chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 12 year old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 20-NOV-2015 (reported as "when the patient was 11 years old"), the patient was vaccinated with first dose of GARDASIL 9 for prophylaxis (lot #, expiry date, dose, strength, vaccination site, route not provided). The reporter stated that, on 29-NOV-2016 (reported as "today"), the patient was seen in the office to receive his second dose of GARDASIL 9 and was administered (lot #, expiry date, dose, strength, vaccination site, route not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, lot#, expiry date and route were not reported). On 12-DEC-2016, the patient was vaccinated with GARDASIL 9 (dose, lot#, expiry date and route were not reported) to continue the series of HPV vaccine. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, via a company representative, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of M-M-R II for prophylaxis, intramuscular route instead of the recommended subcutaneous route (dose, strength, frequency, lot/batch number and expiration date were not reported). No adverse events were reported.  Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None, possible adult flu administered to child less than 3 yrs. of age.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at site (right upper arm) of injection; ice and hydrocortisone at needed.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Reported some swelling noted after a flu shot, BENADRYL taken. Decrease. Reports feels better able to speak breath without difficulty.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Injection site erythema, Local reaction, Vaccination site reaction, Vaccination site swelling
Clinical narrative: PREVNAR give Rt. deltoid 12-12-16: Patient noticed on 12-17-16 redness, swelling, burning sensation on surrounding area of vaccination. Had Dr. appt. 12-20-16 - Localized reaction noted.
Age: 17.0
Sex: F
Vaccine: FLU4, HEPA, MNQ
Symptoms: Dizziness
Clinical narrative: 10:06 pt received vaccines, c/o feeling dizzy. EMS initiated at 10:08 A. No loss of consciousness, no SOB, no itchiness or hives. Positive alert, positive responsive. 10:08 A B/P = 107/64, P-58; 10:13 A, B/P 91/48, P=60, 10:15 A, B/P 122/78, P=80. Pt cleared by EMT at 10:27 A.
Age: 13.0
Sex: M
Vaccine: HEP, HPV4
Symptoms: Dyskinesia, Eye movement disorder, Seizure
Clinical narrative: Patient had seizure activity after receiving HPV #3 and Hep B #3 vaccine. Pt was found on bed with legs straight and jerking motion. Eyes were rolled in back of head.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: 10 days after vaccine developed rash over body. No cold symptoms. No fever (consistent with MMR reaction).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site swelling, Hypoaesthesia, Paraesthesia, Swelling
Clinical narrative: Patient reports swelling, tingling and numbness in left arm. Also, a bump at admin site. Patient reported 12/16/16.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Discomfort, Foaming at mouth, Oropharyngeal pain, Throat tightness
Clinical narrative: Next day, no fever but cough started and had sore throat. Throat constriction and white foam started to come up and continues to today. Not as much foam now but continues. There is no blood or discoloration in sputum. No associated aches and pain but extremely uncomfortable. Drinking lots of fluid. Nothing at site of vaccination. Has not called pharmacy. Has never received pneumonia vaccine before.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Body temperature increased
Clinical narrative: Immunization place Friday 12/9/16. Child spiked 102 temp 1 am Saturday 12/10/16. Taken to ER no other S/S of infection or illness.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Axillary pain, Breast pain, Chills, Headache
Clinical narrative: Received injection 12/12/16 at 9:49AM Rt Deltoid. On 12/14/16 at 5AM pt noted that body aches, weak, painful legs, swelling and pain to Rt armpit radiating to Right breast, nausea, feverish, chills, headaches. Denied vomiting, diarrhea, no redness at injection site. 12/15/16 9AM pt states armpit and Rt breast slightly less swollen and painful.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Received injection 12/12/16 at 9:49AM Rt Deltoid. On 12/14/16 at 5AM pt noted that body aches, weak, painful legs, swelling and pain to Rt armpit radiating to Right breast, nausea, feverish, chills, headaches. Denied vomiting, diarrhea, no redness at injection site. 12/15/16 9AM pt states armpit and Rt breast slightly less swollen and painful.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Inflammation, Pruritus, Pyrexia, Swelling
Clinical narrative: After the injection I had fever itching and a very large area of swelling. I call pharmacy and 1 of the doctors told me to take ADVIL for inflammation. The fever stopped after a week but the swelling and itching lasted longer. The swelling finally went away after 2 week but the itching stopped around the 6 or 7 of Dec.
Age: 92.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypophagia, Injection site erythema, Injection site urticaria, Insomnia
Clinical narrative: Spoke to nurse the following day and nurse noted that patient was not eating or sleeping the entire night. She had a red welt where the PNEUMOVAX 23 was given. The following day nurse stated patient felt better and was up eating and playing bingo.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Head titubation, Impaired work ability, Malaise, Ultrasound scan
Clinical narrative: Patient described missing work due to being ill several days after vaccines given, then developing a knot in the arm where administered. The knot did not resolve, and required an ultrasound at a hospital.
Age: 47.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented 12-10-16 with a red, swollen, hot to touch lower upper left arm. Received PNEUMOVAX 23 and BOOSTRIX 12-7-16 in left arm. Patient has been taking ZYRTEC and ibuprofen with no relief. Recommended patient go to urgent care.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Decreased appetite, Fatigue, Fibromyalgia, Gait disturbance
Clinical narrative: Chronic fatigue, fibromyalgia, joint pain, tender behind knees, difficulty getting up from sitting position, difficulty climbing stairs, decreased flexibility (bending over to pick up objects), decreased appetite.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Tenderness
Clinical narrative: Chronic fatigue, fibromyalgia, joint pain, tender behind knees, difficulty getting up from sitting position, difficulty climbing stairs, decreased flexibility (bending over to pick up objects), decreased appetite.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Hypersomnia, Injection site erythema, Injection site pain
Clinical narrative: Area sore evening after administration. Day after patient worked then went home and slept from late afternoon until 6am next day. At that time patient noticed large (4 x 4 inch) area of redness on arm around injection site. Patient called Rph and counseled to try BENADRYL, ibuprofen and ice. Complained of mild headache as well.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, C-reactive protein, Differential white blood cell count, Full blood count, Gait disturbance
Clinical narrative: 24 hrs after vaccination developed low back pain and lower extremity weakness which progressed up to his thighs and had difficulty walking. Was seen in Emergency room, admitted to hospital and received IVIG. Neurologist consult Dx: Guillain Barre syndrome.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test, Muscular weakness, Red blood cell sedimentation rate
Clinical narrative: 24 hrs after vaccination developed low back pain and lower extremity weakness which progressed up to his thighs and had difficulty walking. Was seen in Emergency room, admitted to hospital and received IVIG. Neurologist consult Dx: Guillain Barre syndrome.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Specialist consultation, X-ray
Clinical narrative: 24 hrs after vaccination developed low back pain and lower extremity weakness which progressed up to his thighs and had difficulty walking. Was seen in Emergency room, admitted to hospital and received IVIG. Neurologist consult Dx: Guillain Barre syndrome.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Follow up appt. 11-09-16 10:30 A.M everything was fine. Since I had not had my flu shot Nurse came in and injected right arm. Enclosed is copy of my previous shots without problems. I have never had such pain - swelling in my arms and now Dr. wants me to have MRI on my shoulder but I feel all of this is from the vaccine or the way it was given.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Depressed level of consciousness, Dizziness, Eye pruritus
Clinical narrative: Approx. 20 hrs after injection-nauseous, dizzy, collapse on floor, weak, can't speak, sweating soaked clothing then chills, fatigue, headache, stomach queasy, itchy eyes, almost unconscious couldn't speak, heavy head, shoulder, neck and arm pain.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Head discomfort, Headache, Hyperhidrosis, Musculoskeletal pain
Clinical narrative: Approx. 20 hrs after injection-nauseous, dizzy, collapse on floor, weak, can't speak, sweating soaked clothing then chills, fatigue, headache, stomach queasy, itchy eyes, almost unconscious couldn't speak, heavy head, shoulder, neck and arm pain.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Neck pain, Pain in extremity, Speech disorder, Syncope
Clinical narrative: Approx. 20 hrs after injection-nauseous, dizzy, collapse on floor, weak, can't speak, sweating soaked clothing then chills, fatigue, headache, stomach queasy, itchy eyes, almost unconscious couldn't speak, heavy head, shoulder, neck and arm pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Limb discomfort, Pruritus
Clinical narrative: Redness and heavy feeling at injection site, itchiness on arms and legs.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt. arm swelled from hand to shoulder and was very sore. After 9 days, it resolved and is better now.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Within 24 hours of receiving vaccines child developed redness and swelling from (R) trochanteric region to distal tibia.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large local reaction left arm improved after 24 hours. No fever.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. stated today she had rxn to immunization given on 11-28-16. Redness, swelling, itching, excessive soreness (aching) about 3-5 inches on and around injection site-left arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX with lot number L035505 and expiration date of 16-DEC-2016 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis. There were no concomitant therapies nor adverse symptoms reported. The reporter also stated that ZOSTAVAX did not have any previous temperature excursions. No product quality complaint was involved.       Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Skin lesion, Vaccination site erythema
Clinical narrative: This is a spontaneous report obtained from a non-contactable consumer. A 57-year-old patient of an unspecified race and gender received  PREVNAR 13 (Lot. N97936, Expiration date: Jan2018) intramuscularly, in the arm, at 0.5 ml, single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced a significant erythema of the arm where the vaccine was administered and lesion at the injection site. Clinical outcome was unknown at time of this report.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: None stated.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Condition aggravated, Genital labial adhesions, Irritability, Pallor, Rash
Clinical narrative: Pt received vaccines (6 month vaccines) on 12/8/16 at wellness appointment in clinic. Other than mild runny nose and labial adhesion and rash (candidal) under neck, exam was normal. MGM notes that pt did well that night but was a "little whiny". No respiratory distress. No fever. Woke up Friday (12/9) and was "pale". TYLENOL given, went to Health Department and noted to have "stopped breathing".
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Respiratory arrest, Rhinorrhoea, Skin candida
Clinical narrative: Pt received vaccines (6 month vaccines) on 12/8/16 at wellness appointment in clinic. Other than mild runny nose and labial adhesion and rash (candidal) under neck, exam was normal. MGM notes that pt did well that night but was a "little whiny". No respiratory distress. No fever. Woke up Friday (12/9) and was "pale". TYLENOL given, went to Health Department and noted to have "stopped breathing".
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Laboratory test, Neuropathy peripheral
Clinical narrative: (+) progressive weakness-significant peripheral neuropathy.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cardiac murmur, Poor feeding infant, Weight gain poor
Clinical narrative: Poor weight gain and feedings with new murmur-referred to cardiology.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pallor, Injection site swelling
Clinical narrative: Left arm swollen, red with a few small pale areas, with some induration (resembling what happens with an infiltrated IV).  These symptoms were observed by RN on 12/14/16 when PPD test on right forearm was read.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Erythema, Pruritus, Skin discolouration, Skin hyperpigmentation
Clinical narrative: She developed itchy prominent discrete red plaques on her skin measuring from 2-6 cm in diameter one hour after receiving the flu shot yesterday area she had not taken any other medications.  She had not eaten any new foods or been exposed to any new substances apart from the flu shot.  She also feels like there is involvement in the upper oral mucosa on the hard or soft palate.  These are somewhat tender to touch. Exam by physician 12/9 and 12/16. She is here to follow up with fixed drug reaction following her flu shot.  See last note for details.  There has been a lot of improvement.  The plaques have decreased significantly and discomfort, itching, and discoloration.  She now has plaques about 3-4 cm in diameter but which are faint, with mild hyperpigmentation and no redness.  Rash is resolving much faster and more easily than when she had the initial drug reaction after taking naproxen and Flexeril years ago.  I visualized the plaques on her right wrist and her left axillary area and they appear much better.  I made this a no charge visit because it was just a brief check in on her vaccination reaction and she had no other concerns.  I gave her the government website to report the vaccination reaction if she would like to do this.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Skin plaque, Tenderness
Clinical narrative: She developed itchy prominent discrete red plaques on her skin measuring from 2-6 cm in diameter one hour after receiving the flu shot yesterday area she had not taken any other medications.  She had not eaten any new foods or been exposed to any new substances apart from the flu shot.  She also feels like there is involvement in the upper oral mucosa on the hard or soft palate.  These are somewhat tender to touch. Exam by physician 12/9 and 12/16. She is here to follow up with fixed drug reaction following her flu shot.  See last note for details.  There has been a lot of improvement.  The plaques have decreased significantly and discomfort, itching, and discoloration.  She now has plaques about 3-4 cm in diameter but which are faint, with mild hyperpigmentation and no redness.  Rash is resolving much faster and more easily than when she had the initial drug reaction after taking naproxen and Flexeril years ago.  I visualized the plaques on her right wrist and her left axillary area and they appear much better.  I made this a no charge visit because it was just a brief check in on her vaccination reaction and she had no other concerns.  I gave her the government website to report the vaccination reaction if she would like to do this.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: SWELLING REACTION ON LEFT SHOULDER. WARM COMPRESSION.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Hyperhidrosis, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Sweating, fever, upset stomach, soreness locally at injection site: advanced to chronic muscle tenderness, lowered shoulder mobility in the injected shoulder.  Pt reports it is difficult to sleep at night on her side.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: Sweating, fever, upset stomach, soreness locally at injection site: advanced to chronic muscle tenderness, lowered shoulder mobility in the injected shoulder.  Pt reports it is difficult to sleep at night on her side.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain
Clinical narrative: Extensive bruising and soreness that continued for three weeks following administration.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Induration, Pruritus, Tenderness
Clinical narrative: Small red welt, hard to the touch, itchy, painful to touch, and looked like a bruise. This increased in size by 12/17 to about a 2 in diameter with the same symptoms. Lost to follow-up, tried multiple time over 72 hours.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Small red welt, hard to the touch, itchy, painful to touch, and looked like a bruise. This increased in size by 12/17 to about a 2 in diameter with the same symptoms. Lost to follow-up, tried multiple time over 72 hours.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt received wrong vaccines.
Age: 1.58
Sex: M
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Local hive at vaccine site.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Discomfort, Tremor
Clinical narrative: As stated before...pt experienced more tremors than usual and more intense tremors than she usually experiences.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Throat irritation
Clinical narrative: DYSPNEA,CLEARING OF THROAT, TICKLE/SCRATCHY THROAT.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient stated that from injection site to just above elbow, she was experiencing itching and swelling around the entire upper arm.
Age: 17.0
Sex: F
Vaccine: FLUX, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site was red, hot and swollen. By morning of 12/20/2016 rash was larger, and arm ached very bad.  Put cold compresses, and gave her Tylenol. By 10:00 p.m. 12/20/16 the top site was 1 1/2" dia.  The bottom site is now 4" x 7", red, hot, hard, and now itching her. I put Benadryl cream on it as well for the itching.  Can't give her Benadryl pills as she takes trazodone 50 mg. for headaches.
Age: 17.0
Sex: F
Vaccine: FLUX, MNQ, VARCEL
Symptoms: Pain in extremity, Rash
Clinical narrative: Site was red, hot and swollen. By morning of 12/20/2016 rash was larger, and arm ached very bad.  Put cold compresses, and gave her Tylenol. By 10:00 p.m. 12/20/16 the top site was 1 1/2" dia.  The bottom site is now 4" x 7", red, hot, hard, and now itching her. I put Benadryl cream on it as well for the itching.  Can't give her Benadryl pills as she takes trazodone 50 mg. for headaches.
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Fatigue, Headache, Joint swelling, Pyrexia
Clinical narrative: Extremely swollen painful joints, headache, mild fever, severe fatigue.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Induration, Mass, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 17-year-old female patient who received BEXSERO (batch number 151401A, expiry date 1st December 2016). On 24th August 2016, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced erythema, induration, mass and swelling. On an unknown date, the outcome of the erythema, induration, mass and swelling were recovered/resolved. It was unknown if the reporter considered the erythema, induration, mass and swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO at right arm and experienced red area measured 2 by 3 (not further specified), hard lump and swollen area. No further information was provided by the healthcare professional.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Irritability, Lethargy, Pyrexia, Wrong patient received medication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 6-month-old male patient who received FLUARIX Quadrivalent (batch number MN5CS, expiry date 30th June 2017. Concomitant products included influenza vaccine. On 6th December 2016, the patient received FLUARIX Quadrivalent (intramuscular) .5 ml. On 6th December 2016, less than a day after receiving FLUARIX Quadrivalent, the patient experienced fever, irritability, lethargy, wrong patient received medication and inappropriate age at vaccine administration. The patient was treated with Acetaminophen. On an unknown date, the outcome of the fever, irritability and lethargy were unchanged and the outcome of the wrong patient received medication and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the fever, irritability and lethargy to be related to FLUARIX Quadrivalent. Additional details were provided as follows: This case was previously reported to a doctor. On 5th December 2016, the patient received a flu vaccine that was possibly a non-GlaxoSmithKline vaccine. On the date of reporting at 9:15 hours, the patient received his 7 year old sister's vaccination FLUARIX Quadrivalent (in his left thigh), which led to wrong patient received medication and an inappropriate age at vaccination. In the evening, the patient exhibited a fever of 102.3 degrees F (rectally), he was fussy, which was abnormal for this patient. The patient appeared lethargic. On 7th December 2016, in the morning, the patient's body temperature was 101.7 degrees F. The patient was treated with acetaminophen at a dose of 80 mg.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, PNC13, RVX
Symptoms: Drug administered to patient of inappropriate age, Irritability, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 7-month-old female patient who received KINRIX. Co-suspect products included Rotavirus vaccine. Concomitant products included PREVNAR 13. On 15th November 2016, the patient received KINRIX (intramuscular) and Rotavirus vaccine. In November 2016, 8 hrs after receiving KINRIX and Rotavirus vaccine, the patient experienced fever and irritability. On 15th November 2016, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the fever and irritability were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the fever and irritability to be possibly related to KINRIX and Rotavirus vaccine. Additional details were provided as follows: The physician reported that KINRIX and Rotavirus vaccine was accidentally administered to a 7 month old patient. This led to inappropriate age at vaccine administration. The mother of the patient stated that the patient was fussy and had a fever in the middle of the night after the vaccination. The brand for Rotavirus vaccine was unknown.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Impaired work ability, Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 28-year-old female patient who received RABAVERT (batch number 595011AA, expiry date 31st May 2019. Co-suspect products included RABAVERT (batch number 595011AA, expiry date 31st May 2019). Concurrent medical conditions included cat bite. Concomitant products included IMOGAM Rabies. On 1st December 2016, the patient received the 1st dose of RABAVERT 1 ml. On 4th December 2016, the patient received the 2nd dose of RABAVERT 1 ml. On 3rd December 2016, 2 days after receiving RABAVERT and not applicable after receiving RABAVERT, the patient experienced itchy rash. In December 2016, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash and itchy rash were unknown. The reporter considered the itchy rash to be possibly related to RABAVERT. It was unknown if the reporter considered the itchy rash to be related to RABAVERT. Additional details were provided as follows: The patient experienced rash which was described as a generalized rash on the patient's arms, legs, abdomen, back and the top of her feet after receiving 1st dose of RABAVERT in her right deltoid. The rash was irregular and itchy. On the same day, the patient also received 1st dose of IMOGAM Rabies. The patient received 2nd dose of RABAVERT in her left deltoid. On 6th December 2016, the patient reported the rash was itching more and she could not go to work. The patient required emergency room visit. The reporter's call was transferred to Medical Information for consultation regarding additional dosing.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a 16-year-old female patient who received BEXSERO (batch number 151303D, expiry date 1st December 2016). On 9th March 2016, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced pain, redness and swelling. On an unknown date, the outcome of the pain, redness and swelling were recovered/resolved. It was unknown if the reporter considered the pain, redness and swelling to be related to BEXSERO. Additional details were provided as follows: The BEXSERO was administered in right arm. No further information was provided by the healthcare professional.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Arm swelling.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Grip strength decreased, Injected limb mobility decreased, Pain, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a 55-year-old female patient who received FLUARIX Quadrivalent. On 4th October 2016, the patient received FLUARIX Quadrivalent. On 4th October 2016, less than a day after receiving FLUARIX Quadrivalent, the patient experienced pain, erythema, swelling, injected limb mobility decreased and grip strength decreased. On an unknown date, the outcome of the pain, erythema, swelling, injected limb mobility decreased and grip strength decreased were unknown. It was unknown if the reporter considered the pain, erythema, swelling, injected limb mobility decreased and grip strength decreased to be related to FLUARIX Quadrivalent. Additional details were provided as follows: the patient received FLUARIX Quadrivalent in her left deltoid and the same day developed pain, redness, swelling and limited range of motion in the left arm. The patient stated that she could not hold a jug of milk. On the date of reporting, the patient presented to the physician office and the physician requested an MRI to be taken for further work up. The sales representative did not have patient demographics or vaccine information and unsure if symptoms of redness and swelling had resolved. The pain and limited range of motion had not resolved. The physician would have administered PREVNAR during the visit on the date of reporting, but did not due to patient's complications following FLUARIX vaccination.
Age: 52.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site pain, Injection site paraesthesia, Neuritis, Neuropathy peripheral, Pain in extremity
Clinical narrative: TDAP right deltoid, soreness persisted and now with tingling, burning pain (R) arm and squeezing feeling in Deltoid. Suspect neuropathy/neuritis from injection rather than from vaccine content.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Body temperature increased, Cough, Diarrhoea
Clinical narrative: Temp the night of vaccines 103 degrees F. No change w/TYLENOL (underdosed). Loose bowel movements. Mild cough last night.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Musculoskeletal pain, Myalgia, Neck pain, Pain
Clinical narrative: No pain at time of or day of injection-next day shoulder pain radiating to neck and pectoral area. Called our office 12/15/16 with symptoms. Still having pain relieved by high dose of MORTIN-suggested next 3xday 15 mins continue NSAID call MD if not better 12/20/16 - not much relief can't see MD until 1/19/17, still pain Deltoid muscle hard.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Erythema, Swelling
Clinical narrative: 12-1-16 received PREVNAR 13 in left arm. Chills, swelled, redness. Went to doctor 12-20-16 and received a steroid cream. May get antibiotic if not better in a few days.
Age: 50.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and pain to injection site.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: Student had soreness for 24 hrs after injection in area of injection which resolved. Then on 12/14/16 developed soreness in same area that lasted at least 48 hrs. No redness, swelling, fever.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Irritability, Vaccination error
Clinical narrative: Patient given varicella and PROQUAD in error. Baby doing well no rash, redness, swelling, just a little more fussy than usual.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Decreased appetite, Dizziness, Fatigue, Feeling abnormal, Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of dizziness in a 18-year-old male patient who received BEXSERO (batch number 157101, expiry date August 2017). On 6th August 2016, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced dizziness, sickness and tiredness. On an unknown date, the outcome of the dizziness, sickness and tiredness were recovered/resolved. It was unknown if the reporter considered the dizziness, sickness and tiredness to be related to BEXSERO. Additional details were provided as follows: The patient was in bed for 24 hours and was sick for 36 to 48 hours. The healthcare professional did not provide any other detail.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Dizziness, Fatigue, Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of dizziness in a 18-year-old male patient who received BEXSERO (batch number 157101, expiry date August 2017). On 6th August 2016, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced dizziness, sickness and tiredness. On an unknown date, the outcome of the dizziness, sickness and tiredness were recovered/resolved. It was unknown if the reporter considered the dizziness, sickness and tiredness to be related to BEXSERO. Additional details were provided as follows: The patient was in bed for 24 hours and was sick for 36 to 48 hours. The healthcare professional did not provide any other detail.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Alopecia, Borrelia test negative, Joint stiffness, Mobility decreased
Clinical narrative: Adverse effect started with stiff joints and muscles and has progressed to the stage of severe pain, hair loss and inability to walk or hardly even move.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Adverse effect started with stiff joints and muscles and has progressed to the stage of severe pain, hair loss and inability to walk or hardly even move.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD (lot # M029601, expiry date 10-DEC-2017, dose, strength, vaccination site, route unspecified) for prophylaxis. The vaccines were exposed to a temperature of 11 Fahrenheit (F) for 24 hours. Stability questions were asked about M-M-R II during the call, however no doses of improperly stored MMRII doses were administered to patients. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Lot number # M029601 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. 30-NOV-2016 a call was placed to the Medical Assistant in order to obtain additional information. The call went to voice mail. A message was left.  All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Product lot # details and narrative were updated. Sender's Comments: US-009507513-1610USA005924: MERCK 1610USA007027: Mfr number.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 30.7F for 3 hours and 30 minutes and in 57.9F for 11 hours and 45 minutes) doses of PNEUMOVAX23 (lot # L018503, expiration date 16-MAR-2017; dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. The call was made because of the data logger. This is one of two reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA009265: MERCK 1610USA010825: Mfr number.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients received ROTATEQ (Lot number: L033543, Expiry date: 30-MAY-2017) (dose, frequency were not reported) which was improperly stored.  No adverse effects reported. Causality assessment was not reported for the events.  This is one of the several reports received from the same reporter. Follow-up information has been received via telephone call from a medical assistant on 20-DEC-2016. The medical assistant reported that she would see if their IT department would be able to run a listing and if able, the medical assistant would fax the listing in. Additional information has been requested. Narrative was updated.; Sender's Comments: US-009507513-1610USA012464: US-009507513-1610USA012470: US-009507513-1610USA012469: US-009507513-1610USA012471:, MERCK 1610USA012472:Mfr number.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 or lot # reported as L03966, expiration date 04-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had two temperature excursions one of 29.9 Fahrenheit (F) for 2 hours 30 minutes and the other of 47.7 (F) for 30 minutes; with a data logger involved. Also it was reported no previously excursions. This is one of several reports received from the same source. Lot number [L03966] is an invalid lot number for hepatitis b vaccine (recombinant). Additional information is not expected because the reporter do not want to be contacted. Sender's Comments: US-009507513-1612USA000346: US-009507513-1612USA000347: US-009507513-1612USA000349: US-009507513-1612USA000350: US-009507513-1612USA000351: US-009507513-1611USA013515.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 or lot # reported as L03966, expiration date 04-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had two temperature excursions one of 29.9 Fahrenheit (F) for 2 hours 30 minutes and the other of 47.7 (F) for 30 minutes; with a data logger involved. Also it was reported no previously excursions. This is one of several reports received from the same source. Lot number [L03966] is an invalid lot number for hepatitis b vaccine (recombinant). Additional information is not expected because the reporter do not want to be contacted. Sender's Comments: US-009507513-1612USA000346: US-009507513-1612USA000347: US-009507513-1612USA000348: US-009507513-1612USA000350: US-009507513-1612USA000351: US-009507513-1611USA013515.
Age: 6.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician referring to a 6 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 30-NOV-2016, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (dose, route, lot# and expiration date were unknown) for prophylaxis. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site reaction, Skin exfoliation
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not provided. On approximately 25-NOV-2016 (reported as "about six days ago"), the patient was vaccinated with a dose of ZOSTAVAX, 19400 plaque-forming units (PFU) (0.65 ml, once, route was unknown) for prophylaxis. Following the vaccination, on an unknown date of 2016, the patient experienced an injection site reaction that consisted of ''numbness'' ''peeling flaky skin'' and redness that localized at the injection site. No treatment was given for the adverse events. The patient was seen in the pharmacy for medical attention. The outcome of the events was unknown. Causality was not provided. Additional information is not expected as there was no consent to contact the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Pain, Pyrexia
Clinical narrative: Information has been received from an unspecified reporter via a company representative referring to a female patient of unknown age.  The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of  ZOSTAVAX 19400 plaque-forming units (PFU)(dose, lot# and expiration date were unknown)intravenously (incorrect route of drug administration)for prophylaxis. On an unknown date, the patient experienced injection site swelling, a fever, chills and "achy" pains. The patient sought medical attention. (details unknown)The outcome of the events was unknown. Causality was not provided.      Additional information is not expected as it is not permitted to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 02-DEC-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX, lot number L025000, expiration date 06-OCT-2016, (dose, route, anatomical location and frequency were not reported), for prophylaxis. No adverse effect reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Injection site pain
Clinical narrative: This spontaneous report was received from a 24 year old female patient. The patient's pertinent medical history included asthma. she was allergic to latex. On 02-DEC-2016, the patient was vaccinated with PNEUMOVAX23, via intramuscular route, in her non-dominant arm, for prevention of pneumonia (strength, dosing details, anatomical location, lot# and expiration date were unknown) and was also vaccinated with influenza virus rha 3v vaccine (baculovirus)(FLUBLOK) at the same time, in the same arm (medication error). Concomitant therapies included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), Montelukast sodium and Progesterone. On 03-DEC-2016, she waked in the middle of the night  experiencing fever, chills, weakness, nausea, loss of appetite and headache. She also stated that the injection sight is rashy, swollen and the pain is extreme. The patient sought medical attention and received treatment for the adverse event. No lab diagnostic tests were performed. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint was involved.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Injection site rash, Injection site swelling, Nausea, Pyrexia
Clinical narrative: This spontaneous report was received from a 24 year old female patient. The patient's pertinent medical history included asthma. she was allergic to latex. On 02-DEC-2016, the patient was vaccinated with PNEUMOVAX23, via intramuscular route, in her non-dominant arm, for prevention of pneumonia (strength, dosing details, anatomical location, lot# and expiration date were unknown) and was also vaccinated with influenza virus rha 3v vaccine (baculovirus)(FLUBLOK) at the same time, in the same arm (medication error). Concomitant therapies included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), Montelukast sodium and Progesterone. On 03-DEC-2016, she waked in the middle of the night  experiencing fever, chills, weakness, nausea, loss of appetite and headache. She also stated that the injection sight is rashy, swollen and the pain is extreme. The patient sought medical attention and received treatment for the adverse event. No lab diagnostic tests were performed. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Pyrexia
Clinical narrative: Information has been received from a physician via Pfizer (MFR control# 2016538484) referring to a currently 64 year old female patient. Information about concurrent condition, medical history and concomitant medication was unspecified. On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, lot#, expiration date and route unknown) for prophylaxis. On an unknown date the patient had allergy to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and experienced fever. The outcome of the events was unknown. The reporter considered the events were related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The patient also had allergy to varicella virus vaccine live (oka/merck)(manufacturer unknown) (captured in MARRS 1612USA005810). Additional information has been requested. Sender's Comments:  US-009507513-1612USA005810.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age. Medical history, concurrent condition and concomitant therapy were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M005714, expiration date 03-OCT-2017, for prophylaxis (strength, frequency, dose, route and lot/batch number were not reported). The vaccine was exposed to temperature of 34.3 F, during 4 hours and 18 minutes. The call was because of data logger. No previous temperature excursions and no adverse effects were reported.  There was no Product Quality Complaint (PQC). Additional information has been requested.