chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Flank pain, Neck pain, Pain
Clinical narrative: This health authority case was initially received on 23-NOV-2015. The cased report was received from a Health Professional and concerns a 29 year old female patient. The patient has a medical history of skin reaction to thiomersal. Thimerosal (indication-reaction: Allergy). The patient had no current illness at the time of vaccination. The patient received AFLURIA on 06-OCT-2015 (unknown stop date, batch no: reported as "2015-2016, .5 ml, route administration: Intramuscular, Dose: 0.5 ml).  The patient was given Advil which didn't really help.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Electrocardiogram normal, Urticaria
Clinical narrative: This case report was received from a Health Professional and concerns a 51 year old female patient. Linked Case Id(s): US-BEH-2016060279 (same patient). Concomitant medications also included saxagliptin. The patient had no medical history or illness at the time of vaccination. The patient received AFLURIA on 28-SEP-2015 (unknown stop date, batch no: U54405, route of administration: Intramuscular, Dose: 0.5 ml site: left arm (LA). No additional drugs suspected. On 02-OCT-2015, 5 days after starting/treatment with AFLURIA the patient experienced hives (non serious, outcome: Not Recovered/Not Resolved. Patient reported to urgent care on 05-OCT-2015, given 98 mg dexamethasone via buttocks; symptoms relief lasted 12 hours. Symptoms returned 03-OCT-2015 acutely. On 08-OCT-2015, 1 week 4 days after starting/treatment with AFLURIA the patient experienced Chest pain (non serious, outcome: Not Recovered/ Not Resolved). Administered EKG, prednisone cetirizine, ranitidine by ER physician. No heart issues on EKG.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Acupuncture, Injection site pain, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: This medically confirmed report was initially received on 13-NOV-2015. The case report was received from a Health Professional concerning a 62 year old female patient. The patient received the flu shot last ear with no problem, but had not received the flu shot before that. The patient received AFLURIA on 14-SEP-2015 (batch no not provided, route of administration: Intramuscular; Dose: 0.5 ml, Site: left arm). No additional drugs suspected. On 14-SEP-2015, 1 day after starting/treatment with AFLURIA the patient experienced flu shot hurt (non serious, outcome: Not Recovered/Not Resolved). On 15-SEP-2015, 2 days after starting/treatment with AFLURIA the patient experienced broken sleep (non serious, Outcome: Not Recovered/Not Resolved. Stiffness upon waking up in morning (non serious, outcome: Not Recovered/Not Resolved. On an unknown date, after starting/treatment with AFLURIA the patient experienced Arm is still sore/Pin in upper left arm where I was vaccinated/Pain was steady and would sometimes travel down arm/pain when I lift Arm over my head or in back/Very bad pain upon waking up (non serious, outcome: Not Recovered/Not Resolved). The patient went to the clinic and was on prednisone for 10 days. She also received acupuncture in that arm since the flu shot. The patient went to her doctor but felt the doctor "below it off". The soreness was not the same as arthritis and it was better now (at the time of reporting). The patient did exercises and was a caregiver. She called her insurance and spoke to the nurse. The patient was prescribed a topical cream. Event treatment: Prednisone, topical cream, acupuncture. The health authority assessed the events as non-serious. The patient believed the events were due to the vaccine.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: This medically confirmed report was initially received on 13-NOV-2015. The case report was received from a Health Professional concerning a 62 year old female patient. The patient received the flu shot last ear with no problem, but had not received the flu shot before that. The patient received AFLURIA on 14-SEP-2015 (batch no not provided, route of administration: Intramuscular; Dose: 0.5 ml, Site: left arm). No additional drugs suspected. On 14-SEP-2015, 1 day after starting/treatment with AFLURIA the patient experienced flu shot hurt (non serious, outcome: Not Recovered/Not Resolved). On 15-SEP-2015, 2 days after starting/treatment with AFLURIA the patient experienced broken sleep (non serious, Outcome: Not Recovered/Not Resolved. Stiffness upon waking up in morning (non serious, outcome: Not Recovered/Not Resolved. On an unknown date, after starting/treatment with AFLURIA the patient experienced Arm is still sore/Pin in upper left arm where I was vaccinated/Pain was steady and would sometimes travel down arm/pain when I lift Arm over my head or in back/Very bad pain upon waking up (non serious, outcome: Not Recovered/Not Resolved). The patient went to the clinic and was on prednisone for 10 days. She also received acupuncture in that arm since the flu shot. The patient went to her doctor but felt the doctor "below it off". The soreness was not the same as arthritis and it was better now (at the time of reporting). The patient did exercises and was a caregiver. She called her insurance and spoke to the nurse. The patient was prescribed a topical cream. Event treatment: Prednisone, topical cream, acupuncture. The health authority assessed the events as non-serious. The patient believed the events were due to the vaccine.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 22 year old female patient. The patient received AFLURIA on 28-Sep-2015 - unknown stop date, Batch no: U54806, Route of administration: unknown, Dose: 0.5 ml. No additional drugs suspected. On 29-Sep-2015, 2 days after starting / treatment with AFLURIA the patient experienced Swollen / Bumped up / Swelling (non serious, outcome: Not Recovered / Not resolved), Got very red / Erythema (non serious, outcome: Not Recovered / Not Resolved), Had a fever in arm / Skin warm (non serious, outcome: Not Recovered / Not Resolved ), Sore / Pain (non serious, outcome: Not Recovered / Not Resolved), Got very itchy / Pruritus (non serious, outcome: Not Recovered / Not Resolved). Reporter's assessment: Non-serious. Reporter's assessment: Non-serious. Company's evaluation and comment: Seriousness criterion/criteria: Non-serious. Listedness: According to the Reference Safety Information, the event Got very itchy / Pruritus is a listed event of AFLURIA, the events Swollen / Bumped up / Swelling, Got very red / Erythema, Had a fever in arm / Skin warm and Sore / Pain are unlisted events of AFLURIA. Case Causality: Possible. VAERS ID: 602263.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Eye pain, Headache, Hyperhidrosis
Clinical narrative: This spontaneous case was initially received on 29-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) 41 years old female patient. Weight: 237 pounds Height: 67 inches. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received  AFLURIA on 26-OCT-2015 (unknown stop date, batch no: U55806, route of administration: Intramuscular, Dose: no information provided). No additional drugs suspected. On 26-OCT-2015, after starting/treatment with AFLURIA the patient experienced tightness of the chest/Chest tightness (non serious, outcome: Recovered/Resolved), Sweating (non serious, outcome: Recovered/Resolved), Orbital pain around her eyes/Orbital eye pain (non serious, outcome: Recovered/Resolved), Chills (non serious, outcome: Recovered/Resolved). Additional information received on 16-DEC-2015: The patient had medical history of allergies to penicillin, Ceclor, Biaxin and sulfa drugs. On 26-Oct-2015, the patient received AFLURIA injection in the left arm. On the night of receiving the vaccine, the patient experienced tightness in her chest which was relieved after taking a couple of puffs of albuterol inhalers. During the course of the night symptoms included 'freezing', shaking, painful eye sockets, headache, major sweat and painful skin all over. She felt better by noon of hte next day. Reporter's comments: non serious.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pain of skin
Clinical narrative: This spontaneous case was initially received on 29-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) 41 years old female patient. Weight: 237 pounds Height: 67 inches. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received  AFLURIA on 26-OCT-2015 (unknown stop date, batch no: U55806, route of administration: Intramuscular, Dose: no information provided). No additional drugs suspected. On 26-OCT-2015, after starting/treatment with AFLURIA the patient experienced tightness of the chest/Chest tightness (non serious, outcome: Recovered/Resolved), Sweating (non serious, outcome: Recovered/Resolved), Orbital pain around her eyes/Orbital eye pain (non serious, outcome: Recovered/Resolved), Chills (non serious, outcome: Recovered/Resolved). Additional information received on 16-DEC-2015: The patient had medical history of allergies to penicillin, Ceclor, Biaxin and sulfa drugs. On 26-Oct-2015, the patient received AFLURIA injection in the left arm. On the night of receiving the vaccine, the patient experienced tightness in her chest which was relieved after taking a couple of puffs of albuterol inhalers. During the course of the night symptoms included 'freezing', shaking, painful eye sockets, headache, major sweat and painful skin all over. She felt better by noon of hte next day. Reporter's comments: non serious.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 68 year old male patient. On 18-SEP-2014, the patient received AFLURIA injection (batch number T506C7) in the left arm (site unknown). On 19-SEP-2014, the patient experienced swelling of left upper arm immediately post vaccination. The outcome was reported as recovered. The health authority assessed the events as non-serious.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: This spontaneous consumer report (initial receipt 29-OCT-2015) concerns a 12 year old male patient who received the flu shot every year since he was born (manufacturer unknown). On 28-OCT-2015, the patient received an intramuscular injection of AFLURIA (batch number: U55406, dose: 0.5 ml). to the right arm. On the same day, the patient also received two other unspecified vaccinations to the left arm.  On 29-OCT-2015 at 5 AM, the patient woke up and noticed itching and a localized reaction at the injection site (several inches in diameter) which included swollen, red and slight pain. The patient's left arm was fine. The patient did not experience a fever. The outcome was not yet recovered. The patient's mother requested pyrogen testing on batch U55406. Quality investigation of batch U55406: Pyrogen testing was not included on the specification  for AFLURIA finished products and was not performed during the manufacturing process. No changes to the method of manufacture of NPH occurred during or prior to the production of the NPH lots used for batch U55406, and all operators involved in the processing of these lots were trained and qualified in aseptic processing. Sterility testing on the bulk was also performed and was satisfactory. A review of all inspection records was performed for batch U55406 and there were no issued noted during the inspection process. NO deviations occurred during the inspection process. The packaging operations for batch U55406 were reviewed and it was confirmed that the batch was packaged according to all relevant procedures. The investigation concluded that there was no risk to the product existing on the market, and that AFLURIA batch U55406 was considered satisfactory for continued use. No root case was able to be identified for the case of localized reaction at the injection site that was reported.   Follow-up received 16-DEC-2015: The patient had no medical history and was not on any concomitant medications at the time of vaccination. On 28-OCT-2015 following vaccination with AFLURIA, the patient experienced a local reaction. The outcome was reported as unknown.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest X-ray normal, Chest discomfort, Chest pain
Clinical narrative: This unsolicited case was received on 24-May-2016 via a third party query tool search on the VAERS database, under reference number 621922. This case involves a 21-years old male patient who received the following vaccinations on 22-Jan-2016: A dose of ACAM2000, (lot number-VV04003A, manufacturer: Sanofi Pasteur Biologics Co) site was reported as unknown via unknown route and received a dose of Biothrax, (lot number-FAV439A, manufacturer: Emergent) in the unknown site via intramuscular route. Information regarding prior vaccination and concomitant medications were not reported. Current Illnesses was reported as none. The patient was ready to be deployed. On 31-Jan-2016, nine days post vaccination; patient had experienced chest pain. On 01 February 2016, ten days post vaccination; patient had experienced heaviness like someone is sitting on his chest, increased pain in the morning-constant, feverish, shortness of breath (SOB) and pain on inspiration, frontal headache (HA), neck stiffness, the small pox injection site healed without swelling, erythema, or drainage. The patient denied cough. There was an impression of myopericarditis. No evidence of heart failure. On an unspecified date, the patient was hospitalized. The patient required emergency visit. Laboratory investigations included Chest X-ray - negative (normal), electrocardiogram: normal sinus rhythm with ST segment depression, mildly elevated Troponin- 0.077, blood creatine phosphokinase increased- 250 and blood creatine phosphokinase MB increased- 0.74. The outcome of the events was reported as unknown. List of documents held by sender: none. Sender's Comments: This case concerns a 21-year-old female patient who developed musculoskeletal stiffness, myopericarditis and headache 10 days after receiving SMALLPOX (VACCINIA) LIVE VACCINE and Anthrax vaccines. Lab data revealed mildly elevated troponin level and NSR with ST depression in Electrocardiogram. However no details regarding patient's medical history, concomitant medications, condition at the time of vaccination, etc. have been provided without which a complete assessment cannot be made. Moreover, as the patient received 2 vaccines concomitantly it is difficult to assess the role of each vaccine in particular.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Dyspnoea, Electrocardiogram ST segment depression, Headache, Musculoskeletal stiffness, Myocarditis
Clinical narrative: This unsolicited case was received on 24-May-2016 via a third party query tool search on the VAERS database, under reference number 621922. This case involves a 21-years old male patient who received the following vaccinations on 22-Jan-2016: A dose of ACAM2000, (lot number-VV04003A, manufacturer: Sanofi Pasteur Biologics Co) site was reported as unknown via unknown route and received a dose of Biothrax, (lot number-FAV439A, manufacturer: Emergent) in the unknown site via intramuscular route. Information regarding prior vaccination and concomitant medications were not reported. Current Illnesses was reported as none. The patient was ready to be deployed. On 31-Jan-2016, nine days post vaccination; patient had experienced chest pain. On 01 February 2016, ten days post vaccination; patient had experienced heaviness like someone is sitting on his chest, increased pain in the morning-constant, feverish, shortness of breath (SOB) and pain on inspiration, frontal headache (HA), neck stiffness, the small pox injection site healed without swelling, erythema, or drainage. The patient denied cough. There was an impression of myopericarditis. No evidence of heart failure. On an unspecified date, the patient was hospitalized. The patient required emergency visit. Laboratory investigations included Chest X-ray - negative (normal), electrocardiogram: normal sinus rhythm with ST segment depression, mildly elevated Troponin- 0.077, blood creatine phosphokinase increased- 250 and blood creatine phosphokinase MB increased- 0.74. The outcome of the events was reported as unknown. List of documents held by sender: none. Sender's Comments: This case concerns a 21-year-old female patient who developed musculoskeletal stiffness, myopericarditis and headache 10 days after receiving SMALLPOX (VACCINIA) LIVE VACCINE and Anthrax vaccines. Lab data revealed mildly elevated troponin level and NSR with ST depression in Electrocardiogram. However no details regarding patient's medical history, concomitant medications, condition at the time of vaccination, etc. have been provided without which a complete assessment cannot be made. Moreover, as the patient received 2 vaccines concomitantly it is difficult to assess the role of each vaccine in particular.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Painful respiration, Pyrexia, Troponin increased
Clinical narrative: This unsolicited case was received on 24-May-2016 via a third party query tool search on the VAERS database, under reference number 621922. This case involves a 21-years old male patient who received the following vaccinations on 22-Jan-2016: A dose of ACAM2000, (lot number-VV04003A, manufacturer: Sanofi Pasteur Biologics Co) site was reported as unknown via unknown route and received a dose of Biothrax, (lot number-FAV439A, manufacturer: Emergent) in the unknown site via intramuscular route. Information regarding prior vaccination and concomitant medications were not reported. Current Illnesses was reported as none. The patient was ready to be deployed. On 31-Jan-2016, nine days post vaccination; patient had experienced chest pain. On 01 February 2016, ten days post vaccination; patient had experienced heaviness like someone is sitting on his chest, increased pain in the morning-constant, feverish, shortness of breath (SOB) and pain on inspiration, frontal headache (HA), neck stiffness, the small pox injection site healed without swelling, erythema, or drainage. The patient denied cough. There was an impression of myopericarditis. No evidence of heart failure. On an unspecified date, the patient was hospitalized. The patient required emergency visit. Laboratory investigations included Chest X-ray - negative (normal), electrocardiogram: normal sinus rhythm with ST segment depression, mildly elevated Troponin- 0.077, blood creatine phosphokinase increased- 250 and blood creatine phosphokinase MB increased- 0.74. The outcome of the events was reported as unknown. List of documents held by sender: none. Sender's Comments: This case concerns a 21-year-old female patient who developed musculoskeletal stiffness, myopericarditis and headache 10 days after receiving SMALLPOX (VACCINIA) LIVE VACCINE and Anthrax vaccines. Lab data revealed mildly elevated troponin level and NSR with ST depression in Electrocardiogram. However no details regarding patient's medical history, concomitant medications, condition at the time of vaccination, etc. have been provided without which a complete assessment cannot be made. Moreover, as the patient received 2 vaccines concomitantly it is difficult to assess the role of each vaccine in particular.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: This unsolicited case was received on 24-May-2016 via a third party query tool search on the VAERS database, under reference number 621922. This case involves a 21-years old male patient who received the following vaccinations on 22-Jan-2016: A dose of ACAM2000, (lot number-VV04003A, manufacturer: Sanofi Pasteur Biologics Co) site was reported as unknown via unknown route and received a dose of Biothrax, (lot number-FAV439A, manufacturer: Emergent) in the unknown site via intramuscular route. Information regarding prior vaccination and concomitant medications were not reported. Current Illnesses was reported as none. The patient was ready to be deployed. On 31-Jan-2016, nine days post vaccination; patient had experienced chest pain. On 01 February 2016, ten days post vaccination; patient had experienced heaviness like someone is sitting on his chest, increased pain in the morning-constant, feverish, shortness of breath (SOB) and pain on inspiration, frontal headache (HA), neck stiffness, the small pox injection site healed without swelling, erythema, or drainage. The patient denied cough. There was an impression of myopericarditis. No evidence of heart failure. On an unspecified date, the patient was hospitalized. The patient required emergency visit. Laboratory investigations included Chest X-ray - negative (normal), electrocardiogram: normal sinus rhythm with ST segment depression, mildly elevated Troponin- 0.077, blood creatine phosphokinase increased- 250 and blood creatine phosphokinase MB increased- 0.74. The outcome of the events was reported as unknown. List of documents held by sender: none. Sender's Comments: This case concerns a 21-year-old female patient who developed musculoskeletal stiffness, myopericarditis and headache 10 days after receiving SMALLPOX (VACCINIA) LIVE VACCINE and Anthrax vaccines. Lab data revealed mildly elevated troponin level and NSR with ST depression in Electrocardiogram. However no details regarding patient's medical history, concomitant medications, condition at the time of vaccination, etc. have been provided without which a complete assessment cannot be made. Moreover, as the patient received 2 vaccines concomitantly it is difficult to assess the role of each vaccine in particular.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram ST segment depression, Headache, Musculoskeletal stiffness, Myocarditis, Painful respiration
Clinical narrative: This unsolicited case was received on 24-May-2016 via a third party query tool search on the VAERS database, under reference number 621922. This case involves a 21-years old male patient who received the following vaccinations on 22-Jan-2016: A dose of ACAM2000, (lot number-VV04003A, manufacturer: Sanofi Pasteur Biologics Co) site was reported as unknown via unknown route and received a dose of Biothrax, (lot number-FAV439A, manufacturer: Emergent) in the unknown site via intramuscular route. Information regarding prior vaccination and concomitant medications were not reported. Current Illnesses was reported as none. The patient was ready to be deployed. On 31-Jan-2016, nine days post vaccination; patient had experienced chest pain. On 01 February 2016, ten days post vaccination; patient had experienced heaviness like someone is sitting on his chest, increased pain in the morning-constant, feverish, shortness of breath (SOB) and pain on inspiration, frontal headache (HA), neck stiffness, the small pox injection site healed without swelling, erythema, or drainage. The patient denied cough. There was an impression of myopericarditis. No evidence of heart failure. On an unspecified date, the patient was hospitalized. The patient required emergency visit. Laboratory investigations included Chest X-ray - negative (normal), electrocardiogram: normal sinus rhythm with ST segment depression, mildly elevated Troponin- 0.077, blood creatine phosphokinase increased- 250 and blood creatine phosphokinase MB increased- 0.74. The outcome of the events was reported as unknown. List of documents held by sender: none. Sender's Comments: This case concerns a 21-year-old female patient who developed musculoskeletal stiffness, myopericarditis and headache 10 days after receiving SMALLPOX (VACCINIA) LIVE VACCINE and Anthrax vaccines. Lab data revealed mildly elevated troponin level and NSR with ST depression in Electrocardiogram. However no details regarding patient's medical history, concomitant medications, condition at the time of vaccination, etc. have been provided without which a complete assessment cannot be made. Moreover, as the patient received 2 vaccines concomitantly it is difficult to assess the role of each vaccine in particular.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Pyrexia, Troponin increased
Clinical narrative: This unsolicited case was received on 24-May-2016 via a third party query tool search on the VAERS database, under reference number 621922. This case involves a 21-years old male patient who received the following vaccinations on 22-Jan-2016: A dose of ACAM2000, (lot number-VV04003A, manufacturer: Sanofi Pasteur Biologics Co) site was reported as unknown via unknown route and received a dose of Biothrax, (lot number-FAV439A, manufacturer: Emergent) in the unknown site via intramuscular route. Information regarding prior vaccination and concomitant medications were not reported. Current Illnesses was reported as none. The patient was ready to be deployed. On 31-Jan-2016, nine days post vaccination; patient had experienced chest pain. On 01 February 2016, ten days post vaccination; patient had experienced heaviness like someone is sitting on his chest, increased pain in the morning-constant, feverish, shortness of breath (SOB) and pain on inspiration, frontal headache (HA), neck stiffness, the small pox injection site healed without swelling, erythema, or drainage. The patient denied cough. There was an impression of myopericarditis. No evidence of heart failure. On an unspecified date, the patient was hospitalized. The patient required emergency visit. Laboratory investigations included Chest X-ray - negative (normal), electrocardiogram: normal sinus rhythm with ST segment depression, mildly elevated Troponin- 0.077, blood creatine phosphokinase increased- 250 and blood creatine phosphokinase MB increased- 0.74. The outcome of the events was reported as unknown. List of documents held by sender: none. Sender's Comments: This case concerns a 21-year-old female patient who developed musculoskeletal stiffness, myopericarditis and headache 10 days after receiving SMALLPOX (VACCINIA) LIVE VACCINE and Anthrax vaccines. Lab data revealed mildly elevated troponin level and NSR with ST depression in Electrocardiogram. However no details regarding patient's medical history, concomitant medications, condition at the time of vaccination, etc. have been provided without which a complete assessment cannot be made. Moreover, as the patient received 2 vaccines concomitantly it is difficult to assess the role of each vaccine in particular.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: There was rash, hives, redness, itching and pain from the top of my elbow to my shoulder of my left arm. The same area was also constantly hot to the touch. The itching spread throughout my body and because of the itching my doctor prescribed me triamcinolone acetonide cream USP. The pain made it very difficult for me to move my arm and do my daily activities of daily life. I was only able to move my arm about 30 degrees outward. No pressure could had applied onto my arm, such as sleeping on my side.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Activities of daily living impaired, Erythema, Mobility decreased, Pain in extremity, Pruritus generalised
Clinical narrative: There was rash, hives, redness, itching and pain from the top of my elbow to my shoulder of my left arm. The same area was also constantly hot to the touch. The itching spread throughout my body and because of the itching my doctor prescribed me triamcinolone acetonide cream USP. The pain made it very difficult for me to move my arm and do my daily activities of daily life. I was only able to move my arm about 30 degrees outward. No pressure could had applied onto my arm, such as sleeping on my side.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Rash, Skin warm, Tenderness, Urticaria
Clinical narrative: There was rash, hives, redness, itching and pain from the top of my elbow to my shoulder of my left arm. The same area was also constantly hot to the touch. The itching spread throughout my body and because of the itching my doctor prescribed me triamcinolone acetonide cream USP. The pain made it very difficult for me to move my arm and do my daily activities of daily life. I was only able to move my arm about 30 degrees outward. No pressure could had applied onto my arm, such as sleeping on my side.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chest pain, Pain
Clinical narrative: Information has been received from a consumer referring to her husband, a 58 year old male patient (retired mail carrier). The patient was in the last stages of renal failure (also reported as only the kidney issues), who was going to get a kidney transplant. One of the requirements from the hospital was to have hepatitis series, the tetanus and the pneumonia vaccine. It was part of the process to be put on front of the board to see if the patient was a good candidate for a kidney transplant. On 13-APR-2016 (also reported as on 14-APR-2016 or 14-MAY-2016), the patient was vaccinated with the first dose of unspecified hepatitis vaccine (manufacturer unknown) (lot#, route and dose were unknown). Concomitant therapies included PREVNAR 13 and tetanus vaccine on the same date. On 19-MAY-2016, roughly around 15:00 or 15:30, the patient went over to the doctor's office and was vaccinated with the second dose of all the three vaccines. The patient also took a lot of unspecified medications on blood pressure for a long time. On 20-MAY-2016 (also reported as on Saturday morning, 21-MAY-2016) at 4:30 in the morning and by 4:30 on Saturday morning, the patient experienced heaviness on his chest. The patient described it as a stabbing pain and it lasted for 5 minutes. The patient was sent to the emergency room. The patient was on heart monitor. Blood was draw and a whole series of blood work were performed. The patient was given the chest x-ray with the isotopes test for the blood clots. But they ruled out any kind of blood "clots' in the lungs and they also ruled out a heart attack and that was what they were concerned about. The patient was kept in the hospital overnight and was released on 22-MAY-2016 afternoon (reported as yesterday afternoon). The reported said that the patient did not have any of that "now" (recovered in May 2016). Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Blood test, Cardiac monitoring, Chest X-ray normal, Chest discomfort, Chest pain
Clinical narrative: Information has been received from a consumer referring to her husband, a 58 year old male patient (retired mail carrier). The patient was in the last stages of renal failure (also reported as only the kidney issues), who was going to get a kidney transplant. One of the requirements from the hospital was to have hepatitis series, the tetanus and the pneumonia vaccine. It was part of the process to be put on front of the board to see if the patient was a good candidate for a kidney transplant. On 13-APR-2016 (also reported as on 14-APR-2016 or 14-MAY-2016), the patient was vaccinated with the first dose of unspecified hepatitis vaccine (manufacturer unknown) (lot#, route and dose were unknown). Concomitant therapies included PREVNAR 13 and tetanus vaccine on the same date. On 19-MAY-2016, roughly around 15:00 or 15:30, the patient went over to the doctor's office and was vaccinated with the second dose of all the three vaccines. The patient also took a lot of unspecified medications on blood pressure for a long time. On 20-MAY-2016 (also reported as on Saturday morning, 21-MAY-2016) at 4:30 in the morning and by 4:30 on Saturday morning, the patient experienced heaviness on his chest. The patient described it as a stabbing pain and it lasted for 5 minutes. The patient was sent to the emergency room. The patient was on heart monitor. Blood was draw and a whole series of blood work were performed. The patient was given the chest x-ray with the isotopes test for the blood clots. But they ruled out any kind of blood "clots' in the lungs and they also ruled out a heart attack and that was what they were concerned about. The patient was kept in the hospital overnight and was released on 22-MAY-2016 afternoon (reported as yesterday afternoon). The reported said that the patient did not have any of that "now" (recovered in May 2016). Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Extra dose administered, Pain
Clinical narrative: Information has been received from a consumer referring to her husband, a 58 year old male patient (retired mail carrier). The patient was in the last stages of renal failure (also reported as only the kidney issues), who was going to get a kidney transplant. One of the requirements from the hospital was to have hepatitis series, the tetanus and the pneumonia vaccine. It was part of the process to be put on front of the board to see if the patient was a good candidate for a kidney transplant. On 13-APR-2016 (also reported as on 14-APR-2016 or 14-MAY-2016), the patient was vaccinated with the first dose of unspecified hepatitis vaccine (manufacturer unknown) (lot#, route and dose were unknown). Concomitant therapies included PREVNAR 13 and tetanus vaccine on the same date. On 19-MAY-2016, roughly around 15:00 or 15:30, the patient went over to the doctor's office and was vaccinated with the second dose of all the three vaccines. The patient also took a lot of unspecified medications on blood pressure for a long time. On 20-MAY-2016 (also reported as on Saturday morning, 21-MAY-2016) at 4:30 in the morning and by 4:30 on Saturday morning, the patient experienced heaviness on his chest. The patient described it as a stabbing pain and it lasted for 5 minutes. The patient was sent to the emergency room. The patient was on heart monitor. Blood was draw and a whole series of blood work were performed. The patient was given the chest x-ray with the isotopes test for the blood clots. But they ruled out any kind of blood "clots' in the lungs and they also ruled out a heart attack and that was what they were concerned about. The patient was kept in the hospital overnight and was released on 22-MAY-2016 afternoon (reported as yesterday afternoon). The reported said that the patient did not have any of that "now" (recovered in May 2016). Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Radioisotope scan normal, Wrong drug administered
Clinical narrative: Information has been received from a consumer referring to her husband, a 58 year old male patient (retired mail carrier). The patient was in the last stages of renal failure (also reported as only the kidney issues), who was going to get a kidney transplant. One of the requirements from the hospital was to have hepatitis series, the tetanus and the pneumonia vaccine. It was part of the process to be put on front of the board to see if the patient was a good candidate for a kidney transplant. On 13-APR-2016 (also reported as on 14-APR-2016 or 14-MAY-2016), the patient was vaccinated with the first dose of unspecified hepatitis vaccine (manufacturer unknown) (lot#, route and dose were unknown). Concomitant therapies included PREVNAR 13 and tetanus vaccine on the same date. On 19-MAY-2016, roughly around 15:00 or 15:30, the patient went over to the doctor's office and was vaccinated with the second dose of all the three vaccines. The patient also took a lot of unspecified medications on blood pressure for a long time. On 20-MAY-2016 (also reported as on Saturday morning, 21-MAY-2016) at 4:30 in the morning and by 4:30 on Saturday morning, the patient experienced heaviness on his chest. The patient described it as a stabbing pain and it lasted for 5 minutes. The patient was sent to the emergency room. The patient was on heart monitor. Blood was draw and a whole series of blood work were performed. The patient was given the chest x-ray with the isotopes test for the blood clots. But they ruled out any kind of blood "clots' in the lungs and they also ruled out a heart attack and that was what they were concerned about. The patient was kept in the hospital overnight and was released on 22-MAY-2016 afternoon (reported as yesterday afternoon). The reported said that the patient did not have any of that "now" (recovered in May 2016). Additional information has been requested.
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Anaphylactic reaction, Food allergy
Clinical narrative: Information has been received from a physician via Pfizer Inc. (manufacturer control # 2016275305) referring to a currently approximately 18 years old female patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were not provided. On an unknown date (reported as "years ago"), the patient was vaccinated with varicella vaccine (manufacturer unknown) (lot #, expiration date, strength, dose and route were not provided). Other suspect therapy included FLUMIST (lot#, dose and route were not reported) on an unknown date. On an unknown date the patient experienced anaphylaxis and had to be put in an ambulance and later recovered. Later on an unspecified date, the patient went to an allergist and was determined to be allergic to gelatin. The physician stated one of the vaccines, she could not remember if it was varicella vaccine (manufacturer unknown) or FLUMIST, contained gelatin. The causality of the event was not provided. Upon internal review, anaphylaxis was considered to be medically significant. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Partial seizures, Seizure
Clinical narrative: Afebrile Partial Seizure.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt administered flu vaccine on 10/20/15 with new symptoms of (L) shoulder pain/limited range of motion since.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Chest X-ray, Full blood count, Headache, Influenza virus test, Metabolic function test
Clinical narrative: Neck pain, head pain, and general body aches all day on 6/1/2016, then on 6/2/2016 he developed photophobia, and high fever, with continued head, neck pain and petechiae on right rib cage area.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Mononucleosis heterophile test, Neck pain, Pain, Petechiae, Photophobia
Clinical narrative: Neck pain, head pain, and general body aches all day on 6/1/2016, then on 6/2/2016 he developed photophobia, and high fever, with continued head, neck pain and petechiae on right rib cage area.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Neck pain, head pain, and general body aches all day on 6/1/2016, then on 6/2/2016 he developed photophobia, and high fever, with continued head, neck pain and petechiae on right rib cage area.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: Inconsolable, scream-crying so hard she couldn't nurse or be put down. I held her for over 4 hours straight of her screaming. Fever wasn't extremely high but we gave her ibuprofen.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, RVX
Symptoms: Fatigue, Irritability, Pyrexia, Vomiting
Clinical narrative: Low grade fever, vomiting, fussiness, and exhaustion. Did not give any medication for fever as it stayed under 100 degrees. Patient continued to vomit after every feeding as of this morning almost 2 days later.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Syncope
Clinical narrative: Fatigue, Syncope.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Rash macular, Urticaria
Clinical narrative: Large, blotchy red hives all over back, arms, and bottom; swollen, red, inflamed bump at injection site all lasting over 3 days.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Blood glucose, Computerised tomogram head, Mouth haemorrhage, Suture insertion, Urinary incontinence
Clinical narrative: Patient was standing in room after administration talking with MA and joking with MA. Patient not dizzy or light headed. MA left to get paperwork for patient. MA heard patient asking for help and found her in the hallway with bloody mouth and had become incontinent of urine. Patient had no recollection of what happen.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Rash, Swollen tongue, Throat tightness, Urticaria
Clinical narrative: When she received the MCV4 (Menactra) within 5 minutes she broke out in hives and rash. it covered her ears, face, legs, back and arms. She was immediately given Benadryl by her doctor and monitored. She then received another dose of Benadryl after about 15 minutes after receiving her first dose and it not working. After over an hour of observation we were sent home with steroid to add to her Benadryl. After returning home within a couple hours she complained of her throat tightening, tongue swelling and shortness of breath. Paramedics were called and the next morning her doctor advised us to take her to the emergency room, sent home with Epi Pen.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Fall, Injection site pruritus, Loss of consciousness, Pain, Rash macular
Clinical narrative: The immunization was administered at 2:00 PM. Around 5:00 PM, she was aching, had some blotchiness on her arms, and was itching at the injection site.  Overnight (around midnight, she didn't know the exact time) she woke up from the pain and achiness and went to take some aleve. She passed out and fell to the ground. An unknown period of time later, she woke up, took 2 220mg aleve tablets, then believes she passed out again as she woke up in a different position than she remembered.   She woke up the next morning with no aching, no rash, some blotchiness, and some bruising from falling.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pruritus
Clinical narrative: It started as itching and slightly painful and continued to get worse and worse day by day.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Chills, Dizziness, Injection site pain, Myalgia
Clinical narrative: Day after vaccine, patient reports nausea, chills, Joint Pain, Muscle Soreness, Dizziness.  The following morning patient reports feeling much better, just soreness at injection site.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea
Clinical narrative: Day after vaccine, patient reports nausea, chills, Joint Pain, Muscle Soreness, Dizziness.  The following morning patient reports feeling much better, just soreness at injection site.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Dehydration, Laboratory test, Pruritus, Pyrexia, Rash
Clinical narrative: Fever began four days following immunization. After about three days, fever subsided and a rash appeared on my arms. Very itchy. Became severely dehydrated and kidneys were assaulted. Only treatment IV fluids, adjusting medications, and closely monitoring labs. Over four weeks later still having symptoms but they are improving.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Renal disorder
Clinical narrative: Fever began four days following immunization. After about three days, fever subsided and a rash appeared on my arms. Very itchy. Became severely dehydrated and kidneys were assaulted. Only treatment IV fluids, adjusting medications, and closely monitoring labs. Over four weeks later still having symptoms but they are improving.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash macular
Clinical narrative: Red/blotchy patches across entire body (arms/legs/torso). Rash is neither raised, nor itchy. Patient hadn't treated in and did not present to pharmacy until 06/01/2016. Onset was significantly delayed (started approximately one month after administration of ZOSTAVAX). Patient/provider unable to determine the root cause of the reaction and patient presented back at pharmacy to inquire the possibility of it being from her immunization.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a 65 year old female patient reporting on herself. The patient's concurrent conditions, medical history were not reported. On 15-JAN-2015, the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiration date unknown). Concomitant therapies included PRED FORTE. On approximately 22-JAN-2015 ("a week later"), the patient had shingles on her eye. The patient received treatment for the event. No laboratory tests were performed. The outcome of ophthalmic herpes zoster was unknown. Causality was not provided by the reporter. Upon internal review, ophthalmic herpes zoster was determined to be medically significant. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Loss of consciousness, Malaise, Memory impairment, Nausea
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 15-year-male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and the patient's concomitant medications were not reported. (loss of consciousness), pallor, he did not remember what happened, nausea, fever of 102, headache, malaise. Fever gone in 24 hours but he was diagnosed with pre septal cellulitis. No fever third day. No headache third day. The outcome of the other adverse events was unknown.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Pallor, Periorbital cellulitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 15-year-male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and the patient's concomitant medications were not reported. (loss of consciousness), pallor, he did not remember what happened, nausea, fever of 102, headache, malaise. Fever gone in 24 hours but he was diagnosed with pre septal cellulitis. No fever third day. No headache third day. The outcome of the other adverse events was unknown.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Confusional state, Headache, Malaise
Clinical narrative: Joint pain, aching muscles, muscle weakness, confusion, generally feeling unwell, seizure, bad headaches, some rashes. Patient after getting a series of three HPV vaccinations, the last of the HPV shots was given on 8/15/13. Patient then started having joint pain, aching muscles, muscle weakness, generally not feeling well. Patient has had some unexplained rashes. In 8/15 he started having seizures, bad headache, confusion. Patient has not been able to finish his senior year of high school. Patient has been seen by three or four different Dr.'s this last nine months. Patient is now very discouraged.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Muscular weakness, Myalgia, Rash, Seizure
Clinical narrative: Joint pain, aching muscles, muscle weakness, confusion, generally feeling unwell, seizure, bad headaches, some rashes. Patient after getting a series of three HPV vaccinations, the last of the HPV shots was given on 8/15/13. Patient then started having joint pain, aching muscles, muscle weakness, generally not feeling well. Patient has had some unexplained rashes. In 8/15 he started having seizures, bad headache, confusion. Patient has not been able to finish his senior year of high school. Patient has been seen by three or four different Dr.'s this last nine months. Patient is now very discouraged.