chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 with batch number L016248 and expiry date-30-JUL-2017 (dosing regimens unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to GARDASIL 9. Additional information has been requested.
Age: 1.28
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K021484 and expiry date on 03-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015 from a certified medical assistant, who reported that she would have to research for the request made for the patient identifiers, lot number and expiration date and the dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 15 month-old patient of unknown gender. On 07-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # was confirmed as K021484 and expiry date was 03-NOV-2016). This is one of several reports received from the same source. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and drug reactions or allergies was reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX, lot number L001325 and expiry date: 13-JAN-2017, (dose, route of administration and injection site were not provided). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information has been received on 03-AUG-2015 informing that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received on 05-AUG-2015 from the reporting certified medical assistant via telephone call. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-month-old patient of unknown gender. On 24-JUN-2015, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX lot number was confirmed as L001325 with an expiry date of 13-JAN-2017. This is one of the several reports received from the same reporter. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Fatigue, Headache, Pain in extremity
Clinical narrative: Arm soreness, fatigue, headache, back pain - no treatment necessary.
Age: 0.48
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Mother reports fever of 102 after administration of vaccines, lasting until morning of 11/6/2015. Fever would resolve with administration of Tylenol and Motrin but then would return. Scheduled pediatrician appointment for afternoon of 11/6/15; coincided with well-child checkup.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Got flu shot on Tuesday 11/3/15. Area around the injection site is warm, sore, and itches. Instructed to take Tylenol and use warm compress.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Fatigue, Pyrexia, Vomiting
Clinical narrative: Fever 102, repetitive vomiting, fatigue.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Developed a reddened knot approx. 5 cm in diameter at injection site. This was warm / painful to touch. Some bruising noted. Also nausea and headache present. Symptoms resolved by Monday (10/12/15). Benadryl gel was applied to the site as needed, no other treatment was required.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Nausea
Clinical narrative: Developed a reddened knot approx. 5 cm in diameter at injection site. This was warm / painful to touch. Some bruising noted. Also nausea and headache present. Symptoms resolved by Monday (10/12/15). Benadryl gel was applied to the site as needed, no other treatment was required.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Laboratory test normal, Lumbar puncture normal
Clinical narrative: Increased temp of 103.2 to 100.9 degrees after being vaccinated.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site urticaria
Clinical narrative: Large local wheal and flare reaction at injection site (Flu vaccine). Baseball size. Tx with 0.1% Triamcinolone cream, Ibuprofen PRN and Sx RE cool compresses.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMR, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 0.3
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Nurse reviewed record to see what infant need for vaccines for this appt. She needed Dtap, IPV, Rota, PCV13, Hib. She gave KINRIX (Dtap-IPV), Rota, PCV-13 and Hib. Nurse should of given PEDIARIX, Hib, PCV13 and Rota. No adverse reaction occurred.
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Croup infectious, Nervousness, Personality change, Seizure like phenomena
Clinical narrative: This spontaneous report was received from a consumer and refers to her daughter, a "toddler" female of unknown age. The patient's medical history and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with a dose of hepatitis B vaccine (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). On an unknown date at the 4th and 6th month vaccines, the patient was vaccinated with a dose of hepatitis B vaccine (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient kept staring in one direction and the mother thought she was having a seizure, also the patient became more anxious, nervous, experienced personality changes and croup on an unspecified date. At the time of the report, the outcome of kept staring in one direction and the mother thought she was having a seizure was reported as recovered on an unspecified date described as her daughter was healthy. Upon internal review, thought she was having a seizure was determined to be medically significant. The relatedness between the events and therapy with hepatitis B vaccine (manufacturer unknown) was not reported. This is one of three reports from the same patient (case #1511USA002447 and 1511USA004138). Additional information is not expected because no contact details were available.
Sex: F
Vaccine: HEP
Symptoms: Staring
Clinical narrative: This spontaneous report was received from a consumer and refers to her daughter, a "toddler" female of unknown age. The patient's medical history and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with a dose of hepatitis B vaccine (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). On an unknown date at the 4th and 6th month vaccines, the patient was vaccinated with a dose of hepatitis B vaccine (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient kept staring in one direction and the mother thought she was having a seizure, also the patient became more anxious, nervous, experienced personality changes and croup on an unspecified date. At the time of the report, the outcome of kept staring in one direction and the mother thought she was having a seizure was reported as recovered on an unspecified date described as her daughter was healthy. Upon internal review, thought she was having a seizure was determined to be medically significant. The relatedness between the events and therapy with hepatitis B vaccine (manufacturer unknown) was not reported. This is one of three reports from the same patient (case #1511USA002447 and 1511USA004138). Additional information is not expected because no contact details were available.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose, Borrelia test, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Received the flu shot on Friday 10/16/15. Woke up Saturday morning 10/17/15 with numbness all around her mouth (teeth and tongue) and nose. Numbness then spread to her arms during the day 10/17. On call center directed her to ER for eval. Rule out stroke, Lymes and blood sugar levels. Numbness continued on the weekend. Saw neurologist on Tues 10/20. Eval done but no diagnostic testing. Numbness continued until 10/23/15. No loss of ROM or muscle strength; just numbness.
Sex: F
Vaccine: DTAP
Symptoms: Cough
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of cough in a adult female patient who received DTPa (Reduced antigen) (dTpa vaccine). In 2014, the patient received dTpa vaccine. On an unknown date, an unknown time after receiving dTpa vaccine, the patient experienced cough. On an unknown date, the outcome of the cough was unknown. It was unknown if the reporter considered the cough to be related to dTpa vaccine. Additional details were received as follows: The patient received a dose of dTpa vaccine (whooping cough, tetanus, and diphtheria) vaccine a year ago, because she was going to be a grandparent. The patient stated that she was experiencing cough since last year.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Erythema at injection site (4 x 5 cm) nontender. Full function of (L) arm. Given Rx for BENADRYL 25 mg QHS.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Patient had hives, itching, swelling, mild pain, tender, warm, inflamed, No SOB. Patient got Triamcinolone 0.1% ointment today for the rashes.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness, Urticaria
Clinical narrative: Patient had hives, itching, swelling, mild pain, tender, warm, inflamed, No SOB. Patient got Triamcinolone 0.1% ointment today for the rashes.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Small flare hives around injection sites (legs) and back - improved w/in 24 hours (occurred night of vaccines given).
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Eyelid oedema, Pyrexia, Rash erythematous, Swelling face
Clinical narrative: Several hours after "flu" was given, mother noticed facial swelling, eyes nearly swollen shut, fever to 100.5, "rash" flat, speckled and red. No respiratory distress per mom. Mom administered ALLEGRA, BENADRYL swelling persisted. Improving for several days (mom called on 11/2/15).
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Bedridden, Influenza like illness, Pain, Quality of life decreased
Clinical narrative: This spontaneous report was received from a 23 year old female patient and refers to herself. The patient's medical history and concurrent conditions were not reported. On an unspecified date in 2011, the patient was vaccinated with the first and only dose of GARDASIL (frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unspecified date in 2011 (reported as two days after the administration of GARDASIL) the patient was bedridden with a terrible pain and flu like symptoms, which worsened as time went on. She stated that she spent the past four years (unspecified dates) working to heal her body and relying on her mother and husband for full support, and that the GARDASIL changed her health and life forever and not because it had protected her. She also stated she lived in chronic pain (since an unspecified date) every moment of her life, with continuous health fluctuations, despite the progress she made. At the time of the report, the outcome of chronic pain, flu like symptoms and quality of life decreased was not recovered. The reporter considered chronic pain, quality of life decreased and flu like symptoms to be related to GARDASIL. Upon internal review, chronic pain and quality of life decreased were considered as disabling events. Additional information is not expected because no contact details were provided.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient. On 09-APR-2015 the patient was vaccinated with ZOSTAVAX. The pharmacist reported that the patient returned on 10-APR-2015, complaining of unspecified "normal side effects". The pharmacist noted that this was reported in VAERS # 573468. No further information was provided. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: C/O pain 3/10 achy to sharp increases with movement, no radiation (L) deltoid after vaccine placed on 10/21/15 at 11:10 am. Pain from 10/21 - 10/25 and then 11/1/15 to present. No redness, swelling at injection site.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Fatigue, body aches, skin at injection site red, hard, swollen, possible "blistering".
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: Developed localized reaction at injection site 55 cm in diameter. Red, hot and tender to touch.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu vaccine 10/21/15. Red/swelling at site 3 days after. Pain LD x 2 wks. Examined by Dr 11/6/15 diagnosis: bursitis (L) arm secondary to flu vaccine. MEDROL DP ordered.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site reaction, Rash maculo-papular
Clinical narrative: Maculopapular rash on (L) thigh about 4" x 4" around injection site, itch, NT, no fever. Tx w/ BENADRYL, cetirizine.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain and limited range of shoulder movement. Has been taking Ibuprofen 600 mg, twice daily and Gabapentin 100mg at bedtime. Advised to check with her doctors.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Flu vaccine administered on 11/4/15. Reported a reddened knot to the injection site, approx. 9 cm in diameter warm / painful to touch on 11/5/15. Also was reporting headache and nausea. Was seen at Occupational Health on 11/5 and instructed to apply ice and use Ibuprofen and Benadryl as needed. The nausea / headache have improved as of 11/6/15, still has some soreness to the injection site.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Flu vaccine administered on 11/4/15. Reported a reddened knot to the injection site, approx. 9 cm in diameter warm / painful to touch on 11/5/15. Also was reporting headache and nausea. Was seen at Occupational Health on 11/5 and instructed to apply ice and use Ibuprofen and Benadryl as needed. The nausea / headache have improved as of 11/6/15, still has some soreness to the injection site.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Asthenia, Malaise
Clinical narrative: Stomach upset lack of energy feeling sick.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Pt experienced pain in his left deltoid after the HPV9 vaccine was given. He has been experiencing a sharp pain in that site whenever he raises his arm and it has persisted for over 2 weeks. He had an x ray of his arm which was negative.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Welts developed on both sides of the rib cage.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Two episodes of grossly bloody stool which also tested hemoccult positive in doctors office.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: I had the flu shot administered and a few hours later I felt tingling in my hand like pins & needles and numbness.  It has been that way ever since, I cant do much without it getting like that & my job requires me to type a lot.  It does not hurt but it does bother me a lot.
Age: 18.0
Sex: M
Vaccine: FLUN4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: RED PAINFUL KNOT TO RIGHT TRICEP AREA AFTER VARICELLA IMMUNIZATION 2 DAYS AGO. TREATED WITH IBUPROFEN 800MG TID, DIPHENHYDRAMINE 25MG PO Q 6 HRS PRN ITHCHING, HEAT/COLD BAGS.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash that extended down the arm the vaccine was administered in. Rash not seen anywhere else on the body.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Injection site erythema, Injection site warmth, Middle insomnia, Pain in extremity
Clinical narrative: Low fever, red spot about the size of a nickel that's raised and hot at injection site, arm pain that's keeps waking me up the last two nights.  Arm is still hot on 11/06/2015.  Asthmatic cough has kicked in & seemed to be timed with the low fever.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Low fever, red spot about the size of a nickel that's raised and hot at injection site, arm pain that's keeps waking me up the last two nights.  Arm is still hot on 11/06/2015.  Asthmatic cough has kicked in & seemed to be timed with the low fever.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Onset of hives within a couple hours after vaccine was administered. Patient started Benadryl.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site induration, Injection site pain, Lymph gland infection
Clinical narrative: Patient reported immediate soreness at injection site and swelling that evening.  Swelling worsened and she was evaluated at urgent care 5 days later.  Patient reports her arm was 2x the size of normal, here was a hard spot at injection site, a ring around the site, and white dots.  States she was diagnosed with a lymph infection and was given a compression bandage and prednisone.  Swelling started to decrease 7 days after injection.  Patient states the vaccine was given in her dominant arm, lower than in the past.  She has always received the vaccine in her non-dominant arm.  Reached out to urgent care for more information but the center was not able to locate her in the system after multiple attempts.  She was given the preservative free Fluarix QIV PFS, which she had never received in the past.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Patient reported immediate soreness at injection site and swelling that evening.  Swelling worsened and she was evaluated at urgent care 5 days later.  Patient reports her arm was 2x the size of normal, here was a hard spot at injection site, a ring around the site, and white dots.  States she was diagnosed with a lymph infection and was given a compression bandage and prednisone.  Swelling started to decrease 7 days after injection.  Patient states the vaccine was given in her dominant arm, lower than in the past.  She has always received the vaccine in her non-dominant arm.  Reached out to urgent care for more information but the center was not able to locate her in the system after multiple attempts.  She was given the preservative free Fluarix QIV PFS, which she had never received in the past.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: C/O REDNESS AND SWELLING IN RIGHT ARM FROM SHOULDER TO ELBOW.  Area, upon inspection, was red, swollen, and warm to touch.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Injection site abscess
Clinical narrative: Patient had an abscess where the injection site was.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pruritus, Skin irritation, Skin ulcer, Wound
Clinical narrative: PATIENT REPORTED AN ITCHY SORE ON HER RIGHT ARM THAT APPEARED TO BE IRRITATED. PATIENT REPORTED SCRATCHING THE SORE WHICH RESULTED IN AN OPEN WOUND.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Vertigo, Vomiting
Clinical narrative: Vertigo when I woke up, followed by viloent vomiting 3 hours later. Vertigo continues 8.5 hours later.
Sex: F
Vaccine: HEP, HIBV, RV5
Symptoms: Anxiety, Croup infectious, Emotional distress, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer and refers to a "toddler" female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date at the 4th and 6th vaccines, the patient was vaccinated with a dose of hepatitis b vaccine (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). Other suspect therapies included HIB (manufacturer unknown) and rotavirus vaccine, (manufacturer unknown) orally, (route, anatomical location, lot number and expiration date were not reported for the other suspect therapies). The patient's concomitant therapies included (unspecified), DTAP. On an unknown date, the patient "became more anxious, nervous and experienced personality changes", also the patient experienced "croup" and developed severe anxiety on an unspecified date which lasted an unspecified period of time. The reporter also stated that her daughter received an unspecified date a dose of DTAP and the patient "freaked out" and developed redness and swelling at the injection site. Her daughter was difficult to console for "3 days after she received the DTAP vaccine". At the time of the report, the outcome of became more anxious, nervous and experienced personality changes, also the patient experienced "croup" and developed severe anxiety was reported as recovery on an unspecified date described as her daughter was healthy. This is one of two reports from the same patient (case # 1511USA002338 and 1511USA004138). The relatedness between the events and therapy with hepatitis b vaccine (manufacturer unknown), HIB (manufacturer unknown) and rotavirus vaccine, oral (manufacturer unknown) was not reported.  Additional information is not expected because no contact details were available.
Sex: F
Vaccine: HEP, HIBV, RV5
Symptoms: Nervousness, Personality change
Clinical narrative: This spontaneous report was received from a consumer and refers to a "toddler" female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date at the 4th and 6th vaccines, the patient was vaccinated with a dose of hepatitis b vaccine (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). Other suspect therapies included HIB (manufacturer unknown) and rotavirus vaccine, (manufacturer unknown) orally, (route, anatomical location, lot number and expiration date were not reported for the other suspect therapies). The patient's concomitant therapies included (unspecified), DTAP. On an unknown date, the patient "became more anxious, nervous and experienced personality changes", also the patient experienced "croup" and developed severe anxiety on an unspecified date which lasted an unspecified period of time. The reporter also stated that her daughter received an unspecified date a dose of DTAP and the patient "freaked out" and developed redness and swelling at the injection site. Her daughter was difficult to console for "3 days after she received the DTAP vaccine". At the time of the report, the outcome of became more anxious, nervous and experienced personality changes, also the patient experienced "croup" and developed severe anxiety was reported as recovery on an unspecified date described as her daughter was healthy. This is one of two reports from the same patient (case # 1511USA002338 and 1511USA004138). The relatedness between the events and therapy with hepatitis b vaccine (manufacturer unknown), HIB (manufacturer unknown) and rotavirus vaccine, oral (manufacturer unknown) was not reported.  Additional information is not expected because no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information was received from licensed practical nurse concerning multiple patients of unknown age or gender. It was reported that on multiple unspecified dates after a 20-JUL-2015 temperature excursion, multiple unspecified patients were administered improperly stored RECOMBIVAX HB (lot #L008660, expiration date 10-NOV-2016) (dosages and routes of administration not provided) or PEDVAXHIB (MARRS# 1510USA014422). Oral, ROTATEQ, PNEUMOVAX23 (pre-filled syringe), and RECOMBIVAX HB (lot #004754, expiration date 10-NOV-2016) appeared on a product list because temperature stability information was asked, but no doses were administered to any patients. No additional information available. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information was received from licensed practical nurse concerning multiple patients of unknown age or gender. It was reported that on multiple unspecified dates after 20-JUL-2015 temperature excursion, multiple unspecified patients were administered improperly stored PEDVAXHIB (lot # J006416, expiration date 25-FEB-2016) (dosages and routes of administration not provided) or RECOMBIVAX HB (MARRS# 1511USA004146). ROTATEQ, PNEUMOVAX 23, and RECOMBIVAX HB (lot # 004754, expiration date 10-NOV-2016) appeared on a product list because temperature stability information was asked, but no doses were administered to any patients. No additional information available. This is one of two reports from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: My daughter was given the vaccine prior to being 6 months which is against the CDC dosing.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Musculoskeletal stiffness
Clinical narrative: Per pt via phone 10/19/15, significant swelling left upper arm, with associated pain and tenderness, stiffness. GI upset first day only. Improvement after 5 days. Red welt at injection site of intradermal influenza vaccination left upper arm.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Pt states pain to left arm immediately after vaccine placed, and pain never went away, 7/10.  Fever of 101.9 11/4/15, took Motrin, effective for fever but not for pain.  Pt woke up this morning w/ a bump on vaccine site, red, hot, and extremely painful.  Seen by Dr. today, w/ dx of possible vaccine reaction vs possible cellulitis. Pt given Rx for Bactrim and Augmentin, pt will start as soon as she gets meds. Pt also currently taking Zithromax for sinusitis dx'd by Dr. on Wed, 11/3/15.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt states pain to left arm immediately after vaccine placed, and pain never went away, 7/10.  Fever of 101.9 11/4/15, took Motrin, effective for fever but not for pain.  Pt woke up this morning w/ a bump on vaccine site, red, hot, and extremely painful.  Seen by Dr. today, w/ dx of possible vaccine reaction vs possible cellulitis. Pt given Rx for Bactrim and Augmentin, pt will start as soon as she gets meds. Pt also currently taking Zithromax for sinusitis dx'd by Dr. on Wed, 11/3/15.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, PPV
Symptoms: Seizure
Clinical narrative: Generalized seizure.
Age: 1.93
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PedVaxHIB in right vastus lateralis on 11/5/2015. The next morning, the mother noticed his leg was swollen, red, and warm to the touch. Informed mother to put cool compress on site and to give child appropriate dose of infant's Tylenol. Informed mother to take child to MD or ED if site becomes worse or if child develops any other symptoms. Mother verbalized understanding.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling above and elbow and pain.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Fatigue, Headache, Lethargy, Nausea
Clinical narrative: Extreme body ache, lethargic, headache, loss of appetite, nausea looking at food.   Felt like a bus hit me. Lasted 7 days.  In bed for a week.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Extreme body ache, lethargic, headache, loss of appetite, nausea looking at food.   Felt like a bus hit me. Lasted 7 days.  In bed for a week.
Age: 41.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Injection site pain, Periarthritis
Clinical narrative: After the Anthrax injection my right shoulder was very sore for several days on the October 10 I ended up in the emergency room since I could move my arm.  I was diagnose with frozen shoulder.  I was given several medications for the pain and a steroid injection.  I'm currently doing physical therapy.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Myalgia, Pain, Peripheral swelling
Clinical narrative: Warmth at injection site, muscle soreness, swelling of arm, general body aches. Patient woke day after injection with symptoms had been self treating but upon seeing the Dr for another reason was told that reporting was necessary so called the pharmacy. Pt has used ice but upon seeing dr has been recommended to use heat.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site bruising, Skin warm
Clinical narrative: Injection site is bruised and the arm is warm to the touch.  Patient also complains of headaches.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Daughter woke me up at 4:45AM and said that her upper lip felt funny. In my sleep state I thought she said her lip was bloody. I told her to put some vasaline on it and go back to bed. When I went to her room at 6:45 to get her up from school, she was up and her upper lip was swollen 2-3 times its normal size. She said it was also tingling. I immediately gave her some ice to put on it and a Benadryl. I called the doctor's answering service, a nurse called me back, and then she put it through to the doctor on call. She took Benadryl throughout the day and by the evening, her upper lip was 90% better. She is claiming her lip is still a little tingly(?)today.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: The shot was probably the most painful shot that I ever had. The point of injection became quite itchy.  I had a large red mark - almost like a welt but not quite - which lasted several days.  It remained slightly discolored until yesterday.   The itchiness was most irritating for 4 days, but in reality the most itchiness lasted for a week.  It even now still itches occasionally - after almost 2 weeks.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Autoimmune neuropathy, Dysphonia, Dyspnoea, Electromyogram abnormal, Myasthenia gravis
Clinical narrative: Dose received in right arm and within 15 -20 min I started clearing my throat then started having a raspy voice and realized I was having difficulty breathing. I immediately took Benadryl 50mg. After 20 min my symptoms improved and I was sent home and after 6 hours similar symptoms returned and I took additional Benadryl. No other throat/breathing issues returned at that time. I did end up with from that time with a change in my health and get dx with Myasthenia gravis and autoimmune neuropathy.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Dose received in right arm and within 15 -20 min I started clearing my throat then started having a raspy voice and realized I was having difficulty breathing. I immediately took Benadryl 50mg. After 20 min my symptoms improved and I was sent home and after 6 hours similar symptoms returned and I took additional Benadryl. No other throat/breathing issues returned at that time. I did end up with from that time with a change in my health and get dx with Myasthenia gravis and autoimmune neuropathy.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Unknown exact time of onset.  Client came back in to the health department after she had been up to get her hair done.  Her arm was quite swollen and warm to touch.  She had good pulses and good sensation, but it did hurt due to the swelling.  Encouraged ice packs off and on for the next day or so.  To take Benadryl as recomended. And to have someone drive for her and maybe stay with her while she was taking the Benadryl.   She did the recommendations and on 10/22/2015 she was much better.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Client complaint of tingling in her hands, arms and feet.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Injection site swelling, Loss of consciousness
Clinical narrative: LA deltoid swelled. Patient then got anxious and passed out.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: RADIATING PAIN FROM ARM DOWN TO FINGERTIPS.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site infection
Clinical narrative: Infection at site of flu vaccination.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling, Myalgia, Petechiae, Rash
Clinical narrative: After receiving the vaccine, patient reported swelling 2 hours at the injection site and also a papular and petechial rash on both upper arms (bicep) area. Confluent red rash just below the neck posterior and anterior upper torso.  Rash was still evident and border of Band-Aid still visible along with a more defined circular rash in the area where injection was placed.  Patient only took naproxen for muscle pain (has a history of weight lifting as well) and reported to same day clinic on 11/6/2015.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash papular
Clinical narrative: After receiving the vaccine, patient reported swelling 2 hours at the injection site and also a papular and petechial rash on both upper arms (bicep) area. Confluent red rash just below the neck posterior and anterior upper torso.  Rash was still evident and border of Band-Aid still visible along with a more defined circular rash in the area where injection was placed.  Patient only took naproxen for muscle pain (has a history of weight lifting as well) and reported to same day clinic on 11/6/2015.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Abnormal behaviour, Hypotonia, Psychomotor skills impaired, Pyrexia, Unresponsive to stimuli
Clinical narrative: She developed a high fever of 104, became limp, and was not responsive. We tried to administer Infant Tylenol (3.75 ml), but she vomited. We rushed to ER at that point and by the time we got there she was more alert and they brought the fever down with Ibuprofen. She continued to have high fever for three days and was struggling with motor skills previously mastered (brining toys to her mouth, grasping, holding our fingers). She is starting to come down from fever today (11/6/15) and seems to be regaining her skills and has begun to act more like herself.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Vomiting
Clinical narrative: She developed a high fever of 104, became limp, and was not responsive. We tried to administer Infant Tylenol (3.75 ml), but she vomited. We rushed to ER at that point and by the time we got there she was more alert and they brought the fever down with Ibuprofen. She continued to have high fever for three days and was struggling with motor skills previously mastered (brining toys to her mouth, grasping, holding our fingers). She is starting to come down from fever today (11/6/15) and seems to be regaining her skills and has begun to act more like herself.
Age: 29.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient reported this to pharmacist (vaccine administer) on 11/6/15 at approx. 3:42pm. The day after receiving his vaccine, he had to go to the urgent care because he could not move his arm. He stated the problems (pain and movement issues) radiated to the shoulder. Doctor treated him with steroids. He currently still has problems with the arm and is seeking physical therapy.
Age: 29.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Joint injury, Joint range of motion decreased, Pain
Clinical narrative: Patient reported this to pharmacist (vaccine administer) on 11/6/15 at approx. 3:42pm. The day after receiving his vaccine, he had to go to the urgent care because he could not move his arm. He stated the problems (pain and movement issues) radiated to the shoulder. Doctor treated him with steroids. He currently still has problems with the arm and is seeking physical therapy.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Condition aggravated, Multiple sclerosis
Clinical narrative: PATIENT STATED HER MS WAS WORSE THAN USUAL.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Bone pain, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory
Clinical narrative: After vaccine, sore arm, fever and aches for 2 days. Muscle/bone/joint pain for over a week. Sore arm presently one week later. Developed mild palpitations several days after vaccine. Palps became more severe on 11/5. No prior history of cardiac problems. Currently under cardiologist care for this issue.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Extrasystoles, Myalgia, Pain, Pain in extremity, Palpitations
Clinical narrative: After vaccine, sore arm, fever and aches for 2 days. Muscle/bone/joint pain for over a week. Sore arm presently one week later. Developed mild palpitations several days after vaccine. Palps became more severe on 11/5. No prior history of cardiac problems. Currently under cardiologist care for this issue.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: After vaccine, sore arm, fever and aches for 2 days. Muscle/bone/joint pain for over a week. Sore arm presently one week later. Developed mild palpitations several days after vaccine. Palps became more severe on 11/5. No prior history of cardiac problems. Currently under cardiologist care for this issue.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt states his arm has been sore since the shot was given on 9/21/15 but as of 11/05/2015 pt states "It really hurts" and he has a hard time lifting it.
Age: 34.0
Sex: F
Vaccine: FLUR3
Symptoms: Headache, Inflammation, Lymph node pain
Clinical narrative: "Left supraclavicular lymph nodes are very tender, inflamed and painful accompanied by a headache".
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Immediate post-injection reaction, Incorrect route of drug administration, Injection site rash, Pain
Clinical narrative: Vaccine was accidentally administered incorrectly, subcutaneously rather than intramuscularly. Resulted in immediate stinging pain, burning pain, 5 inch diameter rash at injection site, bruise-like feeling, hot and tender to the touch. Itchiness increased on day two. Bruise-like pain continued for three days. Redness and swelling dissipated after three days, although still visible where injection was located. MD recommended ice and ibuprofen for swelling. This patient declined- pain and swelling tolerable to not warrant ice or ibuprofen in this writer/patient's opinion. MD stated at maximal healing on 11/05/2015.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin warm, Tenderness
Clinical narrative: Vaccine was accidentally administered incorrectly, subcutaneously rather than intramuscularly. Resulted in immediate stinging pain, burning pain, 5 inch diameter rash at injection site, bruise-like feeling, hot and tender to the touch. Itchiness increased on day two. Bruise-like pain continued for three days. Redness and swelling dissipated after three days, although still visible where injection was located. MD recommended ice and ibuprofen for swelling. This patient declined- pain and swelling tolerable to not warrant ice or ibuprofen in this writer/patient's opinion. MD stated at maximal healing on 11/05/2015.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Muscular weakness, Myalgia
Clinical narrative: Received shot in left arm. Persistent muscle pain and weakness at injection site.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Abdominal pain, Musculoskeletal disorder, Paraesthesia, Tremor
Clinical narrative: Patient experienced significant abdominal pains, tremor/shaking, tingling of injection arm that radiated accross shoulders to opposite arm causing temporary loss of control of the opposite arm.
Age: 64.0
Sex: M
Vaccine: FLUC3
Symptoms: Back pain, Influenza like illness, Injection site pain, Neck pain
Clinical narrative: Pain from injection site (left deltoid) to mid back at 8:00 AM, increasing to neck by noon. Decreased Range of motion and pain in left shoulder by 5:00 PM, lasting extreme for 5 days. Flu-like symptoms by Tuesday.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Rash
Clinical narrative: Elevated temp to max 100 F; rash on chest, neck ears; 2 white bumps on R cheek.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling
Clinical narrative: Local redness and swelling. 128 mm long x 115 mm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: -Redness, itching, swelling at injection site. -Arm remained red and swollen and migrated (hives) toward elbow. -Symptoms resolved on 11/5/15.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pt came to pharmacy on 11/6/15 saying that his left arm has hurt, felt weak, and painful all down his arm since his shot on 9/21/15. He also stated his right arm has also stated hurting. He went to the ER and received treatment.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blepharospasm, Dyspnoea, Loss of consciousness
Clinical narrative: HPV-4 on 6-12-14. HPV-9 on 11-5-15. Teen went to basketball practice - after running reported couldn't breathe - was unable to catch breath - teen passed out came to and had fluttering of eyes transported.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Cellulitis of (R) upper arm. Red, hot to the touch with a lump.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Laboratory test normal, Syncope
Clinical narrative: Syncope 30 min after vaccine visit. 911 called - patient taken to E.D. Negative work-up so far. Cardiologist and Neurologist visits pending.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Oral Rotavirus vaccine was given IM inadvertently; the following day there was swelling redness and induration at the injection site.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red raised area approx 3+ inch in diameter. Warm to touch.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Swollen arm and hot to touch.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Paid on administration. Returned at 5PM. Loss of range of motion. Intermittent pain, patient had physician appointment schedule for 12/22/15 and 11/25/15.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area of swelling, redness, and heat in injection site. Symptoms most noticeable 24-48 hours after administration. Subsided after 48 hours.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Patient has a swollen and bruised injection site. Site got the FLUZONE HD on 11-02-2015. Patient came with complaint on 11-5-2015.
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Pt with mild headache, mild nausea, no vomiting, feeling tired since flu shot 2 days ago. Treatment is reassurance, symptomatic treatment of note, pt just finished an antibiotic last wk for unknown issue.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: This spontaneous report was received from a 66 year old female consumer. The patient's medical history and concurrent condition were not reported. On 03-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. The reported that after receiving the PNEUMOVAX 23 she experienced pain that continued to get worse. The pain was excruciating and she could not move her arm. The outcome of movement disorder and pain was reported as not recovered. The relatedness between movement disorder, pain and PNEUMOVAX 23 was unknown. Additional information is not expected as no reporter details were provided.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth to the injection site.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt claimed she has severe pain in (L) arm/shoulder where she had received a flu vax.
Age: 49.0
Sex: M
Vaccine: FLU3, HEP, HEPA, PPV
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Patient received RECOMBIVAX and FLUVIRIN in right arm and VAQTA 50m/mL and PNEUMOVAX 23 in left arm in deltoid region given IM about 1" or greater apart. He was told to expect injection site soreness post immunization. He complains of pain/inflammation below injection site on left arm near elbow. Pharmacist advised BENADRYL and ibuprofen for symptom relief and notified patient PCP. Also advised patient to seek ER treatment if worsens.