chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dyspnoea, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2015US036640 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS ID: 560575) on 23 Mar 2015. This report refers to a 51 years old female patient. Her current conditions included asthma, allergy and blood pressure. Her concomitant medications were ADVAIR, montelukast and lisinopril/hydrochlorothiazide. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal vaccine (other manufacturer, batch number: not reported); both vaccines administered on 22 Oct 2014. On the same day, she presented with shortness of breath and her arm on left side where shot was given was swollen twice the size and it turned beet red with severe pain. The arm was immobile. Shortness of breath continued for 5 days and she still had pain. The final outcome of the events was reported as complete recovery. The events were reported as non serious, but the event dyspnea was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Conjunctival hyperaemia, Cough, Headache, Malaise
Clinical narrative: Case number PHHY2015US034703, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 560594) website on 23 Mar 2015. This report refers to a 30-year-old male patient. The patient medical history and current illness were none. Concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into the left arm on 06 Jan 2015. On the same day after vaccination, the patient had incredibly infected conjunctiva and high fever with chills. He also had headache and malaise. The onset of the events was nearly instantaneous. The patient began to experience cough and throat swelling within 2.5 hours after vaccination. The events were assessed as non-serious. The outcome and causality of the events was not reported. Seriousness assessment of event "throat swelling" was upgraded based on the information available in source document.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Pharyngeal oedema, Pyrexia
Clinical narrative: Case number PHHY2015US034703, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 560594) website on 23 Mar 2015. This report refers to a 30-year-old male patient. The patient medical history and current illness were none. Concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into the left arm on 06 Jan 2015. On the same day after vaccination, the patient had incredibly infected conjunctiva and high fever with chills. He also had headache and malaise. The onset of the events was nearly instantaneous. The patient began to experience cough and throat swelling within 2.5 hours after vaccination. The events were assessed as non-serious. The outcome and causality of the events was not reported. Seriousness assessment of event "throat swelling" was upgraded based on the information available in source document.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dysstasia, Heart rate increased, Myalgia, Neurological infection
Clinical narrative: Case number PHHY2015US036669, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 560936) website on 23 Mar 2015. This report refers to a 59-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included administration of DTAP (manufacturer and batch number: not reported) DT vaccine (manufacturer and batch number: not reported) and Tetanus vaccine (manufacturer and batch number: not reported). After receiving the vaccination with DTAP vaccine the patient experienced convulsions (at 9 months of age). Further, after DT vaccination, the patient had experienced neurological events (at the age of 22 years and 9 months). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 25 Sep 2014. On the same day after vaccination, the patient had experienced rapid heartbeat and dizziness. The patient took BENADRYL. Several hours later, the patient had severe muscle pain all over body and then had semi-paralysis. Further, the patient was unable to stand up. The final outcome of the events was complete recovery. The events were assessed as non-serious. Causality was not reported. Seriousness assessment of "semi-paralysis" was upgraded based on the NVS-IME list.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Paralysis
Clinical narrative: Case number PHHY2015US036669, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 560936) website on 23 Mar 2015. This report refers to a 59-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included administration of DTAP (manufacturer and batch number: not reported) DT vaccine (manufacturer and batch number: not reported) and Tetanus vaccine (manufacturer and batch number: not reported). After receiving the vaccination with DTAP vaccine the patient experienced convulsions (at 9 months of age). Further, after DT vaccination, the patient had experienced neurological events (at the age of 22 years and 9 months). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 25 Sep 2014. On the same day after vaccination, the patient had experienced rapid heartbeat and dizziness. The patient took BENADRYL. Several hours later, the patient had severe muscle pain all over body and then had semi-paralysis. Further, the patient was unable to stand up. The final outcome of the events was complete recovery. The events were assessed as non-serious. Causality was not reported. Seriousness assessment of "semi-paralysis" was upgraded based on the NVS-IME list.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Nausea
Clinical narrative: Case number PHHY2015US036413, is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 561017) website on 23 Mar 2015. This report refers to a 36-year-old female patient. Medical history included treatment with penicillin and erythromycin with which she had urticaria and metronidazole with which she had urticaria and swelling of throat. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 01 Oct 2014. On the same date one hour after the vaccination, she had shortness of breath and nausea. She did not have lip/tongue swelling, rash or vomiting. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness of shortness of breath was upgraded based on available information in the source document.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Angioedema, Dyspnoea, Eye swelling, Swelling, Swelling face
Clinical narrative: Case number PHHY2015US047331, is an initial spontaneous report from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 562260) website on 21 Apr 2015. This report refers to a 37-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on to her left arm on 15 Oct 2014. On 16 Oct 2014 after the vaccination, she had swelling all over body, face, both eyes and angioedema. Even once she was not able to breathe. She visited an immunologist and still had the symptoms. The final outcome of the events was not recovered. The events were reported as life-threatening. Causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: FLUX, HPVX, MEN, TDAP
Symptoms: Hyperhidrosis, Pallor, Seizure, Syncope
Clinical narrative: Case number PHHY2015US047442, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 562508) website on 21 Apr 2015. This report refers to an 11-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown), HPV (manufacturer and batch number: unknown), meningococcal (manufacturer and batch number: unknown) and TDAP (manufacturer and batch number: unknown) on 26 Jan 2015. On the same date after the vaccination, she was fainting, had possible seizure, paleness and sweating. Following the events she visited the emergency room via ambulance. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness of seizures was upgraded based on available information in the source document.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Case number PHHY2015US047462, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 563132) website on 21 Apr 2015. This report refers to a 44-year-old female patient. Medical history included multiple environmental and food allergies, asthma and Hashimoto's thyroiditis. This poly medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 15 Aug 2014. On the same date after the vaccination, she had itching and swelling of mouth, throat and injection site. She had tightness in chest, heat, swelling, itching, redness at the injection site which was about 4 to 5 inches in diameter that persisted about 10 days. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness of throat swelling and tightness in chest was upgraded based on available information in the source document.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth, Mouth swelling, Oral pruritus, Pharyngeal oedema, Throat irritation
Clinical narrative: Case number PHHY2015US047462, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 563132) website on 21 Apr 2015. This report refers to a 44-year-old female patient. Medical history included multiple environmental and food allergies, asthma and Hashimoto's thyroiditis. This poly medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 15 Aug 2014. On the same date after the vaccination, she had itching and swelling of mouth, throat and injection site. She had tightness in chest, heat, swelling, itching, redness at the injection site which was about 4 to 5 inches in diameter that persisted about 10 days. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness of throat swelling and tightness in chest was upgraded based on available information in the source document.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Body temperature increased, Chills, Decreased appetite, Decreased interest
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) on 11 January 2016. Manufacturer Report Number: 2015357971. This case involves 25-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, route and site of administration not reported) and also received a dose of PREVENAR 13 (batch number, route and site of administration not reported) on 06 October 2015. The patient's medical history and concomitant medications were not reported. The patient's concurrent conditions includes Myelodysplastic Syndrome and had transfusion for every 4-8 weeks. After vaccination, the patient had transfusion for every 2 weeks. On 06 October 2015, about half an hour after vaccination, patient had a horrific side effect. On 08 October 2015, two days following the vaccination, the patient could barely move, she was fatigued, had weakness, she had extreme exhaustion to the point where she could barely put one foot in front of other. The patient's ongoing symptoms included exhaustion, lack of interest, daily temperatures, night sweats, severe night chills, nausea (daily), vomiting (several times), decreased appetite no desire to eat, vertigo. She did not feel well, felt sick, it was reported that the last 5 - 6 weeks were terrible, her immune system was wiped out and knocked out due to the two shots, it was like it stopped her immune system from working and she became very ill. Laboratory data includes WBC-115 and absolute neutrophil count- 0.7, hemoglobin: 8.7 to 6.9 and she had to be transfused. The patient's corrective treatment was not reported. The outcome of the events was not reported. Upon internal review the case was considered as serious because of important medical event unspecified disorder of immune mechanism. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Fatigue, Haemoglobin decreased, Immune system disorder, Malaise, Mobility decreased
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) on 11 January 2016. Manufacturer Report Number: 2015357971. This case involves 25-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, route and site of administration not reported) and also received a dose of PREVENAR 13 (batch number, route and site of administration not reported) on 06 October 2015. The patient's medical history and concomitant medications were not reported. The patient's concurrent conditions includes Myelodysplastic Syndrome and had transfusion for every 4-8 weeks. After vaccination, the patient had transfusion for every 2 weeks. On 06 October 2015, about half an hour after vaccination, patient had a horrific side effect. On 08 October 2015, two days following the vaccination, the patient could barely move, she was fatigued, had weakness, she had extreme exhaustion to the point where she could barely put one foot in front of other. The patient's ongoing symptoms included exhaustion, lack of interest, daily temperatures, night sweats, severe night chills, nausea (daily), vomiting (several times), decreased appetite no desire to eat, vertigo. She did not feel well, felt sick, it was reported that the last 5 - 6 weeks were terrible, her immune system was wiped out and knocked out due to the two shots, it was like it stopped her immune system from working and she became very ill. Laboratory data includes WBC-115 and absolute neutrophil count- 0.7, hemoglobin: 8.7 to 6.9 and she had to be transfused. The patient's corrective treatment was not reported. The outcome of the events was not reported. Upon internal review the case was considered as serious because of important medical event unspecified disorder of immune mechanism. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Nausea, Neutrophil count decreased, Night sweats, Transfusion, Vertigo
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) on 11 January 2016. Manufacturer Report Number: 2015357971. This case involves 25-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, route and site of administration not reported) and also received a dose of PREVENAR 13 (batch number, route and site of administration not reported) on 06 October 2015. The patient's medical history and concomitant medications were not reported. The patient's concurrent conditions includes Myelodysplastic Syndrome and had transfusion for every 4-8 weeks. After vaccination, the patient had transfusion for every 2 weeks. On 06 October 2015, about half an hour after vaccination, patient had a horrific side effect. On 08 October 2015, two days following the vaccination, the patient could barely move, she was fatigued, had weakness, she had extreme exhaustion to the point where she could barely put one foot in front of other. The patient's ongoing symptoms included exhaustion, lack of interest, daily temperatures, night sweats, severe night chills, nausea (daily), vomiting (several times), decreased appetite no desire to eat, vertigo. She did not feel well, felt sick, it was reported that the last 5 - 6 weeks were terrible, her immune system was wiped out and knocked out due to the two shots, it was like it stopped her immune system from working and she became very ill. Laboratory data includes WBC-115 and absolute neutrophil count- 0.7, hemoglobin: 8.7 to 6.9 and she had to be transfused. The patient's corrective treatment was not reported. The outcome of the events was not reported. Upon internal review the case was considered as serious because of important medical event unspecified disorder of immune mechanism. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vomiting, White blood cell count decreased
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) on 11 January 2016. Manufacturer Report Number: 2015357971. This case involves 25-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, route and site of administration not reported) and also received a dose of PREVENAR 13 (batch number, route and site of administration not reported) on 06 October 2015. The patient's medical history and concomitant medications were not reported. The patient's concurrent conditions includes Myelodysplastic Syndrome and had transfusion for every 4-8 weeks. After vaccination, the patient had transfusion for every 2 weeks. On 06 October 2015, about half an hour after vaccination, patient had a horrific side effect. On 08 October 2015, two days following the vaccination, the patient could barely move, she was fatigued, had weakness, she had extreme exhaustion to the point where she could barely put one foot in front of other. The patient's ongoing symptoms included exhaustion, lack of interest, daily temperatures, night sweats, severe night chills, nausea (daily), vomiting (several times), decreased appetite no desire to eat, vertigo. She did not feel well, felt sick, it was reported that the last 5 - 6 weeks were terrible, her immune system was wiped out and knocked out due to the two shots, it was like it stopped her immune system from working and she became very ill. Laboratory data includes WBC-115 and absolute neutrophil count- 0.7, hemoglobin: 8.7 to 6.9 and she had to be transfused. The patient's corrective treatment was not reported. The outcome of the events was not reported. Upon internal review the case was considered as serious because of important medical event unspecified disorder of immune mechanism. List of documents held by sender: none.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported for two patients. This is the second of two reports. A 90-year-old female patient received PREVNAR 13 (lot M20639, expiry date Apr2017, NDC number 0005-1971-01) on 10Nov2015, at 0.5 ml single, intramuscular in right deltoid. Medical history was not provided. Patient did not have diabetes. Patient was not sick at time of vaccination. Concomitant vaccine included FLUZONE (lot UI487AA, expiry date 26May2016) on 27Oct2015, intramuscular in left deltoid. She may have received different brand of flu vaccine the previous year. One to two days after pneumococcal vaccination, in Nov2015, the patient experienced cellulitis and redness. Redness got worse so the patient went to the doctor at either an urgent care or emergency room and was told (per patient) she had cellulitis. She was not hospitalized. She was prescribed clindamycin for treatment. Both cellulitis and redness have recovered completely. Relevant tests: none. The reporting pharmacist clarified that patient was told by the doctor that she had cellulitis but reporter was unsure if this was correct or if patient just reacted to the vaccine.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Headache, VIIth nerve paralysis
Clinical narrative: Onset of Bells Palsy - paralysis on left side of face - unable to blink eye, move lips or mouth, earache and head pain.
Age: 44.0
Sex: M
Vaccine: YF, YF
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 15-Jan-2016. This case involves a 44-year-old male patient, who was vaccinated with a dose of YF vax (batch number: UI267AA expiry date: 28-Jul-2017, dose, dose number was not reported) via intramuscular route in left deltoid on 07-Jan-2016. The patient had no illness at the time of vaccination and had medical history of high cholesterol, cold sores which was treated with VALTREX and back spasms which was treated with FLEXERIL. Concomitant medications were not reported. On 10-Jan-2016, three days following the vaccination, the patient developed arthus reaction, redness, tenderness and swelling from the injection site down to his elbow. Patient had received YF vax in the past and it was unknown whether the patient had any adverse reaction to this vaccine. It was reported that the patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the events was reported as unknown. Upon internal review, the case was considered to be serious due to important medical events: arthus reaction, redness, tenderness and swelling from the injection site down to his elbow. List of documents held by sender: none.
Age: 44.0
Sex: M
Vaccine: YF, YF
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 15-Jan-2016. This case involves a 44-year-old male patient, who was vaccinated with a dose of YF vax (batch number: UI267AA expiry date: 28-Jul-2017, dose, dose number was not reported) via intramuscular route in left deltoid on 07-Jan-2016. The patient had no illness at the time of vaccination and had medical history of high cholesterol, cold sores which was treated with VALTREX and back spasms which was treated with FLEXERIL. Concomitant medications were not reported. On 10-Jan-2016, three days following the vaccination, the patient developed arthus reaction, redness, tenderness and swelling from the injection site down to his elbow. Patient had received YF vax in the past and it was unknown whether the patient had any adverse reaction to this vaccine. It was reported that the patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the events was reported as unknown. Upon internal review, the case was considered to be serious due to important medical events: arthus reaction, redness, tenderness and swelling from the injection site down to his elbow. List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Epicondylitis, Pain in extremity
Clinical narrative: This initial spontaneous report was received from the patient's fiancée referring to her fiancée; a 60 year old male patient. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 06-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX 1 injection (in the left arm; dose, route, lot# and expiration date were not provided). On the same date, the patient experienced tenderness at the injection site on his left side when he received the product. Within a few days on an unspecified date in January 2016; the pain and tenderness radiated down his arm to his elbow and the patient could not grip anything with his left hand. The patient's physician administered CELEBREX on the first visit and he also received cortisone injection (date, trade name, dose and route were not provided) on the second physician visit on 26-JAN-2016. The patient had a routine blood work and recently a general physical (date was unspecified). Results were not provided. He was not hospitalized. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the event was not recovered. The relatedness between the events to the suspect therapy was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Grip strength decreased, Injection site pain
Clinical narrative: This initial spontaneous report was received from the patient's fiancée referring to her fiancée; a 60 year old male patient. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 06-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX 1 injection (in the left arm; dose, route, lot# and expiration date were not provided). On the same date, the patient experienced tenderness at the injection site on his left side when he received the product. Within a few days on an unspecified date in January 2016; the pain and tenderness radiated down his arm to his elbow and the patient could not grip anything with his left hand. The patient's physician administered CELEBREX on the first visit and he also received cortisone injection (date, trade name, dose and route were not provided) on the second physician visit on 26-JAN-2016. The patient had a routine blood work and recently a general physical (date was unspecified). Results were not provided. He was not hospitalized. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the event was not recovered. The relatedness between the events to the suspect therapy was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Blood pressure decreased, Blood test
Clinical narrative: Pt had syncope/lightheadedness on day of 1st dose of GARDASIL 11/17/11. 2 episodes of near syncope 4 mths apart followed. Received 2nd dose HPV 03/09/12. Episodes of near syncope occurred 1x every 2 mths. 3rd dose of HPV was given at my office 10/14/14.  6 mths later she had weekly sx of near syncope, chest pains, chronic nausea, headaches, weight loss. Cardiac eval.
Age: 16.0
Sex: F
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Cardiac stress test, Chest discomfort, Computerised tomogram, Dizziness, Head discomfort
Clinical narrative: Pt had syncope/lightheadedness on day of 1st dose of GARDASIL 11/17/11. 2 episodes of near syncope 4 mths apart followed. Received 2nd dose HPV 03/09/12. Episodes of near syncope occurred 1x every 2 mths. 3rd dose of HPV was given at my office 10/14/14.  6 mths later she had weekly sx of near syncope, chest pains, chronic nausea, headaches, weight loss. Cardiac eval.
Age: 16.0
Sex: F
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Myalgia, Nuclear magnetic resonance imaging, Palpitations, Syncope, Ultrasound scan
Clinical narrative: Pt had syncope/lightheadedness on day of 1st dose of GARDASIL 11/17/11. 2 episodes of near syncope 4 mths apart followed. Received 2nd dose HPV 03/09/12. Episodes of near syncope occurred 1x every 2 mths. 3rd dose of HPV was given at my office 10/14/14.  6 mths later she had weekly sx of near syncope, chest pains, chronic nausea, headaches, weight loss. Cardiac eval.
Age: 16.0
Sex: F
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Urine analysis, Vertigo, X-ray
Clinical narrative: Pt had syncope/lightheadedness on day of 1st dose of GARDASIL 11/17/11. 2 episodes of near syncope 4 mths apart followed. Received 2nd dose HPV 03/09/12. Episodes of near syncope occurred 1x every 2 mths. 3rd dose of HPV was given at my office 10/14/14.  6 mths later she had weekly sx of near syncope, chest pains, chronic nausea, headaches, weight loss. Cardiac eval.
Age: 16.0
Sex: F
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Cardiac stress test normal, Chest pain, Computerised tomogram head normal, Dizziness, Full blood count normal
Clinical narrative: Pt had syncope/lightheadedness on day of 1st dose of GARDASIL 11/17/11. 2 episodes of near syncope 4 mths apart followed. Received 2nd dose HPV 03/09/12. Episodes of near syncope occurred 1x every 2 mths. 3rd dose of HPV was given at my office 10/14/14.  6 mths later she had weekly sx of near syncope, chest pains, chronic nausea, headaches, weight loss. Cardiac eval.
Age: 16.0
Sex: F
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Headache, Laboratory test normal, Nausea, Presyncope, Syncope
Clinical narrative: Pt had syncope/lightheadedness on day of 1st dose of GARDASIL 11/17/11. 2 episodes of near syncope 4 mths apart followed. Received 2nd dose HPV 03/09/12. Episodes of near syncope occurred 1x every 2 mths. 3rd dose of HPV was given at my office 10/14/14.  6 mths later she had weekly sx of near syncope, chest pains, chronic nausea, headaches, weight loss. Cardiac eval.
Age: 16.0
Sex: F
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Thyroid function test normal, Ultrasound abdomen normal, Weight decreased
Clinical narrative: Pt had syncope/lightheadedness on day of 1st dose of GARDASIL 11/17/11. 2 episodes of near syncope 4 mths apart followed. Received 2nd dose HPV 03/09/12. Episodes of near syncope occurred 1x every 2 mths. 3rd dose of HPV was given at my office 10/14/14.  6 mths later she had weekly sx of near syncope, chest pains, chronic nausea, headaches, weight loss. Cardiac eval.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Oedema
Clinical narrative: Developed 2+ pitting edema, warmth and pain in left deltoid area. This was from patient receiving MENACTRA in left deltoid, the patient also received AFLURIA in right deltoid.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Developed 2+ pitting edema, warmth and pain in left deltoid area. This was from patient receiving MENACTRA in left deltoid, the patient also received AFLURIA in right deltoid.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Full blood count normal, Injection site erythema, Injection site pain
Clinical narrative: 26Jan: Pt reported to Dr. with pain and some redness below injection site. Apprx 8in in diameter. Dx:Cellulitis Rx: Cephalexin 500mg x6hrs. 27Jan: @1025 had increased in size by +3in. Rx: Ceftriaxone 1gm IV. 27Jan: @1700 redness increased by +1in. Transported Pt to ER.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Immunoglobulin therapy, Lumbar puncture, Muscular weakness, Plasmapheresis
Clinical narrative: I started with weakness in my legs about 72 hours after the shot. Proceeded to get worse. Then I was admitted to the hospital on 04/16/2015. I received 2 series of IVIG with no result. Then received 6 treatments of plasmapheresis.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Patient states on day of injection the site got sore and red and then warm. Since then she noticed redness, heat and swelling which traveled down that arm and beyond her elbow.
Age: 1.03
Sex: F
Vaccine: MMR, PNC13
Symptoms: Cough, Rash, Respiratory tract congestion
Clinical narrative: Cough, congestion and rash on face and trunk of body.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age. The patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L022262, expiry date 05-NOV-2016, L027732, expiry date 23-FEB-2017 on multiple unspecified dates following an excursion that occurred on 13-JAN-2016. No adverse effects were reported. The temperature was 50.7 with a time frame of 1 hour and 30 minutes. This is one of the several reports received from the same reporter. 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 multiple unspecified patients of unknown age. The patients were vaccinated with improperly stored RECOMBIVAX HB lot # K012875, expiry date 27-JUL-2016 on multiple unspecified dates following an excursion that occurred on 13-JAN-2016. No adverse effects were reported. The temperature was 50.7 with a time frame of 1 hour and 30 minutes. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Rash generalised, Urticaria
Clinical narrative: Broke out in rash and hives all over body. Fussy.
Age: 34.0
Sex: F
Vaccine: YF
Symptoms: Cough, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Extreme tiredness, fever, nausea, headaches, serious chesty cough.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Angiogram, Computerised tomogram, Dizziness, Fatigue
Clinical narrative: SECOND DOSE OF THE GARDASIL, HPV VACCINE WAS ADMINISTERED ON 11/06/2012 AND ON 12/12/2012 WAS SEEN BACK IN THE DOCTORS OFFICE FOR DIZZINESS, NAUSEA, ABDOMINAL PAIN, FATIGUE, AND HEADACHES. DR ORDERED BLOOD WORK AND MONOSPOT, THESE SYMPTOMS HAS CONTINUED SINCE THIS DATE.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Full blood count, Headache, Metabolic function test, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: SECOND DOSE OF THE GARDASIL, HPV VACCINE WAS ADMINISTERED ON 11/06/2012 AND ON 12/12/2012 WAS SEEN BACK IN THE DOCTORS OFFICE FOR DIZZINESS, NAUSEA, ABDOMINAL PAIN, FATIGUE, AND HEADACHES. DR ORDERED BLOOD WORK AND MONOSPOT, THESE SYMPTOMS HAS CONTINUED SINCE THIS DATE.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urine analysis
Clinical narrative: SECOND DOSE OF THE GARDASIL, HPV VACCINE WAS ADMINISTERED ON 11/06/2012 AND ON 12/12/2012 WAS SEEN BACK IN THE DOCTORS OFFICE FOR DIZZINESS, NAUSEA, ABDOMINAL PAIN, FATIGUE, AND HEADACHES. DR ORDERED BLOOD WORK AND MONOSPOT, THESE SYMPTOMS HAS CONTINUED SINCE THIS DATE.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Vomiting
Clinical narrative: VOMITING, RESULTED IN ER TRIP.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Pain, Peripheral swelling
Clinical narrative: Pt received shot and within 3 hours his arm blew up and they were numerous bruises. He felt pain all throughout his body. He went to the ER 2 times.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Bursa injury, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Sharp, burning pain at injection high on left shoulder. Within minutes, arm and shoulder were disabled and crippled. Condition has persisted since 10-17-15.
Age: 76.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Pruritic, itching rash on trunk, right arm and leg. Present for two days prior to report. SoluMedrol 125mg IM given in-office. Prednisone 10-day taper given (starting at 10 mg).
Age: 76.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Pruritic, itching rash on trunk, right arm and leg. Present for two days prior to report. SoluMedrol 125mg IM given in-office. Prednisone 10-day taper given (starting at 10 mg).
Age: 76.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Red, pruritic annular rash over arm and abdomen which developed over two days.
Age: 76.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red, pruritic annular rash over arm and abdomen which developed over two days.
Age: 0.22
Sex: M
Vaccine: RV5
Symptoms: Eye movement disorder, Screaming, Tremor, Vomiting
Clinical narrative: Screaming, vomiting, eyes rolled back, shaking for 3 minutes.
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 19-Jan-2016. This case involves a 69-year-old female patient who was vaccinated with first dose of ADACEL (batch number: U5264AA, expiry date: 15-Jan-2018, dose and route of administration was not reported) in left deltoid and also received first dose of PREVNAR 13 (manufacturer: other, batch number: L99262, dose and route of administration was not reported) in right deltoid on 13-Oct-2015. The patient had no illness at the time of vaccination and no known allergies. Patient had medical history of afib and regularly sees cardiology for monitoring. Concomitant medications were not reported. On 29-Oct-2015, 16 days following the vaccination, the patient developed afib. It was reported that the patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report patient was not recovered from the event. Upon internal review, the case was considered to be serious due to important medical event: afib. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Dysgeusia, Headache, Hypoaesthesia, Injection site pain, Pain
Clinical narrative: Initial unsolicited misuse report received from a nurse on 13 January 2016. This case involves a 49-year-old female patient who was vaccinated with a first dose of ADACEL (batch number U5263AA, expiry date 21 January 2018, route of administration were not reported) in the left deltoid on 20 November 2015 instead of a dose of TENIVAC (batch number, expiry date, site and route of administration were not reported) on an unspecified date for the indication dog bite. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies included cat allergy and no birth defects and medical conditions were reported. Patient had no other vaccinations within four weeks of vaccinations. On 20 November 2015, few hours "same night" following the vaccination patient developed injection site pain in the left deltoid and continuous headache. On 4 December 2015, 14 days following the vaccination patient experienced awful taste in her mouth. On an unspecified date, following the vaccination "During the week of Christmas" patient experienced bilateral foot pain and since then she had numbness and tingling in bilateral hands and feet with intermittent pain. She was worried she may have an autoimmune disorder. It was a wrong vaccine administered case, as patient received ADACEL in error instead of TENIVAC vaccine. It was reported that she didn't want ADACEL as it contained extra chemicals that she did not need. Patient had no laboratory investigation. Corrective treatment was not reported. The outcome of events was not recovered for events bilateral foot pain, numbness, tingling in bilateral hands and feet with intermittent pain and autoimmune disorder and recovered from the events awful taste in her mouth (lasted for four days), injection site pain in the left deltoid (lasted for three days) and continuous headache (lasted for four days). Upon internal review, the company decided to consider the event serious because of important medical event: she may have an autoimmune disorder. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Pain in extremity, Paraesthesia, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a nurse on 13 January 2016. This case involves a 49-year-old female patient who was vaccinated with a first dose of ADACEL (batch number U5263AA, expiry date 21 January 2018, route of administration were not reported) in the left deltoid on 20 November 2015 instead of a dose of TENIVAC (batch number, expiry date, site and route of administration were not reported) on an unspecified date for the indication dog bite. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies included cat allergy and no birth defects and medical conditions were reported. Patient had no other vaccinations within four weeks of vaccinations. On 20 November 2015, few hours "same night" following the vaccination patient developed injection site pain in the left deltoid and continuous headache. On 4 December 2015, 14 days following the vaccination patient experienced awful taste in her mouth. On an unspecified date, following the vaccination "During the week of Christmas" patient experienced bilateral foot pain and since then she had numbness and tingling in bilateral hands and feet with intermittent pain. She was worried she may have an autoimmune disorder. It was a wrong vaccine administered case, as patient received ADACEL in error instead of TENIVAC vaccine. It was reported that she didn't want ADACEL as it contained extra chemicals that she did not need. Patient had no laboratory investigation. Corrective treatment was not reported. The outcome of events was not recovered for events bilateral foot pain, numbness, tingling in bilateral hands and feet with intermittent pain and autoimmune disorder and recovered from the events awful taste in her mouth (lasted for four days), injection site pain in the left deltoid (lasted for three days) and continuous headache (lasted for four days). Upon internal review, the company decided to consider the event serious because of important medical event: she may have an autoimmune disorder. List of documents held by sender: none.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician 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 at 0.5 ml, single. Medical history and concomitant medications were not reported. The patient experienced cellulitis and pain in the arm on an unspecified date, two weeks later after the injection of PREVNAR 13. Cellulitis was right away but the pain was still there 2 weeks later.
Sex: U
Vaccine: PNC
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of an unspecified age, ethnicity and gender received PREVNAR, intramuscular on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced cellulitis on an unspecified date with outcome of unknown. The action taken in response to the event for PREVNAR was not applicable.
Sex: F
Vaccine: PNC
Symptoms: Arthralgia, Cellulitis
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age, and ethnicity received PREVNAR, intramuscular on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced cellulitis on an unspecified date with outcome of unknown. The patient went to an orthopedic because of joint pain from the vaccine. The outcome of the joint pain was unknown. The action taken in response to the event for PREVNAR was not applicable.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Biopsy colon, Colitis microscopic, Colonoscopy abnormal, Diarrhoea, Inflammation
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 69-year-old female patient received PREVNAR 13, via an unspecified route of administration on 30Oct2015 at 0.5 ml, single. Medical history and concomitant medications were not reported. The patient experienced lymphocytic colitis on an unspecified date in 2015 and diarrhoea on 04Nov2015, both with outcome of not recovered. The patient mentioned that a week after she received the shot, she started experiencing diarrhea. She thought it was because of a supplement that she was taking too much of them, so she did not relate it to the shot at all and then she stopped taking the supplement completely and she continued with the diarrhea and it was not going away. With the another couple of weeks the patient ended up going to see a Gastroenterologist, she had a colonoscopy on 22Dec2015 and she has been diagnosed with lymphocytic colitis. When she had the colonoscopy, her doctor took biopsy and when she got the result, her doctor said it was basically an inflammation, so she was just trying the medication that doctor gave to her. She was trying samples of LIALDA 4 a day, and it was the initial stage treatment but she did not know what her doctor will do after this. Before she started taking mesalamine, her doctor recommended her to take IMODIUM for diarrhea.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, fatigue, vomiting, low grade fever onset in evening.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: PT STATES 6 HOURS AFTER VACCINATION STARTED EXPERIENCING REDNESS, SWELLING, AND HEAT. OVER THE LAST 30 HOURS IT HAS SPREAD OVER THE ENTIRE UPPER ARM AND NOW HAS FEVER (TEMP 101).
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Left arm swelling, pain, erythema.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Abnormal behaviour, Activities of daily living impaired, Educational problem, Electroencephalogram, Nuclear magnetic resonance imaging brain
Clinical narrative: Became more difficult, began to drop grades, began to need help with daily activities such as dressing, feeding, and bathing.  Now requires complete help with dressing, feeding, drinking.
Age: 46.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Hypoaesthesia, Motor dysfunction, Muscle spasms
Clinical narrative: Patient received his vaccine in his right deltoid muscle.  The following day, time unspecified, he gradually felt that his left leg went to sleep.  He lost motor control of his leg and had to assist move it with his hands for 24-36 hours.  It gradually improved, but did not go back to normal motor and sensation for almost 3 days per the patient.  He was seen on the 21st and had complete resolution of his symptoms by that time.  He was seen again on 01/28 and remains asymptomatic.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: Pt called and stated that he received the shingles vaccination 01/11/16 and felt fine on Monday but Tue evening and Wed, started to not feel well.  Stated that he felt achy all over like he was getting the flu.  Also stated that at the injection site, it is red, warm to touch, and one blister in the area of the injection site.  Stated that it is a little itchy but no pain at this time.  Advised that the shingles vaccination is a live virus and is possible to have this reaction.  Advised to not pop the blister due to the possibility of it spreading.  Pt stated that today he feels much better. Pt asked what he could use for the itching.  Recommended Benadryl Cream.  Advised to monitor and if no improvement or if symptoms worsen to call our office.