chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 61 year old female patient, who was reporting on herself. The patient's medical history included migraines and four previous cases of shingles (unknown dates), prior to the patient ever being vaccinated with ZOSTAVAX. The patient also had unspecified food allergies. In August 2016, the patient was vaccinated with ZOSTAVAX injection, via subcutaneous route (dose, route and site of administration, lot number and expiration date were not reported) for prevention of shingles. Concomitant therapies included metoprolol. On 24-MAY-2017, reported as 2 days ago, the patient developed shingles. When the patient realized that she had shingles, she sought medical attention with a physician assistant. In response to the patient's outbreak of shingles, the physician assistant prescribed valacyclovir hydrochloride to treat the adverse event. No laboratory diagnostics studies were performed and there was no product quality complaint involved. At the time of the report, the patient did not recover from shingles. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. In September 2016 the patient was vaccinated with GARDASIL for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The patient later received GARDASIL 9 intramuscularly (lot number L014198, expiration date 05-SEP-2017) as the second dose of the HPV series, in December 2016. No adverse effects were reported. 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 pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored injection of ZOSTAVAX lot # M042850, expiration date 18-JAN-2018 (strength, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT). The patient's concomitant medication was not reported. On an unspecified date, the ZOSTAVAX was exposed to a temperature ranges between 6° Fahrenheit (F) and 14°F during a time frame of 45 minutes , which was called by a data logger. There was not previous temperature excursion. Adverse effects were not reported. Additional information has been requested. Lot number M042850 is a valid lot number for ZOSTAVAX.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 20 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. The nurse reported that on 10-JUN-2016 and 24-MAR-2017 the patient was vaccinated with first and second doses of GARDASIL 9 (Strength, dose, route of administration, lot # and expiry date was not reported) for prophylaxis. Subsequently on 02-JUN-2017, the patient was vaccinated with third dose of GARDASIL 9 (lot # M034780, expiry date: 15-APR-2018) for prophylaxis. There was no adverse events. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, unspecified patients were administered with improperly stored doses of VARIVAX (lot # L013824, expiry date : 21-APR-2017) (Strength, dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent(STERILE DILUENT MRK) lot # N007550, expiry date : 03-MAY-2018 (Concomitant). Temperature excursion was reported from 15 degrees Fahrenheit (15°F) to 46 degrees Fahrenheit (46°F) for 15 hours. There was no previous temperature excursions. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is 1 of 2 reports from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1706USA002754:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concurrent conditions was reported. On unknown dates, the unspecified patients were vaccinated with an improperly stored doses of M-M-R II lot number # M039913 with expiration date 26-SEP-2018, lot # M022407 with expiry date 02-MAY-2018; dose, route and frequency were not provided) reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 42 minutes. There was previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA011097: US-009507513-1706USA002251:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, unspecified patients were administered with improperly stored doses of ZOSTAVAX (lot # M041511, expiry date : 08-JAN-2018) (Strength, dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent(STERILE DILUENT MRK) lot # N007550, expiry date : 03-MAY-2018 (Concomitant). Temperature excursion was reported from 15 degrees Fahrenheit (15°F) to 46 degrees Fahrenheit (46° F) for 15 hours. There was no previous temperature excursions. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is 1 of 2 reports from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1706USA001348:
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a 12-year-old female patient. There was no information about patient's concomitant medications and pertinent medical history reported. In June 2015, the patient was vaccinated with a dose of VARIVAX reconstituted with the sterile diluent, (dose, route, anatomical location, lot number and expiration date were not reported for both suspects therapies) for prophylaxis. In June 2016, the patient presented to the pharmacy having herpes zoster described as developed shingles (twelve months after received the VARIVAX which was administered at unspecified pediatrician's office). At the time of the report, the patient recovered from the herpes zoster on an unspecified date. The relatedness between the event and therapy with VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Guillain-Barre syndrome
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician) via a Pfizer sales representative. A patient of unspecified age, race, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced Guillain-Barre on an unspecified date. Outcome of event was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient had soreness feeling around the area, redness.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immunisation, Injection site reaction, Pain, Syringe issue, Underdose
Clinical narrative: Upon administration of ZOSTAVAX vaccination, patient stated an increase in pain, which is normal for a vaccination. However, plunger of syringe was difficult to push and, upon discontinuing vaccination partway through, a small white welt was noticed. CDC was contacted for further instruction on how to proceed and, due to less than half of vaccine given, CDC recommended repeat of vaccination. Patient was alright with this recommendation and was revaccinated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Upon administration of ZOSTAVAX vaccination, patient stated an increase in pain, which is normal for a vaccination. However, plunger of syringe was difficult to push and, upon discontinuing vaccination partway through, a small white welt was noticed. CDC was contacted for further instruction on how to proceed and, due to less than half of vaccine given, CDC recommended repeat of vaccination. Patient was alright with this recommendation and was revaccinated.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: She was responsive and coherent, but then would mention an episode was coming on and she would shake for about 1 minute, almost like seizures. When it would stop, she was able to pick up the conversation right where it left off. She had no appearance of an allergic reaction. Upon talking to her, she did mention that this has happened to her in the past and it was unrelated to a vaccine but the doctors were still trying to determine the cause.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Joint swelling
Clinical narrative: Right thigh and right knee swollen, warm to touch, and appears tender to touch.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Redness and inflammation on the upper arm toward under the arm.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest discomfort, Dyspnoea, Tremor
Clinical narrative: Within 5 minutes of administration the patient got short of breath, chest tightness, shakiness and compaints it was hard to breathe. A few minutes later she compained of severe lower back pain like she "could feel the medicine in her kidneys".
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning to an adult patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On 01-JUL-2016, the patient was vaccinated with the first dose number of VAQTA 50/1.0 U/ml (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. Additionally, on 01-AUG-2016, the patient was administered with the booster (second dose number) of VAQTA 50/1.0 U/ml. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 23-MAY-2017, the patients was vaccinated with improperly stored doses of dose of MMRII injection (recombinant human albumin) (lot # M039904, expiry date 26-SEP-218, dose, site and route of administration were not provided). Sterile diluent used for vaccines reconstitution was properly stored. The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 24 hours. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA012844.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. Between 10-MAY-2017 and 16-MAY-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX with lot number M035693 and expiration date on 07-NOV-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 90 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA008472: US-009507513-1705USA014918.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 05-JUN-2017, the patient was vaccinated with PROQUAD (rHA) lot number M029599, expiration date 10-DEC-2017, and with VARIVAX lot number M034583, expiration date 27-JUL-2018 (dose, frequency, lot number and expiration date were not reported) both for prophylaxis. The patient's concomitant medication included STERILE DILUENT. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of an unknown gender who was less than 50 years old. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were not reported) for prophylaxis. No adverse symptoms reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash, Rash erythematous, Skin warm, Tenderness
Clinical narrative: Red rash from around 1&1/2 inches below shoulder to around 1 inch above the crease of the arm at elbow; painful to touch and hot; pain at resting and active states.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Erythema, Irritability, Pyrexia, Skin infection, Swelling
Clinical narrative: Local redness, swelling, tenderness. Refuses to bear weight on leg. Fussy. Fever to 102 deg F. Treated for local skin infection with cephalexin starting 6/8/17.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Tenderness, Weight bearing difficulty
Clinical narrative: Local redness, swelling, tenderness. Refuses to bear weight on leg. Fussy. Fever to 102 deg F. Treated for local skin infection with cephalexin starting 6/8/17.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Intestinal resection, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception requiring bowel resection.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Enema administration, Ileectomy, Intussusception, Surgery, Ultrasound abdomen abnormal
Clinical narrative: Intussusception requiring bowel resection.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Intussusception requiring bowel resection.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out about 5 min after receiving first dose of HPV. Patient was instructed to sit for 15 min, stood up after 5min.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood thyroid stimulating hormone, Full blood count, Metabolic function test, Musculoskeletal stiffness, Neck pain
Clinical narrative: RIGHT SIDED NECK PAIN, TINGLING AT FINGERTIPS 2ND THROUGH 5TH FINGER AND PAIN AND STIFFNESS IN RIGHT FINGERS.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Paraesthesia, X-ray
Clinical narrative: RIGHT SIDED NECK PAIN, TINGLING AT FINGERTIPS 2ND THROUGH 5TH FINGER AND PAIN AND STIFFNESS IN RIGHT FINGERS.
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Started running fever.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Crying
Clinical narrative: Inconsolable crying.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediate redness (measuring approx. 3x2) noted at injection site; no redness or respiratory distress noted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. Between 10-MAY-2017 and 16-MAY-2017, the unspecified patients were vaccinated with improperly stored doses of PROQUAD with lot number M009746 and expiration date on 23-AUG-2017. On 16-MAY-2017, certainly one dose of PROQUAD with lot number L051099 and expiration date on 17-JUN-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. It was reported that on an unspecified date, the vaccines were exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 90 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA014919: US-009507513-1705USA008472.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure fluctuation, Body temperature increased, Serum sickness
Clinical narrative: Patient noted to Dr. as serum sickness with elevated temps and change in blood pressure
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: LOCALIZED REDNESS TO LEFT ARM AT LOCATION OF IMMUNIZATION. AT OFFICE 2 1/2 INCHES LONG BY 3 INCHES WIDE REDNESS WHEN PATIENT LEFT OFFICE.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: At site of Shot leg became swollen, red, hard, warm, redness spreading over time.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Muscle twitching, Tic, Tourette's disorder
Clinical narrative: Physical Tics and vocal Tics Involuntary movements/twitching. Ongoing and has not stopped.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Began with extreme pain, throbbing and burning at site of injection and diffuse pain throughout my shoulder. Pain continued with stiffness in neck since then. Went back to the clinic and they prescribed a steroid pack for 6 days to calm the area. Still having difficulty lifting the shoulder.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Grip strength decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Soreness and pain with some movements in left arm from deltoid/bicep area down to hand. At first I put this off as a side effect of the vaccination, but it never got better! Weakened grip, painful arm movements, painful to carry items, painful to lift, extend and flex. Painful to rotate lower arm.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Feeling hot, Pain, Rash, Swelling
Clinical narrative: Bumps on back of arm, redness and warmth, mild swelling and pain.
Age: 45.0
Sex: F
Vaccine: HEPAB, PPV, TDAP
Symptoms: Chills, Headache, Musculoskeletal stiffness, Pain, Pruritus
Clinical narrative: Patient had a red, raised rash. Complained of itching, stiffness, and soreness. She also stated she had fever, chills, and a headache.
Age: 45.0
Sex: F
Vaccine: HEPAB, PPV, TDAP
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Patient had a red, raised rash. Complained of itching, stiffness, and soreness. She also stated she had fever, chills, and a headache.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Apathy, Biopsy bone marrow, Blood oestrogen decreased, Blood test, Cardiac monitoring
Clinical narrative: Date of last GARDASIL vaccine was noted to be 5/12/2016, however, daughter was given two prior to this on 5/12/2015 and 7/16/2015.  Several months after the second vaccine, daughter began having daily headaches with migraines at times. She lived with these by taking Motrin or Tylenol that did not alleviate the headaches. In November of 2016 her headaches were progressing in severity and she started experiencing fatigue and body aches. Her mood and motivation also declined. An MRI was ordered with normal results. APN started amitriptyline 10 mgs, which was increased to 20 then 30 and finally 40 mgs with no relief.  All these mentioned symptoms continued and in January of this year she began passing out upon standing up and walking.  The first incident resulted in an ER visit which test showed mild dehydration and low platelet levels. We followed up with the pediatrician that following week and physician ordered more tests indicating low platelets.  After a couple of more appointments and blood tests, with no symptom relief, pediatrician had daughter admitted to hospital.  During this hospital stay, results indicated Flu B and low platelets.  An MRI-V was ordered with normal results. Oncologist wanted us to follow up with her to monitor blood counts to see if recovery of flu would result in normal platelet and white blood cell count. After hospital discharged daughter, we followed up with cardiologist, neurologist, gynecologist and oncologist.  Neurologist diagnosed daughter with POTS and increased amitriptyline to 50 mgs, after EEG was normal. Still no relief of headaches. Cardiologist ran EKG and had daughter wear halter monitor of heart. Gynecologist's tests indicated low estrogen which no cyst on ovaries and is now ordering an MRI to look at pituitary gland.  Daughter had bone marrow biopsy on June 6, 2017 and has now been diagnosed with ITP.  She continues to suffer daily with headaches, irritability, hypersensitivity, body aches, fatigue and low platelets.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram normal
Clinical narrative: Date of last GARDASIL vaccine was noted to be 5/12/2016, however, daughter was given two prior to this on 5/12/2015 and 7/16/2015.  Several months after the second vaccine, daughter began having daily headaches with migraines at times. She lived with these by taking Motrin or Tylenol that did not alleviate the headaches. In November of 2016 her headaches were progressing in severity and she started experiencing fatigue and body aches. Her mood and motivation also declined. An MRI was ordered with normal results. APN started amitriptyline 10 mgs, which was increased to 20 then 30 and finally 40 mgs with no relief.  All these mentioned symptoms continued and in January of this year she began passing out upon standing up and walking.  The first incident resulted in an ER visit which test showed mild dehydration and low platelet levels. We followed up with the pediatrician that following week and physician ordered more tests indicating low platelets.  After a couple of more appointments and blood tests, with no symptom relief, pediatrician had daughter admitted to hospital.  During this hospital stay, results indicated Flu B and low platelets.  An MRI-V was ordered with normal results. Oncologist wanted us to follow up with her to monitor blood counts to see if recovery of flu would result in normal platelet and white blood cell count. After hospital discharged daughter, we followed up with cardiologist, neurologist, gynecologist and oncologist.  Neurologist diagnosed daughter with POTS and increased amitriptyline to 50 mgs, after EEG was normal. Still no relief of headaches. Cardiologist ran EKG and had daughter wear halter monitor of heart. Gynecologist's tests indicated low estrogen which no cyst on ovaries and is now ordering an MRI to look at pituitary gland.  Daughter had bone marrow biopsy on June 6, 2017 and has now been diagnosed with ITP.  She continues to suffer daily with headaches, irritability, hypersensitivity, body aches, fatigue and low platelets.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Hypersensitivity, Immune thrombocytopenic purpura, Inappropriate schedule of drug administration
Clinical narrative: Date of last GARDASIL vaccine was noted to be 5/12/2016, however, daughter was given two prior to this on 5/12/2015 and 7/16/2015.  Several months after the second vaccine, daughter began having daily headaches with migraines at times. She lived with these by taking Motrin or Tylenol that did not alleviate the headaches. In November of 2016 her headaches were progressing in severity and she started experiencing fatigue and body aches. Her mood and motivation also declined. An MRI was ordered with normal results. APN started amitriptyline 10 mgs, which was increased to 20 then 30 and finally 40 mgs with no relief.  All these mentioned symptoms continued and in January of this year she began passing out upon standing up and walking.  The first incident resulted in an ER visit which test showed mild dehydration and low platelet levels. We followed up with the pediatrician that following week and physician ordered more tests indicating low platelets.  After a couple of more appointments and blood tests, with no symptom relief, pediatrician had daughter admitted to hospital.  During this hospital stay, results indicated Flu B and low platelets.  An MRI-V was ordered with normal results. Oncologist wanted us to follow up with her to monitor blood counts to see if recovery of flu would result in normal platelet and white blood cell count. After hospital discharged daughter, we followed up with cardiologist, neurologist, gynecologist and oncologist.  Neurologist diagnosed daughter with POTS and increased amitriptyline to 50 mgs, after EEG was normal. Still no relief of headaches. Cardiologist ran EKG and had daughter wear halter monitor of heart. Gynecologist's tests indicated low estrogen which no cyst on ovaries and is now ordering an MRI to look at pituitary gland.  Daughter had bone marrow biopsy on June 6, 2017 and has now been diagnosed with ITP.  She continues to suffer daily with headaches, irritability, hypersensitivity, body aches, fatigue and low platelets.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza B virus test positive, Irritability, Loss of consciousness, Migraine, Mood altered
Clinical narrative: Date of last GARDASIL vaccine was noted to be 5/12/2016, however, daughter was given two prior to this on 5/12/2015 and 7/16/2015.  Several months after the second vaccine, daughter began having daily headaches with migraines at times. She lived with these by taking Motrin or Tylenol that did not alleviate the headaches. In November of 2016 her headaches were progressing in severity and she started experiencing fatigue and body aches. Her mood and motivation also declined. An MRI was ordered with normal results. APN started amitriptyline 10 mgs, which was increased to 20 then 30 and finally 40 mgs with no relief.  All these mentioned symptoms continued and in January of this year she began passing out upon standing up and walking.  The first incident resulted in an ER visit which test showed mild dehydration and low platelet levels. We followed up with the pediatrician that following week and physician ordered more tests indicating low platelets.  After a couple of more appointments and blood tests, with no symptom relief, pediatrician had daughter admitted to hospital.  During this hospital stay, results indicated Flu B and low platelets.  An MRI-V was ordered with normal results. Oncologist wanted us to follow up with her to monitor blood counts to see if recovery of flu would result in normal platelet and white blood cell count. After hospital discharged daughter, we followed up with cardiologist, neurologist, gynecologist and oncologist.  Neurologist diagnosed daughter with POTS and increased amitriptyline to 50 mgs, after EEG was normal. Still no relief of headaches. Cardiologist ran EKG and had daughter wear halter monitor of heart. Gynecologist's tests indicated low estrogen which no cyst on ovaries and is now ordering an MRI to look at pituitary gland.  Daughter had bone marrow biopsy on June 6, 2017 and has now been diagnosed with ITP.  She continues to suffer daily with headaches, irritability, hypersensitivity, body aches, fatigue and low platelets.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Pain, Platelet count decreased, Postural orthostatic tachycardia syndrome, Ultrasound pelvis
Clinical narrative: Date of last GARDASIL vaccine was noted to be 5/12/2016, however, daughter was given two prior to this on 5/12/2015 and 7/16/2015.  Several months after the second vaccine, daughter began having daily headaches with migraines at times. She lived with these by taking Motrin or Tylenol that did not alleviate the headaches. In November of 2016 her headaches were progressing in severity and she started experiencing fatigue and body aches. Her mood and motivation also declined. An MRI was ordered with normal results. APN started amitriptyline 10 mgs, which was increased to 20 then 30 and finally 40 mgs with no relief.  All these mentioned symptoms continued and in January of this year she began passing out upon standing up and walking.  The first incident resulted in an ER visit which test showed mild dehydration and low platelet levels. We followed up with the pediatrician that following week and physician ordered more tests indicating low platelets.  After a couple of more appointments and blood tests, with no symptom relief, pediatrician had daughter admitted to hospital.  During this hospital stay, results indicated Flu B and low platelets.  An MRI-V was ordered with normal results. Oncologist wanted us to follow up with her to monitor blood counts to see if recovery of flu would result in normal platelet and white blood cell count. After hospital discharged daughter, we followed up with cardiologist, neurologist, gynecologist and oncologist.  Neurologist diagnosed daughter with POTS and increased amitriptyline to 50 mgs, after EEG was normal. Still no relief of headaches. Cardiologist ran EKG and had daughter wear halter monitor of heart. Gynecologist's tests indicated low estrogen which no cyst on ovaries and is now ordering an MRI to look at pituitary gland.  Daughter had bone marrow biopsy on June 6, 2017 and has now been diagnosed with ITP.  She continues to suffer daily with headaches, irritability, hypersensitivity, body aches, fatigue and low platelets.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Contusion, Fatigue, Mood altered, Swelling
Clinical narrative: Extreme tiredness, moody, extreme  swelling and bruising.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Joint swelling, Oedema peripheral, Peripheral swelling, Pruritus generalised, Rash
Clinical narrative: My legs /ankles started to swell. My body started to itch, particularly my legs and arms and middle around my waist and slightly higher. I got a rash. I took Benedryl every 4 hours starting around 7:45 pm on June 6th to present/ continuing to take.  I also took an extra Lasix (which was already prescribed for water in my legs.)  I also washed my legs, arms, middle in case there was some other allergen that had nothing to do with the shot and applied generic anti-itch cream every few hours.  The rash is going away.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Immediate pain that persisted and worsened for 6 days. Pain began at injection site and moved down to elbow and wrist over 3-4 days and then resolved. Diffuse swelling of upper arm noted 2 days after injection and still persists one week later although improved. Erythematous papule of injection site measuring 2mm. Erythematous areas of 7.6cm (width) by 11.7cm (length) distal to injections site measured 3 days after injection with warmth. Resolved on own 2 days later. Both pain and redness resolved 6 days after injection but on Day 8 still with mild upper arm swelling. No treatment given just monitored.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site warmth, Rash papular
Clinical narrative: Immediate pain that persisted and worsened for 6 days. Pain began at injection site and moved down to elbow and wrist over 3-4 days and then resolved. Diffuse swelling of upper arm noted 2 days after injection and still persists one week later although improved. Erythematous papule of injection site measuring 2mm. Erythematous areas of 7.6cm (width) by 11.7cm (length) distal to injections site measured 3 days after injection with warmth. Resolved on own 2 days later. Both pain and redness resolved 6 days after injection but on Day 8 still with mild upper arm swelling. No treatment given just monitored.
Age: 55.0
Sex: F
Vaccine: HPV2, MEN
Symptoms: Abscess, Cerebral disorder, Cough, Deafness unilateral, Ear pain
Clinical narrative: Sneezing, sore throat, headache, body aches, phlegmy cough, earache, sinus pain, fever.
Age: 55.0
Sex: F
Vaccine: HPV2, MEN
Symptoms: Headache, Hypotension, Mastoiditis, Oral fungal infection, Oropharyngeal pain
Clinical narrative: Sneezing, sore throat, headache, body aches, phlegmy cough, earache, sinus pain, fever.
Age: 55.0
Sex: F
Vaccine: HPV2, MEN
Symptoms: Pain, Pneumococcal infection, Productive cough, Pyrexia, Sepsis
Clinical narrative: Sneezing, sore throat, headache, body aches, phlegmy cough, earache, sinus pain, fever.
Age: 55.0
Sex: F
Vaccine: HPV2, MEN
Symptoms: Sinus pain, Sneezing, Thrombosis
Clinical narrative: Sneezing, sore throat, headache, body aches, phlegmy cough, earache, sinus pain, fever.
Age: 77.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypoaesthesia
Clinical narrative: Patient received vaccination on 3/21/17 at PCP clinic visit. He called nurse on 5/3/17 about supplies and reported that he experienced numbness on the right side of his face for approx 3 weeks following administration of immunization.
Age: 67.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Patient given SOLUMEDROL IM x 1 after developing rash following administration of zoster vaccine; also given prednisone dosepack.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to inj site - ADVIL relieved discomfort- cold pack to site 3-4xa day for couple days- RTC if not resolved.
Age: 26.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Eye swelling, Hypersensitivity, Urticaria
Clinical narrative: Pt. reported having an allergic reaction (eyes are swollen and later scattered hives). She received Hep A and YF AM and took one oral typhoid 2:30 pm on 6/6/17. She had taken BENADRYL, which helped.
Sex: U
Vaccine: MENB
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain, injection site mass, injection site induration and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site mass, injection site induration and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, injection site mass, injection site induration and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The health care professional had limited information. No patient or product information was reported. It was stated that there was three patients involved but no more information provided. This was one of the 3 cases reported by same reporter.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Laboratory test normal, Pain in extremity, X-ray limb
Clinical narrative: Had a TDaP vaccination. I went for my 6 month check-up at the Clinic on April 13th, 2017. The doctor's assistant ask me if I had ever received a Whooping Cough vaccination, I told her if I had I would have been so young that I couldn't remember! She told me Whooping Cough was going around and ask if I would like to have the vaccination? I thought about it and felt it might be better to be sure, so I received a Tdap Shot. My arm was sore after that, but I thought this was just normal. However, the pain kept getting worse and is almost unbearable at times. I called the Clinic about this, and a Nurse Practitioner had me come over to the clinic on May 9th, 2017. At that time they took an X-ray and told me to put ice pack and heat on my shoulder and gave me prescription for Diclofenac Gel, this did not help the pain. On May 16th, 2017 I went to our family doctor. She suggested heat pads and lined me up to start Re-hab. I am now doing Re-hab to see if that will help the pain, but as of today the pain is still as bad if not Worse!!!
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Dumping syndrome, Flatulence, Idiosyncratic drug reaction, Impaired work ability
Clinical narrative: Dump syndrome with recurrent flu vaccine x 3.  Interview with ER RN and review of medical records identified the following: He was seen on 11/10/2010 by Allergy Dept for report of 1999 flu shot reaction where he reported 6 hours later developing gas and a dumping syndrome reaction. He advised in 2000 he received another flu vaccine and again had reoccurrence of dumping syndrome requiring rehydration at nearby hospital. He has not received a flu shot since. He denied any rash, angioedema, headaches, myalgia/arthralgia, hives, or anaphylactic like symptoms. During his 11/10/2010 visit to allergy clinic, he received AFLURIA flu vaccine (lot # M54209) to his left arm. He and records advised he had no immediate reactions but later that evening (greater than 5hr) he was in a ER for IVF/rehydration and potassium replacement due to sudden onset of massive nausea and diarrhea. He reported it took 2 days for him to recover and was out of work. He advised he has an ileostomy bag due to prior intestinal surgery, and the sudden massive amount of fluid loss disconnected his ileostomy bag. On 11/10/2010 he was diagnosed with "idiosyncratic reaction to drug and was advised history was not consistent with an IgE mediated hypersensitivity and that providers were unclear as to why a flu shot would cause a dumping syndrome type of reaction". On 10/15/2010 providers documented he called back 6 hours later to report reoccurrence of dump syndrome and they recommended a permanent exemption from flu based on 3rd occurrence of this reaction. He advised other activities can also cause a dump like syndrome to include over-exertion, martial arts competition, and illnesses. He does hydrate prior to/after exercise and treats illness symptomatically.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: Dump syndrome with recurrent flu vaccine x 3.  Interview with ER RN and review of medical records identified the following: He was seen on 11/10/2010 by Allergy Dept for report of 1999 flu shot reaction where he reported 6 hours later developing gas and a dumping syndrome reaction. He advised in 2000 he received another flu vaccine and again had reoccurrence of dumping syndrome requiring rehydration at nearby hospital. He has not received a flu shot since. He denied any rash, angioedema, headaches, myalgia/arthralgia, hives, or anaphylactic like symptoms. During his 11/10/2010 visit to allergy clinic, he received AFLURIA flu vaccine (lot # M54209) to his left arm. He and records advised he had no immediate reactions but later that evening (greater than 5hr) he was in a ER for IVF/rehydration and potassium replacement due to sudden onset of massive nausea and diarrhea. He reported it took 2 days for him to recover and was out of work. He advised he has an ileostomy bag due to prior intestinal surgery, and the sudden massive amount of fluid loss disconnected his ileostomy bag. On 11/10/2010 he was diagnosed with "idiosyncratic reaction to drug and was advised history was not consistent with an IgE mediated hypersensitivity and that providers were unclear as to why a flu shot would cause a dumping syndrome type of reaction". On 10/15/2010 providers documented he called back 6 hours later to report reoccurrence of dump syndrome and they recommended a permanent exemption from flu based on 3rd occurrence of this reaction. He advised other activities can also cause a dump like syndrome to include over-exertion, martial arts competition, and illnesses. He does hydrate prior to/after exercise and treats illness symptomatically.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash, Rash generalised, Rash papular, Urticaria
Clinical narrative: Hives after 2013-2015 flu vaccination: reported receipt of injectable (IM) flu vaccines in 2013 and 2015 with onset of hives few hours later lasting 1-3 days but has not had reactions with intranasal influenza. Review of past reactions: Flu vaccine by PMC/Sanofi (FLUZONE) Lot # UH899AE was given alone on 31 Oct 2013. She advised onset total body itching with scattered outbreaks of mosquito bite like bumps everywhere and hives. Medic advised use of BENADRYL with resolution of all symptoms within a few days. On 15 Oct 2015 she received CSL Lot U56506 (AFLURIA) and again experienced repeat of 2013 reaction of hives and generalized itching allover. She was evaluated on 19 Oct 2015 (see note) where providers reported 5 day Hx of hives that move about on her legs/hands that were not resolving with BENADRYL. She was treated with IM SOLUMEDROL 125mg, and released with oral CLARITIN and topical steroid creams. Providers documented small papular rash to both thighs with raised welts otherwise normal exam. She advised the reaction resolved within a few days and has not reoccurred. She denied any new food groups, detergents, deodorants, clothing, or any other systemic reactions such as angioedema, difficulty breathing, site reactions, headaches, myalgia, arthralgia, et al with either reaction or prior to/after each reaction. Given flu vaccine (AFLURIA) Lot WT58908 Trivalent flu vaccine 11/18/2016 at allergy clinic with no adverse reaction.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adolescent female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO vaccine on an unknown arm. The age at vaccination was not reported. The patient experienced arm pain on the injected arm. Limited information was provided by the sale representative from the nurse practitioner.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received HAVRIX 1440 (batch number 9927T, expiry date unknown). On 30th May 2017, the patient received the 2nd dose of HAVRIX 1440 (subcutaneous) 1 ml. On 30th May 2017, immediately after receiving HAVRIX 1440, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain to be related to HAVRIX 1440. Additional details were reported as follows: The patient received HAVRIX on left arm. The patient reported that the HAVRIX was inadvertently administered via subcutaneous route instead of intramuscular route, which led to inappropriate route of vaccination. The patient experienced injection hurt during administration. The patient planned to follow-up with her physician on an unknown date. The expiration date of the vaccine administered was not provided.