chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information had been received on 21-OCT-2016 from a registered nurse who reported that on 17-OCT-2016, two male patients (ages unknown) (see MARRS# 1611USA007724), received an improperly stored dose of GARDASIL 9 (lot# M017983, expiration date 30-APR-2018). Temperature was 57.7F at time frame of 14 hours. Call was because of a data logger. There was no previous temperature excursion. No adverse effects reported. No further details provided. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient inadvertently received a dose of PNEUMOVAX 23 (lot # M032635, expiration date 05-MAY-2018; dose and route were unknown) instead of PREVNAR 13. 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 was received from a medical assistant and refers to a currently 12 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left arm bicep and tricep with increased warmth, edema and erythema.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. In approximately 2015("about 1 year ago"), the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, frequency, route, lot # and expiration date were not reported). After being administered, on an unknown date, the patient experienced syncope. At the time of this report, the outcome of the event was unknown. The causality between the event and GARDASIL 9 was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a medical assistant referring to a 8 year old female patient. The patient was not pregnant. The patient's pertinent medical history and drug reactions/allergies were not provided. Concomitant therapies included losartan (manufacturer unknown), amlodipine (reported as amlodidine) and oxybutynin. On 31-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L017265, expiration date 10-FEB-2017, subcutaneous, once; dose was unknown). On the same day, 3 hours after the vaccination (reported as "3 hours ago"), the patient's arm was very painful with no swelling and no redness, ice was applied to the arm. The outcome of the event was unknown. The causality assessment was not provided. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, chills, nausea, vomiting, diarrhea approx. 10 hours post vaccine.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypersensitivity, Local swelling, Pain
Clinical narrative: Localized swelling, redness, pain (localized allergic reaction).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Mild problem redness, soreness, swelling and itching.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 12 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Age: 56.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A large amount of swelling, redness and hot to touch where shot was given for about a week. Entire arm was sore. Much worse after second shot.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with VARIVAX lot # L046888, expiration date: 23-NOV-2017, lot # M024680, expiration date: 18-MAY-2018, lot # M0101484, expiration date: 01-MAR-2018 (strength, dose, frequency and route of administration were not reported) which were improperly stored at 8.6 Fahrenheit degrees for 1 hour and 15 minutes. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported. No adverse effect was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA lot # reported as L023939, expiration date 15-MAR-2017, (dosage and therapy route were not provided). Concomitant therapies were not informed. The VAQTA was exposed to 33F for 48 hours. It was informed that there was no previous excursions and it was a call due to data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Lot # L023939 is not valid for hepatitis A vaccine, inactivated. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swollen/sore night of vaccination, swelling increased after exercise next day - red/inflamed. Warm to touch. Seen in clinic 8-12-2016; swelling into elbow, tender to touch. Prescribed Cephalexin and ZYRTEC.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Arm swollen/sore night of vaccination, swelling increased after exercise next day - red/inflamed. Warm to touch. Seen in clinic 8-12-2016; swelling into elbow, tender to touch. Prescribed Cephalexin and ZYRTEC.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Chest pain
Clinical narrative: Pt received HPV 9. Reported same night of administrations, had chest pain. Resolved without treatment. Reported to provider during flu visit two months later. Evaluated by pediatrician.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Erythema, Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Vaccine given in left arm. Started to immediately get itchy and red at site of injection. Progressed to rt. arm and back of neck. Became dizzy. No acute distress. Resolved in one hour.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: Vaccine given in left arm. Started to immediately get itchy and red at site of injection. Progressed to rt. arm and back of neck. Became dizzy. No acute distress. Resolved in one hour.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Staring
Clinical narrative: R deltoid-Tdap injection, then MENACTRA after 2nd injection, within 30-60 seconds child looked blank, MA told to lay down-he blacked out seconds. Layed down x 15-20 mins on 3x2m table. PN at side and MA's.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelled tremendously, was red and hot. I had chills, fever and body aches. My arm was extremely painful and sore for several days.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Arm swelled tremendously, was red and hot. I had chills, fever and body aches. My arm was extremely painful and sore for several days.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site reaction, Pain, Pyrexia, Urticaria
Clinical narrative: Large red whelp to (L) deltoid with body aches and fever that started after receiving tdap shot on 11/07/16.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Onsite reaction, injection site is red and swollen for past days. Referred to her doctor.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed symptoms similar to shingles (i.e. painful rash).
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Headache, Impetigo, Pain, Rash
Clinical narrative: Patient developed symptoms similar to shingles (i.e. painful rash).
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Patient developed symptoms similar to shingles (i.e. painful rash).
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Full blood count normal, Injection site erythema, Injection site swelling, Metabolic function test normal
Clinical narrative: Redness and swelling at injection site that spread to inner arm.
Age: 28.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Red swelling hot where shot given. Fever and chills 24 hours after shot for 12 hours then in 48 hours for 12 hours again fever and chills. After second dose of BEXSERO.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Cellulitis, Hypersensitivity, Pyrexia, Rash, Skin warm
Clinical narrative: In Rt. arm (arm PREVNAR administered) pt. had a rash, hot to the touch, and fever. Dr. diagnosed as allergic reaction and cellulitis. Pt. was treated with diphenhydramine and antibiotics on 11/16/16.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Lymphadenopathy, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient reports having the following side-effects after 7 A.M. (11/16/16). Fever (100 degrees F), headache, stiff neck, swollen glands on left side of neck.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient had swelling and pain in arm next day for 6 days. Reported fever and difficulty breathing but no emergency TXT was seeked.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness
Clinical narrative: Pt reported severe dizziness 1 week after receiving PPSV-23 vaccine.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient was seen by her physician due to developing "redness swollen injection site, and red-circle around the injection site".
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Injection site redness and itching 1 week after injection.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth at injection site (Deltoid to elbow).
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. Information about concurrent condition, concomitant mediation and medical history was not provided. In October 2016 ("within the last month"), the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, frequency, route, lot # and expiration date were not reported). After being administered, the patient experienced syncope. At the time of this report, the outcome of the event was unknown. The causality between the events and GARDASIL 9 was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a office manager refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M007764, 30-JAN-2018. No adverse effect was reported. Temperature was 74.3F for 28 hours and it was administered. There was no previous temperature excursion. This is one of the three cases received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Encephalopathy, Intensive care
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of encephalopathy in a child male patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, 21 days after receiving BEXSERO, the patient experienced encephalopathy (serious criteria GSK medically significant) and felt faint (serious criteria hospitalization). On an unknown date, the outcome of the encephalopathy and felt faint were recovered/resolved. The reporter considered the encephalopathy and felt faint to be unlikely related to BEXSERO. Additional details were provided as follows: The patient was 7 to 10 years old. The age at vaccination was not reported. Three weeks after receiving BEXSERO the patient went to the health center and presented a fainting event. Due to this event he was derived to a hospital where he was admitted to intensive care unit (ICU). The patient had very fast and good evolution. The reporter reported the event to the regulatory agency through the official channel.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Expired product administered, Hypoaesthesia, Injection site pain, Mobility decreased
Clinical narrative: Initial unsolicited report received from other non health care professional on 09 November 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Menactra (batch number: U5068AB, dose, expiration date site and route of administration was not reported) on an unspecified date (reported as in Septmeber last year). The patient's medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had pain at the injection site, experienced numbness in left side to where patient could not use left side of body and also had extreme lower back pain. On an unspecified date patient had emergegncy room visit and was hospitalized for six days because of extreme lower back pain. It was a case of expired vaccine used. As patient claims vaccine was expired at the time of administration. Lab data and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none. Sender's Comments: This case concerns a female patient who developed low back pain, body numbness and pain at the injection site after receiving a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Details regarding latency from vaccination, medical history of the patient, vaccination history, concomitant medications, immune status of the patient and reporter causality were not reported. However details regarding latency, medical history, previous vaccination history, concomitant medications, concurrent conditions and patient immune status at the time of vaccination and other etiologies would be helpful to further assess this case.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site discomfort, Mobility decreased
Clinical narrative: I have received flu vaccine's shots for many years in the past. I have never had a reaction in the arm I received the shot. I don't known what kind of crap was put in my arm since I am still having pain when using that arm. It's to bad that a person can't depend that it will be done right!!!!!!!!
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: I have received flu vaccine's shots for many years in the past. I have never had a reaction in the arm I received the shot. I don't known what kind of crap was put in my arm since I am still having pain when using that arm. It's to bad that a person can't depend that it will be done right!!!!!!!!
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Dysstasia, Gait disturbance, Guillain-Barre syndrome, Laboratory test
Clinical narrative: I was diagnosed with Guillain Barre Syndrome on 05-2015. I was extremely weak in my legs for a month before I was diagnosed. I was paralyzed from my waist down for a month and my hands were very curled. I was in the hospital for 1 month and inpatient rehab for 3 weeks. I currently go to physical therapy 2 times a week. After being paralyzed and learning how to walk again I NEEDED to be in a wheelchair for 6 months due to not being able to withstand the pain in my back. After the wheelchair I have needed to use a can, I currently can't stand for more than 2 minutes without getting extreme shooting nerve pain in my back, hips and legs. I am currently taking Lyrica, oxycodone, Flexeril and Elavil for the excruciating pain I have EVERY day.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle contractions involuntary, Muscular weakness, Neuralgia, Pain, Paralysis
Clinical narrative: I was diagnosed with Guillain Barre Syndrome on 05-2015. I was extremely weak in my legs for a month before I was diagnosed. I was paralyzed from my waist down for a month and my hands were very curled. I was in the hospital for 1 month and inpatient rehab for 3 weeks. I currently go to physical therapy 2 times a week. After being paralyzed and learning how to walk again I NEEDED to be in a wheelchair for 6 months due to not being able to withstand the pain in my back. After the wheelchair I have needed to use a can, I currently can't stand for more than 2 minutes without getting extreme shooting nerve pain in my back, hips and legs. I am currently taking Lyrica, oxycodone, Flexeril and Elavil for the excruciating pain I have EVERY day.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Plasmapheresis, Walking aid user, Wheelchair user
Clinical narrative: I was diagnosed with Guillain Barre Syndrome on 05-2015. I was extremely weak in my legs for a month before I was diagnosed. I was paralyzed from my waist down for a month and my hands were very curled. I was in the hospital for 1 month and inpatient rehab for 3 weeks. I currently go to physical therapy 2 times a week. After being paralyzed and learning how to walk again I NEEDED to be in a wheelchair for 6 months due to not being able to withstand the pain in my back. After the wheelchair I have needed to use a can, I currently can't stand for more than 2 minutes without getting extreme shooting nerve pain in my back, hips and legs. I am currently taking Lyrica, oxycodone, Flexeril and Elavil for the excruciating pain I have EVERY day.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: Severe shingles outbreak.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR
Symptoms: Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: Red hard swollen arm from shoulder to elbow. Hot to touch.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Pallor
Clinical narrative: Patient was in observation area and began feeling warm and lightheaded. Immunizer immediately attended to patient, no other symptoms present. Patient loosened neck and sleeves of clothing, cool compress applied to back of neck and patient placed head between legs. Symptoms began to resolve within seconds. Patient remained in area for another 20 minutes, pallor returned to normal, patient was ambulating without symptoms. Offer was made to patient to arrange additional help or transportation to medical office, patient declined.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Headache, Secretion discharge, Throat irritation
Clinical narrative: Scratchy throat appeared first. Then thick mucous, cough, headache. I am young and healthy, therefore rest, fluids, and MUCINEX are helping with symptoms. I am still not 100 percent recovered almost 2 weeks post vaccine. I have never had any issues with the flu vaccine in the past.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Nodule, Pain in extremity
Clinical narrative: PATIENT'S DAUGHTER CALLED TO REPORT REACTION. PATIENT TOLD HER THAT HER ARM WAS EXTREMELY SORE AND HAD A KNOT THE DAY OF INJECTION. STAYED SORE SEVERAL DAYS AND SHE THOUGHT THINGS WERE IMPROVING UNTIL 11/16/16 WHEN SHE STARTED TO BURN AND ITCH AT INJECTION SITE. NOTICED HIVES ON ARM AND AREA FELT FEVERED. USED ALCOHOL TO COOL OFF BURNING BUT IT CONTINUED TO HURT.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Urticaria
Clinical narrative: PATIENT'S DAUGHTER CALLED TO REPORT REACTION. PATIENT TOLD HER THAT HER ARM WAS EXTREMELY SORE AND HAD A KNOT THE DAY OF INJECTION. STAYED SORE SEVERAL DAYS AND SHE THOUGHT THINGS WERE IMPROVING UNTIL 11/16/16 WHEN SHE STARTED TO BURN AND ITCH AT INJECTION SITE. NOTICED HIVES ON ARM AND AREA FELT FEVERED. USED ALCOHOL TO COOL OFF BURNING BUT IT CONTINUED TO HURT.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Initially redness and swelling on the arm of the injection. Followed by full body rash of the trunk, back, and neck. Ongoing symptoms as of time of report (11/17/2016). She did receive the flu vaccine on the same visit, but the symptoms started on the arm of the PNEUMOVAX.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Computerised tomogram normal, Fatigue, Gait disturbance, Mental impairment
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07-NOV-2016. This case involves an 80-year-old male patient who was vaccinated with a dose of FLUZONE HD) (batch number, expiry date, dose, dose in series were not reported) intramuscularly, in the left deltoid on 18-OCT-2016. Patient's Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Allergy to codeine. Concomitant medications were not reported. On 19-OCT-2016, one day following the vaccination, the patient felt very fatigued and 24 hours later he has instability in walking, severe tremors, having difficulty keeping his thought straight. On an unspecified date, following the vaccination, the patient was diagnosed with mild urinary tract infection. On an unspecified date, the patient was seen in the emergency room and by a neurologist. On an unspecified date, the patient was hospitalized for three days. Lab data reported as on an unspecified date, MRI, CT, chest X-ray all tests were negative and corrective treatment was reported as unspecified medication. The outcome of the events was reported as not recovered (symptoms have improved only slightly). List of documents held by sender: none. Sender's Comments: This case concerns an 80 year old male patient who was hospitalized with diagnosis of mild UTI (Urinary tract infection) with complaints of fatigue, unstable walking, tremors and difficulty in thinking one day after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. However details such as, previous immunization history and tolerance, concurrent conditions, patient immune status at the time of vaccination and diagnostic work-up to confirm alternative etiology/diagnosis etc. are needed for complete assessment of the case.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Tremor, Urinary tract infection
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07-NOV-2016. This case involves an 80-year-old male patient who was vaccinated with a dose of FLUZONE HD) (batch number, expiry date, dose, dose in series were not reported) intramuscularly, in the left deltoid on 18-OCT-2016. Patient's Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Allergy to codeine. Concomitant medications were not reported. On 19-OCT-2016, one day following the vaccination, the patient felt very fatigued and 24 hours later he has instability in walking, severe tremors, having difficulty keeping his thought straight. On an unspecified date, following the vaccination, the patient was diagnosed with mild urinary tract infection. On an unspecified date, the patient was seen in the emergency room and by a neurologist. On an unspecified date, the patient was hospitalized for three days. Lab data reported as on an unspecified date, MRI, CT, chest X-ray all tests were negative and corrective treatment was reported as unspecified medication. The outcome of the events was reported as not recovered (symptoms have improved only slightly). List of documents held by sender: none. Sender's Comments: This case concerns an 80 year old male patient who was hospitalized with diagnosis of mild UTI (Urinary tract infection) with complaints of fatigue, unstable walking, tremors and difficulty in thinking one day after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. However details such as, previous immunization history and tolerance, concurrent conditions, patient immune status at the time of vaccination and diagnostic work-up to confirm alternative etiology/diagnosis etc. are needed for complete assessment of the case.
Sex: M
Vaccine: FLUX
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) via sales representative on 10 Nov 2016. This case involves a male patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, route, dose not reported) on 31 Oct 2016 and a dose of PNEUMOCOCCAL VACCINE on an unspecified date (reported as vaccinated two weeks before flu shot). Patient's pre-existing physician diagnosed allergies, birth defects was not reported and ongoing medical conditions included Type III Gaucher disease. Concomitant medications include CZ [Cerezyme]. It was also reported that patient was on high dose of Cerezyme (6000 units Q2 weeks). Some medications of patient's was adjusted. On 02 Nov 2016, two days following flu vaccination and unspecified timeframe after pneumonia vaccine, the patient experienced seizure. Lab data was not reported and patient received Lamictal from 150 mg to 200 mg every night along with Depakote as corrective treatment. The patient's event outcome was not reported. The case was reported as serious be reporter. List of documents held by sender: none. Sender's Comments: This case concerns a male patient who had a seizure, two days after receiving a dose of INFLUENZA VACCINE. It was reported that the patient had received PNEUMOCOCCAL VACCINE two weeks before his flu shot. The patient has a history of Type 3 Gaucher disease and on treatment with anticonvulsants. Details such as, event information, previous immunization history and tolerance, patient immune status at the time of vaccination and reporter causality are not reported. As multiple vaccines are administered the role of each vaccine cannot be assessed and based on the medical history, the role of vaccine is unlikely.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Acne, Contusion, Erythema, Swelling
Clinical narrative: This spontaneous report received from a pharmacist referred to a 71 year old female patient. The patient's medical history, concurrent conditions were not reported. Historical drug included PREVNAR 13 which taken on an unknown date in 2015. On 21-OCT-2016, the patient was vaccinated with influenza virus vaccine inactivated (unspecified) (FLU SHOT) and in the opposite arm the patient was vaccinated with PNEUMOVAX 23 (lot number: L027732, expiry date: 23-FEB-2017) (dose and route were not reported). The patient's arm that received PNEUMOVAX 23 had redness and swelling that extended to her back and a bruise under her arm that began 1 or 2 days after the injection that worsened after 3 to 4 days. The redness continued and was present a week ago. The patient also experienced pimples on her abdomen and the front of her legs that began on an unspecified date that improved with BENADRYL taken on unspecified dates. The patient went to an unspecified urgent care center on 23-OCT-2016. The event pimples was resolving. It was unknown of her present status or if she had recovered from the other events. Causality assessment was not resolving. It was unknown of her present status or if she had recovered from the other events. Causality assessment was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site pain, Musculoskeletal pain
Clinical narrative: Pain at site of injection, later: arm and shoulder pain, having trouble sleeping; no treatment.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Drooling, Febrile convulsion, Hypotonia, Irritability, Pain in extremity
Clinical narrative: After we got home from his doctors we ate he was normal just legs a little sore. We took a nap on the couch for a couple hours and when we woke up he was very cranky. We layed back down then when we woke up the final time he had a fever of 102.8 I stripped him out a cold rag on his head and layed him next to me while I was sitting on the bed. A couple mins after that his arm began shaking and something told me that wasn't right he started looking at me funny and looking past me so I picked him up mind you his body was so limp like lifeless. I ran upstairs to my mom and she's a RN so she was working his body out saying his name while I screamed around the house looking for his bag. His other hand started shaking and he turned his head to the side like he was going to pass out and a lot of droll started coming out his mouth but it was clear no tint of the milk I just tried to give him so I knew something wasn't right!! He was still shaking as I put his coat on then he let out a LOUD scream and it all stopped like it never happened I quickly put him in his seat and we went to the hospital. Worst experience and nothing I ever want to witness again!!!!!
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Tremor
Clinical narrative: After we got home from his doctors we ate he was normal just legs a little sore. We took a nap on the couch for a couple hours and when we woke up he was very cranky. We layed back down then when we woke up the final time he had a fever of 102.8 I stripped him out a cold rag on his head and layed him next to me while I was sitting on the bed. A couple mins after that his arm began shaking and something told me that wasn't right he started looking at me funny and looking past me so I picked him up mind you his body was so limp like lifeless. I ran upstairs to my mom and she's a RN so she was working his body out saying his name while I screamed around the house looking for his bag. His other hand started shaking and he turned his head to the side like he was going to pass out and a lot of droll started coming out his mouth but it was clear no tint of the milk I just tried to give him so I knew something wasn't right!! He was still shaking as I put his coat on then he let out a LOUD scream and it all stopped like it never happened I quickly put him in his seat and we went to the hospital. Worst experience and nothing I ever want to witness again!!!!!
Age: 1.17
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Full body rash, redness and induration at site of injection.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Pt complained really sore arm, could not sleep due to pain, shoulder feels pulled on, pt states she cannot raise her arm at all.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: 11/17 Patient received her influenza vaccination (FLULAVAL) on the afternoon of 11/15. She reported today that her lymph node under the arm she received the shot began to swell the night of receiving the vaccination. She described to appearance of the lymph node to be about the size of an egg but flatter. She reported that the swelling has been consistent since then. Patient reported that the reaction is limited to only the side that the vaccination was given. She reports no fever or trouble moving muscles. She stated the area is not hot to the touch. Patient reports that she hasn't had a flu shot in 5 years and stated there were no issues when she received her last one. Patient stated that she has a PCP visit scheduled for Monday and will get the situation evaluated at that time. After being recommended to be seen by her provider sooner, she stated that she doesn't plan to be seen sooner than Monday unless her symptoms get much worse.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Patient experienced pain in her wrist and no swelling, which caused her to seek medical advice.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SWOLLEN, HOT, VERY PAINFUL AT INJECTION SITE. COULDN'T LIFT ARM.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Fever occurs with 101.3 F.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pharyngeal oedema, Rash
Clinical narrative: Rash, throat swelling, pain all over.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chest pain, Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: Fever, uncontrollable shaking, throbbing pain radiating from injection site down the arm, pain across the chest, under the collarbone, in the shoulder joint, with pin prick like stabs of pain in the fingertips. Ice on injection site, over the counter pain meds (acetaminophen, aspirin), heating pad.  Pain in shoulder joint and muscles in upper arm persisting as of 11/17/2016.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Paraesthesia, Pyrexia, Tremor
Clinical narrative: Fever, uncontrollable shaking, throbbing pain radiating from injection site down the arm, pain across the chest, under the collarbone, in the shoulder joint, with pin prick like stabs of pain in the fingertips. Ice on injection site, over the counter pain meds (acetaminophen, aspirin), heating pad.  Pain in shoulder joint and muscles in upper arm persisting as of 11/17/2016.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Dyspnoea, Nausea, Vomiting
Clinical narrative: Pt states she woke up this morning with shortness of breath, dizziness, nausea and vomiting x 2.  She had no symptoms until this morning.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule
Clinical narrative: Golf ball size knot appeared at injection site 45 minutes after receiving flu shot.  Cold compress applied to site.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Cyanosis, Irregular breathing, Unresponsive to stimuli, Vomiting
Clinical narrative: Less than one minute after vaccine administration patient stood up from clinic bed and sat in bedside chair and requested water. She then slumped forward and was guided to the ground by the provider. She had full loss of consciousness and was not responding to verbal stimuli. She appeared to have irregular breathing without evidence of cyanosis. She woke less than 30 seconds later and stated she was fine, she was returned to a seated position and began having multiple episodes of emesis. On follow up appointment patient reported that it took about 4 hours for her to feel back to her usual self.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site pain, Pruritus, Scab
Clinical narrative: Area on Left arm muscle. A crusty film appears every few months and itches and falls off. Then it keeps happening. The spot of the vaccine has a stinging feeling almost all the time. It's a discomfort and now I'm afraid to get this year flu vaccine.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Per staff at hospital. Dr. stated patient had weakness, numbness and tingling and symptoms of Guillain-Barre.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Musculoskeletal stiffness, Pyrexia, Rhinorrhoea, Skin reaction, Tremor
Clinical narrative: Mother reported child turned bright red, became stiff, fluid coming out of nose, shaking and this went on for a few minutes.  Mother retrieved sleeping father and they both rushed infant to the local ER.  Infant was back to normal baseline by the time they arrived at the hospital.  Child had a fever of 100.4 and mother had given Tylenol prior to the event occurring.  Temperature at the Wishek ER was 99.8.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Received PNEUMOVAX 23 in left deltoid.  Left arm distal to deltoid and proximal from elbow became red and inflamed.  Swelling and symptoms disappeared in 3-5 days.
Age: 26.0
Sex: F
Vaccine: HPVX
Symptoms: Bursitis, Musculoskeletal pain, Myositis, Pain
Clinical narrative: Sharp pain in shoulder/arm when raised above shoulder level; constant ache in shoulder, pain while doing normal activities (washing hair, putting on/taking off clothes, driving, etc.); diagnosed by orthopedist as having suspect myositis or bursitis after persistent pain for 4 weeks following vaccine. 5.5 weeks out today and physical therapist suspects bursitis.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Abnormal behaviour, Delayed fontanelle closure, Ultrasound scan normal
Clinical narrative: Mom called answering service (office closed) at 0810 am 11/17/16. Stated pt's fontanelle was enlarged, seemed full of fluid, pt. quieter than usual, afebrile, sent to ER. Results negative/WNL.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Pain, Palpitations
Clinical narrative: Palpitation, body aches, shortness of breath, severe headache on the administration date (10/20/16) -> she went to ER and was treated on 10/22-10/23.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Loss of consciousness, Muscle twitching, Urinary incontinence
Clinical narrative: Pt was given her first Gardasil shot this morning while sitting on a chair, after less than a minute, the pt passed out and her head twitched for about 5 seconds. She urinated involuntarily and was diaphoretic. Ammonia capsule was placed close to her nose & she regained consciousness. An attempt was made to call 911 but pt is now alert and oriented so call cancelled. The incident lasted for about 30 seconds. Oxygen provided via face mask at 4L/min. Pt is now alert & oriented w no signs of acute distress. After 5 minutes, she passed out again which lasted for about 10 seconds. Pt again is alert and orieneted. VS stable. PERRLA. No signs of acute distress. Pt was brought to exam table to lie down w ice pack behind her neck. Mom at waiting room was called inside. She will be bringing the pt home. Pt & mom denies any allergies. She is advised to see pcp for second Gardasil shot. She left the clinic in a stable condition w no symptoms/complaints. ER warnings given. Asst manager called pt in PM to f/up, no answer.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Overdose
Clinical narrative: Patient got ZOSTAVAX injection 11/16/2016 and 11/17/2016.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Hives; whelps; redness at site, viewed today 11/17/16, 6 days after vaccination. Patient has had rxn since 11/11/16. Our pharmacy gave her famotidine 10 mg and hydrocortisone 1% crm to take home.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Cardiac stress test, Chest X-ray normal, Culture throat negative, Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches and some congestion lasting 18 days.  Was seen in clinic and had other causes ruled out. i.e. Urinealysis, chest X-ray, threat culture.  All were negative.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion, Urine analysis normal
Clinical narrative: Fever, muscle aches and some congestion lasting 18 days.  Was seen in clinic and had other causes ruled out. i.e. Urinealysis, chest X-ray, threat culture.  All were negative.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: Initial reaction was soreness in arm around injection site. No signs of bruising or swelling around area seen.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Nerve conduction studies, Neurological examination
Clinical narrative: Guillain-Barre Syndrome. IVIG.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Neurological symptom
Clinical narrative: Guillain-Barre Syndrome. IVIG.
Age: 5.0
Sex: M
Vaccine: TYP
Symptoms: Erythema, Rash papular
Clinical narrative: Papular rash erupted on abdomen, shoulders and later jaw line and forehead. Slightly erythematous in a few areas. No itching no oozing, no respiratory issues, no discomfort.
Age: 21.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: The injection site bruised and became red and swollen about 10 days after administration.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Malaise
Clinical narrative: "Felt sick" for 1 day. Also, injection site area of arm became red and painful for a week.  Redness also spread down the arm some.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Flushing, Rash pustular
Clinical narrative: At onset blister was flush with skin; a few hours later, blister/pustule was 1/2 CM raised clear filled.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Headache, Herpes zoster, Pain, Pruritus
Clinical narrative: Shingles rash groin area, buttocks, lower chest, itching, little pain.  102 degree fever, chills, headache.  Rash lasted @ 12 hours, other symptoms lasted 24 hours.  Treated with Benadryl, Caladryl, Tylenol.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, Rash
Clinical narrative: Shingles rash groin area, buttocks, lower chest, itching, little pain.  102 degree fever, chills, headache.  Rash lasted @ 12 hours, other symptoms lasted 24 hours.  Treated with Benadryl, Caladryl, Tylenol.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: SEVERAL DAYS AFTER THE INJECTION PT NOTICED A REDNESS AROUND THE SITE OF INJECTION WHICH TURNED ITCHY.  RED PATCH HAS INCREASED TO ABOUT THE SIZE OF HER PALM OVER THE NEXT DAYS.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A 72-year-old female patient received PREVNAR13 on unknown date at single dose for immunization. 2 days later her arm began to turn extremely red. She went to her physician and he diagnosed cellulitis. He prescribed an antibiotic. The cellulitis last for 6-7 days. The outcome of the other event was unknown. Sender's Comments: Based on the information currently available, a causal relationship between the administration of PREVNAR13 and the occurrence of the reported events cannot be completely excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: FLU4, PNC13
Symptoms: Chills, Headache, Influenza like illness, Pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received a single dose of PREVNAR 13 and a high dose of FLUZONE, both in Oct2016, one in each arm for immunization.  The patient medical history and concomitant medications were not reported.  On an unspecified date, after vaccinations, the patient experienced headache, chills, body ache and flu-like symptoms. The patient recovered from all the events on an unknown date.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Malaise, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative who reported for himself. This elderly male patient received on an unknown date a single dose of PREVNAR 13 and influenza vaccine (manufacturer unknown), both for immunization. Concomitant medications and medical history were not reported. On an unspecified date the patient felt sick and arm was sore. Outcome of the event arm was sore was recovered on an unspecified date after 12 hours. Outcome of the event felt sick was unknown.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Chills, Headache, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Received ADACEL in left deltoid; FLUARIX QUAD and PNEUMOVAX in right deltoid on 10/03/16. Patient has had TDAP and flu shots previously with no adverse reactions. Experienced immediate pain upon injection of the Pnemovax that never ceased. Could not sleep on right arm the night following the vaccines. Following day (10/04/16) had headache that was non-responsive to OTC painkillers and was unable to lift right arm without extreme pain. Later that night began experiencing chills and a fever of 100.4. The next morning (10/05/16) at 5am, fever was at 101.4. Went into doctor at 9am and discussed steroids to lessen immune response or tramadol for headache/arm pain. Only tramadol was given. Went home, took tramadol, and took a nap. Waking up from nap with chills, fever was 102.7. Promptly went to urgent care at 6pm to get steroids. 24 mg of methylprednisolone taken at 7pm. All symptoms were resolved the following morning. Hard to say which vaccine caused adverse reaction or if one large immune response to getting 3 vaccines at once.