chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chills, Diarrhoea, Fatigue, Injection site pain, Lethargy
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a  contactable nurse who reported similar events for two patients, and from a contactable physician. This is the first of two reports. A 17 year-old male patient received the first dose of TRUMENBA, (lot M74091, Expiry Date 30Jun2017) at 0.5 ml single in the right arm and the third dose of GARDASIL 9, (Lot M004116, Expiry Date 12Oct2017) at 1 DF single in the left arm, both intramuscular on 18Jul2016 at 03:15 pm for immunisation.  The patient medical history was not reported.  There were no concomitant medications. No other vaccines were administered within the four weeks prior. The patient previously took for immunisation two doses of human papilloma vaccine, the first dose on 16Nov2015 and the second dose on 26Jan2016. Other past vaccines given for immunisation included Hepatitis B vaccine on 16Nov2009, 15Feb2000 and 24Aug2000, Rotavirus vaccine on an unspecified date, Diphtheria, Tetanus toxoids, Pertussis on 08Apr1999, 10Jun1999, 12Aug1999, 24Aug2000 and 18May2004, Haemophilus Influenzae B on 08Apr1999, 10Jun1999, 12Aug1999, 24Aug2000, Pneumococcal vaccine on 24Aug2000 and 16Feb2001, Polio on 08Apr1999, 10Jun1999, 15Feb2000 and 18May2004, Measles, Mumps and Rubella vaccine on 25May2000, 18May2004, Varicella vaccine on 25May2000, 30Sep2008, Hepatitis A on 14Nov2011, 19Nov2012, DTAP on 17Aug2000, Meningococcal vaccine on 17Aug2010 and 09Mar2015, Influenza on 13Oct2009, 14Nov2011 and 19Nov2012. On 19Jul2016 at 12:00 am the patient experienced chills, vomiting, fever, nausea, diarrhoea, right arm pain injection site, he was tired, fatigued, lethargic and had body aches. Therapeutic measures were taken as a result of the events and included MOTRIN and BENADRYL. The patient was recovering from body aches, he recovered from the other reported events on 20Jul2016. The reporting physician considered there was a reasonable possibility that the events were related to suspect vaccines. Follow-up (21Sep2016):  Follow-up attempts are completed.  No further information is expected. Follow-up (04Oct2016): New information reported from a contactable physician includes: suspect vaccines details (route, anatomical location and time of administration), reaction data (new event body aches was added), details on past vaccines, causality assessment. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016367240 same reporter/ products/events, different patient; 2016367212 Legacy paper report number.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a  contactable nurse who reported similar events for two patients, and from a contactable physician. This is the first of two reports. A 17 year-old male patient received the first dose of TRUMENBA, (lot M74091, Expiry Date 30Jun2017) at 0.5 ml single in the right arm and the third dose of GARDASIL 9, (Lot M004116, Expiry Date 12Oct2017) at 1 DF single in the left arm, both intramuscular on 18Jul2016 at 03:15 pm for immunisation.  The patient medical history was not reported.  There were no concomitant medications. No other vaccines were administered within the four weeks prior. The patient previously took for immunisation two doses of human papilloma vaccine, the first dose on 16Nov2015 and the second dose on 26Jan2016. Other past vaccines given for immunisation included Hepatitis B vaccine on 16Nov2009, 15Feb2000 and 24Aug2000, Rotavirus vaccine on an unspecified date, Diphtheria, Tetanus toxoids, Pertussis on 08Apr1999, 10Jun1999, 12Aug1999, 24Aug2000 and 18May2004, Haemophilus Influenzae B on 08Apr1999, 10Jun1999, 12Aug1999, 24Aug2000, Pneumococcal vaccine on 24Aug2000 and 16Feb2001, Polio on 08Apr1999, 10Jun1999, 15Feb2000 and 18May2004, Measles, Mumps and Rubella vaccine on 25May2000, 18May2004, Varicella vaccine on 25May2000, 30Sep2008, Hepatitis A on 14Nov2011, 19Nov2012, DTAP on 17Aug2000, Meningococcal vaccine on 17Aug2010 and 09Mar2015, Influenza on 13Oct2009, 14Nov2011 and 19Nov2012. On 19Jul2016 at 12:00 am the patient experienced chills, vomiting, fever, nausea, diarrhoea, right arm pain injection site, he was tired, fatigued, lethargic and had body aches. Therapeutic measures were taken as a result of the events and included MOTRIN and BENADRYL. The patient was recovering from body aches, he recovered from the other reported events on 20Jul2016. The reporting physician considered there was a reasonable possibility that the events were related to suspect vaccines. Follow-up (21Sep2016):  Follow-up attempts are completed.  No further information is expected. Follow-up (04Oct2016): New information reported from a contactable physician includes: suspect vaccines details (route, anatomical location and time of administration), reaction data (new event body aches was added), details on past vaccines, causality assessment. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016367240 same reporter/ products/events, different patient; 2016367212 Legacy paper report number.
Age: 14.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Biopsy skin abnormal, Chills, Diarrhoea, Fatigue, Injection site pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse who reported similar events for two patients. This is the second of two reports. A 14 year-old male patient on 18Jul2016 at 3:14 pm received intramuscular for immunisation the first dose of TRUMENBA, (lot M74091, Expiry Date 30Jun2017) at 0.5 ml single in the right arm and the third dose of GARDASIL 9, (Merck, lot M004116, Expiry Date 12Oct2017) at 0.5 ml single in the left arm.  The patient had a normal growth and development. No other vaccine was given within four weeks prior. He was generally a well child. Medical history included penicillin allergy, in 2013 fractures of the base of the proximal phalanx 5th digit of right hand, lentiginous compound on the left parietal scalp, shave biopsied on 12Jan2009 with FU in Sep2016 with no new area of concern, benign nevi, rare.  There were no concomitant medications.  The patient previously took for immunisation two doses of human papilloma vaccine, the first dose on 16Nov2015 and the second dose on 25Jan2016. Other past vaccines given for immunisation included Hepatitis B vaccine on 12Dec2001, 13Feb2002 and 23Apr2003, Rotavirus vaccine on an unspecified date, Diphtheria, Tetanus toxoids, Pertussis on 12Dec2001, 13Feb2002, 18Apr2002, 23Apr2003 and 05Sep2007, Haemophilus Influenzae B on 12Dec2001, 13Feb2002 and 23Apr2003, Pneumococcal vaccine on 12Dec2001, 13Feb2002 and 18Apr2002, Polio on 12Dec2001, 13Feb2002, 18Jul2002 and 16Aug2006, Measles, Mumps and Rubella vaccine on 23Jan2003, 16Aug2006, Varicella vaccine on 23Oct2002, 30Sep2008, Hepatitis A on 05Nov2010, 14Nov2011, DTAP on 12Dec2012, Meningococcal vaccine on 18Feb2014, Influenza on 13Oct2009, 05Nov2010, 14Nov2011 and 12Dec2012. On 19Jul2016 at 12 am the patient experienced right arm pain at injection site, at 8 am he experienced chills, vomiting, fever, nausea, diarrhoea, he also had body aches and was tired, fatigued, lethargic.  Therapeutic measures were taken as a result of the events and included MOTRIN and BENADRYL. The patient was recovering from body aches, he recovered from the other reported events on 20Jul2016. The reporter considered there was a reasonable possibility that the events were related to suspect vaccines. Follow-up (21Sep2016):  Follow-up attempts are completed.  No further information is expected. Follow-up (04Oct2016): New information reported from a contactable nurse includes: suspect vaccines details (route, anatomical location and time of administration), reaction data (new event body aches was added), details on past vaccines and medical history, causality assessment. Sender's Comments: Linked Report(s): US-PFIZER INC-2016367212 same reporter/ products/events, different patient;2016367240 Legacy paper report number.
Age: 14.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Lethargy, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse who reported similar events for two patients. This is the second of two reports. A 14 year-old male patient on 18Jul2016 at 3:14 pm received intramuscular for immunisation the first dose of TRUMENBA, (lot M74091, Expiry Date 30Jun2017) at 0.5 ml single in the right arm and the third dose of GARDASIL 9, (Merck, lot M004116, Expiry Date 12Oct2017) at 0.5 ml single in the left arm.  The patient had a normal growth and development. No other vaccine was given within four weeks prior. He was generally a well child. Medical history included penicillin allergy, in 2013 fractures of the base of the proximal phalanx 5th digit of right hand, lentiginous compound on the left parietal scalp, shave biopsied on 12Jan2009 with FU in Sep2016 with no new area of concern, benign nevi, rare.  There were no concomitant medications.  The patient previously took for immunisation two doses of human papilloma vaccine, the first dose on 16Nov2015 and the second dose on 25Jan2016. Other past vaccines given for immunisation included Hepatitis B vaccine on 12Dec2001, 13Feb2002 and 23Apr2003, Rotavirus vaccine on an unspecified date, Diphtheria, Tetanus toxoids, Pertussis on 12Dec2001, 13Feb2002, 18Apr2002, 23Apr2003 and 05Sep2007, Haemophilus Influenzae B on 12Dec2001, 13Feb2002 and 23Apr2003, Pneumococcal vaccine on 12Dec2001, 13Feb2002 and 18Apr2002, Polio on 12Dec2001, 13Feb2002, 18Jul2002 and 16Aug2006, Measles, Mumps and Rubella vaccine on 23Jan2003, 16Aug2006, Varicella vaccine on 23Oct2002, 30Sep2008, Hepatitis A on 05Nov2010, 14Nov2011, DTAP on 12Dec2012, Meningococcal vaccine on 18Feb2014, Influenza on 13Oct2009, 05Nov2010, 14Nov2011 and 12Dec2012. On 19Jul2016 at 12 am the patient experienced right arm pain at injection site, at 8 am he experienced chills, vomiting, fever, nausea, diarrhoea, he also had body aches and was tired, fatigued, lethargic.  Therapeutic measures were taken as a result of the events and included MOTRIN and BENADRYL. The patient was recovering from body aches, he recovered from the other reported events on 20Jul2016. The reporter considered there was a reasonable possibility that the events were related to suspect vaccines. Follow-up (21Sep2016):  Follow-up attempts are completed.  No further information is expected. Follow-up (04Oct2016): New information reported from a contactable nurse includes: suspect vaccines details (route, anatomical location and time of administration), reaction data (new event body aches was added), details on past vaccines and medical history, causality assessment. Sender's Comments: Linked Report(s): US-PFIZER INC-2016367212 same reporter/ products/events, different patient;2016367240 Legacy paper report number.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 67-year-old female patient received PREVNAR 13 (lot M77339 Expiry Date Jul2017, NDC  00005197105) intramuscular at 0.5 ml, single on 02Aug2016 at 00:03 for immunization at Pharmacy. The patient medical history was not reported. Concomitant medications  included: amlodipine besilate (NORVASC) oral 5mg 1 po qd form 2013 and ongoing for HBP, atorvastatin calcium (LIPITOR) oral 40mg 1 po qhs form 2015 and ongoing for cholesterol, losartan potassium  (COZAAR) oral 50mg 1 po qd from 2013  and ongoing for HBP. No other vaccines were given on same date along with suspect vaccine. No other vaccinations were given within four weeks prior to date of vaccination The patient experienced tingling and burning sensation down to her fingers on 02Aug2016 with outcome not recovered. The AEs did not require an emergency room or physician visit. No specific tests and/or treatment were required. The Pharmacist stated that the patient did not provide to him/her information regarding the reported adverse events with the use of the suspect. The Pharmacist considered there was not a reasonable possibility that the event is related to suspect product.  The Pharmacist was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts are completed. No further information is expected. Follow-up (05Oct2016): New information reported from a contactable Pharmacist included:  Concomitant medications;  course of events; no lab tests; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Flank pain, Gastritis, Influenza like illness, Musculoskeletal pain
Clinical narrative: The initial case was missing the following minimum criteria: ICH-unspecified AE. Upon receipt of follow-up #1 information on 04Oct2016, this case now contains all required information to be considered valid.  This is a follow-up spontaneous report form a contactable consumer.  A 71-year-old female patient received PREVNAR 13 at single dose on 04Oct2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took tetanus toxoid shot received as a kid and she had just a swollen arm. She has had the Tetanus shot since then with no reaction. On 04Oct2016 she experienced nausea with outcome recovered. She is not having nausea at time of reporting  now but does not feel 100% or good. On an unspecified date the patient experienced pain in her right side and left shoulder with outcome unknown, but not in the center over her heart, she thought she was having heart attack. She also had gastritis-like symptoms with outcome unknown, felts bad, like she just got over the flu with outcome unknown. Consumer stated there was no prescribing physician for the shot. Her family physician told her she should get one. Her family physician does not know she is having a problem. No product complaint was filed.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: The initial case was missing the following minimum criteria: ICH-unspecified AE. Upon receipt of follow-up #1 information on 04Oct2016, this case now contains all required information to be considered valid.  This is a follow-up spontaneous report form a contactable consumer.  A 71-year-old female patient received PREVNAR 13 at single dose on 04Oct2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took tetanus toxoid shot received as a kid and she had just a swollen arm. She has had the Tetanus shot since then with no reaction. On 04Oct2016 she experienced nausea with outcome recovered. She is not having nausea at time of reporting  now but does not feel 100% or good. On an unspecified date the patient experienced pain in her right side and left shoulder with outcome unknown, but not in the center over her heart, she thought she was having heart attack. She also had gastritis-like symptoms with outcome unknown, felts bad, like she just got over the flu with outcome unknown. Consumer stated there was no prescribing physician for the shot. Her family physician told her she should get one. Her family physician does not know she is having a problem. No product complaint was filed.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injection site swelling, Injection site warmth, Local reaction, Myalgia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 78-year-old  male patient received PREVENAR 13 (Lot Number: N16515, Expiration Date: Oct2017), via an unspecified route of administration on 30Sep2016 at 0.5 ml single dose for immunization. Medical history included ongoing hypertension and ongoing hyperlipidaemia. The patient's concomitant medications included unspecified hypertension and hyperlipidemia medications. On 30Sep2016, the patient experienced systemic myalgia, body aches, and severe local reaction, described as pain and redness that started about an hour after the shot. On an unknown date in 2016, the patient also reported warmness at the site and an area that was swollen and getting bigger and spreading out. It was unknown how long after the shot the warmness and swollen area began getting bigger and spreading. On 04Oct2016, the patient was in the office to see a healthcare provider. The clinical outcome of the events, warmness at the site and an area that was swollen and getting bigger and spreading out, was unknown. The clinical outcome of events, systemic myalgia, body aches, and severe local reaction, described as pain and redness, was not recovered.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable nurse. A 78-year-old  male patient received PREVENAR 13 (Lot Number: N16515, Expiration Date: Oct2017), via an unspecified route of administration on 30Sep2016 at 0.5 ml single dose for immunization. Medical history included ongoing hypertension and ongoing hyperlipidaemia. The patient's concomitant medications included unspecified hypertension and hyperlipidemia medications. On 30Sep2016, the patient experienced systemic myalgia, body aches, and severe local reaction, described as pain and redness that started about an hour after the shot. On an unknown date in 2016, the patient also reported warmness at the site and an area that was swollen and getting bigger and spreading out. It was unknown how long after the shot the warmness and swollen area began getting bigger and spreading. On 04Oct2016, the patient was in the office to see a healthcare provider. The clinical outcome of the events, warmness at the site and an area that was swollen and getting bigger and spreading out, was unknown. The clinical outcome of events, systemic myalgia, body aches, and severe local reaction, described as pain and redness, was not recovered.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Death, Endotracheal intubation, Headache, Insomnia, Laboratory test
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient's daughter. A 73-year-old female patient received PREVNAR 13, via an unspecified route of administration on 22Mar2016 at 0.5 ml single dose for immunization. Medical history included chronic obstructive pulmonary disease (COPD), diabetes, and heart attack. Concomitant medications were unknown; the patient was taking a lot of medications (medication list was not provided). The patient vaccination history was unknown. The reporter stated that she was reading her mother's chart and that her mother had died. While reading the chart she noted that her mother received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 22Mar2016 from her doctor because she was at high risk. The patient experienced pneumonia, headache, nausea, itching, could not sleep for 2-3 days, and threw up. The clinical course was as follows: The patient sent a letter to her doctor dated 14Apr2016 which she refers to previously reporting headache, nausea, itching, could not sleep for 2-3 days, and threw up after receiving the vaccine. It was reported that the patient required a trip to the emergency room for the events of itching, headache, nausea, and difficulty sleeping. The patient had requested medication for nausea from her doctor and reported that headache was better. The patient underwent lab tests and procedures which included laboratory test with unknown results on 02Apr2016. Patient had a consult with internal medicine doctor on 07Apr2016. Patient complained of sinus issues and was placed on AMOXICLAV 875 mg for seven days from Apr2016 to completion on 14Apr2016. The patient saw the doctor because she was so sick from everything. The patient started to take ZITHROMAX on an unspecified date (described as the Tuesday prior to calling the ambulance, she was taking a Z Pak). The ambulance was called on 30Apr2016 because patient slipped out of bed and they could not get her back into bed. On the following Monday, she was unresponsive. She was admitted to the hospital on 30Apr2016, had to be intubated, lung was tapped a couple of times. The patient had COPD and could not get off of the ventilator. She was transferred to a different hospital three weeks after admittance and never left that hospital. Therapeutic measures were taken as a result of headache, nausea and threw up. The patient died on 10Jun2016 because she got pneumonia on an unknown date. An autopsy was not performed. Reported Cause(s) of Death: pneumonia.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Mechanical ventilation, Nausea, Pneumonia, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient's daughter. A 73-year-old female patient received PREVNAR 13, via an unspecified route of administration on 22Mar2016 at 0.5 ml single dose for immunization. Medical history included chronic obstructive pulmonary disease (COPD), diabetes, and heart attack. Concomitant medications were unknown; the patient was taking a lot of medications (medication list was not provided). The patient vaccination history was unknown. The reporter stated that she was reading her mother's chart and that her mother had died. While reading the chart she noted that her mother received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 22Mar2016 from her doctor because she was at high risk. The patient experienced pneumonia, headache, nausea, itching, could not sleep for 2-3 days, and threw up. The clinical course was as follows: The patient sent a letter to her doctor dated 14Apr2016 which she refers to previously reporting headache, nausea, itching, could not sleep for 2-3 days, and threw up after receiving the vaccine. It was reported that the patient required a trip to the emergency room for the events of itching, headache, nausea, and difficulty sleeping. The patient had requested medication for nausea from her doctor and reported that headache was better. The patient underwent lab tests and procedures which included laboratory test with unknown results on 02Apr2016. Patient had a consult with internal medicine doctor on 07Apr2016. Patient complained of sinus issues and was placed on AMOXICLAV 875 mg for seven days from Apr2016 to completion on 14Apr2016. The patient saw the doctor because she was so sick from everything. The patient started to take ZITHROMAX on an unspecified date (described as the Tuesday prior to calling the ambulance, she was taking a Z Pak). The ambulance was called on 30Apr2016 because patient slipped out of bed and they could not get her back into bed. On the following Monday, she was unresponsive. She was admitted to the hospital on 30Apr2016, had to be intubated, lung was tapped a couple of times. The patient had COPD and could not get off of the ventilator. She was transferred to a different hospital three weeks after admittance and never left that hospital. Therapeutic measures were taken as a result of headache, nausea and threw up. The patient died on 10Jun2016 because she got pneumonia on an unknown date. An autopsy was not performed. Reported Cause(s) of Death: pneumonia.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Sinus disorder, Unresponsive to stimuli, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient's daughter. A 73-year-old female patient received PREVNAR 13, via an unspecified route of administration on 22Mar2016 at 0.5 ml single dose for immunization. Medical history included chronic obstructive pulmonary disease (COPD), diabetes, and heart attack. Concomitant medications were unknown; the patient was taking a lot of medications (medication list was not provided). The patient vaccination history was unknown. The reporter stated that she was reading her mother's chart and that her mother had died. While reading the chart she noted that her mother received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 22Mar2016 from her doctor because she was at high risk. The patient experienced pneumonia, headache, nausea, itching, could not sleep for 2-3 days, and threw up. The clinical course was as follows: The patient sent a letter to her doctor dated 14Apr2016 which she refers to previously reporting headache, nausea, itching, could not sleep for 2-3 days, and threw up after receiving the vaccine. It was reported that the patient required a trip to the emergency room for the events of itching, headache, nausea, and difficulty sleeping. The patient had requested medication for nausea from her doctor and reported that headache was better. The patient underwent lab tests and procedures which included laboratory test with unknown results on 02Apr2016. Patient had a consult with internal medicine doctor on 07Apr2016. Patient complained of sinus issues and was placed on AMOXICLAV 875 mg for seven days from Apr2016 to completion on 14Apr2016. The patient saw the doctor because she was so sick from everything. The patient started to take ZITHROMAX on an unspecified date (described as the Tuesday prior to calling the ambulance, she was taking a Z Pak). The ambulance was called on 30Apr2016 because patient slipped out of bed and they could not get her back into bed. On the following Monday, she was unresponsive. She was admitted to the hospital on 30Apr2016, had to be intubated, lung was tapped a couple of times. The patient had COPD and could not get off of the ventilator. She was transferred to a different hospital three weeks after admittance and never left that hospital. Therapeutic measures were taken as a result of headache, nausea and threw up. The patient died on 10Jun2016 because she got pneumonia on an unknown date. An autopsy was not performed. Reported Cause(s) of Death: pneumonia.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 63-year-old male patient started to receive PREVNAR 13 , subcutaneous from an unspecified date to an unspecified date at single dose for immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient was inadvertently given the PREVNAR 13 subcutaneously instead of intramuscularly and it burned on an unspecified date with outcome of unknown.  The action taken in response to the events for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Arthritis, Blood test normal, Hypokinesia, Joint stiffness
Clinical narrative: This is a spontaneous report from a contactable consumer.  A 69-year-old female patient, started to receive PREVNAR 13, via an unspecified route of administration in her gluteus medius right on unspecified date on 2016 at single dose for immunisation.  Medical history included joint dislocation occurred about four or five maybe six times max from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from 2004 and ongoing, meniscus injury for a torn meniscus occurred twenty years ago from an unknown date and unknown if ongoing and carpal tunnel syndrome in her right hand from an unknown date and unknown if ongoing. Occurred twenty five years ago, drug hypersensitivity from an unknown date and unknown if ongoing developed a severe rash, asthma from an unknown date and unknown if ongoing when she was around 13, passed out at school, does think she still has it, overweight (she does not think she is obese) from an unknown date and unknown if ongoing, encephalitis in her fifties from an unknown date and unknown if ongoing; went on for a month she looked like a freak, cardiac disorder from an unknown date and unknown if ongoing and loss of consciousness when she was around 13 from an unknown date and unknown if ongoing.  Concomitant medication included ranitidine and ASPIRIN.  The patient previously took flu shot, does not remember exact date she received the product; occurred several years back after she received the flu shot, she got deathly ill, was literally bedridden, had to go to urgent care.  The patient experienced could not move left arm at all on 2016 with outcome of recovering, felt shoulders and hips and knees being stiff or something like arthritis or something on 2016 with outcome of not recovered, lethargic on 2016 with outcome of recovering, arthritis on Sep2016 with outcome of not recovered, could not sleep because her arm was hurting so bad on 2016 with outcome of unknown, her arm was hurting so bad  on an unspecified date with outcome of unknown, things she cannot do now that she could do before on an unspecified date with outcome of unknown and the events reported got worsened on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included blood test: extremely low on vitamin D on 2016, blood test and urine analysis tests: everything was coming back all ok on 2016 and blood test: arthritis on Sep2016.  The action taken in response to the events for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable.  Therapeutic measures were taken as a result of could not move left arm at all (hypokinesia), felt shoulders and hips and knees being stiff or something like arthritis or something, lethargy, arthritis and her arm was hurting so bad.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Lethargy, Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Sleep disorder
Clinical narrative: This is a spontaneous report from a contactable consumer.  A 69-year-old female patient, started to receive PREVNAR 13, via an unspecified route of administration in her gluteus medius right on unspecified date on 2016 at single dose for immunisation.  Medical history included joint dislocation occurred about four or five maybe six times max from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from 2004 and ongoing, meniscus injury for a torn meniscus occurred twenty years ago from an unknown date and unknown if ongoing and carpal tunnel syndrome in her right hand from an unknown date and unknown if ongoing. Occurred twenty five years ago, drug hypersensitivity from an unknown date and unknown if ongoing developed a severe rash, asthma from an unknown date and unknown if ongoing when she was around 13, passed out at school, does think she still has it, overweight (she does not think she is obese) from an unknown date and unknown if ongoing, encephalitis in her fifties from an unknown date and unknown if ongoing; went on for a month she looked like a freak, cardiac disorder from an unknown date and unknown if ongoing and loss of consciousness when she was around 13 from an unknown date and unknown if ongoing.  Concomitant medication included ranitidine and ASPIRIN.  The patient previously took flu shot, does not remember exact date she received the product; occurred several years back after she received the flu shot, she got deathly ill, was literally bedridden, had to go to urgent care.  The patient experienced could not move left arm at all on 2016 with outcome of recovering, felt shoulders and hips and knees being stiff or something like arthritis or something on 2016 with outcome of not recovered, lethargic on 2016 with outcome of recovering, arthritis on Sep2016 with outcome of not recovered, could not sleep because her arm was hurting so bad on 2016 with outcome of unknown, her arm was hurting so bad  on an unspecified date with outcome of unknown, things she cannot do now that she could do before on an unspecified date with outcome of unknown and the events reported got worsened on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included blood test: extremely low on vitamin D on 2016, blood test and urine analysis tests: everything was coming back all ok on 2016 and blood test: arthritis on Sep2016.  The action taken in response to the events for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable.  Therapeutic measures were taken as a result of could not move left arm at all (hypokinesia), felt shoulders and hips and knees being stiff or something like arthritis or something, lethargy, arthritis and her arm was hurting so bad.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Urine analysis normal, Vitamin D decreased
Clinical narrative: This is a spontaneous report from a contactable consumer.  A 69-year-old female patient, started to receive PREVNAR 13, via an unspecified route of administration in her gluteus medius right on unspecified date on 2016 at single dose for immunisation.  Medical history included joint dislocation occurred about four or five maybe six times max from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from 2004 and ongoing, meniscus injury for a torn meniscus occurred twenty years ago from an unknown date and unknown if ongoing and carpal tunnel syndrome in her right hand from an unknown date and unknown if ongoing. Occurred twenty five years ago, drug hypersensitivity from an unknown date and unknown if ongoing developed a severe rash, asthma from an unknown date and unknown if ongoing when she was around 13, passed out at school, does think she still has it, overweight (she does not think she is obese) from an unknown date and unknown if ongoing, encephalitis in her fifties from an unknown date and unknown if ongoing; went on for a month she looked like a freak, cardiac disorder from an unknown date and unknown if ongoing and loss of consciousness when she was around 13 from an unknown date and unknown if ongoing.  Concomitant medication included ranitidine and ASPIRIN.  The patient previously took flu shot, does not remember exact date she received the product; occurred several years back after she received the flu shot, she got deathly ill, was literally bedridden, had to go to urgent care.  The patient experienced could not move left arm at all on 2016 with outcome of recovering, felt shoulders and hips and knees being stiff or something like arthritis or something on 2016 with outcome of not recovered, lethargic on 2016 with outcome of recovering, arthritis on Sep2016 with outcome of not recovered, could not sleep because her arm was hurting so bad on 2016 with outcome of unknown, her arm was hurting so bad  on an unspecified date with outcome of unknown, things she cannot do now that she could do before on an unspecified date with outcome of unknown and the events reported got worsened on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included blood test: extremely low on vitamin D on 2016, blood test and urine analysis tests: everything was coming back all ok on 2016 and blood test: arthritis on Sep2016.  The action taken in response to the events for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable.  Therapeutic measures were taken as a result of could not move left arm at all (hypokinesia), felt shoulders and hips and knees being stiff or something like arthritis or something, lethargy, arthritis and her arm was hurting so bad.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Local reaction
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced visual red local reaction after receiving TRUMENBA, one reaction was severe on an unspecified date with outcome of recovered.
Sex: M
Vaccine: FLU4
Symptoms: Chills, Feeling hot, Myalgia
Clinical narrative: Initial unsolicited report received from a nurse (nurse manager) on 27-Sep-2016. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number: UI643AE, expiry date: 30 Jun 2017, dose, dose in series, and site of administration were not reported) intramuscularly on 22-Sep-2016. Illness at the time of vaccination was reported as was no and pre-existing physician diagnosed allergies, birth defects, medical conditions was none. Concomitant medications were not reported. On 22-Sep-2016, same day (overnight) following the vaccination, the patient had developed chills, muscle aches, and he felt warm but did not check his temperature. The patient was hospitalized on an unknown date (days of hospitalized reported as 1). On 23-Sep-2016, the symptoms were improved. The patient required ER/doctor visit. The patient's laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the events. List of documents held by sender: none. Sender's Comments: Patient felt warm, chills and muscle ache following FLUZONE QIV vaccine. Time to onset is compatible, but additional history regarding patient medical history, allergic history, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be ruled out.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Intensive care, Swollen tongue, Urticaria
Clinical narrative: Initial unsolicited report received from a Nurse manager on 27 September 2016. This case involves a female patient (age not reported) who was vaccinated with a dose FLUZONE QIV (batch number: UI643AE, expiration date: 30 June 2017 and dose were not reported) intramuscularly in left deltoid on 22 September 2016. Patient had no Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 22 September 2016, within two hours and fifteen minutes following the vaccination, the patient developed a severe anaphylactic reaction and symptoms of difficulty breathing, widespread hives and tongue swelling. On 22 September 2016, patient was taken to the emergency room visit and was admitted to the ICU (intensive care unit). Lab data was not provided. Patient's corrective treatment was not reported. On an unknown date, patient recovered from the events. It was reported that patient was discharged (next day) on 23 September 2016. List of documents held by sender: none. Sender's Comments: As with other vaccines, anaphylactic reaction is listed following INFLUENZA QUADRIVAL A-B VACCINE. Reported symptoms and time to onset are consistent with the diagnosis of anaphylactic reaction. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), information regarding any drug or food intake during the period between vaccination and reaction and allergy testing to identify the culprit allergen are needed to further assess this case. Based on the available information, a role of the vaccine cannot be ruled out.
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Vomiting
Clinical narrative: Initial unsolicited report received from a nurse on 26 September 2016. This case involves a male patient (age not reported) who was vaccinated with a 0.5 ml dose of FLUZONE (batch number: UI658AA, expiry date, dose, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unpecified date, following the vaccination, patient experienced neck pain and vomited three times. Lab data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Hypertension
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 29 Sep 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Fluzone HD (Batch number: UI666AA, expiry date: 13 April 2017, dose, route and site was not reported) on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to neomycin. Concomitant medications were not provided. On an unspecified date, post vaccination; the patient developed very high blood pressure and had a stroke. Lab data and corrective treatment was not reported. The outcome of the events was reported as unknown. Upon internal review the company decided to consider the event serious because of important medical event stroke. List of documents held by sender: none. Sender's Comments: Patient had stroke and high blood pressure following Fluzone HD vaccine. This is poorly documented case as time to onset is unknown and additionally information regarding patient medical history, any medication history considering the patient age as she may be hypertensive, past vaccination history and its tolerance are needed to further assess the case.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a non-health care professional on 29 Sep 2016. This case was linked with case 2016SA181116 (same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone QIV (Batch number, expiration date, dose, dose in series and site of administration were not reported) intramuscularly on 16 Sep 2016. Patient's medical history as Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not provided. Illness at the time of vaccination was also not provided. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified timeframe following the vaccination, the patient developed redness, swelling and tenderness at the injection site. It was reported that the symptoms progressed over three days to encompass her whole upper arm. Laboratory investigations and corrective treatment were not reported. The patient recovered from all the events on an unknown date (reported as symptoms resolved). List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Induration, Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: Initial unsolicited report received from a non-health care professional on 29 Sep 2016. This case was linked with case 2016SA181109 (same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone QIV (Batch number, expiration date, dose and dose in series were not reported) intramuscularly in right deltoid on 16 Sep 2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at the time of vaccination was also not provided. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, following the vaccination, the patient developed redness, swelling and tenderness, firmness, and the skin darkened at the injection site of the right deltoid. It was reported that this was a person of color. It was also reported that symptoms progressed to the shoulder, neck and left arm also lips had become swollen. patient required emergency room or doctor visit. Laboratory investigations were not provided. It was reported that patient had been on steriod for 24 hours. The patient was not recovered from events (it was reported that it was unknown at this time if there had been any improvement). List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Lip swelling, Local swelling, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a non-health care professional on 29 Sep 2016. This case was linked with case 2016SA181109 (same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone QIV (Batch number, expiration date, dose and dose in series were not reported) intramuscularly in right deltoid on 16 Sep 2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at the time of vaccination was also not provided. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, following the vaccination, the patient developed redness, swelling and tenderness, firmness, and the skin darkened at the injection site of the right deltoid. It was reported that this was a person of color. It was also reported that symptoms progressed to the shoulder, neck and left arm also lips had become swollen. patient required emergency room or doctor visit. Laboratory investigations were not provided. It was reported that patient had been on steriod for 24 hours. The patient was not recovered from events (it was reported that it was unknown at this time if there had been any improvement). List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Skin discolouration, Swelling, Tenderness
Clinical narrative: Initial unsolicited report received from a non-health care professional on 29 Sep 2016. This case was linked with case 2016SA181109 (same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone QIV (Batch number, expiration date, dose and dose in series were not reported) intramuscularly in right deltoid on 16 Sep 2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at the time of vaccination was also not provided. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, following the vaccination, the patient developed redness, swelling and tenderness, firmness, and the skin darkened at the injection site of the right deltoid. It was reported that this was a person of color. It was also reported that symptoms progressed to the shoulder, neck and left arm also lips had become swollen. patient required emergency room or doctor visit. Laboratory investigations were not provided. It was reported that patient had been on steriod for 24 hours. The patient was not recovered from events (it was reported that it was unknown at this time if there had been any improvement). List of documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin dystrophy
Clinical narrative: Initial unsolicited report received from a consumer on 30 Sep 2016. This case involves a 77-year-old female patient who was vaccinated with a dose of Fluzone HD (Batch number: UI654AD, expiration date: 07 Apr 2017, dose, dose in series and site of administration were not reported) intramuscularly on 29 Sep 2016. Patient's medical history as Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Patient denied any illness at the time of vaccination. Concomitant medications were not reported. Patient deined any other vaccinations within four weeks of vaccinations. On 30 Sep 2016, one day following the vaccination, the patient developed red, warm to touch, slightly swollen, with 0.5 inch indention on injection site. It was reported that any other symptoms was denied. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as unknown. List of documents held by sender: none.