chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, MENB
Symptoms: Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a patient who received BEXSERO. Co-suspect products included Hepatitis B vaccine. On an unknown date, the patient received BEXSERO and Hepatitis B vaccine. On an unknown date, an unknown time after receiving BEXSERO and Hepatitis B vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not provided. The field representative reported on behalf of healthcare professional that the patient received BEXSERO and Hepatitis B vaccine on same day (date unknown, manufacturer of Hepatitis B vaccine was unknown) and had been experiencing days of pain. No further details were provided. The healthcare professional would like contact via phone as soon as possible.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Skin test, Urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced allergic reaction, wheals and skin red. On an unknown date, the outcome of the allergic reaction, wheals and skin red were unknown. It was unknown if the reporter considered the allergic reaction, wheals and skin red to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced allergic reaction to dose of FLUARIX QUADRIVALENT confirmed by skin test as wheal intradermal flare type of reaction. The doctor of medicine (MD) did not want to give additional information about the adverse event until he was provided with some information.
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of hives in a 64-year-old female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. After vaccination with FLUARIX QUADRIVALENT the patient experienced large severe hives on the side that the shot was administered. Later it spread to other side. Hives lasted on an off for 3 weeks.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Influenza like illness, Nausea, Urticaria
Clinical narrative: Pt walked in to the Flu Clinic to give an update about his reaction to the flu shot the he received 12/16/16. Pt stated that after he left the hospital approximately 5 hours after the shot he started to have nausea, chills, and large hives on the creases of his arms and legs. Then he started to have flu like symptoms for about 1 week. Pt. was evaluated at hospital for the flu-like symptoms. Pt stated that he is still recovering from being sick.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu like illness-aches, fever, diarrhea. Swelling, redness, tenderness to injection site.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Flu like illness-aches, fever, diarrhea. Swelling, redness, tenderness to injection site.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor, Skin discolouration
Clinical narrative: Pale Skin and Losing color in skin approx. 10 minutes after vaccination. Pediatrician screened patient. emergency kit at the ready if needed.
Age: 29.0
Sex: F
Vaccine: FLUR3
Symptoms: Chest pain, Dizziness, Dyspnoea, Feeling abnormal, Laboratory test
Clinical narrative: Started to feel off. Heart palpitations, shortness of breath, brain fog, chest pain, dizziness/lightheaded.
Age: 29.0
Sex: F
Vaccine: FLUR3
Symptoms: Palpitations
Clinical narrative: Started to feel off. Heart palpitations, shortness of breath, brain fog, chest pain, dizziness/lightheaded.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: PATIENT SAID UNBELIEVABLE PAIN RADIATING TO HER TRICEPT AND LASTED ABOUT 24 HOURS.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Immediate post-injection reaction, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Immediately after the shot, my arm began to get sore and hurt a lot but later that afternoon, the pain worsen and my temperature began to rise.  I was sick for 2.5 days with fever of over 103. I took advil for fever and pain and the fever would not go away.  It would go down a couple of digits and rise back up.  Not until Saturday night did the fever break. 5 days later, my arm is still very sore.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: PATIENT HAS A WARM RED AREA IN UPPER LEFT ARM.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Rash
Clinical narrative: Patient's Left Arm where she received PNEUMOVAX 23 was red from elbow to wrist on 12/31/16. She went to a prompt care on 12/31/16, where they prescribed her a Medrol dosepak. She started the medication on Saturday 12/31/16. Patient reported that by Monday 1-2-17 she was "back to normal and everything was fine." rash resolved
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Rashes and redness in both wrist, arms, neck TX by Dr. Benadryl 12.5mg/5ml, 10 Ml Given po ordered STAT> 1500 Another rash developing in L index finger. Remind pt to wait for another 30 mins.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site nodule, Injection site swelling
Clinical narrative: KNOT WHERE SHOT WAS GIVEN AND SOME SWELLING AROUND SHOT A FEW .
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Anxiety, Bacterial test positive, Blood heavy metal increased, Dehydration
Clinical narrative: Dizziness, headache, ear infection/fluid, dehydration, thirst, food sensitivity, stomach aches, intestinal issues, repeated vaginal infections, fatigue, skin infection, anxiety, sleep issues, overheats.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Ear infection, Fatigue, Feeling hot, Food allergy
Clinical narrative: Dizziness, headache, ear infection/fluid, dehydration, thirst, food sensitivity, stomach aches, intestinal issues, repeated vaginal infections, fatigue, skin infection, anxiety, sleep issues, overheats.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal test positive, Gastrointestinal disorder, Headache, Immune system disorder, Laboratory test abnormal
Clinical narrative: Dizziness, headache, ear infection/fluid, dehydration, thirst, food sensitivity, stomach aches, intestinal issues, repeated vaginal infections, fatigue, skin infection, anxiety, sleep issues, overheats.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Middle ear effusion, Parasite blood test positive, Skin infection, Sleep disorder, Thirst
Clinical narrative: Dizziness, headache, ear infection/fluid, dehydration, thirst, food sensitivity, stomach aches, intestinal issues, repeated vaginal infections, fatigue, skin infection, anxiety, sleep issues, overheats.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal infection, Viral test positive
Clinical narrative: Dizziness, headache, ear infection/fluid, dehydration, thirst, food sensitivity, stomach aches, intestinal issues, repeated vaginal infections, fatigue, skin infection, anxiety, sleep issues, overheats.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Pain
Clinical narrative: Vaccine was administered to top of shoulder despite patient having sufficient flesh in upper arm to administer at that site.  Patient reports severe pain limit range of motion since shot was administered and continuing to the present (1/9/2017).
Age: 0.17
Sex: F
Vaccine: PPV, RVX
Symptoms: Allergy test positive, Allergy to animal, Dermatitis contact, Eczema, Urticaria
Clinical narrative: Skin broke out in hives/eczema. I noticed it 2 weeks after vaccine given as it was getting progressively worse. Went to doctors a month after vaccine was given and doctor said it looked like eczema. was referred to allergist. Allergy doctor said it was contact dermatitis/eczema.  Treatment: take Zyrtec daily, hydrocortisone, vanicream, vanicream soap, hibiclens soap, daily baths. Severe symptoms lasted at least 3 months until treatment started to kick in.
Age: 0.17
Sex: F
Vaccine: PPV, RVX
Symptoms: Dermatitis contact, Eczema, Food allergy, Urticaria
Clinical narrative: Skin broke out in hives/eczema. I noticed it 2 weeks after vaccine given as it was getting progressively worse. Went to doctors a month after vaccine was given and doctor said it looked like eczema. was referred to allergist. Allergy doctor said it was contact dermatitis/eczema.  Treatment: take Zyrtec daily, hydrocortisone, vanicream, vanicream soap, hibiclens soap, daily baths. Severe symptoms lasted at least 3 months until treatment started to kick in. Currently, still treating minor eczema. Treat with mupir/ciclo/flutic cream given by dermatologist.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Very sore arm, with hardness and reddness on upper arm radiating out at least 10 inches from injection site.  Strong aching pain, blotchy skin, swollen muscle, and heat in upper arm.  The pain began to radiate to neck on upper right and down right side of back.  Pain, hardness, redness and blotchy skin moved to bicep area of right arm within two days.  Achy upper body aches, emotional weepiness for two days following injection.  Tenderness continues in upper right arm three days post injection.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Muscle swelling, Pain, Pain in extremity, Rash macular
Clinical narrative: Very sore arm, with hardness and reddness on upper arm radiating out at least 10 inches from injection site.  Strong aching pain, blotchy skin, swollen muscle, and heat in upper arm.  The pain began to radiate to neck on upper right and down right side of back.  Pain, hardness, redness and blotchy skin moved to bicep area of right arm within two days.  Achy upper body aches, emotional weepiness for two days following injection.  Tenderness continues in upper right arm three days post injection.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Redness and swelling. Dr prescribed an antibiotic for cellulitis.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had swelling at and around injection site. Area turned pink for about 2in by 4in and black and blue for an area on the outside of that in l corner. Area was also warm to the touch.
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer (daughter) on behalf of father via Pfizer sales representative. A male patient of an unspecified age reported as (Age: 67; Unit: Unknown) and unspecified ethnicity started to receive PREVENAR 13, via an unspecified route of administration on an unknown date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took influenza vaccine "flu shot" via an unspecified route of administration on an unknown date at a single dose for immunization. Four days after receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) the area of the arm where the vaccine was administer become red, hot, swelled and fatigue. The clinical outcome of the events, vaccine was administer become red, hot, swelled and fatigue, was unknown.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Pt described vaccine being given near elbow and has been painful ever since it was given on 11/18/16. Going to a neurologist hard to raise arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a healthcare professional via Pfizer (case # 2016382414) referring to a female patient of unknown age. The patient's medical history included fibromyalgia, chronic fatigue/malaise, mild hypertension, anxiety, asthma (mild), high cholesterol, migraines/stress headaches, lower lumbar spine (LS)  pain, sleep apnea, hysterectomy, biopsy breast, cervical spinal fusion, carpal tunnel release, radial tunnel release, lumbar vertebral fracture L1, ischemic colitis, colonoscopy, spinal cord stimulator (SCS) implant, implant removed, allergy to PNEUMOVAX 23 (MARRS# 1609USA002894). The patient's historical drug included cortisone. On unknown date in December 2012 the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date the patient had reactions to the vaccine of ZOSTAVAX. The outcome was unknown. The causality was related. This is one of several reports received from the same reporter concerning the same patient. Additional information has been requested. Sender's Comments: US-009507513-1609USA000051: US-009507513-1609USA002894: MERCK 1609USA002895:Mfr number.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56-year-old female patient. The patient's drug reactions/allergies included allergy to an adhesive tape and cephalexin allergy. No information regarding the patient's pertinent medical history and concomitant therapies was provided. On 16-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, injection site, lot# and expiration date were not provided) for "vaccination". On 16-DEC-2016 (also reported as "at an unknown date and time after receiving an injection", the patient's arm became swollen, red and hot. The patient sought medical attention, as he called to the pharmacist. No treatment was given for the adverse events. The outcome of the events was reported as unresolved, at the time of the report. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On 20-DEC-2016, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, strength, dose and frequency were not reported) intramuscularly rather than subcutaneously for prophylaxis. No adverse effects were reported by the patient. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 09-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscularly (dose, lot # and expiry date were not reported) for prophylaxis. Subseqently, the patient showed up in the pharmacy on 28-DEC-2016, to be administered the second dose of GARDASIL 9. No adverse effects were reported. Additional information is not expected as no consent to contact the physician was given.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M036059 with expiry date 03-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The doses were exposed to 51 Fahrenheit (F) for 14 hours 23 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of 4 reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014600:US-009507513-1612USA014601: US-009507513-1612USA014599:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with  improperly stored doses of PNEUMOVAX 23 lot # M036728 with expiry date 20-MAY-2018 and lot # L033707 with expiry date 18-MAY-2017 (dose and route of administration were not reported) for prophylaxis. The doses were exposed to 51 Fahrenheit (F) for 14 hours 23 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of 4 reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014600: US-009507513-1612USA014601: US-009507513-1612USA014444.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # L029615 with expiry date 15-MAY-2017 and lot # M019706 with expiry date 24-OCT-2017 (dose was not reported) for prophylaxis. The doses were exposed to 51 Fahrenheit (F) for 14 hours 23 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of 4 reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA014444: US-009507513-1612USA014601: US-009507513-1612USA014599:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L014429 with expiry date 15-MAR-2018 and lot # M014925 with expiry date 16-FEB-2019 (dose and route of administration were not reported) for prophylaxis. The doses were exposed to 51 Fahrenheit (F) for 14 hours 23 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of 4 reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014600: US-009507513-1612USA014444: US-009507513-1612USA014599.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # M031943, expiration date: 27-DEC-2017; lot # M029595, expiration date: 10-DEC-2017; lot # L046509, expiration date: 17-MAY-2017; dose and route were unknown)(rHA) for prophylaxis. No adverse effects reported. The temperature for the vaccine stored was 10 Fahrenheit degree with 35 minutes time frame. Previous temperature excursion was reported as exposure to 35.6 Fahrenheit for 8 hours and 53 minutes, 13.3 Fahrenheit for 3 hours and 22 minutes, 32.9 Fahrenheit for 24 hours and 34.5 Fahrenheit for 24 hours (cumulative 60 hours and 15 minutes). Data logger was involved.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA006776:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Laboratory test, Seizure
Clinical narrative: This spontaneous report as received from a patient's mother via a company representative refers to an 18 year old female patient. The patient concomitant medications, medical history and drug reactions or allergies were unknown by the reporter. On unknown dates, the patient was vaccinated with doses of GARDASIL for routine vaccination (doses, site, route of administration,  lot # and expiration date were not reported). The patient completed the series of vaccination in approximately 2016 (reported as about one year ago). On unknown dates, patient experienced three different seizures. One of those seizures was severe enough that the patient was admitted to the hospital for one day (start date of hospitalization was not reported). On an unknown date, the patient had  some unspecified neurological tests performed but results were not provided (reported as"inconclusive"). Based on the test it was suggested that the seizures occurred as a result of either the GARDASIL vaccination or there was a possibility that the patient might have smoked some bad marijuana  (reported as "some really bad pot"). On an unknown date, the patient also had a computerized tomography (CT) scan, which results were unknown. The patient had a seizure "recently" and might or might not experience additional seizures moving forward. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Upon internal review, the event of seizures was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, between 03-JAN-2017 and 06-JAN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M007298, expiration date 19-NOV-2017 and lot # M011832, expiration date 25-JAN-2018. No adverse effects were reported. Product quality complaint was not involved. The administered doses of ROTATEQ were stored in the temperature of 35 degrees Fahrenheit for 24 hours. Data logger was involved. There were no previous temperature excursions reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (other health professional) refers to two patient of unknown age. Pertinent medical history and concomitant medications were not reported.    On 27-OCT-2016, the patient was vaccinated with M-M-R II lot # M007279, expiry date 09-FEB-2018, for prophylaxis which were improperly stored (incorrect product storage) temperature/ time: 35.6 F for 24 hours and call was not because of data logger. Previous temperature excursion was 59.4F for 1 hour and AE was administered. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to M-M-R II. No adverse effects were reported. No further information provided. This is one of two reports from same reporter. MARRS # 1701USA003812.  Additional information is not expected as the reporter did not give us consent to contact physician
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant (other health professional) refers to unspecified patient of unknown age. Pertinent medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with  GARDASIL 9 lot # M024261, expiration date 30-JUL-2018, temperature >8 degree celsius but < 25 degree celsius, time frame 231 hours and data logger was used for prophylaxis. There were no previous temperature excursion. On an unknown date, the patient received an improperly stored dose of GARDASIL 9 (incorrect product storage).   Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis. Dosage regimen, route of administration, lot number and expiry date were not reported. It was reported that the patient had "titers of less than 10" for Hepatitis B (Hepatitis B surface antibody negative). It was reported that it could not be ruled out if the patient had RECOMBIVAX HB prior to the titers or another company's Hepatitis B vaccine. The outcome of hepatitis b surface antibody negative was unknown. Causality assessment was not provided by the reporter. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient received GARDASIL (lot: J005925, Expiry date: 27-NOV-2015) on 03-AUG-2013 at age 18 years old and received  GARDASIL 9 (lot M036059, expiry date: 03-JUN-2019) on 06-JAN-2017. The patient did not receive a 3rd dose of GARDASIL or GARDASIL 9. No adverse effects reported. Additional information is not expected as consent to contact physician was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (other health professional) refers to three patient of unknown age. Pertinent medical history and concomitant medications were not reported. On 27-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M017983, expiry date 30-MAY-2018, for prophylaxis which were improperly stored (incorrect product storage) temperature/ time: 35.6 F for 24 hours and call was not because of data logger. Previous temperature excursion was 59.4F for 1 hour and AE was administered. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to M-M-R II. No adverse effects were reported. No further information provided. This is one of two reports from same reporter. MARRS # 1701USA003719 Additional information is not expected as the reporter did not give us consent to contact physician.
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain, Chest pain, Injection site erythema, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer calling on behalf of husband. A male patient of an unspecified age and ethnicity started to receive PREVENAR 13, via an unspecified route of administration on an unknown date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on the "30th" (not further specified) and during the night he was achy all over, he hurt some, he tells, it hurt down in his legs. He had some problems with his chest and abdomen hurting so I ended up calling the paramedics and they said that they thought it could have been a reaction to the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). He was achy all over and he hurt. He had a red spot, probably where the vaccine was in that area, it was kind of a dark reddish, it was probably between an eight and a quarter of an inch across. The clinical outcome of the events was unknown.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Foaming at mouth, Laboratory test, Loss of consciousness, Pain
Clinical narrative: Baby received vaccines around noon time and was fine, after few hours woke up at home, was crying and mother held her she seemed in pain she was straining then has some discoloration on face followed by frothing from mouth and became unconscious for 5-10 min, 911 called taken to nearest Emergency department.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rectal tenesmus, Skin discolouration
Clinical narrative: Baby received vaccines around noon time and was fine, after few hours woke up at home, was crying and mother held her she seemed in pain she was straining then has some discoloration on face followed by frothing from mouth and became unconscious for 5-10 min, 911 called taken to nearest Emergency department.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Tingling behind ear radiating across cheek to mouth.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Loss of consciousness, Muscle twitching
Clinical narrative: Client was sitting in the chair after being given three vaccines. She lost consciousness and began to have some twitching. We assisted her to lie down and she immediately awoke. The entire episode lasted about 30 seconds. We had her lie down on the exam bed and gave her a bottle of water. Her vital signs were checked BP 11/66 P 56 bpm.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On an unspecified date, the patient may have received an improperly stored dose of either: -RECOMBIVAX HB (lot # L040458  expiration date: 04-FEB-18; L044707 expiration date: 06-OCT-2018) -PEDVAXHIB (lot # M027884 expiration date: 19-APR-2019; lot # M027881  expiration date: 13-APR-2019) -ROTATEQ (lot # M026491 expiration date 01-FEB-2018; lot # M034799 expiration date 28-FEB-2018) -GARDASIL 9 (lot # M017983  expiration date: 30-MAY-2018). Route and dosage unknown for prophylaxis for all vaccines except for ROTATEQ (orally; dosage unknown) for prophylaxis. The vaccines were exposed to 14-16 °C for 9 hours. No previous excursions. A data logger was used. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4, MEN
Symptoms: Arthropathy, Autoimmune disorder, Eye disorder, Lung disorder, Pain
Clinical narrative: This spontaneous social media report was received from the patient's parent via other company notification from Pfizer (manufacturer control number 2016578699) and refers to a currently 18 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unspecified date, in early January 2015, the patient was vaccinated with a dose of  GARDASIL (dose, route of administration, lot # and expiration date were not reported). Other suspect therapies included meningococcal vaccine (unspecified) (reported as T104 - FB - Meet Meningitis), which was administered on the same day (dose, indication and route of administration were not reported).  On an unspecified date in 2015 (within a few weeks), the patient started suffering from strange aches and pains and sinus troubles. One month later, on an unknown date in 2015, the otherwise healthy teen, was hospitalized and nearly died from a rare autoimmune disease that attacked his lungs, joints, kidneys and eyes. The patient's parent reported that the patient would live with that disease for the rest of his life.  The outcome of the events of strange aches and pains and sinus troubles was not reported. The outcome of the event of rare autoimmune disease was not recovered. The relatedness between the adverse events and  GARDASIL and meningococcal vaccine (unspecified) was not reported. The event of rare autoimmune disease was considered to be life threatening by the reporter. Upon internal review, the event of rare autoimmune disease was determined to be medically significant.  Additional information has been requested.
Sex: M
Vaccine: HPV4, MEN
Symptoms: Renal disorder, Sinus disorder
Clinical narrative: This spontaneous social media report was received from the patient's parent via other company notification from Pfizer (manufacturer control number 2016578699) and refers to a currently 18 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unspecified date, in early January 2015, the patient was vaccinated with a dose of  GARDASIL (dose, route of administration, lot # and expiration date were not reported). Other suspect therapies included meningococcal vaccine (unspecified) (reported as T104 - FB - Meet Meningitis), which was administered on the same day (dose, indication and route of administration were not reported).  On an unspecified date in 2015 (within a few weeks), the patient started suffering from strange aches and pains and sinus troubles. One month later, on an unknown date in 2015, the otherwise healthy teen, was hospitalized and nearly died from a rare autoimmune disease that attacked his lungs, joints, kidneys and eyes. The patient's parent reported that the patient would live with that disease for the rest of his life.  The outcome of the events of strange aches and pains and sinus troubles was not reported. The outcome of the event of rare autoimmune disease was not recovered. The relatedness between the adverse events and  GARDASIL and meningococcal vaccine (unspecified) was not reported. The event of rare autoimmune disease was considered to be life threatening by the reporter. Upon internal review, the event of rare autoimmune disease was determined to be medically significant.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose number, route, lot number and expiration date were not provided) for prophylaxis. No adverse events reported. No product quality complaint was involved. The vaccines were improperly stored with a temperature of excursion of: >46°F (fahrenheit degrees) but < 77°F (fahrenheit degrees) during 16 hours. There were no previous temperature excursion. This is one of two reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided.; Sender's Comments: US-009507513-1701USA004139:
Sex: M
Vaccine: HPVX
Symptoms: Epilepsy, Seizure
Clinical narrative: Information was received from a consumer found on the Merck social media account, referring to her/his neighbor 'son, a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with unidentified Merck hpv vaccine (reported as "Know HPV"; name, lot number, expired date and dose were not provided) for prophylaxis. On the same day, he started seizing and was now epileptic. Even on medications, the patient had seizures all the time. The outcome of this event was unknown. Upon internal review, the event epileptic seizure was considered to be medically significant. Additional information is not expected, because there is no contact information provided.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar event for 3 patients. This is 3rd of 3 reports. A patient of an unspecified age, gender and ethnicity received PREVENAR 13, via an unspecified route of administration on an unspecified date at single dose, for immunization. The patient medical history and the patient's concomitant medications were not reported. The patient experienced pain redness and swelling at the site of injection. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017006205 Same reporter/drug/AE, different patients.;US-PFIZER INC-2017006187 Same reporter/drug/AE, different patients.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Initial unsolicited report received from a nurse tes on 29-Dec-2016. This case involves a 10-month-old male patient who was vaccinated with a dose of Fluzone QIV (Batch number UT5594MA, expiry date-30 June 2017, dose form and frequency not reported) intramuscularly in left thigh on 27-Dec-2016. Patient's had no pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 27-Dec-2016, the same day following the vaccination, the patient had a drooping of the face and mouth noticed by parents. The patient's parents called physician office and were advised to go to Emergency Room. The patient was diagnosed with Bell's Palsy. The patient was previously vaccinated with a dose of Fluzone QIV (batch number, expiry date, dose form, frequency, route and site of administration not reported) on 14-Oct-2016. Laboratory data and corrective treatment were not reported. The outcome of the event was reported as unknown. Upon internal review the case was considered as serious because of important medical event: Bell's palsy. List of documents held by the sender: None. Sender's Comments: This poorly documented case as patient had Bell's palsy following FLUQUADRI VACCINE. Time to onset is unknown, Clinical details- such as latency from vaccination, medical history, previous vaccination history, clinical details surrounding the event and infectious history are lacking to allow adequate medical assessment. Based on the available information the role of vaccine cannot be assessed.
Age: 1.17
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine administered.
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Pruritus, Rash, Respiratory disorder, Swelling
Clinical narrative: Swelling, breathing problems, requiring oxygen, hives, rash, itching, diarrhea. Also, I was given the TDAP vaccine, despite being allergic to it, when I was pregnant with her and believe this may have also caused vaccine injury to her while she was in utero.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Swelling, breathing problems, requiring oxygen, hives, rash, itching, diarrhea. Also, I was given the TDAP vaccine, despite being allergic to it, when I was pregnant with her and believe this may have also caused vaccine injury to her while she was in utero.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Petechiae, Rash
Clinical narrative: Fine facial rash. Petechial like. No respiratory issues. No rash on any other part of her body.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant concerning multiple patients of unknown demographics. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not informed. On unknown dates, the patients were vaccinated with improperly stored doses of  GARDASIL 9, lot # M011117, expiry date: 17-DEC-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of GARDASIL 9 were exposed to a temperature of 9C and 11C, and were out of range for 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. As of 14-DEC-2016, it was reported that all telephone attempts to obtain follow-up information have been unsuccessful. On 20-DEC-2016, a call was received from the medical assistant who stated that he/she was unable to provide any further information. Additional information has been requested.; Sender's Comments: US-009507513-1610USA004694:US-009507513-1610USA010044:US-009507513-1610USA010046:US-009507513-1610USA010048:US-009507513-1610USA010049:US-009507513-1610USA010050:,MERCK 1610USA010047:Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant concerning multiple patients of unknown demographics. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not informed. On unknown dates, the patients were vaccinated with improperly stored doses of  PROQUAD, lot # L041629, expiry date: 22-APR-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of PROQUAD were exposed to a temperature of 9C and 11C, and were out of range for 30 minutes. A data logger was used to track the temperature and there were no prior excursions.  No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. As of 14-DEC-2016, it was reported that all telephone attempts to obtain follow-up information have been unsuccessful. On 20-DEC-2016, a call was received from the medical assistant who stated that he/she was unable to provide any further information. Additional information has been requested.; Sender's Comments: US-009507513-1610USA010044:US-009507513-1610USA010046:US-009507513-1610USA010047:US-009507513-1610USA010048:US-009507513-1610USA010049 US-009507513-1610USA004694:,MERCK 1610USA010050:Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. On an unknown date, the patient was administered an improperly stored dose of  PROQUAD, lot # M022402, expiration date 01-NOV-2017, (dosage and therapy route were not provided), for prophylaxis. No adverse effects were reported. The dose of PROQUAD was exposed to a temperature of -12C during 3 hours 43 minutes and -10C during 7 hours 38 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 57-year-old female patient. Her concurrent conditions included hyperlipidemia, venous insufficiency in lower extremities, gallstones, extrinsic asthma and seasonal allergies. Concomitant therapies included ADDERALL, SINGULAIR, PROAIR, SYMBICORT, pravastatin and VAGIFEM (reported as "Yuvafem"). On 14-DEC-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (exact dose was not reported, lot # M007768, expiration date: 27-JUN-2017). At the same time, she received a dose of FLUZONE (exact dose, lot # and expiration date were not reported). Both vaccines were administered intramuscularly in the left deltoid, 1.5 inches apart. The same night she received the two vaccines, on 14-DEC-2016, redness, swelling, tenderness and soreness developed in the injected arm. The redness and swelling progressed until it was the worst on 17-DEC-2016 (reported as on Saturday). On the same day, she also experienced a fever of 102 degrees Fahrenheit. The patient did not seek medical attention until 19-DEC-2016, when she consulted the nurse practitioner. The nurse practitioner reports that the patient's left arm was still reddened at the time of the report, approximately 2-3 cm from the patient's elbow, proximally and laterally. The area extended to 10 cm, but there was no induration or "thickening." There was no treatment for the adverse events given. No laboratory diagnostics studies were performed. The outcome of the events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a consumer referring to herself, a 67 year old female patient with amoxixcilin and cefuroxime allergy. The patient's concurrent conditions included herpes zoster. There was no concomitant medication. In approximately 2013 (reported as about 3 years ago), the patient was vaccinated with ZOSTAVAX dose/frequency reported as "one time immunization" and route of administration reported as immunization (lot # and expiration date were not reported) for shingles prevention. The reporter stated that on an unknown date, ZOSTAVAX had almost entirely subdued her sun-rash from Herpes-Zoster(therapeutic response unexpected, pre-existing condition improved). It was reported that the patient sought unspecified medical attention.There were no laboratory diagnostics studies performed. No treatment was given to the patient. At the time of the report, the patient's status was unknown. No product quality complaint was involved. The reporter considered the events as related to ZOSTAVAX. Additional information is not expected as the reporter did not consent to be contacted.
Age: 60.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Rash
Clinical narrative: This spontaneous report was received from a pharmacy intern and refers to a 60 year old female patient. No information about the patient's medical history, concomitant medications and drug reactions or allergies was reported. On 23-DEC-2016, the patient was vaccinated with ZOSTAVAX injection, lot # M014310, expiry date 26-MAY-2017 (dose, route of administration and anatomical location were not specified) and PREVNAR 13 (dose, route of administration, anatomical location, lot # and expiry date were not provided). On 24-DEC-2016, the patient began to experience swelling, redness and bruising at the injection site along with a rash that extended from the patient's arm down to her wrist. No treatment was given due to the adverse events. The patient did not seek the medical attention. The outcome of the events was reported as recovering (reported as "were getting better"). The reporter did not provide the causality assessment between the events and the suspect vaccines. Additional information has been requested.