chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Influenza like illness, Vaccination failure
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a 56-year-old male patient who received Influenza vaccine unspecified. Concurrent medical conditions included HIV infection. In September 2013, the patient received Influenza vaccine unspecified. On an unknown date, 122 days after receiving the Influenza vaccine unspecified, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and influenza A virus infection (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and influenza A virus infection were unknown. It was unknown if the reporter considered the vaccination failure and influenza A virus infection to be related to Influenza vaccine unspecified. Additional information was provided: This case was reported in a literature article and described the occurrence of vaccination failure in 56-year-old male who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The patient was positive for Human Immunodeficiency Virus (HIV) infection. No information on patient's medical history or family history or concomitant medication was provided. On an unspecified date in the 1st week of September 2013, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date in January 2014, between 4 and 5 months after vaccination, the patient was admitted to the hospital with an influenza-like illness. The patient was subsequently diagnosed with influenza A infection confirmed. The case has been considered as vaccination failure. The case been considered serious due to hospitalisation. Treatment was unknown. Outcome of the event was not reported. The authors did not comment on the relationship between influenza A infection and unspecified seasonal influenza vaccine. The authors further stated HIV-infected patients have a decreased immune response to influenza vaccination and any response they have quickly wanes, and this waning immunity places this population at higher risk for influenza infection later in the flu season. The authors stated that "the results of our study provide a clinical correlate to the impaired influenza serological response in HIV-infected patients observed in previous studies by showing that HIV-infected patients who were vaccinated early compared with late were more like to contract flu later in the season. Future studies with clinical endpoints should evaluate vaccination strategies to better protect HIV-infected patients from influenza."
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination failure in a female patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. In December 2014, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Seasonal Influenza vaccine. Additional details were reported as follows: the patient received the vaccination every year. the vaccine received by the patient was a quadrivalent (QIV) vaccine. the age at vaccination was not reported. the patient had a severe bout in late December 2014 or in January 2015. In August 2016, the patient again had a flu. The patient was concerned about compensation for the 4 strain vaccine. This case was considered as suspected vaccination failure since the time to onset of the event and confirmatory laboratory data was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The injection site is very hot to touch and a large red oval is around it.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: 4 x 4 centimeter area of warmth, redness, pain. Treated with Benadryl and Pepcid over the counter, cold compress, Keflex 500mg 3x day #20 and return on 9/12 for re-evaluation.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Hypoaesthesia
Clinical narrative: Lots of redness on arm, numbness, headache - lasted 4 days.  Patient okay now but wanted to make sure it got reported.
Age: 0.13
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Fungal test positive, Herpes simplex test negative, Injection site reaction, Rash pustular
Clinical narrative: Quarter sized vesicular pustular rash as the site of injection noted once band aide was removed.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness and light swelling several inches below site of injection.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Hypersensitivity, Lip swelling, Swelling face
Clinical narrative: Patient developed an allergic reaction which included lip swelling and facial swelling around the eyes.  Symptoms resolved after coming to the ED and receiving Benadryl, solumedrol, and epinephrine.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Colectomy, Enema administration, Intussusception
Clinical narrative: Developed Intussusception.  Needed surgery (Hemicolectomy).
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Gave a KINRIX on the 6th and 5th dose instead of the 5th and 4 th dose.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site inflammation
Clinical narrative: Patient experienced redness and inflammation at vaccination site.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Injection site erythema, Injection site warmth
Clinical narrative: Temp on 104 (seen at ER) with Erythema and warmth at site of vaccine on right thigh.  Improved with oral antibiotics.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted while standing at the counseling window 5 minutes after fluzone administration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Local swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient had fever, nausea, vomiting, area was raised and red.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Pallor, Papule, Rash erythematous
Clinical narrative: Patient returned 30 minutes following visit due to development of red bumps to extremities and face. She did not show any signs of difficulty breathing, oral or lip swelling. She was given 2.5 mg of loratadine and monitored for 45 minutes. Rash present along extremities, and face erythematous, blanching papules. Rash seemed to improve, although still present. She remained well appearing.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt called pharmacy on morning or 9/8, 2 days after vaccination, complaining of swelling and redness to injection site.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Urticaria
Clinical narrative: Arm is red, slightly swollen, warm to the touch at the injection site. Almost appears to be a single large hive approximately 3 X 4 inches. Patient complaining of pain also and still has symptoms as of 9/8/16 even after oral Benadryl and ice application.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT REPORTED INJECTION SITE REACTION IN LEFT ARM AFTER VACCINATION EVENING OF BEING VACCINATED ON 9/6/16. REDNESS, SORENESS, INFLAMMATION, ITCHING, AND SWELLING. PATIENT REPORTS SWELLING HAS GONE DOWN SINCE 9/6 BUT REDNESS HAS MOVED FROM INJECTION SITE DOWN INTO BICEP OF ARM. PATIENT REPORTS TAKING THE FOLLOWING ACTION AT HOME WITH SELF-CARE: PAIN MEDICATION, BENADRYL, AND PLACING ICE ON THE INJECTION SITE.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Balance disorder, Decreased appetite, Lethargy, Local swelling, Pain
Clinical narrative: Extreme lethargy, swollen head and neck, extreme body aches, trouble balancing on feet (fell 3 times when going to bathroom), trouble keeping head from falling sideways when attempting to sit up, extreme loss of appetite for food or drink (lost 10 pounds within 4 days).
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Posture abnormal, Swelling, Weight decreased
Clinical narrative: Extreme lethargy, swollen head and neck, extreme body aches, trouble balancing on feet (fell 3 times when going to bathroom), trouble keeping head from falling sideways when attempting to sit up, extreme loss of appetite for food or drink (lost 10 pounds within 4 days).
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria, Wheezing
Clinical narrative: Diffuse itching/rash/hives and wheezing.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called pharmacy 48 hours after administration of VARIVAX to inquire about reaction at injection site.  Patient reports that injection site is swollen, bruised, red/maroon in color, and itching.  The swelling and redness has become progressively worse and is now the size of sand-dollar.  The swelling is described as "hard as a knot."  The rash has no vesicles or bumps.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Patient called pharmacy 48 hours after administration of VARIVAX to inquire about reaction at injection site.  Patient reports that injection site is swollen, bruised, red/maroon in color, and itching.  The swelling and redness has become progressively worse and is now the size of sand-dollar.  The swelling is described as "hard as a knot."  The rash has no vesicles or bumps.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Patient is bruised at injection site.
Age: 48.0
Sex: M
Vaccine: TD
Symptoms: Fatigue, Injection site pain, Musculoskeletal disorder, Pyrexia
Clinical narrative: Pt experienced more than three days of moderate fever (100.4), fatigue, and significant localized pain at the injection site. Pain was sufficient to impair use of the arm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash pruritic
Clinical narrative: Developed itchy, burning rash.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Skin reaction
Clinical narrative: Patient developed a local skin reaction today at the site the vaccine was given (right deltoid).  Skin is hot to touch, slightly erythematous, slightly tender only when palpated.  No pain otherwise.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right bicep red and swollen.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: Swelling around inject site, raised tight skin.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersomnia, Hypoaesthesia, Influenza, Rhinorrhoea
Clinical narrative: PATIENT STATED SHE HAS THE FLU AFTER RECEIVING THE FLUZONE HD. SHE SAID SHE HAD SLEPT ALL DAY AND HAD RUNNY NOSE. THEN SHE SAID HER LEG WAS NUMB AND MIGHT BE GUILLAIN-BARRE SYNDROME.
Age: 51.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Feeling abnormal, Headache, Pain, Pruritus
Clinical narrative: Red, sore, swollen, warm, itchy, headache, and overall "so-so" feeling.  Patient treated with ice, Benadryl, acetaminophen, and ibuprofen but still felt the same.
Age: 51.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Red, sore, swollen, warm, itchy, headache, and overall "so-so" feeling.  Patient treated with ice, Benadryl, acetaminophen, and ibuprofen but still felt the same.
Age: 25.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Chills, Constipation, Fatigue, Headache, Lethargy
Clinical narrative: Headache, chills, fever of 102, body aches, constant pain at vaccine site, constipation, neck twitch, lethargic, fatigue.
Age: 25.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Muscle twitching, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Headache, chills, fever of 102, body aches, constant pain at vaccine site, constipation, neck twitch, lethargic, fatigue.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Chest X-ray, Culture urine, Full blood count, Seizure
Clinical narrative: Had apparent seizure a few hours after immunizations. T=100.8. There is a fit of seizures.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urine analysis
Clinical narrative: Had apparent seizure a few hours after immunizations. T=100.8. There is a fit of seizures.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Brain scan normal, Chest X-ray normal, Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: Pain (scale 9), muscle spasms radiating from injection site, burning at injection site, Hydromorphone, muscle relaxer (unknown), prednisone, APAP, unknown diagnosis.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: During administration of influenza vaccine to this patient, some of the vaccine leaked and sprayed onto the patient's arm resulting in an incomplete dose being administered.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Redness and induration to bilateral thigh. (Local reaction).
Sex: U
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described of sickness in a patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Influenza vaccine (unspecified season) and got sick. The patient was asking if the shot used to prevent infections more that just the lungs also other parts like nose, ear and throat. Also asking whether the side effects included a cold right after vaccination.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates in 2014, doses of GARDASIL (lot #K001631 with expiry date: 06-NOV-2016 and lot # K002740 with expiry date: 06-AUG-2015, number of doses unspecified) that were improperly stored were administered to the patients. Reported excursion occurred in 2014 but it was not discovered until recent audit of temperature log in August 2016. The reporter confirmed administration of improperly stored vaccine doses. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, red streak down past elbow. Adverse event was gone 8/21/16 at night without medications.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a 65 year old female patient regarding herself. The patient had no medical history or drug reactions/allergies. The patient's concurrent conditions were not reported. On an unspecified date in 2012, the patient was vaccinated with a dose of ZOSTAVAX injection, in the left shoulder, (dose, frequency, lot number and expiration date were not reported). The patient had no concomitant medications. No product quality complaint (PQC) was involved. On an unspecified date in 2016, the patient got an out break and experienced rash on her hip. On an unspecified date the patient sought medical attention and an unspecified treatment was given to treat the rash. No laboratory studies were performed. At the time of the report the outcome of the rash was unknown. The reporter did not provide the causal relationship between ZOSTAVAX and the rash. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 18-JUL-2016 the patient received an improperly stored dose of PROQUAD (lot # L040412, expiry date: 13-APR-2017). No adverse effect reported. the outcome was unknown. No product quality complaint was involved. This is one of several report received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Upper left arm redness swelling 4 inches by 6 inches warm to touch since 10 hrs ago.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema in the leg about 4" in size around the site of DTAP shot.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction
Clinical narrative: 4 x 4 cm area mild redness 7d later local area monitoring.
Age: 46.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen area at inj stie, red, hot to touch, sore. Started after shot was given.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Erythema, Rash, Wheezing
Clinical narrative: 1.) 4 days after HPV9 #1 given: painful rash on chin and mouth, swelling around chin, testicular swelling and pain/itching. DX: Allergy reaction; TX: BENADRYL. 2.) 4 days after HPV9 #2, onset of wheezing, managed with inhalers. 2 days later, onset of red, painful rash on lower cheeks and chin, rash on chest.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Erythema, Oral mucosal eruption, Rash, Testicular pain, Testicular swelling
Clinical narrative: 1.) 4 days after HPV9 #1 given: painful rash on chin and mouth, swelling around chin, testicular swelling and pain/itching. DX: Allergy reaction; TX: BENADRYL. 2.) 4 days after HPV9 #2, onset of wheezing, managed with inhalers. 2 days later, onset of red, painful rash on lower cheeks and chin, rash on chest.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Wheezing
Clinical narrative: 1.) 4 days after HPV9 #1 given: painful rash on chin and mouth, swelling around chin, testicular swelling and pain/itching. DX: Allergy reaction; TX: BENADRYL. 2.) 4 days after HPV9 #2, onset of wheezing, managed with inhalers. 2 days later, onset of red, painful rash on lower cheeks and chin, rash on chest.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Erythema, Oral mucosal eruption, Pain, Pruritus, Rash
Clinical narrative: 1.) 4 days after HPV9 #1 given: painful rash on chin and mouth, swelling around chin, testicular swelling and pain/itching. DX: Allergy reaction; TX: BENADRYL. 2.) 4 days after HPV9 #2, onset of wheezing, managed with inhalers. 2 days later, onset of red, painful rash on lower cheeks and chin, rash on chest.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Testicular pain, Testicular swelling
Clinical narrative: 1.) 4 days after HPV9 #1 given: painful rash on chin and mouth, swelling around chin, testicular swelling and pain/itching. DX: Allergy reaction; TX: BENADRYL. 2.) 4 days after HPV9 #2, onset of wheezing, managed with inhalers. 2 days later, onset of red, painful rash on lower cheeks and chin, rash on chest.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-JUL-2016 the patient received and improperly store dose of PROQUAD (lot # L040412, expiry date: 13-APR-2017) (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapy were not provided. On 15-AUG-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot # M011117, expiration date 07-DEC-2017; dose was unknown). No adverse reactions were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # L037563, expiration date 29-SEP-2017; lot # K016127, expiration date 23-SEP-2016; dose and route not reported). The vaccine was improperly stored in 3.3 Celsius degree for 3 hours and 22 minutes. There were no previous exposures. Data logger was involved. No adverse effect were reported. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact the physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (lot # M017335, expiration date 05-OCT-2017, therapy type rHA; lot # M011662, expiration date 08-SEP-2017, therapy type rHA; dose and route not reported). The vaccine was improperly stored in 3.3 Celsius degree for 3 hours and 22 minutes. There were no previous exposures. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact the physician.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication  were unknown. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose and route unknown, lot# M021407, expiration date: 30-APR-2018). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 20-JUL-2016, the patient received an improperly stored dose of PROQUAD (lot # L040412, expiry date: 13-APR-2017. No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed practical nurse refers to a multiple unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored PROQUAD, therapy type: RHA, Lot# M011661 (expiry date: 08-SEP-2017) (dose not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed practical nurse refers to a multiple unspecified patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, Lot# M004328 (expiry date: 26-JAN-2018, Lot# L048462 (expiry date: 02-DEC-2017 and lot# M023384 (expiry date: 11-MAY-2018) (dose not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Headache, Infarction
Clinical narrative: More freq. HTN, meds no longer worked even when dose increased by 2 times. Suspected infarction in ER, chest pain, freq. HA, ongoing neurological pain head - lumbar shifts. F/U with cardiologist on 9/1/16.
Age: 62.0
Sex: M
Vaccine: MENB
Symptoms: Injection site abscess, Injection site pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown date. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site pain and injection site abscess. On an unknown date, the outcome of the injection site pain and injection site abscess were unknown. It was unknown if the reporter considered the injection site pain and injection site abscess to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The lot numbers were unknown. The reporter would like to be contacted. This is 1 of the 3 cases reported by same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Patient came in 48 hr after given ZOSTAVAX -patient reported redness, warmth and blisters around the injection site.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria, Vomiting
Clinical narrative: Evening following vaccine, pt experienced prolonged vomiting with round of hives within 2 days recurring one week later. Pt saw physician and treated with prednisone and supportive care.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Pain, Pruritus
Clinical narrative: Bitten by a snake and hospital suggested it since I can't remember the last time I had one. At site of injection it is swollen and red, at about 10 hours post injection I started with itching and hives, and my glands on my neck have become swollen and sore.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Bitten by a snake and hospital suggested it since I can't remember the last time I had one. At site of injection it is swollen and red, at about 10 hours post injection I started with itching and hives, and my glands on my neck have become swollen and sore.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner, via company representative, and refers to a 12 year old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 12-AUG-2016, the patient was vaccinated with her first dose of GARDASIL 9, intramuscular, lot # L024993, expiration date 17-OCT-2017. Other suspect therapies included MENVEO (unspecified manufacturer), which was administered "concomitantly with GARDASIL 9" (it was unspecified if the two vaccines were administered in the same arm). On an unspecified time after receiving GARDASIL 9, in August 2016, the patient experienced syncope. The outcome of the event was unknown. The causality for the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dosing details, anatomical locations, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administrated improperly stored doses of ZOSTAVAX (lot # and expiration date were not reported). It was reported that the vaccine was exposed for 2800 hours at -1 C degree. No adverse effects were reported. It was reported that all the vaccines were back in range. The data logger was reported as yes. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
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 medical history, concurrent conditions and drug reactions were not reported. On 22-AUG-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (Concentration, dose and route were not reported), lot # K020214, expiration date 25-MAR-2016. Patient's concomitant medication was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose and route were unknown, lot # L027733 with expiration date 13-SEP-2017, lot # M006708 with expiration date 02-JUN-2018, and lot # L033343 with expiration date 13-SEP-2017). The vaccines were exposed to temperature excursion of 57.0 degrees Fahrenheit (F) for 1 hour and 50.8 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, patients were administrated improperly stored doses of GARDASIL 9 (lot # and expiration date were not reported). It was reported that the vaccine was exposed for 270 hours at 9 C degrees. No adverse effects were reported. It was reported that all the vaccines were back in range. The data logger was reported as yes. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner and refers to an 18 year old female patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisiting allergies, birth defects or medical conditions. At 11:15 AM on 04-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the left arm (dose not reported). At 11:00 AM on 04-APR-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the right arm (dose not reported). Both doses of the vaccine administered to the patient were improperly stored as they underwent a temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Age: 46.0
Sex: M
Vaccine: DTP, RAB
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 46-year-old male patient who received RABAVERT (batch number 596011A, expiry date December 2018). The patient's past medical history included bit (On 15th August 2016 the patient had a bite). Concomitant products included DTPA (Reduced antigen), (DTPA vaccine), Rabies NVS (Rabies Vaccine, Rabies NVS (Rabies Vaccine) and Rabies NVS (rabies Vaccine). On 21st August 2016, the patient received the 1st dose of RABAVERT 1 ml. On 22nd August 2016, 1 days after receiving RABAVERT, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving. The reporter considered the rash to be possibly related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor. The patient had received 3 doses of unknown manufacturer rabies vaccine given approximately 1 month before bite. The patient experienced rash on chest after receiving a dose of RABAVERT for post exposure series. The reporter stated that urgent care visit was required. No Patient or product information was available at the time of the report. The patient's doctor would call with additional details of event.
Sex: U
Vaccine: HEP
Symptoms: Headache, Inappropriate schedule of drug administration, Incomplete course of vaccination, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a patient who received ENGERIX B. Previously administered products included Hepatitis B vaccine (1st dose received in 2000). On 22nd August 2016, the patient received the 2nd dose of ENGERIX B. In August 2016, less than a week after receiving ENGERIX B, the patient experienced pain in arm and headache. On 22nd August 2016, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the pain in arm, headache and drug dose administration interval too long were unknown. It was unknown if the reporter considered the pain in arm and headache to be related to ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The registered nurse noted that the patient had never finished the series of hepatitis vaccine. On 22nd August 2016, the patient received 2nd dose of ENGERIX B vaccine, which led to lengthening of the vaccination schedule. On the date of reporting, the patient reported pain in arm (injected arm) that radiates to neck and headache. The nurse refused to provide details and go through the adverse event reporting form.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ, HEPA, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Patient fainted after vaccine administration on waiting room. Floor woke and was alert and oriented. Pt was able to sit and denied pain. Examined by doctor.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Triaged by nurse; ice and ibuprofen. No indication for antibiotics. Pain posterior upper arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Incorrect route of drug administration
Clinical narrative: I was instructed by another CMA to inject "IM". After completion upon entering into MCIR I was informed this vaccine should have been "SQ".
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Neck pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of neck pain (with radiation) in a 30-year-old female patient who received ENGERIX B (batch number K35HY, expiry date 14th April 2018). On 22nd August 2016, the patient received ENGERIX B. In August 2016, less than a week after receiving ENGERIX B, the patient experienced neck pain (with radiation) and headache. On an unknown date, the outcome of the neck pain (with radiation) and headache were unknown. It was unknown if the reporter considered the neck (with radiation) and headache to be related to ENGERIX B. Additional details were provided as follows: The nurse reported the patient (an employee) received ENGERIX B vaccine in her right arm. On 25th August 2016, when the patient came back for work, she was experiencing pain radiating in her neck and it was causing her to have a headache. The reporter's call was transferred to Medical information for additional information and questions were asked by the reporter on behalf of patient.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Screaming
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 18-year-old female patient who received BEXSERO. Previously administered products included BEXSERO (1st dose received on an unknown date). On 22nd August 2016, the patient received the 2nd dose of BEXSERO. In August 2016, less than a week after receiving BEXSERO, the patient experienced injection site pain, injection site swelling and injection site erythema. On 22nd August 2016, the patient experienced screaming. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and screaming were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and screaming to be related to BEXSERO. Additional details were provided as follows: The patient did not receive any concomitant medication. The patient screamed during vaccination and the next day, she reported pain, redness and swelling at the injection site (left deltoid).
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Product quality issue
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site redness in a patient who received PEDIARIX (batch number 33E9E, expiry date 16th November 2018). This case was associated with a product complaint. On 24th August 2016, the patient received PEDIARIX .5 ml. In August 2016, less than a week after receiving PEDARIX, the patient experienced injection site redness. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site redness and pharmaceutical complaint were unknown. It was unknown if the reporter considered the injection site redness to be related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The office manager reported that they were concerned about this particular lot of PEDIARIX because they had three patients who experienced adverse events within a 2 day period of vaccination. This patient experienced injection site redness. They had used PEDIARIX and never experienced this type of problem so they are concerned that the lot was defective and do not want to use any further doses from it. They had 6 full boxes and then some partial boxes but the field representative did not have an exact total. There was no other obvious defect with these vaccines but reporter advised him that he would register a complaint. The reporter advised the representative that GlaxoSmithKline did not credit or replace for this situation but if the quality department did decide to retrieve some from this lot and found a defect upon investigation, then credit could be arranged. The field representative asked that someone contacted him to provide follow-up regarding how GlaxoSmithKline was proceeding with this complaint. The representative did not have further information. The healthcare professional was supposed to call medical information with additional information. This is one of the 3 cases reported by the same reporter.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product quality issue, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a patient who received PEDIARIX (batch number 33E9E, expiry date 16th November 2018). This case was associated with a product complaint. On 23rd August 2016, the patient received PEDIARIX .5 ml. In August 2016, less than a week after receiving PEDIARIX, the patient experienced fever. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fever and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the fever to be related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The office manager reported that they were concerned about this particular lot of PEDIARIX because they had three patients who experienced adverse events within a 2 day period of vaccination. This patient experienced fever. They had used PEDIARIX for many years and never experienced this type of problem so they are concerned that the lot was defective and do not want to use any further doses from it. They had 6 full boxes and then some partial boxes but the field representative did not have an exact total. There was no other obvious defect with these vaccines but reporter advised him that he would register a complaint. The reporter advised the representative that GlaxoSmithKline did not credit or replace for this situation but if the quality department did decide to retrieve some from this lot and found a defect upon investigation, then credit could be arranged. The field representative asked that someone contacted him to provide follow-up regarding how GlaxoSmithKline was proceeding with this complaint. The representative did not have further information. The healthcare professional was supposed to call medical information with additional information. This is one of the 3 cases reported by same reporter.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Blood creatine phosphokinase, Blood magnesium, Full blood count, Metabolic function test, Muscle spasms
Clinical narrative: Severe leg cramps.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. ON 18-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # M010478, expiration date 01-SEP-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient called office approximately 45 minutes after injection. Reporting pain in (L) elbow, tingling and numbness of arm with possible difficultly breathing. I advised him to seek professional care. Was treated with "steroid" injection, oral prednisone, CLARITIN D. Left ER dept approximately 11:30 am.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Skin discolouration, Vaccination site mass, Vaccination site pain
Clinical narrative: Painful lump appeared at vaccine site the day following vaccine administration. Black bruising began and spread. As of 9/8/16, lump exists but has subsided and black and red bruising. Pt says it still hurts upon touch. Advised pt to consult physician.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # reported as M010440 with expiry date: 09-DEC-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 32.97 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 18-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # M010478, expiration date 01-SEP-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 3 patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 30-AUG-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # reported as M108637, expiration date 11-OCT-2017, subcutaneously, site and doses were not reported). No adverse effects were reported. This is one of two reports received from the same source. Additional information is not expected due to lack of the reporter's contact details.