chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Diarrhoea, Influenza like illness, Pain
Clinical narrative: This spontaneous report was received from a 50 year old female consumer referring to herself. The patient did not have pertinent medical history nor drug reactions/allergies. On 02-MAR-2016, the patient was vaccinated with one dose of ZOSTAVAX, subcutaneously, lot # L039094, expiration date 08-JAN-2016, for prevention of shingles. The patient was not taking concomitant medication. On 03-MAR-2016, the patient experienced achiness (pain) after receiving ZOSTAVAX. The following day, on 04-MAR-2016, the patient experienced flu-like symptoms which included: chills, fever diarrhea, coughing and congestion (influenza like illness). The patient seek medical attention by an office visit but, no treatment was given and lab diagnostics studies were not performed. At the time of reporting, the outcome of pain and influenza like illness was recovering. The reporter did not assess the relatedness from pain and influenza like illness to ZOSTAVAX. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a 50 year old female consumer referring to herself. The patient did not have pertinent medical history nor drug reactions/allergies. On 02-MAR-2016, the patient was vaccinated with one dose of ZOSTAVAX, subcutaneously, lot # L039094, expiration date 08-JAN-2016, for prevention of shingles. The patient was not taking concomitant medication. On 03-MAR-2016, the patient experienced achiness (pain) after receiving ZOSTAVAX. The following day, on 04-MAR-2016, the patient experienced flu-like symptoms which included: chills, fever diarrhea, coughing and congestion (influenza like illness). The patient seek medical attention by an office visit but, no treatment was given and lab diagnostics studies were not performed. At the time of reporting, the outcome of pain and influenza like illness was recovering. The reporter did not assess the relatedness from pain and influenza like illness to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report ass received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 23-MAR-2013, the patient was administered simultaneously a dose of PROQUAD (Merck) (lot number L046507 and expiration date 17-MAY-2017, dose and route of administration were not reported) and VARIVAX (Merck) (dose, route of administration, lot number and expiration dare were not reported). No adverse events were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to multiple unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (exact dose and route od administration were not reported, lot # L048237 with expiration date: 08-MAY_2017). The administered doses experienced a temperature excursion of 30 degrees Fahrenheit for 7 hours. No previous temperature excursion was reported. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to multiple unspecified patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (exact dose and route of administration were not reported, lot # L023232 with expiration date: 25-FEB-2017). The administered doses experienced a temperature excursion of 30 degrees Fahrenheit for 7 hours. No previous temperature excursion was reported. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Acarodermatitis, Papule
Clinical narrative: This spontaneous report was received from a nurse and refers to a 69 year old male patient with chronic kidney disease. On 11-FEB-2016, the patient was vaccinated with ZOSTAVAX in the right arm (exact dose, route of administration, lot # and expiration date were not reported). Other suspect vaccine received on 11-FEB-2016, included DTaP (unspecified), tetanus toxoid, in left arm (exact dose, route of administration, lot # and expiration date were not reported). The patient was vaccinated at local pharmacy. There were no concomitant medications provided. On approximately 25-FEB-2016 (reported as "two weeks later"), the patient was seen in clinic by a physician assistant for bilateral upper extremities papules. The patient was diagnosed with scabies and he received unspecified treatment. The outcome of the event was unknown. The relatedness between the scabies and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event, X-ray
Clinical narrative: None stated.
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 02-MAR-2016, the patient was vaccinated with a dose of PROQUAD (Merck), lot number K010796, expiration date 04-FEB-2016, subcutaneous. Concomitant therapy information was not provided. On 02-MAR-2016, an expired product was administered as the patient was administered an expired dose of PROQUAD (Merck). No adverse event was reported. The outcome of expired product administered and no adverse event was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Chicken pox-like rash after receiving vaccine. No fever, no treatment required.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal pain, Myositis, Ultrasound scan normal
Clinical narrative: Shoulder pain, difficulty raising arm, muscle mildly inflamed, ultrasound negative for hematoma or fluid.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Balance disorder, Chills, Dizziness, Gait disturbance, Injection site erythema
Clinical narrative: On 3/26/16, patient left arm felt pain, Sunday, 3/27/16, the vaccination site was red, swollen and hard. Patient placed ice-pack and took 2 TYLENOL tablets and felt better. In the afternoon, patient felt dizzy, wobbly, face was red, chills and off balance. Sunday night soaked wet with sweat. Felt better with time.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Night sweats, Pain in extremity, Vaccination site induration, Vaccination site swelling
Clinical narrative: On 3/26/16, patient left arm felt pain, Sunday, 3/27/16, the vaccination site was red, swollen and hard. Patient placed ice-pack and took 2 TYLENOL tablets and felt better. In the afternoon, patient felt dizzy, wobbly, face was red, chills and off balance. Sunday night soaked wet with sweat. Felt better with time.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Full blood count, Liver function test, Lymphocyte count decreased, Lymphocyte morphology abnormal
Clinical narrative: ENGERIX 20 mc gm IM on 3-28 - within 3 hrs chills, nausea, vomiting occurred. Re seen 3/29 at same facility. Lab work drawn. IV hydration - ZOFRAN 4 mgm IV. No fever.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Metabolic function test, Nausea, Neutrophil count increased, Vomiting
Clinical narrative: ENGERIX 20 mc gm IM on 3-28 - within 3 hrs chills, nausea, vomiting occurred. Re seen 3/29 at same facility. Lab work drawn. IV hydration - ZOFRAN 4 mgm IV. No fever.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Blister, Macule, Scab
Clinical narrative: Multiple vesicles and macules with some crusted.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain, Hypersensitivity, Urticaria
Clinical narrative: Pt given PREVNAR vaccine - indication age > 65. 3 days later developed urticarial abdominal pain no anaphylaxis - went to ER improved with steroid injection. Diagnosed as allergic reaction - steroid taper, BENADRYL given no other obvious cause of allergic reaction noted.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Chronic tic disorder, Condition aggravated, Joint swelling, Neurological symptom, Oropharyngeal pain
Clinical narrative: Severe sensory integration issues/defensiveness leading to patient manually removing his orthodontia/braces, and sharp exacerbation in neuro-motor tics.  Patient subsequently developed a persistent sore throat with negative strep culture by throat swab.  12/2013 patient's neuromotor tics continued and vocal tics began.   He experienced knee and finger joint swelling.  His strep titre was positive (>800) and he was treated with antibiotics.  His sharply increased neurological symptoms persisted for several months, and the joint swelling recurred several times.  His strep titre subsequently dropped to "normal".
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Peripheral swelling, Sensory integrative dysfunction, Streptococcus test positive
Clinical narrative: Severe sensory integration issues/defensiveness leading to patient manually removing his orthodontia/braces, and sharp exacerbation in neuro-motor tics.  Patient subsequently developed a persistent sore throat with negative strep culture by throat swab.  12/2013 patient's neuromotor tics continued and vocal tics began.   He experienced knee and finger joint swelling.  His strep titre was positive (>800) and he was treated with antibiotics.  His sharply increased neurological symptoms persisted for several months, and the joint swelling recurred several times.  His strep titre subsequently dropped to "normal".
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching and pain left upper arm around injection site.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Activities of daily living impaired, Injection site pain, Pain
Clinical narrative: Extreme pain at injection site and anterior to injection site. Unable to move arm without pain. Unable to perform ADLs days later - seen in office on 3/29/16 with extreme pain. Unable to swim (she is a swimmer).
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Headache, Immediate post-injection reaction, Musculoskeletal stiffness, Paraesthesia, Photophobia
Clinical narrative: Client described headache that started immediately, light sensitivity in Right eye; on 3/28/2016 started experiencing stiff neck and "pin prick feeling" in fingers and lips.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt states that injection arm is painful and hard to move. Also states she started ibuprofen and a pain patch that she already had at home.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Patient was inadvertently given an adult dose of Hepatitis A vaccine instead of a pediatric dose.
Age: 39.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Injection site pain, Malaise, Pyrexia, Sleep disorder
Clinical narrative: My arm where I received the injection hurt badly.  It grew worse throughout the day.  That night my arm hurt so badly that I couldn't sleep. It woke me from my sleep and I had to take pain killers to make it bearable to sleep.  The next day I felt ill, had low grade fever and was not feeling like doing anything.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Patient was mistakenly administered a Prevnar 13 vaccine instead of Pneumovax 23.  Nothing adverse occurred, just a medication error and vaccince given to a patient not age appropriate and for an approved reason.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Electrocardiogram normal, Erythema, Injury, Laboratory test normal, Neurological examination
Clinical narrative: Syncopal episode with injuries sustained; spot redness to face, neck and behind ears.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Syncopal episode with injuries sustained; spot redness to face, neck and behind ears.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node at base of skull in line with my left ear. Painful to the touch, approx. the size of a marble and lasted about a week and a half to two weeks.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Knot, sore & itchy at site of admin (left deltoid).
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Eczema
Clinical narrative: Severe eczema.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Exposure during pregnancy, Feeling abnormal, Loss of consciousness
Clinical narrative: I received the flu vaccine from my OB/gyn and drove across the street to pick up a prescription at pharmacy. When I was in line to pay, approximately 15 minutes after receiving the vaccine, I felt odd, everything started to get fuzzy and dark and I woke up to the cashier helping me up. The ambulance was called because I was pregnant and my BP and blood sugar levels were checked which came back normal. I was released and notified my OB/Gyn of the reaction.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a office manager via a company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of GARDASIL (dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from healthcare professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-MAR-2016, the patient was vaccinated with a dose of improperly stored MMR II lot # L019989, expiration date: 01-JUN-2017, (dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. Also was reported that the temperature excursion was 15 C, the time frame of the excursion was 4 hours, and that the vaccine had not had a previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker, referring to unspecified number of patients of unknown ages and genders. Medical history or concurrent conditions were not reported. Since on unknown date, the patients received improperly stored dose of (Oka/Merck) VARIVAX (lot # L029466, expiration date 06-AUG-2017, Lot # L035128 expiration date 14-SEP-2017) (strength, dose and route were not provided). Concomitant medication was not provided and no adverse effects were reported. It was also reported that temperature was 6 F, time frame was 10 minutes, there was not a product complaint involved and there was not previous temperature excursion. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Shot given 3/24/16 called 3/27/16 and said a little swollen called pt 3/25/16 said deltoid between red and pink- is swollen.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from healthcare professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-MAR-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L03106, expiration date: 18-AUG-2017, (dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. Also was reported that the time frame of the excursion of VARIVAX (Merck) was 4 hours and the vaccine had not had a previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a certified medical assistant via a company representative referring to an 11 year old non-pregnant female patient. The patient did not have concurrent conditions, drug reactions, allergies and medical history. On 08-MAR-2016, the patient was vaccinated with her third dose of GARDASIL 9 lot # L045711, expiration date 08-MAY-2017 (route, dose and anatomical place of vaccination were not reported). The patient did not take concomitant medications and was unspecified when the patient received the previous two doses of GARDASIL 9 series. On an unspecified date between 08 and 09-MAR-2016, the patient developed a widespread rash on an unspecified location of the body. On 10-MAR-2016, the patient sought for medical attention and was seen by a nurses practitioner who prescribed "BENADRYL" every six hours until the resolution of the rash. There was no intervention to prevent serious criteria, the event was not cancer or overdose, the patient did not die nor the experience was life-threatening, there were no significant disability or incapacity, no hospitalization and no product quality complaint was involved. At the time of the report, the outcome of rash generalized was unknown. The reporter did not provide a causality assessment. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mass, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching, lump.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abasia, Rash, Wheelchair user
Clinical narrative: This spontaneous report as received from a consumer (patient's husband) refers to a 68 year old female patient. The patient's pertinent medical history and drug reaction/allergies were none. On 17-JUN-2014, the patient was vaccinated with ZOSTAVAX, (lot number, expiration date unspecified, route reported as injection, dose/frequency reported as directed). Concomitant medication was none. The patient developed a breakout that looked like chickenpox between 20-JUN-2014 and 22-JUN-2014. The patient visited office for seeking medical attention. The patient was still itching and stated that the unspecified salve that she was prescribed as a treatment was not working to address the itching. No diagnostics studies were performed. At the time of reporting, the patient was not recovered from the events. Follow-up information has been received on 29-MAR-2016 in the form of a letter from a consumer concerning his wife. On 17-JUN-2014 the patient received ZOSTAVAX at a local pharmacy. The vaccine was given on the same day that a nurse practitioner gave the patient amoxicillin and AUGMENTIN for an unspecified infection. The result was a rash all over her body. The patient was treated with methotrexate for the severe skin issue. The skin rash was so severe the patient was directed to the emergency room. Prior to 17-JUN-2014 the patient could walk. After the administration of ZOSTAVAX, the patient was no longer able to walk and was confined to a wheelchair. At the time of this letter, the patient continued to be unable to walk and was still confined to a wheelchair. A college professor at a local university felt that the "shingles shot was the root cause of her nerve issues". According to the professor, " the chicken pox virus hides down by the nerves and the sheathing of the nerves". The consumer reported that according to numerous medical professionals, "the shingles shot should have never been administered to my wife being treated for an infection in another area". "The result to my wife and myself have been tragic. She can no longer walk due to an attack on her nerves in her legs in a proximal area". The event of nerve issues/patient no longer able to walk and was confined to a wheelchair is considered disabling. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abasia, Nerve injury, Pruritus, Rash generalised, Rash vesicular
Clinical narrative: This spontaneous report as received from a consumer (patient's husband) refers to a 68 year old female patient. The patient's pertinent medical history and drug reaction/allergies were none. On 17-JUN-2014, the patient was vaccinated with ZOSTAVAX, (lot number, expiration date unspecified, route reported as injection, dose/frequency reported as directed). Concomitant medication was none. The patient developed a breakout that looked like chickenpox between 20-JUN-2014 and 22-JUN-2014. The patient visited office for seeking medical attention. The patient was still itching and stated that the unspecified salve that she was prescribed as a treatment was not working to address the itching. No diagnostics studies were performed. At the time of reporting, the patient was not recovered from the events. Follow-up information has been received on 29-MAR-2016 in the form of a letter from a consumer concerning his wife. On 17-JUN-2014 the patient received ZOSTAVAX at a local pharmacy. The vaccine was given on the same day that a nurse practitioner gave the patient amoxicillin and AUGMENTIN for an unspecified infection. The result was a rash all over her body. The patient was treated with methotrexate for the severe skin issue. The skin rash was so severe the patient was directed to the emergency room. Prior to 17-JUN-2014 the patient could walk. After the administration of ZOSTAVAX, the patient was no longer able to walk and was confined to a wheelchair. At the time of this letter, the patient continued to be unable to walk and was still confined to a wheelchair. A college professor at a local university felt that the "shingles shot was the root cause of her nerve issues". According to the professor, " the chicken pox virus hides down by the nerves and the sheathing of the nerves". The consumer reported that according to numerous medical professionals, "the shingles shot should have never been administered to my wife being treated for an infection in another area". "The result to my wife and myself have been tragic. She can no longer walk due to an attack on her nerves in her legs in a proximal area". The event of nerve issues/patient no longer able to walk and was confined to a wheelchair is considered disabling. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Wheelchair user
Clinical narrative: This spontaneous report as received from a consumer (patient's husband) refers to a 68 year old female patient. The patient's pertinent medical history and drug reaction/allergies were none. On 17-JUN-2014, the patient was vaccinated with ZOSTAVAX, (lot number, expiration date unspecified, route reported as injection, dose/frequency reported as directed). Concomitant medication was none. The patient developed a breakout that looked like chickenpox between 20-JUN-2014 and 22-JUN-2014. The patient visited office for seeking medical attention. The patient was still itching and stated that the unspecified salve that she was prescribed as a treatment was not working to address the itching. No diagnostics studies were performed. At the time of reporting, the patient was not recovered from the events. Follow-up information has been received on 29-MAR-2016 in the form of a letter from a consumer concerning his wife. On 17-JUN-2014 the patient received ZOSTAVAX at a local pharmacy. The vaccine was given on the same day that a nurse practitioner gave the patient amoxicillin and AUGMENTIN for an unspecified infection. The result was a rash all over her body. The patient was treated with methotrexate for the severe skin issue. The skin rash was so severe the patient was directed to the emergency room. Prior to 17-JUN-2014 the patient could walk. After the administration of ZOSTAVAX, the patient was no longer able to walk and was confined to a wheelchair. At the time of this letter, the patient continued to be unable to walk and was still confined to a wheelchair. A college professor at a local university felt that the "shingles shot was the root cause of her nerve issues". According to the professor, " the chicken pox virus hides down by the nerves and the sheathing of the nerves". The consumer reported that according to numerous medical professionals, "the shingles shot should have never been administered to my wife being treated for an infection in another area". "The result to my wife and myself have been tragic. She can no longer walk due to an attack on her nerves in her legs in a proximal area". The event of nerve issues/patient no longer able to walk and was confined to a wheelchair is considered disabling. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abasia, Laboratory test normal, Nerve injury, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer (patient's husband) refers to a 68 year old female patient. The patient's pertinent medical history and drug reaction/allergies were none. On 17-JUN-2014, the patient was vaccinated with ZOSTAVAX, (lot number, expiration date unspecified, route reported as injection, dose/frequency reported as directed). Concomitant medication was none. The patient developed a breakout that looked like chickenpox between 20-JUN-2014 and 22-JUN-2014. The patient visited office for seeking medical attention. The patient was still itching and stated that the unspecified salve that she was prescribed as a treatment was not working to address the itching. No diagnostics studies were performed. At the time of reporting, the patient was not recovered from the events. Follow-up information has been received on 29-MAR-2016 in the form of a letter from a consumer concerning his wife. On 17-JUN-2014 the patient received ZOSTAVAX at a local pharmacy. The vaccine was given on the same day that a nurse practitioner gave the patient amoxicillin and AUGMENTIN for an unspecified infection. The result was a rash all over her body. The patient was treated with methotrexate for the severe skin issue. The skin rash was so severe the patient was directed to the emergency room. Prior to 17-JUN-2014 the patient could walk. After the administration of ZOSTAVAX, the patient was no longer able to walk and was confined to a wheelchair. At the time of this letter, the patient continued to be unable to walk and was still confined to a wheelchair. A college professor at a local university felt that the "shingles shot was the root cause of her nerve issues". According to the professor, " the chicken pox virus hides down by the nerves and the sheathing of the nerves". The consumer reported that according to numerous medical professionals, "the shingles shot should have never been administered to my wife being treated for an infection in another area". "The result to my wife and myself have been tragic. She can no longer walk due to an attack on her nerves in her legs in a proximal area". The event of nerve issues/patient no longer able to walk and was confined to a wheelchair is considered disabling. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash generalised, Skin disorder, Weight decreased, Wheelchair user
Clinical narrative: This spontaneous report as received from a consumer (patient's husband) refers to a 68 year old female patient. The patient's pertinent medical history and drug reaction/allergies were none. On 17-JUN-2014, the patient was vaccinated with ZOSTAVAX, (lot number, expiration date unspecified, route reported as injection, dose/frequency reported as directed). Concomitant medication was none. The patient developed a breakout that looked like chickenpox between 20-JUN-2014 and 22-JUN-2014. The patient visited office for seeking medical attention. The patient was still itching and stated that the unspecified salve that she was prescribed as a treatment was not working to address the itching. No diagnostics studies were performed. At the time of reporting, the patient was not recovered from the events. Follow-up information has been received on 29-MAR-2016 in the form of a letter from a consumer concerning his wife. On 17-JUN-2014 the patient received ZOSTAVAX at a local pharmacy. The vaccine was given on the same day that a nurse practitioner gave the patient amoxicillin and AUGMENTIN for an unspecified infection. The result was a rash all over her body. The patient was treated with methotrexate for the severe skin issue. The skin rash was so severe the patient was directed to the emergency room. Prior to 17-JUN-2014 the patient could walk. After the administration of ZOSTAVAX, the patient was no longer able to walk and was confined to a wheelchair. At the time of this letter, the patient continued to be unable to walk and was still confined to a wheelchair. A college professor at a local university felt that the "shingles shot was the root cause of her nerve issues". According to the professor, " the chicken pox virus hides down by the nerves and the sheathing of the nerves". The consumer reported that according to numerous medical professionals, "the shingles shot should have never been administered to my wife being treated for an infection in another area". "The result to my wife and myself have been tragic. She can no longer walk due to an attack on her nerves in her legs in a proximal area". The event of nerve issues/patient no longer able to walk and was confined to a wheelchair is considered disabling. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, FLU3, FLUX
Symptoms: Neuropathy peripheral
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of neuropathy in a 66-year-old female patient who received Flu Seasonal TIV Dresden. Concurrent medical conditions included drug allergy (ADVAIR, ALEVE, CELEBREX, FLOVENT AERO, Influenza virus vaccine whole, Nitrofurantoin Monohyd Macro caps, Prilosec CPDR, PROZAC tab, PULMICORT flexhaler INHA, SINGULAIR tab, VIOXX tab) and latex allergy. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced neuropathy. On an unknown date, the outcome of the neuropathy was unknown. The reporter considered the neuropathy to be related to Seasonal Influenza vaccine. Additional details were received as follows: This case was not previously received to food and drugs administration. This case has been linked to case US2016GSK040924 reported for the same patient for the events experienced after drugs.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Rotavirus test positive, Ultrasound abdomen normal, Vomiting
Clinical narrative: Vomiting and diarrhea, no fever, for 7 days.
Age: 42.0
Sex: F
Vaccine: PER
Symptoms: Asthma, Cough, Pulmonary function test abnormal
Clinical narrative: Excessive coughing, talking caused severe coughing. Had to keep checking for blood in throat at the coughing was extremely aggressive. Within a week, just breathing caused severe coughing. All day, all throughout the night, while sleeping. None stop coughing for 24/7.  Coughing with my newborn in my arms.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Encephalitis, Mental status changes
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient started therapy with JANUVIA, tablet, per oral (dose, frequency, lot number, expiration date and indication were not provided). Concomitant therapy information was not provided. On an unknown date, the patient experienced an unspecified adverse drug reaction. The action taken regarding therapy with JANUVIA was unknown. The outcome of adverse drug reaction was unknown. The physician rated as related the relationship of the event to JANUVIA. Follow up information has been received on 11-FEB-2016 from the physician via the company representative referring to the currently 61 year old patient. On an unknown date, the patient was vaccinated with an unspecified shingles vaccine (manufacture unknown) (previously reported as JANUVIA). On an unknown date within one week after vaccination, the patient was diagnosed with encephalitis and altered mental status (previously reported as adverse drug reaction). The outcome of encephalitis and altered mental status was unknown. Causality assessment was not provided. Upon internal review, encephalitis was considered to be medically significant. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.
Age: 0.11
Sex: F
Vaccine: FLUX
Symptoms: Bacterial infection, Bronchial wall thickening, Chemotherapy, Chest X-ray abnormal, Circulatory collapse
Clinical narrative: This medically confirmed literature report (initial receipt 15-Mar-2016) concerns an 11 months old female patient who had a medical history of acute lymphoblastic leukemia (ALL) and received a high dose of cytarabine for reinduction II chemotherapy. She presented with a 3 day history of progressively worsening cough and nasal congestion and new onset of fever and respiratory distress with profound neutropenia and lymphopenia for which she was hospitalised. She had received palivizumab immunoprophylaxis 10 days before the development of her illness and 2 doses of seasonal influenza vaccine. Initial evaluation revealed bilateral peribronchial thickening and RSV (respiratory syncytial virus) was detected on a nasopharyngeal wash specimen by PCR. Aerosolized ribavirin treatment was initiated in addition to oxygen support and broad spectrum antibiotic therapy. However, due to progressive respiratory deterioration and increasing fever, a chest x-ray repeated on day 5 of hospitalization demonstrated left lower lobe consolidation pneumonia suggestive of secondary bacterial infection. Her treatment regimen included vancomycin, meropenem, azithromycin, voriconazole, palivizumab, and aerosolized ribavirin. On hospital day 28, her condition progressed to respiratory and hemodynamic failure requiring mechanical ventilation and vasopressor followed by extracorporeal mechanical oxygenation support. She died 2 months after onset of the RSV infection. The outcome was fatal. Reporter's Comments: n/a. Sender's Comments: Company comments: Seriousness: Serious. Fatal Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the agency for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information all events are unlisted except pyrexia, nasal congestion, and cough. Causality: Unassessable. The events pertaining to inappropriate age at vaccine administration is unassessable. For all other events, it is unrelated. The reports pertains to a pediatric patient undergoing chemotherapy who developed various respiratory symptoms. Further investigation revealed that causative agents were RSV and a bacterial pathogen. Patient has also received chemotherapy which can cause neutropenia and lymphopenia. In the clear presence of laboratory demonstration of offending causal agents, and a known recent history of leukemia and chemotherapeutic treatments, the reported systemic symptoms, respiratory events, and hematologic parameters are considered unrelated to influenza vaccine.
Age: 0.11
Sex: F
Vaccine: FLUX
Symptoms: Cough, Death, Extracorporeal membrane oxygenation, Lymphopenia, Mechanical ventilation
Clinical narrative: This medically confirmed literature report (initial receipt 15-Mar-2016) concerns an 11 months old female patient who had a medical history of acute lymphoblastic leukemia (ALL) and received a high dose of cytarabine for reinduction II chemotherapy. She presented with a 3 day history of progressively worsening cough and nasal congestion and new onset of fever and respiratory distress with profound neutropenia and lymphopenia for which she was hospitalised. She had received palivizumab immunoprophylaxis 10 days before the development of her illness and 2 doses of seasonal influenza vaccine. Initial evaluation revealed bilateral peribronchial thickening and RSV (respiratory syncytial virus) was detected on a nasopharyngeal wash specimen by PCR. Aerosolized ribavirin treatment was initiated in addition to oxygen support and broad spectrum antibiotic therapy. However, due to progressive respiratory deterioration and increasing fever, a chest x-ray repeated on day 5 of hospitalization demonstrated left lower lobe consolidation pneumonia suggestive of secondary bacterial infection. Her treatment regimen included vancomycin, meropenem, azithromycin, voriconazole, palivizumab, and aerosolized ribavirin. On hospital day 28, her condition progressed to respiratory and hemodynamic failure requiring mechanical ventilation and vasopressor followed by extracorporeal mechanical oxygenation support. She died 2 months after onset of the RSV infection. The outcome was fatal. Reporter's Comments: n/a. Sender's Comments: Company comments: Seriousness: Serious. Fatal Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the agency for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information all events are unlisted except pyrexia, nasal congestion, and cough. Causality: Unassessable. The events pertaining to inappropriate age at vaccine administration is unassessable. For all other events, it is unrelated. The reports pertains to a pediatric patient undergoing chemotherapy who developed various respiratory symptoms. Further investigation revealed that causative agents were RSV and a bacterial pathogen. Patient has also received chemotherapy which can cause neutropenia and lymphopenia. In the clear presence of laboratory demonstration of offending causal agents, and a known recent history of leukemia and chemotherapeutic treatments, the reported systemic symptoms, respiratory events, and hematologic parameters are considered unrelated to influenza vaccine.
Age: 0.11
Sex: F
Vaccine: FLUX
Symptoms: Nasal congestion, Neutropenia, Pneumonia, Polymerase chain reaction positive, Pyrexia
Clinical narrative: This medically confirmed literature report (initial receipt 15-Mar-2016) concerns an 11 months old female patient who had a medical history of acute lymphoblastic leukemia (ALL) and received a high dose of cytarabine for reinduction II chemotherapy. She presented with a 3 day history of progressively worsening cough and nasal congestion and new onset of fever and respiratory distress with profound neutropenia and lymphopenia for which she was hospitalised. She had received palivizumab immunoprophylaxis 10 days before the development of her illness and 2 doses of seasonal influenza vaccine. Initial evaluation revealed bilateral peribronchial thickening and RSV (respiratory syncytial virus) was detected on a nasopharyngeal wash specimen by PCR. Aerosolized ribavirin treatment was initiated in addition to oxygen support and broad spectrum antibiotic therapy. However, due to progressive respiratory deterioration and increasing fever, a chest x-ray repeated on day 5 of hospitalization demonstrated left lower lobe consolidation pneumonia suggestive of secondary bacterial infection. Her treatment regimen included vancomycin, meropenem, azithromycin, voriconazole, palivizumab, and aerosolized ribavirin. On hospital day 28, her condition progressed to respiratory and hemodynamic failure requiring mechanical ventilation and vasopressor followed by extracorporeal mechanical oxygenation support. She died 2 months after onset of the RSV infection. The outcome was fatal. Reporter's Comments: n/a. Sender's Comments: Company comments: Seriousness: Serious. Fatal Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the agency for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information all events are unlisted except pyrexia, nasal congestion, and cough. Causality: Unassessable. The events pertaining to inappropriate age at vaccine administration is unassessable. For all other events, it is unrelated. The reports pertains to a pediatric patient undergoing chemotherapy who developed various respiratory symptoms. Further investigation revealed that causative agents were RSV and a bacterial pathogen. Patient has also received chemotherapy which can cause neutropenia and lymphopenia. In the clear presence of laboratory demonstration of offending causal agents, and a known recent history of leukemia and chemotherapeutic treatments, the reported systemic symptoms, respiratory events, and hematologic parameters are considered unrelated to influenza vaccine.
Age: 0.11
Sex: F
Vaccine: FLUX
Symptoms: Respiratory distress, Respiratory failure, Respiratory syncytial virus infection
Clinical narrative: This medically confirmed literature report (initial receipt 15-Mar-2016) concerns an 11 months old female patient who had a medical history of acute lymphoblastic leukemia (ALL) and received a high dose of cytarabine for reinduction II chemotherapy. She presented with a 3 day history of progressively worsening cough and nasal congestion and new onset of fever and respiratory distress with profound neutropenia and lymphopenia for which she was hospitalised. She had received palivizumab immunoprophylaxis 10 days before the development of her illness and 2 doses of seasonal influenza vaccine. Initial evaluation revealed bilateral peribronchial thickening and RSV (respiratory syncytial virus) was detected on a nasopharyngeal wash specimen by PCR. Aerosolized ribavirin treatment was initiated in addition to oxygen support and broad spectrum antibiotic therapy. However, due to progressive respiratory deterioration and increasing fever, a chest x-ray repeated on day 5 of hospitalization demonstrated left lower lobe consolidation pneumonia suggestive of secondary bacterial infection. Her treatment regimen included vancomycin, meropenem, azithromycin, voriconazole, palivizumab, and aerosolized ribavirin. On hospital day 28, her condition progressed to respiratory and hemodynamic failure requiring mechanical ventilation and vasopressor followed by extracorporeal mechanical oxygenation support. She died 2 months after onset of the RSV infection. The outcome was fatal. Reporter's Comments: n/a. Sender's Comments: Company comments: Seriousness: Serious. Fatal Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the agency for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information all events are unlisted except pyrexia, nasal congestion, and cough. Causality: Unassessable. The events pertaining to inappropriate age at vaccine administration is unassessable. For all other events, it is unrelated. The reports pertains to a pediatric patient undergoing chemotherapy who developed various respiratory symptoms. Further investigation revealed that causative agents were RSV and a bacterial pathogen. Patient has also received chemotherapy which can cause neutropenia and lymphopenia. In the clear presence of laboratory demonstration of offending causal agents, and a known recent history of leukemia and chemotherapeutic treatments, the reported systemic symptoms, respiratory events, and hematologic parameters are considered unrelated to influenza vaccine.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Erythema, Feeling abnormal, Injection site erythema, Injection site reaction
Clinical narrative: Big red 3" wide streak across the entire arm, welting at the site of injection, Foggy head feeling, felt like my head was going to lift right off, still to this day not feeling well, dizzy, pain in left shoulder and neck since then.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site streaking, Malaise, Musculoskeletal pain, Neck pain, Urticaria
Clinical narrative: Big red 3" wide streak across the entire arm, welting at the site of injection, Foggy head feeling, felt like my head was going to lift right off, still to this day not feeling well, dizzy, pain in left shoulder and neck since then.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date in 2015, an unspecified number of patients were vaccinated with PROQUAD (Merck), lot # L007228 and expiration date 03-SEP-2016 (dose number, strength, and route of administration were not reported), that were improperly stored and exposed to temperatures of 1.6 C. At the time of this report, it was not reported any adverse event. This is one of two cases received from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Information has been received from a physician via a company representative referring to a 14 year old male patient. On an unknown date the patient was vaccinated with GARDASIL 9 (dose, lot# and route were unknown). Concomitant therapy included hepatitis a vaccine, inactivated (manufacturer unknown). On 02-MAR-2016 the patient passed out and hit his head on the door. The patient visited the doctor for the events on an unknown date. The patient recovered from the events in March 2016. Causality was not provided. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Information has been received from a physician via a company representative referring to a 14 year old male patient. On an unknown date the patient was vaccinated with GARDASIL 9 (dose, lot# and route were unknown). Concomitant therapy included hepatitis a vaccine, inactivated (manufacturer unknown). On 02-MAR-2016 the patient passed out and hit his head on the door. The patient visited the doctor for the events on an unknown date. The patient recovered from the events in March 2016. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, concurrent condition and concomitant medication were not reported. On 18-MAR-2016 the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # L006382, expiry date 25-MAY-2016. The vaccine had a temperature excursion of temperature of 30 F for 12 hours. The patient experienced no adverse event. There was no previous temperature excursion and the call was made because of data logger. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified nursing assistant referring to an unspecified number of unspecified patients of unknown age and gender. Since 22-MAR-2016, the patients were vaccinated with doses of incorrectly stored (Merck) VARIVAX (dose and route unknown, temperature excursion on 28.9 F for 2 hours, lot # reported as: L041207, expiry date: 20-OCT-2017). No adverse effects had been reported. Additional information has been requested.