23/15 at 915 am to follow-up with client. Mother state client ws doing fine. Denies any PCP or ER follow-up. Wt 95 lbs. V/S 3:40 pm 92/63, 78, 20-O2 stat RA 99% 345 pm - 93/59, 80, 20-O2 stat RA 100%. Left ambulatory with mother at her side.
Age: 1.87
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Redness and swelling measuring 4-5 cm across with warmth and mild tenderness.
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pneumonia, Rash, Scar
Clinical narrative: Break out on face and neck small bumps and scars and left arm. Patient had pneumonia. 3 meds given but do not go away antibiotic 1 day Oct 16 204 FLUVIRIN Multidose and VAX 23 Sept 17 2014.
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pneumonia, Rash, Skin cancer
Clinical narrative: Break out on face and neck small bumps and scars and left arm. Patient had pneumonia. 3 meds given but do not go away antibiotic 1 day Oct 16 204 FLUVIRIN Multidose and VAX 23 Sept 17 2014.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV
Symptoms: Injection site reaction, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: 4 y/o M BIB mother for routine 4 year WCC. Normal exam prior to receiving DTaP, Flu, and IPV vaccines. Pt developed flat reddish-pink rash on face, arms, trunk, reddish papules on upper back. Received Children's BENADRYL 12.5mg/5ml, 2.5ml PO x1 and itch and rash faded.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Muscle spasms, Rotavirus test positive
Clinical narrative: Pt developed vomiting, diarrhea, decreased appetite, cramping, abdominal pain. Positive for rotavirus after full series of rotavirus vaccine.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Pt developed vomiting, diarrhea, decreased appetite, cramping, abdominal pain. Positive for rotavirus after full series of rotavirus vaccine.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling and itching. Diphenhydramine 50 mg once.
Age: 0.59
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Child developed rash, small hives to (L) cheek/side of face. Scant rash only to (R) side of face/cheek x 5H after 2nd dose of FLUZONE. Advised by MD to give 1/2 tsp or 2 ml of Children's BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: 2cm x 3cm wheal erythemic reaction pinprick outside of reaction occurred approximately 18 hrs after vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram head, Depression, Electroencephalogram, Headache
Clinical narrative: Although patient's symptoms (H/A, depression) appeared at a time (3/14) distant from the last of her GARDASIL shots (6/5/13), her mother has requested I report it now because her personality change has been so dramatic over the past year, mother has read of a similar set of symptoms appearing in an adolescent female of similar age as patient's, eventually attributed (? by whom) to the temporally-proximate GARDASIL vaccine for that young lady. Pt. continues H/A's with sx suggestive of depression. Seen recently at hospital for interpretation of an equivocal MRI. Neurologists there said, "Don't worry." (Pt. is also followed by peds neuro locally). Mom worries about ? (-) effect of GARDASIL series.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Personality change, Urine analysis
Clinical narrative: Although patient's symptoms (H/A, depression) appeared at a time (3/14) distant from the last of her GARDASIL shots (6/5/13), her mother has requested I report it now because her personality change has been so dramatic over the past year, mother has read of a similar set of symptoms appearing in an adolescent female of similar age as patient's, eventually attributed (? by whom) to the temporally-proximate GARDASIL vaccine for that young lady. Pt. continues H/A's with sx suggestive of depression. Seen recently at hospital for interpretation of an equivocal MRI. Neurologists there said, "Don't worry." (Pt. is also followed by peds neuro locally). Mom worries about ? (-) effect of GARDASIL series.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Nurse reported on unspecified dates since 24-DEC-2014, the patients were administered an unspecified number of improperly stored doses of ROTATEQ orally (dose and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports 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 certified medical assistant refers to three unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications were not reported. On an unknown date these three patients were vaccinated with a dose of improperly stored PROQUAD (Merck) (dose, route of administration, lot number were not reported). No adverse events were noted. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician via a company representative referring to three patients of unknown gender and around a year to a year and a half years old. Between 16-FEB-2015 and 27-FEB-2015, these patients were vaccinated with VARIVAX (Merck) (dose, route and lot# were not reported) in the arm. These patients returned to the doctor's office within 7-10 days post vaccination (in approximately 2015) and they experienced injection site reaction including: swelling of the arm, large red bumps, fever and warmth to the touch. The outcome of these events was reported as recovering/resolving. The relationship between these events and VARIVAX (Merck) was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 02-MAR-2015 (reporting day) the patient was vaccinated with an expired dose of RECOMBIVAX HB (strength: 10 (unit was not reported); dose, route were not reported, Batch #: H010671, lot #: 0334AE, expire date: 28-FEB-2015). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to unspecified number of patients of unknown age and gender. No current condition, drug allergic reactions and medical history were reported. On an unspecified dates, unspecified number of patients were vaccinated with VARIVAX (Merck) (strength, dose number, route, lot number and expiry date were unknown) that underwent a supported temperature excursion. No concomitant therapy was reported. No adverse experiences were reported. The outcome of event was unknown. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to unspecified number of patients of unknown age and gender. No current condition, drug allergic reactions and medical history were reported. On an unspecified dates, unspecified number of patients were vaccinated with PROQUAD (Merck) (strength, dose number, route, lot number and expiry date were unknown) that underwent a supported temperature excursion. No concomitant therapy was reported. No adverse experiences were reported. The outcome of event was unknown. No further information was provided. This is one of several reports 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 licensed practical nurse referring to 6 patient of unknown age and gender. On an unknown date the patients were inadvertently administered with a dose of (Oka/Merck) VARIVAX (injection, lot#, dose route were unspecified) respectively, that had been improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 16-MAR-2015, the patient was administered an improperly stored dose of M-M-R II injection, lot # K008814, expiry date; 19-JUN-2016, (dose and route were not reported). No adverse events were reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemoglobin increased, Headache
Clinical narrative: Information has been received from a 57 years old female patient of unknown age. No known history condition and drug allergies. On 20-JAN-2015, the patient was vaccinated with ZOSTAVAX (dose, frequency, lot # and expiration date unknown). The patient experienced slight headache at the time of getting the ZOSTAVAX injection on 20-JAN-2015. On an unknown date in 2015, she went to see her physician for her annual examination and her blood work testing (type unspecified) showed her hemoglobin levels were elevated as if her body was "fighting off an infection". The patient said she was feeling fine on 18-MAR-2015, but was concerned about the outcome of her "blood work" and was working with her physician to undergo further testing. At the time of reporting, the outcome of hemoglobin levels were elevated was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown demographics. There was no information about patient's concurrent condition and medical history. On an unknown date the patient was vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date, the patient experienced itchiness, at the injection site (as reported rejection site), after receiving ZOSTAVAX. Product quality complaint was not involved. The outcome of injection site itchiness was unknown. The causality between injection site itchiness and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 09-MAR-2015 the patient was vaccinated with a dose of improperly stored M-M-R II (dose unspecified in series) (lot # J008154, expiration date: 08-JUL-2015, subcutaneous, 0.5 ml, once). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Nurse reported on unspecified dates since 24-DEC-2014, the patients were administered an unspecified number of improperly stored doses of M-M-R II (dose, route and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site of injection - redness, swelling tenderness involving routine upper arm.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itchiness, redness, swelling, soreness at injection site.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Nurse reported on unspecified dates since 24-DEC-2014, the patients were administered an unspecified number of improperly stored doses of VAQTA (dose, route and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Nurse reported on unspecified dates since 24-DEC-2014, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (dose, route and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Peripheral swelling
Clinical narrative: This report was received from Pfizer and was assigned (Manufacturer Control # 2015071520) for PREVNAR 13. This was originally reported by a physician. This spontaneous repot refers to a 80 year old female patient with no relevant medical conditions who on approximately 24-FEB-2007 (reported as "about 8 years ago"), the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot # and expiration date were not provided). The physician did not known about other medications patient was taking. On an unknown date, the patient had a large local reaction to PNEUMOVAX23 and a peripheral swelling as her entire arm was swelling. The patient did not undergo any laboratory test. The outcome of peripheral swelling and local reaction was recovered on an unknown date (reported as "it took a while to go away"). The reporter considered local reaction and peripheral swelling to be related to PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 03-DEC-2003, the patient was vaccinated with first dose of RECOMBIVAX HB and on 05-JAN-2004, with second dose of RECOMBIVAX HB (dose, product lot#, expiry date not reported). On 05-MAR-2004, the patient was vaccinated with third dose of RECOMBIVAX HB that was on a schedule that was outside of the prescribing information. No adverse events were reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information is not expected as there was no consent to contact the reporter for follow up information.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Hypoaesthesia, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Red, hot left shoulder, numb in left temporal region of face, posterior aspect of left back sore, thoracic level. Fever.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Swelling
Clinical narrative: Localized redness/rash to left deltoid 3 days after vaccine administration. Reaction to imms w/redness/swollenness/hot. Immunization was given 3 days ago. Area of imms is red and warm. No discharge. No f/n/v. Area is improved since yesterday and is less painful. Still 6/10 today.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Face injury, Fall, Nausea
Clinical narrative: BOOSTRIX given at 2:45 pm. After 10 to 15 min. pt c/o nausea. I check O2, pulse (99%) P 80. Unable to get BP reading. I asked for nurse to assist. Pt started coughing at that time. Nurse couldn't get BP due to coughing. Provider evaluated pt and ordered oxygen, BENADRYL and EPI PEN and called 911. Pt fell out of chair, face first. Ambulance took pt to hospital.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: 3/15/15 patient received a IPV on left thigh. Mother states next day it was 2x2 and raised. Thursday gave bath and tried to squeeze it. Friday it was 4x4 at daycare. Today 3/23/15 it is gone. The site was warm but there wasn't any pain.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Father reported today that his daughter still feels "sore" on the site where vaccine was given - RN asked if it is warm to touch, hard to feel and look red but father denies any of these - father mention he will observe few more days and call us back if it gets worse.
Age: 12.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: 10 days post immunization, pt had 3 days of fever, body aches, joint aches (shoulders, knees and hips). 4 (0-10) with extended ROM - TYLENOL for fever, aches, pain. Sx all resolved 3 days later in f/u call.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR
Symptoms: Swelling face, Urticaria
Clinical narrative: Developed hives and facial swelling the afternoon after receiving vaccines treated w/ BENADRYL and resolved w/i 8 hrs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: Arm pain on injection site, thinks it is muscle pain.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Chest discomfort, Conjunctival hyperaemia, Flushing, Pruritus, Radioallergosorbent test positive
Clinical narrative: After receipt of the MMR, she had a few sips of a Starbucks "caramel Macchiato" (contains espresso (coffee), vanilla, milk and caramel - she added nothing else). Approximately 30 minutes following immunization, she noted flushing and intense itching of her palms, then feet, then scalp. Within about 5 minutes, she noted throat tightness and perhaps a degree of chest tightness, she denies cough or wheeze, and coworkers noted facial flushing/blotching. On the way back to medical, throat tightness worsened and she felt her tongue was swelling. In the clinic she observed to have "flushing over face and between eyes; both conjunctivas were injected; there were pinpoint red spots on neck and hands and palms of hands were very red. Bottom of feet were somewhat red. There was 1 fresh hive on her back; chest clear; throat and vulva normal; no obvious distress except for itching." She was treated with epinephrine (IM), BENADRYL (PO) and ALLEGRA (PO) 1 hr after receipt of vaccine. She was observed for 1.5 hours, by which time all the signs and symptoms had cleared and she was released with an EpiPen.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Rash macular, Swollen tongue, Throat tightness, Urticaria
Clinical narrative: After receipt of the MMR, she had a few sips of a Starbucks "caramel Macchiato" (contains espresso (coffee), vanilla, milk and caramel - she added nothing else). Approximately 30 minutes following immunization, she noted flushing and intense itching of her palms, then feet, then scalp. Within about 5 minutes, she noted throat tightness and perhaps a degree of chest tightness, she denies cough or wheeze, and coworkers noted facial flushing/blotching. On the way back to medical, throat tightness worsened and she felt her tongue was swelling. In the clinic she observed to have "flushing over face and between eyes; both conjunctivas were injected; there were pinpoint red spots on neck and hands and palms of hands were very red. Bottom of feet were somewhat red. There was 1 fresh hive on her back; chest clear; throat and vulva normal; no obvious distress except for itching." She was treated with epinephrine (IM), BENADRYL (PO) and ALLEGRA (PO) 1 hr after receipt of vaccine. She was observed for 1.5 hours, by which time all the signs and symptoms had cleared and she was released with an EpiPen.
Age: 1.75
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Patient received her 15-18 mo routine childhood immunizations (DTaP, Hib, and Hep A) on 30JAN2015. In the 10-day interval before onset of the hives and swelling, she was well, taking no medications, nor were new foods or laundry products introduced. On 10FEB2015, her mother noted mild swelling of her feet and hands along with some discrete hive-like lesions. There were no respiratory or GI symptoms, nor was she fussy. Her mother took her to an urgent care center when the swelling and hives didn't abate after 4 hrs. It was noted that hives would appear at sites of her skin that pressure was applied (holding, etc.). Dr. reviewed pictures that mom took of her skin and agreed with the assessment of hand/foot angioedema and urticaria on her wrists and forearms and her legs. She was not febrile or expressing other s/s of illness. The rash was not pruritic or painful. She was prescribed BENADRYL and prednisone.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt's arm at injection is swollen and warm to touch.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling, numbness left hand, leg and arm, feeling of anxiety 3-23-15. Also c/o headache following 1st RABAVERT given 3-15-15.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity
Clinical narrative: Bilateral calf pain. Hurts to touch. No known muscle strain. No redness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Bruising, red, hot on injection site. Started Thu. Monday was better. Ice pack and TYLENOL.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Rash on arm, hot itchy just below (L) shoulder joint and down arm slightly.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Donor has raise, red area below the injection site that is warm to the touch. Donor stated this site came up on 03-21-15. Vaccine was received on 03/20/15. Our medical director suggested alternating hot and cold packs and do see PCP for Abx.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacy intern (other) refers to a 61 year old male patient. No medical history and concurrent condition was reported. The patient had a history of drug allergy while on therapy with lisinopril (manufacturer unknown) (case # 1503USA011015). On 12-FEB-2015, the patient was vaccinated with ZOSTAVAX lot # K020801 with the expiration date of 31-JAN-2016, 0.65 ml, subcutaneous. Concomitant therapies included VIAGRA. On 20-FEB-2015, reporter received an electronic prescription from the patient's unspecified physician for an unspecified antiviral medication. The reporter did not know the reason for the prescription for the unspecified antiviral medication. Patient sought medical attention. No intervention to prevent serious criteria was reported. No product quality complaint (PQC) was involved. This is one of several 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 as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports 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 as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of GARDASI (lot number, expiration dates, doses and routes of administration were not provided). No adverse effects were 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: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of PEDVAXHIB (lot numbers, expiration dates doses and routes of administration were not provided). No adverse effects were reported. This is one of several 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 as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a 41 year old patient. On 14-JUL-2014 the patient inadvertently received a dose of GARDASIL, intramuscular, rather than an ordered dose of RECOMBIVAX HB. The same patient received the first dose of RECOMBIVAX HB on 05-MAY-2014 and received their second dose on 06-OCT-2014 outside of prescribing information. No adverse effects were reported. Outcome of the events were unknown. The reporter health professional considered all the events to be not related to GARDASIL and RECOMBIVAX HB. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Injection site swelling, Pain
Clinical narrative: States was in severe pain the evening of receiving the vaccination and for the whole week following it. Had discomfort for a second week also. States had a raised area at site of injection. That lasted about 1 week. She took MOTRIN for the pain.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site cellulitis, Skin warm, Swelling
Clinical narrative: Patient with cellulitis of injection site. Swelling, redness and warm to touch noted-treated with antibiotic.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Diarrhoea, Frequent bowel movements, Irritability, Middle insomnia, Mucous stools
Clinical narrative: Extreme irritability that began within 24 hours of her vaccine with a hive like rash as well. Odd obsessive thoughts that are not her nature at all, day and night, waking her. Of note per her first DTP she had notable startling for 1 wk and very loose freq. stool mucusy for 3 wks.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Obsessive thoughts, Urticaria
Clinical narrative: Extreme irritability that began within 24 hours of her vaccine with a hive like rash as well. Odd obsessive thoughts that are not her nature at all, day and night, waking her. Of note per her first DTP she had notable startling for 1 wk and very loose freq. stool mucusy for 3 wks.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Culture throat, Headache, Influenza A virus test, Influenza B virus test, Injection site pain
Clinical narrative: Pt. seen in ER on 3/11/15 c/o pain to injection site left arm, left leg and headache. Had fever earlier and heart racing at home. Pulse 127 in ER, BP 131/86.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Pt. seen in ER on 3/11/15 c/o pain to injection site left arm, left leg and headache. Had fever earlier and heart racing at home. Pulse 127 in ER, BP 131/86.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as receive from nurse via company representative refers to 2 patients of unknown demographics. Patients medical history and current condition was not reported. On an unknown date the patients were vaccinated with GARDASIL (strength dose and frequency not reported). Other co-suspects and concomitant medication was not reported. Product quality complaint was not reported. On an unknown date the patients experienced snoopy after receiving GARDASIL. The outcome of syncope was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event occurred or reported. Patient will be revaccinated approx. 1 month from incident date (2/9/15).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Pharyngeal oedema
Clinical narrative: Vaccine administered, pt advised to stay in store for 10 to 15 minutes. She returned to pharmacy after appx. 10 min c/o chest tightness/throat felt like it was swelling. Took her to clinic bp check 132/64 pulse 54. No respiratory distress noted. Had her wait in pharmacy for about 10 min to see if improvement. After when there was no improvement. Administered EPIPEN and advised ER.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Received shot 3/6/15, by March 8th fever 101 degrees arm swollen and red. Tuesday 3/10/15 went to urgent care. Told I had cellulitis given antibiotics for 10 days. Clindamycin 4 times a day.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Borrelia test negative, Chills, Muscular weakness, Pain in extremity
Clinical narrative: Started with ache in both upper arms then ache in back of upper legs. Weakness in back of upper arm and back of upper legs. Chills lasting 1 hour to 2 hours. As of 3-15-15 still having problems only relief is with ADVIL.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Rheumatoid factor negative
Clinical narrative: Started with ache in both upper arms then ache in back of upper legs. Weakness in back of upper arm and back of upper legs. Chills lasting 1 hour to 2 hours. As of 3-15-15 still having problems only relief is with ADVIL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy, small bumps on torso and back starting 2 days after vaccine - getting itchier. Sore throat.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Significant thigh (R) swelling and pain persisting 5 days post vaccination. Painful to touch and to walk as well. Tx - MOTRIN recommended.
Age: 53.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Rash
Clinical narrative: Received vaccine 3/3/15 (PREVNAR and shingles). Rash occurred 3/10/15 (located waistband side).
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient was given VZV #2 vaccine on 3/18/15, later that evening 15 yo patient experienced localized rash, pain, redness to injection site; no fever, no difficulty breathing; no known hx of similar reaction to VZV #1 vaccine; on 3/20/15 pt examined and treated for localized cellulitis.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional (healthcare worker) refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with improperly stored dose of M-M-R II (dose, route and lot number were not provided). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a grandmother referring her granddaughter of unknown age. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, dose and route were unknown) while the patient was pregnant. No adverse events were reported. Additional information is not expected as the reporter declined to participate in answering questions and did not leave contact information.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: 2 days after ZOSTAVAX injection patient developed rash/shingles on (R) trunk.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Antinuclear antibody positive, Arthralgia, Bronchitis, CD4 lymphocytes decreased
Clinical narrative: Information has been received from a published article referring to a 53 years old female patient. This patient presented with a six year lymphopenia of unknown etiology following an acute febrile illness (sore throat, polyarthralgia, fatigue, abdominal pains and diarrhea). She reported recurrent respiratory infections (pneumonia, bronchitis, sinusitis), diarrhea and extreme fatigue. Initial findings revealed a selective lymphopenia of less than 700/ul, normal serum immunoglobulin levels, normal kidney and liver functions, positive Acetylneuraminic acid (ANA) (1:160) of speckled pattern, and a mild M-spike (0.20 g/dl) on serum electrophoresis. Patient reported chronic gut disease for more than 20 years with negative Gastrointestinal examination (GI) evaluation. Further studies revealed isolated CD3+ T cell deficiency (both CD4+ and cosa) <450/ul, normal in vitro lymphocyte proliferation to Passive Hemagglutination (PHA), anti-CD3 mAb, while decreased responses to candida. Her antibody responses to PNEUMOVAX 23 as suboptimal with partial responses to 4 out of 14 antigens; antibody responses to protein antigens Thrombin Time Dilution Test (TT, DT and Hib) were normal. A profound decrease in memory and switched memory B cells on flow cytometry and increased Buff receptor expression was noted. These findings support a primary T cell defect. Additional information has been requested.