chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chest X-ray normal, Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself.  A 68-year-old male patient received the first dose of the PREVNAR 13, intramuscularly in the right arm on an unspecified date in 2014 at a single dose for immunization. Medical history included heart attack which occurred eight years ago, cholesterol, and 'heart.' Concomitant medication included BAYER ASPIRIN taken for years, amlodipine besilate (MANUFACTURER UNKNOWN) taken for years, lisinopril (MANUFACTURER UNKNOWN) for heart taken for years, atorvastatin calcium (MANUFACTURER UNKNOWN) taken for years, VITAMIN B12 taken for years, VITAMIN D3 taken for years, and influenza vaccine which the patient received in the left arm couple of days before receiving the pneumococcal 13-valent conjugate vaccine. On an unspecified date, the patient experienced limited arm movement and pain. The patient waited to see his physician until his regularly scheduled appointment four or five months later. The events were further described as: patient received the pneumococcal 13-valent conjugate vaccine two years ago on an unspecified date in Nov2014 or Dec2014 in the morning between 09:00 and 11:00 and developed limited arm movement and continued to have pain in arm. The patient noticed the limited arm movement and pain either in Dec2014 or Jan2015. The patient could not raise arm above shoulder. The pain was not constant and occurred only when the patient tried to reach, lift arm above shoulder, or bend over to reach. This caused the patient's right shoulder to hurt. The patient underwent lab tests and procedures which included x-ray of arm and chest: nothing showed up on an unspecified date.  Therapeutic measures were taken as a result of limited arm movement and pain, and included exercises. The patient went to the doctor and did exercises, which did not help. The arm exercises included rotating arm back and forth and stretching. The patient sometimes used a rubber band material for the exercises. The clinical outcome of the events, limited arm movement and pain, were not recovered.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: X-ray limb normal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself.  A 68-year-old male patient received the first dose of the PREVNAR 13, intramuscularly in the right arm on an unspecified date in 2014 at a single dose for immunization. Medical history included heart attack which occurred eight years ago, cholesterol, and 'heart.' Concomitant medication included BAYER ASPIRIN taken for years, amlodipine besilate (MANUFACTURER UNKNOWN) taken for years, lisinopril (MANUFACTURER UNKNOWN) for heart taken for years, atorvastatin calcium (MANUFACTURER UNKNOWN) taken for years, VITAMIN B12 taken for years, VITAMIN D3 taken for years, and influenza vaccine which the patient received in the left arm couple of days before receiving the pneumococcal 13-valent conjugate vaccine. On an unspecified date, the patient experienced limited arm movement and pain. The patient waited to see his physician until his regularly scheduled appointment four or five months later. The events were further described as: patient received the pneumococcal 13-valent conjugate vaccine two years ago on an unspecified date in Nov2014 or Dec2014 in the morning between 09:00 and 11:00 and developed limited arm movement and continued to have pain in arm. The patient noticed the limited arm movement and pain either in Dec2014 or Jan2015. The patient could not raise arm above shoulder. The pain was not constant and occurred only when the patient tried to reach, lift arm above shoulder, or bend over to reach. This caused the patient's right shoulder to hurt. The patient underwent lab tests and procedures which included x-ray of arm and chest: nothing showed up on an unspecified date.  Therapeutic measures were taken as a result of limited arm movement and pain, and included exercises. The patient went to the doctor and did exercises, which did not help. The arm exercises included rotating arm back and forth and stretching. The patient sometimes used a rubber band material for the exercises. The clinical outcome of the events, limited arm movement and pain, were not recovered.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Product colour issue
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date as single dose for immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced redness on an unspecified date. A separate concern regarding the color of PREVNAR 13 after shaking vigorously was also reported, date unspecified.  The outcome of redness and separate concern regarding the color of PREVNAR 13 after shaking vigorously was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse reporting on behalf of a physician. This nurse reported similar events for 3 patients. This is the 1st of 3 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe arm pain following the injection on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016503345 Same reporter/drug/event, different patient; US-PFIZER INC-2016503348 Same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse reporting on behalf of a physician. This nurse reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe arm pain following the injection on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016503342 Same reporter/drug/event, different patient; US-PFIZER INC-2016503348 Same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse reporting on behalf of a physician. This nurse reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe arm pain following the injection on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016503342 Same reporter/drug/event, different patient; US-PFIZER INC-2016503345 Same reporter/drug/event, different patient.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 4-month-old female patient (weighting 15 pounds and 9 ounces) received the 2nd shot of PREVNAR 13, (Lot # N05076, exp date Sep2017, NDC #  0005197102, UPC # N300051971022) intramuscular at 0.5 ml, single dose at right thigh on 26Oct2016 at 9:30 am for immunization at Doctor's office. Medical history were none. Concomitant medication included the 2nd shot of ROTAVIRUS VACCINE, (Merck, Lot # M004542) oral and the 2nd shot PENTACEL (Sanofi, Lot # C5233AA) IM at left thigh, both on 26Oct2016 for immunization with no adverse events occurred. The patient previously ROTAVIRUS VACCINE and PENTACEL in 2016. The patient received PREVNAR 13 shot 1st time when she was of 2 months old in 2016 for immunisation and this was her 2nd shot at 4 months. No other vaccines were given 4 weeks prior to the day of suspected vaccine. Patient did not have any siblings. The patient started experiencing redness and swelling in one of her legs probably after 3 or 5 minutes after she was given the shot on 26Oct2016.  Treatment received: Benadryl. Patient was kept in clinic for one and half hours and she was fine (recovered completely). Nurse mentioned that they were going to do a follow up with the allergist doctor to make sure that patient was not allergic to the Prevnar 13. The reporter assessed redness and swelling in one of her legs were Unrelated to Prevnar 13.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Bilateral upper and lower extremity Urticaria.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Patient complained of painful arm since receiving shot. Came in with very red and itchy arm. Gave pt Benadryl, but did not seem to help. Pt went to urgent care who said it was infected. They prescribed Keflex 500mg and Prednisone 20mg. Pt feeling better as of 10/24.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient is reporting a sore arm as of 11/2/16 (19 days post-injection). Was not accurate/consistent rating it on a pain scale of 1-10. Did not report that he still has a lump or induration at injection site, just pain - especially upon elevation of the arm.
Age: 52.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Erythema, Feeling hot, Inflammation, Pain
Clinical narrative: Warmth, redness, inflammation, pain.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Glossodynia, Injected limb mobility decreased, Migraine, Musculoskeletal pain
Clinical narrative: My shoulder is crazy sore (3 days later) and my tongue was sore and I got a migraine.  The shoulder pain is the only one I still have.  But it is very challenging to lift my arm.  :-(  - Per pt.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, and itching of upper arm injection site. Diagnoses with cellulitis on 10/16/2016.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Musculoskeletal stiffness, Neck pain
Clinical narrative: Left neck pain, stiffness and spasm.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness; swelling; itching at site.
Age: 71.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm turned red, was swollen, hurt and she ran a fever --was much worse that night--- told she could  take tylenol or ibuprofen for pain or fever --she said she was a nurse.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Eye swelling, Oropharyngeal pain
Clinical narrative: I am a registered nurse at Medical Center.  I have received the flu vaccine every year since 2007, without any reaction. This year, after my Administrator On Duty gave me the shot about 2 hours after, I started getting swollen eyes and a sore throat. I called the pharmacy, they said to call our AOD. She then told me to call our employee health nurse, who does not get into the office until about 7:30 AM. As the morning proceeded, My symptoms started getting worse, and I felt like I couldn't catch my breath. Once I saw our employee health nurse, she advised me to go to the ER for treatment. Once in the ER, they administered a bolus of fluid for my heart rate (150s), as well as, Benadryl IV, Epinephrine sub Q, and dexamethasone IV.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warm.
Age: 53.0
Sex: F
Vaccine: MENB, MNQ, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: 5 to 6 hours after receiving BEXSERO IM in left deltoid the left arm became swollen and red from shoulder to elbow. Pt. also developed generalized body aches, low grade fever, chills and nausea lasting 48 to 72 hours.
Age: 53.0
Sex: F
Vaccine: MENB, MNQ, PPV
Symptoms: Pyrexia
Clinical narrative: 5 to 6 hours after receiving BEXSERO IM in left deltoid the left arm became swollen and red from shoulder to elbow. Pt. also developed generalized body aches, low grade fever, chills and nausea lasting 48 to 72 hours.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme pain in arm / shoulder where vaccine was administered. Severe loss of mobility.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Rash
Clinical narrative: PATIENT HAS LOCALIZED REACTION WITH RAISED BUMP. RECOMMENDED PATIENT TAKE BENADRYL CREAM AND TABLETS.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Cough, Diarrhoea, Pain, Pyrexia
Clinical narrative: Sever abdominal pains and diarrhea. Soon after body aches and fever of 102+ set in for at over 72 hours. Next congestion and chronic coughing and and chest congestion began. I was given Benadryl for swelling and Ibuprofen for the fever and the pain. A cough suppressant and inhaler were taken to assist with breathing. Excessive fluids given to assist with fluid loss from diarrhea.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Swelling
Clinical narrative: Sever abdominal pains and diarrhea. Soon after body aches and fever of 102+ set in for at over 72 hours. Next congestion and chronic coughing and and chest congestion began. I was given Benadryl for swelling and Ibuprofen for the fever and the pain. A cough suppressant and inhaler were taken to assist with breathing. Excessive fluids given to assist with fluid loss from diarrhea.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Mobility decreased, Pain in extremity, Rash
Clinical narrative: Chills, Loss of arm movement, very sore, rash on arm. Chills and loss of arm movement lasted day of vaccine. Soreness and rash lasted 3 days.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood test, Cardiac stress test, Electrocardiogram, Gait disturbance
Clinical narrative: Weakness in legs, trouble walking then a few days later arm weakness and then severe back pain and then hurt to breathe went to emergency room vomited and fainted.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Painful respiration, Syncope, Ultrasound scan, Vomiting
Clinical narrative: Weakness in legs, trouble walking then a few days later arm weakness and then severe back pain and then hurt to breathe went to emergency room vomited and fainted.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Weakness in legs, trouble walking then a few days later arm weakness and then severe back pain and then hurt to breathe went to emergency room vomited and fainted.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Pain
Clinical narrative: A little swelling and pain around shoulder blade.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Brain scan normal, Eye movement disorder, Muscle rigidity
Clinical narrative: We were sitting at the dinner table and she put her head back and her body went rigid and her eyes rolled back for about 30-45 seconds, then she started to come back around.  She said she could hear us talking but it was all black.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Localized pain, redness, swelling.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Feeling abnormal, Headache, Nausea
Clinical narrative: Patient starting experiencing extreme nausea and feeling funny, mild headache.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Loss of consciousness, Malaise, Syncope
Clinical narrative: Patient stated she wasn't feeling well and immediately collapsed to the ground within 5 mins of receiving the vaccine. After regaining consciousness, she felt a little numbness in 1 finger.
Age: 63.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and whelps all over torso.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redness and inflammation at injection site.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Circular redness at injection site, swelling, pain - persisted for ~ 3 days.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Beginning the night of the vaccination before bedtime, the patient described soreness of her left arm. This progressed to bad pain in the shoulder, fatigue, headache, much redness and swelling towards the elbow from the injection site and pain to the touch up and down the arm. Patient stated that it was starting to resolve 10/30 but still red and painful. She did want to visit a physician at this time. I will follow up with her 11/3/2016.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus, Pyrexia, Urticaria
Clinical narrative: Patient said on 10/29 she developed fever and aching-10/30-sweating and fever-11/1 large hives and itching-she is taking Benadryl and using hydrocortisone topically-vaccine was the only thing that was different so she is concluding that vaccine is the cause of the hives and itching--advised her to contact her doctor tomorrw 11/3. She contacted us today 11/2.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Redness, itch, warmth that covered entire back of arm.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood test, Erythema, Infection, Skin warm
Clinical narrative: Patient said she had redness and warmth to the touch.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient said she had redness and warmth to the touch.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site warmth
Clinical narrative: Patient said she had redness and warmth to the touch.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site joint inflammation, Injection site pain, Injection site reaction
Clinical narrative: Hi dose flu vaccine given approx 1 1/4 inches below acromion process. Felt immediately that shot not in deltoid. Felt bursting like sensation and nausea. Minor pain that day increasing steadily within next several days. E-mail to provider on 9/25 re shoulder pain from shot. Told to come in for return visit. Return visit 10/7. Told to ice and Ibuprofen and TOPRICIN cream. 10/17 notified office that pain still not resolving. Referral made to orthopedics. Seen by Sports Medicine. X-ray and examination. Dx of synovitis and tenosynovitis L shoulder. Steroid shot given into joint. Continue with pain.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Sensory disturbance, Tenosynovitis, X-ray
Clinical narrative: Hi dose flu vaccine given approx 1 1/4 inches below acromion process. Felt immediately that shot not in deltoid. Felt bursting like sensation and nausea. Minor pain that day increasing steadily within next several days. E-mail to provider on 9/25 re shoulder pain from shot. Told to come in for return visit. Return visit 10/7. Told to ice and Ibuprofen and TOPRICIN cream. 10/17 notified office that pain still not resolving. Referral made to orthopedics. Seen by Sports Medicine. X-ray and examination. Dx of synovitis and tenosynovitis L shoulder. Steroid shot given into joint. Continue with pain.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Went to emergency room.  Diagnosed with cellulitis.  Symptoms were large red/pink rash on arm between injection site and elbow, warm, swollen, and painful.  Prescribed Keflex (cephalexin) 500mg, 4 times a day, for 10 days.  Symptoms improved after 48 hours of taking oral antibiotics.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Went to emergency room.  Diagnosed with cellulitis.  Symptoms were large red/pink rash on arm between injection site and elbow, warm, swollen, and painful.  Prescribed Keflex (cephalexin) 500mg, 4 times a day, for 10 days.  Symptoms improved after 48 hours of taking oral antibiotics.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Induration, Pain, Swelling
Clinical narrative: Large swelling, raised hard lump (4 inches in diameter) with pain.
Sex: F
Vaccine: MNQ
Symptoms: Activities of daily living impaired, Asthenia, Bradycardia, Dyspnoea, Fatigue
Clinical narrative: This case was reported by a nurse and described the occurrence of bradycardia in a 17-year-old female patient who received MENVEO. Concurrent medical conditions included multiple allergies. Concomitant products included DEPOMED. In June 2015, the patient received the 2nd dose of MENVEO. In December 2015, 183 days after receiving MENVEO, the patient experienced general body pain. In April 2016, the patient experienced bradycardia (serious criteria GSK medically significant) and fatigue. In June 2016, the patient experienced seizure (serious criteria GSK medically significant) and tremor. On an unknown date, the patient experienced difficulty breathing, breathing rate increased and weakness. The patient was treated with KEPPRA. MENVEO was discontinued (Dechallenge was unknown). Rechallenge with MENVEO was unknown. On an unknown date, the outcome of the bradycardia and fatigue were not recovered/not resolved and the outcome of the seizure and tremor were unchanged and the outcome of the difficulty breathing, breathing rate increased, weakness and general body pain were unknown. It was unknown if the reporter considered the bradycardia, seizure, difficulty breathing, breathing rate increased, weakness, general body pain, fatigue and tremor to be related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. Nurse reported that her daughter received a booster dose of MENVEO as well as a booster shot of DEPOMED in early June 2015. A couple of weeks after that her daughter started noticing some changes. The reporter had a very healthy child and all of a sudden her daughter started experiencing some changes after that shot. Two weeks after receiving MENVEO, the patient experienced difficulty breathing, breathing more excessively, weakness. The reporter said that the patient was a competitive swimmer prior to receiving the shot. In September of 2015, the patient experienced shortness of breath. In December of 2015, approximately 6 months after vaccination, the patient experienced body aches. In April of 2016, approximately 10 months after vaccination, the patient experienced fatigue and bradycardia. In June of 2016, approximately 1 year after vaccination, the patient went in for a neurology consult because of tremors, and seizure like symptoms. The patient took KEPPRA 1200 mg to control the symptoms. Nurse was relating the events to MENVEO.
Sex: F
Vaccine: MNQ
Symptoms: Pain, Respiratory rate increased, Seizure, Tremor
Clinical narrative: This case was reported by a nurse and described the occurrence of bradycardia in a 17-year-old female patient who received MENVEO. Concurrent medical conditions included multiple allergies. Concomitant products included DEPOMED. In June 2015, the patient received the 2nd dose of MENVEO. In December 2015, 183 days after receiving MENVEO, the patient experienced general body pain. In April 2016, the patient experienced bradycardia (serious criteria GSK medically significant) and fatigue. In June 2016, the patient experienced seizure (serious criteria GSK medically significant) and tremor. On an unknown date, the patient experienced difficulty breathing, breathing rate increased and weakness. The patient was treated with KEPPRA. MENVEO was discontinued (Dechallenge was unknown). Rechallenge with MENVEO was unknown. On an unknown date, the outcome of the bradycardia and fatigue were not recovered/not resolved and the outcome of the seizure and tremor were unchanged and the outcome of the difficulty breathing, breathing rate increased, weakness and general body pain were unknown. It was unknown if the reporter considered the bradycardia, seizure, difficulty breathing, breathing rate increased, weakness, general body pain, fatigue and tremor to be related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. Nurse reported that her daughter received a booster dose of MENVEO as well as a booster shot of DEPOMED in early June 2015. A couple of weeks after that her daughter started noticing some changes. The reporter had a very healthy child and all of a sudden her daughter started experiencing some changes after that shot. Two weeks after receiving MENVEO, the patient experienced difficulty breathing, breathing more excessively, weakness. The reporter said that the patient was a competitive swimmer prior to receiving the shot. In September of 2015, the patient experienced shortness of breath. In December of 2015, approximately 6 months after vaccination, the patient experienced body aches. In April of 2016, approximately 10 months after vaccination, the patient experienced fatigue and bradycardia. In June of 2016, approximately 1 year after vaccination, the patient went in for a neurology consult because of tremors, and seizure like symptoms. The patient took KEPPRA 1200 mg to control the symptoms. Nurse was relating the events to MENVEO.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Back pain, Gait disturbance, Hypoaesthesia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of low back pain in a 16-year-old male patient who received BEXSERO (batch number 165401A, expiry date 30th March 2018). Co-suspect products included MENVEO (batch number M16010, expiry date 30th October 2017). Concomitant products included FLUZONE. On 29th September 2016, the patient received BEXSERO .5 ml and MENVEO .5 ml. In October 2016, 15 days after receiving BEXSERO and MENVEO, the patient experienced low back pain (serious criteria hospitalization), numbness of extremities (serious criteria hospitalization) and walking difficulty (serious criteria hospitalization). On an unknown date, the outcome of the low back pain, numbness of extremities and walking difficulty were unknown. It was unknown if the reporter considered the low back pain, numbness of extremities and walking difficulty to be related to BEXSERO and MENVEO. Additional details were reported as follows: This case was reported by a medical assistant (MA). On 29th September 2016, the patient concomitantly received FLUZONE vaccine as well. The patient experienced numbness of arms and legs. The patient required an emergency room visit. The healthcare professional did not know the outcome or how long the patient was in the hospital.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain on injection's site 2 weeks of continued right shoulder pain without improvement.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: Erythema, firmness, tenderness and blistering at injection site ((L) arm). Given Rx: BACTRIM DS q 12 #20.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Localized LUE reaction. 11cm x 13cm area of redness and swelling.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient called and said after receiving the vaccine by few days she is having a tingling sensation in her arm.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Cellulitis
Clinical narrative: Cellulitis of right upper limb.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm is swollen, red down to the elbow. Also warm to touch.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Laceration, Loss of consciousness
Clinical narrative: Pt received vaccine. After about 10 min. PT and Dad started to leave and pt passed out while walking - fell into display and got cut.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: The day after vaccine patient developed 16 cm x 12 cm area of erythema, tenderness and warmth.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site paraesthesia
Clinical narrative: Red sore tingling sensation of upper arm into axilla and left shoulder 8 x 8.5 cm blotchy rash on (L) upper arm. X-ray of (L) shoulder ordered.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Paraesthesia, Rash macular, X-ray
Clinical narrative: Red sore tingling sensation of upper arm into axilla and left shoulder 8 x 8.5 cm blotchy rash on (L) upper arm. X-ray of (L) shoulder ordered.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Peripheral swelling, Scab, Skin warm
Clinical narrative: Swollen, red arm with mild scabbing with an amber crust. Swelling from shoulder to elbow, warmer to touch than other skin. OMNICEF orally started for possible infection. Left arm only affected.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Pain in extremity
Clinical narrative: Pain (left shoulder/left arm) and bruising (left arm) for first 3 days after vaccine. Nine days after vaccine could see bruise healing and no pain at that time.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: 30 minutes after injection given patient started to complain of a bad taste in her mouth; describing a soapy taste; lasted rest of day. Next day taste gone.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient had allergic reaction to the site of administration. It was red, swollen and hot. The rash was in circular shape and felt hard around the injection site. BENADRYL PO was given.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Patient developed a rash starting from the site of injection (R-deltoid) to her bicep.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: No treatment other than heat and elevation. Pt had heat redness and swelling below injection site extended down the arm down to the elbow, more noted on the inside of the arm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Right arm redness, swelling near injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Pain in extremity, Spinal pain
Clinical narrative: Patient received PNEUMOVAX 23 5 minutes later experienced hot feeling and pain in spine and legs - spasms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Patient developed an itchy rash and 3 large welts on back 2 days after receiving ZOSTAVAX.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Balance disorder, Gait disturbance, Insomnia, Lumbar puncture abnormal
Clinical narrative: Tingling in legs and hands. Balance and walking problems. Worsened from early '15 to later '15 when symptoms improved. Situation worsened dramatically from late '15 to mid '16. The second phase resulted in loss of motor controls, mostly in legs and inability to type, tie shoes, or button up shirt. Currently still balance problems, motor controls, and difficulty sleeping due to leg nerve noise and pain. Diagnosis: NMO
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Motor dysfunction, Myelitis transverse, Neuromyelitis optica spectrum disorder, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Tingling in legs and hands. Balance and walking problems. Worsened from early '15 to later '15 when symptoms improved. Situation worsened dramatically from late '15 to mid '16. The second phase resulted in loss of motor controls, mostly in legs and inability to type, tie shoes, or button up shirt. Currently still balance problems, motor controls, and difficulty sleeping due to leg nerve noise and pain. Diagnosis: NMO
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Tingling in legs and hands. Balance and walking problems. Worsened from early '15 to later '15 when symptoms improved. Situation worsened dramatically from late '15 to mid '16. The second phase resulted in loss of motor controls, mostly in legs and inability to type, tie shoes, or button up shirt. Currently still balance problems, motor controls, and difficulty sleeping due to leg nerve noise and pain. Diagnosis: NMO
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a multiple unknown patients of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an multiple unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M027879 and expiry date 24-JAN-2018) (dosing regimen was unknown by the reporter). The vaccine was exposed to temperature of 0.2 degree Celsius for 4 hours and 51 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age (reported as minor) and gender. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL (lot # L040459, expiration date 06-APR-2017; dose and route were not reported). No adverse symptom was reported. The dose of GARDASIL had been exposed to 0.3 Celsius degree for 11 hours with no previous excursions, and data logger was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD, injection, lot # L045676, expiry date 09-MAY-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 PFU (lot # M019646, expiration date 18-JUL-2017, dose and route not reported). There were multiple temperature excursions, and the highest temperature was reported as 26 degree Fahrenheit. Data logger was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a multiple unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an multiple unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot #M018625 and expiry date 11-AUG-2018) (dosing regimen was unknown by the reporter). The vaccine was exposed to temperature of 0.2 degree celsius for 4 hours and 51 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a multiple unknown patients of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an multiple unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004726 and expiry date 19-OCT-2017) (dosing regimen was unknown by the reporter). The vaccine was exposed to temperature of 0.2 degree Celsius for 4 hours and 51 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report was received from a 74 year old male patient regarding himself. The medical history, concurrent conditions and concomitant medications were none. On 19-OCT-2016 at 2:30pm, the patient was re-vaccinated with PNEUMOVAX 23. The patient explained that he had first dose of PNEUMOVAX 23 at an unspecified time 3 or 4 years ago. The first time the patient received PNEUMOVAX 23 he stated that his arm was really sore. After the re-vaccination with PNEUMOVAX 23, the patient experienced the chills and fever. On 19-OCT-2016 at 7:30pm, the patient experienced chills. At an unspecified time after the chills began, the patient's temperature went to 101.5 F. The chills and fever lasted 24 hours and then they resolved. By 20-OCT-2016 evening the patient was feeling fine. There was no treatment rendered for the event. No lab tests were performed. The outcome of the events were reported as recovered/resolved. The patient sought medical attention. 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 medical assistant refers to an unknown number of patient of unknown age and gender. The patients' relevant medical and past drug histories, concomitant medications, and relevant laboratory data are unknown. On 17-OCT-2016, the patients were vaccinated with a dose of GARDASIL 9 lot # M017983, expiration date: 30-MAY-2018, 0.5 ml, intramuscularly. The patients possibly received a dose that had undergone a temperature excursion. The patients had not experienced any adverse reactions and had not been provided any treatments. It was unknown if the patients continue to received GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored vaccine, ROTATEQ (lot # M017514, expiration date 07-NOV-2017) (dose unknown). The vaccine was exposed to 47.1 F for 160 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 712 hours with lowest recorded temperature of 33 F and other one for 216 hours with lowest recorded temperature of 32 F. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # M000768, expiration date 05-JAN-2018) (dose and route unknown). The vaccine was exposed to 47.1 F for 160 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 30-APR-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported). On unspecified dates, the PNEUMOVAX 23 had four temperature excursions of 32 Fahrenheit (F) Degrees (0 Celsius) for 152 hours, 31 Fahrenheit (F) Degrees (-0.555555556 Celsius) for 32 hours, 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for 200 hours, and 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for 40 hours (lowest recorded temperatures). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor was product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had three temperature excursions; one for 712 hours with lowest recorded temperature of 33 F (0.555555556 Celsius) other one for 216 hours with lowest recorded temperature of 32 F (0 Celsius) and other for 64 hours with lowest recorded temperature of 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an unknown age and gender patient. The patient's concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On 14-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # K012424, expired date 05-JUN-2016) (dose and frequency were unknown) intramuscularly. The patient has not experienced an adverse effect. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist referring to his mother, a 84 year old female patient. The patient's pertinent medical history was not provided. There were no drug reactions or allergies. Concomitant therapy included warfarin (blood thinner). On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # L024129 with expiration date January 2017) single dose 0.5 ml dose, subcutaneously. On 29-OCT-2016, the patient experienced "cellulitis on her bicep". The patient contacted the pharmacist to seek medical attention. Unspecified treatment was given for the adverse event. No lab diagnostics studies were performed. At the time of the report, the outcome of the event was reported as recovered. Upon internal review, cellulitis on her bicep was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 14-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1 DS/V TF" with lot number L042846 and expiration date 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 12 Celsius Degrees for 144 hours. The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x 1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 712 hours with lowest recorded temperature of 33F (0.555555556 Celsius) and other one for 216 hours with lowest recorded temperature of 3 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)", This is one of several cases from the same reporter. Additional information has been requested.