chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Herpes zoster
Clinical narrative: Case number PHHY2015US047884, is an initial spontaneous report from a physician via Vaccine Adverse Event Reporting System (VAERS reference number: 567857) website on 21 Apr 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with flu vaccine (manufacturer and batch number: unknown) and PREVANER 13 (other manufacturer, batch number: not reported) on an unknown date. After vaccinations, the patient had herpes zoster. The patient was referred to infectologist. The outcome of the events was unknown. The events were assessed as non-serious. The reporter considered the event was related to pneumococcal vaccine. The causality of the event related to flu vaccine was not reported.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain, X-ray normal
Clinical narrative: Case number PHHY2015US048660, is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 568106) web site received on 21 Apr 2015. This report refers to a 30-year-old female patient. Historical condition was not reported. Concomitant medication included prenatal vitamins. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) into the left arm (intramuscular) on 07 Oct 2014. On 07 Oct 2014 after the vaccination, the patient experienced pain in shoulder and on 09 Oct 2014, noted decreased range of motion along with severe pain. X-ray done in Feb 2015 showed negative result (details not specified). The final outcome of the events was reported as condition unchanged. The events were reported as non-serious. Causality assessment of the events was not reported.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Influenza like illness, Malaise, Wheezing
Clinical narrative: Case number PHHY2015US048661 is an initial spontaneous report from consumer received from the vaccine adverse event reporting system (VAERS reference number: 568147) web site on 21 Apr 2015. This report refers to a 69 year old male patient. Historical condition was not reported. Current condition included chronic obstructive pulmonary disease and asthma. On an unknown date, the patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown). His co-suspects were ADVAIR diskus inhalation powder used for the treatment of asthma and VENTOLIN HFA inhaler used for the treatment of asthma and wheezing. On an unknown date, dose and frequency of both drugs were changed. On an unknown date, after receiving suspect products, the patient experienced cough, sickness and wheezing. The dose of ADVAIR diskus and VENTOLIN HFA were increased. The patient's wife stated that even though the patient got flu shot, he experienced something like the flu and not the actual flu. It was reported that since he was sick, he was taking a little more of ADVAIR and VENTOLIN then usual prescribed dose (overdose). On an unknown date patient was coughing and wheezing more than normal and later was doing a bit better and not coughing as much. Outcome of the cough, sickness and wheezing was reported as recovering and that of influenza like illness was reported as condition unchanged. The events were reported as non-serious. The reporter considered the cough, sickness and wheezing to be unrelated to influenza vaccine and ADVAIR diskus. It was unknown if the reporter considered the cough, overdose, sickness and wheezing to be related to VENTOLIN HFA. No further information was provided.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Diarrhoea, Headache, Injection site discomfort
Clinical narrative: Case number PHHY2015US048663, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 568203) web site on 21 Apr 2015. This report refers to a 23 year old male patient. Historical condition and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) into the left arm intradermally on 03 Mar 2015. On 03 Mar 2015, the patient experienced cough, tickling around injection site, headache and fever. Further, the patient also had chills, nausea and lingered neck aches. On 05 Mar 2015 by 3:30, the patient experienced intense vomiting and diarrhea. Outcome of the events chills, fever, nausea, diarrhea, headache and neck ache lingered were reported as condition unchanged and of the other events was reported as unknown. The events were reported as non-serious. Causality was not reported.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Neck pain, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US048663, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 568203) web site on 21 Apr 2015. This report refers to a 23 year old male patient. Historical condition and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) into the left arm intradermally on 03 Mar 2015. On 03 Mar 2015, the patient experienced cough, tickling around injection site, headache and fever. Further, the patient also had chills, nausea and lingered neck aches. On 05 Mar 2015 by 3:30, the patient experienced intense vomiting and diarrhea. Outcome of the events chills, fever, nausea, diarrhea, headache and neck ache lingered were reported as condition unchanged and of the other events was reported as unknown. The events were reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: Case PHHY2015US048571, is an initial spontaneous report received from consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 568209) website on 21 Apr 2015. This report refers to a female patient of unknown age. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) on an unknown date. On an unknown date, after receiving influenza vaccine, the patient experienced influenza. She stated that her sister also received influenza vaccine but still got flu (refer case PHHY2015US048545). Outcome of the event was not reported. The event was reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: Case number PHHY2015US048545 is an initial spontaneous report received from consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 568209) website on 21 Apr 2015. This report refers to a female patient of unknown age. Concurrent medical conditions included chronic obstructive asthma (with obstructive pulmonary disease). She had no concomitant medications. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) on an unknown date. On an unknown date after vaccination, the patient experienced influenza. Outcome of the event was not reported. The event was reported as non-serious. It was unknown if the reporter considered influenza to be related to vaccination.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Breath sounds abnormal, Bronchitis, Condition aggravated, Dyspnoea, Pyrexia
Clinical narrative: Case number PHHY2015US047910, is an initial spontaneous report received from consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 568277) website on 21 Apr 2015. This report refers to a 55 year old male patient. The patient's past medical history included pneumonia (born with pneumonia). Concurrent medical conditions included hypertension (for 5-10 years) and anemia (since he was a little boy). Concomitant products included Albuterol, ipratropium and trazodone. In 2013, the patient started therapy with ADVAIR Diskus at a dose of one puff inhaled twice a day for chronic obstructive pulmonary disease. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in Oct 2014. In Oct 2014, after receiving the vaccination, the patient was making gurgling breath sounds. On 29 Oct 2014, the patient experienced fever, bronchitis like symptoms and difficulty breathing. Therapy with ADVAIR Diskus was continued with no change. Final outcome of the events was unknown. The events were reported as non-serious. The reporter stated the patient usually get bronchitis about this time every year. The reporter considered the events bronchitis like symptoms, fever, difficulty breathing and gurgling breath sounds to be unlikely related to influenza vaccine and ADVAIR Diskus.
Age: 42.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Injection site pain, Pain, Toothache
Clinical narrative: Case number PHHY2015US050964, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 568526) website on 21 Apr 2015. This report refers to 42-year-old female patient. Concomitant medications included HEB prenatal vitamins (without DHA and EPA). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) in the left arm and hepatitis B vaccine (manufacturer and batch number were unknown) in the right arm on 06 Mar 2015. On the same day the patient experienced toothache on left side which was worse on teeth was pre-existing caps. She also developed soreness at injection site and slight body soreness. Outcome of the events was reported as unknown. The events were reported as non-serious. Causality was not reported.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site inflammation, Joint range of motion decreased, Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2015US048891, is an initial spontaneous report from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 568712) website received on 21 Apr 2015. This report refers to a 65-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) and Pneumo (manufacturer and batch number: unknown) at same site into the right arm on 14 Nov 2013. On 19 Nov 2013, the patient had arm pain, swelling, limited range of motion and also developed acute several local reaction to immunization, but no abscess identified and just had diffuse inflammatory changes at the site, of right arm. Following the events, the patient visited the emergency room. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Tic
Clinical narrative: Case number PHHY2015US048113, is an initial spontaneous report received from consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 568723) website on 21 Apr 2015. This report refers to a male child. Medical history included rondalic epilepsy. Concomitant medication included TRILEPTAL. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) on an unknown date. Three days after receiving the vaccine, the patient began ticing with a milder type of vocalization and it lasted just over 3 months. Outcome of the event was recovered. The event was reported as non-serious. Causality was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2015US048687, is an initial spontaneous report received from the consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 568881) website on 21 Apr 2015. This report refers to a 63 years old female patient. Historical conditions and concomitant medications were none. On 01 Nov 2014, she was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported). The patient reported moderate pain at injection site still 4 months after vaccination (onset date not reported). Final outcome of the event was not reported. Event was reported as non-serious. Causality assessment was not provided.
Age: 77.0
Sex: U
Vaccine: FLUX
Symptoms: Cough, Nasopharyngitis
Clinical narrative: Case number PHHY2015US052225, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 569208) website on 21 Apr 2015. This report refers to a 77-year-old patient of unspecified gender. Medical history included colon cancer, bone cancer and pneumonia. This poly medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly on 25 Dec 2014. On an unknown date the patient received ADVAIR Diskus (batch number 4ZP6123, expiry Feb 2016) for asthma (1 puff). In Dec 2014, less than a week after receiving Influenza vaccine and an unknown time after starting ADVAIR Diskus, the patient experienced cough. On 28 Dec 2014, the patient experienced cold. ADVAIR Diskus was continued with no change. The final outcome of the events was condition unchanged. The events were reported as non serious. It was unknown if the reporter considered the cough and cold to be related to Influenza vaccine and ADVAIR Diskus.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site pain, Mobility decreased, Nuclear magnetic resonance imaging, Screaming
Clinical narrative: Case number PHHY2015US053252 is an initial spontaneous report received from the consumer (also patient) via Vaccine Adverse Event Reporting System (VAERS reference  number: 569449) web site on 21 Apr 2015. This report refers to a 43-year-old female patient. Historical conditions and current illness were none. No concomitant medication was reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch unknown were unknown) on 31 Oct 2014. On the same day after vaccination, the patient experienced intense pain at time of injection. The patient reported that prior to the injection; nurse commented that she would give the shot higher than the patient thought. Over the next few to several weeks the pain worsened, mobility decreased and could barely move. Further the patient was screaming. Four months later mobility was much better but the patient still have a lot of pain. The patient met an orthopedist and had an MRI (result not reported). The patient was on physical therapy now. The final outcome of the events was not reported. Seriousness of the event was reported as not serious. Causality was not reported.
Age: 33.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Clumsiness, Dysstasia, Ear infection, Influenza, Lethargy
Clinical narrative: Case number PHHY2015US051738, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS: reference number: 569600) website on 21 Apr 2015. This report refers to a 33 year old female patient. Historical condition and concomitant medication were none. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported), hepatitis B vaccine (other manufacturer, batch number: not reported) and hepatitis A vaccine (other manufacturer, batch number: not reported) all on 27 Jan 2011. On the same day after vaccination, her leg, where the vaccine was given, swelled to twice of its normal size. She screamed all night long and stopped only to vomit for several times. She became clumsy, unresponsive at times and had trouble while standing. She woke up the next morning and looked thin, pale and lethargic. Afterword, she had constant health issues described as ear infections, colds, flu and staphylococcal infection. She consulted doctors, naturopaths, homeopaths and nutritionists to get her whole body healthy. Final outcome of the events was complete recovery. Events were reported as non-serious. Causality was not reported.
Age: 33.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Nasopharyngitis, Pallor, Peripheral swelling, Screaming, Staphylococcal infection
Clinical narrative: Case number PHHY2015US051738, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS: reference number: 569600) website on 21 Apr 2015. This report refers to a 33 year old female patient. Historical condition and concomitant medication were none. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported), hepatitis B vaccine (other manufacturer, batch number: not reported) and hepatitis A vaccine (other manufacturer, batch number: not reported) all on 27 Jan 2011. On the same day after vaccination, her leg, where the vaccine was given, swelled to twice of its normal size. She screamed all night long and stopped only to vomit for several times. She became clumsy, unresponsive at times and had trouble while standing. She woke up the next morning and looked thin, pale and lethargic. Afterword, she had constant health issues described as ear infections, colds, flu and staphylococcal infection. She consulted doctors, naturopaths, homeopaths and nutritionists to get her whole body healthy. Final outcome of the events was complete recovery. Events were reported as non-serious. Causality was not reported.
Age: 33.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Case number PHHY2015US051738, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS: reference number: 569600) website on 21 Apr 2015. This report refers to a 33 year old female patient. Historical condition and concomitant medication were none. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported), hepatitis B vaccine (other manufacturer, batch number: not reported) and hepatitis A vaccine (other manufacturer, batch number: not reported) all on 27 Jan 2011. On the same day after vaccination, her leg, where the vaccine was given, swelled to twice of its normal size. She screamed all night long and stopped only to vomit for several times. She became clumsy, unresponsive at times and had trouble while standing. She woke up the next morning and looked thin, pale and lethargic. Afterword, she had constant health issues described as ear infections, colds, flu and staphylococcal infection. She consulted doctors, naturopaths, homeopaths and nutritionists to get her whole body healthy. Final outcome of the events was complete recovery. Events were reported as non-serious. Causality was not reported.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Initial unsolicited report received from a consumer on 27 January 2016. This case involves 52-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu vaccine) (batch number- UI260AA, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient was diagnosed with acute disseminated encephalomyelitis (ADEM). Laboratory data and corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none. Sender's Comments: Acute disseminated encephalomyelitis following administration of influenza vaccine have been reported. Manufacturer of the influenza vaccine was unknown. This medically not confirmed case, is poorly documented. More information on time to onset, Past medical history, health condition at vaccination, concomitant medication, investigation results confirming diagnosis and ruling out other alternative etiologies, is required to further assess this case.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Severe (R) shoulder and arm pain spreading to neck and causing headaches. Eventually spreading to (L) shoulder and arm. Pain medication hardly helps. Drs. told us it should get better in a few weeks. 4 weeks  now and no improvement. Lost the whole month of January.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Headache, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe (R) shoulder and arm pain spreading to neck and causing headaches. Eventually spreading to (L) shoulder and arm. Pain medication hardly helps. Drs. told us it should get better in a few weeks. 4 weeks  now and no improvement. Lost the whole month of January.
Age: 55.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Arthralgia, Autoimmune disorder, Blood test normal, Borrelia test negative, Burning sensation
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 15 January 2016 to update the suspect product from Imovax Polio to Imovax Rabies. Initial unsolicited report received from a consumer on 21-Dec-2015. This case involves a 55-year-old female patient who was vaccinated with an intramuscular dose of Imovax (batch number, and site of administration was not reported) and intramuscular dose of Hyperrab (manufacturer: Grifols, batch number and site of administration was not reported) on 14-Dec-2015. Patient's medical conditions include hypothyroidism and illness at time of vaccination was reported as none. Concomitant medications include Synthroid for hypothyroidism. On 15-Dec-2015, one day after vaccination, the patient experienced whole body soreness and felt very tired. Next day, patient experienced muscle pain widespread over the body. On an unspecified date in the week after vaccination, the patient experienced numbness and tingling in all of her fingers and also some chest pain from the anxiety. Laboratory investigations and corrective treatments were not reported. Outcome of all the events was reported as not recovered. Addendum on: Upon internal review, a significant correction was performed on 15 January 2016 to update the suspect product from Imovax Polio to Imovax Rabies. Documents held by sender: none. Follow-up information received from Consumer on 28-Jan-2016. On 14-Dec-2015, patient was administered with Imovax (batch number-K1613, expiry date: 31-Oct-2016) and IVIG 1400 units (batch number-R1AD400091, expiry date: 26-Nov-2016). On 19-Dec-2015, Patient was again administered with Imovax (batch number- 2501, expiry date- 17-Feb-2017) and on 21-Dec-2015, patient was vaccinated with Imovax (batch number-K1729, expiry date: 7-Dec-2016).
Age: 55.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Laboratory test normal, Muscle fatigue, Myalgia, Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 15 January 2016 to update the suspect product from Imovax Polio to Imovax Rabies. Initial unsolicited report received from a consumer on 21-Dec-2015. This case involves a 55-year-old female patient who was vaccinated with an intramuscular dose of Imovax (batch number, and site of administration was not reported) and intramuscular dose of Hyperrab (manufacturer: Grifols, batch number and site of administration was not reported) on 14-Dec-2015. Patient's medical conditions include hypothyroidism and illness at time of vaccination was reported as none. Concomitant medications include Synthroid for hypothyroidism. On 15-Dec-2015, one day after vaccination, the patient experienced whole body soreness and felt very tired. Next day, patient experienced muscle pain widespread over the body. On an unspecified date in the week after vaccination, the patient experienced numbness and tingling in all of her fingers and also some chest pain from the anxiety. Laboratory investigations and corrective treatments were not reported. Outcome of all the events was reported as not recovered. Addendum on: Upon internal review, a significant correction was performed on 15 January 2016 to update the suspect product from Imovax Polio to Imovax Rabies. Documents held by sender: none. Follow-up information received from Consumer on 28-Jan-2016. On 14-Dec-2015, patient was administered with Imovax (batch number-K1613, expiry date: 31-Oct-2016) and IVIG 1400 units (batch number-R1AD400091, expiry date: 26-Nov-2016). On 19-Dec-2015, Patient was again administered with Imovax (batch number- 2501, expiry date- 17-Feb-2017) and on 21-Dec-2015, patient was vaccinated with Imovax (batch number-K1729, expiry date: 7-Dec-2016).
Age: 55.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Vaccination complication
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 15 January 2016 to update the suspect product from Imovax Polio to Imovax Rabies. Initial unsolicited report received from a consumer on 21-Dec-2015. This case involves a 55-year-old female patient who was vaccinated with an intramuscular dose of Imovax (batch number, and site of administration was not reported) and intramuscular dose of Hyperrab (manufacturer: Grifols, batch number and site of administration was not reported) on 14-Dec-2015. Patient's medical conditions include hypothyroidism and illness at time of vaccination was reported as none. Concomitant medications include Synthroid for hypothyroidism. On 15-Dec-2015, one day after vaccination, the patient experienced whole body soreness and felt very tired. Next day, patient experienced muscle pain widespread over the body. On an unspecified date in the week after vaccination, the patient experienced numbness and tingling in all of her fingers and also some chest pain from the anxiety. Laboratory investigations and corrective treatments were not reported. Outcome of all the events was reported as not recovered. Addendum on: Upon internal review, a significant correction was performed on 15 January 2016 to update the suspect product from Imovax Polio to Imovax Rabies. Documents held by sender: none. Follow-up information received from Consumer on 28-Jan-2016. On 14-Dec-2015, patient was administered with Imovax (batch number-K1613, expiry date: 31-Oct-2016) and IVIG 1400 units (batch number-R1AD400091, expiry date: 26-Nov-2016). On 19-Dec-2015, Patient was again administered with Imovax (batch number- 2501, expiry date- 17-Feb-2017) and on 21-Dec-2015, patient was vaccinated with Imovax (batch number-K1729, expiry date: 7-Dec-2016).
Age: 55.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Anxiety, Chest pain, Fatigue, Hypoaesthesia, Myalgia
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 15 January 2016 to update the suspect product from Imovax Polio to Imovax Rabies. Initial unsolicited report received from a consumer on 21-Dec-2015. This case involves a 55-year-old female patient who was vaccinated with an intramuscular dose of Imovax (batch number, and site of administration was not reported) and intramuscular dose of Hyperrab (manufacturer: Grifols, batch number and site of administration was not reported) on 14-Dec-2015. Patient's medical conditions include hypothyroidism and illness at time of vaccination was reported as none. Concomitant medications include Synthroid for hypothyroidism. On 15-Dec-2015, one day after vaccination, the patient experienced whole body soreness and felt very tired. Next day, patient experienced muscle pain widespread over the body. On an unspecified date in the week after vaccination, the patient experienced numbness and tingling in all of her fingers and also some chest pain from the anxiety. Laboratory investigations and corrective treatments were not reported. Outcome of all the events was reported as not recovered. Addendum on: Upon internal review, a significant correction was performed on 15 January 2016 to update the suspect product from Imovax Polio to Imovax Rabies. Documents held by sender: none. Follow-up information received from Consumer on 28-Jan-2016. On 14-Dec-2015, patient was administered with Imovax (batch number-K1613, expiry date: 31-Oct-2016) and IVIG 1400 units (batch number-R1AD400091, expiry date: 26-Nov-2016). On 19-Dec-2015, Patient was again administered with Imovax (batch number- 2501, expiry date- 17-Feb-2017) and on 21-Dec-2015, patient was vaccinated with Imovax (batch number-K1729, expiry date: 7-Dec-2016).
Age: 55.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Pain, Paraesthesia
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 15 January 2016 to update the suspect product from Imovax Polio to Imovax Rabies. Initial unsolicited report received from a consumer on 21-Dec-2015. This case involves a 55-year-old female patient who was vaccinated with an intramuscular dose of Imovax (batch number, and site of administration was not reported) and intramuscular dose of Hyperrab (manufacturer: Grifols, batch number and site of administration was not reported) on 14-Dec-2015. Patient's medical conditions include hypothyroidism and illness at time of vaccination was reported as none. Concomitant medications include Synthroid for hypothyroidism. On 15-Dec-2015, one day after vaccination, the patient experienced whole body soreness and felt very tired. Next day, patient experienced muscle pain widespread over the body. On an unspecified date in the week after vaccination, the patient experienced numbness and tingling in all of her fingers and also some chest pain from the anxiety. Laboratory investigations and corrective treatments were not reported. Outcome of all the events was reported as not recovered. Addendum on: Upon internal review, a significant correction was performed on 15 January 2016 to update the suspect product from Imovax Polio to Imovax Rabies. Documents held by sender: none. Follow-up information received from Consumer on 28-Jan-2016. On 14-Dec-2015, patient was administered with Imovax (batch number-K1613, expiry date: 31-Oct-2016) and IVIG 1400 units (batch number-R1AD400091, expiry date: 26-Nov-2016). On 19-Dec-2015, Patient was again administered with Imovax (batch number- 2501, expiry date- 17-Feb-2017) and on 21-Dec-2015, patient was vaccinated with Imovax (batch number-K1729, expiry date: 7-Dec-2016).
Age: 47.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in upper left arm. Inability to raise arm over shoulder height.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Balance disorder, Dizziness, Dysphagia, Fatigue
Clinical narrative: Began with deep itching feeling in feet. Loss of balance. Foot drop. Bilateral polyneuropathy in feet and hands. Loss of weight, extreme fatigue, dizziness, difficulty swallowing even liquid. Crossed vision.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Peroneal nerve palsy, Polyneuropathy, Pruritus, Strabismus, Weight decreased
Clinical narrative: Began with deep itching feeling in feet. Loss of balance. Foot drop. Bilateral polyneuropathy in feet and hands. Loss of weight, extreme fatigue, dizziness, difficulty swallowing even liquid. Crossed vision.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Asocial behaviour, Autism, Autism spectrum disorder, Crying, Cytogenetic analysis normal
Clinical narrative: My daughter was very warm at the injection site.  She was very irritable and red. There was excessive crying for about 3 to 4 hours.  Nothing that I would do seemed to comfort her.  I did call the after hours doctor's phone number to express my concern and was told that this was normal, but if she continued the following day, to bring her to the hospital.  Her symptoms seemed to get better and she was no longer crying the following day.  Her subsequent well baby visits demonstrated that she was growing well and seemed to be hitting her milestones. A year later, she was walking, but did not typically meet her milestones at 2 years (saying two to three words in a sentence) and was not sociable.  I did enroll her in an Early Intervention Program at age 3, and she was officially diagnosed with PDD/Autism at the same age by the Psychologist associated with the program, and a Developmental Pediatrician.  She is 17 years old now and attends a residential school.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: DNA test for fragile X, Developmental delay, Electroencephalogram normal, Erythema, Injection site warmth
Clinical narrative: My daughter was very warm at the injection site.  She was very irritable and red. There was excessive crying for about 3 to 4 hours.  Nothing that I would do seemed to comfort her.  I did call the after hours doctor's phone number to express my concern and was told that this was normal, but if she continued the following day, to bring her to the hospital.  Her symptoms seemed to get better and she was no longer crying the following day.  Her subsequent well baby visits demonstrated that she was growing well and seemed to be hitting her milestones. A year later, she was walking, but did not typically meet her milestones at 2 years (saying two to three words in a sentence) and was not sociable.  I did enroll her in an Early Intervention Program at age 3, and she was officially diagnosed with PDD/Autism at the same age by the Psychologist associated with the program, and a Developmental Pediatrician.  She is 17 years old now and attends a residential school.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Irritability, Nuclear magnetic resonance imaging brain normal
Clinical narrative: My daughter was very warm at the injection site.  She was very irritable and red. There was excessive crying for about 3 to 4 hours.  Nothing that I would do seemed to comfort her.  I did call the after hours doctor's phone number to express my concern and was told that this was normal, but if she continued the following day, to bring her to the hospital.  Her symptoms seemed to get better and she was no longer crying the following day.  Her subsequent well baby visits demonstrated that she was growing well and seemed to be hitting her milestones. A year later, she was walking, but did not typically meet her milestones at 2 years (saying two to three words in a sentence) and was not sociable.  I did enroll her in an Early Intervention Program at age 3, and she was officially diagnosed with PDD/Autism at the same age by the Psychologist associated with the program, and a Developmental Pediatrician.  She is 17 years old now and attends a residential school.
Age: 0.65
Sex: F
Vaccine: FLUX, HEP, FLUX, HEP
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Fever, Tylenol 2 days. Diarrhea.
Age: 0.65
Sex: F
Vaccine: FLUX, HEP, FLUX, HEP
Symptoms: Diarrhoea, Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: Fever, Tylenol 2 days. Diarrhea.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendon disorder, X-ray normal
Clinical narrative: Sore arm of prolonged duration progressing to decreased mobility of shoulder. No imporvement with PT.  X Ray negative Dx tendonosis by MRI 2 months after injection.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Chest X-ray, Dyspnoea, Electrocardiogram, Pharyngoscopy, Wheezing
Clinical narrative: Had trouble breathing. Wheezing hard.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Chest X-ray, Dyspnoea, Laryngospasm, Wheezing
Clinical narrative: Had trouble breathing. Wheezing hard.
Age: 39.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Body temperature increased, Headache
Clinical narrative: unsolicited report received from a consumer on 27 January 2016. This case involves 39-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu-shot) (batch number, route and site of administration not reported) on 01 October 2015. The patient's medical history and concomitant medications were not reported. On 02 October 2015, 1 day following the vaccination, the patient had experienced strong headache in the morning and elevated temperature (99 degree farad) in the evening. Other laboratory data and corrective treatment were not reported. The outcome of events was not reported. List of Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Myositis, Skin warm
Clinical narrative: Redness and swelling at injection site. Inflamed muscle group tender and warm to touch. Cellulitis.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Tenderness
Clinical narrative: Redness and swelling at injection site. Inflamed muscle group tender and warm to touch. Cellulitis.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Musculoskeletal pain, Oral herpes
Clinical narrative: Extreme soreness in left shoulder, followed by redness around the upper arm and shoulder. I also believe it caused a cold sore due to stressing out my immune system.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Severe muscle pain, fatigue. Pain with left arm movement.  The severity has reduced but has never resolved.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Mom states that patient five bowel movements with bright red blood mixed with mucus starting four days after administration of rotavirus vaccine. She states that this occurred after her first dose at age two months as well. This was reported to VAERS at the time.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Patient received Prevnar13 on 01/27/2016 to right arm. Area is red and warm to touch. Localized to administration area. Patient denied pain or discomfort to site. No drainage or swelling.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Patient did not receive Pentacel dosing correctly. Employee did not mix the 2 bottles of vaccine correctly. She only mixed the one bottle with sterile diluent instead of mixing with the other bottle in the box.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site rash
Clinical narrative: Raised Localized Rash at site of injection, inflammation and slight pain.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Injection site swelling, Local swelling, Tinnitus
Clinical narrative: Swelling at site radiating shoulder and neck.  Tinnitis. Numbness to fingers.  Symptoms decreased with time.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Balance disorder, Diarrhoea, Dizziness, Hypoaesthesia, Insomnia
Clinical narrative: Swelling at site radiating shoulder and neck.  Tinnitis. Numbness to fingers.  Symptoms decreased with time.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pain in extremity, Swelling, Tinnitus
Clinical narrative: Swelling at site radiating shoulder and neck.  Tinnitis. Numbness to fingers.  Symptoms decreased with time.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Muscle weakness, leg pain from knee up to groin. Symptoms especially worse at night. Patient has had MRI and being treated with steroids/NSAIDs.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain, Blood test, Chest X-ray, Chest pain, Dehydration
Clinical narrative: Headache, side body pain, kidney and liver pain, rib pain, abdominal pain, dehydration, arm pain, ear pain, weight loss, chest pain, dizziness, heart racing, numbness in face, emotional, depression, tired all the time, throat feels like its swollen, vomiting.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Depression, Dizziness, Ear pain, Emotional distress, Fatigue
Clinical narrative: Headache, side body pain, kidney and liver pain, rib pain, abdominal pain, dehydration, arm pain, ear pain, weight loss, chest pain, dizziness, heart racing, numbness in face, emotional, depression, tired all the time, throat feels like its swollen, vomiting.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Flank pain, Headache, Hepatic pain, Hypoaesthesia, Musculoskeletal chest pain
Clinical narrative: Headache, side body pain, kidney and liver pain, rib pain, abdominal pain, dehydration, arm pain, ear pain, weight loss, chest pain, dizziness, heart racing, numbness in face, emotional, depression, tired all the time, throat feels like its swollen, vomiting.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Pain in extremity, Palpitations, Pharyngeal oedema, Renal pain, Ultrasound abdomen
Clinical narrative: Headache, side body pain, kidney and liver pain, rib pain, abdominal pain, dehydration, arm pain, ear pain, weight loss, chest pain, dizziness, heart racing, numbness in face, emotional, depression, tired all the time, throat feels like its swollen, vomiting.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Ultrasound pelvis, Urine analysis, Vomiting, Weight decreased
Clinical narrative: Headache, side body pain, kidney and liver pain, rib pain, abdominal pain, dehydration, arm pain, ear pain, weight loss, chest pain, dizziness, heart racing, numbness in face, emotional, depression, tired all the time, throat feels like its swollen, vomiting.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash, Urinary tract infection
Clinical narrative: Herpes zoster diagnosis in a 2-dose varicella vaccine recipient. Diagnosed by Dr. in ED. Painful rash in one dermatome. Rx for antiviral. Had UTI one month before HZ diagnosis.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Incision site cellulitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer-Sponsored Program "IBCC (inbound Call Center for HCPs)". A 65-year-old male patient received PREVNAR 13, in left arm, in Jan2016. No other vaccines were administered the same day. Relevant medical history included knee arthroplasty approximately 1.5 months before vaccination (unknown which knee was replaced). Concomitant medications included AFLURIA, intramuscular; ZOSTAVAX, subcutaneous and NORCO, for pain after surgery. The patient experienced cellulitis at the incision of knee replacement on an unspecified date. The reporter assessed the event as unrelated to PREVNAR 13. Outcome of the event was unknown.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 27Jan2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse and from a contactable medical assistant via Pfizer Sales Representative. This medical assistant reported similar events on five patients. This is the first of five reports. A 84 year-old female patient of unspecified ethnicity received PREVNAR 13 (lot number 177780, expiry date 01Jan2017, NDC number: 0005-1971-02), via an unspecified route of administration, on the arm, on 19Aug2015, at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The patient experienced cellulitis on 26Aug2015. She received a course of antibiotics to treat the event and she was recovering from the event as of 31Aug2015.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of vaccination failure in a female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Seasonal Influenza vaccine. Additional details were provided as follows: This case was received via BAXALTA. This case was considered as suspected vaccination failure as the time to onset for the influenza and lab test confirmation for the strain were unknown. The patient gave consent to contact her.
Age: 81.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Arthralgia, Injected limb mobility decreased, Myalgia
Clinical narrative: Initial unsolicited report received from Consumer via partner company (Pfizer) on 25-Nov-2015. This case involves a 81-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (INFLUENZA VACCINE) (batch number was unknown, expiry date and route of administration were not reported) in left arm and with a dose of PNEUMOCOCCAL POLYSACCHARIDE VACCINE (Prevnar 13) (manufacturer: Pfizer, batch number was not available, expiry date and route of administration were not reported) in right arm on 28-Oct-2015 sometime after 14:30 hours. It was reported that patient had no illness at the time of vaccination. Medical history and concomitant medications were not reported. Patient had not reported this adverse event previously. On unspecified date after vaccination, patient had experienced limitation of right arm movement, muscle pain and joint pain. Patient reported that side effects did not start on the same day that she received the vaccine. Patient did not require an emergency doctor visit. No Lab test had been performed and corrective treatments were not reported. At the time of report, events were still persisting (ongoing) and patient was not recovered from the events. Documents held by sender: none. Follow up information received from Consumer in on 21 January 2016. The event coding was updated from limited movement to injected limb mobility decreased. No additional information provided.
Age: 1.13
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, MMR, PNC13, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Herpes zoster diagnosis in a one-dose varicella vaccine recipient. Child was in remission from leukemia. Also has history of eczema. Hospitalized from 5/14-5/23/15. Painful rash in multiple dermatomes.
Age: 51.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Patient had initial injection site pain that lasted approximately 1 week.  Since injection he has had pain that migrates around entire left arm.  He states it is a deep muscle like pain.  It is not constant but comes and goes.  Patient has taken Tylenol and Ibuprofen but neither relieves the pain.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Computerised tomogram, Electrocardiogram, Electroencephalogram, Endotracheal intubation, Laboratory test
Clinical narrative: Seizure-lasting approximately 30 minutes.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Seizure, X-ray
Clinical narrative: Seizure-lasting approximately 30 minutes.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Herpes zoster diagnosis in herpes zoster vaccine recipient. Diagnosed by hospital dermatology. Painful rash in one dermatome. Lasted less than 4 weeks. Treated with Valtrex. History of cancer.
Age: 18.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: 10 minutes after vaccine administration patient developed a large area of swelling and redness around the injection site. Pt also experienced itching. Pt was treated with 50 mg Benadryl and ice packs. Pt was observed for 30 minutes and then released.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain, X-ray normal
Clinical narrative: Administered on the shoulder, very high, was not painful, but did not feel like it was normal. It hurt at night and continued to hurt for weeks. Certain positions it hurts. Dull pain.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Cellulitis with redness, swelling and pain to touch; induration of 1 cm at injection site SC left upper outer arm; redness, swelling and pain started left upper arm. Cellulitis migrated to left elbow and left forearm, with pain by 2/6/16, with resolution of left upper arm redness and swelling. By 2/8/16 still with redness, slight swelling and pain left elbow and left forearm.