chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Platelet count normal, Rash, Urine analysis normal
Clinical narrative: A physician report concerns an 8 year old male patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications. He received FLUMIST QUADRIVALENT (intranasal) on 06-Oct-2014. The patient initially complained of swollen elbow on 04-Nov-2014, then noted rash on ankles and developed abdominal pain and was diagnosed with Henoch-Schonlein purpura. The patient was treated with naproxen. At the time of reporting, the Henoch-Schonlein purpura (HSP) was ongoing. The reporter assessed the Henoch-Schonlein purpura (HSP) to be serious on the basis of hospitalization.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Electroencephalogram, Loss of consciousness, Petit mal epilepsy
Clinical narrative: Periods of dizziness and "blacking out." After EEG results we know now these are absence seizures. She also has debilitating chronic joint pain.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abasia, Asthenia, Body temperature, Cough, Dyspnoea
Clinical narrative: Swollen eyes, swollen lips, weakness not able to walk or get out of bed. Arm was red like a beehive from shoulder down to elbow for a week. Temp. Blurred vision, deep cough, hard to breathe, swollen glands. Shots in one arm. They gave me same pneumonia shot as last year. BENADRYL and antihistamine.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Eye swelling, Lip swelling, Lymphadenopathy, Mobility decreased
Clinical narrative: Swollen eyes, swollen lips, weakness not able to walk or get out of bed. Arm was red like a beehive from shoulder down to elbow for a week. Temp. Blurred vision, deep cough, hard to breathe, swollen glands. Shots in one arm. They gave me same pneumonia shot as last year. BENADRYL and antihistamine.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vision blurred
Clinical narrative: Swollen eyes, swollen lips, weakness not able to walk or get out of bed. Arm was red like a beehive from shoulder down to elbow for a week. Temp. Blurred vision, deep cough, hard to breathe, swollen glands. Shots in one arm. They gave me same pneumonia shot as last year. BENADRYL and antihistamine.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Severe shingles rash along T8 on left abdomen with minor rash on adjacent dermatomes. Itching, pain, and blistering. Ibuprofen for pain and topical calamine lotion.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Dyspnoea, Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: It began with soreness at site of injection and traveled down my arm to my hand- where my fingers and hand were sore and had a tingling numb sensation.  Then about two hours later, these symptoms stopped and my heart began racing and I had tightness in my chest/difficulty catching full breath for several hours.  I spoke with my doctor who stated that he  did not believe this is from the shot, I disagree with him and believe that my symptoms were an allergic reaction as I have not ever experienced this before.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations, Paraesthesia
Clinical narrative: It began with soreness at site of injection and traveled down my arm to my hand- where my fingers and hand were sore and had a tingling numb sensation.  Then about two hours later, these symptoms stopped and my heart began racing and I had tightness in my chest/difficulty catching full breath for several hours.  I spoke with my doctor who stated that he  did not believe this is from the shot, I disagree with him and believe that my symptoms were an allergic reaction as I have not ever experienced this before.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Cannot lift arm up, back and over shoulder without discomfort.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Breast pain
Clinical narrative: Pain right side of right breast.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Rash, soreness, and swollen area around injection site.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child received flu shot at flu clinic provided by Department of Health, on 11/18/2014. Child presents to me, the school nurse, on 11/20/2014 at 8:42 AM with a 10mm area of redness, warmth and swelling to area around injection site. Temp 99.5 orally. Mother notified. Mother took child to doctor visit. Per mother, child had labs drawn, diagnosed with cellulitis and placed on oral antibiotics.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: The afternoon on 11/22/14 after pt got her flu shot, her whole arm went numb and hand painful. She says it's slowly going back to normal.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Lymph node pain, Platelet count normal, Red blood cell sedimentation rate normal, Ultrasound scan abnormal, White blood cell count normal
Clinical narrative: The patient developed a tender supraclavicular lymph nodes 4 days after the vaccine. Ultrasound showed 2 discrete LN, measuring 1.2 cm and 0.7 cm, both tender to palpation. Blood work very reassuring WBC 5.5 Hgb 13.8 Plt 263, ESR 2.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates in 2014 (exact date unspecified) the patients were vaccinated with ROTATEQ (therapy route defaulted to oral, dose, lot number was not reported), which was improperly stored since 28-OCT-2014. No adverse effects were reported. Follow-up information has been received from the Licensed Practical Nurse. In 2014 (exact date unspecified), unspecified number of patients were vaccinated with an improperly stored since 28-OCT-2014 ROTATEQ (therapy route defaulted to oral, lot# K001450, expiry date: 18-NOV-2015). No adverse effects were reproted. The reporter also stated that she did not have the information available at that time but she might fax the information at a later time. The reporter stated, that the refrigerator's main thermometer was broken and the backup thermometer did not show any temperature excursions. This is one of several reports 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 nurse practitioner refers to 11 unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ (lot number, expiry date was unknown). Concomitant medications were not reported. No adverse effects reported. The outcome of the events were unknown. This is one of the 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 as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown date in 2014 (exact date unspecified) the patients were vaccinated with ROTATEQ (therapy route defaulted to oral, dose, lot number was not reported0, which was improperly stored since 28-OCT-2014. No adverse effects were reported. Follow-up information has been received from the Licensed Practical Nurse. In 2014 (exact date unspecified), unspecified number of patients were vaccinated with an improperly stored since 28-OCT-2014 ROTATEQ (therapy route defaulted to oral, lot# reported as: K006458, with an expiry date: 24-FEB-2016). No adverse effects were reported. The reporter also stated that he did not have the information available at that time but she might fax the information at a later time. The reporter stated, that the refrigerator's main thermometer was broken and the backup thermometer did not show any temperature excursions. This is one of several reports 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 as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates in 2014 (exact date unspecified) the patients were vaccinated with ROTATEQ (therapy route defaulted to oral, dose, lot number was not reported), which was improperly stored since 28-OCT-2014. No adverse effects were reported. Follow-up information has been received from the Licensed Practical Nurse. In 2014 (exact date unspecified), unspecified number of patients were vaccinated with an improperly stored since 28-OCT-2014 ROTATEQ (therapy route defaulted to oral, lot# K007243, expiry date: 13-DEC-2015). No adverse effects were reported. The reporter also stated that she did not have the information available at that time but she might fax the information at a later time. The reporter stated, that the refrigerator's main thermometer was broken and the backup thermometer did not show any temperature excursions. This is one of several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site mass, Injection site pain, Injection site warmth, Pain
Clinical narrative: Soreness, pain at injection site within 4.5-5.0 hrs. Bump at injection site, no redness, heat at site. Now has numbness/tingling down into fingers, and soreness up into neck on injection side. "Moving my arm like to carry groceries or put my hand thru a sleeve is increasingly painful."
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Soreness, pain at injection site within 4.5-5.0 hrs. Bump at injection site, no redness, heat at site. Now has numbness/tingling down into fingers, and soreness up into neck on injection side. "Moving my arm like to carry groceries or put my hand thru a sleeve is increasingly painful."
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, refers to an unspecified patients. No pertinent medical history was reported. Since 12-SEP-2014, an unspecified number of patients have been administered ROTATEQ (dose, frequency, route were not reported), all of which underwent supported temperature excursions. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: None stated.
Age: 0.4
Sex: F
Vaccine: UNK
Symptoms: Laboratory test, Unevaluable event
Clinical narrative: My daughter has many health problems related to dental amalgams and thimerosal in vaccines.
Age: 15.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea, general fatigue.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Paraesthesia, Tinnitus
Clinical narrative: DONOR EXPERIENCED SWEATING, RINGING IN EARS, AND TINGING IN HANDS FOR ABOUT 5 MINS AFTER RECEIVING VACCINATION.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Rash like sores appeared on left forearm 2X5 rectangle, as well as the corner of left eye extending to the eyebrow area. Patient states area around eye the rash burns mildly (3/10), the area on left forearm area itches. Patient denies fever, nausea, vomiting or being light headed.
Age: 19.0
Sex: U
Vaccine: TYP
Symptoms: Abdominal distension, Abdominal pain, Nausea
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a physician, via a company representative and concerns a 19 year old subject of unspecified gender. The subject's weight, height and medical history were not reported. The subject received typhoid vaccine oral ty21a (capsule, hard, oral) 1 dose total, on 06-MAY-1999, 08-MAY-1999, 10-MAY-1999 and 12-MAY-1999 as a prophylactic vaccination. Concomitant medications included poliomyelitis vaccine inactivated, meningococcal polysaccharide, tetanus vaccine and hepatitis A vaccine as prophylactic vaccination. On 07-MAY-1999, 1 day after starting typhoid vaccine oral ty21a the subject developed abdominal pains. On 14-MAY-1999, 8 days after starting typhoid vaccine oral ty21a the subject developed nausea, bloating and abdominal pain. Action taken with typhoid vaccine oral ty21a was not applicable. The subject had recovered from abdominal pains on an unspecified date. The subject outcome was unknown for events nausea and bloating. This report was serious (medically significant).
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Oropharyngeal pain, Urticaria
Clinical narrative: Received flu vaccine on 10/7/14 at 100 pm. she states shortly thereafter developed sore throat then redness on neck which progressed to hives-treated in ED at 500 pm for allergic reaction-disch meds: prednisone/famotidine/BENADRYL/albuterol/epipen.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Urticaria
Clinical narrative: Rec'd Tdap and Flu vaccines on 10/29/14 at 7:45 AM. At 3 PM on 10/29/14, had hives on chest and forearms. 10/30/14-symptoms worse. Sent to Emergency Dpt. No redness or swelling at injection sites. Prescribed Prednisone, PEPCID, BENADRYL.
Sex: U
Vaccine: FLU3
Symptoms: Cellulitis, Injection site nodule
Clinical narrative: Initial unsolicited report was received on 10 November 2014 from a healthcare professional. A patient (date of birth was not reported) had received on an unspecified day FLUZONE Intradermal (lot number, route and site of administration not reported) and an unspecified amount of time later, experienced a large knot at injection site. The patient was taken to the hospital and was diagnosed with cellulitis. Treatments, concomitant medication and past medical history were not reported. Outcome was unknown. The reporter for this case is the same as for case 2014SA155798. Documents held by sender: none.
Age: 1.38
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray abnormal, Cough, Laboratory test normal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 238 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 11 November 2014. These 238 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 11 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 1 dose of PENTACEL on 10 December 2012, batch number C4293AA, a dose of DAPTACEL on 11 February 2013, batch C4154BA, a dose of PENTACEL on 11 April 2013, batch C4294AA and a dose of DAPTACEL, batch number C4508AA on 24 February 2014 (routes and sites not reported). On 28 September 2014, the subject developed a cough and paroxysmal cough on 20 October 2014 without a whoop approximately 7 months after the last dose. The subject experienced posttussive vomiting on an unreported date. The subject did not experience cold symptoms. The subject experienced sleep disturbance and did not experience apnea. Laboratory testing included a negative PCR on 31 October 2014. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 31 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 03 November 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case, and was OB related. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.38
Sex: F
Vaccine: DTAP
Symptoms: Pneumonia, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 238 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 11 November 2014. These 238 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 11 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 1 dose of PENTACEL on 10 December 2012, batch number C4293AA, a dose of DAPTACEL on 11 February 2013, batch C4154BA, a dose of PENTACEL on 11 April 2013, batch C4294AA and a dose of DAPTACEL, batch number C4508AA on 24 February 2014 (routes and sites not reported). On 28 September 2014, the subject developed a cough and paroxysmal cough on 20 October 2014 without a whoop approximately 7 months after the last dose. The subject experienced posttussive vomiting on an unreported date. The subject did not experience cold symptoms. The subject experienced sleep disturbance and did not experience apnea. Laboratory testing included a negative PCR on 31 October 2014. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 31 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 03 November 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case, and was OB related. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Incorrect route of drug administration, Injection site reaction, Paraesthesia
Clinical narrative: This reporter also reported two other patients who experienced an event which is captured in case number 2014SA159410. Initial spontaneous report received on 17 November 2014 from a healthcare provider. An unidentified patient, gender, age and date of birth was not reported was vaccinated intramuscularly with INFLUENZA INTRADERMAL, batch, site and date of administration were not reported. The patient's concomitant medications were not reported. Pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as none, unknown. The patient was not ill at the time of vaccination. The patient experienced numbness and tingling in their arm with loss of grip strength. One of the patients that were reported required an emergency room/ doctor visit on an unspecified date. The patient was told that it was an injection site issue and was told to follow up in a few months. The patient outcome is not recovered. Documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLU4, UNK, FLU4, UNK
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Diarrhoea, Injection site induration
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site swelling in a 34-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5ZT94 ?, expiry date 30th June 2014). Co-suspect products included MEDICATION UNKNOWN (VACCINE). Previously administered products included influenza vaccine with an associated reaction of pain in extremity and influenza vaccine with an associated reaction of nausea. On 6th November 2014, the patient received FLULAVAL QUADRIVALENT and VACCINE. On 6th November 2014, 0 min after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling (serious criteria disability), injection site hardness, injection site warmth and musculoskeletal stiffness. On 7th November 2014, the patient experienced vomiting, chills, stomach upset, diarrhea and low grade temperature. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site swelling, injection site hardness, injection site warmth and musculoskeletal stiffness were recovering/resolving and the outcome of the vomiting, chills, stomach upset, diarrhea and low grade temperature were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea and low grade temperature to be related to FLULAVAL QUADRIVALENT. The reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea and low grade temperature to be not reported if related to FLULAVAL QUADRIVALENT. Additional information: The reporter (patient) was a physical therapy assistant. The patient had no known allergies. There was no concomitant medication. Injection site reaction occurred in the evening of 6 November 2014, neck and back stiffness during the night. On 7 November 2014, within 24 hours of vaccination, the patient experienced stomach upset with vomiting and diarrhea, chills and low grade temperature. As of the day she was recovered about 75% but she could not keep anything in her stomach. She could not do anything all day and took ibuprofen to get some sleep. Stomach upset with vomiting and diarrhea, chills and low grade temperature all lasted for 72 hours. She did not contact a health care professional. Refer to case US2014GSK023616 for tolerance to previous vaccination.
Age: 34.0
Sex: F
Vaccine: FLU4, UNK, FLU4, UNK
Symptoms: Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Vomiting
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site swelling in a 34-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5ZT94 ?, expiry date 30th June 2014). Co-suspect products included MEDICATION UNKNOWN (VACCINE). Previously administered products included influenza vaccine with an associated reaction of pain in extremity and influenza vaccine with an associated reaction of nausea. On 6th November 2014, the patient received FLULAVAL QUADRIVALENT and VACCINE. On 6th November 2014, 0 min after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling (serious criteria disability), injection site hardness, injection site warmth and musculoskeletal stiffness. On 7th November 2014, the patient experienced vomiting, chills, stomach upset, diarrhea and low grade temperature. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site swelling, injection site hardness, injection site warmth and musculoskeletal stiffness were recovering/resolving and the outcome of the vomiting, chills, stomach upset, diarrhea and low grade temperature were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea and low grade temperature to be related to FLULAVAL QUADRIVALENT. The reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea and low grade temperature to be not reported if related to FLULAVAL QUADRIVALENT. Additional information: The reporter (patient) was a physical therapy assistant. The patient had no known allergies. There was no concomitant medication. Injection site reaction occurred in the evening of 6 November 2014, neck and back stiffness during the night. On 7 November 2014, within 24 hours of vaccination, the patient experienced stomach upset with vomiting and diarrhea, chills and low grade temperature. As of the day she was recovered about 75% but she could not keep anything in her stomach. She could not do anything all day and took ibuprofen to get some sleep. Stomach upset with vomiting and diarrhea, chills and low grade temperature all lasted for 72 hours. She did not contact a health care professional. Refer to case US2014GSK023616 for tolerance to previous vaccination.
Age: 34.0
Sex: F
Vaccine: FLU4, UNK, FLU4, UNK
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Diarrhoea, Injection site induration
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site swelling in a 34-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5ZT94 ?, expiry date 30th June 2014). Co-suspect products included MEDICATION UNKNOWN (VACCINE). Previously administered products included influenza vaccine with an associated reaction of pain in extremity and influenza vaccine with an associated reaction of nausea. On 6th November 2014, the patient received FLULAVAL QUADRIVALENT and VACCINE. On 6th November 2014, 0 min after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling (serious criteria disability), injection site hardness, injection site warmth and musculoskeletal stiffness. On 7th November 2014, the patient experienced vomiting, chills, stomach upset, diarrhea and low grade temperature. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site swelling, injection site hardness, injection site warmth and musculoskeletal stiffness were recovering/resolving and the outcome of the vomiting, chills, stomach upset, diarrhea and low grade temperature were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea and low grade temperature to be not reported if related to FLULAVAL QUADRIVALENT. The reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea, low grade temperature to be not related to FLULAVAL QUADRIVALENT. Additional information: The reporter (patient) was a physical therapy assistant. The patient had no known allergies. There was no concomitant medication. Injection site reaction occurred in the evening of 6 November 2014, neck and back stiffness during the night. On 7 November 2014, within 24 hours of vaccination, the patient experienced stomach upset with vomiting and diarrhea, chills and low grade temperature. As of the day she was recovered about 75% but she could not keep anything in her stomach. She could not do anything all day and took ibuprofen to get some sleep. Stomach upset with vomiting and diarrhea, chills and low grade temperature all lasted for 72 hours. She did not contact a health care professional. Refer to case US2014GSK023616 for tolerance to previous vaccination.
Age: 34.0
Sex: F
Vaccine: FLU4, UNK, FLU4, UNK
Symptoms: Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Vomiting
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site swelling in a 34-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5ZT94 ?, expiry date 30th June 2014). Co-suspect products included MEDICATION UNKNOWN (VACCINE). Previously administered products included influenza vaccine with an associated reaction of pain in extremity and influenza vaccine with an associated reaction of nausea. On 6th November 2014, the patient received FLULAVAL QUADRIVALENT and VACCINE. On 6th November 2014, 0 min after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling (serious criteria disability), injection site hardness, injection site warmth and musculoskeletal stiffness. On 7th November 2014, the patient experienced vomiting, chills, stomach upset, diarrhea and low grade temperature. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site swelling, injection site hardness, injection site warmth and musculoskeletal stiffness were recovering/resolving and the outcome of the vomiting, chills, stomach upset, diarrhea and low grade temperature were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea and low grade temperature to be not reported if related to FLULAVAL QUADRIVALENT. The reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea, low grade temperature to be not related to FLULAVAL QUADRIVALENT. Additional information: The reporter (patient) was a physical therapy assistant. The patient had no known allergies. There was no concomitant medication. Injection site reaction occurred in the evening of 6 November 2014, neck and back stiffness during the night. On 7 November 2014, within 24 hours of vaccination, the patient experienced stomach upset with vomiting and diarrhea, chills and low grade temperature. As of the day she was recovered about 75% but she could not keep anything in her stomach. She could not do anything all day and took ibuprofen to get some sleep. Stomach upset with vomiting and diarrhea, chills and low grade temperature all lasted for 72 hours. She did not contact a health care professional. Refer to case US2014GSK023616 for tolerance to previous vaccination.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Condition aggravated
Clinical narrative: This spontaneous report was received from a 58 year old female licensed practical nurse, reporting on herself, with asthma, congestive obstructive pulmonary disease (COPD), cramping, diarrhea and flushing all over the body to penicillin, hypothyroidism and drug reaction/allergy to sulfur. In October 2005, patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, dose number, lot number, expiration date and route were not reported). Concomitant therapies includes Basic Water Pill, thyroid, asthma and COPD unspecified therapies. Licensed practical nurse reported she was admitted to the Hospital on 05-NOV-2014 for asthma exacerbation. Nurse reported she was discharged from the hospital on 08-NOV-2014. At the time of the report the outcome was reported as not recovered. Patient did not performed lab diagnostics studies. Patient sought medical attention. The licensed practical nurse considered the event as serious due the hospitalization. This is one (1) of two (2) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a other health professional and described the occurrence of swollen arm at the injection site in a unk patient who received FLULAVAL (batch number 4597B, expiry date June 2015). This case was associated with a product complaint. In 2014, the patient received FLULAVAL (intramuscular). On an unknown date, unknown after receiving FLULAVAL, the patient experienced swollen arm at the injection site and pharmaceutical product complaint. On an unknown date, the outcome of the swollen arm at the injection site was not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the swollen arm at the injection site to be probably related to FLULAVAL. It was unknown if the reporter considered the pharmaceutical product complaint to be related to FLULAVAL. Additional information about the product complaint received on 19 November 2014: This is one of the 5 cases received by the same reporter for the same vaccine (with the same lot number).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a other health professional and described the occurrence of swollen arm at the injection site in a 57-year-old female patient who received FLULAVAL (batch number 4597B, expiry date June 2015). This case was associated with a product complaint. Concurrent medical conditions included diabetes. On 17th October 2014, the patient received the 1st dose of FLULAVAL (intramuscular). On 18th October 2014, 1 days after receiving FLULAVAL, the patient experienced swollen arm at the injection site, soreness at the injection site and redness at the injection site. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the swollen arm at the injection site, soreness at the injection site and redness at the injection site were recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the swollen arm at the injection site, soreness at the injection site and redness at the injection site to be probably related to FLULAVAL. It was unknown if the reporter considered the pharmaceutical product complaint to be related to FLULAVAL. Additional information about the product complaint received on 19 November 2014: The events required a doctor visit (or an emergency room visit). This is one of the 5 cases reported by the sane reporter for the same vaccine (with the same lot number).
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Paraesthesia
Clinical narrative: Burning pain "deep" at injection site at time of injection.  The pain has gotten worse and is now limiting movement of shoulder.  Numbness and tingling in arm extending into hand and all fingers.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient received HPV #3. Patient was scared and crying. Dad had to hold patient down. After vaccine was given patient said she felt dizzy. Patient laid down on exam table for 5 minutes. BP 111/67. Patient stated she felt better and sat up. Gave patient water and crackers due to not eating her lunch. BP 96/70. Patient stood up BP 102/70. Walked patient to car and informed parent if patient feels dizzy again have her lay down and if condition gets worse take to ER.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Extreme nausea, dizziness, stayed in all day, better on 11/24/14 but still lingering nausea.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Swollen, red, warm upper arm (from elbow to shoulder).
Age: 26.0
Sex: F
Vaccine: FLUC3
Symptoms: Asthenia, Hypoaesthesia, Pain
Clinical narrative: Pt reports sx: Pain; Weakness when moving arm worsened around 12 pm; Dulled sensation and numbness along upper arm for 6" to just above elbow. Denies HA, fever.
Age: 42.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, FLUC3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PAIN, SWELLING, REDNESS AT INJECTION SITE THAT APPEARED THE NEXT DAY AFTER INJECTION AND WORSENED INITIALLY, BUT RESOLVED 2-3 DAYS LATER AFTER ADMINISTRATION OF DIPHENHYDRAMINE AND ACETAMINOPHEN.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Throat closing.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Eyelid margin crusting, Eyelid oedema, Ocular hyperaemia, Pyrexia
Clinical narrative: Father states that upon waking up the morning following immunization child had red, puffy eyes that were matted shut and had a fever of 103.  Child has continued to have cough & fever and has not been eating very well.  Parent states they have not taken child to physician, however states child will be seeing a physician today.
Age: 20.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Leukocytosis, Pyrexia
Clinical narrative: Low-grade fever with pain, swelling, and redness at injection site that worsened initially before symptoms/signs resolved 2-3 days after initial presentation. Treatment included analgesics - acetaminophen and ibuprofen. Patient's tachycardia and leukocytosis also worsened, but improved with treatment - fluids and antibiotics.
Age: 20.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, PPV
Symptoms: Tachycardia
Clinical narrative: Low-grade fever with pain, swelling, and redness at injection site that worsened initially before symptoms/signs resolved 2-3 days after initial presentation. Treatment included analgesics - acetaminophen and ibuprofen. Patient's tachycardia and leukocytosis also worsened, but improved with treatment - fluids and antibiotics.
Age: 20.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Low-grade fever with pain, swelling, and redness at injection site that worsened initially before symptoms/signs resolved 2-3 days after initial presentation. Treatment included analgesics - acetaminophen and ibuprofen. Patient's tachycardia and leukocytosis also worsened, but improved with treatment - fluids and antibiotics.
Age: 57.0
Sex: M
Vaccine: FLUC3
Symptoms: Cluster headache
Clinical narrative: Fist cluster headache occurred, treated with sumitriptan. Two events each of the next 3 days. Then 3 events a day ongoing. ran 5 day course of an antiviral last week, no change. Please help.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Mass, Pain, Swelling
Clinical narrative: Swollen, painful lump.  Still have today.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Somnolence
Clinical narrative: Crying a lot, falling asleep between crying episodes.  Thigh of administration is red to the lower part of the knee anteriorly and thigh appears swollen.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Hard knot at injection site has continued to get larger and is now the size of the palm of my hand and is hot to the touch.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site bruising, Injection site swelling, Pruritus
Clinical narrative: Erythema, Pruritis, Swelling and Bruise at injection site.
Age: 46.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Abdominal pain, Culture, Malaria antibody test, Pain, Pyrexia
Clinical narrative: Pain and high fever, Abdominal pain.
Age: 46.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Viral test
Clinical narrative: Pain and high fever, Abdominal pain.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection on right thigh.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Joint swelling, Local swelling, Night sweats, Paraesthesia
Clinical narrative: Around 12:00 Noon 11/23/2014, patient started having "severe needle pricking" pain around the elbow up to 1/2 the distance to his shoulder and half the distance to his hand. His elbow swelled up and his hands swelled up about 5-10%. He took ibuprofen 400mg at 4:00 pm 11/23/2014 and then 600mg ibuprofen around bedtime. He used ice packs. He experienced sweating during the night. On 11/24/2014--the swelling was decreased. He saw his doctor at 1:00 PM 11/24/2014 and was instructed to take some Benadryl if needed.
Age: 74.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Bone pain, Fatigue, Headache, Muscular weakness
Clinical narrative: Fatigue, aching body, muscle pain, joint pain, multiple joints involved, low grade fever max 99.8. Loss of muscle strength, worse at night with intense pain on pressure areas in bed. This continue for three weeks easing off on third week but remaining on fourth. Headaches also like never before. On third week seems to have Neuromuscular involvement with decrease musculature, fatigue and much decrease strength even on regular activity. Cannot stand for too long. Waking without symptoms, is limited now. Pain was deep in muscle structures involving fascia and compromising bone as well. This fourth week post vaccination is somewhat better but not normal. Except for fluids increase,Vit C 100mg/day, and Aleve/Advil for pain no other drug was use. Temp was never over 1.
Age: 74.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Fatigue, aching body, muscle pain, joint pain, multiple joints involved, low grade fever max 99.8. Loss of muscle strength, worse at night with intense pain on pressure areas in bed. This continue for three weeks easing off on third week but remaining on fourth. Headaches also like never before. On third week seems to have Neuromuscular involvement with decrease musculature, fatigue and much decrease strength even on regular activity. Cannot stand for too long. Waking without symptoms, is limited now. Pain was deep in muscle structures involving fascia and compromising bone as well. This fourth week post vaccination is somewhat better but not normal. Except for fluids increase,Vit C 100mg/day, and Aleve/Advil for pain no other drug was use. Temp was never over 1.
Age: 74.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Exercise electrocardiogram, Laboratory test
Clinical narrative: Fatigue, aching body, muscle pain, joint pain, multiple joints involved, low grade fever max 99.8. Loss of muscle strength, worse at night with intense pain on pressure areas in bed. This continue for three weeks easing off on third week but remaining on fourth. Headaches also like never before. On third week seems to have Neuromuscular involvement with decrease musculature, fatigue and much decrease strength even on regular activity. Cannot stand for too long. Waking without symptoms, is limited now. Pain was deep in muscle structures involving fascia and compromising bone as well. This fourth week post vaccination is somewhat better but not normal. Except for fluids increase,Vit C 100mg/day, and Aleve/Advil for pain no other drug was use. Temp was never over 1.
Age: 74.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Myalgia, Polyarthritis, Polyneuropathy
Clinical narrative: Fatigue, aching body, muscle pain, joint pain, multiple joints involved, low grade fever max 99.8. Loss of muscle strength, worse at night with intense pain on pressure areas in bed. This continue for three weeks easing off on third week but remaining on fourth. Headaches also like never before. On third week seems to have Neuromuscular involvement with decrease musculature, fatigue and much decrease strength even on regular activity. Cannot stand for too long. Waking without symptoms, is limited now. Pain was deep in muscle structures involving fascia and compromising bone as well. This fourth week post vaccination is somewhat better but not normal. Except for fluids increase,Vit C 100mg/day, and Aleve/Advil for pain no other drug was use. Temp was never over 1.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Mild redness/tenderness at injection site, persistent over course of several days. Patient notified clinic of redness, was advised to apply cool compresses, dose ibuprofen/acetaminophen as needed for pain, and to try diphenhydramine 25-50mg dosing to help reduce local reaction.  Patient advised to seek further medical attention if worsening redness/pain.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site anaesthesia, Injection site pain
Clinical narrative: Pain and numbness in the right arm...radiating down the arm from the injection site.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Rash erythematous, Urticaria
Clinical narrative: RED RASH WITH WHELPS NEAR ADMINISTRATION SITE.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Depressed level of consciousness, Dizziness, Dysstasia, Gait disturbance, Nausea
Clinical narrative: Extreme dizziness and a little nausea.  I could not stand up when I got up in the morning.  I was a bit better the next day but now a week later I still have spells of vertigo, walk into walls, feel like I might pass out mixed with times of feeling fine.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Extreme dizziness and a little nausea.  I could not stand up when I got up in the morning.  I was a bit better the next day but now a week later I still have spells of vertigo, walk into walls, feel like I might pass out mixed with times of feeling fine.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, warm, tender at injection site. Continuing to enlarge. Approximately the size of an orange at 1800. Have had flu shots every year for past 15 years without any reaction.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Acne, Injection site erythema, Injection site inflammation, Injection site reaction, Pain in extremity
Clinical narrative: Strange itchy rash at the injection site with pronounced raised pimples. A patch about 2" in diameter, redness, and inflamed. Arm was extremely sore for the first two days following the injection.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Rash pruritic
Clinical narrative: Strange itchy rash at the injection site with pronounced raised pimples. A patch about 2" in diameter, redness, and inflamed. Arm was extremely sore for the first two days following the injection.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red warm area 4x4 cm at site of VARIVAX administration at right thigh. Oral BENADRYL administered in office.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Soreness of arm (left arm) where vaccine was administered - dull, constant ache from elbow to shoulder. Cannot sleep on affected side. Limited range of motion of affected arm.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Painful respiration
Clinical narrative: Chest pain and shortness of breath developed 2 hrs after vaccine c/o "hurts to breath". EKG-NSR. Chest-no acute cardiopulmonary disease. TORADOL 60mg IM.
Age: 63.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Pruritus
Clinical narrative: Severe itching to arm. Redness.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Described feeling funny after flu shot today weird, feeling all of her body parts, lightheaded. No SOB, swelling of tongue, chest tightness, rash.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Rash generalised
Clinical narrative: Rash - all over body - developed after getting FLUMIST.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema, Ocular hyperaemia, Swollen tongue
Clinical narrative: Patient reports anaphylactic reaction (shortness of breath, redness, hives, red eyes, swollen tongue, trouble breathing).
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: Patient reports anaphylactic reaction (shortness of breath, redness, hives, red eyes, swollen tongue, trouble breathing).
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Depressed mood, Dyspnoea, Generalised erythema, Ocular hyperaemia
Clinical narrative: Patient reports anaphylactic reaction (shortness of breath, redness, hives, red eyes, swollen tongue, trouble breathing).
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Swollen tongue
Clinical narrative: Patient reports anaphylactic reaction (shortness of breath, redness, hives, red eyes, swollen tongue, trouble breathing).