chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.89
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash erythematous, Rash generalised
Clinical narrative: 4/8/2016: Vaccine: DTaP (SK 9D7CM) and Hib-PRP-OMP (Merck L038501) to right thigh; and preservative free quad influenza (SP U5387AA) and PCV13 (Pfizer L82219) to left thigh. 4/9/2016: ER LWBS bilateral leg pain, redness, swelling, refuses to walk on legs x 24 hours "since vaccinated yesterday". Temp 101.2F. 4/11/2016: called for immunization reaction - ER. 4/12/2016: ENT visit for tubes in ears (per dad mom say visit was 4/4 for 5 episodes ear infections in the last 6 months. During these episodes, he's fussy, pulls at ears, and has fevers as high as 104. Each episode resolves after antibiotic treatment, however, they often recur 6 weeks later. His father's side of the family has extensive history of ear infections requiring tubes (dad's dad, brother, grandfather). The patient also snores at night but the parents have not noticed episodes consistent with apnea. 4/13/2016: ER: agitated with generalized rash, Temp 99.9 F - providers diagnosed as viral exanthem (varicella). 4/14-18/2016: referral to office. Mom reports her son (18 months of age) began to develop mild fever and red rash to first his trunk and head-face about 4/13/2016 in which he was taken to the ER for and on 4/14 his rash now included bilateral arms and legs. The ER providers note documented this rash as generalized with small vesicles on patches of erythematous skin and being "varicelliform". Childs fever had been treated with TYLENOL with resolution. Child was acting age appropriate, happy and in no acute distress. On 4/15/2016 mom sent me picture of his reaction. Rash had not changed but was not worse and he was acting more himself. On 4/18/2016 mom advised rash was almost gone and no other issues had developed. He was acting his normal self, walking, playing, eating, etc.
Age: 1.89
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Rash vesicular, Snoring, Viral rash
Clinical narrative: 4/8/2016: Vaccine: DTaP (SK 9D7CM) and Hib-PRP-OMP (Merck L038501) to right thigh; and preservative free quad influenza (SP U5387AA) and PCV13 (Pfizer L82219) to left thigh. 4/9/2016: ER LWBS bilateral leg pain, redness, swelling, refuses to walk on legs x 24 hours "since vaccinated yesterday". Temp 101.2F. 4/11/2016: called for immunization reaction - ER. 4/12/2016: ENT visit for tubes in ears (per dad mom say visit was 4/4 for 5 episodes ear infections in the last 6 months. During these episodes, he's fussy, pulls at ears, and has fevers as high as 104. Each episode resolves after antibiotic treatment, however, they often recur 6 weeks later. His father's side of the family has extensive history of ear infections requiring tubes (dad's dad, brother, grandfather). The patient also snores at night but the parents have not noticed episodes consistent with apnea. 4/13/2016: ER: agitated with generalized rash, Temp 99.9 F - providers diagnosed as viral exanthem (varicella). 4/14-18/2016: referral to office. Mom reports her son (18 months of age) began to develop mild fever and red rash to first his trunk and head-face about 4/13/2016 in which he was taken to the ER for and on 4/14 his rash now included bilateral arms and legs. The ER providers note documented this rash as generalized with small vesicles on patches of erythematous skin and being "varicelliform". Childs fever had been treated with TYLENOL with resolution. Child was acting age appropriate, happy and in no acute distress. On 4/15/2016 mom sent me picture of his reaction. Rash had not changed but was not worse and he was acting more himself. On 4/18/2016 mom advised rash was almost gone and no other issues had developed. He was acting his normal self, walking, playing, eating, etc.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Information has been received from Licensed Practical Nurse (LPN) referring to a pregnant female patient of unknown age. On 16-OCT-2012, the patient was vaccinated with her first dose of GARDASIL (lot# H010915, expiration date 13-FEB-2015, intramuscular). The second (lot# J007354, expiration date 20-FEB-2016) and third (lot# J010668, expiration date 29-APR-2016) doses were administered on 11-NOV-2013 (inappropriate schedule of drug administration) and 26-AUG-2014 (inappropriate schedule of drug administration) respectively. On 06-APR-2016 (also reported as 06-APR-2017), the patient was vaccinated with a "fourth" dose of GARDASIL 9 (lot # L019297, expiration date 18-AUG-2017, intramuscular, dose was not reported). The nurse reported that the patient was pregnant when the GARDASIL 9 was administered on 06-APR-2016 (unspecified gestation) (exposure during pregnancy). The pregnancy outcome was pending. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product packaging confusion, Wrong drug administered
Clinical narrative: Information has been received from a nurse reporting to a patient of unknown age and gender. On 14-APR-2016 the patient was accidentally vaccinated with a dose of PROQUAD (Merck) (dose, lot# were not reported) and VARIVAX (Merck) dose, lot# were not reported) in the same office visit (Product packaging confusion and wrong vaccine administered). The patient should have received M-M-R II instead of PROQUAD (Merck) but because the boxes of M-M-R II and PROQUAD (Merck) "looked similar", the patient accidentally received PROQUAD (Merck) instead of M-M-R II. No adverse event was reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Disturbance in attention, Dizziness, Gait disturbance
Clinical narrative: Extreme dizziness, hard to focus or walk. I know dizziness was mentioned in the handout, but this is rough!
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Mass, Papule
Clinical narrative: Lumps under skin, overlying pink papules.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Pyrexia, Vomiting
Clinical narrative: Pt. developed joint pain, redness at injection site, fever and vomiting the day after immunization for 24 hrs. Pt treated with TYLENOL and BENADRYL.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 07-APR-2016, the patient was inadvertently vaccinated with an expired dose of MMR II, lot # K005109 (dose and route unspecified), expiration date 04-APR-2016. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of allergy in a female patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown. It was unknown if the reporter considered the allergy to be related to FLUARIX.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome or CIDP within 3 weeks of influenza immunization.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Cognitive disorder, Hypoaesthesia, Speech disorder, VIIth nerve paralysis
Clinical narrative: Flu shot provided on 3/22/2016. Facial numbness, facial droop, difficulty speaking, arm/hand numbness, decreased object recognition and processing sensations all right sided on 3/30/16.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to unspecified patients. Patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23, lot # L017406 and expiry date 26-FEB-2017 also with lot # L019835 and expiry date 23-MAR-2017 (strength, dose, anatomical location and route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-APR-2016 the patient was inadvertently vaccinated with expired dose of RECOMBIVAX HB (lot # J007946, expiry date: 24-MAR-2016). No adverse effect was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: At site of injection patient experienced a raised, red swollen area approx. 5 inches diameter. Painful to touch. As of 2 pm 4/1/16 symptoms improving. As of 2 pm 4/2/16 improved much more. Cephalexin prescribed - Patient did not use Cephalexin.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HPV4
Symptoms: Drug administered to patient of inappropriate age, Vaccination error
Clinical narrative: Pt. received GARDASIL vaccine in error.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to unspecified patients. Patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # L038018 and expiry date 13-SEP-2017 (strength, dose, anatomical location and route were not reported). No adverse events were reported and no product complaint was involved. 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 was received from a registered nurse, referring to unspecified patients. Patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB, lot # L030872 with expiry date 11-JUN-2018, lot# L035880 with expiry date 11-AUG-2018 and lot # L038501 with expiry date 16-AUG-2018, (strength, dose, anatomical location and route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to unspecified patients. Patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # L019297 with expiry date 18-AUG-2017, lot# L044475 with expiry date 12-MAY-2017, lot # K026247 with expiry date 29-JAN-2017, lot # L027282 with expiry date 21-SEP-2017 and lot # L036245 with expiry date 09-FEB-2018, (strength, dose, anatomical location and route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site reaction, Lipoma
Clinical narrative: Lipoma on left thigh at site of PEDIARIX injection. Rx: supportive care.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea, Urticaria
Clinical narrative: Nausea, headache, hives. Given BENADRYL at home.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Anxiety, Chest discomfort, Dizziness, Epistaxis, Nodule
Clinical narrative: Nosebleed, chest tightness, anxious, dizzy. Knot (baseball size) on Rt arm.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Immediate post-injection reaction
Clinical narrative: Patient immediately had pain throughout all of her joints. She stayed at pharmacy for 20 minutes and then went to the ER (4/4/16) later that night. ER gave her IV fluids and medication for her reaction to MMR vaccine. She was released at 5 am 4/5/16.
Age: 28.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Gave patient Tdap instead of Td as patient had first Tdap in 2006. Patient needed Td just not the pertussis portion. Patient has no adverse consequences due to shot being given.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: It began to itch and became swollen and red. When I woke up this morning, there was no change in size or color, and it was still itchy.
Age: 44.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Pain in the shoulder joint.  Pain seemed to worsen over the week, became severe with limtd range of motion 2:00 am 4/17/16.
Age: 44.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Injection site nodule, Joint range of motion decreased, Musculoskeletal discomfort
Clinical narrative: Pain in the shoulder joint.  Pain seemed to worsen over the week, became severe with limtd range of motion 2:00 am 4/17/16.
Age: 44.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pain in the shoulder joint.  Pain seemed to worsen over the week, became severe with limtd range of motion 2:00 am 4/17/16.
Age: 44.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Pt reports that the day of injection she had a 'knot' where the Tdap was given and a little shoulder discomfort. She did not feel this was out of the ordinary. Took ibuprofen. 1 week later the pain began to be progressively worse and noticed decreased ROM. Having to take much more ibuprofen than she usually does. 2 days prior to calling (called 13 days after injection) she had 10/10 joint pain at night 'like someone was pulling my shoulder off'. Once ADVIL kicks in, is tolerable. She states ROM is limited and she is sore in general - can't hook a bra, etc. At no time did she have redness or inflammation at injection site. Denies fevers. Shoulder continues to be very painful.
Age: 44.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Injection site nodule, Joint range of motion decreased, Musculoskeletal discomfort
Clinical narrative: Pt reports that the day of injection she had a 'knot' where the Tdap was given and a little shoulder discomfort. She did not feel this was out of the ordinary. Took ibuprofen. 1 week later the pain began to be progressively worse and noticed decreased ROM. Having to take much more ibuprofen than she usually does. 2 days prior to calling (called 13 days after injection) she had 10/10 joint pain at night 'like someone was pulling my shoulder off'. Once ADVIL kicks in, is tolerable. She states ROM is limited and she is sore in general - can't hook a bra, etc. At no time did she have redness or inflammation at injection site. Denies fevers. Shoulder continues to be very painful.
Age: 44.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pt reports that the day of injection she had a 'knot' where the Tdap was given and a little shoulder discomfort. She did not feel this was out of the ordinary. Took ibuprofen. 1 week later the pain began to be progressively worse and noticed decreased ROM. Having to take much more ibuprofen than she usually does. 2 days prior to calling (called 13 days after injection) she had 10/10 joint pain at night 'like someone was pulling my shoulder off'. Once ADVIL kicks in, is tolerable. She states ROM is limited and she is sore in general - can't hook a bra, etc. At no time did she have redness or inflammation at injection site. Denies fevers. Shoulder continues to be very painful.
Age: 54.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Hypoaesthesia, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 4/14 9:00 am Pain and swelling at injection site (left arm). 4/14 4:30 pm Numbness of pinky and ring finger of left hand. 4/14 6:00 pm Fever 101.8°F until 4/18. 4/14 8:30 pm Dry cough fits until 4/18. 4/19 complete finger numbness persists.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Cellulitis, Drug administered at inappropriate site, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: She complained that the vaccine burned at the time it was given. I then noticed that it was given in the subcutaneous fatty tissue of her arm and not the deltoid muscle. Within 2 hours she was complaining that her arm hurt. The next morning (Sat) she said her arm was very painful and had a small red spot were the vaccine was given. By that evening she had a half dollar sized red area and was given Benadryl. The next day (Sun) the red area continued spreading, swelling, and was hot to the touch. The area was from her elbow and up about 6 inches. She was given more Benadryl. By that evening it had spread about 2 more inches upward and an inch more below her elbow. Her primary MD was notified and advised us to go to the ER. The ER diagnosed her with cellulitis and prescribed Keflex 4X/day Sunday around 8:00 PM. Monday the area continued spreading and had wrapped around to the back side of her arm. We elevated, iced it, and gave her more Benadryl. This morning it was about the same or maybe a little less red.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: She complained that the vaccine burned at the time it was given. I then noticed that it was given in the subcutaneous fatty tissue of her arm and not the deltoid muscle. Within 2 hours she was complaining that her arm hurt. The next morning (Sat) she said her arm was very painful and had a small red spot were the vaccine was given. By that evening she had a half dollar sized red area and was given Benadryl. The next day (Sun) the red area continued spreading, swelling, and was hot to the touch. The area was from her elbow and up about 6 inches. She was given more Benadryl. By that evening it had spread about 2 more inches upward and an inch more below her elbow. Her primary MD was notified and advised us to go to the ER. The ER diagnosed her with cellulitis and prescribed Keflex 4X/day Sunday around 8:00 PM. Monday the area continued spreading and had wrapped around to the back side of her arm. We elevated, iced it, and gave her more Benadryl. This morning it was about the same or maybe a little less red.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: She complained that the vaccine burned at the time it was given. I then noticed that it was given in the subcutaneous fatty tissue of her arm and not the deltoid muscle. Within 2 hours she was complaining that her arm hurt. The next morning (Sat) she said her arm was very painful and had a small red spot were the vaccine was given. By that evening she had a half dollar sized red area and was given Benadryl. The next day (Sun) the red area continued spreading, swelling, and was hot to the touch. The area was from her elbow and up about 6 inches. She was given more Benadryl. By that evening it had spread about 2 more inches upward and an inch more below her elbow. Her primary MD was notified and advised us to go to the ER. The ER diagnosed her with cellulitis and prescribed Keflex 4X/day Sunday around 8:00 PM. Monday the area continued spreading and had wrapped around to the back side of her arm. We elevated, iced it, and gave her more Benadryl. This morning it was about the same or maybe a little less red.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to unspecified patients. Patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL lot # K007264 with expiry date 02-MAR-2017, (strength, dose, anatomical location and route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.05
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, raised at site. Duration >3 cm. Temp. 101. Diameter 7 x 6.5, measured by dr.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Onset redness, warmth, induration at site of VARICELLA injection. Evaluated by P.C.P. 4/18/16 and given oral antibiotics and topical steroid cream. Father states area size of hen egg.
Age: 10.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Induration, Oedema, Skin warm
Clinical narrative: Father stated onset induration, erythema, warmth, edema began same day of administration, increasing in intensity. On 4/17/16, he took son to local ER. KEFLEX, oral steroid, started. On 4/18/16, he saw PCP who added steroid topical cream to other meds.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Red, swollen painful arm post vaccine for 3-5 days.
Age: 1.01
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Cough, Injection site erythema, Irritability, Pyrexia
Clinical narrative: Pt Mother noticed a ''red mark'' to left thigh that started sometime during the week after receiving vaccine. She denies any itching or problems, only a 1.5cm red mark.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Glassy eyes, Injection site swelling, Paraesthesia
Clinical narrative: At about 5:00 PM, pt. c/o chills, decreased appetite, slight swelling at injection site, & mom noticed glassy eyes but no fever, and gave ibuprofen. Pt. didn't sleep well during the night & awoke with same symptoms, as well as shivering with chills & tingling in right arm. Her temp was 98.1 & mom gave ibuprofen.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Poor quality sleep
Clinical narrative: At about 5:00 PM, pt. c/o chills, decreased appetite, slight swelling at injection site, & mom noticed glassy eyes but no fever, and gave ibuprofen. Pt. didn't sleep well during the night & awoke with same symptoms, as well as shivering with chills & tingling in right arm. Her temp was 98.1 & mom gave ibuprofen.
Age: 27.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pt had pain in deltoid that radiated to the shoulder towards the neck. Painful to move the arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: After vaccination red line started to appear above band aid. Band aid removed. the skin was bright red at injection site, and started to spread. Skin hot to touch, Swelling involved Entire upper arm down to elbow joint making movement painful. Redness went around my arm approximately 5 inches long by 3 inches wide. On April 19 redness starting to subside. Arm still hurts, skin color now pink in color still as large as has been.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: After vaccination red line started to appear above band aid. Band aid removed. the skin was bright red at injection site, and started to spread. Skin hot to touch, Swelling involved Entire upper arm down to elbow joint making movement painful. Redness went around my arm approximately 5 inches long by 3 inches wide. On April 19 redness starting to subside. Arm still hurts, skin color now pink in color still as large as has been.
Age: 5.0
Sex: M
Vaccine: HPV9, MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse effects have been reported.  Immunization given was incorrect, GARDASIL 9 was given instead of KINRIX.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on arm, fever > hdyrocrotisone 2.5% cream; Ranitidine 50 mg PO BID
Age: 1.56
Sex: M
Vaccine: HEPA
Symptoms: Otitis media, Pyrexia, Tonsillitis
Clinical narrative: High fever, 104, after Hep A vaccine. *Also child had tonsillitis and O.M.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Injection site erythema, Injection site warmth
Clinical narrative: PREVNAR 13 given on 4/13/16 - pt. noticed discomfort on 4/16/16. She came to clinic on 4/18/16 and was told to use ice. She returned to clinic on 4/19/16 to see provider. Redness from upper arm (L) to halfway down arm. Warm to touch.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Electroencephalogram, Eye movement disorder, Pyrexia
Clinical narrative: Eyes rolling to side or up and diagonal. Both eyes will go in same direction during episode. It lasts for just a second and then he's back to normal. It happened 7-10 times over the course of 4 days. In addition, three days after shot my son got a high fever (102) and that lasted on/off for about ten days. We went to the pediatrician's office on 4/11 because of the odd eye movement. He recommended we get an EEG. That was completed on 4/14. We are currently scheduled to get a brain MRI done on 5/6/16.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Localized skin bruising, with large area of redness, swelling, warmth covering over lateral upper extremity.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Grandmother, who is pt's guardian, called clinic to report that pt woke up with hives on his arms and legs that were very itchy the morning after the flu shot was given. Grandmother is giving Benadryl with temporary relief. No difficulties breathing or swallowing. Pt advised to go to UC at that time but to ED if having difficulties breathing. Grandmother called back the next day stating pt went to UC and received treatment with steroids but that s/s were returning. Sent pt back to UC where pt received further treatment for an allergic reaction. Pt was seen in clinic as a f/u on 3/31/16 with Dr.
Age: 0.9
Sex: F
Vaccine: DTAP, HEP
Symptoms: Dyskinesia, Injection site reaction, Vaccination site nodule
Clinical narrative: PER MOTHERS REPORT THIS AM INFANT STARTED WITH LIGHT JERKING OF RIGHT ARM. LATER ON IN THE MORNING SHE NOTICED SOME JERKING TO RIGHT LEG. THROUGHOUT THE DAY INFANT STILL CONTINUES WITH JERKING MOTIONS OF ARM AND LEG. MOTHER ALSO REPORTS LARGE KNOT TO RIGHT LEG WHERE VACCINE WAS ADMINISTRATED. F/U APPT WAS MADE FOR CHILD IN AM AND MOTHER WAS NOTIFIED TO MONITOR CHILD AND TO TAKE TO ER IF JERKING GOT WORSE OR APPEARED TO HAVE SEIZURE LIKE ACTIVITY.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Injection site rash
Clinical narrative: Small bump on inj. site.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Arm is hurting.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Pruritus, Secretion discharge
Clinical narrative: Client reports pain, oozing, itching, painful blisters going across her back with some going down her spine.
Age: 0.21
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Abnormal behaviour, Agitation, Decreased appetite, Dyskinesia, Head banging
Clinical narrative: Baby became very agitated and fidgety would not sleep at night anymore, was not nursing well.  Baby was flailing arms around and hitting and moving head in head butting motion.  Baby was not cooing or smiling anymore she changed drastically.  These symptoms lasted 10-12 days gave baby a bath to soak in epsom salt for 20-30 min.
Age: 0.21
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Insomnia, Restlessness
Clinical narrative: Baby became very agitated and fidgety would not sleep at night anymore, was not nursing well.  Baby was flailing arms around and hitting and moving head in head butting motion.  Baby was not cooing or smiling anymore she changed drastically.  These symptoms lasted 10-12 days gave baby a bath to soak in epsom salt for 20-30 min.
Age: 12.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Injection site swelling, Injection site warmth, Lip swelling, Pyrexia, Swelling face
Clinical narrative: Swollen upper arm in sight of shots and hot to touch.  Swollen lips and face.  Fever. Called Dr. at 6:35 AM, he prescribed a steroid, Advil, and Benadryl.
Age: 66.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Dyspnoea, Headache, Injected limb mobility decreased, Injection site swelling, Musculoskeletal pain
Clinical narrative: Shoulder pain, decreased mobility in arms, swelling at injection site, shortness of breath, fever 3 hrs after, body aches, and headaches. Had symptoms for 3 days and did not receive treatment.
Age: 66.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Shoulder pain, decreased mobility in arms, swelling at injection site, shortness of breath, fever 3 hrs after, body aches, and headaches. Had symptoms for 3 days and did not receive treatment.
Age: 49.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Pt returned to pharmacy 5 day later stating.
Age: 86.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Rash generalised
Clinical narrative: Generalized rash.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dyskinesia, Hypotonia, Nausea, Staring
Clinical narrative: Patient on 4/8/16 after receiving the MENACTRA vaccine #2 walked into the waiting room. She called out to her mother as she was slipping to the floor. Mother caught her laid her down. Her body was initially limp. She then opened her eyes, stared and had a 5-10 sec episode of jerky movements of her arms and legs and then became limp. She felt tired and nauseated for 20 mins afterwards. She then drank water and felt better. Pt referred to the ER for evaluation. Pt also had blood drawn at the time of the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site mass
Clinical narrative: Lump on LT thigh where KINRIX (DTAP/IPV) was given. Patient was seen in clinic for lump on 4/14/16. Mom was advised to monitor for any pain, fever, redness, or drainage and to call with any concerns.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Injection site discolouration, Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: L leg (distal to site of pediarix and HIB) was swollen and red and patient had non-stop crying after leaving office.  Infant returned to office around 4pm and was noted to have edema and redness of L leg and leg at times was purple in color.  Infant was crying intensely and very difficult to console.  She was treated with a dose of Benadryl and observed in the office for >1 hour.  Her swelling improved and erythema and purple discoloration resolved.  She continued to be very fussy but would console if mom held her upright and bounced.  Infant otherwise had a normal exam.  She returned home and follow up with the mother by phone the following day noted that she was very fussy and difficult to console the entire evening until falling asleep.  The next morning she awoke and was back to baseline without leg swelling or fussiness.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability
Clinical narrative: L leg (distal to site of pediarix and HIB) was swollen and red and patient had non-stop crying after leaving office.  Infant returned to office around 4pm and was noted to have edema and redness of L leg and leg at times was purple in color.  Infant was crying intensely and very difficult to console.  She was treated with a dose of Benadryl and observed in the office for >1 hour.  Her swelling improved and erythema and purple discoloration resolved.  She continued to be very fussy but would console if mom held her upright and bounced.  Infant otherwise had a normal exam.  She returned home and follow up with the mother by phone the following day noted that she was very fussy and difficult to console the entire evening until falling asleep.  The next morning she awoke and was back to baseline without leg swelling or fussiness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Rash
Clinical narrative: Patient called stating she developed rash and pain in her armpit gland.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Anxiety, Chest discomfort, Hyperhidrosis, Pruritus, Somnolence
Clinical narrative: Patient was very anxious while receiving immunizations. Approximately 5 minutes after immunizations, patient developed intense itching of feet/lower legs and began wheezing. Patient became very sweaty and sleepy 2-3 minutes later. Albuterol 2.5mg started and EPIPEN Jr given. Itching improved. After albuterol complete, still wheezing/tight chest, so second treatment started. Sats 88-90% during this time, Heart Rate in 120's. EMSA called during this process to transport to ER. Patient did not develop hives.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Patient was very anxious while receiving immunizations. Approximately 5 minutes after immunizations, patient developed intense itching of feet/lower legs and began wheezing. Patient became very sweaty and sleepy 2-3 minutes later. Albuterol 2.5mg started and EPIPEN Jr given. Itching improved. After albuterol complete, still wheezing/tight chest, so second treatment started. Sats 88-90% during this time, Heart Rate in 120's. EMSA called during this process to transport to ER. Patient did not develop hives.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm at injection site, started hurting around 6 PM, around 6:30 noticed redness and swelling top of the arm, then in AM of 4/14 the redness and swelling moved down the arm, and now 4/19 is at the elbow.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who was referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patient was vaccinated with the first and second doses of GARDASIL 9 (route, concentration, anatomical place of vaccination, lot # and expiration date were not reported). Concomitant therapies were not reported. Then, on 01-APR-2016 (reported as "today"), the patient went to the office and was vaccinated with the third dose of the aforementioned vaccine, which according to the reporter was "two weeks earlier than the recommended schedule". No adverse effects were reported and no product quality complaint was involved. 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 concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 04-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a registered nurse and was referring to a 12 month old male patient. There were no relevant history and concurrent conditions. On 24-MAR-2016, the patient was vaccinated with a dose of (Merck) PROQUAD in the right thigh, with the lot # L045678 and expiration date 09-MAR-2017 (route, dose number and dose were not provided). On the same date, the patient was also vaccinated with a dose of (Merck) VARIVAX in the left thigh, with the lot # L037559 and expiration date 29-SEP-2017 (route, dose number and dose were not provided). The patient did not have any concomitant medication. At the time of reporting, it was unknown if relevant test was preformed. 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 concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 12-Jan-2016, the patient received an improperly stored dose of PROQUAD with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. 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: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 19-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. 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: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 19-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: This spontaneous report was received from an other health professional (who was also an administrator), via a company representative, and refers to a 12 year old male patient. Information regarding medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, lot number and expiration date were not provided), intramuscular. Concomitant medications were not reported. On an unknown date the patient developed hives on his arm and torso, as well as redness, tenderness and swelling at the injection site. The patient received BENADRYL as treatment for the adverse events. There were not laboratory studies performed. At the time of reporting, the patient had recovered from all the events (date unspecified). It was reported that the patient did not seek medical attention. No product quality complaint was reported. Additional information is not expected, as there was no consent to contact the physician.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 77 year old female patient. Information regarding concurrent conditions and drug reactions or allergies was reported as nothing abnormal. On 29-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 dose 1 (route of administration, lot #, expiration date, and dose were not provided). Concomitant therapies were reported as multiple unspecified medications. On the same date of vaccination the patient's arm "double in size" (Peripheral swelling), felt dizzy and was in pain, these events happened at her home; no treatment was provided, however the peripheral swelling was going down on its own; according to these information the patient called to the medical attention office in order to seek medical attention. Product quality complains was not involved. The physician stated that no laboratory studies were performed, neither the events caused disability or hospitalization, additionally these events were not considered life threatening. At the time of reporting the outcome of dizziness, peripheral swelling and pain was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. 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 concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 02-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. 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: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 07-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 04-APR-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # K007246, expiration date: 17-MAR-2016), orally (dose and frequency were unspecified). Concomitant medications were unspecified. No adverse effects were reported. No product quality complaint was involved. 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 concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 18-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. 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 referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with the improperly stored doses of GARDASIL lot #: K011562, expiration date on 08-APR-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. The vaccines were stored in a temperature of 32F during 60 hours. Previous temperature excursion was 32F for 156 hours and 52F for 36 hours. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 15-OCT-2015 the patent was vaccinated with a dose of GARDASIL 9 (lot# L001312, expiration date: 24-FEB-2017, route and dose were unknown). Then on 14-DEC-2015, the patient received a dose of GARDASIL (lot # K023432, expiration date: 18-JUN-2016, route and dose were unknown). This was outside the recommendations per the prescribing information for both products. No adverse effects were reported. 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 concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 07-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with lot # L032761, expiration date 24-FEB-2017 (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Cough, Pyrexia, Skin warm, Urticaria
Clinical narrative: Patient had raised welt (very large hive) and hot to touch. Ran a fever for 3-4 days. Cough (Pt. not sure if attributed to vaccine).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt received ZOSTAVAX at pharmacy on 3/10/2016. He got diagnosed "shingles" about 3-4 days later. Currently he is being treated for shingles.