chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # K015994, exp. date on 23-SEP-2016, and Lot # L008275, exp. date on 11-MAR-2017, (strength, route of administration and dose were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapies were not reported. On 18-OCT-2015, the patient was vaccinated with an expired dose of VARIVAX (Merck) lot # J012375, expiration date: 03-OCT-2015 (dose and route were not provided). The reporter asked if the dose needed to be re-administered. Nurse also wanted this provided as feedback since the dating of the vaccine shows as "03-OCT-2015" and this created confusion for the nurse administering the vaccine. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with doses of GARDASIL (dose, frequency, route, lot # and expiration date were not reported). It was reported that the patient completed the series of GARDASIL receiving the last dose when she was 41 years of age. No adverse experiences were reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician concerning a 26 year old female patient. The patient had no pertinent medical history or drug reactions or allergies. The patient was not pregnant. On 18-SEP-2015, the patient was vaccinated with the first dose of GARDASIL 9 (Lot#, dose and route not provided). There were no concomitant medications. On an unspecified date in 2015, after receiving the GARDASIL 9 the patient experienced swelling at the injection site. On an unspecified date in 2015, the patient's whole arm eventually swelled up and the swelling lasted for one full month. No treatment was given for the patient's adverse event. On an unspecified date, the swelling resolved on itself. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concurrent conditions or drug allergies/drug reactions described. The reporter stated that on multiple unspecified dates, the patients were administered improperly stored doses of ZOSTAVAX injection (lot# L016283 with expiration date 16-AUG-2016 and lot# reported as L029482 with expiration date 06-NOV-2016; dose, route and frequency were not provided). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' current conditions and medical history were not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot # K026247, exp. 29-JAN-2017) (route and dose unspecified). There was no concomitant medication described. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' current conditions and medical history were not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of oral, ROTATEQ (lot # L008057, exp. 01-DEC-2016) (dose unspecified). There was no concomitant medication described. No adverse symptoms were reported. This is one of several reports received from the same source. 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 medical assistant referring to multiple patients of unknown age. On an unknown date, multiple patients were vaccinated with M-M-R II lot # L011528, expiration date 03-APR-2017, that were improperly stored. No adverse effect was reported. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 6 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with doses of PEDVAXHIB (dose, route, lot # and expiration date were not reported). First dose of PEDVAXHIB was administered at 2 months of age, second dose administered at 4 months of age and third dose administered to the patient at 6 months of age. No adverse effect was reported. 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 pharmacist refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On 05-NOV-2015, the patient was vaccinated with first dose of improperly stored VARIVAX (Merck) (dose, route and lot# were not reported) which was stored in a refrigerator for less than 72 hours. After pharmacist realized that improperly stored VARIVAX (Merck) dose was administered to patient, pharmacist considered the first dose as invalid and on 14-NOV-2015 administered another VARIVAX (Merck) dose. No adverse effects 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 as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot# L023230, expiry date 28-JUL-2017 and lot# L016428, expiry date 30-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional, refers to a 17 year old male patient. No medical history or concurrent conditions were reported. On 31-JUL-2015, the patient was vaccinated with an unspecified dose GARDASIL 9 lot # K026247 (dose was not provided). Concomitant therapies were not provided. No adverse effects were reported. The reporter refers that product quality complaints were not involved. 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 register nurse, refers to an unknown number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (Merck), (lot#, expiration date, strength, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pustular, Scab
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old male patient with insomnia, high blood pressure and high cholesterol. The patient has no pertinent medical history and no drug allergies. On 03-NOV-2015 the patient was vaccinated with ZOSTAVAX (lot # L028282, expiration date 28-OCT-2016, 0.65 ml, subcutaneous). Concomitant therapies included zolpidem, unspecified medication to reduce blood pressure and unspecified medication to lower cholesterol. On 10-NOV-2015 the patient had rash on both of his lower legs. On the same day, the patient came to the pharmacy to seek medical attention and the reporter stated that the rash "looked like scabbed over pustules". No lab diagnostics studies were performed and no treatment was given for the events. Outocme of the events was not recovered. Causality assessment was not reported. Aditional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Stomatitis
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a one dose of VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced mouth sores. It could not have been determined if the mouth sores developed before or after the vaccination. The outcome of the adverse event was not provided. The relatedness between mouth sores and VARIVAX (Merck) was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (lot# L008059, expiry date 18-DEC-2016 and lot# L010844, expiry date 16-NOV-2016; exact dose was not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in an unspecified number of patients who received ENGERIX B adult (batch number C3TY3, expiry date 13th April 2018). On an unknown date, the patients received ENGERIX B adult 1 ml. On an unknown date, immediately after receiving ENGERIX B adult, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to ENGERIX B adult. Additional details were received as follows: The unknown number of patients received a dose of ENGERIX B vaccine and experienced pain and pressure while the vaccine got pushed through. Patient's details were not provided. The reporter stated that, there were more than one batch number and expiry dates for ENGERIX B received by patients but they were not provided.
Age: 45.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Acute febrile neutrophilic dermatosis, Arthralgia, Biopsy skin abnormal, C-reactive protein increased, Dermatitis
Clinical narrative: The patient is a 52 year old male. Patient received ANTHRAX #6, Hepatitis B #2 and Typhoid vaccines on 16 Apr '09. He was clinically well at the time and had no previous reaction to vaccinations. On 14 May '09 he was seen for tempr 103.3, myalgias, arthralgias, rash and 'erythematous nodules' on hands, elbows and knees, and "red fingertips". He had an elevated CRP and ESR. Due to concern for vasculitis, patient was immediately sent for dermatology evaluation and started on prednisone, and LEVAQUIN. A biopsy on 18 May '09 showed a "neurotrophillic, granulomatous and mixed dermal inflammatory infiltrate", and was subsequently diagnosed with Sweets Syndrome. This syndrome can be associated with a medication, infection, illness or vaccination. Symptoms: fever, rash, oth nonspecific skin eruption, joint pain.
Age: 45.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Erythema, Myalgia, Nodule, Palisaded neutrophilic granulomatous dermatitis, Pyrexia
Clinical narrative: The patient is a 52 year old male. Patient received ANTHRAX #6, Hepatitis B #2 and Typhoid vaccines on 16 Apr '09. He was clinically well at the time and had no previous reaction to vaccinations. On 14 May '09 he was seen for tempr 103.3, myalgias, arthralgias, rash and 'erythematous nodules' on hands, elbows and knees, and "red fingertips". He had an elevated CRP and ESR. Due to concern for vasculitis, patient was immediately sent for dermatology evaluation and started on prednisone, and LEVAQUIN. A biopsy on 18 May '09 showed a "neurotrophillic, granulomatous and mixed dermal inflammatory infiltrate", and was subsequently diagnosed with Sweets Syndrome. This syndrome can be associated with a medication, infection, illness or vaccination. Symptoms: fever, rash, oth nonspecific skin eruption, joint pain.
Age: 45.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Rash, Red blood cell sedimentation rate increased
Clinical narrative: The patient is a 52 year old male. Patient received ANTHRAX #6, Hepatitis B #2 and Typhoid vaccines on 16 Apr '09. He was clinically well at the time and had no previous reaction to vaccinations. On 14 May '09 he was seen for tempr 103.3, myalgias, arthralgias, rash and 'erythematous nodules' on hands, elbows and knees, and "red fingertips". He had an elevated CRP and ESR. Due to concern for vasculitis, patient was immediately sent for dermatology evaluation and started on prednisone, and LEVAQUIN. A biopsy on 18 May '09 showed a "neurotrophillic, granulomatous and mixed dermal inflammatory infiltrate", and was subsequently diagnosed with Sweets Syndrome. This syndrome can be associated with a medication, infection, illness or vaccination. Symptoms: fever, rash, oth nonspecific skin eruption, joint pain.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Nausea, Rash
Clinical narrative: Erythema, fatigue, nausea. The rash is not general body rash but rather restricted to her right thigh/knee area but looks bad.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Throbbing pain (L) arm down to 1st 3 digits T. 97.5 BP 100/56 Given prednisone and Tramadol.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local erythematous reaction at the injection site. Asymptomatic for infection, no treatment given.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 17-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K010016, expiration date 05-AUG-2015 (route was not provided). Concomitant therapy information was not provided. On 17-OCT-2015, there was an expired product administered as the patient received an expired dose of PNEUMOVAX 23. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Flushing, Throat tightness, Urticaria
Clinical narrative: Gave Tdap to new employee. She stated "can't remember last tetanus shot, so long ago." States rash and red arm after previous tetanus, but dr said was due to horse serum and not reason to avoid future tetanus shot. Developed flushed face and hives and felt like throat closing off. to ER ay 11:13 am. Epinephrine ZANTAC and steroids given. Released to home at 13:05.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-NOV-2015 (also reported as today), the patient was vaccinated with a dose of ZOSTAVAX vial (lot # L025001, expiration date 06-OCT-2016, subcutaneously, dose and route of administration were not reported) that was reconstituted with distilled water which was outside the labeled recommendations in the ZOSTAVAX prescribing information. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort
Clinical narrative: Initial report received from a healthcare professional on 09 October 2014. A female patient whose medical history was unknown and concomitant medications not reported, had received an intramuscular dose of FLUZONE QUADRIVALENT (batch number UI188AB, expiry date 30 June 2015, dose number not reported), in right deltoid, on 09 October 2014. On 09 October 2014, 3.5 hrs after vaccination, the patient experienced chest tightness which worsened when she stood 5/10. The patient was sent to the emergency room and there was no follow-up at this time. Corrective treatment and laboratory investigations were not reported. The outcome of the event was not reported. List of documents held by sender: none. This case is linked to case# 2014SA140000 (same reporter, same vaccine). Follow-up information received from healthcare provisional on 4 March 2015. No additional information to provide.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a non health professional refers to a 14 year old male patient. The patient was healthy and had regular visits to the pediatrician's office for periodic check-ups since birth. Those check-ups visits showed no evidence of any pre-existing health issues, specifically no evidence of cardiac abnormalities, psychological disorders or substance abuse. The patient had been training for the high school football team from four to five hours a day for the two months prior to his death without incident. On 19-AUG-2013, date the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not reported). On 20-AUG-2013 the patient was found to be unresponsive in bed. The outcome of death was reported as fatal. The reporter considered death to be related to GARDASIL. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Grip strength decreased
Clinical narrative: Initial unsolicited report received from a pharmacist on 01 September 2015. This case involves a 75-year-old male patient who had received a dose of FLUZONE HD (batch number- UI435AA, expiration date: 06 April 2016) through unknown route in left deltoid on 31 August 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions, other medical history and concomitant medications were not reported. It was also reported that patient did not receive any other vaccinations within four weeks prior to vaccination. On 01 September 2015, next day after vaccination, the patient awoke and found that he could not move his left arm at all. Patient also reported that he had no grip strength with the hand. Patient required an ER/doctor visit. Lab data and corrective treatments were not reported. Outcome of the events was reported as unknown. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Grip strength decreased, Injected limb mobility decreased
Clinical narrative: Initial unsolicited report received from a pharmacist on 01 September 2015. This case involves a 75-year-old male patient who had received a dose of FLUZONE HD (batch number- UI435AA, expiration date: 06 April 2016) through unknown route in left deltoid on 31 August 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions, other medical history and concomitant medications were not reported. It was also reported that patient did not receive any other vaccinations within four weeks prior to vaccination. On 01 September 2015, next day after vaccination, the patient awoke and found that he could not move his left arm at all. Patient also reported that he had no grip strength with the hand. Patient required an ER/doctor visit. Lab data and corrective treatments were not reported. Outcome of the events was reported as unknown. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU4, TDAP, FLU3, TDAP
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient states vaccine given too high on shoulder, and damaged rotator cuff had to have surgery.
Age: 57.0
Sex: F
Vaccine: FLU4, TDAP, FLU3, TDAP
Symptoms: Drug administered at inappropriate site, Rotator cuff syndrome, Surgery
Clinical narrative: Patient states vaccine given too high on shoulder, and damaged rotator cuff had to have surgery.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Received inj. 11/5/2015 red area 11/6/2015. Runny nose sneezing, cough sore arm. 11-7-2015 redness slowly moving down Rt arm. 11-8, 11-9, move down brachial area to just above Rt elbow. 11-10-2015 saw PCP 12 noon. Given clindamycin.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Cough, Erythema, Pain in extremity, Rhinorrhoea
Clinical narrative: Received inj. 11/5/2015 red area 11/6/2015. Runny nose sneezing, cough sore arm. 11-7-2015 redness slowly moving down Rt arm. 11-8, 11-9, move down brachial area to just above Rt elbow. 11-10-2015 saw PCP 12 noon. Given clindamycin.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Sneezing
Clinical narrative: Received inj. 11/5/2015 red area 11/6/2015. Runny nose sneezing, cough sore arm. 11-7-2015 redness slowly moving down Rt arm. 11-8, 11-9, move down brachial area to just above Rt elbow. 11-10-2015 saw PCP 12 noon. Given clindamycin.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Induration, Pain, Swelling
Clinical narrative: Red, swelling, releasing heat, hard, painful.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Induration, Nodule, Peripheral swelling
Clinical narrative: Arm swelled, turned red and swollen. Had a hard knot.  Got cellulitis and spent 2 days in hospital.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary mass, Musculoskeletal pain, Pain in extremity
Clinical narrative: On 11/04/15, sharp aching pain in and all around deltoid and shoulder. The following morning, when applying deodorant, I noticed a lump underneath my left arm pit. I went to my job Employee Health Department as well as my private physician.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Erythema, Flushing
Clinical narrative: 7:50 Flu shot given. 7:52 -> chest tightness, breathing, dizzy, red flush skin. EPIPEN 0.3mg injected at 752PM and called paramedics. Pt ok after 1st dose of EPIPEN.
Age: 3.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Dyspnoea, Eyelid oedema, Grunting, Skin disorder, Tongue pruritus
Clinical narrative: Information has been received from a medical assistant referring to a 3 year old male patient. There were no pertinent medical history, drug reactions or allergies. On 16-NOV-2015, the patient received a delayed routine vaccination with one dose of M-M-R II (lot # L011528, expiration date 03-APR-2017, 0.5 ml, subcutaneous). There was no concomitant medication. Shortly after the vaccination on 16-NOV-2015, the patient developed an itchy tongue and two "bug-bite like marks on his face". The patient was given TYLENOL and BENADRYL as treatment. Then shortly after administering the TYLENOL and BENADRYL, the patient developed swollen eyelids and was having difficulty breathing. He kept grunting like it was hard for him to breathe. EPIPEN was then used and the patient was taken to the hospital for further observation. The patient was not admitted to the hospital and was released at about 11:00 PM on that night. No lab diagnostics studies were performed. At the time of report, the patient's eyelids were still a little swollen but the other events were resolved (reported as "otherwise he was good"). The causality between the events and M-M-R II was unspecified. Upon internal review, the events were considered to be medically significant. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Eye swelling, Irritability, Odynophagia, Swollen tongue, Urticaria
Clinical narrative: Information has been received from a medical assistant referring to a 3 year old male patient. There were no pertinent medical history, drug reactions or allergies. On 16-NOV-2015, the patient received a delayed routine vaccination with one dose of M-M-R II (lot # L011528, expiration date 03-APR-2017, 0.5 ml, subcutaneous). There was no concomitant medication. Shortly after the vaccination on 16-NOV-2015, the patient developed an itchy tongue and two "bug-bite like marks on his face". The patient was given TYLENOL and BENADRYL as treatment. Then shortly after administering the TYLENOL and BENADRYL, the patient developed swollen eyelids and was having difficulty breathing. He kept grunting like it was hard for him to breathe. EPIPEN was then used and the patient was taken to the hospital for further observation. The patient was not admitted to the hospital and was released at about 11:00 PM on that night. No lab diagnostics studies were performed. At the time of report, the patient's eyelids were still a little swollen but the other events were resolved (reported as "otherwise he was good"). The causality between the events and M-M-R II was unspecified. Upon internal review, the events were considered to be medically significant. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Dyspnoea, Eyelid oedema, Grunting, Skin disorder, Tongue pruritus
Clinical narrative: Pt developed hives within minutes of vaccines, periorbital swelling, swallowing discomfort, tongue swelling. Pt was very fussy. Gave BENADRYL and EPIPEN Jr. Pt did well went to ED for follow-up.
Age: 3.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Eye swelling, Irritability, Odynophagia, Swollen tongue, Urticaria
Clinical narrative: Pt developed hives within minutes of vaccines, periorbital swelling, swallowing discomfort, tongue swelling. Pt was very fussy. Gave BENADRYL and EPIPEN Jr. Pt did well went to ED for follow-up.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Abasia, Blood test, Dysstasia, Electromyogram, Guillain-Barre syndrome
Clinical narrative: Woke up in the morning and had difficulty standing. Went to facility around 10:00 AM. Was referred to another facility. Arrived there at 3:00 PM and was unable to walk at all. Used a wheelchair to get into facility  Was admitted with a diagnosis of Guillain Barre Syndrome. Remained at facility for 6 days and received IV/IG treatment for 6 days. Was then transferred to hospital and remain there today 11/20/2015. Receiving IV/IG treatment twice weekly and getting physical therapy. Still cannot stand or walk.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Immunoglobulin therapy, Lumbar puncture, Nuclear magnetic resonance imaging spinal, Wheelchair user
Clinical narrative: Woke up in the morning and had difficulty standing. Went to facility around 10:00 AM. Was referred to another facility. Arrived there at 3:00 PM and was unable to walk at all. Used a wheelchair to get into facility  Was admitted with a diagnosis of Guillain Barre Syndrome. Remained at facility for 6 days and received IV/IG treatment for 6 days. Was then transferred to hospital and remain there today 11/20/2015. Receiving IV/IG treatment twice weekly and getting physical therapy. Still cannot stand or walk.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Local swelling, Malaise
Clinical narrative: Started not being able to breath, then chest pains (lots of pressure), then swelling in my neck, face and chest. this started within 20 to 25 minutes of getting the injection. I was on my way home when it first started.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling, Swelling face
Clinical narrative: Started not being able to breath, then chest pains (lots of pressure), then swelling in my neck, face and chest. this started within 20 to 25 minutes of getting the injection. I was on my way home when it first started.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dysphonia, Functional gastrointestinal disorder, Headache, Malaise
Clinical narrative: Patient stated that she woke up with "intestinal tract twisting" feeling a throbbing headache, hoarseness and a decreased appetite.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash, Rash erythematous, Swelling face
Clinical narrative: Rash, itching, arms, face and back. Red spots all over. Face Swollen. Medication administered at School -Nurse - Benadryl.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Gait disturbance, Muscle spasms, Pain in extremity
Clinical narrative: Mild leg cramps in right leg. 11/18 cramp in left leg calf becoming severe to inhibit walking and very painful until 11/19 when at 5am severe diarrhea began (all clear fluid at least 12 times) and continuing into today 11/20/15.
Age: 49.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: PAIN AND TINGLING IN left UPPER ARM. PERIODIC NUMBNESS.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Periarthritis, Tendon injury
Clinical narrative: Patient experiencing "frozen shoulder" saw a physician and stated it was from vaccine damaging tendon. Patient unble to lift arm above shoulder level. Was planning to undergo physical therapy to resolve.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Muscle tightness, Oedema
Clinical narrative: Left deltoid tenderness and pain.  Small interstitial edema with muscle tightness with movement.  Onset-10/14/2015 to date. Treatment--OTC anti-inflammatory and heat.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blister, Erythema, Pyrexia
Clinical narrative: Pt. reports of redness from elbow to armpit and approx. 6 inch diameter of blistering. Also low-grade fever. Onset 11/12/15 that evening. Cleared up 11/16/15 with remaining redness.
Age: 75.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Arm still sore after immunization. Describes pain as "4". No redness, or heat or swelling reported.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Since date of administration, arm has been sore, with pain. Describes pain as "10". Reports no redness, heat or swelling.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient received a FLUZONE HD shot on 11/11/15. On 11/19/15 she returns to the pharmacy complaining of arm pain. Patient does not mention any treatment for the pain. She mentions a desire to file a complaint.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness in both arms after vaccines. No fever or discomfort. Warm to touch.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Incorrect product storage, Pain in extremity, Peripheral swelling
Clinical narrative: Pt received PNEUMOVAX 23 8/31/15; fridge temps were off during that time and we were instructed to re-vaccinated. Pt came back on 11/16/15 and received PNEUMOVAX 23 in (L) deltoid and flu vaccine (R) deltoid. Later that evening arm became swollen, red and painful. Seen by provider following day on 11/17/15. Treated w/ KEFLEX and BACTRIM.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: Rash left arm and is painful. Also warm to touch. Pt. given cephalexin 500mg one cap TID x7 days.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Headache
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 57-year-old female patient who received FLULAVAL Quadrivalent (batch number 93T79, expiry date June 2016). On 4th November 2015, the patient received FLULAVAL Quadrivalent (intramuscular) .5 ml. On 5th November 2015, 1 days after receiving FLULAVAL Quadrivalent, the patient experienced headache. In November 2015, the patient experienced increased blood pressure. The patient was treated with IMITREX. On an unknown date, the outcome of the headache and increased blood pressure were not recovered/not resolved. It was unknown if the reporter considered the headache and increased blood pressure to be related to FLULAVAL Quadrivalent. Additional details were received as follows: The patient experienced headache every day since she had received a dose of FLULAVAL Quadrivalent. In November 2015, less than a week after receiving FLULAVAL Quadrivalent, the patient also experienced blood pressure elevated.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Electromyogram, Neuralgic amyotrophy, Nuclear magnetic resonance imaging
Clinical narrative: Parsonage-Turner Syndrome as documented by Dr. Physical therapy did not improve condition.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Vaccination error
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 72 year old female patient. The patient's relevant medical history and concomitant medications were not reported. On 22-SEP-2015, the patient received a dose of PNEUMOVAX 23 injection in the arm (dose, route, lot # and expiration date were not reported). It was reported, that on the same day and on the same arm, the patient "high dose" of influenza (FLUZONE HT) injection (dose, route, lot # and expiration date were not reported). On 22-SEP-2015, the patient developed an unspecified reaction from shoulder to elbow on the vaccination arm. The patient sought medical attention by visiting an unspecified urgent clinic on an unknown date, in 2015. The patient was treated with unspecified steroids for the event. The outcome of the event of unspecified reaction from shoulder to elbow was unknown. The relatedness between the event and PNEUMOVAX 23 and FLUZONE HT was not reported. Additional information is not expected, as no pharmacist's contact details were provided.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a female patient of unknown age reporting on herself. The patient's pertinent medical history included high blood pressure, no drug reactions or allergies. In early October 2015, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly (dose, site of administration, lot#, expiry date were not reported). On the same day, patient was vaccinated with an unspecified influenza virus vaccine (manufacturer unknown) reported as "flu" vaccine (dose, site and route of administration, lot#, expiry date were not reported). The other patient's concomitant medications included unspecified blood pressure medications. On an unknown date in 2015, after receiving PNEUMOVAX 23, the patient experienced rash. The patient was prescribed unspecified medications for treatment of her rash by her family physician. No lab diagnostics studies were performed. The outcome of rash was reported as not recovered/not resolved (reported as "she is still experiencing a rash"). The patient sought medical attention by contacting a physician. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information is not expected as the reporter did not wish a further contact.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Developed rash on forehead, left arm and chest, DX chicken pox.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Tension, Vaccination site erythema, Vaccination site oedema, Vaccination site warmth
Clinical narrative: Left arm where vaccine administered and approximately 6 inches below vaccine site, with warmth, mild edema and erythema without clear demarcation, tense, not TTP; no skin breakage, fluctuance or drainage.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain in extremity, Rash macular, Skin warm, Tenderness
Clinical narrative: On 11/16/2015, pt was seen in clinic for follow up visit. During visit, pt was ordered to receive Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23) Immunization/Injection. Per documentation, pt received an injection of 0.5 mL in left deltoid after "area was prepared aseptically free from redness, swelling, or any abnormalities" (Lot #L024129; exp: 1/21/2017). It was noted that pt "tolerated well without incident. Pt received written literature and verbalized understanding". On 11/18, pt sent an e-mail to provider stating "I am having a reaction to the pneumovax that I received on Monday. I noticed yesterday that my arm was sore, which I expected, but got a little worse throughout the day. Last night while getting ready for bed I noticed in the mirror that the area above my armpit and to the side (on my arm) were both splotchy red and very tender/sore and feel warm...." MD replied with instructions to "Take tylenol 650 mg and benadryl 25 mg right away" and return to clinic. On11/18, pt returned to clinic for evaluation. On exam, pt was found to have no fever, no swelling, no induration, no fluctuance, no drainage and no axillary adenopathy. Area was slightly tender to touch and slightly warm to touch. MD diagnosed cellulitis and pt was prescribed cephalexin 500 mg PO BID x 10 days. Pt treatment ongoing.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Migraine, Pyrexia
Clinical narrative: MIGRAINE, COUGH, FEVER.
Sex: M
Vaccine: MEN
Symptoms: Meningococcal infection
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 19 November 2015 to add the updated company comment and to add the related case ids in the company narrative and related cases field. Initial unsolicited report received from the literature on 12 November 2015. This case is linked to 2015SA184911, 2015SA188405, 2015SA188406, 2015SA188407 and 2015SA188408 (same literature). This case involves one of the six male patients (age group between 18-64 years) who was vaccinated with a dose of Quadrivalent meningococcal vaccine (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. Medical history included Homosexuality (Men Who Have Sex with Men) and concomitant medication were not reported. The HIV status of the patient was not reported. On an unspecified date following the vaccination, the patient developed serogroup C meningococcal disease. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, company assessed the event of serogroup C meningococcal disease as serious and important medical event. List of documents held by sender: none. Addendum on 19 November 2015: Upon second medical examination of the case during internal review, a significant correction was performed on 19 November 2015 to add the updated company comment and to add the related case ids in the company narrative and related cases field.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site joint pain, Sleep disorder
Clinical narrative: I administered the AFLURIA vaccine on 10-23-15. Patient's wife called 11-18-15 stating that her arm and her husband's arm was having pain in their shoulder joint, in the arm where the shot was given. She said patient could not lay on his arm at night to sleep. She said it was not the injection site but the shoulder joint.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Mobility decreased
Clinical narrative: I administered the AFLURIA vaccine on 10-23-15. Patient called 11-18-15 saying her shoulder joint had been hurting her since she got the injection. She said her arm had been hard to raise and she had difficulties dressing. She had history of bursitis. She had flu shots in past but it had never affected her in this way. Recommended warm compress and TYLENOL or ibuprofen.
Age: 82.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Fatigue, Feeling cold, Malaise, Pain
Clinical narrative: I was working on my car in my garage. It was a nice fall day. We got our shots about 4:00 PM at the local stored. The pharmacist gave us the shots. I got a flu shot in one arm and a pneumococcal conjugate PCV13 shot in the other arm. About 7:00 PM, I started to get cold, achy and tired. By 8:00 PM, I went into the house. I have never been that cold before. I took a long hot shower and laid down on my couch and spent the night there. In the morning, I went to bed and spent the whole day there. I slept all night and woke up on Thursday 10-15-15 feeling normal. It is the first time I have ever got a bad reaction from a shot. I did not take my temperature. I was really sick! I've been normal since the 15th. I did not go to the doctor.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Areflexia, Blood copper, Blood folate normal, Blood heavy metal test, Blood thyroid stimulating hormone normal
Clinical narrative: Both legs started going numb a few days later. Numbness has been gradually ascending. About that same time noted her hands felt numb and her arms feel heavy. Legs started to hurt after a few more days from about the knee level down. Having trouble with weakness in legs. Able to walk for short distances.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood zinc, C-reactive protein normal, Demyelination, Electromyogram abnormal, Electrophoresis protein
Clinical narrative: Both legs started going numb a few days later. Numbness has been gradually ascending. About that same time noted her hands felt numb and her arms feel heavy. Legs started to hurt after a few more days from about the knee level down. Having trouble with weakness in legs. Able to walk for short distances.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, HIV antibody negative, Hypoaesthesia, Limb discomfort, Muscular weakness
Clinical narrative: Both legs started going numb a few days later. Numbness has been gradually ascending. About that same time noted her hands felt numb and her arms feel heavy. Legs started to hurt after a few more days from about the knee level down. Having trouble with weakness in legs. Able to walk for short distances.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve conduction studies abnormal, Neuropathy peripheral, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Paraesthesia
Clinical narrative: Both legs started going numb a few days later. Numbness has been gradually ascending. About that same time noted her hands felt numb and her arms feel heavy. Legs started to hurt after a few more days from about the knee level down. Having trouble with weakness in legs. Able to walk for short distances.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Polyneuropathy, Red blood cell sedimentation rate normal, Scoliosis, Sensory loss, Vitamin B12 normal
Clinical narrative: Both legs started going numb a few days later. Numbness has been gradually ascending. About that same time noted her hands felt numb and her arms feel heavy. Legs started to hurt after a few more days from about the knee level down. Having trouble with weakness in legs. Able to walk for short distances.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Left upper arm swollen and red. Pain in touching, moving or pressure  down past bicep. Put ice, took naproxen. Didn't help. Lasted 3 days.
Age: 19.0
Sex: F
Vaccine: FLUN4
Symptoms: Head injury, Syncope
Clinical narrative: After receiv. FLUMIST pt stood up to leave, turning door knob and fainted, hitting head on the wall. As soon as nurse went to assist pt and yelled for help pt aroused. Pulse stayed strong and regular. Pt was not pale or clammy. Assisted to sitting position gave cold cloth and juice and referred to ER.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest X-ray, Musculoskeletal pain
Clinical narrative: Began having worsening low back pain and severe pain in left shoulder and upper back.
Age: 18.0
Sex: M
Vaccine: MEN, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 5in x 6in erythema, swollen, warm to touch and tender area on back of L arm where Varicella was given at Pt. First 3 days ago. ZYRTEC given today, hydrocortisone cream 1 % applied and ice pack applied.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dyskinesia, Swelling face
Clinical narrative: Per mom, pt awoke with left side of face swollen and pt could not control the left side of her face. no other symptoms per mom.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain, MD dx of cellulitis.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pruritus
Clinical narrative: Adverse Effects began as itching only. Progressed over the next day and a half to a large area of inflammation that was red in color.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Sharp pain during injection. Has had left shoulder pain since, with raising and reaching. Pain will occasionally radiate down her arm, left side neck pain.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Induration, Skin warm, Syncope
Clinical narrative: Patient developed a temperature of 10; warmth, redness, and hard left arm; frontal headache; period of syncope. Patient was started on Clindamycin HCL 300 mg Q.I.D. x 4 days.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Vaccination complication
Clinical narrative: Shoulder pain and limited range of motion then lead to extreme shoulder pain that felt like a torn rotator cuff. Went to PCP and was told it was a vaccine reaction, given steroids and prescribed Physical therapy.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Shoulder pain and limited range of motion then lead to extreme shoulder pain that felt like a torn rotator cuff. Went to PCP and was told it was a vaccine reaction, given steroids and prescribed Physical therapy.